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Provenge history refresher:

Published on: psa-rising.com
The Unreachable Unavailability of Provenge
*FDA’s mission statement: To promote and protect public health.
Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill.
Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness presently. Since such patients will likely die in a short period of time, treatment options, even if they are not entirely unproven, are often desired by such patients.
This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues.
The Food And Drug Administration (FDA), however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. Reform has to start somewhere at some time.
Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men. Furthermore, out of all cancer types more are dying from prostate cancer now than other cancer diagnoses.
For those unaware, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant.
Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA blood test, as PSA is a protein produced by prostate cancer cells. If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.
Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge.
Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill.
Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer.
Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as taxotere. The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only.
This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients.
While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials. The FDA announced this to the public in the early Spring of 2007, I believe.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself!
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea.
Novacea had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge.
As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment.
Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them.
At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway. Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown.
What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge.
So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others.
A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so. It is an individual decision in such cases that should be void of interference from others.
“Politics is the systematic organization of hatreds.” --- Henry Adams
Dan Abshear
Author’s note: What has been written is based upon information and belief
]]> Tue, 19 May 2009 23:16:56 -0400
Provenge history refresher:

Published on: psa-rising.com
The Unreachable Unavailability of Provenge
*FDA’s mission statement: To promote and protect public health.
Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill.
Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness presently. Since such patients will likely die in a short period of time, treatment options, even if they are not entirely unproven, are often desired by such patients.
This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues.
The Food And Drug Administration (FDA), however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. Reform has to start somewhere at some time.
Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men. Furthermore, out of all cancer types more are dying from prostate cancer now than other cancer diagnoses.
For those unaware, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant.
Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA blood test, as PSA is a protein produced by prostate cancer cells. If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.
Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge.
Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill.
Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer.
Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as taxotere. The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only.
This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients.
While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials. The FDA announced this to the public in the early Spring of 2007, I believe.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself!
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea.
Novacea had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge.
As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment.
Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them.
At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway. Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown.
What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge.
So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others.
A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so. It is an individual decision in such cases that should be void of interference from others.
“Politics is the systematic organization of hatreds.” --- Henry Adams
Dan Abshear
Author’s note: What has been written is based upon information and belief
]]> http://seekingalpha.com/article/35344-dendreon-s-provenge-is-it-over?source=feed#comment-501907 501907 psa-rising.com

The Unreachable Unavailability of Provenge

*FDA’s mission statement: To promote and protect public health.

Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill.

Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness presently. Since such patients will likely die in a short period of time, treatment options, even if they are not entirely unproven, are often desired by such patients.

This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues.

The Food And Drug Administration (FDA), however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually.

Reform has to start somewhere at some time.

Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men.

Furthermore, out of all cancer types more are dying from prostate cancer now than other cancer diagnoses.

For those unaware, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant.

Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA blood test, as PSA is a protein produced by prostate cancer cells.

If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.

Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge.

Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill.

Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer.

Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as taxotere.

The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only.

This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy.

The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.

Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients.

This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients.

While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials.

The FDA announced this to the public in the early Spring of 2007, I believe.

Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007.

This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner at the time was a prostate cancer survival himself!

Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea.

Novacea had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge.

As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea.

In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment.

Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.

Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them.

At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway.

Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.

The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown.

What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge.

So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others.

A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so.

It is an individual decision in such cases that should be void of interference from others.

“Politics is the systematic organization of hatreds.” --- Henry Adams
Dan Abshear

Author’s note: What has been written is based upon information and belief
]]> Wed, 13 May 2009 09:47:18 -0400 psa-rising.com

The Unreachable Unavailability of Provenge

*FDA’s mission statement: To promote and protect public health.

Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill.

Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness presently. Since such patients will likely die in a short period of time, treatment options, even if they are not entirely unproven, are often desired by such patients.

This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues.

The Food And Drug Administration (FDA), however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually.

Reform has to start somewhere at some time.

Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men.

Furthermore, out of all cancer types more are dying from prostate cancer now than other cancer diagnoses.

For those unaware, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant.

Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA blood test, as PSA is a protein produced by prostate cancer cells.

If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.

Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge.

Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill.

Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer.

Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as taxotere.

The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only.

This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy.

The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.

Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients.

This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients.

While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials.

The FDA announced this to the public in the early Spring of 2007, I believe.

Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007.

This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner at the time was a prostate cancer survival himself!

Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea.

Novacea had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge.

As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea.

In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment.

Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.

Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them.

At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway.

Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.

The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown.

What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge.

So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others.

A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so.

It is an individual decision in such cases that should be void of interference from others.

“Politics is the systematic organization of hatreds.” --- Henry Adams
Dan Abshear

Author’s note: What has been written is based upon information and belief
]]> http://seekingalpha.com/article/136942-merck-and-elsevier-cross-the-line-in-joint-medical-journal?source=feed#comment-500289 500289
The Atrophy Of Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies during my intimate experience with them , the frequent and intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others possibly tops the list.

By this atrophy of the scientific method absent of authenticity that has been known to occur, harm and damage is possibly done to the health of the public.

Most would agree that the science of research should be sound and as aseptic as possible- completely free of deliberate and reckless interference.

However, it appears, money and increased profits can be a catalyst for disregard for human health with the clinical trial process that is largely unregulated.

This is particularly a factor on post-marketing studies of various pharmaceutical companies, as some pharmaceutical corporations seem to be deliberately conducting nothing less than seeding trials- with about a 50 percent tax credit for these trial sponsors.

Trials that exist that are in fact pointless and void of scientific benefit.

Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of drugs and devices to benefit mankind.

Then, in 1980, the Bayh-Dole Act, Public Law 96-517,was created, which allowed for such places with their researchers to profit off of their discoveries that were performed for pharmaceutical companies and others in the past.

Furthermore, such academic institutions were coerced to license patented inventions to those pharmaceutical companies that will then commercialize these discoveries paid for in large part by the taxpayers who funded this research to a degree.

This resulted in the creation of for-profit research trial sites without any academic affiliation that are called Contract Research Organizations.

CROS utilize primarily community patient care clinics whose staff are absent of any research training compared with the former researchers that existed decades ago. They are regulated, so they say, by institutional review boards, or IRBs. Both are for profit and essentially cater to the sponsor of the clinical trial in which all are involved with manipulating.

Because of this structure, the clinical trial investigators of these pharmaceutical sponsored trials are likely novice compared with academic researchers.

This, of course, happens with intent by the sponsor who can and does control all aspects of the clinical trial protocol at the site locations of a clinical trial that the pharmaceutical company structures and even gives the trial the title they want for their marketing purposes.

These quite numerous CROS are in fact for- profit, with some CROs making billions of dollars a year, and this market continues to grow.

The trials conducted at such places again are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their particular drug chosen to be studied.

Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for this drug of theirs to be studied in this manner.

This coercion is done by various methods of deception in subtle and tacit methods.

As a result, research in this protocol of the sponsor ensures favorable results of the sponsor’s medication that is involved in the clinical trial they clearly own.

These activities are again believed to be absent of true or applied regulation to any degree, and therefore have the autonomy to create whatever they want to benefit the pharmaceutical sponsor.

There likely is a collusive relationship between the sites, the CRO, and the sponsor, as this whole system is planned beforehand by the pharmaceutical sponsor of their clinical trial to again be utilized to increase the market share of the drug studied that they promote.

Guest authorship has been known to be aggressively recruited by sponsors by paying a known opinion leader to sign off on the completed clinical trial.

Furthermore, the pharmaceutical sponsor recruits investigators to be used for this function of what ultimately is a fabricated clinical trial protocol.

The trial manuscript and protocol design is prepared by those employed by the drug company sponsor upon specific direction of this sponsor on how this should be prepared.

The medical program coordinator of a particular sponsored trial is an actual employee of the sponsoring drug company.

This person also may act as the publisher, manuscript version reviewer, and the clinical trial director who works with the drug company’s hired CRO editors whose objectives are to benefit the sponsor.

Typical and ultimate cost of the final manuscript of the trial to the sponsor created by the hired CRO and the recruited ghostwriters exceeds 1000 dollars per page, some have said.

Merck engages in this behavior, which shocked many, as they were always viewed as an ethical pharmaceutical company that always placed patients over profits.

Apparently, this is no longer the case. There are other well known and large pharmaceutical corporations that consider this plan of action standard operating procedures to ensure growth of their drugs.

Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known again as ghostwriters.

These people are usually not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers.

One does not need research training or certification in order to perform this function. Rarely do clinical trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the pharmaceutical sponsor.

Also, these hired mystery writers are known to make about 100 grand a year performing this deception full time.

This activity removes accountability and authenticity of the fabricated clinical trial even further.

The corruptive act is finally completed by the sponsor hiring again a known thought leader as an author to have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked or required by the hired author, others have said.

To have the trial published, the sponsor has been known to pay an obscure journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example.

Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry.

So benefits of pharmaceuticals that are studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks as a result of this process.

The purchased reprints of the fabricated clinical trial are then bought by the sponsor of the study from the medical journal they hired to publish this trial.

The reprints are eventually distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation that has happened with such a trial that benefits the drug they promote for their employer.

As a bonus, the sponsor may agree to pay the chosen medical journal to advertise their products to be placed in this journal as well.

Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, as stated previously.

If so, our health care treatment options with drugs that are claimed to have benefits that are absent have now become unreliable in large part due to such corruptive situations.

Not to mention the absence of objectivity that has been intentionally eliminated with trials produced in this way.

More now than ever, meds are removed from the market or are given black box warnings due to the damaging effects of drugs approved by the FDA. We as citizens need to dig deep and ask why this is happening.

Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method.

More importantly, research should be conducted in a way that the sponsor cannot in any way interfere in such ways described in this article, which would require independent clinical trial sites with no involvement from the maker of the drug studied in a clinical trial.

And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters.
Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course.

We can no longer be dependent on others for our optimal health.

Knowledge is power, and is also possibly a lifesaver.

“Ethics and Science need to shake hands.” ……. Richard Cabot

Dan Abshear

Author’s note: What has been written was based upon information and belief.

Published on: brainblogger.com


]]> Tue, 12 May 2009 10:05:33 -0400
The Atrophy Of Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies during my intimate experience with them , the frequent and intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others possibly tops the list.

By this atrophy of the scientific method absent of authenticity that has been known to occur, harm and damage is possibly done to the health of the public.

Most would agree that the science of research should be sound and as aseptic as possible- completely free of deliberate and reckless interference.

However, it appears, money and increased profits can be a catalyst for disregard for human health with the clinical trial process that is largely unregulated.

This is particularly a factor on post-marketing studies of various pharmaceutical companies, as some pharmaceutical corporations seem to be deliberately conducting nothing less than seeding trials- with about a 50 percent tax credit for these trial sponsors.

Trials that exist that are in fact pointless and void of scientific benefit.

Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of drugs and devices to benefit mankind.

Then, in 1980, the Bayh-Dole Act, Public Law 96-517,was created, which allowed for such places with their researchers to profit off of their discoveries that were performed for pharmaceutical companies and others in the past.

Furthermore, such academic institutions were coerced to license patented inventions to those pharmaceutical companies that will then commercialize these discoveries paid for in large part by the taxpayers who funded this research to a degree.

This resulted in the creation of for-profit research trial sites without any academic affiliation that are called Contract Research Organizations.

CROS utilize primarily community patient care clinics whose staff are absent of any research training compared with the former researchers that existed decades ago. They are regulated, so they say, by institutional review boards, or IRBs. Both are for profit and essentially cater to the sponsor of the clinical trial in which all are involved with manipulating.

Because of this structure, the clinical trial investigators of these pharmaceutical sponsored trials are likely novice compared with academic researchers.

This, of course, happens with intent by the sponsor who can and does control all aspects of the clinical trial protocol at the site locations of a clinical trial that the pharmaceutical company structures and even gives the trial the title they want for their marketing purposes.

These quite numerous CROS are in fact for- profit, with some CROs making billions of dollars a year, and this market continues to grow.

The trials conducted at such places again are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their particular drug chosen to be studied.

Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for this drug of theirs to be studied in this manner.

This coercion is done by various methods of deception in subtle and tacit methods.

As a result, research in this protocol of the sponsor ensures favorable results of the sponsor’s medication that is involved in the clinical trial they clearly own.

These activities are again believed to be absent of true or applied regulation to any degree, and therefore have the autonomy to create whatever they want to benefit the pharmaceutical sponsor.

There likely is a collusive relationship between the sites, the CRO, and the sponsor, as this whole system is planned beforehand by the pharmaceutical sponsor of their clinical trial to again be utilized to increase the market share of the drug studied that they promote.

Guest authorship has been known to be aggressively recruited by sponsors by paying a known opinion leader to sign off on the completed clinical trial.

Furthermore, the pharmaceutical sponsor recruits investigators to be used for this function of what ultimately is a fabricated clinical trial protocol.

The trial manuscript and protocol design is prepared by those employed by the drug company sponsor upon specific direction of this sponsor on how this should be prepared.

The medical program coordinator of a particular sponsored trial is an actual employee of the sponsoring drug company.

This person also may act as the publisher, manuscript version reviewer, and the clinical trial director who works with the drug company’s hired CRO editors whose objectives are to benefit the sponsor.

Typical and ultimate cost of the final manuscript of the trial to the sponsor created by the hired CRO and the recruited ghostwriters exceeds 1000 dollars per page, some have said.

Merck engages in this behavior, which shocked many, as they were always viewed as an ethical pharmaceutical company that always placed patients over profits.

Apparently, this is no longer the case. There are other well known and large pharmaceutical corporations that consider this plan of action standard operating procedures to ensure growth of their drugs.

Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known again as ghostwriters.

These people are usually not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers.

One does not need research training or certification in order to perform this function. Rarely do clinical trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the pharmaceutical sponsor.

Also, these hired mystery writers are known to make about 100 grand a year performing this deception full time.

This activity removes accountability and authenticity of the fabricated clinical trial even further.

The corruptive act is finally completed by the sponsor hiring again a known thought leader as an author to have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked or required by the hired author, others have said.

To have the trial published, the sponsor has been known to pay an obscure journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example.

Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry.

So benefits of pharmaceuticals that are studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks as a result of this process.

The purchased reprints of the fabricated clinical trial are then bought by the sponsor of the study from the medical journal they hired to publish this trial.

The reprints are eventually distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation that has happened with such a trial that benefits the drug they promote for their employer.

As a bonus, the sponsor may agree to pay the chosen medical journal to advertise their products to be placed in this journal as well.

Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, as stated previously.

If so, our health care treatment options with drugs that are claimed to have benefits that are absent have now become unreliable in large part due to such corruptive situations.

Not to mention the absence of objectivity that has been intentionally eliminated with trials produced in this way.

More now than ever, meds are removed from the market or are given black box warnings due to the damaging effects of drugs approved by the FDA. We as citizens need to dig deep and ask why this is happening.

Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method.

More importantly, research should be conducted in a way that the sponsor cannot in any way interfere in such ways described in this article, which would require independent clinical trial sites with no involvement from the maker of the drug studied in a clinical trial.

And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters.
Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course.

We can no longer be dependent on others for our optimal health.

Knowledge is power, and is also possibly a lifesaver.

“Ethics and Science need to shake hands.” ……. Richard Cabot

Dan Abshear

Author’s note: What has been written was based upon information and belief.

Published on: brainblogger.com


]]> http://seekingalpha.com/article/39167-pfizer-s-lyrica-gets-fda-approval-to-treat-fibromyalgia?source=feed#comment-448753 448753 This is why the syndrome of Fibromyalgia is so difficult to define objectively and treat for health care providers, who are usually primary care physicians. Rheumatologists have said that Fibromyalgia Syndrome is the second most common musculoskeletal diagnosis after osteoporosis.
Fibromyalgia is a very controversial syndrome. Some doubt it is as prevalent as others believe (3 to 6 percent of the population, some have determined). About 80 percent of the sufferers that are diagnosed with fibromyalgia are women. Furthermore, fibromyalgia is not a disease- it is a syndrome. A syndrome is what you call something that has multiple symptoms that occur together. A disease, however, is an actual dysfunction of one’s physiology in some manner.
Fibromyalgia syndrome is considered a muscle condition that involves varying intensities of chronic pain for a prolonged period of time. As a result of this pain which is rather brutal with many sufferers, their physical function becomes limited. In addition, the location of the pain associated with fibromyalgia is determined by the health care provider according to at least 11 of 18 defined tender points at various locations on the human body.
Regardless, fibromyalgia is misunderstood by the medical community overall. To further complicate the subject of fibromyalgia syndrome, some have suggested that the pharmaceutical companies that make the only two medications actually approved for the treatment of fibromyalgia, which are the drug giants Pfizer with their drug Lyrica, and Eli Lilly, the maker of Cymbalta, have conducted what is known as disease mongering.
Disease mongering is when others expand the diagnostic criteria for a particular medical issue though various ways of informing the public of the potential undetected cases of such an issue through advertising, primarily.
Also, another method of disease mongering is though the funding of various related associations and societies through educational grants to be the voice for those who conduct disease mongering with deliberate intent to increase the profit of their medications. There is evidence to support this claim- with more funds from these companies dedicated to advertising much more than grants.
Yet it is clear that fibromyalgia syndrome exists, as there are so many diagnosed with this medical issue that share the same symptoms, which include other symptoms besides pain alone. And it often takes a great deal of time for a patient that has fibromyalgia to receive the correct diagnosis due to the absence of any objective diagnostic testing to assess this syndrome. The fibromyalgia patient often goes through numerous other diagnostic testing, such as blood work and X-Rays, as their doctor orders such tests to rule out other diseases and disorders that may be present with the symptoms expressed with fibromyalgia syndrome.
Variables associated with those diagnosed with fibromyalgia syndrome include those patients with a history mental illness. They also tend to be overweight and live an inactive lifestyle, overall. Also, there seems to be an association with those diagnosed with fibromyalgia and these patients being in a state of low socioeconomic status.
Also in over 50 percent of those diagnosed with fibromyalgia, the patients are experiencing mental stress, emotional distress, as well as some sort of family conflicts as well. In fact, this stress amplifies the symptoms of fibromyalgia if these emotions are expressing themselves in the fibromyalgia patient. Insomnia is associated with fibromyalgia as well. It appears that mean age of onset of Fibromyalgia is around 40 years old, yet fibromyalgia syndrome can occur at any age.
Aside from systemic pain of varying degrees with the fibromyalgia patient, the patient experiences affective disorders typically. Since the symptoms of fibromyalgia also could indicate other disease states in 25 percent of the patients, usually X-Rays and blood work are examined to rule out other possible causes for the symptoms.
The Journal of the American Medical Association gave these symptoms the name of Fibromyalgia in the mid 1980s, as well as this association publically acknowledging that it is a disabling illness
There is evidence the cause is neurological. Upon examining the spinal fluid of a fibromyalgia patient, their serotonin levels are low, which is a neurotransmitter that has multiple emotional functions, as well as elevations of the neuro-chemical protein called substance P, which is the catalyst for pain. The patients also have elevated levels of what is called nerve growth factor (NGF). NGF is a protein molecule that, when elevated, is also associated with Alzeimer’s disease, and, believe it or not, one falling in love.
Furthermore, some fibromyalgia patents have had their brains scanned for abnormalities that may be present, and their brains in fact have shown varying degrees of structural dysfunction with their brains due to fibromyalgia.
So some suspect not only the cause may be some sort of central nervous system injury, but also there is evidence the syndrome is from some sort of viral infection, it has been reported.
Treatment of the fibromyalgia patient includes not only the drugs mentioned earlier, but also other medications for pain, anxiety, and insomnia in particular. Lifestyle changes are recommended for the fibromyalgia patient, as well as many other treatment methods in order to relieve their discomfort. Physical exercise is appropriately recommended for the fibromyalgia patient as well.
What is perhaps not recommended enough is cognitive or behavioral therapy for the fibromyalgia patient. There seems to be a strong association between fibromyalgia syndrome and psychogenic or psychophysiological causes for their symptoms.
Or, perhaps the fibromyalgia patient is suffering from some sort of guilt for some reason that is amplifies the unfortunate syndrome they are forced to tolerate.
Mea Culpa is Latin, meaning, ‘my fault’.
Pain is a Latin word as well. Its meaning: a fine or penalty.
Further research, however, is needed regarding this unfortunate syndrome experienced by so many others for no solid reason defined yet.
ww.fmaware.org
Dan Abshear
]]> Thu, 02 Apr 2009 00:04:04 -0400 This is why the syndrome of Fibromyalgia is so difficult to define objectively and treat for health care providers, who are usually primary care physicians. Rheumatologists have said that Fibromyalgia Syndrome is the second most common musculoskeletal diagnosis after osteoporosis.
Fibromyalgia is a very controversial syndrome. Some doubt it is as prevalent as others believe (3 to 6 percent of the population, some have determined). About 80 percent of the sufferers that are diagnosed with fibromyalgia are women. Furthermore, fibromyalgia is not a disease- it is a syndrome. A syndrome is what you call something that has multiple symptoms that occur together. A disease, however, is an actual dysfunction of one’s physiology in some manner.
Fibromyalgia syndrome is considered a muscle condition that involves varying intensities of chronic pain for a prolonged period of time. As a result of this pain which is rather brutal with many sufferers, their physical function becomes limited. In addition, the location of the pain associated with fibromyalgia is determined by the health care provider according to at least 11 of 18 defined tender points at various locations on the human body.
Regardless, fibromyalgia is misunderstood by the medical community overall. To further complicate the subject of fibromyalgia syndrome, some have suggested that the pharmaceutical companies that make the only two medications actually approved for the treatment of fibromyalgia, which are the drug giants Pfizer with their drug Lyrica, and Eli Lilly, the maker of Cymbalta, have conducted what is known as disease mongering.
Disease mongering is when others expand the diagnostic criteria for a particular medical issue though various ways of informing the public of the potential undetected cases of such an issue through advertising, primarily.
Also, another method of disease mongering is though the funding of various related associations and societies through educational grants to be the voice for those who conduct disease mongering with deliberate intent to increase the profit of their medications. There is evidence to support this claim- with more funds from these companies dedicated to advertising much more than grants.
Yet it is clear that fibromyalgia syndrome exists, as there are so many diagnosed with this medical issue that share the same symptoms, which include other symptoms besides pain alone. And it often takes a great deal of time for a patient that has fibromyalgia to receive the correct diagnosis due to the absence of any objective diagnostic testing to assess this syndrome. The fibromyalgia patient often goes through numerous other diagnostic testing, such as blood work and X-Rays, as their doctor orders such tests to rule out other diseases and disorders that may be present with the symptoms expressed with fibromyalgia syndrome.
Variables associated with those diagnosed with fibromyalgia syndrome include those patients with a history mental illness. They also tend to be overweight and live an inactive lifestyle, overall. Also, there seems to be an association with those diagnosed with fibromyalgia and these patients being in a state of low socioeconomic status.
Also in over 50 percent of those diagnosed with fibromyalgia, the patients are experiencing mental stress, emotional distress, as well as some sort of family conflicts as well. In fact, this stress amplifies the symptoms of fibromyalgia if these emotions are expressing themselves in the fibromyalgia patient. Insomnia is associated with fibromyalgia as well. It appears that mean age of onset of Fibromyalgia is around 40 years old, yet fibromyalgia syndrome can occur at any age.
Aside from systemic pain of varying degrees with the fibromyalgia patient, the patient experiences affective disorders typically. Since the symptoms of fibromyalgia also could indicate other disease states in 25 percent of the patients, usually X-Rays and blood work are examined to rule out other possible causes for the symptoms.
The Journal of the American Medical Association gave these symptoms the name of Fibromyalgia in the mid 1980s, as well as this association publically acknowledging that it is a disabling illness
There is evidence the cause is neurological. Upon examining the spinal fluid of a fibromyalgia patient, their serotonin levels are low, which is a neurotransmitter that has multiple emotional functions, as well as elevations of the neuro-chemical protein called substance P, which is the catalyst for pain. The patients also have elevated levels of what is called nerve growth factor (NGF). NGF is a protein molecule that, when elevated, is also associated with Alzeimer’s disease, and, believe it or not, one falling in love.
Furthermore, some fibromyalgia patents have had their brains scanned for abnormalities that may be present, and their brains in fact have shown varying degrees of structural dysfunction with their brains due to fibromyalgia.
So some suspect not only the cause may be some sort of central nervous system injury, but also there is evidence the syndrome is from some sort of viral infection, it has been reported.
Treatment of the fibromyalgia patient includes not only the drugs mentioned earlier, but also other medications for pain, anxiety, and insomnia in particular. Lifestyle changes are recommended for the fibromyalgia patient, as well as many other treatment methods in order to relieve their discomfort. Physical exercise is appropriately recommended for the fibromyalgia patient as well.
What is perhaps not recommended enough is cognitive or behavioral therapy for the fibromyalgia patient. There seems to be a strong association between fibromyalgia syndrome and psychogenic or psychophysiological causes for their symptoms.
Or, perhaps the fibromyalgia patient is suffering from some sort of guilt for some reason that is amplifies the unfortunate syndrome they are forced to tolerate.
Mea Culpa is Latin, meaning, ‘my fault’.
Pain is a Latin word as well. Its meaning: a fine or penalty.
Further research, however, is needed regarding this unfortunate syndrome experienced by so many others for no solid reason defined yet.
ww.fmaware.org
Dan Abshear
]]> http://seekingalpha.com/article/120778-expecting-post-stimulus-catalyst-for-stem-cell-research-companies?source=feed#comment-448752 448752
The apex of cellular therapy and regenerative/reparative medicine has been reborn after an 8 year moratorium that basically halted federal funding for stem cell research with most states in the U.S.

