The answer, of course, is competition. You need somebody watching out for the other guy who stands to make a great deal more money if the other guy tries to pull a fast one. That’s a whole new subject.

I know enough about the FDA, met a couple of their doctors while I was working for a researcher. I know they think of themselves as conscientious men and women who try their best to guard the welfare of the American people and make sure that drugs are safe and effective before being let loose on the population. Much of the time, they are successful.

However, there are flaws in the system. Doctors are allowed to go from Pharmaceutical companies into the FDA and from the FDA into Pharmaceutical companies. Consequently, their judgment can be affected unduly by Pharmaceutical companies trying to rush their products to market.

Another flaw is that Pharmaceutical companies are not required to publish, or even make known, ALL the results of their studies. Therefore, some thing can be kept hidden from the FDA. Drug companies can and do hide negative results. I would like to have more access to information on Vioxx. I have a feeling I know exactly what happened with that class of drugs. The hid the negative and/or classified adverse effects as not being due to the drug itself. When a drug is under study, and a patient has an adverse event, the doctor running the study–who is NOT immune from undue influence, their studies and therefore, to some degree, their careers and success are in the hands of pharmaceutical companies who hold the purse strings–has to determine if that event is thought to be due to the drug or not. There’s all kinds of paperwork that has to be filed with the Human Subjects Committee at the institution along with copies going to the drug company and available to the FDA. There is always the possibility of human error but when you factor in the other things, there is way too much opportunity for skewing of data. And people die.

I have a lot of respect for the purpose of the FDA; I have a lot of suspicion about how their mission is carried out and about the probability of the use of undue influence. Anyone who sees otherwise is hopelessly naive IMO.

I know the doctors running the studies will mostly disagree with this but again, their salaries depend on these studies to a certain degree. They are almost all very good researchers, conscientious doctors with the welfare of the patient at heart. OTOH, this system can unreasonably withhold life-saving treatments for an undue period of time waiting for study results when reason says that there is NO other treatment and you have to balance the possibility of extending lives against the entry of an unproven drug. If the result is death without the drug and there is an ounce of hope, then I have to fall on the side of hope.

It’s a complicated subject.

Now, ask me about the NIH. I love those guys.