An Undisclosed Conflict On The FDA Avandia Panel?
14 CommentsBy Ed Silverman // July 20th, 2010 // 6:37 am
When the FDA held a media briefing prior to the controversial advisory panel last week for the Avandia diabetes drug, an agency official was asked whether any conflict of interest waivers were issued for the panel members. Under pressure, you may recall, the agency revised its those rules and now attempts to vet financial holdings or relationships to drugmakers that are provided by panel members (see this).
In response, Jill Warner, acting associate commissioner for Special Medical Programs, said none were issued. However, there was an undisclosed, ongoing relationship involving one panel member. David Capuzzi, an endicrinologist who has been a professor at Thomas Jefferson University in Philadelphia, last year earned $3,750 as a speaker for GlaxoSmithKline, which sells Avandia (see the list). A Glaxo spokesman also tells us Capuzzi was paid $8,000 through 2008 and another $3,000 earlier this year. But Capuzzi says these were not for speaking about Avandia. Instead, he says he chatted about Lovaza, a drug designed to lower triglycerides, although the Glaxo spokesman says at least one talk, prior to 2008, was about Avandia.
“I told (the FDA) about my speaking for different companies, but I have never given a talk, nor received any income for work or services on rosiglitazone (Avandia) or for any other TZD (glitazone drug) in the past,” Capuzzi tells us. “In the past, I’ve spoken for another drug, Lovaza, but the FDA doesn’t consider a different product for the same company to be a conflict of interest.” But did he tell the FDA, specifically, about his relationship with Glaxo? “No, nobody asked me that question that way. I’m new (to the advisory committee). But I have nothing to hide. I believe in full disclosure. I just wasn’t asked that question.” For the record, Capuzzi defended Avandia during the recent FDA panel meeting and, as The Wall Street Journal notes, voted to keep it on the market, although he says he rarely prescribes the pill, doesn’t “like the whole class of drugs” and prefers to prescribe metformin.
As for the FDA, a spokeswoman sent us this statement: “Before each meeting, FDA screens all advisory committee members who are special government employees or regular government employees for conflicts of interest. Members are required to report all current financial interests and those held within the previous 12 months that could be affected by the discussion and outcomes of the meeting, or that would present appearance issues. FDA takes these allegations very seriously and is investigating the matter.”
We asked Art Caplan, who heads the University of Pennsylvania’s BioEthics Center, about this situation and he says disclosure should have been made. “Any talking about Avandia, you can’t excuse telling the FDA. It may not be major, it may be awhile ago, but you’ve got to tell. Avandia is in the middle of a firestorm. This is a very specific, very heated, very important battle about this drug, its competitors and public health. I’m hoping people would disclose instead of people having to go digging up after the fact. We’re doing exactly what we don’t want - asking why didn’t you tell us?
“I think the FDA relies on its advisors, speakers and panelists to disclose, and they don’t do independent verification. They expect disclosure. It’s pretty clear the duty is on the person. I think you can’t accept an explanation of naivete….If it happened in the past five years, that’s a problem. A connection to Glaxo should have been disclosed, although it’s a little less of a problem. But common sense says when in doubt, say something. Granted, we’re talking about smaller amounts of money, but it’s a big-stakes issue.”
UPDATE: We should note that, in the past, Caplan served on the advisory committee on bioethics for GlaxoSmithKline (see his bio).
Stephany
http://www.jefferson.edu/cardiology/cardiovascprev.cfm
He’s been around the block as a Principle Investigator for several drug companies. It’s amazing the FDA does not research their panel members ahead of time, it’s not difficult to find out information.
MsPiggy
GSK stacks the 5 voting member committee with shills, and its the dog ate their homework excuse that caused them serious conflict amnesia.
This kind of behavior is what we have come to expect from the FDA after all.
I gather we’ll have to spend hours searching the conflict records of the other voting committee members now.
Certd
This study was NOT Avandia. Avandia was an SB compound not GW.
A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging (0.25 to 10 mg) Clinical Evaluation of Oral G1262570X as a Monotherapy in Subjects with Type 2 Diabetes Mellitus
Sponsor: Glaxo Wellcome, Inc.
Dates: 5/98 - 4/00
Principal Investigator: David Capuzzi, MD
pharmavet
David Capuzzi is an outstanding scientist with unquestioned integrty. I know because I have worked with him.
Stephany
Well, then with that we can all rest easy Pharmavet.
MsPiggy
I wouldn’t care if this were a “person” labeled the “second coming” - not disclosing an obvious conflict of interest related to a company with a drug under review is inexcusable.