Now the NIH can award grants to scientists involved with biomedical research involving stem cell therapy through the CMS to each state in the U.S.

While never banned, stem cell research had limited funding during this time. And this was unfortunate, because there are several likely uses of stem cells.

These uses include the replacement of tissues in the human body, as well as repairing cell types that are defective. Also, stem cells can deliver genetic therapies that are needed in certain patients.

ESCs are totiplotent if obtained from the morula which is a pre-blastocyst stage. Normally, the stem cells are acquired from the blastocyst itself. From this source, the stem cells can be any cell in the human body except for the placenta, and are pluripotent.

Embryonic stem cells are obtained from a 4 day old embryo called a blastocyst, and are pluripotent from this source. The blastocyst contains about 100 cells, and is not suitable at this stage for implantation into the uterine wall.

The inner core of the blastocyst has about 20 cells, and this is where stem cells are obtained.

These cells are unspecialized cells that can be developed or morphed into the over 200 cells available in the human body through differentiation, as ESCs are undifferentiated by nature.

As such, they can become any human cell, as long as they are prevented from clumping or crowding together when explanted into cultures as they are propagated. After stem cells are cultured, they are moved to what are called stem lines.

Until recently, ESCs were believed to be most beneficial instead of the adult stem cell alternative (ASC), as these stem cells are limited to application to the tissue the stem cells were obtained from only. However ASCs (somatic stem cells) now can be coerced into differentiation through plasticity (trans-differentiation). This likely will reduce if not eliminate those opposed to stem cell therapy because of moral and ethical reasons related to the utilization of ESCs.

Thanks to molecular biology, four transcription factors control the transfer of genetic information from DNA to RNAS to regulate gene expression. So ASCs can have the same beneficial qualities as ESCs.

In the past, viral vectors and exotic genes interfered with the purity of ASCs. Now ASCs are re-programmed using plasmids instead of viruses and oncogenes that can become detrimental for the patient treated.

So now, ASCs can safely become induced pluripotent cells with the same potential as ESCs. As a result, the ASCs are free of genetic artifacts that potentially can interfere with transgene sequences.

They are capable of, and are able to renew and reproduce with minimal effort, stem cells, under the right laboratory conditions.

Human blood can be reproduced with stem cells under the right conditions, it has been shown by researchers.

SCT can also be used to investigate disease states for better treatment options.

Disease-specific stem cell lines, which are those cells that are pluripotent and are created with the same genetic errors of certain diseases, are studied for this reason.

So there clearly is a huge potential for stem cell-based therapies. The first FDA approved clinical trial occurred early in 2009. This human trial will involve evaluating primarily the safety of ESCs designed to be used as treatment for spinal cord injury patients. The trial was submitted by Geron Corp.

Pfizer, the largest drug company, has implemented stem cell research, as they are an asset to drug discovery by creating within the organization a regenerative medicine unit. Other large pharma companies are implemented similar research protocols for the same reasons.

Geron Corp. in California is the world’s leading esc developer, and financed researchers at Univ. of Wisconsin, who isolated the first human esc in 1998.

Stem cell therapy potentially can cure multiple sclerosis, among other disases and those with damaged human tissue. The therapy prevents the advancement of disease, as well as reverses the neurological dysfunctions associated with MS. Patients are injected with their own stem cells obtained from their bone marrow, which are called haemopoietic stem cells.

These particular stem cells are the origin of all blood cells. Further large clinical trials are needed to support these results. Studies have shown between 70 and 80 percent of MS patients who received stem cell therapy did not relapse afterwards.

Allogenic, or donor transplants, have a risk of graft versus host disease. Autologous, which is the patient’s own stem cells, are preferable and most beneficial. Similar results from this autologous bone marrow transplant cellular therapy are seen with Chron’s disease as well.

During the procedure, the immune system is reset so it is not in an autoimmune state where it attacks the human body. The process lasts about 2 months, and consists of 6phases:

1. Initial chemo
2. Release of stem cells
3. Acquisition of stem cells
4. Cells are then frozen until ready for transplant
5. Second chemo to reduce leukocytes
6. Autologous stem-cell transplant. Immune system is reset.

Positive results from stem cell therapy are seen usually within a month, and patients can request another treatment about 6 months after the first treatment presently. This stem cell paradigm of therapy addresses the etiology of a disease state, instead of focusing on the symptoms only. As such, this is the practice of regenerative medicine with the implementation of SCT.

Some believe ethical restraints are needed regarding the use of ESCs for therapeutic reasons. Yet they improve the quality of life of those with devastating diseases which involves suffering without any relief.

So stem cell therapy and research may be the most right and ethical thing to do for such patients. Not only is the tremedous suffering relieved with those possessed with devistating diseases, their functional ability is restored for those who receive stem cell therapy.

Embryos are acquired from fertility clinics (IVFs) that have thousands routinely stored and are abnormally fertilized. This means that they could never go on to become a human, and would be destroyed otherwise.

Ironically, one could argue it is inappropriate to discard what may be valuable and ethical for others, potentially.

Most couples with frozen embryos would gladly give them to such research, surveys have concluded.

These embryos are believed by many to not be morally equivalent to human life, but only have the potential for life. And they are used for therapeutic cloning, known as somatic cell nuclear transfer, and not reproductive cloning.

Ten states have banned this cloning out of ignorance, it seems. Bioethic principles, which are beneficience, or physician-centered decisions, as well as non-maleficence, which is first do no harm, are not corrupted.

Furthermore, autonomy, which is the patient’s right to determine their health, and justice or fairness remain intact.

Stem cells should be utilized for those terminally ill as well, many believe. Many are seeking stem cell therapy overseas due to retrictions that exist in the U.S. presently. The United Kingdom is believed to be the leader in stem cell research p

]]> Thu, 02 Apr 2009 00:02:23 -0400
The apex of cellular therapy and regenerative/reparative medicine has been reborn after an 8 year moratorium that basically halted federal funding for stem cell research with most states in the U.S.

Now the NIH can award grants to scientists involved with biomedical research involving stem cell therapy through the CMS to each state in the U.S.

While never banned, stem cell research had limited funding during this time. And this was unfortunate, because there are several likely uses of stem cells.

These uses include the replacement of tissues in the human body, as well as repairing cell types that are defective. Also, stem cells can deliver genetic therapies that are needed in certain patients.

ESCs are totiplotent if obtained from the morula which is a pre-blastocyst stage. Normally, the stem cells are acquired from the blastocyst itself. From this source, the stem cells can be any cell in the human body except for the placenta, and are pluripotent.

Embryonic stem cells are obtained from a 4 day old embryo called a blastocyst, and are pluripotent from this source. The blastocyst contains about 100 cells, and is not suitable at this stage for implantation into the uterine wall.

The inner core of the blastocyst has about 20 cells, and this is where stem cells are obtained.

These cells are unspecialized cells that can be developed or morphed into the over 200 cells available in the human body through differentiation, as ESCs are undifferentiated by nature.

As such, they can become any human cell, as long as they are prevented from clumping or crowding together when explanted into cultures as they are propagated. After stem cells are cultured, they are moved to what are called stem lines.

Until recently, ESCs were believed to be most beneficial instead of the adult stem cell alternative (ASC), as these stem cells are limited to application to the tissue the stem cells were obtained from only. However ASCs (somatic stem cells) now can be coerced into differentiation through plasticity (trans-differentiation). This likely will reduce if not eliminate those opposed to stem cell therapy because of moral and ethical reasons related to the utilization of ESCs.

Thanks to molecular biology, four transcription factors control the transfer of genetic information from DNA to RNAS to regulate gene expression. So ASCs can have the same beneficial qualities as ESCs.

In the past, viral vectors and exotic genes interfered with the purity of ASCs. Now ASCs are re-programmed using plasmids instead of viruses and oncogenes that can become detrimental for the patient treated.

So now, ASCs can safely become induced pluripotent cells with the same potential as ESCs. As a result, the ASCs are free of genetic artifacts that potentially can interfere with transgene sequences.

They are capable of, and are able to renew and reproduce with minimal effort, stem cells, under the right laboratory conditions.

Human blood can be reproduced with stem cells under the right conditions, it has been shown by researchers.

SCT can also be used to investigate disease states for better treatment options.

Disease-specific stem cell lines, which are those cells that are pluripotent and are created with the same genetic errors of certain diseases, are studied for this reason.

So there clearly is a huge potential for stem cell-based therapies. The first FDA approved clinical trial occurred early in 2009. This human trial will involve evaluating primarily the safety of ESCs designed to be used as treatment for spinal cord injury patients. The trial was submitted by Geron Corp.

Pfizer, the largest drug company, has implemented stem cell research, as they are an asset to drug discovery by creating within the organization a regenerative medicine unit. Other large pharma companies are implemented similar research protocols for the same reasons.

Geron Corp. in California is the world’s leading esc developer, and financed researchers at Univ. of Wisconsin, who isolated the first human esc in 1998.

Stem cell therapy potentially can cure multiple sclerosis, among other disases and those with damaged human tissue. The therapy prevents the advancement of disease, as well as reverses the neurological dysfunctions associated with MS. Patients are injected with their own stem cells obtained from their bone marrow, which are called haemopoietic stem cells.

These particular stem cells are the origin of all blood cells. Further large clinical trials are needed to support these results. Studies have shown between 70 and 80 percent of MS patients who received stem cell therapy did not relapse afterwards.

Allogenic, or donor transplants, have a risk of graft versus host disease. Autologous, which is the patient’s own stem cells, are preferable and most beneficial. Similar results from this autologous bone marrow transplant cellular therapy are seen with Chron’s disease as well.

During the procedure, the immune system is reset so it is not in an autoimmune state where it attacks the human body. The process lasts about 2 months, and consists of 6phases:

1. Initial chemo
2. Release of stem cells
3. Acquisition of stem cells
4. Cells are then frozen until ready for transplant
5. Second chemo to reduce leukocytes
6. Autologous stem-cell transplant. Immune system is reset.

Positive results from stem cell therapy are seen usually within a month, and patients can request another treatment about 6 months after the first treatment presently. This stem cell paradigm of therapy addresses the etiology of a disease state, instead of focusing on the symptoms only. As such, this is the practice of regenerative medicine with the implementation of SCT.

Some believe ethical restraints are needed regarding the use of ESCs for therapeutic reasons. Yet they improve the quality of life of those with devastating diseases which involves suffering without any relief.

So stem cell therapy and research may be the most right and ethical thing to do for such patients. Not only is the tremedous suffering relieved with those possessed with devistating diseases, their functional ability is restored for those who receive stem cell therapy.

Embryos are acquired from fertility clinics (IVFs) that have thousands routinely stored and are abnormally fertilized. This means that they could never go on to become a human, and would be destroyed otherwise.

Ironically, one could argue it is inappropriate to discard what may be valuable and ethical for others, potentially.

Most couples with frozen embryos would gladly give them to such research, surveys have concluded.

These embryos are believed by many to not be morally equivalent to human life, but only have the potential for life. And they are used for therapeutic cloning, known as somatic cell nuclear transfer, and not reproductive cloning.

Ten states have banned this cloning out of ignorance, it seems. Bioethic principles, which are beneficience, or physician-centered decisions, as well as non-maleficence, which is first do no harm, are not corrupted.

Furthermore, autonomy, which is the patient’s right to determine their health, and justice or fairness remain intact.

Stem cells should be utilized for those terminally ill as well, many believe. Many are seeking stem cell therapy overseas due to retrictions that exist in the U.S. presently. The United Kingdom is believed to be the leader in stem cell research p

]]> http://seekingalpha.com/article/115025-lilly-litigation-begs-the-question-should-whistleblower-employees-profit?source=feed#comment-357528 357528
Atypical Psychotics And Unsealed Documents


Not long ago, I got the joy and despair of viewing many documents that were initially not to be seen, by order of the Department of Justice, yet found their way on various locations on the internet- specifically, the website: furiousseasons.com. The documents are, or were, in fact, evidence against Eli Lilly entirely representing their decade of deception promoting and over-medicating others with their drug called Zyprexa, which is in a class of medications called atypical anti-psychotics. While a new a new molecular entity by definition, this new class called atypical antipsychotics in fact is chemically similar to the older and typical anti-psychotics that exist, such as Haldol. In many ways, the older antipsychotics are safer as well as being similar in efficacy compared with the atypicals such as Zyprexa. Perhaps this is why Eli Lilly did the things they did because they knew Zyprexa caused perhaps more harm than good for those who took the medication. Of the several available atypical anti-psychotics now available, Zyprexa and Clozaril, which was the first atypical anti-psychotic, are believed to have the most toxic adverse events to those who take these two in particular.

Launched in 1996, Eli Lilly did not appear to consider any adverse effects that may occur to those who take this drug, yet it is believed that there was reason to believe that there should be caution regarding its use. With the belief that the maker of Zyprexa is and will be exonerated from any responsibility related to Zyprexa, many surmise that Eli Lilly was pleased that others were taking Zyprexa , and was confident that they would be exonerated from any responsibility from the adverse effects of the drug.

At the time Zyprexa was granted approval for marketing, the medication was indicated only for schizophrenia and mania that exists in those with bipolar disorder. Schizophrenia has been defined as a disease that causes the sufferer to deviate from true reality, along with visual and auditory hallucinations. Bipolar disorder is another mental disorder where the victim alternates from states of heightened neurokinetics to periods of what can be brutal depression for the sufferer.

Eli Lilly, known in recent years for their focus on marketing over science or research, greatly desired and hoped that Zyprexa would be a welcome blockbuster, which is a medication that exceeds a billion dollars a year in sales as a minimum. Likely because of this state of greed of Eli Lilly, they did not consider or evaluate any possible damage this flagship drug may cause others. And Eli Lilly appeared to have the obedient and manipulated sales force presumed to be a necessity for this monetary goal to occur without interference.

Pharmaceutical representatives overall are attractive and young individuals with little if any medical knowledge or training, but are determined to have charming personalities along with a perception of obedience, and this is all Eli Lilly in particular wanted from the members of their sales force. The sales vocation is normally associated to contain members with a high affinity for money, so corruptive acts such as off label promotion or overt kickbacks is not typically a consideration of such people, overall, as history has shown. Therefore, if Eli Lilly’s sales representatives who happen to be instructed to sell Zyprexa for dementia or depression, the orders will likely be followed. Or if this sales force is instructed to pay specifically targeted doctors large amounts of money for doing little or no work for this money given to such doctors, it still is not a problem for the sales force to maintain their obedience to their corporate God.

A few years after Eli Lilly launched Zyprexa, they appeared anxious due to their obvious disappointment regarding the initial prediction that was speculated about the growth of this drug that was not meeting their expectations, so they had meetings throughout the nation, known as ‘plan of action’ meetings, and concluded afterwards that there is great benefit from a monetary paradigm of implementing ‘seeding trials’, as they are a mechanism for generating needed, although fabricated data void of any scientific gain of knowledge. This amazingly was done and implemented afterwards rather overtly. Even more unbelievable is that around this time, the Zyprexa sales force was instructed by Eli Lilly management to seek out clinical trial sites, along with investigators for these trials. One voiced stipulation was that the investigators had to either be Eli Lilly prescribing supporters or high volume prescribers. This protocol described was written internally, along with the etiology for performing these sham clinical trials. Anything in writing can be golden, from an illegal situation such as this.

In addition to the clinical trial plan of action, Eli Lilly instructed its sales force to utilize inaccurate promotional material that Eli Lilly gave its Zyprexa reps without exception, even though this material was false and misleading, which was the intent of Eli Lilly, according to others, along with this material being greatly unbalanced and suggested uses for Zyprexa that were not indicated if not unproven, which can and has been harmful to patients because of this. To further saturate and corrupt the Zyprexa sales force, they were coerced to blunt assertively what are at this time widely recognized adverse effects of this medication, such as massive weight gain, along with glucose and lipid abnormalities- all of which are dangerous to the user of this medication.

The corrosive promotion of Zyprexa by Eli Lilly continued as the dangerous company intentionally altered certain Zyprexa articles by rewriting them, followed by being reviewed internally after this art work. The purpose was to stimulate what Eli Lilly believed was clearly absent, which was much needed commercial interest related to Zyprexa.

Then it came time to essentially buy benign support groups in hopes that this would improve the growth of Zyprexa. One example is that Eli Lilly paid the American Diabetes Association for their assistance in obtaining endocrinologist consultants, which is a medical specialty that treats, among other things, diabetes. To reduce any possibility of an unexpected contingency doing this, they went ahead and hired a good sized team of diabetes educators. In 1999, Eli Lilly altered a Zyprexa report that originally illustrated the glucose problem with the medication, and did so with deliberate intent and reckless disregard for others. Eventually, the American Diabetes Association became quite the critic of Eli Lilly because of their harmful behavior regarding Zyprexa.

Amazing alliances between Eli Lilly and the Bush administration have existed as well. George H.W. Bush became an Eli Lilly director after leaving the CIA and lobbied to infect third world countries with Lilly medications. He also did his best to maximize tax breaks further for this industry that now employs both himself and his political affiliation. In fact, many members of this administration have some connection with Eli Lilly. It seems to be a revolving door issue once again. One could speculate that the Zyprexa campaign continued for so long because of the relationships the maker of the drug had and has with other powerful people.

The next psychotic tactic Eli Lilly created was an advisory board paid well by this company to focus on the progressing concerns of Zyprexa. This tactic did work briefly, but did not change the view of the drug by the medical community in any way, or the maker of this drug.

It is at this point that the medical community began to get vexed and irritated by Eli Lilly’s deceptive and overtly destructive tactics, which included the company’s own speakers that were utilized in the past. This event of Eli Lilly being ostracized was because of their disregard for those they are obligated to serve in the medical community. Perhaps most disturbing was the company’s intentional holding of crucial safety information related to Zyprexa even before the drug was even approved. For example, Eli Lilly’s Zyprexa representatives were instructed without doubt to neutralize the legitimate concerns doctors may have about Zyprexa, if not outright fear regarding this deadly drug they now perceived as being a clear reality. The representatives were in agreement of continuing to dodge or neutralize legitimate concerns about Zyprexa, with the promise of Eli Lilly’s management team to fill their wallets more if they maintain obedience regarding this directive that caused harm in the form of such physiological disorders as metabolic syndrome associated with Zyprexa, yet the sales force still denied the association due to the insistence of their employer. Essentially, the Zyprexa representatives with Eli Lilly were trained, perhaps aggressively, to disarm negative perceptions about Zyprexa, even though these perceptions continuously proved to be valid. This deeply troubled many Zyprexa representatives, as at this point they were aware of the dangers of the drug they were promoting in order to maintain employment.

Also, and of no great surprise, off label promotion with Zyprexa was a norm within the organization and certainly encouraged by Eli Lilly management. Encouraging doctors to prescribe Zyprexa for depression is one example. Amazingly, reflecting back on the behavioral flaws by Eli Lilly for quite some time, they did not alter their method of business even though there was a strong perception regarding this company being both aggressive and greedy, and likely criminal in the way they chose to conduct their business. And depression was not the only off label claim with Zyprexa. Eli Lilly considered such criminal acts as off label promotion as ‘redefining the market’. This is yet another example of their absurdity.

In the year 2000, Eli Lilly greatly expanded what was called their long term care sales force to expand Zyprexa intake in the elderly. This, as a reminder, is deadly- as Zyprexa is harmful to older citizens- specifically pneumonia and eventual premature death result from Zyprexa intake. At the same time, Eli Lilly developed a strategy to neutralize the obvious weight gain associated with Zyprexa with other patient populations. Does the whole corporation believe U.S. citizens are without thought or intelligence?
Yet in 2002, Eli Lilly was having financial disappointments, which again did not shock many. So to stay in form, they went on a mission to develop speakers to align with them and to not educate others, but to pacify other doctors in hopes that their problems with Zyprexa would disappear. After the speaker episode, Eli Lilly had the audacity to claim that Zyprexa was indeed the best in the class of atypical antipsychotics. Such a statement appears psychotic, to say the least. And now the market for atypicals is about 5 billion a year, so there seemed to be no end as to what Eli Lilly might try next. Also in this year our FDA called Eli Lilly ‘a sponsor’. I find that a bit disturbing. As disturbing as the covert meetings Eli Lilly had with the FDA as well. Well, if you are going to have a friend,that is the right one. Eli Lilly also bribed select reporters to speak or annotate favorably about Zyprexa, and they did.

As the new millennium progressed over a few years, lawsuits became a concern for Eli Lilly regarding Zyprexa. Doing what any responsible corporate entity would most certainly do, the upper management of Eli Lilly had the audacity to blame the media for the way they handled their patients. Around this time, Eli Lilly needed and did hire a public relations firm because of their image crisis. About the same time, Eli Lilly implemented a nationwide program entitled, “Operation: restore confidence”. I’m not sure how a fully rational and conscious group of Eli Lilly people could create something so ridiculous and unrealistic. Equally deviating from reality of Eli Lilly’s behavior is that they actually thought they could increase Zyprexa growth by hammering home astronomical efficacy with the drug which, of course, does not outweigh the damage of the drug to the patient who takes it.

Another failure illustrated above caused Eli Lilly to hire a group called Lifeplan Marketing, who convinced the organization to create a brand new market establishing Zyprexa as the standard of care. This is yet another psychotic act by this Midwest group of manipulators, who were at one time a well respected pharmaceutical corporation. Humans do not forget- especially pain.

