New Study on Drug Safety

I know, I know, I am terribly behind on the Article Reviews. A fascinating study appeared in the Archives of Internal Medicine today, reporting that serious adverse drug events ("ADEs") tripled between 1998 and 2007, from 34,966 to 89,842. Reported deaths also nearly tripled, rising from 5,519 to 15,107.

What's more, there is ample reason to suspect that these estimates are conservative. First, there is a long tradition of underreporting of ADEs. Where such ADEs occur in relation to clinical trials, there are added financial and academic pressures to downplay an ADE, or, where possible, avoid labeling a side effect an actual ADE. Second, a study published in Drug Safety less than three weeks ago found that "doctors frequently ignored or dismissed patients' concerns about such side effects." Such dismissal feeds into the first problem, because it renders it highly unlikely the physician will deem the side effects ADEs. In turn, this means the side effects are not reported to the FDA.

According to the WaPo article about the study,

The findings raise important concerns about American drug safety monitoring, said Harvard Medical School professor Jerry Avorn, author of "Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs."

"We already know that there is horrendous underreporting of side effects. Ninety to 99 percent of serious side effects are not reported by doctors," he said.

Yet the FDA relies heavily on their reports. Tracking a drug's safety once it hits pharmacies -- so-called post-market surveillance -- is a critical part of keeping patients safe, particularly since clinical trials with limited enrollees and a limited study period cannot catch every side effect.

It is stories like this that render me unable to take very seriously claims that the FDA should be abolished or neutered because its lengthy biologic approval processes undermine health.

It is certainly true that there is much to criticize about both the FDA and the relevant regulatory scheme, and it is also true that there are opportunity costs to imposing requirements that must be satisfied before biologics are permitted to enter the stream of commerce. More onerous requirements may result in delay of market entry, which can obviously deleteriously impact a person's health. Less onerous requirements, however, can also have a profound impact on population and individual health.

This is a very real policy problem, and yet the policy solution some advance in response to this problem is to minimize the very significant reasons militating in favor of drug safety monitoring and regulation and urge that all such regulation should be abolished.

This "solution" seems to me both simplistic and unwise, because it either ignores or minimizes the very real risks to population health that would attend abrogation of drug safety regulation. That, by all accounts, the numbers of serious side effects resulting from biologics are significantly underestimated does not strengthen the abolitionists' case.