“IF I LIVED IN NEW ZEALAND, I’D BE DEAD.” That is how Virginia Postrel’s editor wanted to title her article in the March Atlantic. As Virginia Postrel elaborates, it is more accurate to conclude, as her article does: “If I lived in New Zealand, I wouldn’t be dead, just a lot poorer. But if every place were like New Zealand, far fewer complex new drugs would get developed in the first place. And my odds of survival would be much, much lower.” She speaks of New Zealand because a New Zealand government agency called Pharmac can and does restrict the use of novel drugs. In May 2005 the results were announced of the clinical test which established that a drug called herceptin was dramatically effective against the kind of early-stage breast cancer that Virginia Postrel had. Until 2007, more than two years later, New Zealand’s agency would not fund the use of herceptin for that kind of early-stage breast cancer. I feel for the women in New Zealand who had the kind of early-stage breast cancer that herceptin is effective against during those two years.
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Thirty-five years ago Sam Peltzman published a study concluding that the number of new drugs introduced annually declined after passage of the thalidomide-generated regulatory statute. (The decline was not apparent in the raw data, but after including other variables Peltzman argued that more innovations would have been expected if the previous relationships had not been interrupted by the statute.) One factor that he did not consider is that there might have been a decline anyway as the possibilities of developing new antibiotics were exhausted.
The statutory regime is surprisingly inconsistent with what common-sense decision theory would suggest. If the drug being considered isn’t likely to produce significant benefits, more testing for side effects is justified; if the drug is aimed at an otherwise fatal condition, prior testing is much less justified. Thalidomide, which the legislators had in mind, seemingly fell into the first category: the manufacturer wanted something different to compete with tranquilizers that were already working pretty well. But there is a curious irony in the later history of thalidomide, which I’ll mention in the next post.
Apparently thalidomide doesn’t harm mice the way it can harm humans, so it was originally promoted as a soporific without side-effects. After the dangers became apparent and it was taken off the market, a doctor treating lepers grabbed an old bottle of thalidomide for a patient who was having serious problems sleeping. The patient slept well, and his worst wounds healed. The doctor noticed and did careful testing; the drug turned out to be very effective for leprosy. Now thalidomide seems to be helpful with multiple myeloma. At first it was prescribed for non-approved use (OK it seems if the drug is not “promoted” to patients), but I think it now has been approved for some myeloma patients.
There’s irony here. If the drug had not been widely distributed, with free samples even, the serendipitous discovery of benefits might not have been made, or perhaps not so quickly. Or perhaps more cautious testing and analysis of how thalidomide works might have led to the same discoveries?
There’s further irony for me personally. A good friend here in Williamsburg was diagnosed last week with multiple myeloma.