COVID-19, Current Events, Guest Column, Medicine, What's New

Vaccinated or Not, Acute COVID-19 in High-Risk Patients Demands Early Treatment

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Vaccinated or Not, Acute COVID-19 in High-Risk Patients Demands Early Treatment

It is important to understand that COVID-19 always starts out with mild symptoms, so don’t make the mistake of assuming a “mild” case and ignoring early treatment. Take the approach that COVID-19 will be a short mild upper respiratory infection with prompt early therapy.  

There is a list of over-the-counter nutraceuticals and aspirin that all households should have in stock to be ready. For the prescription drugs, a doctor will need to call these orders into a pharmacy, and this can be done by your doctor if they are willing and capable, and if not, by national or regional telemedicine services.   

The links below give the key websites for you to access to get treatment guides and access telemedicine services. Do this early since outbreaks tend to jam up these services. Many have learned that early at-home treatment gives more effective medications than the hospital offers. The goal is to get as many days of multidrug home treatment before throwing in the towel for the hospital. If things worsen usually driven by extreme difficulty in breathing, a trip to the emergency room should be considered. 

Patients are encouraged to take their home medications into the hospital and continue them since in-hospital care is commonly minimal and has a major focus on giving oxygen and mechanical ventilation. The National Institutes of Health Guidelines, which are strictly followed by most hospitals, do not advise treatment until a patient requires oxygen, this means that some patients go days in the hospital with no therapy. 

That is the reason why it is so important to pack up home medications and take them to the hospital in the rare case treatment at home fails. Once in the emergency room, seniors should demand a monoclonal antibody infusion before release to home or admission. These lifesaving treatments are available to outpatients only, and sadly, once admitted to the hospital they are not offered in the current nihilistic approach to COVID-19 hospitalized care. 

The most important drugs in the hospital are blood thinners and patients should demand full dose blood thinners (enoxaparin injections or heparin infusions) and adult aspirin. These are not offered to many patients and when COVID-19 deaths occur in the hospital the most common finding is blood clots in the lungs and elsewhere in the body due to inadequate anticoagulation. Hopefully with these tips, for those who have COVID-19 or will get it soon, whether vaccinated or not, will be useful in keeping the syndrome to a mild 4-day cold and a deliverance to natural immunity which reigns superior over the failed attempts at vaccine protection. 

The monologue of this McCullough Report kicks off with a segment from an interview with Sebastian Gorka, Ph.D., who himself received successful early treatment and then moves into a detailed step by step approach of what should be done for children with serious background medical problems or presenting with severe symptoms and all adults over age 50 particularly the elderly and those with background medical problems.

This week’s show features Dr. Chris Montoya, Ph.D., who is a research professor of psychology and “brain science” at Thompson Rivers University in Kamloops British Columbia, Canada. I’ve asked him to help us understand the mass psychosis that is occurring where doctors are in a trance, brainwashed into not treating COVID-19, losing empathy, and then without concern over safety or efficacy, are blindly promoting the failed mass vaccination program. His insights are terrific.

So, let’s get real, let’s get loud, on America Out Loud Talk Radio, this is The McCullough Report!

The McCullough Report: Sat/Sun 2 PM ET Encore 7 PM – Internationally recognized Dr. Peter A. McCullough, known for his iconic views on the state of medical truth in America and around the globe, pierces through the thin veil of mainstream media stories that skirt the major issues and provide no tractable basis for durable insight. Listen on iHeart Radio, our world-class media player, or our free apps on Apple, Android, or Alexa.

COVID-19, Guest Column, Medicine, What's New

COVID-19: Is College Worth the Risk of the Shot?

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by Jane M. Orient, MD

Are you one of the millions of American students (or their parents) facing the choice of taking the COVID shot or being barred from school?

The 800 reported cases of heart inflammation, now being investigated by the Centers for Disease Control and Prevention (CDC), give a new urgency to the question. The most poignant case might be the 19-year-old girl, a journalism student at Northwestern University, who died two months after receiving her first dose of the Moderna product. Even a heart transplant could not save her.

One of the world’s most widely published cardiologists, Dr. Peter McCullough, fears that many of these formerly fit and healthy young people will wind up with heart failure.

Depending on the amount of underreporting, the rate of heart problems in young men following the COVID jab may be 600 times the background rate.

Half the patients with a diagnosis of heart failure live less than 5 years. Even if heart damage is mild, the patient might not be able to participate in athletics or aspire to be a pilot, firefighter, or soldier, or to engage in any physically demanding occupation.

