It is a serious and unconscionable mistake that the FDA has used inpatient data to block emergency use petitions for outpatient use. Further, already back in March, the FDA approved the emergency use of hydroxychloroquine for hospitalized patients, for whom it is demonstrably less effective than for outpatients. If hydroxychloroquine satisfied the FDA criteria for emergency inpatient use in March, it should more than satisfy those criteria now for outpatient use, where the evidence is much stronger.
I can only speculate about the cause of the FDA’s recalcitrance. Hydroxychloroquine is an inexpensive, generic medication. Unlike certain profit-generating, patented medications, which have been promiscuously touted on the slimmest of evidence, hydroxychloroquine has no natural financial constituency. No one will get rich from it.
Further, it seems quite possible that the FDA, a third of whose funding comes from drug companies, is under intense pressure from those companies to be extremely conservative in its handling of hydroxychloroquine. If hydroxychloroquine is used widely and comes to be recognized as highly effective, the markets for expensive and patented COVID-19 medications, including intravenous drugs that can only be used in the hospital, will shrink substantially.
Whatever the reason for the FDA’s stonewalling on hydroxychloroquine, this much is certain: Americans are dying unnecessarily, the economy is in disarray, and the threads that bind our society together have frayed. I am speaking out, but where is everyone else? Where are our elected officials, including those who are themselves physicians? Some, including Rep. Andy Biggs of Arizona, have been discussing evidence of the drug's effectiveness, but where are the rest?
This issue should not be a partisan one. If our elected officials are not willing to pry open the FDA, we must elect new officials. Why are we silent? The time to speak is now.
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