Comments on Theodore Cohen's articles RSS Syndication from SeekingAlpha.com http://seekingalpha.com/author/theodore-cohen/articles http://seekingalpha.com/article/73065-dendreon-the-fda-s-commissioner-doth-protest-too-much?source=feed#comment-457074 457074 Wed, 08 Apr 2009 22:59:09 -0400 My father past away from CHemo and it was horrible.

I hope president Obama would change this money greed policy and healthcare reforms.
Regards
David
]]> http://seekingalpha.com/article/76081-dendreon-the-provenge-approval-scandal-one-year-later?source=feed#comment-276264 276264 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/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-262702 262702 Tue, 23 Sep 2008 14:19:38 -0400
Don't narrow your mind.]]> http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-209434 209434 Sat, 19 Jul 2008 13:21:27 -0400 http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-202626 202626 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/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-196766 196766 Tue, 01 Jul 2008 15:48:44 -0400 http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-189764 189764 Sat, 21 Jun 2008 13:14:54 -0400 http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-184742 184742 Fri, 13 Jun 2008 07:13:35 -0400 http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-184399 184399 Thu, 12 Jun 2008 14:30:42 -0400 http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-184371 184371 Thu, 12 Jun 2008 13:58:29 -0400
Probably the most important point is that we know Provenge is aimed at end-stage, dying prostate cancer patients. These people do not have choices.
If you want, please repeat with me: these people do not have choices - and are going to die anyway.

Provenge has been voted safe! 17-0! Even the conflicted doctors voted it is safe!
What's the downside of giving Provenge to the dying?

The British now have hospitals where experimentation can be used on patients who request it. As I understand it, it can go beyond what's being tried in the clinic, it can go to treatment that Doctors and Patients agree to. The advantage of such a program is that anecdotal data can be gotten on different uses of drugs which if effective can result in additional trials to see if the results can be duplicated.

The FDA is not permitting such experimental work, even for those willing to try it and also willing to sign off all legal claims against those treating them. I'm not suggesting that drugs untried in people be used experimentally first, but after they're proven safe in a Phase I and have advanced to Phase II they should be made available as long as documentation's provided on how they're to be used, and why they've been selected for the specific application.

I strongly believe that the USA fail to equal or exceed acts like what the British are doing it won't be long before they're no longer a world leader in drug development. The FDA's been driving up the cost of US approval, while extending time to approval tremendously; this might be fine to determine a headache medicine is completely safe, but it's not fine for a drug designed to benefit the victims of terminal diseases like cancer. It's time to take Approvable out of the FDA vocabulary, especially if people are dying waiting for the drug. An approval with any number of conditions that must be met is fine, as long as it still means that people who need it can get it after the approval.]]> http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-184370 184370 Thu, 12 Jun 2008 13:58:14 -0400
Sam Waksal's daughter had sold 2.5 million dollars worth of ImClone shares on December 27, 2001, the day before the announcement and subsequent stock decline.

The next day, there were rumors that Martha Stewart may also have sold in advance of the news, thanks to a direct tip from her friend, Sam Waksal.

On June 9, the Wall Street Journal says that Harlan Waksal knew three days in advance that the FDA would reject the Erbitux application.

Later, it would become clear that Alan Bennett, a lawyer for Bristol-Myers in Washington, had sent an email to Harlan Waksal and Bristol-Myers management saying that Richard Pazdur, an FDA employee, told him the Erbitux application would be rejected the following Friday, which turned out to be the case.

On June 12, Sam Waksal was arrested by the FBI on insider trading charges.

Martha Stewart was arrested and served prison time.

Dr. Richard Pazdur is still at the FDA… ]]> http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-184368 184368 Thu, 12 Jun 2008 13:58:03 -0400 Among the NOs, Dr. Sher and Dr. Hussain.

Provenge achieved a 200% increase in overall survival measured at 3 years… with multiple recipients alive and well over 6 years later.