Another potential risk is infertility. This might not become apparent for years, as college students are generally postponing childbearing until they achieve educational or career goals. But an early warning signal is coming from fertility clinics, where eggs and sperm from previously successful donors are not producing viable embryos.

Having a significant fraction of our young people disabled or infertile is a truly existential risk.

Yet, despite objections from physicians, hundreds of colleges are still insisting that students get the jab, even those already immune, who gain no conceivable benefit.

Legal challenges may be undertaken, but courts have generally been unsympathetic to challenges to vaccine mandates. A Texas court just dismissed a challenge by some 116 employees of the Houston Methodist hospital system, who will be fired if they decline the shots.

Many will take the shots, even against their better judgment, because of peer pressure, continued trust in the CDC, the belief that these genetically engineered products are no different from other vaccines, or the high cost of disrupting their career plans. Since the purveyors of the products are protected from liability, all costs—even of death and disability—will be borne by students and their families.

For further information:

·         Summary of reports to VAERS

·         Weekly summaries of reports to British Yellow Card system (scroll down to “vaccine analysis print” for the various brands)

Contact [email protected] or (520) 323-3110 if you would like to discuss these issues.

Jane M. Orient, M.D.

Executive Director, Association of American Physicians and Surgeons

COVID-19, Guest Column, Medicine, What's New

Ending COVID-19 Infectious Precautions with the GGRX Prophylaxis and Treatment Protocol

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by Wayne L. Iverson, MD. August 24, 2020

After 8 months of having the American public follow specific infectious precautions by government mandate, the various medications, antibiotics and anti-viral therapies have had no impact on ending the COVID-19 infectious precautions. The COVID-19 infectious precautions with face masks, sterilization of public surface areas, social distancing, avoidance of personal contact, the closing of businesses, schools, shopping centers and even church, have pushed the concept of infectious precautions to an extreme level. COVID-19 infections fall into the category of Community Acquired Illness (CAI) and join the list of other Community Acquired Organisms (CAO). Various opinions have been offered as to the virulence and prognosis of COVID-19 as an agent for infection responsible for a CAI.

I believe it is well recognized that some people merely contract COVID-19 and do not manifest an illness. Others have an acute respiratory infection or flu like illness and spontaneously recover with their own body’s defenses. Additionally, others, especially those with uncompensated and debilitating medical conditions such as being immune compromised as a cancer patient on chemotherapy or a patient with COPD on nasal oxygen or CPAP, when infected by any CAO including COVID-19, may progress, have additional complications and die.

In my experience, as a physician who is American Board Certified in Internal Medicine, who practices clinical medicine and actually diagnosis and treats patients with CAI, I have had a chance to form a considered opinion about COVID-19. On a scale of 1-10, with 10 being the most severe, I would rate COVID-19 as 6 and a moderately severe case of Influenza as 8. As such, healthy patients with medically compensated conditions who manifest an illness from COVID-19 recover as usual for a CAI. Patients who have an uncompensated and debilitating medical condition may not recover from COVID-19 or any other CAO.

Recent and current government mandated infectious precautions have produced an unprecedented economic loss and multifaceted hardship on the American public. These mandates have caused the loss of tax payers’ dollars from congressionally approved programs, the loss of income of working people, the loss of business revenue from closures, the loss of new tax dollars from a stable economy, and the loss of best practices in school education. The American public has developed extreme worries and concerns to the point of being germaphobic and feeling like they are being forced to live in a bubble. These negative economic factors and hardships can be remedied by ending COVID-19 infectious precautions with the GGRX Prophylaxis and Treatment Protocol.

This article outlines a return to normality in American day to day activities with the GGRX Prophylaxis and Treatment Protocol. This Protocol allows Federal, State and local governments to discontinue all government mandates related to infectious precautions with COVID-19 and return any related policies and procedures to the local physicians, hospitals and medical community. The government mandated infectious precautions have been unduly extreme to the point of forcing every healthy person, including those who have immunity from COVID-19, in every venue, to highest level of Infectious Precautions donning extensive garb in the mode relegated to Reverse Isolation. The Standard Infectious Precautions that were in place in 2019 can be resumed and COVID-19 can be dealt with in the same manner as Influenza or any other CAO.

