Methotrexate

Methotrexate, a drug used to treat leukemia in children, was in danger of running out this week.  The FDA now  claims that this crisis has been averted.  The problem here was that one of the four manufacturers of the drug was shut down this year for quality-related issues.  As of today, the other three are increasing production to cover the shortfall.  This is not the first time I have discussed drug shortages.

I know that there are problems with the FDA.  Making drugs is costly, a huge barrier to entry for small companies or companies that want to serve small populations.  The approval process isn't nearly as nimble as it should be.  For example, cancer drugs have to show tumor shrinkage to progress, but in metastatic breast cancer, tumor shrinkage isn't correlated with increased survival.  No doubt, I believe the process needs to change.

But given that other countries don't face the same problems, I think that the problem is more closely linked to ineffective incentives rather than over-regulation.

For the moment, though, I ask that we, as cancer advocates, don't take the eye off the ball.  There is much work to be done.  We can argue about the answers all day long, but the worst thing we can do is ignore it.

Tangentially Related:  Diane Rehm is tackling the problem of counterfeit cancer drugs today.  CLICK HERE.