Why Are Some Governors Blocking Physicians’ Attempts to Save Lives in Coronavirus Pandemic?
by Elizabeth Lee Vliet, M.D.
While people’s lives and jobs are being devastated by the coronavirus pandemic (COVID-19), and there has been no FDA-approved treatment, governors or state pharmacy boards in Nevada, Michigan, New York, Ohio, and Texas are issuing emergency orders to restrict which medications doctors can use to save lives.
These politicians have no background in infectious disease, medicine, research design, or epidemiology, yet they presume to dictate to front-line physicians who are reading the emerging research and caring for patients.
Many doctors are using older medicines, FDA approved for more than 70 years and widely used worldwide to treat malaria, lupus, and rheumatoid arthritis—chloroquine and hydroxychloroquine (Plaquenil). They often add azithromycin (Z-pak), a commonly used antibiotic with some activity against this virus.
These politicians are presuming to decide that doctors may not prescribe these drugs “off-label,” i.e. for anything other than the disease for which the FDA originally approved the drug. Their pretext is that we do not have large randomized controlled clinical trials (RCT) for this new indication.
While we are facing one of the most devastating public health crises in our lifetime, there is NO time to wait for the years-long process of an RCT to provide “proof.” Doctors who use the drugs can observe first-hand how patients respond.
While governors have been handing down orders, doctors in the U.S. and overseas have been reporting remarkable success in treating COVID-19 patients: reductions in hospitalization, less need for scarce ventilators, less need for ICU and intubations, and significantly lower death rates. Two studies from France, conducted by Dr. Didier Raoult, specialist in infectious disease and viral illness, are very promising. Besides helping relieve signs of illness, hydroxychloroquine plus azithromycin also appears to shorten the period of infectivity, which is critically important in controlling disease spread. Data on safety and effectiveness of hydroxychloroquine and azithromycin are coming in almost daily from more than 10 countries, including Canada, Australia, Israel, South Korea, and China.
Several Governors jumped on this restriction bandwagon soon after President Trump announced at a recent Corona Task Force briefing that chloroquine and hydroxychloroquine showed hope in treating COVID-19, based on several small clinical studies from Johns Hopkins, France, and (at last count) eight other countries. He did not say he recommended these medicines, as some media have falsely stated.
After 70 years of experience, physicians are well-acquainted with potential side effects, and are aware of patients who should not take them. On the whole, they are quite safe. Dr. Vladimir Zelenko, a board-certified family physician in a small community in New York state hard hit with coronavirus infections, has been successfully using the combination of hydroxychloroquine, azithromycin, zinc and vitamin C to treat almost 700 patients in the outpatient setting. His results are remarkable: zero deaths, zero intubations/ventilators needed, and only four patients hospitalized due to pneumonia. This protocol has been effective in several countries to decrease hospitalizations, and reduce the duration of viral shedding that is a risk to other people.
Yet Governor Cuomo’s emergency order restricted this treatment to only hospitalized patients, and only those in a New York approved clinical trial. Such a rigid restriction of FDA-approved medicines being used off label to help patients stay out of the hospital makes no sense. Why is a politician making arbitrary medical edicts?
Those who are afraid of “off-label” use need to know that physicians use medications in this way constantly. Until this crisis, there has been no outcry about doctors using old medicines for new uses. This freedom has allowed more rapid discovery of life-saving treatments. Here are a few of many possible examples:
- Amitriptyline (Elavil®), first approved for depression, is now used for nerve pain.
- Trazodone, approved for depression, is widely used at lower doses for sleep.
- Sildenafil (Viagra®), approved for erectile dysfunction, is also used to treat pulmonary artery hypertension.
- The anti-parasite medicines nifurtimox and eflornithine were successfully used off label to treat children with the rare, fatal brain cancer neuroblastoma.
