The Vioxx Hex

It's a real thrill when the editorial page of the Washington Post starts to sound like, well, me (e.g. here and here).

Politicians and regulators should be asking themselves whether a system of massive cash awards to people who may or may not have been adversely affected by Vioxx is a logical, fair or efficient way to run a drug regulatory system. They should also be asking whether juries that scorn medical evidence are the right judges of what information should or should not have been on a prescription label. After all, Vioxx was produced and sold legally. The drug was approved by the Food and Drug Administration, and its label did warn of coronary side effects. It is possible, even probable, that Merck was negligent in its decision to ignore early warnings of the cardiovascular risks of Vioxx. But the company has already paid a price for that negligence, in the losses it has suffered after abruptly taking Vioxx off the market. Fair compensation for the injured needn't entail disproportionate financial punishment as well.

In the long term, using the courts to "send a message" to Merck isn't going to help consumers. If the result is an even more cautious FDA approval system and a more cautious pharmaceutical industry, that will keep innovative drugs off the market for much longer. More people will die waiting for new treatments. The cost of producing new drugs will rise dramatically. Already, there are whole areas of medicine -- women's health during pregnancy, for example -- that are made so risky by liability issues that companies may stop doing research in them.

The first principle of reforming this system should be that a company that follows the FDA's rather extensive guidelines should be protected from punitive, if not compensatory, damages.