By Elizabeth Lee Vliet, MD

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. 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.

By Elizabeth Lee Vliet, M.D.

A recent poll of more than 6,000 doctors from 30 countries found that 37 percent rated hydroxychloroquine (HCQ) as the best treatment for novel coronavirus disease (COVID-19).

Yet, during a recent webinar on COVID-19, doctors across the United States described threats from many governors and state medical boards for prescribing HCQ and azithromycin “off label” for non-hospitalized COVID-19 patients.

It was shocking to hear that our front-line warriors are not only having their medical decisions blocked, but are being threatened with disciplinary actions, and even loss of license in some states.

The international poll conducted by Sermo highlighted crucial differences between the U.S. and other countries. Many fewer U.S. physicians–only 23 percent—had prescribed HCQ, while 72 percent of Spanish physicians used it as their first choice in COVID-19. Also, in the U.S. it was most commonly used for hospitalized high-risk patients with severe symptoms, while in other countries it was equally used for out­ patients with mild symptoms at onset of disease.

HCQ has been FDA-approved for malaria since World War II, and it is now also approved for treating lupus and rheumatoid arthritis.

These findings mean the U.S. lags behind other countries in using HCQ to prevent infection, to reduce the time that a person sheds virus and can infect others, and to keep patients out of hospitals and off ventilators.

Basic science and clinical outcomes studies from more than 10 countries show that HCQ works both before and after COVID-19 enters the cells. It increases zinc transport across the cell membrane, and the two work together to keep the virus from multiplying itself using our own cells’ machinery.

It is the viral multiplication or replication that triggers the inflammatory cascade, or cytokine storm that damages organs, especially the lungs leading to the acute respiratory distress syndrome (ARDS) and deaths.

Adding the antibiotic azithromycin, or possibly doxycycline for elderly with contraindications, shows a synergistic effect, as reported from France, China, and several clinical outcomes studies in the U.S.

A new 2020 study showed an additional way that HCQ works: it prevents the virus from attaching to host cell surface molecules. The authors conclude: “Our data do support the use of chloroquine and preferentially hydroxychloroquine as a first intention therapy for patients infected with SARS-CoV-2 (COVID-19).”

On Mar 28, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization for HCQ to treat COVID-19—but restricted this approval to hospitalized patients.

That restriction means loss of the critical early window of opportunity to achieve four urgent goals to stop the pandemic: (1) prevent the virus attaching to host cells, (2) reduce viral replication that prolongs time of infectivity and spread, (3) reduce the number of hospitalizations and need for intubation and mechanical ventilators, and (4) reduce risk of multi-organ damage and death or permanent lung impairment after recovery.

At the Apr 4 Corona Virus Task Force Briefing, reporters continually focused on the potential shortage of ventilators, yet no one was asking about using effective medication approaches to keep patients from becoming so critically ill that they need mechanical ventilation.

When World Health Organization and U.S. experts say there is “no evidence that any medicine can prevent or cure” COVID-19, they correctly mean We don’t yet have a randomized, placebo-controlled, double blind clinical trial (RCT). But designing, setting up, conducting, and analyzing any RCT takes years. And that is only one form of evidence in medicine. Case studies (pejoratively called “anecdotes”) and decades of safe use worldwide provide other valid sources of clinical outcomes evidence, which have guided physicians for more than 2,000 years.

As a matter of historical record, we had no RCT “proving” that smoking caused lung cancer, but that did not stop common-sense recommendations by the Surgeon General and physicians who advised patients to stop smoking cigarettes, based on clinical outcomes showing higher lung cancer and heart attack deaths in smokers.

We have no time for an RCT. We can’t wait months for a vaccine. People are dying every day. Staggering numbers of people have lost jobs, incomes, and ability to live life normally. We cannot ignore the well-known fact that times of massive unemployment lead to lost lives, from drug addiction, depression/suicide, domestic violence, and losing access to medical care. These losses could exceed those from the virus if the country remains shut down for a prolonged period. This is real damage, not just theoretical, and it is escalating every day.

In this war against the invisible virus, doctors–our soldiers on the front line– simply must be free to use the medicines at hand, to the best of their ability and judgment for each patient, free of politicians and bureaucrats’ second-guessing and threats.

Doctors must be able to prescribe, pharmacists to dispense, and patients to take already-approved drugs for this novel use against a novel enemy. About 20 percent of all prescriptions are for “off-label” uses. The FDA may restrict pharmaceutical companies marketing for off-label uses, but it has no authority to interfere with doctors’ prescribing them off-label. That is called the practice of medicine. It is unprecedented—and lethal—for state governors and medical boards to forbid the freedom to prescribe long-approved and safely used medications.

America urgently needs a Presidential directive to remove the FDA’s red tape and state political obstacles to save lives, reduce the rate of spread of COVID-19. Hospitals must quickly be fully opened to treat patients with urgent medical and surgical needs beyond COVID-19 to avoid losing hospitals and medical staff. We should .  consider India’s approach with a national recommended guide for physicians. Stop this patchwork quilt of governors’ arbitrarily deciding what prescriptions can and cannot be used in each state.

In a war to save lives and our country, we must fight with all the weapons we have at hand, even if not yet “proven.”

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 Sex, 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.

As Reported by WikiLeaks: https://wikileaks.org/podesta-emails/emailid/927

Affordable Care Act

Hillary Clinton Said She Wants Us To Have A Debate Where Our Differences Are Fully Aired On Healthcare Reform Since There Are Different Approaches. “Now, what does that have to do with health care reform?  Well, I want to see us have a debate where our differences are fully aired because, clearly, there are different approaches about what we think can work.  We don’t have one size fit all.  Our country is quite diverse.  What works in New York City is not necessarily going to work in Harrison, Arkansas or Albuquerque, so we do need to have people who are looking for common ways of approaching problems using evidence but leaving their blaming, their gaming, their shaming, point scoring at the door.  Because when we think about it, our country is such a remarkable accomplishment.  Think about how diverse we are.  We’ve had lots of disagreements.  We even had a civil war for heaven sakes, so it’s not like we just — you know, like in those drug commercials where we just hold hands and dance through the meadows while somebody is telling you everything that can go wrong like your ear’s falling off if you take the drug they’re advertising.” [02262014 HWA Remarks at HIMMS [Orlando].DOC, p. 10] Continue reading →