At least one human wanted to let everyone know he did not, nor will he ever forget his experience as a Zyprexa representative with Eli Lilly. His name is Shahram Ahari and he aligned with a non-profit advocacy group called Pharmedout, which was created due to a state settlement from another pharmaceutical company. He spends his days now making others aware of things such as what you have read. I’ve spoken with Shahram, and I admire his assistance with others trying to correct this medical mess.

Eli Lilly appears pathologically persistent in frightening ways. Next was a national implementation plan of action which focused on training the Zyprexa sales force to use what was called a J.C.P. study to emphasize the numerous off label benefits of Zyprexa. At the same time, Eli Lilly determined that primary care doctors should be their number one Zyprexa targets. With this new focus, the sales force for Zyprexa were somehow convinced to tell doctors that fatigue is really the only side effect that presents itself with Zyprexa use. Again, citizens are overall not catatonic about such actions.

While on this off label role with Zyprexa, they resurrected their long term care efforts by taking on Aricept, and Alzheimer’s drug, and encouraged others to switch to Zyprexa. The reaction for this misbehavior was Zyprexa being removed from Medicaid in 2004.
Allan Reier was the Zyprexa product team leader at the time. He may have developed the unbelievable strategy of visiting psychiatrists to assure them they will not be sued if they prescribe Zyprexa for their patients.

So, now we are at a point where Eli Lilly had a flash of reality and preferred no media contact. Gosh, what a surprise. There was also the disclosure of Eli Lilly creating if not funding deceptive front groups to screen others in order to sell more Zyprexa as well.

The other tactical plan from Eli Lilly was to re-implement blunting techniques regarding Zyprexa. My guess is that they dragged this into a week- long meeting. This of course included dodging concerns by doctors that they are normally encouraged to partner with, historically. Such tactical plans of action were associated with such clever names as, ‘Viva Zyprexa’, or Zyprexa Limitless”. Maybe the next one will be ‘Zyprexa Revenue Regression’.

Another tactic authorized by Eli Lilly was to use those bonafide contract research organizations (CROs) to manufacture safety, health, and outcomes database studies. A deceptive publication plan followed. CROs are commercial research organizations that include substandard research investigators and the sponsor of these clinical trials, Eli Lilly, has the ability to alter aspects of such trials for their own benefit. This was done as they still encouraged children to consume Zyprexa- near a million of them due to an arrangement that Zyprexa will be promoted by the ADD drug Strattera.
As stated earlier, previously sealed and damaging documents got exposed at the end of 2006, and are accessible on the internet and some websites, such as furiousseasons.com, which is what this article is based upon entirely.

Perhaps the documents should have been exposed immediately instead of being held from public view. Many facts that you have read in this article are from these authentic documents that are more disturbing than fiction. The information is accurate, and many others are finally informed instead of deceived or denied their right to know.

Eli Lilly makes over 4 billion dollars a year on Zyprexa.
Eli Lilly has had to pay well over a billion dollars for Zyprexa damage to others between 2006 and 2007.
Eli Lilly raised the price in Europe of Zyprexa by nearly 20 percent afterwards.

“Character is what a man is in the dark” --- Dwight Moody

Dan Abshear

Author’s note: What has been written is based upon information and belief..
]]> Fri, 16 Jan 2009 10:07:40 -0500
Atypical Psychotics And Unsealed Documents


Not long ago, I got the joy and despair of viewing many documents that were initially not to be seen, by order of the Department of Justice, yet found their way on various locations on the internet- specifically, the website: furiousseasons.com. The documents are, or were, in fact, evidence against Eli Lilly entirely representing their decade of deception promoting and over-medicating others with their drug called Zyprexa, which is in a class of medications called atypical anti-psychotics. While a new a new molecular entity by definition, this new class called atypical antipsychotics in fact is chemically similar to the older and typical anti-psychotics that exist, such as Haldol. In many ways, the older antipsychotics are safer as well as being similar in efficacy compared with the atypicals such as Zyprexa. Perhaps this is why Eli Lilly did the things they did because they knew Zyprexa caused perhaps more harm than good for those who took the medication. Of the several available atypical anti-psychotics now available, Zyprexa and Clozaril, which was the first atypical anti-psychotic, are believed to have the most toxic adverse events to those who take these two in particular.

Launched in 1996, Eli Lilly did not appear to consider any adverse effects that may occur to those who take this drug, yet it is believed that there was reason to believe that there should be caution regarding its use. With the belief that the maker of Zyprexa is and will be exonerated from any responsibility related to Zyprexa, many surmise that Eli Lilly was pleased that others were taking Zyprexa , and was confident that they would be exonerated from any responsibility from the adverse effects of the drug.

At the time Zyprexa was granted approval for marketing, the medication was indicated only for schizophrenia and mania that exists in those with bipolar disorder. Schizophrenia has been defined as a disease that causes the sufferer to deviate from true reality, along with visual and auditory hallucinations. Bipolar disorder is another mental disorder where the victim alternates from states of heightened neurokinetics to periods of what can be brutal depression for the sufferer.

Eli Lilly, known in recent years for their focus on marketing over science or research, greatly desired and hoped that Zyprexa would be a welcome blockbuster, which is a medication that exceeds a billion dollars a year in sales as a minimum. Likely because of this state of greed of Eli Lilly, they did not consider or evaluate any possible damage this flagship drug may cause others. And Eli Lilly appeared to have the obedient and manipulated sales force presumed to be a necessity for this monetary goal to occur without interference.

Pharmaceutical representatives overall are attractive and young individuals with little if any medical knowledge or training, but are determined to have charming personalities along with a perception of obedience, and this is all Eli Lilly in particular wanted from the members of their sales force. The sales vocation is normally associated to contain members with a high affinity for money, so corruptive acts such as off label promotion or overt kickbacks is not typically a consideration of such people, overall, as history has shown. Therefore, if Eli Lilly’s sales representatives who happen to be instructed to sell Zyprexa for dementia or depression, the orders will likely be followed. Or if this sales force is instructed to pay specifically targeted doctors large amounts of money for doing little or no work for this money given to such doctors, it still is not a problem for the sales force to maintain their obedience to their corporate God.

A few years after Eli Lilly launched Zyprexa, they appeared anxious due to their obvious disappointment regarding the initial prediction that was speculated about the growth of this drug that was not meeting their expectations, so they had meetings throughout the nation, known as ‘plan of action’ meetings, and concluded afterwards that there is great benefit from a monetary paradigm of implementing ‘seeding trials’, as they are a mechanism for generating needed, although fabricated data void of any scientific gain of knowledge. This amazingly was done and implemented afterwards rather overtly. Even more unbelievable is that around this time, the Zyprexa sales force was instructed by Eli Lilly management to seek out clinical trial sites, along with investigators for these trials. One voiced stipulation was that the investigators had to either be Eli Lilly prescribing supporters or high volume prescribers. This protocol described was written internally, along with the etiology for performing these sham clinical trials. Anything in writing can be golden, from an illegal situation such as this.

In addition to the clinical trial plan of action, Eli Lilly instructed its sales force to utilize inaccurate promotional material that Eli Lilly gave its Zyprexa reps without exception, even though this material was false and misleading, which was the intent of Eli Lilly, according to others, along with this material being greatly unbalanced and suggested uses for Zyprexa that were not indicated if not unproven, which can and has been harmful to patients because of this. To further saturate and corrupt the Zyprexa sales force, they were coerced to blunt assertively what are at this time widely recognized adverse effects of this medication, such as massive weight gain, along with glucose and lipid abnormalities- all of which are dangerous to the user of this medication.

The corrosive promotion of Zyprexa by Eli Lilly continued as the dangerous company intentionally altered certain Zyprexa articles by rewriting them, followed by being reviewed internally after this art work. The purpose was to stimulate what Eli Lilly believed was clearly absent, which was much needed commercial interest related to Zyprexa.

Then it came time to essentially buy benign support groups in hopes that this would improve the growth of Zyprexa. One example is that Eli Lilly paid the American Diabetes Association for their assistance in obtaining endocrinologist consultants, which is a medical specialty that treats, among other things, diabetes. To reduce any possibility of an unexpected contingency doing this, they went ahead and hired a good sized team of diabetes educators. In 1999, Eli Lilly altered a Zyprexa report that originally illustrated the glucose problem with the medication, and did so with deliberate intent and reckless disregard for others. Eventually, the American Diabetes Association became quite the critic of Eli Lilly because of their harmful behavior regarding Zyprexa.

Amazing alliances between Eli Lilly and the Bush administration have existed as well. George H.W. Bush became an Eli Lilly director after leaving the CIA and lobbied to infect third world countries with Lilly medications. He also did his best to maximize tax breaks further for this industry that now employs both himself and his political affiliation. In fact, many members of this administration have some connection with Eli Lilly. It seems to be a revolving door issue once again. One could speculate that the Zyprexa campaign continued for so long because of the relationships the maker of the drug had and has with other powerful people.

The next psychotic tactic Eli Lilly created was an advisory board paid well by this company to focus on the progressing concerns of Zyprexa. This tactic did work briefly, but did not change the view of the drug by the medical community in any way, or the maker of this drug.

It is at this point that the medical community began to get vexed and irritated by Eli Lilly’s deceptive and overtly destructive tactics, which included the company’s own speakers that were utilized in the past. This event of Eli Lilly being ostracized was because of their disregard for those they are obligated to serve in the medical community. Perhaps most disturbing was the company’s intentional holding of crucial safety information related to Zyprexa even before the drug was even approved. For example, Eli Lilly’s Zyprexa representatives were instructed without doubt to neutralize the legitimate concerns doctors may have about Zyprexa, if not outright fear regarding this deadly drug they now perceived as being a clear reality. The representatives were in agreement of continuing to dodge or neutralize legitimate concerns about Zyprexa, with the promise of Eli Lilly’s management team to fill their wallets more if they maintain obedience regarding this directive that caused harm in the form of such physiological disorders as metabolic syndrome associated with Zyprexa, yet the sales force still denied the association due to the insistence of their employer. Essentially, the Zyprexa representatives with Eli Lilly were trained, perhaps aggressively, to disarm negative perceptions about Zyprexa, even though these perceptions continuously proved to be valid. This deeply troubled many Zyprexa representatives, as at this point they were aware of the dangers of the drug they were promoting in order to maintain employment.

Also, and of no great surprise, off label promotion with Zyprexa was a norm within the organization and certainly encouraged by Eli Lilly management. Encouraging doctors to prescribe Zyprexa for depression is one example. Amazingly, reflecting back on the behavioral flaws by Eli Lilly for quite some time, they did not alter their method of business even though there was a strong perception regarding this company being both aggressive and greedy, and likely criminal in the way they chose to conduct their business. And depression was not the only off label claim with Zyprexa. Eli Lilly considered such criminal acts as off label promotion as ‘redefining the market’. This is yet another example of their absurdity.

In the year 2000, Eli Lilly greatly expanded what was called their long term care sales force to expand Zyprexa intake in the elderly. This, as a reminder, is deadly- as Zyprexa is harmful to older citizens- specifically pneumonia and eventual premature death result from Zyprexa intake. At the same time, Eli Lilly developed a strategy to neutralize the obvious weight gain associated with Zyprexa with other patient populations. Does the whole corporation believe U.S. citizens are without thought or intelligence?
Yet in 2002, Eli Lilly was having financial disappointments, which again did not shock many. So to stay in form, they went on a mission to develop speakers to align with them and to not educate others, but to pacify other doctors in hopes that their problems with Zyprexa would disappear. After the speaker episode, Eli Lilly had the audacity to claim that Zyprexa was indeed the best in the class of atypical antipsychotics. Such a statement appears psychotic, to say the least. And now the market for atypicals is about 5 billion a year, so there seemed to be no end as to what Eli Lilly might try next. Also in this year our FDA called Eli Lilly ‘a sponsor’. I find that a bit disturbing. As disturbing as the covert meetings Eli Lilly had with the FDA as well. Well, if you are going to have a friend,that is the right one. Eli Lilly also bribed select reporters to speak or annotate favorably about Zyprexa, and they did.

As the new millennium progressed over a few years, lawsuits became a concern for Eli Lilly regarding Zyprexa. Doing what any responsible corporate entity would most certainly do, the upper management of Eli Lilly had the audacity to blame the media for the way they handled their patients. Around this time, Eli Lilly needed and did hire a public relations firm because of their image crisis. About the same time, Eli Lilly implemented a nationwide program entitled, “Operation: restore confidence”. I’m not sure how a fully rational and conscious group of Eli Lilly people could create something so ridiculous and unrealistic. Equally deviating from reality of Eli Lilly’s behavior is that they actually thought they could increase Zyprexa growth by hammering home astronomical efficacy with the drug which, of course, does not outweigh the damage of the drug to the patient who takes it.

Another failure illustrated above caused Eli Lilly to hire a group called Lifeplan Marketing, who convinced the organization to create a brand new market establishing Zyprexa as the standard of care. This is yet another psychotic act by this Midwest group of manipulators, who were at one time a well respected pharmaceutical corporation. Humans do not forget- especially pain.

At least one human wanted to let everyone know he did not, nor will he ever forget his experience as a Zyprexa representative with Eli Lilly. His name is Shahram Ahari and he aligned with a non-profit advocacy group called Pharmedout, which was created due to a state settlement from another pharmaceutical company. He spends his days now making others aware of things such as what you have read. I’ve spoken with Shahram, and I admire his assistance with others trying to correct this medical mess.

Eli Lilly appears pathologically persistent in frightening ways. Next was a national implementation plan of action which focused on training the Zyprexa sales force to use what was called a J.C.P. study to emphasize the numerous off label benefits of Zyprexa. At the same time, Eli Lilly determined that primary care doctors should be their number one Zyprexa targets. With this new focus, the sales force for Zyprexa were somehow convinced to tell doctors that fatigue is really the only side effect that presents itself with Zyprexa use. Again, citizens are overall not catatonic about such actions.

While on this off label role with Zyprexa, they resurrected their long term care efforts by taking on Aricept, and Alzheimer’s drug, and encouraged others to switch to Zyprexa. The reaction for this misbehavior was Zyprexa being removed from Medicaid in 2004.
Allan Reier was the Zyprexa product team leader at the time. He may have developed the unbelievable strategy of visiting psychiatrists to assure them they will not be sued if they prescribe Zyprexa for their patients.

So, now we are at a point where Eli Lilly had a flash of reality and preferred no media contact. Gosh, what a surprise. There was also the disclosure of Eli Lilly creating if not funding deceptive front groups to screen others in order to sell more Zyprexa as well.

The other tactical plan from Eli Lilly was to re-implement blunting techniques regarding Zyprexa. My guess is that they dragged this into a week- long meeting. This of course included dodging concerns by doctors that they are normally encouraged to partner with, historically. Such tactical plans of action were associated with such clever names as, ‘Viva Zyprexa’, or Zyprexa Limitless”. Maybe the next one will be ‘Zyprexa Revenue Regression’.

Another tactic authorized by Eli Lilly was to use those bonafide contract research organizations (CROs) to manufacture safety, health, and outcomes database studies. A deceptive publication plan followed. CROs are commercial research organizations that include substandard research investigators and the sponsor of these clinical trials, Eli Lilly, has the ability to alter aspects of such trials for their own benefit. This was done as they still encouraged children to consume Zyprexa- near a million of them due to an arrangement that Zyprexa will be promoted by the ADD drug Strattera.
As stated earlier, previously sealed and damaging documents got exposed at the end of 2006, and are accessible on the internet and some websites, such as furiousseasons.com, which is what this article is based upon entirely.

Perhaps the documents should have been exposed immediately instead of being held from public view. Many facts that you have read in this article are from these authentic documents that are more disturbing than fiction. The information is accurate, and many others are finally informed instead of deceived or denied their right to know.

Eli Lilly makes over 4 billion dollars a year on Zyprexa.
Eli Lilly has had to pay well over a billion dollars for Zyprexa damage to others between 2006 and 2007.
Eli Lilly raised the price in Europe of Zyprexa by nearly 20 percent afterwards.

“Character is what a man is in the dark” --- Dwight Moody

Dan Abshear

Author’s note: What has been written is based upon information and belief..
]]> http://seekingalpha.com/article/32444-clarifying-the-issues-surrounding-dendreon-s-provenge?source=feed#comment-276846 276846
Terminal patients are those who are not expected to live due to usually illness such as advanced cancer. If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or a tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. So, the FDA may not be an ideal judge regarding such issues as treatment options for very sick patients.
Prostate cancer is rather frequent, with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease. It is the third most common cancer one can acquire, and the United States has the most cases diagnosed n the world, which usually strikes men past the age of fifty. One million do have prostate cancer in the United States, and about thirty thousand will die from the disease each year. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are, the higher of what are called Gleason Scores will be, and the severe cases are the most difficult to treat, of course.
Yet innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy, specifically a hazardous drug called Taxotere, as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as Taxodere, which include cytotoxic side effects and haematological adverse events. The immunotherapy method developed by Dendreon requires the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack within the diseased body what is called PAP, which is on prostate cancer cells only. This treatment requires only three such injections in a period of six weeks. This results in life extension twice that of Taxodere, and Provenge is free of the discomfort of the only other treatment of Taxotere. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and other caregivers who treat such patients. While Provenge was on fast track status at this time at the FDA, as they at the time agreed with the benefits of this new therapy, the FDA panel recommended with clarity the approval of Provenge based on its proven and superior efficacy and safety that was demonstrated in its trials, as they announced in March of 2007. Lifespan extension of severe prostate cancer patients was twice as long with Provenge versus Taxotere, which is the only other treatment indicated for this stage of prostate cancer that had only superficial efficacy, and is free of the toxic effects of this chemotherapy agent.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself! Many found this ruling completely unbelievable.
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering to provide support for this similar prostate cancer drug treatment being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment were fabricated in these letters, it is believed Oncologists were speculated to lobby and pressure the FDA not to approve Provenge due to anticipated revenue loss. Yet overall, the disapproval by the FDA of Provenge angered and saddened many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of etiology for not approving Provenge, as they should have, according to the data about the therapy last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. Clearly, because of their lack of desirable and beneficial treatment options, most are willing to assume any risks of unapproved, yet potentially and likely beneficial treatments such as Provenge. Because they have a terminal illness, these benefits provided by Provenge take priority over any possible safety issues of unapproved treatments for them. The controversy could be concluded by a terminal patient signing a waiver of some sort, perhaps, stating that they are responsible for the consequences of an unapproved treatment regimen such as Provenge. Yet the FDA, with reckless disregard and with deliberate intent, denied what likely was a great treatment therapy for these very ill patients. Several have concluded that the FDA ultimately harmed others more by not approving Provenge, or offering any valid explanations explaining their action. Thier action was irrational, as one considers the agreement of the FDA and others regarding the need of the benefits provided by Provenge for the sickest of the sick with advanced prostate cancer.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge at this time, and why they have not remains completely unknown. What is known is that they are accelerating and worsening the illness, an illness the FDA pledged to protect so long ago. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health, but with what appears to be overt collusion with venture capitalists and corporations. This needs to be corrected in any way possible for the lives of others- regardless of their own present health state today. Because of the FDA's flaws in the past regarding drugs taken off the market along with increasing black box warnings of other drugs, which happens often with both, the individual should be the deciding factor in such matters of deciding thier treatment course presently, along with their health care provider, due to this unreliable administration called the FDA.
“Facts do not cease to exist because they are ignored.” --- Aldous Huxley
Dan Abshear

]]> Wed, 08 Oct 2008 11:12:09 -0400
Terminal patients are those who are not expected to live due to usually illness such as advanced cancer. If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or a tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. So, the FDA may not be an ideal judge regarding such issues as treatment options for very sick patients.
Prostate cancer is rather frequent, with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease. It is the third most common cancer one can acquire, and the United States has the most cases diagnosed n the world, which usually strikes men past the age of fifty. One million do have prostate cancer in the United States, and about thirty thousand will die from the disease each year. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are, the higher of what are called Gleason Scores will be, and the severe cases are the most difficult to treat, of course.
Yet innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy, specifically a hazardous drug called Taxotere, as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as Taxodere, which include cytotoxic side effects and haematological adverse events. The immunotherapy method developed by Dendreon requires the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack within the diseased body what is called PAP, which is on prostate cancer cells only. This treatment requires only three such injections in a period of six weeks. This results in life extension twice that of Taxodere, and Provenge is free of the discomfort of the only other treatment of Taxotere. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and other caregivers who treat such patients. While Provenge was on fast track status at this time at the FDA, as they at the time agreed with the benefits of this new therapy, the FDA panel recommended with clarity the approval of Provenge based on its proven and superior efficacy and safety that was demonstrated in its trials, as they announced in March of 2007. Lifespan extension of severe prostate cancer patients was twice as long with Provenge versus Taxotere, which is the only other treatment indicated for this stage of prostate cancer that had only superficial efficacy, and is free of the toxic effects of this chemotherapy agent.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself! Many found this ruling completely unbelievable.
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering to provide support for this similar prostate cancer drug treatment being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment were fabricated in these letters, it is believed Oncologists were speculated to lobby and pressure the FDA not to approve Provenge due to anticipated revenue loss. Yet overall, the disapproval by the FDA of Provenge angered and saddened many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of etiology for not approving Provenge, as they should have, according to the data about the therapy last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. Clearly, because of their lack of desirable and beneficial treatment options, most are willing to assume any risks of unapproved, yet potentially and likely beneficial treatments such as Provenge. Because they have a terminal illness, these benefits provided by Provenge take priority over any possible safety issues of unapproved treatments for them. The controversy could be concluded by a terminal patient signing a waiver of some sort, perhaps, stating that they are responsible for the consequences of an unapproved treatment regimen such as Provenge. Yet the FDA, with reckless disregard and with deliberate intent, denied what likely was a great treatment therapy for these very ill patients. Several have concluded that the FDA ultimately harmed others more by not approving Provenge, or offering any valid explanations explaining their action. Thier action was irrational, as one considers the agreement of the FDA and others regarding the need of the benefits provided by Provenge for the sickest of the sick with advanced prostate cancer.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge at this time, and why they have not remains completely unknown. What is known is that they are accelerating and worsening the illness, an illness the FDA pledged to protect so long ago. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health, but with what appears to be overt collusion with venture capitalists and corporations. This needs to be corrected in any way possible for the lives of others- regardless of their own present health state today. Because of the FDA's flaws in the past regarding drugs taken off the market along with increasing black box warnings of other drugs, which happens often with both, the individual should be the deciding factor in such matters of deciding thier treatment course presently, along with their health care provider, due to this unreliable administration called the FDA.
“Facts do not cease to exist because they are ignored.” --- Aldous Huxley
Dan Abshear

