FDA Pulls Wolfe Off Panel Over ‘Intellectual’ Conflict
13 CommentsBy Ed Silverman // December 6th, 2011 // 1:29 pm
In an unusual move, the FDA has yanked Sid Wolfe from a planned meeting of its Drug Safety and Risk Management Advisory Committee this coming Thursday due to an ‘intellectual conflict of interest.’ The panel is scheduled to review the risks and benefits of blood clots linked to birth control pills containing a hormone called drospirenone (here are the briefing materials).
The most popular pills are Yaz and Yasmin, which are sold by Bayer. Wolfe, who heads the Public Citizen Health Research Group, says the reason cited is a newsletter called ‘Worst Pills, Best Pills News’ and the WorstPills web site, in which the group has labeled both pills as ‘do not use.’ Why? The listings say these can cause dangerous elevations in blood potassium levels and, more recently, because they also significantly increase the risk of blood clots and an increased risk of blood clots in the lungs.
And so, he issued an announcement a short while ago disclosing his removal and that he received a phone call this morning that the decision was made by Janet Woodcock who heads the Center for Drug Evaluation and Research. Wolfe, by the way, has served on the panel for more than three years and, he adds, has recused himself on four previous occasions in which Public Citizen had pending citizen petitions to ban the various drugs that were being discussed.
In response to the FDA call, he writes, that he “pointed out that it is likely, if not certain, that other members of the committee and of the Reproductive Health Drugs Advisory Committee, both attending the meeting on Thursday, have previously decided to stop prescribing the drugs or to keep prescribing them based on their knowledge of the increasing number of studies documenting this serious risk (some studies do not show the risk).
“In their personal medical practice, then, they acted on the basis of published information to advise women for or against the drugs. If intellectual conflict of interest means being informed and subsequently having opinions on a drug, many more members of advisory committees, even without a financial conflict of interest, would have to be excluded because they know too much. The resulting committees would be noticeably less well-informed than now is the case, and the FDA and the public would be the losers.”
Initially, Wolfe was offered time during the public session of the meeting to present his views, which he declined. He says he then spoke with Jayne Peterson of the FDA Advisors and Consultants Office, who took the matter up with other CDER folks. What happened? Wolfe says he could participate in the meeting, but with the same limitation accorded to the drug industry representative: speaking but not voting. He again declined.
“For members of a scientific and technical advisory committee, possessing information and expert views on matters within the purview of the committee is not a conflict of interest. To the contrary, qualified experts are likely to have developed views on a variety of subjects based on their professional experience, including their own independent research and their review of data compiled by other researchers. The fact that experts have acquired information and reached conclusions in the course of their work should not be a disqualifying factor and, as a legal matter, does not render the advisory committee not ‘fairly balanced,’ under the Federal Advisory Committee Act,” he says.
“Disqualifying advisory committee members because they have views on scientific matters threatens the utility of advisory committees in several ways. First, it deprives agencies of advice from the very experts most qualified to give it – those who have actual knowledge and research experience concerning the subjects to be addressed by the committee. Second, it deters qualified scientists from accepting appointment to advisory committees out of concern that their very expertise may become a matter of distracting controversy. And finally, it encourages politicization of scientific matters as interested parties seek to exclude scientists whose views are inconvenient to them.”
[UPDATE: On Wednesday, December 7, Wolfe called us to say that he decided to change his mind and participate as a non-voting member. "I stayed up last night and read more documents and it just seemed that it would be not right, from a public health perspective, not to participate just because they did such a stupid thing. So I decided I would go, and under protest, would participate fully otherwise. At a later time, hopefully, the whole issue of intellectual conflict of interest will be dealt with."]
[UPDATE ONE: We should note that the microphone was turned off during an August 2010 FDA panel meeting when Wolfe attempted to discuss publicly available documents that reflected poorly on Jazz Pharmaceutical to responsibly market a drug that was being reviewed that day. The drugmaker paid $20 million in penalties to resolve criminal and civil off-label marketing charges. The episode led to an unusual exchange between Wolfe and an FDA official (read more here).]
[UPDATE THREE: A loyal reader reminds us that, in 2009, the FDA 'disinvited' cardiologist Sanjay Kaul from an FDA committee that was set to review the Effient bloodthinner now sold by Eli Lilly. The drugmaker had complained to agency officials about comments that Kaul made about the drug, although the FDA later acknowledged that dismissing him from the panel was a mistake (see this and this).]
We have asked the FDA for comment and will update you accordingly.
Lisa Williams (Van Syckel)
I have always considered Janet Woodstock’s decisions on certain issues very disturbing, again, I don’t think the woman can find her way out of a brown paper bag. “It’s Just My Opinion”
Metrocare
Interesting take on this particular FDA issue. Good article!
