quiact

Pfizer's Lyrica Gets FDA Approval to Treat Fibromyalgia

The experience of pain from Firbromyalgia Syndrome appears to be due to a complex phenomenon with humans. The reason for the occurrence of pain can be physical, psychological, or a combination of both of these causes. And how one defines or describes the intensity of the pain they experience varies as much as the types of pain that exist. Although the origin may be the same from one person to another, the experience of pain is, in fact, a subjective emotional response to the sensation and perception of the pain itself.
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

A Tale of Three Pharmaceuticals: Abbott Labs, Pfizer and Eli Lilly & Co.

Your elation bypasses the devastating damage all three companies have repeatedly performed, and this should be addressed before comments from a venture capitalist who views a patient as a commodity.

More Big Pharma Layoffs: What This May Mean

You Have Now Been Sampled

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).

More Big Pharma Layoffs: What This May Mean

You Have Now Been Sampled

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).

Pfizer Losing Battle Against Scientific Journals

Published on 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.