Gamma Globulin (GG) has been an FDA approved treatment for years for various types of infections and conditions. Its use for COVID-19 would be designated off label, but for 2020 any medication, antibiotic or anti-viral treatment for COVID-19 would be designated off label as well. GG has been used successfully for decades as prophylaxis and treatment of Infectious Hepatitis Type A. 

The theory of how GG works is that it contains immunoglobulin antibodies which boost a patient’s immunity against disease. Reports on GG effectiveness for Hepatitis A infections have been as high as 85-95% and is considered a safe therapy. Although GG has not been aggressively promoted as a therapy for COVID-19, this lack of recognition, in my opinion, is due to logistics and misconceptions and should not be a barrier for using GG to combat COVID-19 and mitigate government mandates at this time. 

AP News on August 11, 2020 published a report that the governor of Oklahoma and others are donating plasma to COVID-19 patients to help them recover. Johns Hopkins University of Medicine has tallied and published in the Wall Street Journal vast numbers of Americans deemed to be COVID-19 cases and it is generally believed that the number of such individuals is actually higher. That being the case, there should be vast numbers of people who have antibodies against COVID-19 and the harvesting and production of fresh GG in the 2nd and 3rd quarter of 2020 may be especially effective in treating COVID-19. This latter conclusion alone could very well have been one reason GG usefulness was not recognized earlier this year.

The Gamma Globulin Prophylaxis and Treatment Protocol (GGRX Protocol) I am suggesting is as follows: 

1) Return America to normality and end government mandated infectious precautions. 

2) Local Physicians, Hospitals and Medical Facilities, resume their prior 2019 Standard Infectious Precautions for community acquired illnesses (CAI) and community acquired organisms (CAO), and handle COVID-19 as any other CAO. 

3) Healthy individuals (including individuals who have compensated medical conditions) should resume life as normal. This means, go back to work, school, sporting events, church and the like as they did in 2019. 

4) If a healthy individual is going to a location or a venue considered high risk for COVID-19, he or she could elect to receive a GG injection prior to entry. 

5) If a person becomes ill with a COVID-19 infection, he or she can elect to have a GG injection as adjunctive treatment. This individual could receive his or her physician’s usual therapy for a CAI. 

6) In people who have been ill with COVID-19 or any CAO, 24 hours after recovery (feeling better and having no fever) they can elect to resume all of their usual daily activities. 

7) GG injections may be used in conjunction with COVID-19 vaccine in the same manner as Hepatitis A Virus (HAV) with this objective factored in by the pharmaceutical companies manufacturing the vaccine. 

8) Ordering COVID-19 Screening Tests and COVID-19 Antibody Tests should only be performed by physicians on specific patients under their medical care and be obtained with the consent of the patient. These tests may be used to help guide treatment protocol.

In summary, the GGRX Protocol is designed to provide an additional treatment option in the fight against COVID-19. The use of Gama Globulin outlined in this Protocol is one which physicians and their patients should decide if it is advisable and should be used on a case by case basis. Additionally, the GGRX Protocol provides an end to government mandated infectious precautions which have been so disruptive to the economy, Americans’ livelihood and their freedom to enjoy their daily activities.

Wayne L. Iverson, MD is a Physician in Winchester, KY and a Former Candidate for Congress 2012 CA District 52 Media Contact: Wayne Iverson (858) 204-8701 Mailing Address: P.O. Box 4197 Winchester, KY 40392 Email: [email protected]. This article may be freely republished with acknowledgement of the author.

COVID-19, Current Events, Featured, Medical Ethics, Medicine, Op-eds, What's New

COVID Chaos: A Prison Without Bars

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The COVID-19 lockdown has its benefits: a chapter a day of the unabridged version of Aleksandr Solzhenitsyn’s The Gulag Archipelago, a study in fear and redefined “normal” values, among many other lessons.

Lately I’ve seen face coverings stenciled with “I can’t breathe.” The beauty of the statement is its dual meaning. It can be a nod to George Floyd, an arrestee who apparently suffocated at the hands of a rogue law enforcement officer or it can be a statement of the wearer’s condition behind the mask. More generally, it can be a statement about the suffocation of society as a whole.

Free speech is the bedrock of our politics, but media manipulation is now rampant. Under the guise of fact-checking, our modern day newspapers—YouTube, Facebook, and Twitter—have become the arbiters of what constitutes a worthy opinion or fact in contrast to “misinformation.” Scientists were certain that something heavier than air could not maintain flight. The misinformed Wright brothers proved them wrong.

