Andy’s Take: We Care About Conflicts Of Interest
7 CommentsBy Ed Silverman // April 21st, 2008 // 9:40 am
In his weekly equivalent of a fireside chat, FDA commish Andy von Eschenbach last Friday shared his thoughts about advisory committees and conflicts of interest. You may recall this is a hot-button topic because FDA critics say the agency is too soft on panel members who have some financial tie that may sway their thinking. Industry generally counters that most, if the not the best, experts will have done some consulting or speaking work for a drug or device maker, anyway.
In response to the criticism, the FDA last spring proposed new conflict of interest rules and issued a guidance last fall (look here). The guidelines would allow scientific experts who accept less than $50,000 in corporate grants, contracts and consulting fees - or hold less than that amount in company stock - to still serve on advisory committees. But that could happen only if the need for their services outweighs a potential conflict. However, they would be barred from voting. And more recently, the FDA sponsored a study saying it would be difficult to find unconflicted experts, although consumer groups disagreed (look here).
So last Friday, Andy writes: “Many of you may not be aware of the great lengths we at the FDA go to to ensure the integrity of our advisory committees - to assure that we get good information and advice. FDA carefully scrutinizes each committee member for potential conflicts of interest - we review who they work for, any contract work they’ve done, and even any investments and stock they or their family members hold.
“We weigh the potential for those financial holdings to bias their participation with the need for their expertise and determine whether they should participate, and issue a waiver if appropriate. When a waiver is granted, we then share this information publicly so that others know what conflict might exist. As consumers and patients we all benefit when diverse groups of world-class scientific and medical experts consult with FDA and provide us with the best possible advice about emerging technologies and difficult regulatory decisions.”
That may be so, Andy, but $50,000 is still a lot of money. And meanwhile, the FDA has yet to enact the guidelines, even though the comment period ended Dec. 31. An FDA spokeswoman writes us that the agency is “developing final guidance consistent with the new requirements of FDAAA enacted last September.” There’s no word on when the guidance will be enacted, though. In the interim, more committees continue to meet.
Jason L
This hypocrisy is palpable. Von E is either
retardedly myopic or the King of Smarm - maybe both.
He has the nerve to blather about great lengths the FDA
goes to ensure AC credibility. What a joke!
Howard Scher???? Ummm Andy your nose is growing
at an exponential rate.
The *only* great lengths I have seen FDA go to in the past years is the response in sending some thugs to a flower
shop.
Resign Andy!
kelatious
Ed,
Seems to me that “Andy’s Take” isn’t working out for the FDA all that well. I understand that the FDA is trying to appear more open and caring to the American public….it’s just not working.
“Andy’s Take” should be renamed to something more suitable, something that explains how America has been “Taken” by the FDA.
Why do the “Andy’s Take” takes I’ve read seem to, at least in some way, pertain to the Provenge Debacle? Strange, indeed!
Maybe Dr. Von Eschenbach should just take his act elsewhere, and resign from the FDA, he hasn’t done any good work there, anyway.
kel
Tony F
To remind Ed’s readers if they are not up-to-speed on exactly how badly the Scher Conflict of Interest situation appears to be in the FDA Provenge Advisory Committee meeting, take a look at these alleged COI for Dr. Howard Isadore Scher of Sloan Kettering.
In order to sit in judgment of Provenge, Scher certified to the FDA that he had 3 Conflict of Interests. These 17 (SEVENTEEN) have been found on the internet for Scher.
NOTE particularly items 1 & 17
1. NOVACEA: grants & research support; STUDY CHAIR of DN-101
…. and 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; 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 Mar 6, 07; since removed 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. Novacea Investor
Despite the above being reported to the Health & Human Services investigate office and the FDA investigative office, nothing has been done for almost a year to investigate these allegations that Scher may have violated the law by his apparently failure to disclose ALL his COI.
However, when two individuals sent flowers to the Commissioner of the FDA several weeks ago, the FDA sent 2 investigators–within 1 business day–to the florist who delivered the flowers in order to get the names and other information about who sent Dr. Andy flowers.
FDA investigates flower senders, but not serious allegations of potential wronging by a Temporary Government Employee speaks volumes of how Dr. von Eschenbach runs the FDA.
Finally, remember that Provenge is a treatment for TERMINAL prostate cancer victims… it’s not about an aspirin or an OTC supplement… this is about life and death.
83 men die daily from prostate cancer and some 28,801 have died just since last May 9th when the FDA postponed Approval/Conditional Approval for Provenge… a treatment all AC members voted to be “safe” by a 17-0 ballot.
Approve Provenge NOW and, Dr. Andy, fulfill your duties of office or resign.
Tony F
Kyoto27
“FDA carefully scrutinizes each committee member for potential conflicts of interest - we review who they work for, any contract work they’ve done, and even any investments and stock they or their family members hold.”
Is Andy just playing a sick ‘baiting’ game here to draw comments? Or is he having a conscience attack?
In Shakespeare’s Macbeth, Lady McBeth, plagued by guilt for her part in the killing of Duncan, utters the famous line “Out Damn Spot!” while in a state of almost manic sleepwalking. Is there blood on the hands of Andy here? Maybe ‘Andy’s Take’ is some sort of manic cleansing act?
MyPharmalotID
Speaking of William Shakespeare (and with apologies), take a look at this article:
Dendreon: The FDA’s Commissioner Doth Protest Too Much!
http://seekingalpha.com/article/73065-dendreon-the-fda-s-commissioner-doth-protest-too-much?source=yahoo#comment_form
LILLI
Congress is to blame for allowing the medical profession, healtcare industries, hospitals and pharmceutical companies to direct our government. As I have said before what good is this dicussion if no one is disciplined. Elected and appointed officals must obey their oath of office and their reponsiblity is to the people, not to the greed of the power of money. Too many lives are being lost becuse of the corruption in our federal and state governments. We must stop paid lobbyists from influnencing our elected and appointed officials.
scott
It’s bad enough that Dr. Von E is incompetent to lead the FDA, being obviously incapable of reining in ambitious bureaucrats like Dick Pazdur. What is actually worse is that Dr. Von E lacks basic integrity and has the gall to claim that he is serious about cleaning up the COI problem. The facts show otherwise, and no amount of Dr. Von E’s blather can change the facts.
His lack of integrity comes as no surprise, however, after we have heard his usual response to criticism about FDA’s many procedural and substantive failures in its handling of the Provenge BLA, his infamous claim that the FDA is a “science-based” organization. If only that were true. If only Dr. Von E would face up to the reality that turf wars and greed have displaced science when a select few so decided.
It is offensive that Dr. Von E. thinks we are too ignorant to see the truth.
I cannot imagine a more abject failure of leadership than what we have seen from Dr. Von E. What a disgrace to our government, the medical profession, and to our nation.
RESIGN NOW!