Last week in this space, there was a brief exposition of the plight of Merck's Vioxx, a drug being withdrawn from the American market after clinical trials turned up an increase in heart attacks and strokes in individuals taking the drug.
The poster child for drug recalls is thalidomide, which was introduced in Europe in the 1950s as a sedative, and which subsequently proved effective against morning sickness during pregnancy. The side effects would become apparent nine months later: a shockingly-high incidence of birth defects, notably grossly deformed or foreshortened limbs. [Link contains a photo which some may find upsetting.] The FDA had not approved the drug for use in the United States at the time, although it was sold in Canada.
However, in 1998, the FDA did approve thalidomide, sold under the brand name Thalomid, as a leprosy treatment; it has also shown promise in dealing with certain tissue disorders in AIDS patients, and as a treatment for multiple myeloma. The known hazards of course still exist, but the manufacturer states them quite specifically in the prescribing information [link requires Adobe Reader], and even if you're prescribed the drug, you can't get it without signing up for a very specific regimen that includes contraception and pregnancy testing.
While Vioxx is not comparable to thalidomide in its effects, the history of thalidomide may provide some hope for Merck, which was indeed seeking a new use for Vioxx at the time of the recall. If the risks are known and are stated up front, and if patients are given the proper information beforehand, it's conceivable that the FDA may once again grant approval for the drug at some point in the future. The precedent is there.
Of course, there's always the question of why anyone would want to take any kind of drug that has the potential for serious side effects. In that previous piece, I summed it up this way:
In pharmaceuticals, as elsewhere in life, there ain't no such thing as a free lunch.
Even the mildest of drugs carries a price tag beyond mere currency. And with the newest drugs, inevitably there are big price tags, to help cover the costs of research and testing. Avalide, a relatively new drug I take to regulate my blood pressure, costs around $1300 a year, which by the standards of today is fairly inexpensive; the typical "cocktail" of anti-AIDS drugs runs around $10,000 a year.
Which is precisely why some of our politicians envision importing drugs from areas where prices are controlled, thereby bypassing those big price tags. I'm not so sure this is such a great idea. For one thing, fully half the spam I get is from individuals offering to get me drugs from outside the US, and I wouldn't trust any of these people as far as I could throw them. More to the point, I'm thinking that the threat of massive importation from, say, Canada, is just a precursor to the threat of price controls, and we all know how well price controls work: not very.
Yes, yes, of course, drug companies are making money hand over fist these days, and therefore they must be punished. Right. Uh-huh. Tell me this: how much oil did the 1980 "windfall profits tax" produce? Would you believe minus 400,000 barrels a day?
If you think price controls are going to improve the supply of drugs, I suggest you're getting your drugs from a guy on a street corner.
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Copyright © 2004 by Charles G. Hill