FDA Panelist Sid Wolfe: ‘I Hope To Have Influence’
3 CommentsBy Ed Silverman // November 5th, 2008 // 12:46 pm
On August 8, the FDA made Sid Wolfe, the long-standing consumer advocate at Public Citizen Health Research Group and a well-known thorn in the side of the pharmaceutical industry, a permanent four-year member of the Drug Safety & Risk Management Advisory Committee. His term began August 8 and lasts through May 31, 2012, although few knew this because the appointment was only recently disclosed. We chatted with Wolfe about his new role, which takes him from outsider to something a little closer to insider. This is an excerpt…
Pharmalot: How did this come about?
Wolfe: There’s been, for a very long time, a consumer consortium with the responsibility from consumer groups that go throught first phase of nominating consumer reps for FDA advisory committees. It’s a regular process. If an opening comes up, which is usually known well in advance. The consortium will be told we need you to nominate a consumer rep for an advisory committee and that’s what happened here. You know, I had been on the same committee in an acting capacity last spring. Anyway, I was notified by the FDA that I’d been nominated, among other canddiates, for this spot…I’m a little surprised that it got cleared by the people at CDER, but there you go.
Pharmalot: Why take on this role?
Wolfe: The committee is advisory to FDA, which sometimes takes a committee’s advice and sometimes doesn’t. I don’t see it in conflict… The difference is that, in these public sessions where you can stand up and say something, you’re limited to 2 or 5 minutes, or maybe 10 in the extreme, and it’s a function of how many people want to testify. Maybe the committee members want to ask one of those people something, but they don’t get the opportunity. It’s a much more limited form of participation.
As a member of the committee, I’ll get documents in advance - however many weeks or whatever - and be able to go over them more carefully than when you get them two days in advance when posted on the FDA web site. And I get to ask questions of the FDA, the company or other people who are providing info for the commitee, and get to vote on whatever the issue is. So it allows me much more room to influence decision making. The two are inconsistent, though.
Pharmalot: You don’t feel you’ll be compromised somehow?
Wolfe: Theoretically, no. I was on the committee in an acting capacity last spring and didn’t feel I was cmoprsied at all. I’m interested in this topic. I wouldn’t have spent three-quarters of my time for the past 37 years if I didn’t think it was important and didn’t have something to contribute. I can’t think, theoretically, how it would happen…I’m not allowed to make public any info I get advance…
I’ve always been sympathetic to the people in the FDA who are doing the work, looking at drugs. We did that survey in 1998 that showed their opinions were being disregarded. I feel that being on the advisory committee, in a sense, is supporting the work of those people who are doing a good job. I can’t imagine in what way or how I’d be copted. I’m not arrogant enough to think it’s impossible, but I don’t think it’s very likely to happen. I’ve been doing this a long time and don’t think I’ve been co-opted. And if I have, I hope someone brings it to my attention, so I can learn from it.
Pharmalot: Should the drugmakers worry about your presence? Wolfe: I can’t answer for them…It depends on their view of the purpose of the FDA. I’m sure it varies from company to company. I don’t really think I’m on the inside. The reason the committee came into being in 2001 or 2002 was because the FDA felt there weren’t enough experts focusing on safety..So the idea was to augment whatever thereapeutic committee is dealing with a drug, for approval or a review of safety consideration of a drug already on the market…
They have some influence, but FDA doesn’t have to accept advice of the committee. I see some of these remarks made about my participation that people should worry I’ll get on this or that drug. I just can’t comment, not because I don’t want to. There are many people in the drug industry who are perfectly honest and do good work, and others who are obsessed with marketing and cut corners. So I’m sure there are people in the companies who don’t see a problem (with my committee role) and others who do…But it really depends on who in the industry is answering this question.
Chris
I think is a big step in the right direction. The public needs people to look out for their best interests.
atlex
Just another example of FDA being in bed with Big Pharma!!!
Steve Walker
The appointment of Sid Wolfe to the FDA’s Drug Safety and Risk Management Advisory Committee makes a joke out of the agency’s new conflict of interest rules. He has, by his own admission above, spent 3/4’s of his time over the last 37 years trying to get drugs deemed safe and effective by the FDA, pulled off the market. In doing so, he had to make do with the same kind of access to information the rest of us get under SEC rules. An avowed anti-industry activist who is not a patient advocate, but rather a paid employee of Public Citizen (which is an organization that exists for the sole purpose of acting as an aggressive self-appointed industry watchdog 0- his part being watching the pharma and bio industry) is not only not free of financial conflicts of interest, but also suffers from a serious ideological conflict of interest.