27,000 men with end-stage prostate cancer will die needlessly early (some will die needlessly period) each year the Provenge is delayed by the FDA.

Certainly FDA has approved drugs against the recommendations of its advisory panel, but I am not aware of a decision to overrule a strong positive panel vote for a terminal illness that has no really acceptable treatment options. This decision would appear to be unprecedented, and calls for a full and open public statement of why the FDA disagrees with this panel and cannot make this drug available to terminal patients. We know of course it was not due to safety concerns. Also, if FDA found the clinical trial data submitted by Dendreon (Provenge producer company) to be insufficient, why did it even submit the data to a panel of experts for their opinions?

Some of those doctors that voted “NO” as to the effectiveness evidence even had letters (urging the FDA NOT to approve Provenge) “leaked” to the media. They were Dr. Sher and Dr. Hussain. I let you judge on the ethics of this behaviour.

On May 30, 2007, news was that Schering-Plough Corp. said it had agreed pay Novacea Inc. up to $440 million for rights to develop the smaller drugmaker’s prostate cancer treatment, causing Novacea shares to double.
Both Dr. Sher and Dr. Hussain are Novacea consultants.
Do you think Schering-Plough would have paid $60 million immediately and an additional $380 million to Novacea if Provenge was on the market?

Why the FDA - for the first time in its history - did not approve a drug deemed safe and effective by its own panel?
How is that Dr. Sher and Dr. Hussain - with their obvious and enormous conflicts of interest - took part in the panel?
Who did choose Dr. Sher and Dr. Hussain?

We already have proof that Provenge works (two phase III trials). Many people are going to die due to the delay. Who is accountable?
Why isn’t this revolutionary and extremely safe treatment available NOW?
I can’t imagine the motives are about monetary gains.]]> http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-184210 184210 Thu, 12 Jun 2008 11:26:36 -0400
“Sorry, but the data are pretty uncompelling--the vaccine doesn't enhance survival in a statistically significant way.”

Pharmaco needs to go back to school:


He asserts that the D9901 study did not attain statistical significance for survival when the final data was released in October 2004. This is an incorrect assertion. The overall survival p value was 0.01, easily beating the p=0.05 threshold. This goes to the crux of the anger of the Provenge advocates. Statistical significance on survival is the "gold standard" by which the FDA judges all oncology treatments, and Provenge met it with flying colors in the 9901 trial.

In addition, the p value for the primary endpoint of cancer progression was p=0.052, barely missing the p=0.050 threshold. For Howard Scher and Maha Hussain, this narrow miss was blown up to be an utter failure. They said that because the p value did not reach 0.050, then all additional data (including survival) should be discarded. Basically, their position was that because the odds of being successful in progression were only 94.8% and not 95.0%, there was no correlation between the two metrics and the 99.0% survival odds should be thrown in the trash.

So Pharma Man, the data does suggest it prolongs survival. And the data also suggests our FDA’s decision to de-rail Provenge had nothing to do with good science and a lot do with politics and money. Period. Next?

]]> http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-184133 184133 Thu, 12 Jun 2008 10:25:36 -0400
2. The effectiveness of Provenge is not really the point. The FDA is not complying with the law and our tax dollars are being spent to defend them in court. I'd rather see those tax dollars spent on Provenge. What is the FDA trying to hide? Why don't they just release the information.

3. Provenge is safe and they are trying to get permission to give it to patients who are going to die very soon. Where is the risk of approving it with the requirement that the results be tracked? What is the FDA afraid of?

Generally, when there are unanswered questions of this type, you will find a money trail that leads to the truth. Time will tell. Perhaps the truth will set Provenge free.]]> http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-184126 184126 Thu, 12 Jun 2008 10:20:28 -0400
Statistics? What ignorance! What arrogance!

Who the hell are you to tell a dying man that 4+ months is nothing?

Let me guess - you work at the FDA right?

What a complete disgusting sleeze you are.

