The Libertarians generally want to get rid of the FDA. I'm sure in your mind they qualify for the loony bin.
But as you pointed out, the FDA is a mixed bag. It's a mixed bag because drug interactions are complex and our knowledge so limited. The best we can come up with are drugs that pass statistical studies showing improvement for a large population while eliminating the drugs which show harmful effects for even a tiny minority. By definition, that eliminates a lot of drugs that could help targeted people -- if only we knew how to evaluate that risk.
Perhaps someday in the distant future we will know enough about drugs, genetics, cell biology, etc. to accurately predict the interactions of any drug on any person. Then at that point we can effectively eliminate the FDA. It won't be needed anymore.
There are some areas of regulation where we can argue over whether it’s necessary. And there are some where we can’t.
Drugs are an area where we can’t, and generally don’t.
The Pure Food and Drug Act was passed in 1906. I haven’t heard of anyone wanting to eliminate the FDA, and if I do hear of one I think they need to go to the political equivalent of the loony bin.
That’s because drugs, even good drugs that do good things, can kill you. So the question is one of balance. How does the agency balance benefits and risks?
By getting it wrong, starting in 1999, the FDA is costing Glaxo SmithKline $2.36 billion this quarter to help clean up the Avandia mess. (Of course, Glaxo never blew the whistle on itself, either.)
Similar mistakes were made with the drug known as Fen-Phen. A drug designed to help people lose weight caused heart disease — the plaintiff’s bar made a fortune. (Anyone wanting to argue against regulation must understand the bar is the back-up plan. And if you want to argue against both you’re just asking to kill people.)
So now a new set of weight loss drugs are before the agency. An abundance of caution is expected. But the news on one, Lorcaserin, is so good that it’s raising the specter of a new era for weight loss drugs.
Such a new era is needed. I just came home from breakfast and the obesity epidemic is really getting sad — the lady at the next booth could barely squeeze into it.
The Lorcaserin study meant to find side effects was called BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management).
The drug itself is similar to an anti-depressant — it’s technically a selective serotonin 2C receptor agonist. That means it mimics the behavior of serotonin, a neurotransmitter involved in mood, appetite, sleep, muscle contraction, memory and learning.
The pill showed modest improvements in weight loss, against a placebo, but the big news was that it was actually seen as safer than the two current market leaders — Meridia and Xenical.
What has placed the focus on the agency again is that two other weight loss drugs — Qnexa and Contrave — are also in the approval waiting room. Qnexa might get called up sooner. but it has more side effects.
Qnexa combines an amphetamine and anti-convulsant, while Contrave combines an anti-depressant and an anti-convulsant. As previously noted, Lorcaserin is just one chemical.
Following the Avandia mess, you might excuse the FDA for an over-abundance of caution. The connections between those who test drugs and those who make them could bear a lot more scrutiny. And in the case of weight loss, a slightly increased risk of heart attack needs to be balanced against the certainty of eventual hypertension (or diabetes) for the morbidly obese.
Where do you think the balance should be?
