There is a new development in the tragic saga of hydroxychloroquine. The FDA, under Commissioner Hahn, has now refused to release more than 60 million doses of hydroxychloroquine stored in the Strategic National Stockpile.
Let that sink in: While Americans are dying every day of COIVD-19, FDA’s Dr. Hahn has refused the release of hydroxychloroquine donated for the PEOPLE of America to help save lives in the Pandemic.
On the Voice of Nation talk radio show, August 24th program, we discussed the ways the FDA has blocked all physician-led efforts to expand access to cheap, FDA-approved, currently available generic medicines – in particular hydroxychloroquine – for doctors and patients to use in early outpatient, home-based COVID-19 treatment. Early use of HCQ, with zinc, is one step that could dramatically reduce the alarming death rate caused by the failed Fauci-Hahn model of waiting to treat until people are critically ill and hospitalized when none of our medicines work as well.
Legal Counsel for the Association of American Physicians and Surgeons (AAPS), Andrew Schlafly, contacted the FDA on August 20 requesting release of the HCQ in the National Stockpile. The request for release was denied.
On August 21, Mr. Schlafly filed an Emergency Motion for another injunction to compel the FDA to release the hydroxychloroquine in the Strategic National Stockpile for use by Americans as initially intended.
This HCQ supply sitting in government warehouses is medicine that President Trump and Secretary of HHS Azar arranged for pharmaceutical companies to donate to be used for the American people specifically for treatment of COVID.
Secretary Azar’s specific direction at the beginning of the Pandemic was for HCQ to be distributed to doctors’ offices, clinics, hospitals, and pharmacies for use by frontline physicians across America, outpatient early treatment and inpatient treatment as needed. It was never intended to be restricted to just hospitalized patients, as Rick Bright put in place with his first Early Use Authorization issued on March 28th.
WHY is the FDA allowed to continue to sabotage the National Emergency early directives of HHS Secretary Azar and the President of the United States to make this medicine available for doctors and patients to decide to use?
Rick Bright’s restriction to use only in hospitalized patients has since been rescinded, but the damage was done with the FDA’s language. FDA posted a warning of “outpatient harm,” but at the same time it was clear that FDA’s restriction for use in hospitalized patients meant that the FDA’s own data came almost exclusively from critically ill, hospitalized patients. It is medically improper to extrapolate inpatient data to outpatients earlier in the disease. It is this false narrative, ignoring the outpatient safety data, that is costing lives.
By the late stage of COVID disease, when people are hospitalized and critically ill, we know that virus-triggered inflammatory damage is a direct cause of injury to heart, lungs, and kidneys, leading to heart arrhythmias, kidney failure, respiratory failure needing respiratory support. Heart damage occurs in COVID-19 late stage illness, even in people who have never received HCQ. The virus has even been found in heart muscle tissue. HCQ is being wrongly blamed for heart arrythmias not seen in healthier outpatients over the 65 years of its use worldwide.
The key to success with HCQ is to use it early, within the first 5 days of symptoms. No responsible physician has ever said that HCQ is a panacea or a cure-all for COVID-19. That exaggerated language came from the media in their political attacks on the President and physicians using this medicine, who are simply trying to save lives.
The FDA’s stonewalling has led to a mounting death toll of Americans, almost 1000 people a day, that could largely have been prevented with early treatment options as used in the majority of other countries around the world.
Dr. Harvey Risch, Yale Professor of Epidemiology, estimated that 100,000 Americans died needlessly as a result of the FDA actions to restrict early use of HCQ, as part of an established triple therapy combination with zinc and azithromycin.
The war on hydroxychloroquine specifically has been an especially dangerous precedent, unlike any attack on an established, widely used, safe medication I have seen in my entire career. Physicians want and need to be free to use all available medicines as we think medically appropriate for our patients, with patients able to consent to off-label new uses, as we do every single day for all other diseases we treat.
If the FDA continues to block release of the millions of doses of hydroxychloroquine in the National Stockpile, the Senate Oversight committee should immediately call for the President to remove Dr. Hahn as FDA Commissioner and put him in a role where he cannot continue to cause damage to American lives with his inaction.
There are many well-qualified physicians, knowledgeable in the early treatment of COVID, who could immediately step up and serve as Acting FDA Commissioner and release the National Stockpile for physicians and patients to use now.
We could save thousands of lives with this one step.