]]> http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-184109 184109 Thu, 12 Jun 2008 10:07:27 -0400
You are right, the FDA said there is a 1 in 40 chance that the survival evidence was reached by pure chance. You would not want to waste your tax dollars on a 39/40 chance that you extend the life of a dying man. Heck you could use that money to put gas in your SUV or your boat!

Even the FDA has not yet given a reason why Provenge did not receive conditional approval, which would have allowed these men access while the IMPACT trial continued. Go ahead call and ask them. They won't tell you just like they have not told the other 100 people who have asked.

Why has the FDA hidden docuements. Why does the FDA refuse to answer a patient petition filed over 10 months ago? Why, becasue one angry man (Dr. Pazdur) due to his anger, ambition and lack of compassion, had the ability that the FDA seemingly allows to sabotage a BLA to serve his own agenda.

Von E is to weak of a commissioner do deal with the likes of Dr. Pazdur.

Provenge deserved proper due process. Something they have yet to receive. You can argue all you want about whether Provenge should have been approved or not (even though the FDA has admitted it lacks the scientific ability to evaluate new drugs such as Provenge yet ignores its own hand picked experts) but the real issue is the lack of due process it's BLA received. Would you like your fate put soley in the hands of Richard Pazdur?]]> http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-184066 184066 Thu, 12 Jun 2008 09:28:12 -0400
PCa patients are suffering and dying needlessly while a far safer and proven superior treatment is sidelined for years by these fools at the FDA. I honestly think the term "wicked" is one which most aptly describes these government scum.

They have stolen hope and life itself. These FDA officials are criminals of the worst sort and should, in truth, be brought up on criminal charges.
]]> http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-184061 184061 Thu, 12 Jun 2008 09:23:34 -0400 http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-183992 183992 Thu, 12 Jun 2008 08:34:56 -0400
And, remember, part of the medical treatment for terminal prostate cancer victims includes castration and administration of female hormones because the cancer feeds off androgen.. i.e. testerone.. at least for a while.

As to Dr. Cohen's article, another documented and concise report on the continuing stone-walling by our FDA and, in this case, stone-walling against terminal prostate cancer victims. These men are dying at the rate of 83 per day (or some 30,000 per year)--an unconscieneable action.

Regarding Dr. Howard Isadore Scher of Sloan Kettering in NYC and his involvement in the denial of Provenge to terminal cancer patients, he certified to the FDA--in order to sit in judgment of Provenge at the FDA Advisory Committee meeting--that he had only 3 Conflict of Interests.

Internet research has found 17 possible COI for Scher. These 17 COI have been reported to the FDA Investigative Office and the Health and Human Services Investigation division without having any investigation done by either department to date.

Note, in particular, items #1 and #17 in the list of Scher's alleged COI!

1. NOVACEA:
… Grants & Research support;
… STUDY CHAIR of DN-101, Asentar-since HALTED as ineffective
… a Direct competitor to Provenge

2. GPB BIOTECH: Financial conflict of interest per Scher in MedPage

3. PHARMION: Financial conflict of interest per Scher in MedPage

4. SANOFI-AVENTIS: Grants & Research support

5. BRISTOL MYERS SQUIBB: Consultant, Grants & Research

6. MILLENNIUM PHARMCEUTICALS: grant of Research support

7. COUGAR BIOTECHNOLOGY: Principal Investigator; Advisory Board;

8. INNOVIVE PHARMACEUTICALS: Principal Investigator, Scientific Advisory Board

9. INFINITY PHARMACEUTICALS: Principal Investigator

10. BIOGEN-IDEC: jointly held stock with spouse

11. PFIZER: jointly held stock with spouse

12. GENTA: Scientific Advisory Board (March 6, 2007; since removed , but cached)

13. CONFOMA THERAPEUTICS: Scientific Advisory Board

14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2

15. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II

16. MEDIVATION, INC: Principal Investigator MDV3100

17. PROQUEST INVESTMENTS:
… Consultant;
… Scientific Advisory Board;
… Limited Partner FINANCIAL interest.


Thank You, Dr. Cohen, for your well-spoken article!]]> http://seekingalpha.com/article/81043-dendreon-s-provenge-government-agencies-play-hide-and-seek-with-facts?source=feed#comment-183978 183978 Thu, 12 Jun 2008 08:24:01 -0400 http://seekingalpha.com/article/76081-dendreon-the-provenge-approval-scandal-one-year-later?source=feed#comment-181309 181309 Sun, 08 Jun 2008 12:28:21 -0400
I look for a complete failure for the current trial and bankruptcy for Dendreon.

