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