‘Emergency Use’ Allows for Unapproved Drug Use
[Report by James G. Dickinson and David McFarland] In what some close observers saw as a hidden political directive from President Trump, FDA 3/30 issued an emergency use authorization (EUA) to permit the distribution and use of 30 million doses of hydroxychloroquine sulfate donated by Sandoz and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with caronavirus. The action allows these and other companies to donate additional doses. HHS says the companies have ramped up production to provide additional supplies for the commercial market.
Just three days ago, FDA publicly rebuffed Trump’s persistent praise of the drug, saying a randomized clinical trial was the best way to assess its value against coronavirus. What changed FDA’s mind so quickly? Nobody is saying, just as nobody did when FDA apparently buckled for the first time to clandestine White House pressure in 2000 with the even more controversial approval of the abortion drug mifepristone, or RU-486.
FDA issued the EUA to HHS’ Biomedical Advanced Research and Development Authority to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile to be distributed and prescribed by doctors when a clinical trial is not available or feasible. HHS says it requires that fact sheets provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating caronavirus be made available to healthcare providers and patients, including the known risks and drug interactions. According to the RxList Web site, common serious side effects include: muscle weakness, twitching, uncontrolled movement, loss of balance or coordination, blurred vision, light sensitivity, seeing halos around lights, pale skin, easy bruising or bleeding, confusion, unusual thoughts or behavior, or seizures (convulsions).
As with mifepristone, not everyone is on board expanding chloroquine’s use without adequate data. Science magazine reports that former FDA principal deputy commissioner Joshua Sharfstein (a Democrat) said: “The best way to know whether a medication for Covid-19 is effective is through a high-quality clinical trial. Efforts to widely distribute unproven treatments are misguided at best and dangerous at worst.” Many scientists are critical of the small French clinical study of just 42 patients that stoked interest in the drug’s use, according to Science. Darren Dahly, a co-author of one of several critiques of that initial study and a principal statistician at the University College Cork School of Public Health, said it would be “egregious” to recommend treatments for millions of people based on such a small trial, regardless of its quality. “This is insane!” tweeted Gaetan Burgio, an Australian National University expert on drug resistance, noting what he sees as lapses in the six-day trial, including inconsistent testing of virus levels in the patients, Science reports.