Congress Won’t Hold A Provenge Hearing
9 CommentsBy Ed Silverman // February 13th, 2008 // 3:12 pm
In another blow to an ad hoc group of prostate-cancer patients and stock investors, the House Energy & Commerce Committee has decided not to hold a hearing into the controversy over the FDA’s handling of Dendreon’s Provenge vaccine. In a letter sent earlier today to four congressmen who had requested a hearing on behalf of a non-profit called Care To Live, the committee declined to take up the cause. (Here is the letter).
“An investigative hearing prior to an agency’s final decision runs the risk of interfering with the normal regulatory process,” wrote John Dingell, who chairs the committee, and Frank Pallone, who chairs the health subcommittee. “As you can understand, as the committee conducts oversight of the FDA or any other agency, it must be careful to balance the need for aggressive oversight with the equally compelling need to avoid the appearance of political interference that favors a particular interest.”
The controversy erupted last spring, after an FDA advisory panel recommended the agency approve Provenge. But then two FDA panel members wrote the agency urging a go-slow approach, and the FDA shortly thereafter decided to delay approval. One panel member was Howard Scher, an oncologist at Memorial Sloan-Kettering Cancer who serves on the advisory board of a venture capital firm that invested in Novacea, which is developing a rival cancer med. The other was Maha Hussain, a University of Michigan oncologist.
The behind-the-scenes machinations caused a firestorm - the two cancer docs say they received threats; the chain of events fueled debate about the use and approval of experimental meds, and some cancer patients and Dendreon investors filed a lawsuit against the FDA. The suit 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, although a federal judge recently dismissed most of the suit.
In further explaining their decision, Dingell and Pallone pointed to waivers that were issued to Scher and Hussain, and then cited a recently enacted FDA regulation governing conflicts of interest. You can read here about the new regs, which were proposed last spring. Although that will likely be of little comfort to the Provenge activists, given that the new regulation was passed after the Provenge episode. A committee spokesman writes us to say that no one will be available to discuss the decision.
Scott Riccio, who heads another group that is pressing for Provenge approval, A Right To Live, send us this statement: “We’re saddened for the patients who have already been lost because they couldn’t access such a promising and potentially lifesaving new therapy….
“…We’re saddened for the patients still fighting for their lives who have been denied the hope that shedding some light on this regulatory process gone wrong might bring new possibility of meaningful change. We hoped that by asking and answering the clear and compelling ethical questions raised by Congressman Michaud (and supported by more than a dozen members of Congress now), the course of this tragedy might be shortened or changed and future tragedies might be averted.
More than 20,000 men with late-stage prostate cancer have died without being able to fight their cancer by getting access to Provenge. When the FDA does ultimately approve this new therapy as they have with so many other promising therapies that they couldn’t appropriately understand and evaluate in a timely manner, what should we tell the families of these men for whom this unnecessary delay was decidedly a ‘final decision’?”
And Kerry Donahue, the lawyer for Care To Live, just wrote us this response: “What Congress does not get is that the FDA might NEVER make a final decision. Therefore, never be subject to oversight. What about investigating the delay caused by the improper actions of Scher and Hussain and the 23,000 men that have already died since their conspiracy with Dr. Pazdur (the FDA official the group accuses of orchestrating the delay in approval)?
“It’s the delay stupid! It’s about investigating the conflicts of interest. Is Congress saying they will go back and reconsider the conflicts once Provenge is eventually approved or denied? Or are they saying that the thousands of men who died so a few doctors could profit is okay so log as the FDA is still thinking about it?”
Tom
I’m sure that many readers aren’t big Scott Gottlieb fans, but the attached opinion piece on Provenge written by the former FDAer in 2005 probably still holds more or less true today. I usually try not to convict the purported scoundrels exposed on Pharmalot before all the facts are in (due process applies to everyone, even Pharma and FDA), but this story continues to disturb me. Yes, FDA has become much more cautious and politically wary in approving new treatments. However, when they have a chance to sign off a product for life-threatening disease, it’s a win-win opportunity and they tend to jump at it, even if there are still open questions about safety and efficacy. http://www.forbes.com/business/healthcare/2005/02/18/cz_sg_0218soapbox_inl.html.
Bob DeVivo
Again we see that greed and politics overcome good medical advancements. Together with the SEC, the FDA has become a tool of the rich and established, more interested in maintaining their influence than justice. It makes a life-long Republican like me feel ashamed that this has occurred during a Republican Administration, but does show another example of why the best Federal Government is a small Federal Government. The spread of Naked Shortselling, with huge “failures-to-deliver”, show that the SEC is no better than the FDA, as far as protecting retail investors and medical patients from shameful manipulation.
Matt
I’m absolutely disgusted by this. Congressman Dingell - come reelection, expect a massive campaign run against you.
achchhaa
How sad…..
MyPharmalotID
To the House Committee on Energy and Commerce:
The fact is, this was not about approval…the FDA has set in motion, with Dendreon, the protocols necessary to obtain approval for Provenge.
As for the new COI rules and regulations, had they been in place before March 29, 2007, a study released prior to the Provenge Advisory Committee meeting demonstrated that neither Dr. Scher nor Dr. Hussain would have been permitted to participate in that meeting.
(BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS MARCH 26, 2007)
“Under the draft guidance, Scher either would be prevented from voting or excluded from the meeting.”
