June 2nd, 2020
by Dr. Elizabeth Lee Vliet
What President Trump called a potential “game-changer” in the battle against COVID-19-a safe, cheap, effective treatment, available NOW-is suddenly seen as a highly dangerous drug. Of the fake news and misinformation that has proliferated in this pandemic, the most harmful is the claim that hydroxychloroquine (HCQ) is a serious heart hazard. That incorrect claim has been supported by prestigious medical journals.
This negative message contradicts 65 years of experience of safe, worldwide use of HCQ for malaria, lupus, and rheumatoid arthritis. Hundreds of millions of patients have taken it without difficulty and without serious side effects. Recent studies in several countries have shown that if used early, within the first week of symptoms, HCQ is safe and highly effective for COVID-19.
Yet the Food and Drug Administration is severely restricting its use to hospitalized patients, and doing nothing to counter the fearmongering.
On May 27, Yale professor of epidemiology Harvey S. Risch published an article in the American Journal of Epidemiology entitled: “Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis.”
Dr. Risch referred to five clinical trials, including two controlled trials, which showed “significant major out-patient efficacy” of hydroxychloroquine plus azithromyxin (HCQ+AZT). No cardiac problems were noted in these trials. He concluded: “Evidence about use of hydroxychloroquine alone, or of hydroxychloroquine+azithromycin in inpatients, is irrelevant concerning efficacy of the pair in early high-risk outpatient disease. Five studies, including two controlled clinical trials, have demonstrated significant major outpatient treatment efficacy.”
Dr. Risch concluded that theoretical fears of cardiac events were not borne out in real-world usage and were vastly overshadowed by lives saved. He writes: “These medications need to be widely available and promoted immediately for physicians.”
The FDA in its drug evaluation database has only 62 cardiac deaths attributed to HCQ out of 50 MILLION prescriptions for HCQ, an actual risk of 1.2 per one million people. You have a TEN-fold greater risk (1/74,000) of dying in a fatal car accident on a 1000-mile road trip than dying from a heart arrhythmia if you take HCQ.
The combination HCQ+AZT has been in widespread standard-of-care use in the U.S. and elsewhere for decades in older adults with multiple comorbidities. A large Oxford-based record-linkage study involving more than 300,000 patients with rheumatoid arthritis led to an estimate of only 47/100,000 cardiac arrhythmias attributable to these drugs, most not fatal.
But the media are ignoring this Yale report, instead hammering on studies of critically ill hospitalized patients that show no benefit when HCQ is used far too late in patients in whom severe organ damage has already been done-often to the heart. One study performed in Brazil and published in JAMA on Apr 24 used double the known lethal dose of chloroquine in debilitated, critically ill patients, many with multiple other diseases. Brazilian scientists have demanded JAMA immediately retract this study. The Brazilian government has launched a judicial investigation into the authors’ ethical and legal violations of approved dose guidelines, yet JAMA has still refused to retract the publication.
The recent Lancet data-mining report, also heavily covered in the news, again only included severely ill hospitalized patient, including those in that Brazilian study. Leading scientists from several countries are questioning the validity and accuracy of the data.
To put HCQ safety in perspective, consider the risks of common over-the-counter medicines (OTC) that most people don’t think twice about using:
- Tylenol (acetaminophen) is the number 1 cause of acute liver failure in the U.S., ahead of hepatitis, with a death rate of 20-40 percent. It is also the second overall cause of liver failure requiring liver transplant.
- Common pain relievers Aleve and Advil account for 21 percent of U.S. adverse drug events. They lead to a 50 percent increase in risk of acute kidney failure, and significant risks of life-threatening gastrointestinal bleeding.
- OTC proton-pump inhibitors (“acid-reducers”) cause a 31 percent increased risk of hip fracture, and 54 percent increased risk of spine fracture.
Other countries, which use HCQ prophylactically or early, have dramatically lower COVID-19 death rates than the U.S., as shown in the newly updated table below for May 30, 2020. The U.S. death rate is nearly 20 times that of India, and 265 times the FDA’s estimated rate of HCQ-related heart problems!
The President has the legal authority under the Defense Production Act in the Presidential Emergency Powers to bypass the FDA and change HCQ to over the counter during this National Emergency. Its long safety record supports that as a reasonable option when compared to risks of common current OTC medicines.
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.