[Ip-health] FDA Emergency Use Declaration on hydroxychloroquine sulfate and chloroquine phosphate politically problematic

Baker, Brook b.baker at northeastern.edu
Mon Mar 30 11:59:31 PDT 2020

FDA Emergency Use Declaration on hydroxychloroquine sulfate and chloroquine phosphate politically problematic

On March 29, 2020, the Department of Health and Human Services announced that it was accepting donations of hydroxychloroquine and chloroquine, two anti-malaria drugs currently being investigated in multisite clinical trials for possible use in the treatment of COVID-19, see https://www.hhs.gov/about/news/2020/03/29/hhs-accepts-donations-of-medicine-to-strategic-national-stockpile-as-possible-treatments-for-covid-19-patients.html. These are potential COVID-19 medicines inappropriately touted by President Trump on national television on March 19 when he had a “hunch” that these medicines would be effective against COVID-19.  Trump’s hunches, do not good science make.

Although Anthony Fauci immediately clarified that these medicines were not yet approved for use against COVID-19 and that clinical trials would shortly inform decisions by regulatory bodies whether these older medicines should receive a new medical indication, HHS has for some inexplicable reason jumped the gun on science.

At the very least, this decision creates the appearance of political influence at a time when our regulatory bodies and scientists need to continue to stand far away from Presidential politics.  At its worst, this, and other precipitous decisions by regulators might undermine regulatory integrity more broadly and thus public confidence in the safety and efficacy of medicines, vaccines, diagnostics, and devices “rushed” to the market with inadequate scientific justification.  Even in emergency contexts, where some relaxation of red tape might be warranted to justify access to medicines and health technologies that have evidence that they are “good enough,” to jump the gun on a President’s hunch is just plain wrong.  This decision could drive patients and clinicians in the wrong direction on medicines that have negative side effects and that might do little or nothing to affect the progression of COVID-19.

It would have been nice to see a better rationale for HHS’s decision other than that the White House has jawboned some donations from Novartis and that the White House had also set up a collaboration with Oracle to unofficially collect data on use of hydroxychloroquine and chloroquine for off label use – essentially a massive, unscientific “trial” that risks confounding evidence from real clinical trials currently going on, see https://www.nytimes.com/2020/03/24/us/politics/trump-oracle-coronavirus-chloroquine.html<https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.nytimes.com%2F2020%2F03%2F24%2Fus%2Fpolitics%2Ftrump-oracle-coronavirus-chloroquine.html&data=02%7C01%7Cb.baker%40northeastern.edu%7C22618e952e9d463825fa08d7d4bfe316%7Ca8eec281aaa34daeac9b9a398b9215e7%7C0%7C0%7C637211792941554446&sdata=FKYPaluZwatwKxT7SwwX0hn4vevFXOoe2RbIbc%2BtP7s%3D&reserved=0>.

Professor Brook K. Baker
Northeastern U. School of Law
416 Huntington Ave.
Boston, MA 02115
Honorary Research Fellow, University of KwaZulu Natal
Health GAP (Global Access Project) Senior Policy Analyst
(w) 617-373-3217
(c) 617-259-0760
b.baker at northeastern.edu
Skype:  brook_baker

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