]]> http://seekingalpha.com/article/76081-dendreon-the-provenge-approval-scandal-one-year-later?source=feed#comment-166796 166796 Tue, 13 May 2008 10:47:14 -0400 While nowhere could I find sufficient data to independently analyze, a back of envelope analysis I was able to do with what I could find – about the 34% of treatment group alive after 5 years vs. 11% of controls with 147 people studied – showed the groups survival rates substantially overlapping. I surely hope results of the larger study currently underway allow for quick approval of Provenge. But I think the FDA is correct in being careful in approval of a very expensive treatment that, from what we likely know today, may or may not be effective. I also think paranoia about panel conflicts of interest is not warranted. The panel is made up of experts who have intellectual, academic, and –not surprisingly – often financial interests in their field. As far as I can tell, all of them acknowledged areas of potential conflict as part of the panel process.

]]> http://seekingalpha.com/article/76081-dendreon-the-provenge-approval-scandal-one-year-later?source=feed#comment-164744 164744 Fri, 09 May 2008 09:30:55 -0400 http://seekingalpha.com/article/76081-dendreon-the-provenge-approval-scandal-one-year-later?source=feed#comment-164220 164220 Thu, 08 May 2008 12:35:10 -0400 The FDA has made many mistakes on approving drugs. People that are given months to live are willing to try anything to get better or live another day including: degrading, expensive, painful, radiation therapy. People in the end should be able to make their own informed choices. They should also be given choices.]]> http://seekingalpha.com/article/76081-dendreon-the-provenge-approval-scandal-one-year-later?source=feed#comment-163803 163803 Wed, 07 May 2008 21:40:01 -0400 Best wishes.]]> http://seekingalpha.com/article/76081-dendreon-the-provenge-approval-scandal-one-year-later?source=feed#comment-163657 163657 Wed, 07 May 2008 16:37:08 -0400
... to expand on the allegations against Dr. Howard Isadore Scher of Sloan Kettering in NYC may have more Conflicts of Interest than the 3 (Three) he certified having to the FDA in order to sit in judgment of Provenge on the FDA Advisory Committee meeting in March '07, look at what's been found on the internet for him:

17 (SEVENTEEN) Conflicts of Interests--NOTE #1 and # 17, in particular:


1. NOVACEA: grants & research support
... STUDY CHAIR of DN-101 which is ...
... a Direct competitor to Provenge

2. GPB BIOTECH: financial conflict of interest per Scher in MedPage

3. PHARMION: financial conflict of interest per Scher in MedPage

4. SANOFI-AVENTIS: grants & research support

5. BRISTOL MYERSSQUIBB: consultant, grants & research

6. MILLENNIUM PHARMCEUTICALS: grant of research support

7. COUGAR BIOTECHNOLOGY: principal investigator; advisoryboard;

8. INNOVIVE PHARMACEUTICALS: principal investigator

9. INFINITY PHARMACEUTICALS: principal investigator

10. BIOGEN-IDEC: jointly held stock with spouse

11. PFIZER: jointly held stock with spouse

12. GENTA: scientific advisory board (as of March 6, 2007; since removed from web but
cached)

13. CONFOMA THERAPEUTICS: scientific advisory board

14. DEPARTMENT of DEFENSE: Principal Investigator PCClinical Trials-P1 and P2

15. AMBRILIABIOPHARMA INC: Principal Investigator PCK3145, Phase I/II

16. MEDIVATION, INC: principal investigator MDV3100

17. PROQUEST INVESTMENTS:
... member Board of Directors
... Scientific Advisor
... INVESTED in Novacea.

83 men die each 24 hours, 7 days a week, 52 weeks a year from Prostate Cancer....
.... some 30,000 men each YEAR!