No doubt Capuzzi’s glowing defense of Advandia had nothing to do with his cozy relationship related to GSK & Big Pharma?
I feel much better now that he has personal references here in the comment section.
docsonal
Now we have another piece of news that rival Takeda paid another panel member who voted against Avandia ( See Url above)
http://online.wsj.com/article/SB10001424052748704723604575379292803755042.html
The company said that Dr. Thomas gave two talks as a member of its Diabetes Speakers’ Bureau. In an email, Dr. Thomas confirmed speaking about Actos and estimated he was paid about $2,000 to $3,000 for the talks.
Dr. Thomas said he gave all information about his relationship with Takeda to the FDA. “I do not remember there being any issue brought up about the Takeda speakers bureau” by the FDA., he said. “This may be due to the fact this was several years ago.”
He said the FDA’s review of potential conflicts was thorough. “This was one of the most extensive and time-consuming evaluations prior to any FDA meeting I have attended,” Dr. Thomas said.
The FDA didn’t immediately respond to requests for comment about Dr. Thomas.
On Monday, Glaxo said it paid about $14,750 over several years to Dr. Capuzzi. He was one of only three panelists who wanted Avandia to stay on the market with no additional warnings or restrictions, and he spoke out at the meeting in the drug’s favor.
A Glaxo spokesman said that Dr. Capuzzi didn’t give talks on Avandia, but he was paid by the company as a consultant on an Avandia advisory board sometime before 2009. The amount was $750, Glaxo said. Dr. Capruzzi could not be immediately reached for comment.
FDA officials said they are trying to determine why Dr. Capuzzi’s relationship with Glaxo was apparently not flagged during the financial vetting leading up to the panel meeting”
Interesting that the FDA supposedly scrutinized this particurlar AdCom panel. So much for a thorough review of COI !! Cant they find endocrinologists without Conflicts of Interest.?
Skeptical
The bottom line is, even if the panel member is not directly working on the drug under question but has other consulting agreements with the company, it is still a conflict of interest. Don’t bite the hand that feeds.
Kaia
A 16-Week Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety and Efficacy of Hypolipidemic Therapy with an HMGCOA Reductase Inhibitor (Atorvastatin) in Type 2 Diabetes Mellitus Patients Treated with Rosiglitazone (BRL49653) 4 mg Bid
Sponsor: SmithKline Beecham
Dates: 4/99 - 3/00
Principal Investigator: David Capuzzi, MD
pharmavet
I would say with about 95% probability that I am the only one on these boards that has actually even met Dr. Capuzzi, let alone worked with him over the years. I find it interesting how easy it is for people to take pot shots at a man whom you have most likely only heard about through the blogosphere. With all due respect to Ed, I hope that you all don’t rely on Pharmalot as your only source of information. I would also predict that Ed himself would support that perspective.
MsPiggy
Dear pharmavet;
I have little doubt you have great respect for Dr. Capuzzi. But unfortunately I heard very similar defenses from colleagues proclaiming what a great person Harvard’s J. Biederman was, and then once again in defense of Nemeroff @ Emory.
It’s only takes a poor lapse in judgment to go from respected to notorious in life. The comments above are based on the evidence as reported to date.
I am reminded today that those same colleagues that defended the aforementioned above, now speak a very different tune on the subject matter and are some of their most outspoken critics.
I gather time will tell. Time in this case is not so kind to those who died ingesting this drug.
JenL1125
I have known Dave capuzzi for the past 39 years and I can state, without a shadow of a doubt, that he is one of the most brilliant, ethical, dignified and honest people in the world. Each of us should be thankful that doctors and men like him still exist. For all of you who cast stones without knowing everything there is to know in your firestorms of self-righteousness, I feel badly for you. How unfortunate that your hateful mentalities could even allow you to hope that a person who has lived his life so decently and altruistically will no longer be “respected”, but considered “notorious”.
Justice in MI
I haven’t commented on this issue, but I will to this extent–
I don’t think FDA’s AC policy has anything to do with assessing an individual’s character. No disclosure policy is, or ever could be.
Such policies are simply based on the premise that financial ties should be made known. That is, in turn, based on the premise that–in the broad scheme of things–significant financial ties are correlated with decision-making in some _proportion_ of people (again, it’s about probability in a population, not the character of an individual).
Whether there was a relationship here which even rises to the standard of “should have been made known” is, as I understand it, the question.
Jon Shuster
What about Steve Nissen? He has received significant support from Takeda, makers of Actos. His presentation slides clearly show a salesperson approach to the deliberations.