7.21.2008

Welcome to The Jungle

I like the FDA. Its one of my favorite institutions. One has a distinct peace of mind when there is an organization that makes sure my medications are safe and effective, and that the food I eat is fit for human consumption.
In theory, at least.
Given the recent happy fun time with salmonella poisoning, as well as numerous articles (see Discover Magazine, New Scientist) about the utter inadequacy of drug testing, one does have to wonder what is going on. In recent years, the approval procedure performed by the FDA has been paid for by the companies themselves (somehow this seems like a bad idea). Eighteen years ago, if the FDA made a mistake, approved and unsafe or ineffective drug, or did not perform rigorous inspections of food prep factories, there would be a congressional hearing to explain what happened. There have been two oversight hearings since then. The relationship between the FDA and the prescription drug industry is very friendly. The drug companies even gave the FDA commissioner an award for doing a good job.
Wait a tick there...
As a monitoring agency, I would hope that the relationship between the FDA and the drug companies would be an adversarial one, with the drug companies constantly complaining about the stringent requirements enforced by the FDA. This used to be true. It isn't now. There are some rather obvious reasons for this, not the least of which is the drug companies funding of congressional campaigns.
Recently studies have shown that bladder control drugs are strongly connected to the onset of Alzheimer's, to the point that if a patient is taken off of the drug, they lose all symptoms of dementia. This is just one sign of the fact that the monitoring and research of these drugs is insufficient. This isn't just the FDA's fault. If there is no money, no vigilance on the part of either the congress or the citizens, and a strong motivation to keep things the way they are, who the hell is surprised that things slip through? There are reasons that we have these regulations, and those are to prevent the spread of disease and to prevent drug companies from selling snake oil (potentially harmful snake oil) to unwitting consumers. As a student of biology, I know the high likelihood of things not going quite to plan, and the temptation to alter results even a little bit to make it fit your hypothesis.
This is not how science is done. It is certainly not the goal of science, which is to test the hypothesis, and take that data, be it positive, negative, or completely random, and form another hypothesis based on that data. There is no wrong answer. When money gets involved, the answer is always "does this result cost us more money or get us more earnings?" The drug companies often complain about the expense of developing a new drug. If this is so, why is it that they are paying such enormous amounts of money to campaigns? Why is it that the executives are multimillionaires? In other words, where is the corporate focus? It should be in providing the best, safest drug possible, which will be used widely because it IS in fact the safest and most effective drug on the market. If your goal is merely to make your executives and stockholders rich, I would suggest that you invest in alternative energy sources right now, since they are going to be getting popular Real Soon Now.
I find this all extremely frustrating, because of all of the Federal Institutions I would want to participate in in my career, the FDA and the CDC are it. If the first goal is to please the drug companies and the second to keep people safe--maybe I want to become a Congresswoman before anything else.
They need money, oversight, educated employees, and a distinct line between their goals and those of the drug companies. Until those things happen, I think I'll be getting my tomatoes from the local farm stand.

1 comment:

Kyrias said...

I would say, read my post about mad-cow disease and whatnot - except that would involve finding it, which I can't.
At any rate, it is interesting that you reference "The Jungle" because although I have issues with their treatment of drugs, my ultimate concern is their stance towards mad-cow disease in this country. It's truly horrific.