Estelle On Why The FDA Is Screwed Up

She was an administrative type, accompanying me to a meeting to which I did not particularly want to go.  I had told her about some particularly useless drugs that had been FDA approved since I don’t remember when, and she asked me the question that covered everything.

“Why doesn’t the FDA work?”

Well, I needed to start with what I thought the problem was NOT.  I did not think the problem was the individuals who did the work, although I know some thought that the workings were unethical and had quit because they were “whistle blowing” types.  I told quickly, as I often have, the story of talking to FDA folks at a pharmacology meeting where a large drug company had paid us all for our time with a catered gourmet cruise of San Francisco Harbor, around Alcatraz.  Some company employees actually told us the best way to avoid seasickness was to consume large amounts of imported French cheese, which at the time, I was delighted to do. The FDA employees I met then,were overworked bureaucrats who seemed to be trying really hard to review incredible amounts of scientific articles about various substances, and trying really hard to be fair. They were so fatigued and overwhelmed I though some of them might need a check-up on their mental status, which had been doubtlessly affected by exhaustion.  I certainly thought they deserved the French cheese.(“Although it was the last thing they were interested in and I single handedly ate a great deal of it.”)

But wait, there’s more.  I am a lot smarter now.  I don’t overeat, even French cheese.

The meeting I was at was before 2000.  Agencies of the government seem to be better at political negotiation than science.  It took 14 months after the agency knew about Vioxx causing heart disease and stroke to pull it from the market. Every time I read something about the FDA, I ask the same question that if anybody else asks, nobody answers. How many people died? Clearly the situation where human life is honored above all things does not exist in these United States.

Anything I know about FDA personnel suggests they are probably smart enough to at least question things that need questioning.  But after that, scientific inquiry seems to be lost in the pressure to approve. I have heard there is not enough in the way of money or personnel to track things closely enough, probably true. I have also heard about political pressures and long processes. Definitely true. And when a decision is made, no “teeth.” Lots, I mean lots, of scientific safety reviews requested, generally things that have to do with long-term effects, that are requested but just never seem to get done.

No force of law, here.  Just polite requests, ignored because Big Pharma Corporations seem to rule here.  Science, even common sense, do not.

I don’t know how much is going on right now, but not too long ago I heard that drug companies pay “user fees” to the FDA to review their drugs. Since these fees are paying a lot of individual salaries, maybe half of the scientific personnel, we do not exactly have objectivity here. I personally have come to a state where every time, yes I mean every time, that I read a scientific article I have to know who paid for the research. Given the financial status of things, I would be shocked if I found out anyone had seen fit to cease this process. Good Lord, I actually found the page on line where these fees can be
submitted electronically.

I am not going to do any more research for this post.  I would get too depressed to function today, and I gotta function.

I ceased trusting the FDA long ago. The best way out is to either find a doctor who reviews both domestic and foreign literature about anything you want to take, or to do so yourself. We have another of the list of things you just can’t trust the government to do.