El Sid
Lisa, re the brown paper bag, why do you think old Janet has survived this long?
john
As I understand it, the purpose of these meetings is for a panel of experts to consider the detailed data presented by FDA and by the Sponsor, hopefully exchange ideas, and come up with an expert consensus, thus serving as an advisor to the FDA.
I can see several problems with having people who have previosly taken a strong stand on the issue under discussion on the panel. One is that it may be difficult for such an individual to change their mind in the light of new data presented by the FDA or sponsor. The other is that it undercuts the indepedent advisory nature of the committee and turns it into a forum in which panelists of strongly held, preformed opinions play to the cameras.
Dr. Wolfe seems to me to come to these meetings not to deliberate but to advocate a strongly held, preformed point of view. He has voted no (against approval or for withdrawal) 90% of the time, which seems to me well out of the medical mainstream. Its good that his POV should be heard, but perhaps as a presenter. Having him as a voting member seems to me out of step with the purpose of the committee.
john
“Initially, Wolfe was offered time during the public session of the meeting to present my views, which he declined”
Ed, was this a slip? :>)
Lisa Williams (Van Syckel)
El Sid,
Because sometimes it’s not what you know, but who you know.
El Sid
Thanks, Lisa. To note, the correct spelling of Dr Janet’s name is WoodCOCK. It’s an important distinction. I doubt that she was at three days of peace, love and music.
harpy
weird. isn’t having an expert opinion the exact reason they waive financial conflicts of interest?
Joleen Chambers
I was invited (documentation to prove it) to the 1/13/11 MDUFA Medical Device User Fee Agreement meeting at FDA in DC. I paid $1700 of my own money for travel expenses to represent my brother, Steven Baker, MedWatch Adverse Event #5009052. He has a failed “innovative” 510(k) cleared Tornier elbow implant that failed in just 4 months. The “revision” operation did not solve the problem and he is now in medical and legal purgatory.
Although the table was set with my name, FDA staffers pulled me aside before the meeting and told me I could not participate because I did not represent a Consumer Group. (My documentation prior to invitation was clear and honest.)
I hesitate to give you my opinion of who/what prompted this undemocratic action for fear of an “intellectual conflict of interest”!
Bette
Joleen, I feel bad for you but rest assured, you’re not the first family member to be treated in a shabby fashion. I remember one distraught woman (her little girl had died from an ADHD drug) weeping in front of a combined pediatric-psychopharmacoloy FDA hearing and good old Tom Laughren did his usual act – alternately pretending to sleep and looking annoyed. Several times, I’ve watched family members try to talk with either Drs. Laughren or Temple when they’ve literally tried to run away. These are the very family members who, like yourself, have had a family member killed by a psych. drug and who want the adverse event attached to a real person’s name. For shame on the FDA. Let’s hope the PDUFA reauthorization now going on includes a restructuring of not only the open public hearin gperiod but also results in replacing some very negative, pharma-phriendly FDA staff members, whose behavior reflects their total lack of impartiality and compassion.
john
Harpy, how odd that we saw the same issue from such completely different points of view! I was thinking that Wolfe was making an excellent case for relaxing conflict of interest rules for those with financial ties to the industry.
Wolfe actually has a strong incentive to almost always vote “no”. Imagine the loss of credibility if the head of a pharmaceutical watchdog group voted for a drug that was later pulled due to unexpected toxicity. On the other hand, there is no downside to voting against approval.
This is why I think he should be seen as an advocate, and not as a voting member.
vince
Now you go right out there and speak in the public views portion ‘….We should note that the microphone was turned off during an August 2010 FDA panel meeting when Wolfe attempted to discuss publicly available documents that reflected poorly on Jazz Pharmaceutical to responsibly market a drug that was being reviewed that day……..” Long ago the FDA became a partner with industry …..
john
Well vince, like the article said, the FDA approval process is about safety and effectiveness. If a drug became available to treat an illness of a member of your family, would you like to see the Fda deny approval as a method of punishing the manufacturer for prior bad acts?
Everyone has a point of view and feels that what they have to say is more important than what anyone else has to say. Thats why meeting that hopes to be effective has rules of order. I think it was completely apprpriate to shut off Dr. Wolfe’s microphone when he ignored instructions from the chair. I’d expect them to do the same thing if a presenting sponsor spoke out of order.
Does pharma have the FDA in its pocket? I don’t think Roche would agree, having just been publicly roasted and having approval for avastin in breast cancer pulled. Dendreon would like to know why it took two extra years to get provenge approved, and Arena, Vivus and Orexigen would very much like their putative errand boy to approve their obesity drugs. Genzyme, JNJ and Hospira would like to start making drugs again, and Lilly and Pfizer would like their multi billion dollar fines back please.