The Ivermectin battle rages on. The consensus of scientific and public health opinion is not only that the drug doesn’t work but that it could be dangerous in COVID care. The placebo effect, small sample sizes, improper or absent controls are cited as demeaning the value of studies showing positive results. On the other hand, a coterie of activist proponents aggressively champion its use, both prophylactically and as last-resort care. Case-series and individual miracle results are touted as proof-positive of the drug’s effectiveness.
The pros and cons of Ivermectin for COVID use have been discussed at length elsewhere. That’s not what this piece is about. Presented here is a question similar to one I’ve raised before: until we have clear scientific answers – who decides what course of conduct society follows? This week we turn to hospital care and medical practice and legal actions liable to upend the practice of medicine in America.
A new – and unwelcome-- development for hospitals and doctors
Families are now demanding hospitals prescribe ivermectin for their relatives dying from COVID-19. Most hospitals won’t provide the drug, don’t stock it, and don’t affiliate doctors who approve its use for COVID. Those demanding the drug, interestingly, including many who are against government intervention in the form of mask and vaccine mandates, are now lassoing the legal system and turning to the courts (also a government branch) for assistance. (Whatever works, I guess.).
At least nine cases have been filed, and seven courts have rendered decisions favoring the plaintiffs ( the patient’s families). In one case, physicians were also named as defendants.
It appears these judges are deciding with their hearts – not their minds or according to our legal standards, not comprehending why doctors won’t administer potentially dangerous drugs -- when the judge sees them as the patient’s last chance. To be sure, legal scholars question the patients’ right even to bring such an action. One bioethicist even called the decisions unethical [1].
According to the Daubert case, which governs scientific evidence, ivermectin use doesn’t rise to the standard of a scientifically valid treatment – for now. Yet, even the disavowal of its use by Merck (the manufacturer) hasn’t swayed these courts. Their analysis identified:
- No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies;
- No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and;
- A concerning lack of safety data in the majority of studies.
We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.
Nor does fear of malpractice suits for unwarranted off-label drug prescription seem to excite the judiciary. Neither did the hospitals’ insistence on allowing only credentialled staff to prescribe or treat patients sway two NY courts. In one recent case, hospital lawyers invoked a recent Ohio law, called the conscience clause, giving health care providers the “freedom to decline” any service that violates their conscience, which may have made a difference.
The most recent case may signal a turn-around
Last month, Julie Smith, the wife of Jeffery Smith, a hitherto healthy 51-year old, sought court intervention to compel West Chester Hospital to administer ivermectin to her husband. She lost. On September 6, Ohio’s Judge Michael Oster reversed an earlier temporary injunction in the same case that directed the prescription.
What changed? On what basis was the demand denied?
In July, Jeffrey had been admitted to West Chester Hospital for COVID-19 and almost immediately was admitted to ICU. On August 1, he was sedated and placed on a ventilator, where he apparently remains. Around August 19, Ms. Smith sought outside medical advice “… regarding her husband’s medical condition and using Ivermectin,” from Ivermectin-advocate Dr. Fred Wagshul. (For med-mal purists, it might be argued that Wagshul wasn’t even her husband’s doctor, but rather her medical advisor).
Ms. Smith contended that “Dr. Wagshul is one of the foremost [sic] experts on using Ivermectin in treating Covid-19…; he supports the use of Ivermectin to treat Jeffrey, and prescribed Ivermectin to him,” and he wouldn’t have prescribed it if he thought it would hurt her husband.
“Fred Wagshul told The Ohio Capital Journal it was akin to “genocide” not to use the drug in Covid-19 treatment, and the science behind its efficacy is “irrefutable.” He also said the FDA’s discouraging of its use among Covid patients was part of a larger conspiracy.”
Dr. Wagshul prescribed 30 mg. daily via ten 3 mg. tablets for three weeks. [2] The hospital refused to honor the prescription even though Ms. Smith agreed to release the hospital from liability, which sounds helpful but might be useless.[3] Instead, the hospital claimed that neither they nor their clinicians should be told how to practice medicine, i.e.., compelled to use unproven medications– by courts or by any others:
"At UC Health, we respect the expertise of our clinicians and appreciate the scientific rigor used to develop treatments, medications and other therapies. We do not believe that hospitals or clinicians should be ordered to administer medications and/or therapies, especially unproven medications and/or therapies, against medical advice.”
