by Michael Hiltzik
Doctors and hospital administrators are facing yet another way in which the pandemic has shaken up social and medical norms: a string of lawsuits in which judges have ordered them to treat patients with ivermectin, a drug that lacks any scientific evidence of effectiveness.
In at least a half-dozen cases around the country, local judges have overruled hospitals or doctors who refused to administer the drug to patients with advanced COVID-19 disease. And more are in the works.
Ralph Lorigo, the Buffalo, N.Y., lawyer who has brought almost all these cases, said he has nearly 40 lawsuits in the works.
But legal experts and bioethicists say that judges who order treatments with unproven and unapproved drugs are overstepping the law and responsible judicial authority.
“The question is whether the intervention being sought is within the standard of care, or rejected by the consensus of the medical profession,” said New York University bioethicist Arthur Caplan. “Nobody of any standing anywhere seems to believe it ought to be used as a COVID therapy. It’s pretty hard for a judge to tell a doctor to use it.”
But that’s happening.
Caplan is right about medical opinion on ivermectin as a COVID treatment. The drug was developed as an anti-parasite treatment, commonly used in a veterinary formulation to de-worm livestock and household pets, and to treat parasitic infections generally found in tropical regions. No valid scientific studies support its efficacy against COVID.
The Centers for Disease Control and Prevention, the Food and Drug Administration and the American Medical Association and other professional bodies all advise against it.
Even its leading U.S. manufacturer, Merck, says there is “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.”
But its cause has been taken up by anti-vaccine activists and conspiracy mongers who maintain the drug industry and medical establishment have deliberately suppressed information about its efficacy.
A vocal ivermectin lobby has promoted the drug as a magic bullet against COVID, turning it into something of a political darling; radio host Joe Rogan recently claimed that ivermectin helped him defeat a case of COVID, though he listed several other nostrums as part of his therapy.
In his lawsuits and in a recent interview, Lorigo has repeated many of the ivermectin lobby’s talking points. He asserts the pharmaceutical industry hasn’t conducted large-scale trials of ivermectin to establish its efficacy against COVID because as an old drug it can’t match the profits promised by COVID vaccines.
Lorigo contends that the National Institutes of Health has taken a “neutral” position on ivermectin, a point often made by ivermectin advocates. But that’s a simplistic interpretation of the NIH findings, which on balance are highly skeptical of the medication’s effect on COVID.
The NIH notes that doses of ivermectin necessary to replicate antiviral effects found in the lab would be as much as 100 times higher than doses approved for humans. Most studies reporting possible positive results, NIH says, have “significant methodological limitations.”
Among the flaws: They were too small; they were open-label trials, meaning that the researchers and participants knew what they were testing; patients received other drugs, making it impossible to distinguish any ivermectin effect; or they cited irrelevant clinical results. Others have found indications of fraud in some highly publicized studies promoting ivermectin.
The ivermectin lawsuits share some features with the “right-to-try” movement, which reached its climax in 2018 with the passage of several state laws and a federal law purporting to give desperately ill patients a crack at treatments that hadn’t passed full review by the FDA.
As we reported at the time, however, right-to-try was never really about giving desperate patients a last chance; it was an effort financed by the Koch brothers to undermine the authority of the FDA as a regulatory agency. This was made clear by the federal law’s main sponsor, Sen. Ron Johnson (R-Wis.), after it was signed by President Trump.
Indeed, for all the brouhaha, right-to-try laws appear to have been a bust. It isn’t known how many patients have sought and received drugs under right-to-try, but only two cases have been documented in the years since the federal law’s passage.
Although it’s not unheard of for judges to issue orders in cases involving disputes over medical care, those generally involve disagreements over the application of accepted medical treatments. In a typical case, a judge will order a treatment to be continued or its withdrawal blocked until medical authorities and patients’ families resolve their differences.
Judges in the ivermectin lawsuits have been taking the opposite approach by ordering the administration of an unproven treatment — an “unprecedented step,” in the view of James M. Beck, a Philadelphia product liability lawyer. Federal judges have consistently held that patients have no “fundamental right to use any drug, regardless of its legality.”
That brings us back to Lorigo and his lawsuits.
In one sense, said University of Wisconsin bioethicist R. Alta Charo, judges’ orders at least insulate hospitals and doctors from the consequences of what might be considered malpractice — the prescribing of a drug without established evidence of safety or efficacy for the purpose.
“No reputable place is going to prescribe this stuff when they’ve been told directly by the FDA not to do it,” Charo said. “But at least they’re insulated from liability for medical malpractice because the court ordered them to commit medical malpractice.”
What may be most dispiriting about judges trying to force doctors and hospitals into administering an unproven and probably useless medication for COVID-19 is how it plays into an alarming anti-science theme in American discourse.
Michael Hiltzik is a columnist for the Los Angeles Times.