Vladimir Lenin recognized that the media are propagandists and their information presented should be “easy to digest, most graphic, and most strongly impressive.” With COVID-19, the media create irrational fear with daily charts of deaths and case numbers without corresponding recoveries. They fail to mention that many deaths were of patients with serious underlying conditions or who were already in hospice and had weeks to live and coincidentally tested positive. The raw numbers are unaccompanied by the CDC’s instruction to classify a death as COVID-19 even if merely suspected or, in some cases, with a negative test. There is no corresponding warning with blinking lights that the tests have false positives or that the daily report of “increases” includes old tests that were not previously reported.

As Lenin noted, “ideas are much more fatal than guns.” Thus, where propaganda and media bias do not succeed, censorship will. Currently, a vocal physician is being silenced and investigated for questioning the motives and possible over-reporting of COVID-19 as the cause of death. Censorship is our polite version of “disappearing” dissidents. We are not Communist China and cannot allow the treatment of Dr. Li Wenliang, a Wuhan ophthalmologist to be the “new normal.” In December 2019, he courageously warned his colleagues on social media about the new SARS-like pneumonia cases but knew that he “would probably be punished.” Indeed, Chinese officials forced him to sign a letter accusing him of “making false comments” that had “severely disturbed the social order.” Fortunately for scientific advancement of our relentless search for COVID-19 treatments and mitigation, many questioned the official story about the novel coronavirus coming from a pangolin at a Wuhan wet market.

Censorship, corrupt scientific inquiry, and media bias have no place in medicine. It is not clear that lockdowns are scientifically sound. Curiously, social justice protests are allowed despite lockdowns. One epidemiological analysis concluded lockdowns in Western Europe had no effect on COVID-19 deaths. Additionally, studies show severe psychological effects of quarantines. The 5 states with the most COVID-19 deaths from March through April showed a 35 to 400 percent increase in deaths from various non-respiratory underlying causes, including diabetes, heart diseases, Alzheimer’s disease, and cerebrovascular diseases. Some 80,000 diagnoses of five common cancers may be missed or delayed by early June because of disruptions to medical care caused by the COVID-19 pandemic.

Most reviews conclude that masks do not slow down the spread of the SARS-CoV-2 virus (that causes COVID-19). Studies show non-medical masks do not stop aerosolized droplets less than 2.5 microns. A group of 239 scientists from multiple disciplines from 32 countries have recently agreed that SARS-CoV-2 is spread by such small droplets. They recommend improving indoor ventilation infection controls as the key protective measure. Handwashing and social distancing—but not masks—were advised. The CDC recommends masks.

Faced with a global pandemic, physicians were exploring hydroxychloroquine (HCQ), which had been favorably studied during the 2003 SARS epidemic, as a prophylactic or an early treatment. Numerous reports of HCQ’s efficacy on thousands of patients continue to mount. Once the media labelled it “Trump’s drug,” the fix was in. The long-awaited randomized clinical trial showing no benefit was gleefully reported by the media. However, the media were silent when the study was found to be so corrupt that it had to be retracted. Detroit’s Henry Ford Hospital’s large 3-month observational study that showed a significant reduction in mortality in hospitalized patients with HCQ and validated HCQ’s over 60-year record of safety garnered little media attention.

These (purposefully) chaotic times are an opportunity for a movement toward government control and the suppression of individuality. Lockdowns keep us apart and stifle the free exchange of ideas and social communion. As Eric Hoffer explained in True Believer, a mass movement deliberately makes the present “mean and miserable. . . . People whose lives are barren and insecure seem to show a greater willingness to obey than people who are self-sufficient and self-confident.” Becoming a psychological cripple is not an option.

Is this chaos a new form of plastic surgery? When the bandages (masks) are removed will you be a changed person?

COVID-19, Culture & Society, Featured, Media & Press, Medical Ethics, Medicine, Op-eds, Politics, What's New

COVID-19 and the Universal Health Scare

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Politicians are a strange lot. Not content with merely being Speaker of the House, Nancy Pelosi is moonlighting as Surgeon General, opining on what medications the President should be taking. Service to the public is a distant memory. The new charge is to invent catchy phrases, like the “new normal,” to quietly coax us into obeying dictates, while ignoring facts and science.

It is not normal to base lifting the lockdowns on the trend in positive novel coronavirus (aka SARS-CoV-2) tests. Predictably, positive tests (with many folks never becoming symptomatic) will continue to increase as more tests are done. Given that the stated goal of lockdowns was to lessen the strain on hospital resources, using hospitalization trends makes more sense.

