Philosopher Stone: FDA: Definitely not "First, Do No Harm"

A vital phrase for those in the medical profession, "First, do no harm", goes back to the ancient Greeks (though, contrary to popular belief, it is not found in the Hippocratic Oath).

The following paragraph from the Wikipedia entry for this phrase (Primum non nocere) does a nice job summarizing its importance:

It is one of the principal precepts all medical students are taught in medical school. It reminds a physician that he or she must consider the possible harm that any intervention might do. It is most often mentioned when debating use of an intervention with an obvious chance of harm but a less certain chance of benefit.

I mention this important precept in relation to the WashingtonPost story, Teen Suicides Up Sharply For First Time In Years. (Thanks to John Enright for the link.) And what is the speculated reason in this news story as to the likely cause (or the biggest reason) for this increase in teen suicides? The actions of the FDA.

How so? Well, remember several years ago when the FDA got wind of studies that indicated that some anti-depressant medications (e.g., SSRIs) could have increased rates of suicides in the young, especially during the first few weeks of taking the medications as the body and mind adjusted to them? Their reaction to this was to further regulate such medications, and do so in scare-tactic fashion, by forcing the companies producing them to put big black box suicide warnings on them, targeted at teenagers specifically.

So what happened? Well, surprise, surprise: use of such medications declined dramatically amongst teens. But it is exactly these medications that are credited with helping to reduce the rate of suicide for many years previous. I mean, the biggest cause of suicide is no doubt severe depression, right? And what do people take for depression? Anti-depressant medications. So scaring people away from the medication that will help them... real bright, FDA, real bright.

Did the FDA factor this inevitable outcome into their decision process? I suspect not, or at least not well enough. The FDA has a pattern of reflexively regulating drugs based on studies (particularly big noise-making ones) that show or suggest (more or less well) negative side-effects from taking those drugs. After all, history in the US has thus far shown that no one will get fired at the FDA, nor will budgets be slashed, when thousands or millions of people die because the latest life-saving drugs are held up by FDA rules, regulations, and bureaucracy. But failing to regulate something when there is a shred of evidence that some people might have a negative side-effect -- they can't let that happen!

And this is not something the FDA can simply tweak and get better at doing. The FDA, or any such regulating body, simply can't do a very good job of weighing the personal benefits of new drugs against the possible personal negative side-effects for those same people or others. The benefits are too personal: each individual would have a different value hierarchy, meaning for one person it might worth the increased risk of heart attack to be rid of some other ailment they have, but for someone else it would not. A drug that could save millions from one killer ailment, is held up because it might increase the risk of some other ailment for those same people or others. Rather than leave it alone, regulation keeps the drug from the people who need it and want it. By what moral right does the FDA do this, by what moral right do they get to make these value decisions?

In the current case of the teen-suicide warnings, did the FDA consider the externalities of this decision? Did they weigh the harm that such a policy would do against the supposed good it could do? At first glance, one might see nothing wrong with informing people about studies on a drug that indicate a greater statistical chance of suicide amongst a population. But in addition to the above points, there is a crucial difference that complicates this case that doesn't complicate other drug studies. Unlike medications that cure one ailment but might lead to increased heart-attack risk, here we are talking about suicide -- so free will comes into play. Even if full free-will is somewhat inhibited when severe depression develops, this greatly complicates any studies in this area (in a way that doesn't arise for studies on the pancreas), making studies and aggregate statistical analysis far more difficult.

All of that said, and while I'm no expert on this, as I have said before (see my posting on this) I am prima facie doubtful of the studies indicating increased suicide as an effect of using SSRIs or other anti-depressants. Often people start taking these medications after their first visit to a doctor for depression, and because they take a while to take effect, the depression can continue to get worse before the medications help the people help themselves and begin to get better. But this is not the fault of the medication! The person was likely going to keep trending downward for a while regardless, and if they had waited until they pretty bad off before seeing the doctor, well, they might be suicidal or nearly so already.

Further, a person might become increasingly depressed when they first start trying an SSRI and don't see immediate results -- especially if their doctor didn't impress on them how the drugs work (the time needed, etc.). They might conclude "This isn't even helping? So nothing will, and I can't bear it!". But again, this is not the fault of the medication!

Do the studies the FDA relied on to require the warning boxes for teens take into account all of these kinds of points? I wonder. I don't know either way, but I wonder.

What is obvious about the track record of SSRIs and other anti-depressants (from what I gather from this article and elsewhere) is that they have been a major factor in decreasing suicide rates. Until, that is, the FDA got involved, scared teens (and their doctors) away from the medications, and the rates apparently went sharply up again. Take away a major weapon in one's battle against depression, and surprise, surprise, more people will become increasingly depressed and commit suicide. That should have been obvious to FDA regulators, but apparently it wasn't.

Btw, I've written a few posts on the FDA here at Philosopher Stone. Check them out!