A year after approval of the Provenge prostate-cancer vaccine was delayed by the FDA, a group of prostate-cancer patients - and some investors, too - plan to stage a series of nationwide protests that will include the largest annual gathering of oncologists. The events are planned by a non-profit called Care To Live, which is battling the FDA in court in what has, so far, been an unsuccessful attempt to force the agency to reverse course.
The protests are being organized for New York, Philadelphia, Cleveland, Madison, Atlanta, Seattle, Dearborn, and Tampa, as well as in Chicago, where the American Society of Clinical Oncology will hold its meeting. Other groups expected to join include the Cancer Cure Coalition, the Abigail Alliance, A Right To Live, and the Sarcoma Foundation of America. (Here is the schedule with times and places).
The specter of a protest is likely to unnerve the American Society of Clinical Oncology, because threats were allegedly made at last year’s event against two cancer docs who were dissenters on the FDA panel that recommended approval for Provenge. After the FDA panel meeting, those two docs - Howard Scher of Sloan-Kettering Memorial Cancer, and Maha Hussain of the University of Michigan - wrote FDA officials urging the go-slow approach that the agency adopted. The New York protest is, not surprisingly, scheduled to be held at Sloan-Kettering.
The behind-the-scenes machinations caused a firestorm - cancer patients have rallied outside FDA offices, and the controversy further fueled a debate about the use and approval of experimental meds. The lawsuit, meanwhile, claims the two panel members held undisclosed financial conflicts of interest and alleged a Byzantine power play involving a key FDA official who sought to sway the outcome of the approval.
Meanwhile, CareToLive has recently taken to running advertisements in newspapers in Maryland - where FDA headquarters are located -featuring people who are suffering from prostate cancer.
5 Comments
To flesh out your story a bit--i.e. the alleged Conflict of Interests of 2 Doctors on the March '07 FDA Advisory Committee, Dr. Howard Isadore Scher of Sloan-Kettering in NYC certified to the FDA that he had only 3 Conflicts of Interest in order to qualify to sit in judgment of Provenge.
Here's 17 found on the internet for Scher:
1. NOVACEA: Grants & Research support; STUDY CHAIR of DN-101
… a DIRECT competitor to Provenge
… DN-101 failed its clinical trial
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; Advisory Board;
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 PC Clinical Trials-P1 and P2
15. AMBRILIABIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
16. MEDIVATION, INC: Principal Investigator MDV3100
17. PROQUEST INVESTMENTS, … Board of Directors … Advisor … INVESTED in Novacea.
So, where's the HHS and the FDA investigative offices investigation of these allegations?
Both offices have been sent written allegations of UNdisclosed COI for Scher....
... oh, I forgot, they were off investigating--within 1 business day--who sent flowers on the March 29th first anniversary of the FDA AC Committee's overwhelming positive vote on Provenge... 17-0 that it's safe and 13-4 that it shows efficacy.
Approve Provenge NOW!
and
Resign Dr. Andy....
Will anyone with the power ever investigate the severe, undisclosed conflicts of interest of Drs. Scher and Hussain? Provenge will be proven out with either the interim or the final results of the ongoing trial and will eventually get to the patients. No matter the outcome of Provenge, the undisclosed conflicts of the minority who swayed the FDA's decision should be fully investigated.
When you perform the research and understand the facts surrounding the FDA actions before, during and after the Provenge approval process, it is very clear that power, financial gain, big pharma tactics and FDA arrogance were more important than terminally ill prostate cancer patients who have/had no alternative to death.
When you identify the individuals who made sure their personal gains/interests won over a safe, effective and natural way to fight prostate cancer, it will surprise you how these people hide behind their dedication and visibility in the cancer and FDA community. When you view their personal actions that circumvented (more like superseded) the FDA process and understand how the FDA permitted and continues to permit this type of behavior it will make you sick.
By not acting against these specific actions, it appears Congress continues to permit this type of corrupt, unethical and egregious behavior within and surrounding the FDA approval process.
Kudos to the protestors who will not let this die, unlike these individuals who were personally responsible for the deaths of 30,000 end stage cancer patients who would have one last chance to survive.
Do the research, review the actions of the FDA and these individuals and you will want to support these protestors. Because in this country in this day and age, these actions should not have happened and they need to stop.
Yeah, yeah, the doctors were threatened and still no one has put forth any proof or police report. It just keeps detouring people away from the real story.
If a patient has to go to the doctor, does that patient want a doctor with experience or without exerience? Common sense says, we want one with experience. Well guess what? Here is what Dr. Scher said at the Provenge Advisory Committee hearing:
"Personally I have no experience with this agent (Provenge), so I'd just like to ask clinicians who have used it.
http://www.fda.gov/ohrms/dockets/ac/07/transcripts/2007-4291T1.pdf
Dr. Scher makes his comment on the top of page 87. How silly does it look that the FDA sided with such an inexperienced doctor?
Not only that, he was leading a competing trial for Novacea and advising an investment firm which just happened to be invested in that Novacea. That firm's founding partner was sitting on the Board of Directors of Novacea. Nice and cozy, eh?
Provenge was voted safe 17-0, even by this silly doctor. It was voted 13-4 that it showed substantial evidence of efficacy which is the Congressional standard for approval. We know several people who are on Provenge and they are doing fine. It was voted safe so what's the problem?
How dare these conflicted doctors interfere with something safe and effective for dying patients who have no other options?
So when they were called on the carpet about this, that is when they concocted a threatened story just because Maha was yelled at at the Junovan Advisory Committee hearing? They dressed it up nicely with bodyguards and plastic shields. Where's the police report? Where's the proof of the threats? Enough already!
The Provenge people weren't even at the Junovan hearing because they were busy dealing with the breaking news that Provenge was delayed. May 9, 2007, remember?
Yeah, this is really nice how the twisted story gets told. Is anyone even interested in the truth?
Now, if you want to listen to an experienced doctor, listen to Dr. David Penson, he worked with the agent Provenge:
"This is not like classic chemo; there is no loss of hair, no sickness associated with it. We are disappointed because I think that many of the people who are involved in the study, many of the site investigators who are experienced with the drug, feel that it’s a safe drug and that it works… that it extends life in a very desperate group of patients."
Now what patient wouldn't want that?
Coast to Coast demonstrations. What a great idea!
Everyone should attend a protest demonstration nearest them.
Time to show the FDA that they can't just deny safe effective therapies and not get any heat about it.
Men are dying and the FDA does not care. They are a tightly wound political organization that does everything in the name of power and politics and COULD CARE LESS ABOUT THE PATIENTS.
The ad is excellent also...I can't wait to see this weeks ad...... I here it is going to be awesome!