The legal saga began August 20 when Julie Smith filed a 215-page complaint seeking Emergency Medical Declaratory Judgment and Injunctive Relief, containing more than a dozen exhibits, deftly amalgamating medical literature and two court orders favoring plaintiffs. On August 23, in an ex parte (without the other side being present) hearing, Judge Greg Howard ordered that ivermectin be administered “as prescribed” pending a new hearing before Judge Michael Oster on September 2 and 3. After hearing both sides, Judge Oster overruled Judge Howard’s directive.
Judge Oster’s Opinion is important.
First Judge Oster noted that in the interim between his ruling and Judge Howard’s, the CDC, FDA, AMA, American Pharmacists Association, and the American Society of Health-System Pharmacists (ASHP) all issued statements against the use of the drug.
“Our legal system must stay firmly rooted in proper legal interpretation of the law, not what individual judges think the law should be. This Court is called upon to make its ruling irrespective of all sympathy, passion, or prejudice.”
In addition to Dr. Wagshul’s not being a credentialled physician at West Chester, Judge Oster noted the good doctor did not examine Mr. Smith; indeed, he did not even see him or discuss the case with Smith’s doctors. This did not stop Wagshul from prescribing ivermectin. Further, Wagshul testified that “I honestly don't know” if continued use of ivermectin ‘will benefit Jeff Smith.’ [4] (Reportedly, Dr. Wagshul is not board-certified in any specialty and has not worked in a hospital for ten years; likely, he wouldn’t have been credentialled to practice at West Chester even if he applied.)
Perhaps most significant is Judge Oster’s attention to public policy and deference to the rule of law, which applies beyond the confines of his 12-page decision. He also seems to poke the NY judges for deciding based on emotion- rather than conforming with the legal standards necessary to obtain an injunction. He ends his opinion with a paean to the independent practice of medicine:
“While this court is sympathetic to the Plaintiff and understands the idea of wanting to do anything to help her loved one, public policy should not and does not support allowing a physician to try “any” type of treatment on human beings. Rather, public policy supports the safe and effective development of medications and medical practices. … What is more, public policy, in this case, encompasses a number of broader issues, including a hospital's standard of care decisions, mandating doctors and nurses to provide care they believe unnecessary, ethical concerns of all doctors involved, patient autonomy, fiduciary duty, accreditation standards for patient protections, obligating one doctor to carry out the treatment regimen/plan of another doctor, interplay of RC. 4743.10, and whether a court should medicate or legislate from the bench.”
The Dangers of Mob-Medicine
Hospital credentialing of its staff protects the public. Allowing patients to bypass this requirement by selecting doctors, not on the hospital register who defer to the patient’s whims or medical choices defeats this objective. Letting people without training or experience decide for themselves matters that affect public health endangers everyone.
Relying on ivermectin, which may or may not work, at the expense of vaccines, which at least prevent severe disease – increases hospital COVID patients and takes up beds – causing unnecessary deaths. It also deflects the courts' attention by prompting legal cases -- that wouldn’t arise if patients were vaccinated.
Not surprisingly, perhaps, Julie Smith extols the virtues of as-yet experimental use of ivermectin, but “…. she and her husband were not vaccinated and chose not to be because “it was an experimental vaccine and we did not feel confident about it.”
More cases will surely follow. These are matters decided based on state law, and we can expect to see significant variation in judicial decisions and hence great variations in the accepted standards of the practice of medicine. Not a good thing for anyone.
(1) Reportedly, Professor Arthur Caplan suggested hospitals disregard the court decisions. Tempting, perhaps, but not wise. In addition to risking a contempt order, civil fines, and criminal penalties (including jail time), failure to comply with a judicial order, even one ill-advised, is the beginning of anarchy. The proper and prudent response is an appeal.
[2] A patient sedated on a ventilator cannot swallow, so tablets would have to be crushed and administered through a separate tube.
[3] Clever plaintiffs’ lawyers likely could side-step such waivers made in the state of desperation and psychological extremis.
[4] This practice is not unusual in COVID para-therapeutics, and most of the doctors in the nine lawsuits followed the same non-examination practice. Dr. Zalenko, too, prescribed hydroxychloroquine without examining patients. New telemedicine rules in Ohio impose strictures on prescribing medications when the physician has not examined the patient.
