Congressmen Call For Probe Into The FDA, Provenge And Conflicts Of Interest
9 CommentsBy Ed Silverman // December 13th, 2007 // 12:50 pm
You read it here first. Three congressmen today wrote a letter to the House Energy and Commerce Committee to hold a hearing into allegations that undislosed financial conflicts of interest among FDA advisory committee members may have swayed an FDA decision to delay approval of Provenge, a prostate cancer vaccine being developed by Dendreon.
“Many ethical questions remain about the two panelists who voted no on approving this drug,” Mike Michaud (D-Maine) says in a statement. “I believe that the FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge. Congress needs to get to the bottom of this. I believe a full disclosure is necessary in order to restore confidence in the FDA.” Along with Michaud, Dan Burton (R-IN) and Tim Ryan (D-OH) signed the letter, which you can read here.
[UPDATE: The committee will review the issue, a congressional source tells us].
For those who haven’t followed the controversy over Provenge, an FDA advisory panel last spring recommended full agency approval. But then a curious thing happened - 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 particular, the drama has centered on the origins of the letters written by Scher (pictured at left) and Hussain, which some believe were orchestrated by Richard Pazdur, who heads the FDA’s Office of Oncologic Drugs and is now rumored to become the agency’s new safety chief. The FDA is conducting an internal investigation, but has repeatedly declined comment, citing the pending litigation.
“We need to ensure that the FDA gets life-saving drugs to the market as quickly and as safely as possible,” Michaud stated. “Our priority is to ensure the prompt and efficient approval of therapies such as Provenge that could potentially benefit millions of Americans with cancer.”
UPDATE: Dendreon stock soared nearly 15 percent shortly after the news broke.
Lisa Van S
Pretty Impressive!!.. Dan Burton has been critical of Vaccines and their possible link to autism. And has supported the Black Box Warnings on Antidepressants.
And before everyone chimes in,…. Id like to say this.
I believe that this vaccine should be approved, we are talking about medication to treat cancer. If it has the potential to save a life,..GO FOR IT.
MyPharmalotID
About time! The FDA continues to be one of the most corrupt agencies in this administration.
And where is HHS’ Office of the Inspector General (OIG), now that he’s free once again to investigate the FDA? Up to now, an agreement between the FDA and HHS placed the burden of investigation under the FDA…for what good that did! But HHS OIG now is free to pursue the matter independently.
If HHS’ OIG doesn’t move on this quickly, the issue will bury his agency’s credibility together with the FDA’s. But come to think of it, the latter’s credibility and integrity probably are beyond redemption at this point.
paul b
Fantastic job again, Ed. We need to get more representatives to sign on to this letter, so that the investigation indeed takes place. This thing could yet blow WIDE open, as it well should. Sure hope Howie’s having a nice day today. Ta ta, Maha.
Hard Ball
BRAVO, BRAVO, Congressmen. (standing ovation)
If Provenge can save half of them, if it can make what little time that they have left, better, then they deserves to be allowed to attempt it. I applaud these Congressmen and I am pleasantly shocked that anyone in government can be as responsive.
Keep going… take the corruption out wherever you can grab it cleanly by the neck.
Tom Smith
Pazdur and many within the FDA think they are above the law and Congress well they may find out differently in short order! PAZDUR MUST GO!!!! Andy von needs to fire him and do what should have been done back in May approve PROVENGE NOW!!!!
Tony F
Well, well, well…. maybe, just maybe, the pigeons are coming home to roost after all…
Those familiar with this part of the Provenge tale recall that Scher certified to the FDA that he had 3 conflict of interests–2 competing company associations and 1 personal stock holding — per his filing in late February available at the FDA website.
17 (SEVENTEEN) have apparently been found on the net:
…. please particularly note #1 and #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 MYERS SQUIBB: 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. 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
There appears to be a significant and disturbing difference between his 3 disclosures to the FDA and the alleged 17 COI’s found so far on the internet.
Lastly, let’s not forget the 83 men who die EACH DAY from prostate cancer and their families. God Bless them and their loved ones!
Since May 9th FDA adverse decision on Provenge, over 18,011 men have died….. in just 7 months.
Where’s the public outcry against this travesty?
qwickster
Great job keeping on top of this issue Ed! These 3 congressmen are making a great statement for patients and a firm stance that conflicts of interest are NOT acceptable in the FDA when approving drugs, especially when dealing with life saving therapies. Continue to keep us posted.
phil_vardena (Pharm. D.)
Hi Ed,
nice job on your part.
My favourite questions during the hearing would probably be those below:
On May 9, 2007, “Black Wednesday”, the FDA said “NO” to Provenge, issuing a Complete Response letter. A few weeks after the FDA delaying letter regarding Provenge, on May 30, 2007, news was that Schering-Plough Corp. said it had agreed pay Novacea Inc. (a competitor to Dendreon) 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?
Also, did Novacea and Schering-Plough Corp. arrange the deal in a couple of weeks? What kind of due diligence was Schering-Plough able to do in twenty days?
What did Dr. Sher and Dr. Hussain know when they sat at the panel?
Regards,
phil
Scott
Ed,
Glad to see this discussed and I am hopeful that congress follows through on their investigation. I have only one concern, depending on how long this investigation takes it is depriving those in need of treatment as well as allowing the competition to move their clinical trials along. this seems somewhat unjust. Could this be a calculated move by the competition? Regardless of the outcome of the investigations the bottom line is Provenge’s approval and use has been delayed while the competition’s progress continues to move forward.