Ideoblog - The new witch doctors
By Larry Ribstein on Regulation
Today's W$J has an editorial that captures the angst of my last post on the painkillers. What we're both decrying is the threat that the litigation system, and perhaps soon the drug approval process, will no longer let patients and their doctors decide to weigh pain relief against cardiovascular, gastrointestinal, or other risks.
I'm interested not only because I recently took one of the Cox-2's that started all this, but because this reminds me of securities regulation where, again, the regulators and the litigators are making decisions the market ought to be making.
Two things makes this worse than the usual problems with litigation and regulation. First, it involves more than just money. Yesterday I found myself wondering whether I should engage in certain activities (running, walking) if I faced the possibility of long-term pain without the relief I'm used to being able to get from pills. Lots of people may soon be making these choices. Even worse, it doesn't stop with pain or a particular disease.
Second is the nature of the risk involved. As far as I'm aware, we don't even know the precise mechanism that causes the side effects that are appearing in the drug studies. The problems are emerging as statistical artifacts in studies looking for other things -- Alzheimer's, cancer, heart benefits rather than risks. The statistics may mean something, but they may not, and we can't even know what. We have no real clue whether these drugs are net harmful. If this sort of evidence is enough to short-circuit these drugs, where does it stop?
The tenuous nature of the risk suggests not only that we shouldn't be yanking these drugs, but that we should be careful about what to disclose. Disclosure is appropriate if we can identify a class of people who ought to be concerned about the drug. If not, this is like the "watch for falling rock" sign on the highway. Possibly people at risk of heart disease, if they know who they are, should be careful -- but maybe not, depending on the scientific explanation for the statistical link, and if we're equally sure that the drug has no special benefits (Alzheimer's, colon cancer) for these same people.
So the regulators and the litigators are becoming the new witch doctors. The statistics speak to us through the oracles, and we must obey. The tragedy is that we are not a pre-scientific society. We are not filling the gaps in our ignorance -- we're putting aside what we know. |