It is not normal for New York and Minnesota governors to insist that COVID-19 patients be admitted to nursing homes, even after it became clear that nursing homes were a hotspot for infections and up to 81% of COVID-19 deaths.

It is not normal for healthy people to walk around wearing masks—particularly when it is not recommended by the sainted World Health Organization.

It is not normal to never see your parents, children, or grandparents. Older folks suffer from loneliness in the best of times.

It is not normal for children to stay home from school indefinitely. When children do go back to school, it is not normal to tell them they have to wear masks and might not be able to play or eat with one another. Meanwhile, the CDC’s latest report tells us that the infection fatality rate for those aged 0-49 years is 0.05%. The CDC’s latest numbers are what Stanford researchers predicted in April.

It is not normal to have cellphone apps that track your movements. I suppose helicopter parents and stalkers would make good use of them.

It is not normal to propose “immunity passes” enabling the holders to move about society unimpeded. Immunity passes make no scientific sense given that the serology tests are unreliable, the length of immunity to SARS-CoV-2 is unknown, and invites social stigmatization.

The real “new normal” is politicians being blatant with their old games. It is normal for California’s Governor Newsom to make a secret $1 billion deal with BYD, a Chinese-based electric bus maker, to manufacture N95 masks at $3.30 a piece. Kudos to his fellow Democrat legislators for seeking transparency about his pandemic spending spree. To his credit, Los Angeles Mayor Eric Garcetti purchased 24 million “Made in America” masks from Honeywell at 79 cents a mask.

COVID-19 is a handy justification for Congress to promote a political ideology rather than propose targeted measures to assist those struggling with the consequences of the virus. The HEROES Act, the fourth stimulus bill, presents a path to universal basic income by paying some workers more to stay home than they would receive by returning to work. The CARES Act suspended student loan payments, but the HEROES Act paves the way for free college tuition for all by forgiving up to $10,000 of student loans for every borrower.

Moreover, the HEROES Act contains a multitude of other agenda-driven programs like access to financial services and the marketplace for minority-owned cannabis-related businesses, diversity in banking, a Post Office bail-out, $50 million to the Environmental Protection Agency for environmental justice grants, economic impact payments to illegal immigrants, permanent voting by mail, and the clearly relevant requirement that the President inform Congress of the reasons for not filling a vacancy for an Inspector General position.

The proposed Medicare Crisis Program Act of 2020 would provide health insurance for those who lost their health insurance due to the COVID-19 lockdown and its consequences. We want to help those who lost their jobs, but why use a newly-minted premium-free Medicare program as the vehicle? Is it to get people accustomed to Medicare covering all age groups?

The CONTACT initiative requires the CDC to work with states to implement a national system for testing, contact tracing, surveillance, containment and mitigation of COVID-19. (Have we done this for the infectious and deadly flu?). The CDC regulations, instruct authorities to use the “least restrictive means” in implementing public health measures. However, “when an individual is identified as a threat to the health and welfare of others, such as refusing medical treatment at a healthcare facility and refusing to self-quarantine, the government may take the individual into custody.”

The government has been known to abuse its power—whether through cultivating fear, regulatory force, or by individual miscreants. Frederick Douglass warned, “Find out just what any people will quietly submit to and you have the exact measure of the injustice and wrong which will be imposed on them.” We cannot let a declaration of a public health emergency become the new gauge of what it takes to break our spirit of liberty.

COVID-19, Culture & Society, Current Events, Medicine, Op-eds, What's New

Hoarding Toilet Paper is Not the New Normal

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By Marilyn M. Singleton, MD, JD

During my last visit to the grocery store, after directing me to the hermetically sealed conveyor belt, the clerk grinning proudly said, “welcome to the new normal.” No, thank you. These ad hoc restrictions on our liberties are not normal—at least in the United States of America.

In the name of public health, prisoners have been released from jail, physicians are being restricted in what drugs they can use to treat their COVID-19 patients, and cancer patients are having their treatments delayed as “elective.”

Every day 7,400 people die in the United States from many causes, including infectious diseases, but running totals are not broadcast on every medium. The unceasing barrage of news programs about the coronavirus/COVID-19 have become a means to whip us into submission.

The mayor of Los Angeles is perversely proud that 99 percent of “non-essential” businesses are closed and threatens to sue those who have not closed. A local town has issued 129 citations at $1,000 a pop for non-compliance. Riverside county plans to cite residents witnessed to have their faces uncovered.

