Some thoughts on drugs and the management of risk.

There’s an interesting article in today’s LAT about one possible solution to the problem of antibiotic resistance; doctors are pulling older antibiotics out of the drug closet.

The nice thing about this is that many bacteria, such as the one that causes MRSA, haven’t had a chance to develop a resistance to these older drugs. The trade-off, though, is that there’s a reason many of these drugs went out of common use. For example, chloramphenicol, the centerpiece drug in the article, went out of favor because it carried a risk of triggering aplastic anaemia. The Wikipedia article on chloramphenicol gives the risk at 1 out of every 24,000 to 40,000 people (for oral dosage). (Please do not get your medical advice from Wikipedia. This has been a public service announcement.) That’s pretty high by modern standards, but a lot better than dying of MRSA; at least, that’s the point of view of the doctors quoted by the LAT.

This is just the most current example of a topic that fascinates and frustrates me; the trade-off between safe and effective in drug design. You say the word “thalidomide” to people and they’re horrified; rightfully so. But it turns out that thalidomide is effective for treating multiple myeloma and complications of leprosy. Are the benefits of thalidomide worth the risks of birth defects? Who gets to decide?

We saw much the same thing with Vioxx; there were (and are) people who were willing to trade a relatively small risk of cardiac complications for effective pain relief, especially since many of these people were unable to tolerate aspirin or other pain relievers.

Now we’re seeing this with Avandia, too; an effective drug for managing blood sugar and reducing the chances of diabetes complications. But, once again, it appears to carry a relatively small risk of cardiac complications, and that’s leading to calls for it to be pulled from the market.

We’re letting the FDA make the decisions for us on how much risk we’re willing to tolerate in order to get results. Is that the best way to do it? Would we be better off if the FDA was only responsible for making sure doctors had all the information? Once they do have all the relevant information, shouldn’t the risk/reward trade-off be an informed decision by the doctor and patient?

3 Responses to “Some thoughts on drugs and the management of risk.”

  1. Earl Cooley III says:

    The bad thing about Avandia was the weaselly behavior of the maker that, by willfully withholding data, didn’t give the FDA a chance at the time to make a reasoned decision with all the available information.

  2. stainles says:

    Earl:

    Avandia, Vioxx, or both? I’m more familiar with charges of weaselly behavior by the makers of Vioxx, and less so with such behavior by the Avandia folks.

  3. Earl Cooley III says:

    Diabetes Drug Maker Hid Test Data, Files Indicate

    “With Avandia, GlaxoSmithKline has done more than hide trial data. An F.D.A. reviewer who closely examined a landmark Avandia clinical trial called “Record,” found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial’s tally of adverse events, mistakes that further obscured Avandia’s heart risks.”