]]> http://seekingalpha.com/article/32444-clarifying-the-issues-surrounding-dendreon-s-provenge?source=feed#comment-276845 276845
Terminal patients are those who are not expected to live due to usually illness such as advanced cancer. If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or a tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. So, the FDA may not be an ideal judge regarding such issues as treatment options for very sick patients.
Prostate cancer is rather frequent, with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease. It is the third most common cancer one can acquire, and the United States has the most cases diagnosed n the world, which usually strikes men past the age of fifty. One million do have prostate cancer in the United States, and about thirty thousand will die from the disease each year. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are, the higher of what are called Gleason Scores will be, and the severe cases are the most difficult to treat, of course.
Yet innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy, specifically a hazardous drug called Taxotere, as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as Taxodere, which include cytotoxic side effects and haematological adverse events. The immunotherapy method developed by Dendreon requires the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack within the diseased body what is called PAP, which is on prostate cancer cells only. This treatment requires only three such injections in a period of six weeks. This results in life extension twice that of Taxodere, and Provenge is free of the discomfort of the only other treatment of Taxotere. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and other caregivers who treat such patients. While Provenge was on fast track status at this time at the FDA, as they at the time agreed with the benefits of this new therapy, the FDA panel recommended with clarity the approval of Provenge based on its proven and superior efficacy and safety that was demonstrated in its trials, as they announced in March of 2007. Lifespan extension of severe prostate cancer patients was twice as long with Provenge versus Taxotere, which is the only other treatment indicated for this stage of prostate cancer that had only superficial efficacy, and is free of the toxic effects of this chemotherapy agent.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself! Many found this ruling completely unbelievable.
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering to provide support for this similar prostate cancer drug treatment being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment were fabricated in these letters, it is believed Oncologists were speculated to lobby and pressure the FDA not to approve Provenge due to anticipated revenue loss. Yet overall, the disapproval by the FDA of Provenge angered and saddened many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of etiology for not approving Provenge, as they should have, according to the data about the therapy last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. Clearly, because of their lack of desirable and beneficial treatment options, most are willing to assume any risks of unapproved, yet potentially and likely beneficial treatments such as Provenge. Because they have a terminal illness, these benefits provided by Provenge take priority over any possible safety issues of unapproved treatments for them. The controversy could be concluded by a terminal patient signing a waiver of some sort, perhaps, stating that they are responsible for the consequences of an unapproved treatment regimen such as Provenge. Yet the FDA, with reckless disregard and with deliberate intent, denied what likely was a great treatment therapy for these very ill patients. Several have concluded that the FDA ultimately harmed others more by not approving Provenge, or offering any valid explanations explaining their action. Thier action was irrational, as one considers the agreement of the FDA and others regarding the need of the benefits provided by Provenge for the sickest of the sick with advanced prostate cancer.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge at this time, and why they have not remains completely unknown. What is known is that they are accelerating and worsening the illness, an illness the FDA pledged to protect so long ago. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health, but with what appears to be overt collusion with venture capitalists and corporations. This needs to be corrected in any way possible for the lives of others- regardless of their own present health state today. Because of the FDA's flaws in the past regarding drugs taken off the market along with increasing black box warnings of other drugs, which happens often with both, the individual should be the deciding factor in such matters of deciding thier treatment course presently, along with their health care provider, due to this unreliable administration called the FDA.
“Facts do not cease to exist because they are ignored.” --- Aldous Huxley
Dan Abshear

]]> Wed, 08 Oct 2008 11:12:01 -0400
Terminal patients are those who are not expected to live due to usually illness such as advanced cancer. If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or a tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. So, the FDA may not be an ideal judge regarding such issues as treatment options for very sick patients.
Prostate cancer is rather frequent, with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease. It is the third most common cancer one can acquire, and the United States has the most cases diagnosed n the world, which usually strikes men past the age of fifty. One million do have prostate cancer in the United States, and about thirty thousand will die from the disease each year. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are, the higher of what are called Gleason Scores will be, and the severe cases are the most difficult to treat, of course.
Yet innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy, specifically a hazardous drug called Taxotere, as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as Taxodere, which include cytotoxic side effects and haematological adverse events. The immunotherapy method developed by Dendreon requires the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack within the diseased body what is called PAP, which is on prostate cancer cells only. This treatment requires only three such injections in a period of six weeks. This results in life extension twice that of Taxodere, and Provenge is free of the discomfort of the only other treatment of Taxotere. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and other caregivers who treat such patients. While Provenge was on fast track status at this time at the FDA, as they at the time agreed with the benefits of this new therapy, the FDA panel recommended with clarity the approval of Provenge based on its proven and superior efficacy and safety that was demonstrated in its trials, as they announced in March of 2007. Lifespan extension of severe prostate cancer patients was twice as long with Provenge versus Taxotere, which is the only other treatment indicated for this stage of prostate cancer that had only superficial efficacy, and is free of the toxic effects of this chemotherapy agent.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself! Many found this ruling completely unbelievable.
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering to provide support for this similar prostate cancer drug treatment being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment were fabricated in these letters, it is believed Oncologists were speculated to lobby and pressure the FDA not to approve Provenge due to anticipated revenue loss. Yet overall, the disapproval by the FDA of Provenge angered and saddened many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of etiology for not approving Provenge, as they should have, according to the data about the therapy last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. Clearly, because of their lack of desirable and beneficial treatment options, most are willing to assume any risks of unapproved, yet potentially and likely beneficial treatments such as Provenge. Because they have a terminal illness, these benefits provided by Provenge take priority over any possible safety issues of unapproved treatments for them. The controversy could be concluded by a terminal patient signing a waiver of some sort, perhaps, stating that they are responsible for the consequences of an unapproved treatment regimen such as Provenge. Yet the FDA, with reckless disregard and with deliberate intent, denied what likely was a great treatment therapy for these very ill patients. Several have concluded that the FDA ultimately harmed others more by not approving Provenge, or offering any valid explanations explaining their action. Thier action was irrational, as one considers the agreement of the FDA and others regarding the need of the benefits provided by Provenge for the sickest of the sick with advanced prostate cancer.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge at this time, and why they have not remains completely unknown. What is known is that they are accelerating and worsening the illness, an illness the FDA pledged to protect so long ago. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health, but with what appears to be overt collusion with venture capitalists and corporations. This needs to be corrected in any way possible for the lives of others- regardless of their own present health state today. Because of the FDA's flaws in the past regarding drugs taken off the market along with increasing black box warnings of other drugs, which happens often with both, the individual should be the deciding factor in such matters of deciding thier treatment course presently, along with their health care provider, due to this unreliable administration called the FDA.
“Facts do not cease to exist because they are ignored.” --- Aldous Huxley
Dan Abshear

]]> http://seekingalpha.com/article/36622-dendreon-disapproval-fda-builds-a-bridge-to-afterlife?source=feed#comment-276315 276315
Terminal patients are those who are not expected to live due to usually illness such as advanced cancer. If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or a tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. So, the FDA may not be an ideal judge regarding such issues as treatment options for very sick patients.
Prostate cancer is rather frequent, with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are, which is determined by such methods as bone scans and Gleason’s scores, the more difficult it is to treat such patients.
Yet innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as Taxodere. The immunotherapy method developed by Dendreon requires the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack within the diseased body what is called PAP, which is on prostate cancer cells only. This treatment requires only three such injections in a period of six weeks. This results in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel recommended with clarity the approval of Provenge based on its proven and substancial efficacy and safety demonstrated in its trials, as they announced in March of 2007. This was expected by many, as Provenge was given Fast Track status by the FDA because of the potential of this therapy for terminal patients.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself! Many found this ruling completely unbelievable.
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering to provide support for this similar prostate cancer drug treatment being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment were fabricated in these letters, it is believed. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. Because most are willing to assume any risks of unapproved, yet potentially beneficial treatments such as Provenge. Because they have a terminal illness, possible benefits clearly take priority over safety issues of unapproved treatments for them. The controversy could be concluded by a terminal patient signing a waiver of some sort, perhaps, stating that they are responsible for the consequences of an unapproved treatment regimen such as Provenge. Yet the FDA, with reckless disregard and overt harshness, denied what likely was a great treatment method for these very ill patients, so the FDA ultimately harmed others more by not approving Provenge, or offering any exceptions with such cases, which in this situation seems most rational, considering the available data with Provenge.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge at this time, and why they have not remains completely unknown. What is known is that they are harming those they pledged to protect so long ago. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others, regardless of thier present health state today. Because of the FDA's flaws in the past regarding drugs taken off the market along with increasing black box warnings of other drugs, which happens often with both, the individual should be the deciding factor in such matters of deciding thier treatment course along with thier health care provider, and not an unreliable Administration.
“Facts do not cease to exist because they are ignored.” --- Aldous Huxley
Dan Abshear

]]> Tue, 07 Oct 2008 19:28:39 -0400
Terminal patients are those who are not expected to live due to usually illness such as advanced cancer. If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or a tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. So, the FDA may not be an ideal judge regarding such issues as treatment options for very sick patients.
Prostate cancer is rather frequent, with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are, which is determined by such methods as bone scans and Gleason’s scores, the more difficult it is to treat such patients.
Yet innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as Taxodere. The immunotherapy method developed by Dendreon requires the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack within the diseased body what is called PAP, which is on prostate cancer cells only. This treatment requires only three such injections in a period of six weeks. This results in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel recommended with clarity the approval of Provenge based on its proven and substancial efficacy and safety demonstrated in its trials, as they announced in March of 2007. This was expected by many, as Provenge was given Fast Track status by the FDA because of the potential of this therapy for terminal patients.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself! Many found this ruling completely unbelievable.
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering to provide support for this similar prostate cancer drug treatment being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment were fabricated in these letters, it is believed. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. Because most are willing to assume any risks of unapproved, yet potentially beneficial treatments such as Provenge. Because they have a terminal illness, possible benefits clearly take priority over safety issues of unapproved treatments for them. The controversy could be concluded by a terminal patient signing a waiver of some sort, perhaps, stating that they are responsible for the consequences of an unapproved treatment regimen such as Provenge. Yet the FDA, with reckless disregard and overt harshness, denied what likely was a great treatment method for these very ill patients, so the FDA ultimately harmed others more by not approving Provenge, or offering any exceptions with such cases, which in this situation seems most rational, considering the available data with Provenge.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge at this time, and why they have not remains completely unknown. What is known is that they are harming those they pledged to protect so long ago. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others, regardless of thier present health state today. Because of the FDA's flaws in the past regarding drugs taken off the market along with increasing black box warnings of other drugs, which happens often with both, the individual should be the deciding factor in such matters of deciding thier treatment course along with thier health care provider, and not an unreliable Administration.
“Facts do not cease to exist because they are ignored.” --- Aldous Huxley
Dan Abshear

]]> http://seekingalpha.com/article/76081-dendreon-the-provenge-approval-scandal-one-year-later?source=feed#comment-276264 276264
Terminal patients are those who are not expected to live due to usually illness such as advanced cancer. If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or a tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. So, the FDA may not be an ideal judge regarding such issues as treatment options for very sick patients.
Prostate cancer is rather frequent, with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are, which is determined by such methods as bone scans and Gleason’s scores, the more difficult it is to treat such patients.
Yet innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as Taxodere. The immunotherapy method developed by Dendreon requires the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack within the diseased body what is called PAP, which is on prostate cancer cells only. This treatment requires only three such injections in a period of six weeks. This results in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel recommended with clarity the approval of Provenge based on its proven and substancial efficacy and safety demonstrated in its trials, as they announced in March of 2007. This was expected by many, as Provenge was given Fast Track status by the FDA because of the potential of this therapy for terminal patients.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself! Many found this ruling completely unbelievable.
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering to provide support for this similar prostate cancer drug treatment being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment were fabricated in these letters, it is believed. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. Because most are willing to assume any risks of unapproved, yet potentially beneficial treatments such as Provenge. Because they have a terminal illness, possible benefits clearly take priority over safety issues of unapproved treatments for them. The controversy could be concluded by a terminal patient signing a waiver of some sort, perhaps, stating that they are responsible for the consequences of an unapproved treatment regimen such as Provenge. Yet the FDA, with reckless disregard and overt harshness, denied what likely was a great treatment method for these very ill patients, so the FDA ultimately harmed others more by not approving Provenge, or offering any exceptions with such cases, which in this situation seems most rational, considering the available data with Provenge.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge at this time, and why they have not remains completely unknown. What is known is that they are harming those they pledged to protect so long ago. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others, regardless of thier present health state today. Because of the FDA's flaws in the past regarding drugs taken off the market along with increasing black box warnings of other drugs, which happens often with both, the individual should be the deciding factor in such matters of deciding thier treatment course along with thier health care provider, and not an unreliable Administration.
“Facts do not cease to exist because they are ignored.” --- Aldous Huxley
Dan Abshear

]]> Tue, 07 Oct 2008 18:27:03 -0400
Terminal patients are those who are not expected to live due to usually illness such as advanced cancer. If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or a tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. So, the FDA may not be an ideal judge regarding such issues as treatment options for very sick patients.
Prostate cancer is rather frequent, with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are, which is determined by such methods as bone scans and Gleason’s scores, the more difficult it is to treat such patients.
Yet innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as Taxodere. The immunotherapy method developed by Dendreon requires the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack within the diseased body what is called PAP, which is on prostate cancer cells only. This treatment requires only three such injections in a period of six weeks. This results in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel recommended with clarity the approval of Provenge based on its proven and substancial efficacy and safety demonstrated in its trials, as they announced in March of 2007. This was expected by many, as Provenge was given Fast Track status by the FDA because of the potential of this therapy for terminal patients.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself! Many found this ruling completely unbelievable.
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering to provide support for this similar prostate cancer drug treatment being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment were fabricated in these letters, it is believed. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. Because most are willing to assume any risks of unapproved, yet potentially beneficial treatments such as Provenge. Because they have a terminal illness, possible benefits clearly take priority over safety issues of unapproved treatments for them. The controversy could be concluded by a terminal patient signing a waiver of some sort, perhaps, stating that they are responsible for the consequences of an unapproved treatment regimen such as Provenge. Yet the FDA, with reckless disregard and overt harshness, denied what likely was a great treatment method for these very ill patients, so the FDA ultimately harmed others more by not approving Provenge, or offering any exceptions with such cases, which in this situation seems most rational, considering the available data with Provenge.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge at this time, and why they have not remains completely unknown. What is known is that they are harming those they pledged to protect so long ago. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others, regardless of thier present health state today. Because of the FDA's flaws in the past regarding drugs taken off the market along with increasing black box warnings of other drugs, which happens often with both, the individual should be the deciding factor in such matters of deciding thier treatment course along with thier health care provider, and not an unreliable Administration.
“Facts do not cease to exist because they are ignored.” --- Aldous Huxley
Dan Abshear

]]> http://seekingalpha.com/article/96929-a-tale-of-three-pharmaceuticals-abbott-labs-pfizer-and-eli-lilly-co?source=feed#comment-263423 263423 Wed, 24 Sep 2008 09:42:57 -0400 http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-262702 262702
Don't narrow your mind.]]> Tue, 23 Sep 2008 14:19:38 -0400
Don't narrow your mind.]]> http://seekingalpha.com/article/25187-top-six-socially-responsible-healthcare-and-pharmaceutical-firms?source=feed#comment-242702 242702 Sun, 31 Aug 2008 14:51:15 -0400 http://seekingalpha.com/article/87695-biotech-bucks-the-market-trend?source=feed#comment-218475 218475
Beginning in the late 1970s, biopharmaceuticals were being researched for conceptual production in those places once called academic institutions, and conducted basic research to identify new product candidates and applied a great amount of research. The same protocol is applied with biopharmaceutical companies today as it was then.
The first biopharmaceutical ever was synthetic insulin called Humulin made by Genetech in 1982, that utilizing what is called rDNA technology, which also is used to produce human growth hormones. Later the rights were sold to Eli Lilly for this insulin.
Biopharmaceuticals are distant and covert relatives of big pharmaceuticals, whose products are typically small molecule and carbon based in their design. Due to the lack of innovation and creation of truly unique products, large pharmaceutical corporations in particular have become intimate with the innovative biopharmaceutical companies more often now than ever. In fact, large pharmaceutical companies often acquire biopharmaceutical companies. These large pharmaceuticals do this because of the unlikely possibility that biopharmaceuticals will have generic products with therapeutic equivalents for some time. In addition, biopharmaceutical companies have historically been and experienced accelerated growth that has proven to be quite lucrative for them.
How do these drugs differ from typical drugs that have been made before this advent of biopharmaceuticals? Unlike the small molecule, synthetic, carbon based pharmaceuticals of yesterday, biopharmaceuticals, classified under what is called Red biotechnology due to this being a medical process in the biotechnology world, essentially are larger and very complex modified proteins derived from living biological materials that vary depending on what medication will be manufactured and for what disease state. In fact, it is difficult to identify the clinically active component of a biopharmaceutical drug, which is why there is no pathway for generic copies of such drugs, as it would require expensive and meticulous clinical trial processes. Yet recently, a company called Insmed demonstrated bioequivalence to Amgen’s Nupogen that increases white blood cells. While there still is no defined pathway for follow-on biologics, this study demonstrated that another biologic drug can show that it is therapeutically equivalent. Insmed’s drug in this study will not be available for marketing until next year or later, though. Amgen recently had to pay a settlement to JNJ, who makes an identical drug called Procrit, for rebates and incentives Amgen was giving Oncologists for using Nupogen, and this will be addressed later.
Also, a transformed host cell is developed to synthesize this protein that is altered and then inserted into a selected cell line. The master cell banks, like fingerprints, are each unique and cannot be accurately duplicated, which is why there are no generic biopharmaceuticals as of yet, as there is no known process to create them. So the altered molecules are then cultured to produce the desired protein for the eventual biopharmaceutical product. These proteins are very complex and are manufactured from living organisms and material chosen for whatever biopharmaceutical that may be desired to be created. It is difficult to identify the clinically active component of biopharmaceutical drugs. So manufacturing biopharmaceuticals clearly is a different and innovative process, and a small manufacturing change could and has raised safety issues of a particular biopharmaceutical in the developing process. Also, it takes about 5 years to manufacture a biopharmaceutical. And each class has a different method of production and alteration of life forms to create what the company intends to develop. Yet overall, their development methods are rather effective.
Over 20 biopharmaceutical drugs were approved in 2005, I believe, and their growth tripled of what large pharmaceuticals experienced then. Also, just last year, biopharmaceutical companies made close to 80 billion in sales as well. Presently, over 20 biopharmaceutical products are blockbusters by definition. They are overall very effective treatments for what are viewed as very difficult diseases to manage. This is due to the fact that some pharmaceutical products target specific etiologies of these diseases, while limiting side effects because of the specific way in which such products work.
Unlike traditional medications that have been created in the same way for decades, biopharmaceutical companies seek through their research specific disease targets by genetic analysis and then search for a way to manipulate this target in a very specific way to provide superior treatment for such patients. Furthermore, these products are biologically synthesized and manipulated to maximize their efficacy while not crossing into a patient’s bloodstream.
There are about a dozen f different classes or mechanisms of action of biopharmaceuticals that have about a half of dozen different types of uses today. Often, Label alterations for additional disease states occurs often as well due to the progressive and novel effectiveness of biopharmaceuticals. Some of these drugs are catalysts for apoptosis of tumor cells. Others may cause angiogenesis to occur to block blood supply to the tumors of cancer patients. Then some biopharmaceuticals have multiple modes of action that benefit certain patient types and their diseases greatly, as with most biopharmaceutical products, the safety and efficacy is evident and reinforced with clinical data and eventual experience with the biopharmaceutical that is chosen to be utilized. And this clinical data is of a different method as well in comparison with what are traditional medications. For example, patients in the clinical trial involving a pharmaceutical are profiled, which allows better interpretation of this clinical data on their products.
Some biopharmaceuticals appear to be more noteworthy than others, such as Enbrel, which was originally created for the many forms of RA, which is a devastating form of arthritis that is caused by the patient’s own immune system attacking them to manifest this disease.
At one point, demand exceeded supply for Embrel, as the efficacy and safety was evident and unexpected by its manufacture. As a result of both doctors and affected patients seeking this drug, there were anticipated to be over 1000 patients on a waiting list for Enbrel for several weeks.
Enbrel was approved in 1998 and was developed from what are called monoclonal antibiodies, which is one of several ways in which biopharmaceuticals are produced. In fact, some call the 1990s overall the biopharmaceutical decade.
Partnering of biopharmaceutical companies and larger pharmaceutical companies began during this time as well, if not being acquired by large pharmaceutical companies. Needless to say, large corporate pharmaceutical companies have a very high affinity for potential blockbusters.
The country of Belgium provides the most biotech products to the biopharmaceutical companies in the United States, and the U.S. leads the world in regards to biopharmaceutical product creation- with more than 70 percent of both revenues and research and development expenditures in this country. Canada is ranked number two in this area, others have said.
Some biopharmaceutical drugs are more profitable than others as well. Biopharmaceuticals compose around 10 percent of the pharmaceutical market presently, I understand. And with the government health care programs who are the largest U.S. payers for pharmaceuticals, Medicare pays 80 percent of the cost of biopharmaceuticals, as many are administered in the doctor’s office.
One other controversial, yet profitable biopharmaceutical class is known as EPOs. The two that are available are actually identical, yet have different names of Procrit and Epogen. Both are indicated for anemia that is experienced in patients on dialysis or who have cancer in particular. Doctors are monetarily incentivized to exceed dosing requirements of these agents for their anemic patients. When this happens, it potentially causes premature deaths as well as accelerating the progression of cancer patients placed on one of these meds. Once this tactic was exposed, there are now limitations regarding the amounts authorized to be given to particular patients placed on these EPOs. They are in the class of hormone biopharmaceutical drugs, which is another type of several classes of biopharmaceuticals, and they reduce the need for blood transfusions as they increase RBC proliferation safely and effectively if dosed properly.
Another controversy involving biopharmaceuticals is that, while they overall are very efficacious and safe, the typical cost of biopharmaceuticals is rather unbelievable, as the cost approaches 10 thousand dollars a year for many of them. F urthermore, with cancer drugs, they are used together with chemotherapy for their treatment regimens, so others have argued the limite improvement in the quality of life of some patients on biopharmaceuticals, considering the devastating side effects of chemo treatment. Another criticism of biopharmaceuticals is that, with cancer patients in particular, they normally provide an extension of their life of only a few months.
Several years ago, I saw Roy Vagelos, former CEO of Merck Pharmaceuticals, and heard him speak to others at Washington University in St. Louis about his views on medicines. And during his presentation, he stated something similar regarding the cost of biopharmaceuticals and asked as well about whether or not the value related to the cost of biopharmaceuticals is truly clinically beneficial for such a brief life extension of cancer patients in particular, for the most part.
An issue or issues are always associated with new paradigms and innovations. Yet there are only a few biopharmaceuticals out of many available with debatable benefits with the high price tag. It ends up being what the market will bear for what their makers charge others. Yet the real question is the clinical evidence behind biopharmaceuticals: If a biopharmaceutical stops tumor progression without harming such patients is clearly both safe and effective.
Another difference with biopharmaceuticals is that they are also regulated by what is called The Public Service Act, and are involved in authorizing the marketing of biopharmaceuticals.
Safety protocols regarding biopharmaceuticals are a mystery to me as well. What is known is that biopharmaceuticals have the potential to discover therapies to treat the cause of a particular disease state instead of treating such a disease only symptomatically. They set out to solve unmet clinical needs by science that has yet to be proven. Biopharmaceuticals save, enhance, and extend the quality of life of patients with terrible diseases, and over 250 million people have benefited from their products.
Yet presently, few biopharmaceutical companies are actually profitable. Also, with biopharmaceuticals, some years are better than others from a revenue and market share growth point of view. Yet like any business, some years are better than others, and biopharmaceuticals are anticipated to offer quite a bit to public health in the future, with a focus on cancer patients in particular.
The cost of developing a biopharmaceutical exceeds a billion dollars, with about a third actually making it to market. The market size of biopharmaceuticals is rapidly approaching 100 billion dollars a year, with average annual growth between 10 and 20 percent.
With cancer biopharmaceuticals, between70and 80 percent of them are believed to be prescribed off-label, so it will be interesting on how these drugs will be used in such disease states now and in the future.
So the future looks good for this industry, as biologics have tremendous marketing power along with superior therapeutic value.
Regardless of the challenges and flaws that exist with biopharmaceuticals and their makers, I’m pleased to see the results and realization of true innovation in pharmacology by taking a different path of drug development. Furthermore, I believe others should behave in a similar manner and be inspired by the biopharmaceutical companies and what they have done and continue to do for the benefit of patients regarding the issue of innovation.
“The progressive development of man is vitally dependent on invention.” --- N. Tesla
Dan Abshear (what has been written is based upon information and belief)