The United States FDA on Sunday March 28, 2020 issued an Emergency Use Authorization (EUA) for hydroxychloroquine and chloroquine to be used as approved treatments for COVID 19. This EUA illustrates my point: Governors should NOT be jumping into medical decision-making on limited data and with no medical training, especially at a time of a National Emergency and pandemic when medical information is changing rapidly, and to save lives we must use the tools we have at hand, as safely as possible in a war against an invisible enemy.
Physicians take the Oath of Hippocrates to use their best medical judgement to prescribe treatments for the benefit of their patients to the best of their ability and above all to “Do no harm.”
Can Governors who are restricting physicians’ prescription decisions in the COVID 19 pandemic truthfully say the same?
Dr. Elizabeth Lee Vliet, M.D.is a preventive and climacteric medicine specialist with medical practices in Tucson AZ and Dallas TX that take an integrated approach to evaluation and treatment of women and men with complex medical and hormonal problems. Dr. Vliet is also President of International Health Strategies, Ltd., a global healthcare and education service company whose mission is twofold: liberty and privacy in treatment options and preservation of the Oath of Hippocrates focus on the individual patient.
Dr. Vliet is the 2007 recipient of the Voice of Women award from the Arizona Foundation for Women for her pioneering advocacy for the overlooked hormone connections in women’s health. Dr. Vliet received her M.D. degree and internship in Internal Medicine at Eastern Virginia Medical School, then completed specialty training at Johns Hopkins Hospital.
Dr. Vliet is a Director of the Association of American Physicians and Surgeons.Dr. Vliet has appeared on FOX NEWS, Cavuto, Stuart Varney Show, Fox and Friends and syndicated radio shows across the country addressing the economic and medical impact of the new healthcare bill.
Dr. Vliet’s 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 Testosterone.
Dr. Vliet’s medical and educational website is www.HerPlace.com. For more on healthcare, go to www.TakeBackMedicine.com or http://www.aapsonline.org
To book Dr. Vliet for interviews, or for permission to publish articles, email Rose Henning rosehenning@herplace.com or call 520-797-9131 (MST).
This older, politically conservative woman,(me) is ready to start making noise about not be able to get Hydroxychloroquine
to fend of this potentially deadly virus. I’ve never been good at taking no for an answer and would love to find like minded people to band together.
Great article. Thank you. It is a preventative too. Read this PDF. All those governors banning it are harming. Americans “This FDA filed clinical trial and the study published by Chinese researchers below, showed MAJOR improvements in outcomes when using Hydroxycloroquine.
Better yet was what was written about those who already were using HCQ previously for lupus, etc. (note that in America, Plaquenil has 5 million regular subscriptions)
In the hospital studied, those using HQC regularly and had pneumonia, did not test positive…..and conversely, those who were positive with Corona, had no one who had taken HQC regularly. Quotes from the actual study are below.
“Significance: Among patients with COVID-19, the use of HCQ could significantly shorten TTCR and promote the absorption of pneumonia.
Trial registration: URL: ( clinical trials .gov) The unique identifier: ChiCTR2000029559.”
“Interestingly, through a follow-up survey, we found that none of our 80 SLE patients who took long-term oral HCQ had been confirmed to have SARS-CoV-2 infection or appeared to have related symptoms. In addition, among the 178 patients diagnosed with COVID-19 pneumonia in our hospital, none were receiving HCQ treatment before admission. All predicting the use of HCQ in SARS-CoV-2 infections. As one of the clinical research registration units in China, we aimed to investigate the efficiency of HCQ in patients with COVID-19 in this study.”
https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v2.full.pdf
The China study’s motivation to print this Feb trial publicly was this in the China clinical trial list of references.
“March 19, 2020 press release.
“The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.
As part of those efforts, President Trump has directed the FDA to continue its work with the public and private sector to ensure the availability of potentially safe and effective life-saving drugs to patients who are in desperate need, including those infected with COVID-19.”
Considering that 9 manufacturers are ramping up production, 250 million doses, says someone believes this is the answer, along with President Trump. (: