FINALLY, we have very encouraging news on the hydroxychloroquine (HCQ) front!
SIX positive clinical studies were released at the beginning of July:
- three from the United States (one from Michigan at Henry Ford Hospital, and two from New York state, including the one by Dr. Vladimir Zelenko),
- three from other countries (Portugal, India, and Brazil)
The bottom line from all six: HCQ given early in COVID-19, alone or with zinc and azithromycin, reduces hospitalizations and deaths, with no serious heart or other adverse events in the short 5-7 day course of treatment for COVID-19.
Most media ignored these six positive studies, continuing to focus on fear-mongering about HCQ “dangers” from now discredited, poorly designed and seriously flawed reports from use in critically ill hospitalized patients.
Then in a stunning development, Henry Ford Health System (Detroit MI) team of physicians, researchers and ethicists in early July filed an urgent application with FDA Commissioner Dr. Hahn applying for FDA to issue a new Emergency Use Authorization (EUA) and approval of HCQ for COVID-19 early, outpatient use. The Henry Ford clinical trial of HCQ early in hospitalized COVID patients showed a 50% reduction in deaths. This open letter supports this FDA EUA Request and is signed by clinicians, medical researchers, statisticians, and ethicists.
Baylor Scott & White Heart Vascular Institute in Dallas TX issued an urgent letter in support of the Henry Ford EUA application for HCQ to be used in early outpatient treatment of COVID-19 patients, based on the remarkably positive outcomes in their own clinical study of prophylactic use of HCQ in their own healthcare workers.
The Henry Ford and Baylor letters have been posted above for Americans to see firsthand this critical new information since the mainstream media is still suppressing crucially important medical information that can both save lives and help America reopen safely.
The Baylor letter in support of FDA approval for HCQ use in outpatients is particularly important because it is from the Heart and Vascular Institute, was authored by a cardiologist, showed benefit for a weekly prophylaxis regimen, and described no adverse cardiac outcomes in their patient series. This directly rebuts the constant media hype about “heart dangers of hydroxychloroquine.”
Both Baylor and Henry Ford are well-respected, and it is significant how well documented these letters are with regard to safety and effectiveness and the rationale for use. Their information lends very credible US research support to exactly the information I have been sending to President Trump, and getting out in editorials and media interviews since the April 10 letter I wrote to President Trump signed by 1,305 physicians, healthcare workers and concerned patients asking for this new EUA.
These highly credible US research teams further support the safety data since HCQ was first FDA-approved in 1955, and many of us have been describing since February/March, and again presented to the FDA and Trump administration key officials the May 25 letter and medical proposal my pharmacist colleague and I prepared based on my research of the world medical literature and clinical outcomes studies from other countries, as well as the few early and smaller outpatient clinical outcomes studies in the US.
But now these new studies have provided even more success data, additional safety data in actual COVID-19 patients, AND we have two major medical center teams requesting the same FDA approval for outpatient therapy that we have been requesting through our physician-led efforts since late March.
HCQ was first FDA-approved more than 65 years ago for malaria, later for lupus and rheumatoid arthritis, and has been safely used worldwide in hundreds of millions of patients since then. More than 15 years ago, CDC conducted in-vitro studies that showed HCQ was a potent anti-viral agent in the 2002-2003 SARS-COV-1 outbreak, also initially from China and spread around the world. In 2020, HCQ has been widely used in dozens of countries as a safe and effective treatment for the novel coronavirus COVID-19. In all reports, including the CDC findings published in 2005, it is most effective to block viral entry into the cells and viral replication IF given within the first 5 days of symptoms.
At some point, the Trump Administration has to take charge of this out of control situation with people dying and businesses shut down because FDA roadblocks, and Governors’ restrictive orders illegally overriding normal FDA regulations that allow physicians to prescribe ANY FDA-approved medication (including HCQ) however they deem medically appropriate for a given patient, based on their clinical evaluation and judgment.
Physicians in many states also face threats of investigation by their state medical boards for prescribing HCQ for COVID-19, and state pharmacy boards direct pharmacists to refuse to dispense HCQ for COVID patients. Such political interference with doctors’ ability to treat patients has never happened before in my medical career.
The medical situation is now reaching desperate levels with more Governors closing down businesses again, and doctors (EVEN a sitting US Senator Physician!) being threatened/investigated by their State Medical Boards for prescribing HCQ perfectly appropriately, and patients unable to access HCQ early for optimal benefit.
This disaster HAS to be reined in. What is it going to take? How many more people have to die? We need a massive grassroots effort from the public – that’s YOU reading this article — to speak up in support of this new EUA Application from Henry Ford doctors, supported by Baylor physicians.