Re Dr. Maha Hussain: “The waiver notes that Hussain is the principal investigator on a research contract awarded by a competing company for a product that is not related to Provenge. Under the draft guidance this probably would not be considered a conflict. However, the fact that her husband owns stock in three competing companies, valued at $15,000-$300,000, would at minimum prevent her from voting. If the total value of the stock exceeds $50,000, Hussain wouldn’t even be at the table if the new policy were in effect.”
But all this is closing the barn door after the horse escaped!
The call for hearings in the House Committee on Energy and Commerce, plain and simple, was to investigate alleged ethical and legal COI violations by two special government employees. The violations were centered around their participation during and following the Provenge March 29, 2007, Provenge Advisory Committee meeting, and involved such things as letters disparaging Provenge (requested by someone within the FDA, in the case of Dr. Scher’s letter) that were ghost-written, in part, by government employees at NCI (and possibly the FDA); letters written to the FDA by Drs. Scher, Hussain, and Fleming that were leaked to The Cancer Letter; the relationships among Dr. Scher, ProQuest Investments, Novacea, and Schering Plough; the announcement of a $440 million co-development deal for Asentar (in the same prostate cancer space as Provenge) between Novacea and Schering Plough, just 3 weeks after the FDA sent Dendreon a Complete Response letter, and other “interesting” events and associations.
All of which raises an interesting question for the House Committee on Energy and Commerce:
Who represents the American Public – and, especially, prostate cancer patients - in this travesty?
Who is responsible for investigating what surely must be seen by all, at this point, as “suspect activities” worthy of someone’s attention?
FDA Ethics? They certainly have been notified, and are, I’m sure aware of the situation.
HHS Office of the Inspector General (OIG)? He regained the ability to oversee the FDA just a few months ago, but as far as I can see, he, too, is missing in action (MIA).
The SEC? They were pretty quick to jump all over a previous head of the FDA for infractions that involved stock market holdings, and there’s no question, given the fact that Dendreon has been on the RegSHO list for months and months, now, that they are aware of the situation…but they haven’t weighed in yet, either. It might be interesting to know why they haven’t looked, for example, at the increase in short interest following the favorable March 29, 2007, Advisory Committee meeting. Did someone on the Street know something about which we mere mortals were not aware?
GAO Fraudnet? It would seem to me that this organization might wonder what FDA and NCI employees were doing helping a private citizen (remember, Dr. Scher submitted his letter on Memorial Sloan Kettering stationery) write a letter to the government, disparaging a drug that was under FDA review…especially since Dr. Scher served as a special government employee during the Advisory Committee meeting. To what account were the federal employees charging their time while they worked on a private citizen’s business?
Again, Congress, who is looking out for our interests?
Inquiring minds would like answers.
Phil Vardena (Pharm. D.)
From the letter:
“FDA has not yet made a final decision on this product, and it is the practice of this Committee to allow a regulatory agency such as FDA to complete its statutorily-mandated processes and render a final decision before initiating formal investigative action”
Call me optimistic, but this to me boils down to: If you don’t approve, we investigate!
That said, we know Provenge works. Investors will have their reward.
My thoughts are with PC patients, who are being denied a chance to live longer and live better.
Regards,
phil
suzy
Apparently the FDA is not accountable to anyone … it’s a sad day for prostate cancer victims.
Advisory panel members: you now have the go-ahead to make those lucrative deals with competitors of drugs/vaccines you are reviewing.
IMHO Pazdur wins again. He (and his underlings) can continue to leak information to hedge funds and big pharma with no impunity.
walldiver
Dingell is being disingenuous when he says that Scher disclosed his financial/research conflicts of interest. Or did he somehow not get the info that Scher was tied to the hip with Proquest/Novacea? At least one, and perhaps both, of the Novacea and Proquest COIs were not disclosed to the FDA by Scher prior to the March 2007 advisory panel meeting. Novacea’s future depended on the clinical, regulatory, and commercial success of its investigational drug Asentar, a direct competitor of Provenge’s in hormone-refractory prostate cancer. Scher was the lead investigator of Asentar’s pivotal Phase 3 trial. Scher served on both the board of directors of biotech venture capital firm Proquest Investments and its scientific advisory board. Proquest made a bundle of money (tens of millions of dollars) on its Novacea investment after Scher helped remove the Provenge obstacle from Asentar’s path. How did this occur? Schering Plough signed a lucrative partnership deal with Novacea for Asentar, several weeks after the adverse Provenge decision by the FDA. This deal would have been much less lucrative for Novacea and Proquest if Provenge had been approved. In fact, it’s possible that the Schering/Novacea deal never would have happened. It’s all water under the bridge now, though, since Asentar’s Phase 3 trial had to be halted in midstream by the safety monitoring people due to the high number of deaths in the Asentar arm. However, the damage has been done. By the time May 2008 comes around, another 30,000 men will have needlessly died, without any hope, of advanced prostate cancer. A death so painful (prostate cancer metastases split your pelvic bone apart) to be unimaginable. Provenge could have extended the lives of 25% of those 30,000 men by an extra four to six years beyond their typical life expectancy. But hey, who cares anyway? Scher and Proquest already made their millions. Isn’t that what it’s really all about?
Tony F
1. SHOW me the alleged threats to Scher and Hussain… having a spokesperson say so doesn’t make it so…
2. For the new folks reading Ed’s continuing coverage on this debacle who are unaware of why folks are calling for an investigation of Scher here is some internet data gathered.
One must remember, he personally certified to the FDA he had 3 Conflict of Interests; the internet shows some 17,,,,
1. NOVACEA: grants & research support; STUDY CHAIR of DN-101; 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, Board of Directors, Advisor. Invested in Novacea.