Approve Provenge NOW!

and

Resign Dr. von Eschenback! Your stewardship of the FDA has been abysmal and continues to harm the American citizens.

]]> http://seekingalpha.com/article/76081-dendreon-the-provenge-approval-scandal-one-year-later?source=feed#comment-163616 163616 Wed, 07 May 2008 15:42:22 -0400
You - can't - fake - survival.

Patients on the placebo lived a maximum of 4 years, while patients taking Provenge are still living after 5,6,7 years.

I'm not sure how you can sleep at night. ]]> http://seekingalpha.com/article/76081-dendreon-the-provenge-approval-scandal-one-year-later?source=feed#comment-163414 163414 Wed, 07 May 2008 11:28:17 -0400 cgi.ebay.com/ws/eBayIS...







FDA SAYS, “WAIT” TO DYING MEN



Nationwide Prostate Cancer Rally MAY 30th Over FDA Failure to Approve Safe, Effective Immunotherapy.



1 in 6 men get prostate cancer. 75 American men die from it every day. The FDA has not approved a treatment for stage IV prostate cancer in over 43 years.



Care To Live, a not for profit corporation, seeks transparency and accountability from the FDA, as to why they disregarded the advice of their hand selected Congressionally mandated Advisory Panel of experts, who voted Provenge overwhelmingly safe and effective. Without cause or explanation, in an unprecedented action, the FDA denied licensure. We are seeking immediate access to Provenge for all men with end stage prostate cancer.



On May 30, 2008, CareToLive will take to the streets to protest with the men desperately seeking Provenge. Over a year has passed, and 27,000 American men have died without hope, since the FDA denied the licensure of Provenge, an immunotherapy the FDA panel voted 17-0 safe and overwhelmingly voted effective. This is a noninvasive, non-toxic, immune building treatment, which works by employing your own body’s healthy cells to fight the cancer.



Men like Eduardo Garcia, who have had the 3 treatments, have gone from being incapacitated, to living healthy, productive lives, for as long as six years and counting. Dendreon, the company that perfected this treatment, also has similar treatments for breast, ovarian, colon, lung, kidney, and cervical cancers, in their sights.



The dysfunctional FDA's reason for delay has never been explained, as it was not science based, since survival and safety have clearly been demonstrated.



CareToLive filed a Citizens Petition for the FDA to reconsider the wrongful denial, (the only recourse the FDA allows), on July 26, 2007. The FDA has failed to follow Federal regulation and to this day they have not properly responded to our Petition, which seeks immediate access to Provenge for these desperate men. The FDA also refuses to respond to the CareToLive Freedom of Information Act request, which they know would prove that a few FDA insiders, who cared more about serving their own interests, rather than the best interest of the patients, purposely sabotaged Provenge.



“In memory of our members who have recently passed away, never having been given the chance Provenge recipient Eduardo Garcia had, we will continue to fight on, every day, in every way we can. Please come out and join us,” said CareToLive spokesperson, Mike Kearney.



Please join with me on May 30th, 2008, in Westlake Park, outside in downtown Seattle, Washington, from 1 PM to 3 PM, as a show of solidarity with our brothers who have been tossed aside by our incompetent, cold blooded health czars. Visit CareToLive.com for additional details.

Thank You, Jason Burdine Coordinator Seattle Jason.Burdine@gmail.com
]]> http://seekingalpha.com/article/76081-dendreon-the-provenge-approval-scandal-one-year-later?source=feed#comment-163398 163398 Wed, 07 May 2008 11:16:24 -0400 http://seekingalpha.com/article/76081-dendreon-the-provenge-approval-scandal-one-year-later?source=feed#comment-163325 163325 Wed, 07 May 2008 10:02:25 -0400