https://www.washingtonexaminer.com/opinion/hydroxychloroquine-works-in-high-risk-patients-and-saying-otherwise-is-dangerous
As of Wednesday, some 165,000 people in the United States have died from COVID-19. I have made the case in the American Journal of Epidemiology and in Newsweek that people who have a medical need to be treated can be treated early and successfully with hydroxychloroquine, zinc, and antibiotics such as azithromycin or doxycycline. I have also argued that these drugs are safe and have made that case privately to the Food and Drug Administration.
The pushback has been furious. Dr. Anthony Fauci has implied that I am incompetent, notwithstanding my hundreds of highly regarded, methodologically relevant publications in peer-reviewed scientific literature. A group of my Yale colleagues has publicly intimated that I am a zealot who is perpetrating a dangerous hoax and conspiracy theory. I have been attacked in news articles by journalists who, ignorant of the full picture, have spun hit pieces from cherry-picked sources.
These personal attacks are a dangerous distraction from the real issue of hydroxychloroquine's effectiveness, which is solidly grounded in both substantial evidence and appropriate medical decision-making logic. Much of the evidence is presented in my articles.
To date, there are no studies whatsoever, published or in pre-print, that provide scientific evidence against the treatment approach for high-risk outpatients that I have described. None. Assertions to the contrary, whether by Fauci, the FDA, or anyone else, are without foundation. They constitute misleading and toxic disinformation.
What do you need to know to evaluate these smears against hydroxychloroquine? '''
...The only available systematic information about adverse events among outpatients is discussed in my article in the American Journal of Epidemiology, where I show that hydroxychloroquine has been extremely safe in more than a million users.
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.
Harvey Risch, M.D., Ph.D., is a professor of epidemiology at Yale School of Public Health.
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