]]> Wed, 30 Jul 2008 12:13:20 -0400
Beginning in the late 1970s, biopharmaceuticals were being researched for conceptual production in those places once called academic institutions, and conducted basic research to identify new product candidates and applied a great amount of research. The same protocol is applied with biopharmaceutical companies today as it was then.
The first biopharmaceutical ever was synthetic insulin called Humulin made by Genetech in 1982, that utilizing what is called rDNA technology, which also is used to produce human growth hormones. Later the rights were sold to Eli Lilly for this insulin.
Biopharmaceuticals are distant and covert relatives of big pharmaceuticals, whose products are typically small molecule and carbon based in their design. Due to the lack of innovation and creation of truly unique products, large pharmaceutical corporations in particular have become intimate with the innovative biopharmaceutical companies more often now than ever. In fact, large pharmaceutical companies often acquire biopharmaceutical companies. These large pharmaceuticals do this because of the unlikely possibility that biopharmaceuticals will have generic products with therapeutic equivalents for some time. In addition, biopharmaceutical companies have historically been and experienced accelerated growth that has proven to be quite lucrative for them.
How do these drugs differ from typical drugs that have been made before this advent of biopharmaceuticals? Unlike the small molecule, synthetic, carbon based pharmaceuticals of yesterday, biopharmaceuticals, classified under what is called Red biotechnology due to this being a medical process in the biotechnology world, essentially are larger and very complex modified proteins derived from living biological materials that vary depending on what medication will be manufactured and for what disease state. In fact, it is difficult to identify the clinically active component of a biopharmaceutical drug, which is why there is no pathway for generic copies of such drugs, as it would require expensive and meticulous clinical trial processes. Yet recently, a company called Insmed demonstrated bioequivalence to Amgen’s Nupogen that increases white blood cells. While there still is no defined pathway for follow-on biologics, this study demonstrated that another biologic drug can show that it is therapeutically equivalent. Insmed’s drug in this study will not be available for marketing until next year or later, though. Amgen recently had to pay a settlement to JNJ, who makes an identical drug called Procrit, for rebates and incentives Amgen was giving Oncologists for using Nupogen, and this will be addressed later.
Also, a transformed host cell is developed to synthesize this protein that is altered and then inserted into a selected cell line. The master cell banks, like fingerprints, are each unique and cannot be accurately duplicated, which is why there are no generic biopharmaceuticals as of yet, as there is no known process to create them. So the altered molecules are then cultured to produce the desired protein for the eventual biopharmaceutical product. These proteins are very complex and are manufactured from living organisms and material chosen for whatever biopharmaceutical that may be desired to be created. It is difficult to identify the clinically active component of biopharmaceutical drugs. So manufacturing biopharmaceuticals clearly is a different and innovative process, and a small manufacturing change could and has raised safety issues of a particular biopharmaceutical in the developing process. Also, it takes about 5 years to manufacture a biopharmaceutical. And each class has a different method of production and alteration of life forms to create what the company intends to develop. Yet overall, their development methods are rather effective.
Over 20 biopharmaceutical drugs were approved in 2005, I believe, and their growth tripled of what large pharmaceuticals experienced then. Also, just last year, biopharmaceutical companies made close to 80 billion in sales as well. Presently, over 20 biopharmaceutical products are blockbusters by definition. They are overall very effective treatments for what are viewed as very difficult diseases to manage. This is due to the fact that some pharmaceutical products target specific etiologies of these diseases, while limiting side effects because of the specific way in which such products work.
Unlike traditional medications that have been created in the same way for decades, biopharmaceutical companies seek through their research specific disease targets by genetic analysis and then search for a way to manipulate this target in a very specific way to provide superior treatment for such patients. Furthermore, these products are biologically synthesized and manipulated to maximize their efficacy while not crossing into a patient’s bloodstream.
There are about a dozen f different classes or mechanisms of action of biopharmaceuticals that have about a half of dozen different types of uses today. Often, Label alterations for additional disease states occurs often as well due to the progressive and novel effectiveness of biopharmaceuticals. Some of these drugs are catalysts for apoptosis of tumor cells. Others may cause angiogenesis to occur to block blood supply to the tumors of cancer patients. Then some biopharmaceuticals have multiple modes of action that benefit certain patient types and their diseases greatly, as with most biopharmaceutical products, the safety and efficacy is evident and reinforced with clinical data and eventual experience with the biopharmaceutical that is chosen to be utilized. And this clinical data is of a different method as well in comparison with what are traditional medications. For example, patients in the clinical trial involving a pharmaceutical are profiled, which allows better interpretation of this clinical data on their products.
Some biopharmaceuticals appear to be more noteworthy than others, such as Enbrel, which was originally created for the many forms of RA, which is a devastating form of arthritis that is caused by the patient’s own immune system attacking them to manifest this disease.
At one point, demand exceeded supply for Embrel, as the efficacy and safety was evident and unexpected by its manufacture. As a result of both doctors and affected patients seeking this drug, there were anticipated to be over 1000 patients on a waiting list for Enbrel for several weeks.
Enbrel was approved in 1998 and was developed from what are called monoclonal antibiodies, which is one of several ways in which biopharmaceuticals are produced. In fact, some call the 1990s overall the biopharmaceutical decade.
Partnering of biopharmaceutical companies and larger pharmaceutical companies began during this time as well, if not being acquired by large pharmaceutical companies. Needless to say, large corporate pharmaceutical companies have a very high affinity for potential blockbusters.
The country of Belgium provides the most biotech products to the biopharmaceutical companies in the United States, and the U.S. leads the world in regards to biopharmaceutical product creation- with more than 70 percent of both revenues and research and development expenditures in this country. Canada is ranked number two in this area, others have said.
Some biopharmaceutical drugs are more profitable than others as well. Biopharmaceuticals compose around 10 percent of the pharmaceutical market presently, I understand. And with the government health care programs who are the largest U.S. payers for pharmaceuticals, Medicare pays 80 percent of the cost of biopharmaceuticals, as many are administered in the doctor’s office.
One other controversial, yet profitable biopharmaceutical class is known as EPOs. The two that are available are actually identical, yet have different names of Procrit and Epogen. Both are indicated for anemia that is experienced in patients on dialysis or who have cancer in particular. Doctors are monetarily incentivized to exceed dosing requirements of these agents for their anemic patients. When this happens, it potentially causes premature deaths as well as accelerating the progression of cancer patients placed on one of these meds. Once this tactic was exposed, there are now limitations regarding the amounts authorized to be given to particular patients placed on these EPOs. They are in the class of hormone biopharmaceutical drugs, which is another type of several classes of biopharmaceuticals, and they reduce the need for blood transfusions as they increase RBC proliferation safely and effectively if dosed properly.
Another controversy involving biopharmaceuticals is that, while they overall are very efficacious and safe, the typical cost of biopharmaceuticals is rather unbelievable, as the cost approaches 10 thousand dollars a year for many of them. F urthermore, with cancer drugs, they are used together with chemotherapy for their treatment regimens, so others have argued the limite improvement in the quality of life of some patients on biopharmaceuticals, considering the devastating side effects of chemo treatment. Another criticism of biopharmaceuticals is that, with cancer patients in particular, they normally provide an extension of their life of only a few months.
Several years ago, I saw Roy Vagelos, former CEO of Merck Pharmaceuticals, and heard him speak to others at Washington University in St. Louis about his views on medicines. And during his presentation, he stated something similar regarding the cost of biopharmaceuticals and asked as well about whether or not the value related to the cost of biopharmaceuticals is truly clinically beneficial for such a brief life extension of cancer patients in particular, for the most part.
An issue or issues are always associated with new paradigms and innovations. Yet there are only a few biopharmaceuticals out of many available with debatable benefits with the high price tag. It ends up being what the market will bear for what their makers charge others. Yet the real question is the clinical evidence behind biopharmaceuticals: If a biopharmaceutical stops tumor progression without harming such patients is clearly both safe and effective.
Another difference with biopharmaceuticals is that they are also regulated by what is called The Public Service Act, and are involved in authorizing the marketing of biopharmaceuticals.
Safety protocols regarding biopharmaceuticals are a mystery to me as well. What is known is that biopharmaceuticals have the potential to discover therapies to treat the cause of a particular disease state instead of treating such a disease only symptomatically. They set out to solve unmet clinical needs by science that has yet to be proven. Biopharmaceuticals save, enhance, and extend the quality of life of patients with terrible diseases, and over 250 million people have benefited from their products.
Yet presently, few biopharmaceutical companies are actually profitable. Also, with biopharmaceuticals, some years are better than others from a revenue and market share growth point of view. Yet like any business, some years are better than others, and biopharmaceuticals are anticipated to offer quite a bit to public health in the future, with a focus on cancer patients in particular.
The cost of developing a biopharmaceutical exceeds a billion dollars, with about a third actually making it to market. The market size of biopharmaceuticals is rapidly approaching 100 billion dollars a year, with average annual growth between 10 and 20 percent.
With cancer biopharmaceuticals, between70and 80 percent of them are believed to be prescribed off-label, so it will be interesting on how these drugs will be used in such disease states now and in the future.
So the future looks good for this industry, as biologics have tremendous marketing power along with superior therapeutic value.
Regardless of the challenges and flaws that exist with biopharmaceuticals and their makers, I’m pleased to see the results and realization of true innovation in pharmacology by taking a different path of drug development. Furthermore, I believe others should behave in a similar manner and be inspired by the biopharmaceutical companies and what they have done and continue to do for the benefit of patients regarding the issue of innovation.
“The progressive development of man is vitally dependent on invention.” --- N. Tesla
Dan Abshear (what has been written is based upon information and belief)


]]> http://seekingalpha.com/article/86393-merck-schering-plough-s-heart-drug-couldn-t-have-done-worse?source=feed#comment-212920 212920 brainblogger.com:

A Failed Attempt to Improve Misperceived Greatness: The ENHANCE Trial

While it seems that pharmaceutical company sponsors of clinical trials usually end up with results that clearly favor their meds studied in their trial, there are rare exceptions, and Merck and Schering proved that with their disappointing ENHANCE Trial, which many have heard about through the media not long ago. The drugs studied were Vytorin, which was compared with Zocor
Vytorin is a combination med for high cholesterol and contains Merck’s Zocor, which is now generic, and Schering’s Zetia, which works differently than Zocor, which is one of many statin drugs. Both Vytorin and Zetia are co-promoted by Merck and Schering. So, several years ago, an outcomes study was initiated to prove superiority of Vytorin over Zocor. The trial was named the ENHANCE trial, and possibly this trial was initiated because Zocor is generic now, and not a priority from a profit paradigm of its creator.
After several years passed, a disappointment arrived for the sponsors of this trial, which was first brought to the attention of Schering in March of 2007, yet the results existed since the spring of 2006, I believe upon information and belief.
The disappointment is that Vytorin lacked anticipated benefit or superiority over Zocor. Since about 1 million scripts were written for both Vytorin and Zetia every week in 2007, combined with what I believe was about 5 billion in revenue for these two drugs that year, this was a problem for the drug makers, meaning a fear of shareholder reaction. Perhaps for Schering in particular, it was more of a calamity, since over half of their profits and earnings were from these two drugs with Schering, I understand.
Being the responsible corporations both companies are, of course, alterations occurred after such events were discovered that fractured numerous rules and regulations with clinical trials, possibly in illegal and unethical tactics.
The trial sponsors delayed the release of the trial results for secrecy reasons, it has been speculated. Results from the trial existed, yet were not disclosed at the time of their discovery. After several months of possessing these trial results that were only known to the manufacturers, they created or implemented some atrocious tactics to improve the trial’s unimpressive results following the original results of this ENHANCE study. At the end of 2007, the companies changed the primary endpoint of the trial, which is what the results were measured upon during the entire course of the trial. Sort of like sorting cards to make a good hand not dealt to you. Anyway, since their deliberate concealment of these trial results was clearly wrong, to respond to those who asked where the results were actually as they had been anticipated for quite some time, and while such trial manipulation was occurring and results were being kept secret, Schering stated that continued data analysis from the trial results was the etiology for the delay.
With clinical trials, case report forms are used to record data from the trials, and are created in a manner where further analysis is not normally necessary, as such forms are quite clear and often not subject to interpretation as implied by the trial sponsors, one could conclude. So at the end of 2007, both Merck and Schering got the attention of relevant government officials who contacted both companies regarding this ENHANCE trial due to such suspicions on the facts known and presented, and an investigation began into the activities of both companies regarding this trial at that point.
This became a catalyst for the ENHANCE trial results to be finally released at the beginning of 2008, which caught the attention of major media organizations, as expected. In the spring of 2008, a very large cardiology meeting was held, where the audience was told, I understand, to stick with statins due to this trial’s lack of outcomes for Vytorin, when the ENHANCE trial was discussed at this meeting. Furthermore, it has been said that a cardiologist at this meeting also suggested that a moratorium should occur with the utilization of Vytorin by prescribers, since statins are much less expensive, and are highly regarded, as they have been available for a couple of decades, starting with Mevacor in the 1980s. Of course and as expected, Merck and Schering were not pleased, nor were they surprised at the review of Vytorin at this particular meeting. The following month after this cardiology meeting, Schering’s earnings dropped by 48 percent, as I recall. Also during much of this year, Schering in particular blamed the media for amplifying the situation regarding the ENHANCE trial.
Now, these cholesterol drugs promoted by Merck and Schering, Zetia and Vytorin, were aggressively marketed in a number of ways, including investing I believe about 200million dollars in 2007 for DTC ads for these products. To add to this, and soon after both meds were launched, reps from both companies made inferences to doctors about outcomes regarding plaque accumulation and how Vytorin was superior in that area, which, of course, this ENHANCE trial proved it is in fact not the case whatsoever. It did not matter, apparently, to both Merck and Schering that such claims were is entirely void of proof, which is not unique to any pharma rep, in my opinion. No remorse or regret from the makers of these drug makers, either, which did not shock many. Yet what is known now is that these companies, as stated by other researchers, performed junk science with their deliberate manipulation of this ENHANCE trial using such tactics. Also, last year, Zetia and Vytorin had about 20 percent of the cholesterol lowering market. It does not seem that there will be an increase of this percentage because of this scandal. Possibly if they presented the truth, the future of these meds might be better than what is anticipated presently.
Worst of all regarding this ENHANCE trial scandal is the harm caused to both doctors and patients. The ENHANCE trial concerned and confused both of these participants in the health care system. Furthermore, it’s likely they were devastated by being so clearly misled by the marketing of both Merck and Schering regarding the false benefits of Vytorin they were led to believe by the companies that promoted them- the health care providers in particular.
This whole situation is another example of the progressively frequent discovery of corruption of the scientific method by placing profits over the well-being of patients, which harms the well being of patients. In addition, most were shocked by Merck behaving in such a way in particular because of what use to be their excellent reputation as an ethical pharmaceutical company. And this alone shows the progression and infiltration of such damaging ethical atrophy that desperately needs to be stopped and corrected for the sake of others- for everyone.
Don’t just say something. Have something to say- to the right people, with conviction and with others who share your views.
“Try not to become a man of success, but rather try to become a man of value.” --- Albert Einstein
Dan Abshear

Author’s note: What you have read is based upon information and belief. Thank you

]]> Wed, 23 Jul 2008 23:46:15 -0400 brainblogger.com:

A Failed Attempt to Improve Misperceived Greatness: The ENHANCE Trial

While it seems that pharmaceutical company sponsors of clinical trials usually end up with results that clearly favor their meds studied in their trial, there are rare exceptions, and Merck and Schering proved that with their disappointing ENHANCE Trial, which many have heard about through the media not long ago. The drugs studied were Vytorin, which was compared with Zocor
Vytorin is a combination med for high cholesterol and contains Merck’s Zocor, which is now generic, and Schering’s Zetia, which works differently than Zocor, which is one of many statin drugs. Both Vytorin and Zetia are co-promoted by Merck and Schering. So, several years ago, an outcomes study was initiated to prove superiority of Vytorin over Zocor. The trial was named the ENHANCE trial, and possibly this trial was initiated because Zocor is generic now, and not a priority from a profit paradigm of its creator.
After several years passed, a disappointment arrived for the sponsors of this trial, which was first brought to the attention of Schering in March of 2007, yet the results existed since the spring of 2006, I believe upon information and belief.
The disappointment is that Vytorin lacked anticipated benefit or superiority over Zocor. Since about 1 million scripts were written for both Vytorin and Zetia every week in 2007, combined with what I believe was about 5 billion in revenue for these two drugs that year, this was a problem for the drug makers, meaning a fear of shareholder reaction. Perhaps for Schering in particular, it was more of a calamity, since over half of their profits and earnings were from these two drugs with Schering, I understand.
Being the responsible corporations both companies are, of course, alterations occurred after such events were discovered that fractured numerous rules and regulations with clinical trials, possibly in illegal and unethical tactics.
The trial sponsors delayed the release of the trial results for secrecy reasons, it has been speculated. Results from the trial existed, yet were not disclosed at the time of their discovery. After several months of possessing these trial results that were only known to the manufacturers, they created or implemented some atrocious tactics to improve the trial’s unimpressive results following the original results of this ENHANCE study. At the end of 2007, the companies changed the primary endpoint of the trial, which is what the results were measured upon during the entire course of the trial. Sort of like sorting cards to make a good hand not dealt to you. Anyway, since their deliberate concealment of these trial results was clearly wrong, to respond to those who asked where the results were actually as they had been anticipated for quite some time, and while such trial manipulation was occurring and results were being kept secret, Schering stated that continued data analysis from the trial results was the etiology for the delay.
With clinical trials, case report forms are used to record data from the trials, and are created in a manner where further analysis is not normally necessary, as such forms are quite clear and often not subject to interpretation as implied by the trial sponsors, one could conclude. So at the end of 2007, both Merck and Schering got the attention of relevant government officials who contacted both companies regarding this ENHANCE trial due to such suspicions on the facts known and presented, and an investigation began into the activities of both companies regarding this trial at that point.
This became a catalyst for the ENHANCE trial results to be finally released at the beginning of 2008, which caught the attention of major media organizations, as expected. In the spring of 2008, a very large cardiology meeting was held, where the audience was told, I understand, to stick with statins due to this trial’s lack of outcomes for Vytorin, when the ENHANCE trial was discussed at this meeting. Furthermore, it has been said that a cardiologist at this meeting also suggested that a moratorium should occur with the utilization of Vytorin by prescribers, since statins are much less expensive, and are highly regarded, as they have been available for a couple of decades, starting with Mevacor in the 1980s. Of course and as expected, Merck and Schering were not pleased, nor were they surprised at the review of Vytorin at this particular meeting. The following month after this cardiology meeting, Schering’s earnings dropped by 48 percent, as I recall. Also during much of this year, Schering in particular blamed the media for amplifying the situation regarding the ENHANCE trial.
Now, these cholesterol drugs promoted by Merck and Schering, Zetia and Vytorin, were aggressively marketed in a number of ways, including investing I believe about 200million dollars in 2007 for DTC ads for these products. To add to this, and soon after both meds were launched, reps from both companies made inferences to doctors about outcomes regarding plaque accumulation and how Vytorin was superior in that area, which, of course, this ENHANCE trial proved it is in fact not the case whatsoever. It did not matter, apparently, to both Merck and Schering that such claims were is entirely void of proof, which is not unique to any pharma rep, in my opinion. No remorse or regret from the makers of these drug makers, either, which did not shock many. Yet what is known now is that these companies, as stated by other researchers, performed junk science with their deliberate manipulation of this ENHANCE trial using such tactics. Also, last year, Zetia and Vytorin had about 20 percent of the cholesterol lowering market. It does not seem that there will be an increase of this percentage because of this scandal. Possibly if they presented the truth, the future of these meds might be better than what is anticipated presently.
Worst of all regarding this ENHANCE trial scandal is the harm caused to both doctors and patients. The ENHANCE trial concerned and confused both of these participants in the health care system. Furthermore, it’s likely they were devastated by being so clearly misled by the marketing of both Merck and Schering regarding the false benefits of Vytorin they were led to believe by the companies that promoted them- the health care providers in particular.
This whole situation is another example of the progressively frequent discovery of corruption of the scientific method by placing profits over the well-being of patients, which harms the well being of patients. In addition, most were shocked by Merck behaving in such a way in particular because of what use to be their excellent reputation as an ethical pharmaceutical company. And this alone shows the progression and infiltration of such damaging ethical atrophy that desperately needs to be stopped and corrected for the sake of others- for everyone.
Don’t just say something. Have something to say- to the right people, with conviction and with others who share your views.
“Try not to become a man of success, but rather try to become a man of value.” --- Albert Einstein
Dan Abshear

Author’s note: What you have read is based upon information and belief. Thank you

]]> http://seekingalpha.com/article/81246-10-reasons-in-store-clinics-will-succeed?source=feed#comment-209498 209498
Recently in the media, issues have been addressed regarding the specialty of primary care or family practice doctors and the shortage of them in the U.S. In summary, reasons for the shortage that exists are due to the specialty not being that profitable for a doctor compared with other specialties. As a consequence, the doctors view the specialty as not a desirable choice apparently quite often, although the specialty is greatly needed in the health care system and for the public health.
As a layperson, I view primary care as ultimately a specialist in nothing in particular, yet knowledgeable in a large variety of medical areas, which I believe, makes them very valuable to those patients seeking restoration of their health. Furthermore, there is a comfort level with those in this specialty compared with other specialties, one could speculate. So the shortage of primary care doctors is in fact disappointing. Perhaps most disappointing is the atrophy of the doctor-patient relationship unique with such doctors.
Yet one possible solution is what is known as retail care clinics, and their popularity was increasing not long ago for a variety of reasons. And their eventual need has yet to be determined and is only speculated by others at this time. Of particular note of most of these types of clinics is that are normally staffed with nurse practitioners, who are, like doctors, more thorough than others, but are favored by many as a vocation and sought as treatment providers progressively.
First, I’ll offer a definition of a retail clinic: A retail clinic is a medical treatment facility that is usually located in a convenient location, such as a shopping area, and are smaller than most doctors’ offices in regards to geographical space. Usually, these clinics are staffed with a nurse practitioner that often have the ability and authority to provide the same quality care as a primary care physician, and do so with the same standards regarding accountability and autonomy. If you happen to go to one for what may be considered a mild ailment, for example, for such conditions as allergies or the flu, you will notice a unique and pleasant paradigm towards your care at such a clinic in comparison with present medical offices that are possibly demoralized if not largely apathetic:
These urgent care light clinics are normally and amazingly quick for a patient treated at such a location. You are normally in and out of there within a half hour or so. This includes a thorough assessment and treatment regimen offered. Unlike typical doctor offices, these clinics are walk-in clinics, so there is no over-booking of patients, which is what typically occurs at current offices of doctors, as many are focused on daily volume of patients, as they are usually a member of a large health care system that instructs these offices in such a way.
With these convenience care clinics, you actually dialogue with your health care provider more so than you have experienced in a traditional doctor’s office due to other doctor offices often being incredibly busy from seeing too many patients during a typical day for reasons described above. And this is not to imply that the health care providers at typical doctor offices do not care about you and one’s particular health issues, yet possibly is due to limited resources, possibly.
The cost of going to such a retail clinic, which is sometimes termed an ‘urgent care light’ clinic or convenience care clinic, that have already been mentioned, is usually about ¾ or less than the cost of a typical primary care doctor visit, I understand
You will likely notice no decline in the quality of care that you receive. In fact, likely you will experience greater quality on many different levels, both on a personal and clinical level, yet this premise lacks certainty due to the many variables involved.
Critics of such clinics include the American Medical Association and various medical societies, yet in my opinion, they are simply vexed because of the invasion of these clinics on their turf and their infiltration into their group without being invited, perhaps.
If it is discovered that you need greater medical care or attention than the retail clinic can provide for you during your visit at their urgent care light clinic, you will most likely be referred to a nearby location that can provide the care you are determined to need by the clinic’s heath care provider, who has likely has some familiarity and possibly some relationships with the hospitals and others in the medical community for which they serve.
So most patients of these retail clinics are pleased with the care they receive from them, which is why they continue to grow in number under different names, as they have become franchises, yet the concept of this pay as you go health care is fairly new, only the future will tell if this method is preferred by those seeking minor restoration of their health.
These retail clinics, it appears, provide possibly provide a response to the shortage of primary care doctors that some believe exist, and possibly are an answer to other problems that exist in the health care system in the U.S., which includes wait time and frequent distant relationships from their other health care providers. One could conclude that the retail clinics seem in a way more authentic than the dominant structure, and may be more beneficial ultimately for the public health, with exceptions, of course.
Dan Abshear
“Compassion is the basis of all morality.” --- Arthur Schopenhauer
Author’s note: What has been written is based upon information and belief