Obamacare’s architect, Dr. Ezekiel Emmanuel, has suggested that the country stay on lockdown for one and a half years, or “until we find a vaccine or effective medications.” This is lunacy.

According to a Kaiser Family Foundation poll, 40 percent of women, 37 percent of men and nearly half of parents with a child younger than 18 years old report they have either lost their job, income, or had their hours reduced without pay. A classic 1979 study found that for every 10 percent increase in the unemployment rate, mortality increased by 1.2 percent, cardiovascular disease by 1.7 percent, cirrhosis of the liver by 1.3 percent, suicides by 1.7 percent, arrests by 4 percent, and reported assaults by 0.8 percent. Pre-pandemic, nearly 20 people per minute were physically abused by an intimate partner in the United States. Predictably, episodes of domestic violence and child abuse have now increased. Closed businesses have become easy targets for thieves.

There is a rational course of action without shutting down human contact and the economy. Sweden has no more deaths or symptomatic infections per capita than many other countries despite choosing to merely encourage its citizens to physically distance as much as possible.

We must allow physicians to treat their patients as they see fit with effective drugs. Multiple physicians around the world are reporting success with hydroxychloroquine: a new off-label use for this FDA-approved drug for a new virus. If this virus is akin to Armageddon, then all reasonable ideas should be welcomed. The erection of barriers to the use of this potentially life-saving drug by many governors and state medical boards is appalling and unforgiveable. Hydroxychloroquine was approved for medical use in the United States more than 60 years ago. It has been safely used for years for malaria prophylaxis, autoimmune disease, and porphyria, a blood disease affecting hemoglobin (that carries oxygen to our tissues). Hydroxychloroquine is on the World Health Organization’s List of Essential Medicines, the “most effective and safe” to meet the most important needs of a health system. Widespread use of this inexpensive drug could obviate the need for ICU beds and ventilators.

In addition to early treatment, we must have a rational policy for getting people back to work. All states are not affected equally. Let’s test every working person for antibodies to the SARS-CoV-2 virus that causes COVID-19. We may find that many have had an asymptomatic infection. These immune individuals will not pass the disease to others. At-risk individuals can choose to stay at home.

Ending the lockdown is not about Wall Street or disregard for people’s lives; it about saving lives. Advanced stages of non-COVID diseases, suicides, domestic violence, increase in substance abuse and mental health disorders, permanent poverty, and dissolution of the middle class are unacceptable. Our society must not be fractured into those who live in gated communities and those who live in the streets, trailer parks, and decaying homes that they can no longer afford to keep up.

We all want to do our part to attenuate the number of serious COVID infections in our communities. But we cannot hand our lives over to the government, particularly when the virus has become an opportunity for Congress to pass pork-filled legislation, for showboating governors to out-quarantine each other, and for politically connected tech companies to share cell phone tracking data with the government. I would hate to think some have a financial incentive for promoting a yet-to-be tested and approved vaccine in lieu of an effective, inexpensive and readily available treatment.

People are saying America will never be the same. Hopefully, this will not mean the statists have succeeded in using COVID as an excuse to enact laws that will permanently curtail our liberties and freedom to practice medicine in the best interest of our patients.

Bio: Dr. Singleton is a board-certified anesthesiologist. She is Immediate Past President of the Association of American Physicians and Surgeons (AAPS). She graduated from Stanford and earned her MD at UCSF Medical School.  Dr. Singleton completed 2 years of Surgery residency at UCSF, then her Anesthesia residency at Harvard’s Beth Israel Hospital. While still working in the operating room, she attended UC Berkeley Law School, focusing on constitutional law and administrative law.  She interned at the National Health Law Project and practiced insurance and health law. She teaches classes in the recognition of elder abuse and constitutional law for non-lawyers.

COVID-19, Current Events, Featured, Medicine, Op-eds, What's New

Will the FDA Find Courage in the Age of COVID-19?

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By Marilyn M. Singleton, MD, JD

While on lockdown to save our neighbors from a lonely death from the disease called CoViD-19, many of us have turned to movies. I beg you not to rent Pandemic, Contagion, or 28 Days Later. Try Harriet instead. Harriet Tubman was the epitome of bravery and courage in the face of insurmountable odds. Her escape from slavery and returning again and again into the belly of the beast to save others should inspire us all. The health professionals working day and night to care for an ever increasing number of sick patients make me proud to be a doctor. And kudos to the grocery store workers, postal workers, police and many others who are performing essential jobs with a smile.