Public Citizen and Sid Wolfe are in the business of beating up drug companies and destroying both approved, and even yet to be approved, drugs; often based on a very biased view of the available scientific data. The FDA’s advisory committees should be staffed with serious, qualified, open-minded people who have a balanced view of both the risks and benefits of medical treatments.
While Sid Wolfe and Public Citizen serve a valuable function in keeping an eye on the industry and raising flags where they find (or manufacture) them, the FDA must be the impartial arbiter of the safety and effectiveness of drugs.
The FDA has some very serious problems with the way it administers its advisory committees, and one of them is revealed here in the appointment of Sid Wolfe.
He is man dedicated and immensely motivated to keeping industry honest, and for that he deserves respect for his role at Public Citizen OUTSIDE the FDA deliberations process, but he is also a man with a strong bias toward excessive emphasis on the risks of medical treatments, and a strong de-emphasis of drug benefits. If it were up to Sid Wolfe, many of the effective medicines and treatments Americans rely on today would not be available. That makes him unqualified to be a member of this committee, and it also reveals how politics and incompetence inside FDA can result in someone who should not get past the first cut (because of obvious conflicts and bias) somehow does?
Anyone interested in exactly which groups nominated Dr. Wolfe? Who is in the consortium he refers to above? Where does their money come from? Waht are their goals and missions? I am interested, and we asked FDA earlier this year (in writing) to increase their transparency with respect to how they administer advisory committees so the public could see clearly the influence special interests were exerting through advisory committee nominations and appointments. One of those suggestions was making nominations public. Another was explaining the internal FDA member selection process, including who makes the selections, a matter of public record on their web page. Niether of those suggestions was adopted, and so the problem of outside influence over the FDA through selection of biased advisory committee members continues.
Patients are the ones directly affected by the risks and benefits of medical treatments. Therefore, the consumer representative on the drug safety committee should be a true patient advocate who speaks only for patients, says what patients would say, and votes the way patients would vote; not a salaried employee of a non-profit corporation that exists for the sole purpose of raking industries and their products over the coals - rightly or wrongly.
So Dr. Wolfe will now get proprietary information regarding drugs to be considered by the committee about four weeks before anyone else. The day before an advisory committee meeting, the information that is not considered too proprietary to release, will be released to the public. Any guesses on whether Public Citizen will have planned a running start for going after a drug company or individual product?
That’s what they do, and they are often wrong - at least in the view of the FDA and true medical experts - but by the time anyone figures that out, the drug is trashed, the company is financially devastated, and patients and physicians have an inaccurate view of a safe and effective drug that they should have continued taking, but didn’t.
I thought it was FDA’s job to decide whether drugs are safe enough, should or not be approved, and what the label should look like. I guess not - anymore.
It is one thing for someone to cherry pick data sets off the internet, conduct a junk science analysis of the data, and drop a manufactured biased conclusion about a medical treatment into the media. It is an entirely another when the FDA puts someone who has been doing that for a living for 37 years into an official position to get proprietary information early, then have direct input and a vote on what FDA should do with it, while at the same time trashing the treatment through a powerful non-profit corporation he directs.
Sid Wolfe is a good guy providing a valuable service to the public through his role at Public Citizen, but he is an extremist when it comes to weighing the risks and benefits of medical treatments, and he is obviously seriously conflicted here. He should have known better than to accept this position, and FDA should have known better than to appoint him, when he indicated his willingness to serve after being nominated.
This isn’t about drug safety. this is about the integrity of the FDA’s advisory committee process. There hasn’t been any integrity to the process for a very long time, and the effects have been devastating inw ays that virtually none of the media outlets have yet reported. The truth about thow the FDA administers its advisory committees will surprise you, and the effects have not been what most people think.
We have talked to some members of Congress about this, but they don’t seem interested. Maybe this extremely odd appointment will finally convince them to look into what the FDA has really been doing with its advisory committees.
So now what?
Steve Walker
Abigail Alliance