]]> Sat, 19 Jul 2008 16:15:50 -0400
Recently in the media, issues have been addressed regarding the specialty of primary care or family practice doctors and the shortage of them in the U.S. In summary, reasons for the shortage that exists are due to the specialty not being that profitable for a doctor compared with other specialties. As a consequence, the doctors view the specialty as not a desirable choice apparently quite often, although the specialty is greatly needed in the health care system and for the public health.
As a layperson, I view primary care as ultimately a specialist in nothing in particular, yet knowledgeable in a large variety of medical areas, which I believe, makes them very valuable to those patients seeking restoration of their health. Furthermore, there is a comfort level with those in this specialty compared with other specialties, one could speculate. So the shortage of primary care doctors is in fact disappointing. Perhaps most disappointing is the atrophy of the doctor-patient relationship unique with such doctors.
Yet one possible solution is what is known as retail care clinics, and their popularity was increasing not long ago for a variety of reasons. And their eventual need has yet to be determined and is only speculated by others at this time. Of particular note of most of these types of clinics is that are normally staffed with nurse practitioners, who are, like doctors, more thorough than others, but are favored by many as a vocation and sought as treatment providers progressively.
First, I’ll offer a definition of a retail clinic: A retail clinic is a medical treatment facility that is usually located in a convenient location, such as a shopping area, and are smaller than most doctors’ offices in regards to geographical space. Usually, these clinics are staffed with a nurse practitioner that often have the ability and authority to provide the same quality care as a primary care physician, and do so with the same standards regarding accountability and autonomy. If you happen to go to one for what may be considered a mild ailment, for example, for such conditions as allergies or the flu, you will notice a unique and pleasant paradigm towards your care at such a clinic in comparison with present medical offices that are possibly demoralized if not largely apathetic:
These urgent care light clinics are normally and amazingly quick for a patient treated at such a location. You are normally in and out of there within a half hour or so. This includes a thorough assessment and treatment regimen offered. Unlike typical doctor offices, these clinics are walk-in clinics, so there is no over-booking of patients, which is what typically occurs at current offices of doctors, as many are focused on daily volume of patients, as they are usually a member of a large health care system that instructs these offices in such a way.
With these convenience care clinics, you actually dialogue with your health care provider more so than you have experienced in a traditional doctor’s office due to other doctor offices often being incredibly busy from seeing too many patients during a typical day for reasons described above. And this is not to imply that the health care providers at typical doctor offices do not care about you and one’s particular health issues, yet possibly is due to limited resources, possibly.
The cost of going to such a retail clinic, which is sometimes termed an ‘urgent care light’ clinic or convenience care clinic, that have already been mentioned, is usually about ¾ or less than the cost of a typical primary care doctor visit, I understand
You will likely notice no decline in the quality of care that you receive. In fact, likely you will experience greater quality on many different levels, both on a personal and clinical level, yet this premise lacks certainty due to the many variables involved.
Critics of such clinics include the American Medical Association and various medical societies, yet in my opinion, they are simply vexed because of the invasion of these clinics on their turf and their infiltration into their group without being invited, perhaps.
If it is discovered that you need greater medical care or attention than the retail clinic can provide for you during your visit at their urgent care light clinic, you will most likely be referred to a nearby location that can provide the care you are determined to need by the clinic’s heath care provider, who has likely has some familiarity and possibly some relationships with the hospitals and others in the medical community for which they serve.
So most patients of these retail clinics are pleased with the care they receive from them, which is why they continue to grow in number under different names, as they have become franchises, yet the concept of this pay as you go health care is fairly new, only the future will tell if this method is preferred by those seeking minor restoration of their health.
These retail clinics, it appears, provide possibly provide a response to the shortage of primary care doctors that some believe exist, and possibly are an answer to other problems that exist in the health care system in the U.S., which includes wait time and frequent distant relationships from their other health care providers. One could conclude that the retail clinics seem in a way more authentic than the dominant structure, and may be more beneficial ultimately for the public health, with exceptions, of course.
Dan Abshear
“Compassion is the basis of all morality.” --- Arthur Schopenhauer
Author’s note: What has been written is based upon information and belief

]]> http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-202626 202626
*FDA’s mission statement: To promote and protect public health

Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness presently. Since such patients will likely die in a short period of time, treatment options, even if they are not entirely unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. Reform has to start somewhere at some time.
Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men. Furthermore, out of all cancer types more are dying from prostate cancer now than other cancer diagnoses.
For those unaware, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant. Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA blood test, as PSA is a protein produced by prostate cancer cells. If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.
Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as taxotere. The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only. This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials. The FDA announced this to the public in the early Spring of 2007, I believe.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself!
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway. Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown. What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others. A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so. It is an individual decision in such cases that should be void of interference from others.

“Politics is the systematic organization of hatreds.” --- Henry Adams

Dan Abshear

Author’s note: What has been written is based upon information and belief
]]> Thu, 10 Jul 2008 20:12:54 -0400
*FDA’s mission statement: To promote and protect public health

Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness presently. Since such patients will likely die in a short period of time, treatment options, even if they are not entirely unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. Reform has to start somewhere at some time.
Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men. Furthermore, out of all cancer types more are dying from prostate cancer now than other cancer diagnoses.
For those unaware, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant. Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA blood test, as PSA is a protein produced by prostate cancer cells. If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.
Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as taxotere. The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only. This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials. The FDA announced this to the public in the early Spring of 2007, I believe.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself!
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway. Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown. What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others. A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so. It is an individual decision in such cases that should be void of interference from others.

“Politics is the systematic organization of hatreds.” --- Henry Adams

Dan Abshear

Author’s note: What has been written is based upon information and belief
]]> http://seekingalpha.com/article/76414-celgene-corp-q1-2008-earnings-call-transcript?source=feed#comment-201926 201926
Celgene may be one of the top ten biopharmaceutical companies in existence out of 200 companies or so, and one of the few that are actually profitable.

Thalmide is the comeback drug of all drugs considering its history, yet proved itself to be an asset in the onconology. More importantly, Revlimid was approved a couple of years ago and is a cleaner drug than thalmide. Revlimid is a immunomodulating drug that has many mechanisms of action that delay the progression of multiple myeloma and in some cases, remission occurs when patients take this medication. A deadly hematological cancer, about one third of all cases can advance to leukemia from multiple myeloma. Revliid stops the spread of myeloma for several months, and is highly active against the many etiologies and aspects of this disease state, along with being highly efficacious and safe for use, and this has been proven often. Revlinid increases the survival and response rates to ensure durable disease control for appropriate patients. Doctors adapted and contine to adopt to Revlinid rather quickly because of the clinical data behind the drug that has continuously proven it to be very safe and efficacious compared with previous treatment options available. For anemia, most patients on Revlimid achieve independence from transfusions during treatment with this medication. Not bad or being an analogue of Thalmide.

Pts. on Revlimid has improved complete response rates due to the drug being a powerful angiogenesis inhibitor and catalyst of apoptosis in regards to tumor destruction. More incredibly compelling traits of this drug is that it inhibits TNF and continued cancer cell growth, while simulating the production of T-cells, interleukin, and interferon, as well as being an excellent cytogenic remitting agent as well, all of which benefit a patient who has a cancer of this nature.

Revlimid is approaching 2 billion annual sales due to the preferred agent for the diseases for which it treats, with Velcade being the only competitor, and not much of one at that. Celgene's pipeline is interesting as well.

Celgene is one of the most richly valued biopharmaceutical companies relative to it's earnings. The company remains independent, and finally, Celgene puts 2 to 3 times as much revenue in thie research and development than other drug makers, which is 30 to 40 percent of thier annual revenue. Thier innovation is obvious, and acquisitions appropriate. I'm sure haematolgists would concur with much of what has been written. Pt's actually get thier money's worth with this agent.]]> Wed, 09 Jul 2008 21:52:52 -0400
Celgene may be one of the top ten biopharmaceutical companies in existence out of 200 companies or so, and one of the few that are actually profitable.

Thalmide is the comeback drug of all drugs considering its history, yet proved itself to be an asset in the onconology. More importantly, Revlimid was approved a couple of years ago and is a cleaner drug than thalmide. Revlimid is a immunomodulating drug that has many mechanisms of action that delay the progression of multiple myeloma and in some cases, remission occurs when patients take this medication. A deadly hematological cancer, about one third of all cases can advance to leukemia from multiple myeloma. Revliid stops the spread of myeloma for several months, and is highly active against the many etiologies and aspects of this disease state, along with being highly efficacious and safe for use, and this has been proven often. Revlinid increases the survival and response rates to ensure durable disease control for appropriate patients. Doctors adapted and contine to adopt to Revlinid rather quickly because of the clinical data behind the drug that has continuously proven it to be very safe and efficacious compared with previous treatment options available. For anemia, most patients on Revlimid achieve independence from transfusions during treatment with this medication. Not bad or being an analogue of Thalmide.

Pts. on Revlimid has improved complete response rates due to the drug being a powerful angiogenesis inhibitor and catalyst of apoptosis in regards to tumor destruction. More incredibly compelling traits of this drug is that it inhibits TNF and continued cancer cell growth, while simulating the production of T-cells, interleukin, and interferon, as well as being an excellent cytogenic remitting agent as well, all of which benefit a patient who has a cancer of this nature.

Revlimid is approaching 2 billion annual sales due to the preferred agent for the diseases for which it treats, with Velcade being the only competitor, and not much of one at that. Celgene's pipeline is interesting as well.

Celgene is one of the most richly valued biopharmaceutical companies relative to it's earnings. The company remains independent, and finally, Celgene puts 2 to 3 times as much revenue in thie research and development than other drug makers, which is 30 to 40 percent of thier annual revenue. Thier innovation is obvious, and acquisitions appropriate. I'm sure haematolgists would concur with much of what has been written. Pt's actually get thier money's worth with this agent.]]> http://seekingalpha.com/article/82927-diabetes-stocks-remain-healthy?source=feed#comment-200177 200177
With some diabetic patients, the hormone insulin may be absent, yet necessary for their survival. As I recall, a man named Pauescu developed the concept of insulin replacement, and discovered a method of using insulin secreted from pigs as a replacement method for humans, which was effective at that time. Legend has it that this concept originated in a dream this man had on a night soon before his idea became reality several decades ago. Yet presently, this hormone which is naturally produced by the pancreas normally has advanced as far as treatment goes for the diabetic patient through synthetic engineering, as this is needed for survival for some diabetic patients.
Recently, the Denver Bronco’s quarterback, Jay Cutler, was recently diagnosed with diabetes, a disease that affects over 20 million people. As I recall, part of his treatment regimen involves what is called an insulin pump. They are approximately the size of a cell phone, and the users of such pumps are called, in the diabetic community, ‘pumpers’. Developed primarily for type 1, or insulin-dependent diabetic patients, the pumps can be used by some type 2 diabetic patients if they have some dependence on insulin replacement, which has steadily increased over the years. The importance of the device is improved management of the disease, which can cause life-threatening consequences if the disease of diabetes is not controlled properly. By the way, he takes it off for games, practice, etc.
The three elements The Pumps: A New Paradigm in diabetes management of an insulin pump include the pump itself and its components, such as the insulin tube for delivery of insulin, and a catheter that delivers basal and bolus doses, which are dependent on preset calculations. The amount of insulin is rapid acting to ensure maximal pharmacokinetics to create intensive insulinotherapy for required diabetes management. These insulin amounts are ultimately determined by the patient’s doctor, who is usually an Endocrinologist, including bolus doses determined by the patients glucose level calculated with their carbohydrate intake, also known as the meal- time dose. Furthermore, the amount of insulin delivered by these methods is quite small due to the nature of the medication being rapid acting.
The makers of such pumps tend to partner with associations relevant to the disease of diabetes, as well as local chapters of such organizations as the ADA and Endocrinology societies that may exist, along with contacting diabetes educators frequently at different locations throughout the country. Unfortunately, there are few Endocrinologists in the United States, as it is not one of the more lucrative specialties of a doctor, so treatment of diabetes is dependent on many others who are not doctors, but patient care specialists regarding this disease.
Competing companies are few, as there are approximately 5 insulin pumps in the market, with Medtronic having the largest share of 30 percent, as I understand. In addition, some pumps avoid the possibility of metabolic action therapy due to their dosing precision, in addition, there is at least one pump that has long acting lithium battery that averages about a 6 week lifespan, yet a pump user should have a battery replacement with them at all times. The personalized insulin and carbohydrate ratio provided by insulin pumps greatly reduces any incidence of such complications as hypoglycemia. Also, in addition to storing and recording glucose and carbohydrate values with a back up mechanisms, some insulin pumps have a low basal rate, which I understand is an advantage as well. Regardless, and in my opinion, the ultimate advantages of insulin pumps exist with all that are available to patients presently.
The cartridges of the insulin pumps hold a large number of units of insulin, which is an additional benefit. Further benefits include the fact that the pumps are convenient and reliable- especially if damage is avoided to the pump. Most importantly, the personal service provided to the patients by the caregivers of existing diabetic teams in health care facilities from hospitals to health care centers dedicated to the disease of diabetes ensures proper management of their disease, much to the benefit of those who have diabetes.
The market growth of insulin pumps is anticipated at over 10 percent a year, as only 20 percent of type 1 diabetic patients have utilized these pumps out of over a million type 1 diabetics in the United States. The market is speculated to be greater than one billion dollars and is expected to increase due to speculated growth of the Insulin pump market. Many believe this therapy is superior in comparison with previous treatment options available to diabetic patients, along with being less cumbersome for these patients. Because of this, there is decreased mortality along with increased quality of life for diabetics, as they are assured of better control of their disease in this rather convenient way. This has been proven by better A1C blood tests and glycemic control of diabetic patients.
The steady dosing maintains the patient’s metabolic requirements and decreases long term consequences associated with diabetics. It has also been proven that insulin pumps result in fewer hospitalizations, ER visits, and episodes of hypoglycemia due to the excellent control provided by the insulin pumps while providing the necessary intensive therapy for their disease state. The fast acting insulin used in these pumps is created through genetic engineering, I believe. In addition, patients are encouraged to check their blood sugar greater than three times a day while on the insulin pump. So this system is both friendly to the user and is clearly a very convenient form of treatment for them. The A1C test, by the way, is a blood test that reflects the diabetic patient’s average blood sugar over a period of a few months.
Those who may be interested in insulin pumps will include those described already, along with hospitals, long term care facilities, home health care agencies, pediatricians, and possibly dialysis clinics, to name a few. Most likely, those considered for insulin pumps will be diabetic patients that are unable to achieve compliance with their current treatment regimen, along with other benefits of insulin pumps stated so far.
The diabetes team for a diabetic patient may include an Endocrinologist, a diabetes educator, a dietician, along with the insulin pump representative. Follow ups with this team may include review the progress of the insulin pump for the patient and how the patient is tolerating the treatment. Often, classes can be scheduled through an institution or center regarding insulin pump training a few times a month. Education and training about the insulin pump may include the following:


1. Glycemic control importance and how to prevent and treat as needed
2. Basal and bolus concepts and how they contribute to the treatment
3. Pump basics and strategies. Negative effects stressed to pt. if their pump is not used properly.
4. Importance of knowing blood sugar and why. Definitions of terms like A1C
5. How to deliver a bolus dose after checking carbohydrate intake
6. How to check the pump’s memory
7. Troubleshooting, phone number access, and how to replace battery
8. Emphasize the safety of the insulin pump if operated correctly
9. Keeping a glucagon injection and spare battery with you



Ultimately after training others, it is important that the patient acknowledges understanding of how the device works, as well as the consequences that may occur if directions are not followed that are ultimately determined by the patients doctor. And fortunately, doctors and others who treat diabetes now have a new tool or device to assure compliance and longevity of these patients.

Innovation is a wonderful thing, such as what has been described. Control of such a large and devastating disease is of great importance, so there seems to be a much desired need for pumpers now and likely in the future. Especially for those patients who slack on following their prescribed treatment regimen. And this will have to do until relevant transplants to reverse diabetes become more frequent and less complicated.

“Death destroys a man. The idea of death saves him.” --- E.M. Forster


Dan Abshear

Author’ note: What has been annotated is based upon information and belief

]]> Mon, 07 Jul 2008 17:54:21 -0400
With some diabetic patients, the hormone insulin may be absent, yet necessary for their survival. As I recall, a man named Pauescu developed the concept of insulin replacement, and discovered a method of using insulin secreted from pigs as a replacement method for humans, which was effective at that time. Legend has it that this concept originated in a dream this man had on a night soon before his idea became reality several decades ago. Yet presently, this hormone which is naturally produced by the pancreas normally has advanced as far as treatment goes for the diabetic patient through synthetic engineering, as this is needed for survival for some diabetic patients.
Recently, the Denver Bronco’s quarterback, Jay Cutler, was recently diagnosed with diabetes, a disease that affects over 20 million people. As I recall, part of his treatment regimen involves what is called an insulin pump. They are approximately the size of a cell phone, and the users of such pumps are called, in the diabetic community, ‘pumpers’. Developed primarily for type 1, or insulin-dependent diabetic patients, the pumps can be used by some type 2 diabetic patients if they have some dependence on insulin replacement, which has steadily increased over the years. The importance of the device is improved management of the disease, which can cause life-threatening consequences if the disease of diabetes is not controlled properly. By the way, he takes it off for games, practice, etc.
The three elements The Pumps: A New Paradigm in diabetes management of an insulin pump include the pump itself and its components, such as the insulin tube for delivery of insulin, and a catheter that delivers basal and bolus doses, which are dependent on preset calculations. The amount of insulin is rapid acting to ensure maximal pharmacokinetics to create intensive insulinotherapy for required diabetes management. These insulin amounts are ultimately determined by the patient’s doctor, who is usually an Endocrinologist, including bolus doses determined by the patients glucose level calculated with their carbohydrate intake, also known as the meal- time dose. Furthermore, the amount of insulin delivered by these methods is quite small due to the nature of the medication being rapid acting.
The makers of such pumps tend to partner with associations relevant to the disease of diabetes, as well as local chapters of such organizations as the ADA and Endocrinology societies that may exist, along with contacting diabetes educators frequently at different locations throughout the country. Unfortunately, there are few Endocrinologists in the United States, as it is not one of the more lucrative specialties of a doctor, so treatment of diabetes is dependent on many others who are not doctors, but patient care specialists regarding this disease.
Competing companies are few, as there are approximately 5 insulin pumps in the market, with Medtronic having the largest share of 30 percent, as I understand. In addition, some pumps avoid the possibility of metabolic action therapy due to their dosing precision, in addition, there is at least one pump that has long acting lithium battery that averages about a 6 week lifespan, yet a pump user should have a battery replacement with them at all times. The personalized insulin and carbohydrate ratio provided by insulin pumps greatly reduces any incidence of such complications as hypoglycemia. Also, in addition to storing and recording glucose and carbohydrate values with a back up mechanisms, some insulin pumps have a low basal rate, which I understand is an advantage as well. Regardless, and in my opinion, the ultimate advantages of insulin pumps exist with all that are available to patients presently.
The cartridges of the insulin pumps hold a large number of units of insulin, which is an additional benefit. Further benefits include the fact that the pumps are convenient and reliable- especially if damage is avoided to the pump. Most importantly, the personal service provided to the patients by the caregivers of existing diabetic teams in health care facilities from hospitals to health care centers dedicated to the disease of diabetes ensures proper management of their disease, much to the benefit of those who have diabetes.
The market growth of insulin pumps is anticipated at over 10 percent a year, as only 20 percent of type 1 diabetic patients have utilized these pumps out of over a million type 1 diabetics in the United States. The market is speculated to be greater than one billion dollars and is expected to increase due to speculated growth of the Insulin pump market. Many believe this therapy is superior in comparison with previous treatment options available to diabetic patients, along with being less cumbersome for these patients. Because of this, there is decreased mortality along with increased quality of life for diabetics, as they are assured of better control of their disease in this rather convenient way. This has been proven by better A1C blood tests and glycemic control of diabetic patients.
The steady dosing maintains the patient’s metabolic requirements and decreases long term consequences associated with diabetics. It has also been proven that insulin pumps result in fewer hospitalizations, ER visits, and episodes of hypoglycemia due to the excellent control provided by the insulin pumps while providing the necessary intensive therapy for their disease state. The fast acting insulin used in these pumps is created through genetic engineering, I believe. In addition, patients are encouraged to check their blood sugar greater than three times a day while on the insulin pump. So this system is both friendly to the user and is clearly a very convenient form of treatment for them. The A1C test, by the way, is a blood test that reflects the diabetic patient’s average blood sugar over a period of a few months.
Those who may be interested in insulin pumps will include those described already, along with hospitals, long term care facilities, home health care agencies, pediatricians, and possibly dialysis clinics, to name a few. Most likely, those considered for insulin pumps will be diabetic patients that are unable to achieve compliance with their current treatment regimen, along with other benefits of insulin pumps stated so far.
The diabetes team for a diabetic patient may include an Endocrinologist, a diabetes educator, a dietician, along with the insulin pump representative. Follow ups with this team may include review the progress of the insulin pump for the patient and how the patient is tolerating the treatment. Often, classes can be scheduled through an institution or center regarding insulin pump training a few times a month. Education and training about the insulin pump may include the following:


1. Glycemic control importance and how to prevent and treat as needed
2. Basal and bolus concepts and how they contribute to the treatment
3. Pump basics and strategies. Negative effects stressed to pt. if their pump is not used properly.
4. Importance of knowing blood sugar and why. Definitions of terms like A1C
5. How to deliver a bolus dose after checking carbohydrate intake
6. How to check the pump’s memory
7. Troubleshooting, phone number access, and how to replace battery
8. Emphasize the safety of the insulin pump if operated correctly
9. Keeping a glucagon injection and spare battery with you



Ultimately after training others, it is important that the patient acknowledges understanding of how the device works, as well as the consequences that may occur if directions are not followed that are ultimately determined by the patients doctor. And fortunately, doctors and others who treat diabetes now have a new tool or device to assure compliance and longevity of these patients.