This is the time for positive action, not panic. For background, coronaviruses are a big family of RNA viruses named for the crown-like spikes found on their surface. They exist around the world cause mostly upper respiratory tract infections (“common colds”) in adults. This new coronavirus is in the same family as the Severe Acute Respiratory Syndrome coronavirus (SARS-CoV) identified in humans in 2002 and Middle East Respiratory Syndrome coronavirus (MERS-CoV) identified in 2012. The CoViD-19 virus is called SARS-CoV-2 for its similarity to SARS-CoV.

While scientists are furiously experimenting with possible vaccines, the virus is sprinting from country to country despite travel restrictions. There are likely among us “healthy carriers” of the virus who have no signs or symptoms of the disease but can infect others. So if CoViD-19 is here for a while, the world has to look to effective treatments of afflicted individuals today—not a year from now. Some researchers seem to have found a strong contender.  

Separate studies from a major medical center in France and jointly from South Korea and China have found that inexpensive, readily available anti-malarial drugs chloroquine phosphate or hydroxychloroquine are an effective treatment. But the Federal Drug Administration (FDA) is dragging its feet, despite the President’s urgings, to approve the drug for anti-viral use. Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and the White House’s advisor has dismissively called the studies “anecdotal” meaning “based on or consisting of reports or observations of usually unscientific observers.”

In 2004, separately a Belgian virologist and our Centers for Disease Control and Prevention found that chloroquine inhibited SARS-CoV growth in primate cells when given before or after exposure to the virus. Human trials could not be done because thankfully the SARS epidemic had just ended. Fast forward to February 2019. In South Korea, these drugs were given by physicians and scientists in the CoViD-19 Central Clinical Task Force. These studies showed “certain curative effect” with “fairly good efficacy.” Further, patients treated with chloroquine demonstrated a better drop in fever, improvement of lung CT scan images, and required a shorter time to recover compared to parallel groups.

More promising is a study of 36 patients actively ill from CoViD-19 by a noted research team from France. Of the 20 patients treated with hydroxychloroquine alone, 70 percent had no detectable virus within 6 days; those treated with hydroxychloroquine and azithromycin (an antibiotic with some anti-viral action) had a 100 percent success rate. Yes, the study is small, but these are extraordinary times.

On March 22, Gov. Cuomo announced that the FDA is allowing New York state to start a trial of hydroxychloroquine and azithromycin. Let’s move on this!

Chloroquine and hydroxychloroquine are approved by the FDA for malaria, rheumatoid arthritis, and systemic lupus erythematosus. The FDA is well aware that physicians prescribe plenty of drugs that are “off label,” that is drugs approved by the FDA for other conditions. Indeed, one fifth of all prescriptions are off label. For example, aspirin was approved for pain relief, but had many years of off-label success for the prevention of heart attacks before the FDA finally approved the off-label use.

Mike Tyson said “we all have a plan until we are punched in the face.” FDA’s “plan” is to regulate products and promote safe and effective drugs. This is the FDA’s moment to bravely keep us safe by shifting gears and deregulating a valuable product. Pharmacists must be allowed to fill such prescriptions. Let doctors do what they do best: use their independent judgment. Let physicians consult with their patients and let them choose to take the off-label medicine, or approved anti-viral medicines that have failed against CoViD-19 in studies—or no treatment at all.

While people are struggling to pay for their next meal, we need bold action now. For 6 billion dollars all Americans could be treated—saving hundreds of billions of dollars in lost income and retirement savings.

Bayer began with donating 3 million tablets to our government. More companies are stepping up. Novartis has pledged a global donation of up to 130 million hydroxychloroquine tablets, pending regulatory approvals for COVID-19. Mylan is increasing production in West Virginia to make 50 million tablets. Teva is donating 6 million tablets to hospitals around the U.S. For context, each patient’s treatment would use up to14 tablets.

Do your job, FDA and protect the public. Approve hydroxychloroquine now for COVID-19. Meanwhile, physicians may legally prescribe these drugs because they are approved for other indications.

Bio: Dr. Singleton is a board-certified anesthesiologist. She is Immediate Past President of the Association of American Physicians and Surgeons (AAPS). She graduated from Stanford and earned her MD at UCSF Medical School.  Dr. Singleton completed 2 years of Surgery residency at UCSF, then her Anesthesia residency at Harvard’s Beth Israel Hospital. While still working in the operating room, she attended UC Berkeley Law School, focusing on constitutional law and administrative law.  She interned at the National Health Law Project and practiced insurance and health law. She teaches classes in the recognition of elder abuse and constitutional law for non-lawyers. 

