Submitted By Elizabeth Lee Vliet, M.D.
(5-21-20) How could a cheap, effective drug, FDA-approved and in use worldwide since 1955, suddenly be restricted for outpatient use by American physicians? On March 28, 2020, as physicians worldwide were seeing striking success using hydroxychloroquine to treat COVID-19, the FDA erected bureaucratic barriers.
Rick Bright, Ph.D., is an FDA bureaucrat, vaccine researcher, and was appointed by President Obama on November 15, 2016 to head BARDA (Biomedical Advance Research and Development Authority, a sub-agency of the FDA). In an unprecedented move, Bright expanded his power and claimed credit for being the person imposing his will on all of us.
In an appalling admission, Bright said: “Specifically, and contrary to misguided directives, I limited the broad use of chloroquine and hydroxychloroquine, promoted by the administration as a panacea, but which clearly lack scientific merit.” Meanwhile, he promoted both remdesivir, a never-approved experimental antiviral in development by Gilead Sciences, and a vaccine for COVID-19. Early effective use of the older, safe, and available hydroxychloroquine, whose patents had expired decades ago, would decrease demand for these new products.
Rick Bright’s dictatorial decree restricts the use of chloroquine (CQ) and hydroxychloroquine (HCQ) from the National Strategic Stockpile in COVID-19 to hospitalized patients only. States are using Bright’s fiat to impose broad restrictions limiting the drugs’ availability for physicians to use for outpatients to help them recover without hospitalization.
In other countries, early use in outpatients is changing the life-and-death equation by reducing severity and spread of illness, greatly reducing the need for hospitalization and ventilators and markedly reducing deaths.
By his own admission, Rick Bright, who is not a physician, knowingly and unilaterally countermanded Secretary of Health and Human Services Alex Azar, Admiral Giroir in charge of Public Health Service and the President of the United States, who had directed BARDA to establish a Nationwide Expanded Access Investigational New Drug (“IND”) protocol for chloroquine, which would provide significantly greater outpatient access for the drug than would an Emergency Use Authorization (EUA). Unlike an EUA, a Nationwide Expanded Access IND protocol would make the drug available for the treatment of COVID-19 outside a hospital setting at physicians’ medical discretion based on patients’ needs.
How does one non-physician bureaucrat have such power with impunity? How can one person brag about blocking physicians’ attempt to reduce hospitalization and deaths during a national emergency?
It is a falsehood to say that the administration promoted HCQ as a “panacea” or that this medicine “clearly lacks scientific merit.” Both statements are contradicted by video recordings of Presidential briefings, by NIH/CDC studies going back 15 years, and by U.S. and worldwide clinical outcomes studies in COVID-19.
It is unprecedented to restrict physicians from prescribing FDA-approved drugs for a newly discovered use-“off-label.” This is contrary to FDA regulations in place since World War II.
Basic science studies published in 2005 from our own CDC and NIH showed clearly that CQ and HCQ work early in SARS-CoV to block viral entry and multiplication, and suggested that they would not work as well in late-stage disease when the viral load had become huge. When SARS-CoV-1 waned and disappeared by late 2003, the drugs were not submitted for FDA-approval for this coronavirus.
In 2019, when Chinese doctors recognized the deadly impact of SARS-CoV-2, they began trying known and available anti-viral medicines, especially CQ and HCQ, based on 15-year-old studies. They shared information with South Korea, India, Turkey, Iran, and several other countries, who also began quickly and successfully using CQ and HCQ, alone or with azithromycin. Later, Brazil, Israel, Costa Rica, Australia, and others followed, with good results .
Based on these initial clinical reports, President Trump said, at an early press briefing, that CQ and HCQ “offered hope.”
More studies have replicated these findings. HCQ given within the first week of symptoms, especially with zinc, can prevent the virus from entering your body’s cells and taking over, much like people use locks and alarms to stop burglaries. Waiting until you are in the ICU is like installing home locks and alarm system after burglars have invaded, vandalized your home, and stolen all your valuables. The drugs cannot reliably undo the damage from the exaggerated immune response, or cytokine storm, triggered by COVID-19
Examples from the world data on May 18, 2020, which is updated daily, show how Third-World countries are faring far better than the U.S., where entrenched bureaucrats, governors, and medical and pharmacy boards are interfering with physicians’ medical decisions.
