A bit later than I expected, the Food and Drug Administration (FDA) has opted to revoke its approval – for use against breast cancer – of the drug Avastin (H/T The Washington Post). As the formal decision notes, research on the effectiveness of the drug against breast cancer found that the risk of potential side effects was too great compared to the associated health benefits. While the decision does not bar ‘off-label’ prescription of the drug (since it is approved for use against other cancers), insurance carriers will likely drop coverage, if they haven’t already.
The approval of Avastin for breast cancer was handled under an expedited FDA process, and continued post-approval testing is part of the process. As previously approved drugs have been dis-approved without an expedited approval process, it shouldn’t be surprising that it would happen for something that went through a faster process. The specifics of the decision, and the FDA Commissioner’s rationale behind the withdrawal, are in Section V of the decision (starting on page 33).
Much like recent decisions over preventative health screenings, these issues revolve around risk, and can likely never be resolved to a degree where nobody would be angered by the decision. They also highlight another problem about handling medical care for large groups. Absent an ability to determine who would definitely suffer the problematic side effects from a particular drug (or screening), regulators don’t have an effective means of providing useful treatments that could seriously harm or kill parts of the population. Same goes for insurance carriers, though they’re concerned with minimizing their risks.
There will no doubt be serious objections to the decision, as there were when the relevant Advisory Committee voted to recommend withdrawal back in June. Unfortunately, the debates in this space typically focus on individual drug or screening approvals, and don’t really address the underlying challenges of risk assessment, personalized medical treatment, and cost controls. They quickly diverge into arguments about who is being killed by the decision, which nearly guarantees that thoughtful discussion quickly leaves.