Les Jones

Science > Derek Lowe: Aspirin Would Never Get out of the Lab Today

Derek Lowe via Marginal Revolutions

Actually, [aspirin's] use more or less doubles the risk of a severe gastrointestinal event, which in most cases means bleeding seriously enough to require hospitalization. Lower doses such as those prescribed for cardiovascular patients and various formulation improvements (coatings and the like) only seem to improve these numbers by a small amount. Such incidents, along with others brought on by other oral anti-inflammatory drugs, are the most common severe drug side effects seen in medical practice.

It doesn't take too long to see these effects in a research program. Aspirin causes gastric lesions in rats and dogs, which are the standard small and large animal models for drug toxicity. This side effect occurs at levels which would raise red flags for any new compound.

The FDA approval process, combined with worries about pharmaceutical liability, probably means that we're missing out on some useful and important drugs.

As Megan McCardle has noted, drug companies currently have the worst of both worlds. They spend a billion dollars or more per drug to prove that it's safe according to government standards, yet if those government-approved standards fail to uncover problems, the drug companies lose their shirt in civil court while the government stands on the sidelines. If government safety standards are no guarantee of safety for the public, and no shield of liabilty for the drug makers, then who is the beneficiary of the standards?