COVID-19, Current Events, Featured, Medicine, Op-eds, Politics, What's New

What is Worse: Going Viral or Verbal Quarantine?

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As the death toll and cases of 2019- nCoV (aka novel coronavirus) infection rises, our curiosity increases as to the epidemic’s when, why, where, and how. Is the new virus naturally occurring, animal to human transmission, a bioweapon? “Official stories” aside, the world wide information highway is our best available tool to look for answers. The truth will eventually be revealed. As of the first week in February, folks are being quarantined as some 4,000 cases a day are diagnosed. And the physician who warned officials early on was verbally quarantined as a rumor monger, now has died of the disease.

Censorship has consequences not only for public safety but for shrinking the marketplace of ideas. Thus, with all the issues about which to educate ourselves, we should all be outraged at Elizabeth Warren’s proposal to censor “disinformation” on social media. Now her plan to “create civil and criminal penalties for knowingly disseminating false information” is limited to influencing elections. But once acquiesced to, censorship tends to metastasize to other areas. The paternalistic powers that be, worried that the unwashed masses will not be able to discern conspiracy theories from alternate positions, will determine your opinion for you.

Social media, while ubiquitous and public, are private speech. For years, social media platforms have “moderated” content using opaque algorithms that are finally coming to light. While safeguards were designed to eliminate dangerous or abusive content, certain viewpoints are more likely to be censored by Twitter and Facebook than others, perverting the marketplace of ideas.

Censorship has now infiltrated our routine social interactions under the guise of offensiveness. There was a time when the seven words you cannot say on television were blatant profanities. Now it’s like whack a mole trying to keep up with what we are allowed to say not only online but in polite mixed company. California tried to pass a law where someone using “he” instead of “she” could face a $1,000 fine and up to a year in jail. It’s gotten to the place where animal lovers are offended if we call our dogs “pets” rather than our companions.

Most importantly, political opinions should go viral, not be quarantined. Many folks with opinions differing from those of the tribal chieftains find themselves whispering in dark corners like drug dealers. Actually, drug dealers in San Francisco have it better: they can sell drugs openly on the street without recourse. The LGBT tribe attempted to quarantine gay conservatives who did not fit the mold by cancelling scheduled #WalkAway town hall venues citing #WalkAway as a hate group. The hate? Encouraging LGBT folks to leave the Democrat party. Undeterred, they move the town halls to the streets. Scott Presler, a conservative gay man who is cleaning up inner cities across America, concludes that “what the left fears most is other people seeing that we exist.”

We have presidential candidates with disparate views from socialism to freedom from government regulations. We want Bernie Sanders to explain why public ownership of utilities, banks and major industries is something that would improve our lives in the long term and how that is consistent with our Constitution. Or Pete Buttigieg to defend abolishing the electoral college. What we don’t want is the power brokers quarantining those who do not bow to their orthodoxy. Why is it that CNN excluded Rep. Tulsi Gabbard (who is known for not being influenced by special interest groups) from its town halls despite her having higher poll numbers than participants Andrew Yang and Deval Patrick? Why did the Democratic National Committee change the debate rules for Michael Bloomberg but not for Julian Castro or Cory Booker?

When it comes to medical care, physicians want to be free to discuss all sides of any issue with patients. If a physician believes mutilating young children at the altar of transgenderism is wrong, she should be free to say so. If a physician wants to discuss the pros and cons of vaccination with his patients, his license should not be at risk.

If some physicians believe that single payer health care is wrong for the country’s medical care, we want a discussion—not to be labelled a heartless, cruel ignoramus. If we do not want medical decisions to be made by bureaucrats, do not want rationing, and do not want decreased medical innovation, we want the chance to present the facts. While rank partisanship keeps legislation that promotes personalized medical care from being brought to the House floor, Walmart and CVS are opening clinics staffed by nurse practitioners. We cannot let patients’ only options be big corporations or big government.

As Frederick Douglass said, “power concedes nothing without a demand…The limits of tyrants are proscribed by the endurance of those whom they suppress.” We cannot cede our personal power to the government. Surely the government has its Constitutional duties, but just like with containing the 2019-nCoV virus, we still must wash our own hands and cough into our own elbows.

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