Accutane v. the FDA
As anyone who has visited a pharmacy or turned on a television knows, there are nearly as many available remedies for acne as there are people to buy them. Drying creams, antibiotic ointments, facial peels, exfoliating gels - the sheer quantity is mind-boggling, yet the vast majority of these treatments have no effect on acne (as any dermatologist will freely admit). While some other moderately effective remedies do exist, for those with severe acne, there is really only one medication that has a significant and lasting impact: Accutane, the vitamin A-based drug that acts to shrink the oil-producing sebaceous glands, resulting in a face that is free of both acne and excessive oiliness. Furthermore, these effects are often permanent, providing relief not only from the physical symptoms, but from the low-grade psychological torture of going through one's day-to-day life constantly expecting breakouts. For many teenagers enduring the shame, humiliation and peer ridicule accompanying a case of severe acne, Accutane is truly a miracle drug.
Why am I bringing this up? Well, the one nagging problem with the drug has always been its potential to cause serious developmental defects in fetuses exposed to Accutane. The risk has always been known, and in the past several years preventative measures have been increased to such a degree that women wishing to take the medication must pledge to take two forms of birth control while on the medication - even if they do not engage in intercourse! - and submit to monthly blood and pregnancy tests. Given that Accutane is prescribed to hundreds of thousands, the odd pregnancy still does occur (and is usually promptly aborted), but apparently even the unprecedented safeguards surrounding the drug were not enough for the FDA, which yesterday announced that all patients (men included, despite their presumably low risk of pregnancy!) taking the drug and doctors prescribing it must enroll in a goverment registry and undergo even more stringent tests. If such safeguards still do not prevent further pregancies, the drug may be taken off the market altogether, the article claims.
Now, since our government, thankfully, cannot control what people do in the privacy of their own homes, it is virtually guaranteed that some extremely careless, irresponsible or just plain stupid folks will still find a way to get pregnant. The question here can be simply stated: is it just to ban a drug that has been enormously helpful to millions of people because of the lack of responsibility of a tiny minority (160 "Accutane babies" born in the last 20 years out of more than 20 million users)? No one wants to see babies born with severe, incapacitating defects, but if doctors and the FDA enact the most stringent possible safeguards, shouldn't patients assume the remaining share of the responsibility? And given that the average male has an exactly zero percent chance of pregnancy by my calculations, what logic would compel the drug to be banned for both men and women? Would allowing only men to take Accutane violate some unspoken equality-of-access clause that the FDA secretly maintains? Given that at least one recent medication has been approved by the FDA for use in preventing heart disease among African-Americans only (it does not have a beneficial effect on other races), this theory doesn't seem to hold any water. In any case, at a time when hundreds of thousands of abortions are performed every year on healthy fetuses, it seems odd for the FDA to zealously target a medicine for endangering the health of a scant handful of unborn children. There are tangled ethical issues here, for sure, but speaking as someone who has been a beneficiary of this amazing drug, it would be a great shame if it were taken off the market.
(As a side note, Accutane has also been linked to depression and suicidal thoughts in some patients, but studies have shown that the suicide rate for Accutance users is not different in any statistically significant way from that of the general population. In my own experience, the tremendous boon in confidence and self-assuredness resulting from the disappearance of acne far outweighed any vague "feelings of depression" that could possibly have occurred, and I have seen the same thing in a number of other people as well).