Innovation is a wonderful thing, such as what has been described. Control of such a large and devastating disease is of great importance, so there seems to be a much desired need for pumpers now and likely in the future. Especially for those patients who slack on following their prescribed treatment regimen. And this will have to do until relevant transplants to reverse diabetes become more frequent and less complicated.

“Death destroys a man. The idea of death saves him.” --- E.M. Forster


Dan Abshear

Author’ note: What has been annotated is based upon information and belief

]]> http://seekingalpha.com/article/83877-genentech-s-avasitin-price-is-unsustainable?source=feed#comment-200171 200171 Mon, 07 Jul 2008 17:35:26 -0400 http://seekingalpha.com/article/48924-more-big-pharma-layoffs-what-this-may-mean?source=feed#comment-199533 199533
While the pharmaceutical industry’s image and reputation has and appears to continue to suffer, added damage has expressed itself with costly patent expirations. Yet the big pharma task forces still insist that reps provide incredible value, and the more the better, as the drug reps are the givers of gifts, and reciprocity in the form of prescriptions just has to occur, as the samples reps dispense are around 20 billion a year, along with the reps themselves costing about 5 billion a year by the pharmaceutical industry. It is possible for prescribers to order samples on the internet to be delivered to their practice, but this remains rare presently
As a big pharma ex drug rep for over a decade, which during that period the number of drug reps actually tripled, the drug rep’s vocation has become more ridiculous, and possibly void of any true sense of accomplishment due to their customers preventing them from interaction or even presence in order for the drug reps to follow directives of the health care givers, and not their own employers, which is to influence their prescribing habits via direct dialogue along with the giving of gifts. The job has become nothing more than doing lunches and leaving samples at offices, for the most part. My perception formed from my own analysis of how drug reps operate in today’s environment in the medical community has led me to draw such conclusions, which I believe to be accurate.
So they may be named at times in different ways, these promoters will be referred to now only as drug reps, which number close to 100,000 in the U.S. presently to influence close to 1 million prescribers in this country, it is believed, yet is probably less now due to big pharma cutting thousands of reps recently. The cost to the pharmaceutical industry of these drug reps is around 5 billion dollars a year. Income for each rep grosses close to or above 100,000 grand a year on average, along with great benefits and a company car, as well as stock options as they gladly work from their homes and set their own hours, which I understand is much less than 8 hours a day.
The main function these days of drug reps, I believe, is primarily to offer doctors various types of inducements of a certain value that are not gifts, but bribes, by definition. The drug sampling of doctors may be considered an inducement, and a rather valuable one for the drug rep, as many believe that these samples are what ultimately influence the doctor’s prescribing habits over anything else, including statements from drug reps. This may be why the drug industry spends around 20 billion every year on samples. Yet I want to be clear on what I am saying: drug reps are some of the smartest people you will meet that do in fact have great paying jobs with great benefits. Most importantly and my opinion, I believe most reps really WANT to do well for their employers, yet are prohibited from doing so now because of how their employers are now viewed in their medical community.
Many years ago, drug reps have used their persuasive, yet ethical, abilities to influence the prescribing habits of doctors in an honest and ethical manner, as they focused on the benefits for the doctor’s patients with a particular drug that the detailer may promote to such a doctor. However presently, most health care providers now simply prevent drug reps to speak with them- now this is especially true when they are in clinic treating and assessing patients. More and more medical establishments are completely banning drug reps from their locations, and I speculate that this is occurring for many reasons, which may include the following:
The doctors lose money. Doctors are normally busy, so their time is valuable. As a drug rep, you are an incredible waste of their time. Yet they will accept your samples still. The credibility you possibly have thought you had and were perceived as such by doctors as a drug rep is no longer viewed to exist to any noticeable degree by the prescriber. For example and this is based on my experience and my colleagues, doctors view any information you may provide to them as biased and embellished. In my opinion, based on information and belief, their view regarding their assessment of you as a drug rep is accurate due to the statistical gymnastics the employers of drug reps engage in, which effectively and ultimately is permitting and encouraging the drug reps to lie to the doctor and likely are unaware of the statements stated by them are misleading. Doctors by their very nature seek answers objectively. And doctors do in fact find out about drugs through other methods besides the representative of the drug’s maker, such as the internet and experience with certain medications. Most drug reps in this country in particular mostly hire drug reps based on such qualities as the candidate’s looks as well as their personality, overall. Furthermore, it is possible that pharmaceutical companies desire their drug reps to be obedient and to not question what is asked of them. Upon speculation, this can be possibly determined by the background of the candidate, which may indicate they seek popularity as well as are money driven. In addition, most drug reps do not have degrees remotely related to any aspect of anything of a scientific or clinical nature.
During my decade as a drug rep, I would encounter on very rare occasion another rep that may have been a nurse or researcher, and this is concerning that others do not have similar backgrounds because the type of training necessary is rare for a drug rep. In fact, based on my opinion, many do not particularly care to acquire education related to such medical or clinical topics. They learn the basics in order to sell their promoted products. Yet anyone who has ever worked with doctors in a clinical setting, or in a hospital working in a clinical nature, likely they would agree that a drug rep should want to and seek all related to the complexities involved in the restoration of another’s health.
Many drug reps, it is believed, are void of any complete interest in medicine completely, and I believe this to be necessary. In addition, ethical considerations due to their possible deliberate ignorance created by the necessity of what they are required to say or do by their employers may be viewed as a disturbing fallacy as well. This allows them with the encouragement and coercion of their employer to embellish the benefits of their promoted products at times in addition to offering inducements to doctors in various ways- most of all of which are rather covert, yet performed and issued to select prescribers upon instruction of their employer. Examples may be creating a check from your company to a certain supporting doctor and handing this check to thank a doctor for supporting your company’s products for doing little if anything for your employer to justify this check. Or tangible items are given to such prescribers, such as TVs or DVDs which may or may not be utilized in a particular doctor’s office. It happens often, such activities.
From the drug rep’s perspective, it is unlikely they will even consider the possibility to question their pharmaceutical employer due to the great risk of losing income and benefits that they are unlikely to acquire at another place of employment. Because of their consistent and conscious effort to keep their high-paying jobs, the drug reps always appear overtly anxious to please their superiors- regardless of any ethics or legalities regarding any activity they may be required to perform. With big pharma in particular, each drug rep is given a variety of budgets, such as a chunk of cash for doctor office lunches that they are required to spend in a certain period of time. Another chunk of cash may be assigned to a rep to pay assigned or registered speakers of their employer to speak to other prescribers about a disease state related to the drug rep’s promoted product. These activities, in my time with big pharma, were never monitored or questioned by managers or superiors. What I did notice is that my annual raises were greater than others according to the amount I spent for that particular year, as this, according to a big pharma company, was a very objective and noticeable variable with securing and keeping your employment in big pharma.
While legally risky, the drug companies continue to dispense to their reps these large budgets their drug reps are in effect coerced to dispense with complete autonomy and possibly the spending can be fabricated, which is too complicated to fully explain. This design perhaps is why there are now various state and federal disclosure laws that are presently being considered to mandate the release of all funds dispensed from pharmaceutical companies as far as why a company’s funds were spent and for what reason or method. Because, according to the lobbyists of pharma companies, they consistently insist that whatever they spend always is for the benefit of public health. As mentioned earlier, presently such activities are quite covert. Yet if such laws are mandated, it is likely the accounting of pharma companies will become rather creative and incomplete. In summary, as a big pharma drug rep, my budgets were unlimited, and I typically spent more than I made though the activities I have mentioned so far. And this is not an isolated case. Historically, pharma lavished doctors with expesive gifts and trips. Now it is about funding for them, such as financial grants. Basically, the two remain synonymous and ethically conflicting.
Another issue is what is referred to as data mining. The American Medical Association sells this prescribing data on individual doctors to pharmaceutical companies or pharmacies, by providing others identifying numbers of a particular doctor, such as a state license number or DEA number, which allows them to track the scripts a doctor writes not far from real time availability. This data shows the volume of scripts of a particular doctor and what the doctor has been prescribing for the doctor’s patient for their disease state, and this data reveals competitor products to the drug rep as well. Aside from being deceiving and dishonest, the data allows a pharma company to ‘reward’ those doctors who support their products, while treating the other doctors with ‘neglect’, which means the non-supporters of a pharma company will not receive any inducement or remuneration from a particular pharma company. The data, by the way, only reflects numbers linked with particular products, and fortunately is free of patient names- this data that is provided to all drug reps. What has been described is the method typical with all big pharma companies, in my opinion, and I worked for three of them. It appears to be manipulative in a psychological paradigm- a combination of Pavlovian responses combined with positive and negative reinforcement.
So such methods create a toxic culture required to be absorbed by those members of such a pharma company. Furthermore, the tactics implemented by pharma companies vacuum the judgment of prescribers, which may prevent patients from receiving objective treatment. Yet on the most basic level, it is the samples left with prescribers that ultimately determine their prescribing habits- with various inducements to some doctors running close in second place. Yet remarkably, prescribers are prescribing more and more generics, which typically are not sampled to prescribers. I find this comforting that the manipulation efforts of the pharma industry are not as effective as they believe they are in a rather delusional way. Yet what is happening now in regards of branded meds vs. generic meds, insurance companies are flat out paying doctors to switch patients to a generic if one is available, as well as initiating generic medication treatment for their patients. I speculate they are paying doctors for this as a response of what pharma has been doing for quite a long time. From a clinical paradigm, if a medication is providing desired treatment and good tolerability for a particular patient, one could argue it would be unethical to switch treatment for financial gain, further complicated by the fact that most patients are aware that insurance company payments to doctors for this even occur.
It is likely and I believe that most drug reps are good and intelligent people who unfortunately are coerced to do things that may be considered corruptive to others in order to maintain their employment. In other words, the drug reps have compromised their integrity, ultimately.
It seems that external regulation is necessary to prevent the drug companies from allowing the autonomy of drug reps that exists, with their encouragement, which forces the reps to do the wrong thing for the medical community, possibly. Because it is obvious that internal controls with such corporations exist on paper often, but clearly are discouraged to be enforced. It is possible that these pharma companies falsely believe that being an ethical company would make them a company without excess profit. One can only speculate on their true motives. Yet it appears that overt greed has replaced ethics with this element of the health care system, which is the pharmaceutical industry, as illustrated with what occurs within these companies. However, reversing this misguided focus of drug companies is not impossible if the right action is taken for the benefit of public health. Likely, if there are no drug reps, there is no one to employ such tactics mentioned earlier. Because authentically educating doctors does not appear to be the reason for their vocation. This is far from being the responsibility of a pharmaceutical sales representative. Perhaps most frightening is that most drug reps fail to dig deep enough to realize that what they do at times may damage public health.

“Fear ensures loyalty.” --- Author unknown

Dan Abshear (what has been written is based upon information and belief).



]]> Mon, 07 Jul 2008 01:37:17 -0400
While the pharmaceutical industry’s image and reputation has and appears to continue to suffer, added damage has expressed itself with costly patent expirations. Yet the big pharma task forces still insist that reps provide incredible value, and the more the better, as the drug reps are the givers of gifts, and reciprocity in the form of prescriptions just has to occur, as the samples reps dispense are around 20 billion a year, along with the reps themselves costing about 5 billion a year by the pharmaceutical industry. It is possible for prescribers to order samples on the internet to be delivered to their practice, but this remains rare presently
As a big pharma ex drug rep for over a decade, which during that period the number of drug reps actually tripled, the drug rep’s vocation has become more ridiculous, and possibly void of any true sense of accomplishment due to their customers preventing them from interaction or even presence in order for the drug reps to follow directives of the health care givers, and not their own employers, which is to influence their prescribing habits via direct dialogue along with the giving of gifts. The job has become nothing more than doing lunches and leaving samples at offices, for the most part. My perception formed from my own analysis of how drug reps operate in today’s environment in the medical community has led me to draw such conclusions, which I believe to be accurate.
So they may be named at times in different ways, these promoters will be referred to now only as drug reps, which number close to 100,000 in the U.S. presently to influence close to 1 million prescribers in this country, it is believed, yet is probably less now due to big pharma cutting thousands of reps recently. The cost to the pharmaceutical industry of these drug reps is around 5 billion dollars a year. Income for each rep grosses close to or above 100,000 grand a year on average, along with great benefits and a company car, as well as stock options as they gladly work from their homes and set their own hours, which I understand is much less than 8 hours a day.
The main function these days of drug reps, I believe, is primarily to offer doctors various types of inducements of a certain value that are not gifts, but bribes, by definition. The drug sampling of doctors may be considered an inducement, and a rather valuable one for the drug rep, as many believe that these samples are what ultimately influence the doctor’s prescribing habits over anything else, including statements from drug reps. This may be why the drug industry spends around 20 billion every year on samples. Yet I want to be clear on what I am saying: drug reps are some of the smartest people you will meet that do in fact have great paying jobs with great benefits. Most importantly and my opinion, I believe most reps really WANT to do well for their employers, yet are prohibited from doing so now because of how their employers are now viewed in their medical community.
Many years ago, drug reps have used their persuasive, yet ethical, abilities to influence the prescribing habits of doctors in an honest and ethical manner, as they focused on the benefits for the doctor’s patients with a particular drug that the detailer may promote to such a doctor. However presently, most health care providers now simply prevent drug reps to speak with them- now this is especially true when they are in clinic treating and assessing patients. More and more medical establishments are completely banning drug reps from their locations, and I speculate that this is occurring for many reasons, which may include the following:
The doctors lose money. Doctors are normally busy, so their time is valuable. As a drug rep, you are an incredible waste of their time. Yet they will accept your samples still. The credibility you possibly have thought you had and were perceived as such by doctors as a drug rep is no longer viewed to exist to any noticeable degree by the prescriber. For example and this is based on my experience and my colleagues, doctors view any information you may provide to them as biased and embellished. In my opinion, based on information and belief, their view regarding their assessment of you as a drug rep is accurate due to the statistical gymnastics the employers of drug reps engage in, which effectively and ultimately is permitting and encouraging the drug reps to lie to the doctor and likely are unaware of the statements stated by them are misleading. Doctors by their very nature seek answers objectively. And doctors do in fact find out about drugs through other methods besides the representative of the drug’s maker, such as the internet and experience with certain medications. Most drug reps in this country in particular mostly hire drug reps based on such qualities as the candidate’s looks as well as their personality, overall. Furthermore, it is possible that pharmaceutical companies desire their drug reps to be obedient and to not question what is asked of them. Upon speculation, this can be possibly determined by the background of the candidate, which may indicate they seek popularity as well as are money driven. In addition, most drug reps do not have degrees remotely related to any aspect of anything of a scientific or clinical nature.
During my decade as a drug rep, I would encounter on very rare occasion another rep that may have been a nurse or researcher, and this is concerning that others do not have similar backgrounds because the type of training necessary is rare for a drug rep. In fact, based on my opinion, many do not particularly care to acquire education related to such medical or clinical topics. They learn the basics in order to sell their promoted products. Yet anyone who has ever worked with doctors in a clinical setting, or in a hospital working in a clinical nature, likely they would agree that a drug rep should want to and seek all related to the complexities involved in the restoration of another’s health.
Many drug reps, it is believed, are void of any complete interest in medicine completely, and I believe this to be necessary. In addition, ethical considerations due to their possible deliberate ignorance created by the necessity of what they are required to say or do by their employers may be viewed as a disturbing fallacy as well. This allows them with the encouragement and coercion of their employer to embellish the benefits of their promoted products at times in addition to offering inducements to doctors in various ways- most of all of which are rather covert, yet performed and issued to select prescribers upon instruction of their employer. Examples may be creating a check from your company to a certain supporting doctor and handing this check to thank a doctor for supporting your company’s products for doing little if anything for your employer to justify this check. Or tangible items are given to such prescribers, such as TVs or DVDs which may or may not be utilized in a particular doctor’s office. It happens often, such activities.
From the drug rep’s perspective, it is unlikely they will even consider the possibility to question their pharmaceutical employer due to the great risk of losing income and benefits that they are unlikely to acquire at another place of employment. Because of their consistent and conscious effort to keep their high-paying jobs, the drug reps always appear overtly anxious to please their superiors- regardless of any ethics or legalities regarding any activity they may be required to perform. With big pharma in particular, each drug rep is given a variety of budgets, such as a chunk of cash for doctor office lunches that they are required to spend in a certain period of time. Another chunk of cash may be assigned to a rep to pay assigned or registered speakers of their employer to speak to other prescribers about a disease state related to the drug rep’s promoted product. These activities, in my time with big pharma, were never monitored or questioned by managers or superiors. What I did notice is that my annual raises were greater than others according to the amount I spent for that particular year, as this, according to a big pharma company, was a very objective and noticeable variable with securing and keeping your employment in big pharma.
While legally risky, the drug companies continue to dispense to their reps these large budgets their drug reps are in effect coerced to dispense with complete autonomy and possibly the spending can be fabricated, which is too complicated to fully explain. This design perhaps is why there are now various state and federal disclosure laws that are presently being considered to mandate the release of all funds dispensed from pharmaceutical companies as far as why a company’s funds were spent and for what reason or method. Because, according to the lobbyists of pharma companies, they consistently insist that whatever they spend always is for the benefit of public health. As mentioned earlier, presently such activities are quite covert. Yet if such laws are mandated, it is likely the accounting of pharma companies will become rather creative and incomplete. In summary, as a big pharma drug rep, my budgets were unlimited, and I typically spent more than I made though the activities I have mentioned so far. And this is not an isolated case. Historically, pharma lavished doctors with expesive gifts and trips. Now it is about funding for them, such as financial grants. Basically, the two remain synonymous and ethically conflicting.
Another issue is what is referred to as data mining. The American Medical Association sells this prescribing data on individual doctors to pharmaceutical companies or pharmacies, by providing others identifying numbers of a particular doctor, such as a state license number or DEA number, which allows them to track the scripts a doctor writes not far from real time availability. This data shows the volume of scripts of a particular doctor and what the doctor has been prescribing for the doctor’s patient for their disease state, and this data reveals competitor products to the drug rep as well. Aside from being deceiving and dishonest, the data allows a pharma company to ‘reward’ those doctors who support their products, while treating the other doctors with ‘neglect’, which means the non-supporters of a pharma company will not receive any inducement or remuneration from a particular pharma company. The data, by the way, only reflects numbers linked with particular products, and fortunately is free of patient names- this data that is provided to all drug reps. What has been described is the method typical with all big pharma companies, in my opinion, and I worked for three of them. It appears to be manipulative in a psychological paradigm- a combination of Pavlovian responses combined with positive and negative reinforcement.
So such methods create a toxic culture required to be absorbed by those members of such a pharma company. Furthermore, the tactics implemented by pharma companies vacuum the judgment of prescribers, which may prevent patients from receiving objective treatment. Yet on the most basic level, it is the samples left with prescribers that ultimately determine their prescribing habits- with various inducements to some doctors running close in second place. Yet remarkably, prescribers are prescribing more and more generics, which typically are not sampled to prescribers. I find this comforting that the manipulation efforts of the pharma industry are not as effective as they believe they are in a rather delusional way. Yet what is happening now in regards of branded meds vs. generic meds, insurance companies are flat out paying doctors to switch patients to a generic if one is available, as well as initiating generic medication treatment for their patients. I speculate they are paying doctors for this as a response of what pharma has been doing for quite a long time. From a clinical paradigm, if a medication is providing desired treatment and good tolerability for a particular patient, one could argue it would be unethical to switch treatment for financial gain, further complicated by the fact that most patients are aware that insurance company payments to doctors for this even occur.
It is likely and I believe that most drug reps are good and intelligent people who unfortunately are coerced to do things that may be considered corruptive to others in order to maintain their employment. In other words, the drug reps have compromised their integrity, ultimately.
It seems that external regulation is necessary to prevent the drug companies from allowing the autonomy of drug reps that exists, with their encouragement, which forces the reps to do the wrong thing for the medical community, possibly. Because it is obvious that internal controls with such corporations exist on paper often, but clearly are discouraged to be enforced. It is possible that these pharma companies falsely believe that being an ethical company would make them a company without excess profit. One can only speculate on their true motives. Yet it appears that overt greed has replaced ethics with this element of the health care system, which is the pharmaceutical industry, as illustrated with what occurs within these companies. However, reversing this misguided focus of drug companies is not impossible if the right action is taken for the benefit of public health. Likely, if there are no drug reps, there is no one to employ such tactics mentioned earlier. Because authentically educating doctors does not appear to be the reason for their vocation. This is far from being the responsibility of a pharmaceutical sales representative. Perhaps most frightening is that most drug reps fail to dig deep enough to realize that what they do at times may damage public health.

“Fear ensures loyalty.” --- Author unknown

Dan Abshear (what has been written is based upon information and belief).