Instead of orchestrating a war on HCQ, the media should be asking key questions, such as:
- How does ONE person, by his own admission, block directives from his superiors to expand availability of HCQ for outpatients and nursing home patients in the U.S.?
- What is the cost in lives and economic damage resulting from one person’s decision to restrict physicians’ independent medical decision-making?
- How many nursing home deaths could have been prevented if physicians had been allowed early access to HCQ?
- Why are U.S. doctors and nurses prevented from using HCQ prophylactically when workers in China, South Korea, India, Brazil, Argentina, Israel, Australia, Turkey, France, and other countries can be protected?
- Why does the U.S. with its a much more sophisticated medical infrastructure have a much higher mortality rate than poor countries?
Bright’s disastrous bureaucratic decision may well be remembered as one of the worst preventable medical tragedies in our time. Never again should one government employee be allowed unrestrained power without oversight, and allowed to make a sweeping order interfering with the prescribing authority of front-line physicians trying to save lives.
Whoever wrote this article needs a few classes in validity of studies. They should also probably fact check information before publishing it. The prescribing of Plaquenil is NOT being blocked. It is being limited to the correct use of it, but it is absolutely not being blocked. Patients with positive COVID tests can get it, I don’t understand why this article is written to make it seem like they cannot? Also, one person did not make this decision. Boards of Pharmacies and Medical Boards were the front runners in getting these orders passed. Please re-evaluate this article and edit it (or delete it, it’s beyond editing) to reflect correct information.
These stories are submitted for publication, this is the author’s info-
Author/Contributor short bio:
Dr. Vliet has been a leader in patient centered, individualized medical care. Since 1986, she has practiced medicine independent of insurance contracts that interfere with patient-physician relationships and decision-making. Dr. Vliet focus is medical freedom and free market approaches to healthcare. Dr. Vliet is the founder of Vive Life Center and Hormone Health Strategies with medical practices in Tucson AZ and Dallas TX, specializing in preventive and climacteric medicine with an integrated approach to evaluation and treatment of women and men with complex medical and hormonal problems from puberty to late life.
Dr. Vliet is a 2014 Ellis Island Medal of Honor recipient for her national and international educational efforts in health, wellness, and endocrine aging in men and women, and is recognized in the US as a motivational speaker in health and wellness and a powerful patient advocate, proponent of free market approaches to lower healthcare costs. Dr. Vliet is the recipient of Voice of Women Award from Arizona Foundation for Women in recognition of her pioneering advocacy for the overlooked hormone connections in women’s health.
Dr. Vliet’s consumer health books include: It’s My Ovaries, Stupid; Screaming To Be Heard: Hormonal Connections Women Suspect– And Doctors STILL Ignore; Women, Weight and Hormones; The Savvy Woman’s Guide to PCOS, The Savvy Woman’s Guide to Great Strength, and Stamina.
Dr. Vliet is a past Director of the Association of American Physicians and Surgeons (AAPS), a member of the AAPS Editorial Writing Team on healthcare reform, and a member of International Menopause Society and the International Society for The Study of the Aging Male (ISSAM). She received her M.D. degree and internship in Internal Medicine at Eastern Virginia Medical School, and completed specialty training at Johns Hopkins Hospital. She earned her B.S. and Master’s degrees from the College of William and Mary in Virginia.
Dr. Vliet has appeared on FOX NEWS, Cavuto, Stuart Varney Show, Fox and Friends, Sean Hannity and many nationally syndicated radio shows across the country as well as presented hundreds of Healthcare Town Halls addressing the economic and medical impact of the 2010 healthcare law and free market reforms, as well as seminars and radio shows on healthcare reform, Men’s Health and Women’s Health.
Dr. Vliet speaks as an independent physician, not as an official spokesperson for any organization or political party. Dr. Vliet has no financial ties to any health care system or health insurance plan. Her allegiance and advocacy is to and for patients.