And so the red-hot Provenge controversy just grew a little more heated. A non-profit that calls itself Care To Live this morning filed a lawsuit in federal court in Ohio against FDA commish Andy von Eschenbach; Richard Pazdur, who heads the FDA Office of Oncologic Drugs; and Howard Scher, a Sloan Kettering-Memorial oncologist and FDA advisory panel member, for their "improper conduct...and inappropriate actions," among other alleged activities having to do with Provenge approval.
The group wants the FDA to immediately approve Provenge or at least reconvene an advisory panel, without Scher, to review the medication; declare the FDA can't interfere with Provenge marketing, sale and use, absent additional findings or tests results that indicate any further safety concerns; and that the defendants improperly denied available aid to dying patients and are liable for any injuries caused to them, among other things.
The lawsuit, which you can read here, recounts the laundry list of complaints that prostate-cancer patients and investors have voiced - particularly on the Internet - in recent months because Dendreon's Provenge vaccine was endorsed by an FDA panel in March, but then delayed in June.
That happened after Scher and one other panel member wrote the agency, urging further review of Provenge data, an action that some patients and investors believe was part of a conspiracy. Since then, allegations of conflicts of interest have surfaced on the Internet concerning Scher and the other panel member, Maha Hussain. The SEC, meanwhile, is investigating Provenge clinical trials.
15 Comments
JMHO of course! The attorneys love this kind of material. In the end, we may win; however, the time factor will in all likelyhood put us down the road 2/3 years and walla, it efficacy has fullfilled it's time frame and the FDA then give us the big go ahead and case dismissed. We win/lose and the big pharms keep on going, making their big bucks while many thousand of PC patients in the mean time go by the wayside.
WOW! Ed!!!
Just over 2 hours after the suit was filed against Scher, Pazdur and the FDA, here you are reporting about it and letting us know what it's about AND providing a copy of same.
It will most interesting to see if this suit will FINALLY attract the attention of the FDA... particularly regarding the 15 Conflict of Interests (COIs) that the internet shows for Scher when compared to only the 3 he told the FDA about.
Does anyone think this suit can accomplish several purposes at once such as enabling TERMINAL PCa patients access to a safe drug with apparent efficacy for treatment of AIPC and, at the same time, get the FDA Ethics committee to look at these 15 (found so far) COIs reportedly attributed to Scher?
I'd sure LOVE to be there at Discovery when those named folks and their associates, etc are deposed under oath.
Please keep us informed and thank you for keeping prostate cancer patients and their family and friends informed as to the lastest! You are quick on the draw on this... Thanks....
Let's hope the suit has legs. The FDA seriously needs to be relieved of its despotism. A safe drug in a critical, and critically underserved, space should be available, period, even if its record of efficacy is hampered by out of date clinical paradigms designed for the reigning treatment regime, chemotherapy. Give the thing conditional approval and get the show on the road, for God's sake. 30K men dying each year is not enough justification for an action that should stand on its own on humanitarian grounds and common decency?
And these bureaucrats call themselves public servants. God speed this lawsuit.
Bravo to the Lawsuit. This drug was run off course by the corrupt FDA. Conditional approval should be given to Provenge as it is safe and effective.
Great article Ed! A breath of fresh air in which the article clearly states the facts and does not diminish the COI wrongdoings by the FDA. This story continues to have legs and hopefully this lawsuit will bring to light the true intentions of these individuals who are preventing a safe and effective therapy treatment for thousands of men - some of which are in my family.
Mr. Ed Silverman,
Thank you for reporting the facts, and providing a copy of the lawsuit to PC patients and their families.
I applaud you.
Jim 4097 You are correct with the 17-0 and 14-3 vote by the Advisory Panel. The FDA should have at least given Provenge a CONDITIONAL LETTER! These men are in the last stages of the disease and most will die within ~12-18 months. I hope this suit brings to light the obvious misdoings of the FDA! MONEY, POWER, BIG CHEMO PHARMA,THE BIG BOYS(HF's) on Wall-Street run Washington DC! Great article Ed! Please keep us posted on this most important story!
Thank you Mr. Silverman for your prompt coverage of this vital story of concern to all the PC patients. Seems the rest of the press, excluding CNBC’s Mike Huckman, are more worried about covering these young Hollywood drama queens! The Provenge saga is sad unto itself because so many hopes will be cut short and fears realized because the FDA’s game against Provenge was rigged!
Seems nobody wants to help these dying men, not the FDA, not Big Pharma and certainly not the SEC. This fight had been left to the patient advocates and stockholders turned PC activists. Something is sorely wrong with the FDA concerning Provenge and I hope this lawsuit brings forth the ugly truth so that the American public can see that their fathers, brother, uncles and friends died in vain at the hands of a few at the FDA…..
Ed, as a prostate cancer patient I am most interested in, and thank you for, your article on Provenge. The most disturbing issue to me is the incredible lists of conflicts of interest the FDA people apparently have. Ed, I'm sure you and members of your family have or will have medical issues causing a need for medications. Don't you agree that it is wrong that the treatments you will receive will be determined by individuals who have more positions in financial arrangements than they do in charitable or humanitarian arrangements? It seems the FDA is just filled with egos and ties to paid advisory positions. Why isn't any major newspaper or member of congress looking into this issue of blatant conflicts of interest? Looks like we will have to rely on you, Ed, to delve into this and keep us informed. These are my and your and everyone else's medical needs some members of the FDA are using for personal gain.
Thank you for your work.
Thank you for your work on the provenge story.
Mr. Ed Silverman,
thank you for the clean interest and exposure you give to this mess, writing about it and publishing information regarding the law suit against the FDA.
Best regards
Thank you very much for your continued reporting of what many consider a miscarriage of public duty and responsibility by the FDA. Dr. Howard Scher's participation in the Provenge advisory panel is akin to a defendant's own sibling participating on a jury resulting in a hung jury decision. Knowing of Dr. Scher's close professional relationship to ProQuest Investments, how is the public to believe that the FDA made the correct decision? Surely you can see the travesty of his participation in this matter. Such conflicts of public and personal interest jeopardize the legitimacy of one proclaiming to act on behalf of the public's best interests.
As you may be aware, September 16th - 22nd is Prostate Cancer Awareness Week. Please join us September 18th to rally against the FDA's decision regarding Provenge for the treatment of prostate cancer. Every voice counts. You can find out more at http://www.arighttolive.com
Very Best Regards,
PH
If you have prostate cancer, how do you become a plantiff in this case.
[...] representatives for patients who want the FDA to reverse its Provenge decision — are now suing FDA officials and one of the two advisory-panel member whose critical letters ended up in Cancer [...]
My letters to the Senators from Ohio urging approval of Provenge resulted in a letter from our Democratic Senator giving some details about the Provenge situation and advising that there had been a law suit filed but no specifics on it. I received a letter from our Republican Senator, George Voinovich, today that was entirely unrelated to the issue I inquired about. With people like this running Congress it is no wonder our Government is so screwed up.