]]> http://seekingalpha.com/article/48924-more-big-pharma-layoffs-what-this-may-mean?source=feed#comment-199532 199532
While the pharmaceutical industry’s image and reputation has and appears to continue to suffer, added damage has expressed itself with costly patent expirations. Yet the big pharma task forces still insist that reps provide incredible value, and the more the better, as the drug reps are the givers of gifts, and reciprocity in the form of prescriptions just has to occur, as the samples reps dispense are around 20 billion a year, along with the reps themselves costing about 5 billion a year by the pharmaceutical industry. It is possible for prescribers to order samples on the internet to be delivered to their practice, but this remains rare presently
As a big pharma ex drug rep for over a decade, which during that period the number of drug reps actually tripled, the drug rep’s vocation has become more ridiculous, and possibly void of any true sense of accomplishment due to their customers preventing them from interaction or even presence in order for the drug reps to follow directives of the health care givers, and not their own employers, which is to influence their prescribing habits via direct dialogue along with the giving of gifts. The job has become nothing more than doing lunches and leaving samples at offices, for the most part. My perception formed from my own analysis of how drug reps operate in today’s environment in the medical community has led me to draw such conclusions, which I believe to be accurate.
So they may be named at times in different ways, these promoters will be referred to now only as drug reps, which number close to 100,000 in the U.S. presently to influence close to 1 million prescribers in this country, it is believed, yet is probably less now due to big pharma cutting thousands of reps recently. The cost to the pharmaceutical industry of these drug reps is around 5 billion dollars a year. Income for each rep grosses close to or above 100,000 grand a year on average, along with great benefits and a company car, as well as stock options as they gladly work from their homes and set their own hours, which I understand is much less than 8 hours a day.
The main function these days of drug reps, I believe, is primarily to offer doctors various types of inducements of a certain value that are not gifts, but bribes, by definition. The drug sampling of doctors may be considered an inducement, and a rather valuable one for the drug rep, as many believe that these samples are what ultimately influence the doctor’s prescribing habits over anything else, including statements from drug reps. This may be why the drug industry spends around 20 billion every year on samples. Yet I want to be clear on what I am saying: drug reps are some of the smartest people you will meet that do in fact have great paying jobs with great benefits. Most importantly and my opinion, I believe most reps really WANT to do well for their employers, yet are prohibited from doing so now because of how their employers are now viewed in their medical community.
Many years ago, drug reps have used their persuasive, yet ethical, abilities to influence the prescribing habits of doctors in an honest and ethical manner, as they focused on the benefits for the doctor’s patients with a particular drug that the detailer may promote to such a doctor. However presently, most health care providers now simply prevent drug reps to speak with them- now this is especially true when they are in clinic treating and assessing patients. More and more medical establishments are completely banning drug reps from their locations, and I speculate that this is occurring for many reasons, which may include the following:
The doctors lose money. Doctors are normally busy, so their time is valuable. As a drug rep, you are an incredible waste of their time. Yet they will accept your samples still. The credibility you possibly have thought you had and were perceived as such by doctors as a drug rep is no longer viewed to exist to any noticeable degree by the prescriber. For example and this is based on my experience and my colleagues, doctors view any information you may provide to them as biased and embellished. In my opinion, based on information and belief, their view regarding their assessment of you as a drug rep is accurate due to the statistical gymnastics the employers of drug reps engage in, which effectively and ultimately is permitting and encouraging the drug reps to lie to the doctor and likely are unaware of the statements stated by them are misleading. Doctors by their very nature seek answers objectively. And doctors do in fact find out about drugs through other methods besides the representative of the drug’s maker, such as the internet and experience with certain medications. Most drug reps in this country in particular mostly hire drug reps based on such qualities as the candidate’s looks as well as their personality, overall. Furthermore, it is possible that pharmaceutical companies desire their drug reps to be obedient and to not question what is asked of them. Upon speculation, this can be possibly determined by the background of the candidate, which may indicate they seek popularity as well as are money driven. In addition, most drug reps do not have degrees remotely related to any aspect of anything of a scientific or clinical nature.
During my decade as a drug rep, I would encounter on very rare occasion another rep that may have been a nurse or researcher, and this is concerning that others do not have similar backgrounds because the type of training necessary is rare for a drug rep. In fact, based on my opinion, many do not particularly care to acquire education related to such medical or clinical topics. They learn the basics in order to sell their promoted products. Yet anyone who has ever worked with doctors in a clinical setting, or in a hospital working in a clinical nature, likely they would agree that a drug rep should want to and seek all related to the complexities involved in the restoration of another’s health.
Many drug reps, it is believed, are void of any complete interest in medicine completely, and I believe this to be necessary. In addition, ethical considerations due to their possible deliberate ignorance created by the necessity of what they are required to say or do by their employers may be viewed as a disturbing fallacy as well. This allows them with the encouragement and coercion of their employer to embellish the benefits of their promoted products at times in addition to offering inducements to doctors in various ways- most of all of which are rather covert, yet performed and issued to select prescribers upon instruction of their employer. Examples may be creating a check from your company to a certain supporting doctor and handing this check to thank a doctor for supporting your company’s products for doing little if anything for your employer to justify this check. Or tangible items are given to such prescribers, such as TVs or DVDs which may or may not be utilized in a particular doctor’s office. It happens often, such activities.
From the drug rep’s perspective, it is unlikely they will even consider the possibility to question their pharmaceutical employer due to the great risk of losing income and benefits that they are unlikely to acquire at another place of employment. Because of their consistent and conscious effort to keep their high-paying jobs, the drug reps always appear overtly anxious to please their superiors- regardless of any ethics or legalities regarding any activity they may be required to perform. With big pharma in particular, each drug rep is given a variety of budgets, such as a chunk of cash for doctor office lunches that they are required to spend in a certain period of time. Another chunk of cash may be assigned to a rep to pay assigned or registered speakers of their employer to speak to other prescribers about a disease state related to the drug rep’s promoted product. These activities, in my time with big pharma, were never monitored or questioned by managers or superiors. What I did notice is that my annual raises were greater than others according to the amount I spent for that particular year, as this, according to a big pharma company, was a very objective and noticeable variable with securing and keeping your employment in big pharma.
While legally risky, the drug companies continue to dispense to their reps these large budgets their drug reps are in effect coerced to dispense with complete autonomy and possibly the spending can be fabricated, which is too complicated to fully explain. This design perhaps is why there are now various state and federal disclosure laws that are presently being considered to mandate the release of all funds dispensed from pharmaceutical companies as far as why a company’s funds were spent and for what reason or method. Because, according to the lobbyists of pharma companies, they consistently insist that whatever they spend always is for the benefit of public health. As mentioned earlier, presently such activities are quite covert. Yet if such laws are mandated, it is likely the accounting of pharma companies will become rather creative and incomplete. In summary, as a big pharma drug rep, my budgets were unlimited, and I typically spent more than I made though the activities I have mentioned so far. And this is not an isolated case. Historically, pharma lavished doctors with expesive gifts and trips. Now it is about funding for them, such as financial grants. Basically, the two remain synonymous and ethically conflicting.
Another issue is what is referred to as data mining. The American Medical Association sells this prescribing data on individual doctors to pharmaceutical companies or pharmacies, by providing others identifying numbers of a particular doctor, such as a state license number or DEA number, which allows them to track the scripts a doctor writes not far from real time availability. This data shows the volume of scripts of a particular doctor and what the doctor has been prescribing for the doctor’s patient for their disease state, and this data reveals competitor products to the drug rep as well. Aside from being deceiving and dishonest, the data allows a pharma company to ‘reward’ those doctors who support their products, while treating the other doctors with ‘neglect’, which means the non-supporters of a pharma company will not receive any inducement or remuneration from a particular pharma company. The data, by the way, only reflects numbers linked with particular products, and fortunately is free of patient names- this data that is provided to all drug reps. What has been described is the method typical with all big pharma companies, in my opinion, and I worked for three of them. It appears to be manipulative in a psychological paradigm- a combination of Pavlovian responses combined with positive and negative reinforcement.
So such methods create a toxic culture required to be absorbed by those members of such a pharma company. Furthermore, the tactics implemented by pharma companies vacuum the judgment of prescribers, which may prevent patients from receiving objective treatment. Yet on the most basic level, it is the samples left with prescribers that ultimately determine their prescribing habits- with various inducements to some doctors running close in second place. Yet remarkably, prescribers are prescribing more and more generics, which typically are not sampled to prescribers. I find this comforting that the manipulation efforts of the pharma industry are not as effective as they believe they are in a rather delusional way. Yet what is happening now in regards of branded meds vs. generic meds, insurance companies are flat out paying doctors to switch patients to a generic if one is available, as well as initiating generic medication treatment for their patients. I speculate they are paying doctors for this as a response of what pharma has been doing for quite a long time. From a clinical paradigm, if a medication is providing desired treatment and good tolerability for a particular patient, one could argue it would be unethical to switch treatment for financial gain, further complicated by the fact that most patients are aware that insurance company payments to doctors for this even occur.
It is likely and I believe that most drug reps are good and intelligent people who unfortunately are coerced to do things that may be considered corruptive to others in order to maintain their employment. In other words, the drug reps have compromised their integrity, ultimately.
It seems that external regulation is necessary to prevent the drug companies from allowing the autonomy of drug reps that exists, with their encouragement, which forces the reps to do the wrong thing for the medical community, possibly. Because it is obvious that internal controls with such corporations exist on paper often, but clearly are discouraged to be enforced. It is possible that these pharma companies falsely believe that being an ethical company would make them a company without excess profit. One can only speculate on their true motives. Yet it appears that overt greed has replaced ethics with this element of the health care system, which is the pharmaceutical industry, as illustrated with what occurs within these companies. However, reversing this misguided focus of drug companies is not impossible if the right action is taken for the benefit of public health. Likely, if there are no drug reps, there is no one to employ such tactics mentioned earlier. Because authentically educating doctors does not appear to be the reason for their vocation. This is far from being the responsibility of a pharmaceutical sales representative. Perhaps most frightening is that most drug reps fail to dig deep enough to realize that what they do at times may damage public health.

“Fear ensures loyalty.” --- Author unknown

Dan Abshear (what has been written is based upon information and belief).



]]> Mon, 07 Jul 2008 01:37:13 -0400
While the pharmaceutical industry’s image and reputation has and appears to continue to suffer, added damage has expressed itself with costly patent expirations. Yet the big pharma task forces still insist that reps provide incredible value, and the more the better, as the drug reps are the givers of gifts, and reciprocity in the form of prescriptions just has to occur, as the samples reps dispense are around 20 billion a year, along with the reps themselves costing about 5 billion a year by the pharmaceutical industry. It is possible for prescribers to order samples on the internet to be delivered to their practice, but this remains rare presently
As a big pharma ex drug rep for over a decade, which during that period the number of drug reps actually tripled, the drug rep’s vocation has become more ridiculous, and possibly void of any true sense of accomplishment due to their customers preventing them from interaction or even presence in order for the drug reps to follow directives of the health care givers, and not their own employers, which is to influence their prescribing habits via direct dialogue along with the giving of gifts. The job has become nothing more than doing lunches and leaving samples at offices, for the most part. My perception formed from my own analysis of how drug reps operate in today’s environment in the medical community has led me to draw such conclusions, which I believe to be accurate.
So they may be named at times in different ways, these promoters will be referred to now only as drug reps, which number close to 100,000 in the U.S. presently to influence close to 1 million prescribers in this country, it is believed, yet is probably less now due to big pharma cutting thousands of reps recently. The cost to the pharmaceutical industry of these drug reps is around 5 billion dollars a year. Income for each rep grosses close to or above 100,000 grand a year on average, along with great benefits and a company car, as well as stock options as they gladly work from their homes and set their own hours, which I understand is much less than 8 hours a day.
The main function these days of drug reps, I believe, is primarily to offer doctors various types of inducements of a certain value that are not gifts, but bribes, by definition. The drug sampling of doctors may be considered an inducement, and a rather valuable one for the drug rep, as many believe that these samples are what ultimately influence the doctor’s prescribing habits over anything else, including statements from drug reps. This may be why the drug industry spends around 20 billion every year on samples. Yet I want to be clear on what I am saying: drug reps are some of the smartest people you will meet that do in fact have great paying jobs with great benefits. Most importantly and my opinion, I believe most reps really WANT to do well for their employers, yet are prohibited from doing so now because of how their employers are now viewed in their medical community.
Many years ago, drug reps have used their persuasive, yet ethical, abilities to influence the prescribing habits of doctors in an honest and ethical manner, as they focused on the benefits for the doctor’s patients with a particular drug that the detailer may promote to such a doctor. However presently, most health care providers now simply prevent drug reps to speak with them- now this is especially true when they are in clinic treating and assessing patients. More and more medical establishments are completely banning drug reps from their locations, and I speculate that this is occurring for many reasons, which may include the following:
The doctors lose money. Doctors are normally busy, so their time is valuable. As a drug rep, you are an incredible waste of their time. Yet they will accept your samples still. The credibility you possibly have thought you had and were perceived as such by doctors as a drug rep is no longer viewed to exist to any noticeable degree by the prescriber. For example and this is based on my experience and my colleagues, doctors view any information you may provide to them as biased and embellished. In my opinion, based on information and belief, their view regarding their assessment of you as a drug rep is accurate due to the statistical gymnastics the employers of drug reps engage in, which effectively and ultimately is permitting and encouraging the drug reps to lie to the doctor and likely are unaware of the statements stated by them are misleading. Doctors by their very nature seek answers objectively. And doctors do in fact find out about drugs through other methods besides the representative of the drug’s maker, such as the internet and experience with certain medications. Most drug reps in this country in particular mostly hire drug reps based on such qualities as the candidate’s looks as well as their personality, overall. Furthermore, it is possible that pharmaceutical companies desire their drug reps to be obedient and to not question what is asked of them. Upon speculation, this can be possibly determined by the background of the candidate, which may indicate they seek popularity as well as are money driven. In addition, most drug reps do not have degrees remotely related to any aspect of anything of a scientific or clinical nature.
During my decade as a drug rep, I would encounter on very rare occasion another rep that may have been a nurse or researcher, and this is concerning that others do not have similar backgrounds because the type of training necessary is rare for a drug rep. In fact, based on my opinion, many do not particularly care to acquire education related to such medical or clinical topics. They learn the basics in order to sell their promoted products. Yet anyone who has ever worked with doctors in a clinical setting, or in a hospital working in a clinical nature, likely they would agree that a drug rep should want to and seek all related to the complexities involved in the restoration of another’s health.
Many drug reps, it is believed, are void of any complete interest in medicine completely, and I believe this to be necessary. In addition, ethical considerations due to their possible deliberate ignorance created by the necessity of what they are required to say or do by their employers may be viewed as a disturbing fallacy as well. This allows them with the encouragement and coercion of their employer to embellish the benefits of their promoted products at times in addition to offering inducements to doctors in various ways- most of all of which are rather covert, yet performed and issued to select prescribers upon instruction of their employer. Examples may be creating a check from your company to a certain supporting doctor and handing this check to thank a doctor for supporting your company’s products for doing little if anything for your employer to justify this check. Or tangible items are given to such prescribers, such as TVs or DVDs which may or may not be utilized in a particular doctor’s office. It happens often, such activities.
From the drug rep’s perspective, it is unlikely they will even consider the possibility to question their pharmaceutical employer due to the great risk of losing income and benefits that they are unlikely to acquire at another place of employment. Because of their consistent and conscious effort to keep their high-paying jobs, the drug reps always appear overtly anxious to please their superiors- regardless of any ethics or legalities regarding any activity they may be required to perform. With big pharma in particular, each drug rep is given a variety of budgets, such as a chunk of cash for doctor office lunches that they are required to spend in a certain period of time. Another chunk of cash may be assigned to a rep to pay assigned or registered speakers of their employer to speak to other prescribers about a disease state related to the drug rep’s promoted product. These activities, in my time with big pharma, were never monitored or questioned by managers or superiors. What I did notice is that my annual raises were greater than others according to the amount I spent for that particular year, as this, according to a big pharma company, was a very objective and noticeable variable with securing and keeping your employment in big pharma.
While legally risky, the drug companies continue to dispense to their reps these large budgets their drug reps are in effect coerced to dispense with complete autonomy and possibly the spending can be fabricated, which is too complicated to fully explain. This design perhaps is why there are now various state and federal disclosure laws that are presently being considered to mandate the release of all funds dispensed from pharmaceutical companies as far as why a company’s funds were spent and for what reason or method. Because, according to the lobbyists of pharma companies, they consistently insist that whatever they spend always is for the benefit of public health. As mentioned earlier, presently such activities are quite covert. Yet if such laws are mandated, it is likely the accounting of pharma companies will become rather creative and incomplete. In summary, as a big pharma drug rep, my budgets were unlimited, and I typically spent more than I made though the activities I have mentioned so far. And this is not an isolated case. Historically, pharma lavished doctors with expesive gifts and trips. Now it is about funding for them, such as financial grants. Basically, the two remain synonymous and ethically conflicting.
Another issue is what is referred to as data mining. The American Medical Association sells this prescribing data on individual doctors to pharmaceutical companies or pharmacies, by providing others identifying numbers of a particular doctor, such as a state license number or DEA number, which allows them to track the scripts a doctor writes not far from real time availability. This data shows the volume of scripts of a particular doctor and what the doctor has been prescribing for the doctor’s patient for their disease state, and this data reveals competitor products to the drug rep as well. Aside from being deceiving and dishonest, the data allows a pharma company to ‘reward’ those doctors who support their products, while treating the other doctors with ‘neglect’, which means the non-supporters of a pharma company will not receive any inducement or remuneration from a particular pharma company. The data, by the way, only reflects numbers linked with particular products, and fortunately is free of patient names- this data that is provided to all drug reps. What has been described is the method typical with all big pharma companies, in my opinion, and I worked for three of them. It appears to be manipulative in a psychological paradigm- a combination of Pavlovian responses combined with positive and negative reinforcement.
So such methods create a toxic culture required to be absorbed by those members of such a pharma company. Furthermore, the tactics implemented by pharma companies vacuum the judgment of prescribers, which may prevent patients from receiving objective treatment. Yet on the most basic level, it is the samples left with prescribers that ultimately determine their prescribing habits- with various inducements to some doctors running close in second place. Yet remarkably, prescribers are prescribing more and more generics, which typically are not sampled to prescribers. I find this comforting that the manipulation efforts of the pharma industry are not as effective as they believe they are in a rather delusional way. Yet what is happening now in regards of branded meds vs. generic meds, insurance companies are flat out paying doctors to switch patients to a generic if one is available, as well as initiating generic medication treatment for their patients. I speculate they are paying doctors for this as a response of what pharma has been doing for quite a long time. From a clinical paradigm, if a medication is providing desired treatment and good tolerability for a particular patient, one could argue it would be unethical to switch treatment for financial gain, further complicated by the fact that most patients are aware that insurance company payments to doctors for this even occur.
It is likely and I believe that most drug reps are good and intelligent people who unfortunately are coerced to do things that may be considered corruptive to others in order to maintain their employment. In other words, the drug reps have compromised their integrity, ultimately.
It seems that external regulation is necessary to prevent the drug companies from allowing the autonomy of drug reps that exists, with their encouragement, which forces the reps to do the wrong thing for the medical community, possibly. Because it is obvious that internal controls with such corporations exist on paper often, but clearly are discouraged to be enforced. It is possible that these pharma companies falsely believe that being an ethical company would make them a company without excess profit. One can only speculate on their true motives. Yet it appears that overt greed has replaced ethics with this element of the health care system, which is the pharmaceutical industry, as illustrated with what occurs within these companies. However, reversing this misguided focus of drug companies is not impossible if the right action is taken for the benefit of public health. Likely, if there are no drug reps, there is no one to employ such tactics mentioned earlier. Because authentically educating doctors does not appear to be the reason for their vocation. This is far from being the responsibility of a pharmaceutical sales representative. Perhaps most frightening is that most drug reps fail to dig deep enough to realize that what they do at times may damage public health.

“Fear ensures loyalty.” --- Author unknown

Dan Abshear (what has been written is based upon information and belief).



]]> http://seekingalpha.com/article/69583-pfizer-losing-battle-against-scientific-journals?source=feed#comment-199529 199529 brainblogger.com

The Human Injury of Lost Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies during my intimate experience with them , the intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others possibly top the list, as they often were sponsored by a pharmaceutical company. By this atrophy of the scientific method absent of authenticity, harm and damage is possibly done to the health of the public. Most would agree that the science of research should be sound and as sterile and aseptic as possible- completely free of interference. However, it appears, money and increased profits can be a catalyst for reckless disregard for human health that is largely unregulated. This is particularly a factor on post-marketing studies of various pharmaceutical companies because others seem to be deliberately ignorant.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds and devices to benefit mankind. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places with their researchers to profit off of their discoveries that were performed for pharmaceutical companies and others in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations that are often composed of primarily community patient care clinics absent of any research training compared with the former. Because of this structure, investigators of these pharmaceutical sponsored trials are likely void by sponsor design of necessary research experience or quality regarding their research purpose and ability to ensure its sterility, yet benefit it’s supporter. These quite numerous CROS are in fact for- profit, with some CROs making billions of dollars a year.
The trials conducted at such places again are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their particular med being studied in the trial. Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for this studied drug of theirs. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner ensures favorable results of the sponsor’s medication after the trial is complete. Their activities are again believed to be absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor; as such sites are largely unregulated.
Guest authorship has been known to be aggressively recruited by sponsors and usually the sponsors seek investigators to be recruited for this function in addition to being the lead investigator of their fabricated clinical trial. The trial manuscript and protocol design is prepared by those employed by the pharma sponsor upon specific direction of this pharma sponsor. The medical program coordinator of a particular sponsored trial is an actual employee of the sponsoring pharma company and also acts as the publisher, manuscript version reviewer and trial director who works with their pharma company’s hired CRO editors whose objectives are to benefit the sponsor. Typical and ultimate cost of the final manuscript of the trial to the sponsor created by the hired CRO exceeds 1000 dollars per page, some have said. Merck engages in this behavior, which shocked many, as they were always viewed as an ethical pharmaceutical company that always placed patients over profits. Apparently not.
Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known as ghostwriters. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked by the hired author.
To have the trial published, the sponsor has been known to pay a journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks. The purchased reprints bought by the sponsor of the study are distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation. As a bonus, the sponsor may pay this journal to advertise their products to be placed in this journal as well.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, as stated previously. If so, our health care treatment options with meds are now undetermined in large part due to such corruptive situations, as well as the absence of objectivity that has been intentionally eliminated with trials produced in this way. Trust in the scientific method in this type of activity illustrated in this article is absent and replaced with what could be harmful to others.
More now than ever, meds are removed from the market or are given black box warnings, which is basically eliminating future growth of the black box drug. Now I understand why this may be occurring.
Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor cannot in any way interfere in such ways described in this article, which would require independent clinical trial sites with no involvement of the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health. Knowledge is power, and is also possibly a lifesaver.


“Ethics and Science need to shake hands.” ……. Richard Cabot

Dan Abshear
Author’s note: What has been written was based upon information and belief.
]]> Mon, 07 Jul 2008 01:34:51 -0400 brainblogger.com

The Human Injury of Lost Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies during my intimate experience with them , the intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others possibly top the list, as they often were sponsored by a pharmaceutical company. By this atrophy of the scientific method absent of authenticity, harm and damage is possibly done to the health of the public. Most would agree that the science of research should be sound and as sterile and aseptic as possible- completely free of interference. However, it appears, money and increased profits can be a catalyst for reckless disregard for human health that is largely unregulated. This is particularly a factor on post-marketing studies of various pharmaceutical companies because others seem to be deliberately ignorant.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds and devices to benefit mankind. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places with their researchers to profit off of their discoveries that were performed for pharmaceutical companies and others in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations that are often composed of primarily community patient care clinics absent of any research training compared with the former. Because of this structure, investigators of these pharmaceutical sponsored trials are likely void by sponsor design of necessary research experience or quality regarding their research purpose and ability to ensure its sterility, yet benefit it’s supporter. These quite numerous CROS are in fact for- profit, with some CROs making billions of dollars a year.
The trials conducted at such places again are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their particular med being studied in the trial. Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for this studied drug of theirs. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner ensures favorable results of the sponsor’s medication after the trial is complete. Their activities are again believed to be absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor; as such sites are largely unregulated.
Guest authorship has been known to be aggressively recruited by sponsors and usually the sponsors seek investigators to be recruited for this function in addition to being the lead investigator of their fabricated clinical trial. The trial manuscript and protocol design is prepared by those employed by the pharma sponsor upon specific direction of this pharma sponsor. The medical program coordinator of a particular sponsored trial is an actual employee of the sponsoring pharma company and also acts as the publisher, manuscript version reviewer and trial director who works with their pharma company’s hired CRO editors whose objectives are to benefit the sponsor. Typical and ultimate cost of the final manuscript of the trial to the sponsor created by the hired CRO exceeds 1000 dollars per page, some have said. Merck engages in this behavior, which shocked many, as they were always viewed as an ethical pharmaceutical company that always placed patients over profits. Apparently not.
Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known as ghostwriters. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked by the hired author.
To have the trial published, the sponsor has been known to pay a journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks. The purchased reprints bought by the sponsor of the study are distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation. As a bonus, the sponsor may pay this journal to advertise their products to be placed in this journal as well.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, as stated previously. If so, our health care treatment options with meds are now undetermined in large part due to such corruptive situations, as well as the absence of objectivity that has been intentionally eliminated with trials produced in this way. Trust in the scientific method in this type of activity illustrated in this article is absent and replaced with what could be harmful to others.
More now than ever, meds are removed from the market or are given black box warnings, which is basically eliminating future growth of the black box drug. Now I understand why this may be occurring.
Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor cannot in any way interfere in such ways described in this article, which would require independent clinical trial sites with no involvement of the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health. Knowledge is power, and is also possibly a lifesaver.


“Ethics and Science need to shake hands.” ……. Richard Cabot

Dan Abshear
Author’s note: What has been written was based upon information and belief.
]]>