Post-marketing Surveillance

The Zyprexa story, reminiscent of Vioxx. This is starting to become a pattern: drug maker gets sued over adverse affects that it downplayed during the FDA approval process. Often times the adverse affects - in this case the onset of diabetes after taking the anti-schizophrenic drug for some years - don't show up immediately.

The pharma industry, I hope, is learning the hard way that it needs to be transparent about pre-market data. There is no sense in covering up a potential adverse affect or promoting an off-label use (which is illegal anyway) when there will most certainly be a billion dollar lawsuit down the line. The FDA has undergone a considerable amount of criticism recently for its lax regulatory control, and in the past I presume that manufacturers whose drugs had been approved by the FDA had better protection from lawsuits. But all that is starting to change.

On the one hand I am glad that there are vigilantes among the medical malpractice, public health and communities. Big pharma's primary motivation is to make money, not cure disease. Moreover, the FDA is underfunded and understaffed. And lastly drug adverse affects may not show up until some years of use, or, they may be uncommon enough that they do not show up in the pre-market clinical trials that are usually based on hundreds-to-thousands not millions of patients. For these three reasons, post-market surveillance is absolutely critical to patient safety (which is not to say that drug makers or the government should be funding massive clinical trials for years before a drug is approved - that's impractical and financially unfeasible).

On the other hand, the medical community needs to make sound decisions that are in concordance with each individual patient's goals and desires - in the Zyprexa case, a doc should not be prescribing the medication to someone who may be at risk for developing diabetes - unless this risk is pretty small and the patient is fully aware of that risk in light of the potential benefits of the drug.