Years ago, as a medical student, I volunteered for select medical experiments. These included vaccine trials for hepatitis B. and meningococcus. I even participated in a vaccine trial for “turista”, traveler’s diarrhea. For the capstone of that trial, I spent the weekend in a clinical research facility and swallowed a solution containing E. coli, the causative agent of turista. I fared well. As the walls were paper thin, I heard the test subject in the adjacent room. She was not as lucky. She spent all weekend in the bathroom. She was likely part of the control group.
Volunteers were paid but mostly they participated to be the lucky pioneers protected from these illnesses. As someone considering the practice of surgery, a needle stick by a patient with hepatitis B could end my career or even my life. While any clinical trial poses a risk, we participated for the perceived benefits.
Today, we have a new enemy, the coronavirus which causes the COVID-19 illness.
Our brothers and sisters providing healthcare around the world are working tirelessly to deliver care, preparing for the worst, and staying true to the Hippocratic oath. Those in non-clinical fields are researching paths to treatment and prevention. Everyone has a role to play.
The broader public has been asked to wash our hands and avoid close contact. There aren’t enough gloves, masks, and gowns to go around. Those delivering care need them — they are in the front lines.
Lockdown brought our economy to a screaming halt. When lives are at stake, we all want to help. If it’s for a reasonable period of time, it’s a small sacrifice.
Coronavirus is a tough opponent. It spreads easily and aggressively. Can we really enforce a functional quarantine for months? Can our parents and grandparents endure the isolation? How about those with less than optimal baseline health?
As a population, can we do more?
Yes. In reference to Drs. Colyer and Hinthorn’s thoughtful March 22 Wall Street Journal Commentary, These Drugs Are Helping Our Coronavirus Patients, we should embark on the largest clinical trial ever.
But first, some background.
For decades, public health officials distributed a medication named chloroquine to prevent and treat malaria. As the organism causing malaria became resistant, new compounds replaced chloroquine. A close cousin to chloroquine, hydroxychloroquine, is used today to treat conditions such as lupus and rheumatoid arthritis. Some astute scientist must have observed that lupus patients being treated for malaria received benefit against both
Over the past few weeks, several randomized controlled trials were conducted to test the effect of chloroquine in treating COVID-19. Therapeutic effects were observed in fever reduction, improvements on chest imaging studies and impeding disease progression. Chloroquine was declared useful medical agent for COVID-19 in the sixth edition of the New Coronavirus Pneumonia Diagnosis and Treatment Plan, released by the National Health and Care Commission of China on February 19th.
On March 17th, the AIFA Scientific Technical Commission of the Italian Medicines Agency expressed a favorable opinion to include the off-label use of chloroquine and hydroxychloroquine for treating COVID-19.
When options are few, life and death decisions must be made with the evidence at hand. That’s how it always works in the emergency department, the surgical suite, and the battlefield.
Researchers recently identified how chloroquine and hydroxychloroquine likely prevent the virus from entering the cell. They explained how the virus is more effectively eliminated when it does breach a cell. Hydroxychloroquine also has a known mechanism of action preventing “cytokine storm”, the body’s extreme overreaction to a virus which causes secondary damage as it tries to fight the infection. The science accumulated to date is more than an empiric anecdotal observation.
Many ER physicians, intensive care doctors, and pulmonologists have already stocked reasonable quantities of hydroxychloroquine for themselves. The existing data are enough for them– even if the FDA wouldn’t have agreed in more normal times. As this is a fast-moving target, FDA granted chloroquine and hydroxychloroquine emergency use authorization on March 29th.
Some doctors are not waiting. Dr. Vladimir Zelenko is a board-certified family practice physician who serves the Hasidic Jewish community in Orange County, New York. He estimates 60% of this community has been infected with coronavirus. He has been treating hundreds of patients with hydroxychloroquine and over-the-counter zinc supplements. Not one of his patients has needed to be hospitalized. His recommendation was to prescribe hydroxychloroquine to medium and high-risk patients in the earliest phase of suggested infection. Do not wait. And he continued, consider prophylactic treatment in high-risk patients.
Chloroquine and hydroxychloroquine have both been on the market for many years. We understand their safety profile. They are cheap and increasingly available. The companies that manufacture and distribute these compounds are ramping up quickly. It’s much easier than ramping up ventilator production (which should still be done). Furthermore, once a pill is made, it just needs to be distributed. Once a ventilator is made, it needs to be distributed and used by trained personnel. There are a finite number of people who can intubate patients, oversee, and manage ventilators. Once a COVID-19 patient requires a ventilator, the mortality rate goes up. We should be doing all we can to prevent patienst from ever deteriorating so much to need a ventilator.
The modest proposal.
Instead of just treating the sickest patients with chloroquine or hydroxychloroquine, let’s use these medications to prevent its spread and mitigate illness for those who are exposed. We used them to prevent and treat malaria. Let’s do the same for COVID-19. And then let’s study the results.
Sure, there should be reasonable restrictions, because there are risks. We can exclude people with medical problems made worse by the drugs – such as those with abnormal heart rhythms, certain eye diseases, liver, or kidney problems. Not everyone is a candidate for chloroquine or hydroxychloroquine. We can start with front line providers and those in the geographic hot zones – New York, San Francisco, New Orleans, Detroit and Seattle. Participation is this giant clinical trial would be entirely elective. Everyone has a different risk profile. Some are early adopters. Others are fast followers. Some will never participate. The more people who participate, the sooner we will know if the medications work to prevent and/or treat COVID-19.
We know that early use of antivirals can make a profound difference in limiting spread of influenza. In a JAMA article now almost 20 years old, post-exposure prophylaxis with oseltamivir (Tamiflu) protected close contacts of influenza-infected persons against influenza illness, prevented outbreaks within households, and was well tolerated. Also, viral shedding was inhibited in contacts taking oseltamivir, with 84% protective efficacy.
How long should seemingly healthy patients take this prophylactic medication? What about dose and frequency? Those designing the trial will make the call.
Importantly, we will need to ensure an adequate supply of hydroxychloroquine remains available for those who depend on it to treat lupus and arthritis. We cannot forget about these patients. Many have no alternative safe or effective treatment.
I can see the naysayers wringing their hands cautioning we first need to wait for more data. We should test versus placebo. And the early reports are not large clinical trials.
We don’t have the luxury of time.
In addition, several medical licensing boards have warned physicians not to prescribe these medications to themselves or their families. The warning was based on near-term shortages affecting patients who depend upon hydroxychloroquine for treating lupus and rheumatoid arthritis. That’s a reasonable concern. And it’s a solvable problem. But some licensing boards went further. They argued it was unethical for physicians to pre-emptively prescribe such unproven medications for themselves or their families. That is unfair. Doctors are in the front-line treating patients with suspected coronavirus. You don’t send a SWAT team into a dangerous environment without Kevlar. If doctors believe such medications will protect, that’s enough for me. Perfectly ethical.
Let’s acknowledge the risk to broadly disseminating these medications. For many, these risks are counterbalanced by waiting and living in fear. Most Americans are clamoring to do more. It doesn’t feel right limiting ourselves to handwashing and isolation. Let’s embark on the largest clinical trial ever. As Todd Beamer reportedly commanded on United Flight 93, “Let’s roll.”
 My take, distributing the medication to as many people as possible may actually take advantage of the placebo effect. Sitting around waiting for badness to happen squeezes the adrenal glands. That can’t help. The better study would compare medication versus placebo versus nothing.
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Jeffrey Segal, MD, JD
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Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.
Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.
Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.
In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.
Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.