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Judge’s order on refuted COVID-19 treatment raises old questions about medical authority

The anti-parasite medicine is being studied, but results are not promising, health officials say

An Ohio judge has ordered a hospital to administer the anti-parasite drug ivermectin to a patient who is in dire condition due to COVID-19.

The patient, Jeffrey Smith, 51, has been in intensive care for several weeks, his condition worsening. When doctors said they were running out of treatment options, his wife, Julie Smith, began researching online and found references to ivermectin as a potential treatment. She got a prescription from Dr. Fred Wagshul, a founder of the Front Line COVID-19 Critical Care Alliance, which lauds ivermectin against COVID-19. But the hospital and its doctors refused to give him the drug, so she appealed to the courts.

“My husband is on death’s doorstep,” Julie Smith wrote in court documents. “He has no other options.”

The Butler County Common Pleas Court judge, Gregory Howard, ordered the hospital to provide 30 mg of ivermectin daily for three weeks.

The ruling has attracted a lot of attention because the drug’s value against COVID-19 has been largely dismissed within the medical community, and its manufacturer, Merck, recommends against it. The Food and Drug Administration and the Centers for Disease Control and Prevention have both said the drug has not been proven effective as a prevention or treatment for COVID-19. Those statements have done little to prevent people from trying it. Some are using a veterinary version designed to rid horses and cows of parasites with doses deemed far too high for humans.

The judge’s order highlights a history of sometimes tense interaction between patients and their families, the medical community and the courts.

Doctors, hospitals and parents sometimes clash over the course of treatment for children with life-threatening illnesses, requiring the courts to decide. Courts often hear cases involving mental health and whether an evaluation and treatment should be ordered for someone who doesn't want it or isn’t able to get it. Hospitals and families sometimes disagree on terminating life support.

But even Smith’s attorney, Ralph Lorigo, called it very unusual for a judge to order a specific medicine to be given to a patient, according to the Buffalo News.

The Ohio Capital Journal reported that Lorigo has successfully filed a similar case against one hospital in Chicago and two in Buffalo, New York.

The pandemic has put some patients in dire medical crisis, said Lorigo.

Their families are desperate for anything that could help.

Ivermectin branches out

“Ivermectin was introduced as a veterinary drug in the late 1970s, and the discovery of its effectiveness in combating certain parasitic diseases in humans won the 2015 Nobel Prize for medicine,” The New York Times reported,

Prescribing ivermectin against COVID-19 is an “off-label” use that, while not recommended, is not illegal, as the drug has been approved by the FDA.

The version intended for human use is typically prescribed for intestinal nematode parasites like roundworm or topically for lice. Ivermectin’s manufacturer, Merck, has actively discouraged the drug’s use for COVID-19.

The pharmaceutical giant issued a statement earlier this year that said while scientists continue to study ivermectin, “no scientific basis” has been found for therapeutic use or in preventing COVID-19. Merck said there’s “no meaningful evidence” that it works against the virus and there’s “a concerning lack of safety data” in the early studies that did find some value. Those studies circulated widely online.

The journal Nature noted that the preprint study from Egypt on which much of the excitement around ivermectin against COVID-19 was based was withdrawn over “ethical concerns.”

Those concerns, Nature reported, included “dozens of patient records that seemed to be duplicates, inconsistencies between the raw data and the information in the paper, patients whose records indicate they died before the study’s start date, and numbers that seemed to be too consistent to have occurred by chance.”

For ivermectin, every viewpoint on its effectiveness against the virus has a backer. A research review from Newcastle University in the United Kingdom found ivermectin reduces death, even with that suspect data removed. A recent review of 14 ivermectin studies exceeding 1,600 participants concluded none showed evidence ivermectin can prevent COVID-19, make those patients healthier or reduce mortality. The largest study, the Together Trial with 1,300 patients, was stopped by the safety monitoring board early after no evidence was found it beat a placebo at keeping COVID-19 sufferers out of the hospital.

CNB News quoted the National Institutes of Health: “​​Seven studies on the drug have published results in the U.S. National Library of Medicine, but all of them have small sample sizes, incomplete information and significant methodological limitations.” The institute noted several ongoing clinical trials might change whether the drug could be prescribed for COVID-19 in the future.

The confusing data hasn’t tempered enthusiasm — or perhaps it’s desperation. The CDC said prescriptions of ivermectin soared to 88,000 the week of Aug. 6-13, compared to just a few thousand before the pandemic. CDC also reported that ivermectin-prompted calls to poison control centers rose 400%. Fox 13 reported a fivefold increase in calls to the Utah Poison Control Center about the drug. Center medical director Dr. Michael Moss speculated the interest came from the finding ivermectin stopped COVID-19 from spreading in lab cultures.

Yale University medical toxicologist Dr. Asim Tarabar, who teaches emergency medicine, told the Miami Herald people who are getting sick from off-use of the medicine might be “reluctant to pick up the phone,” creating an undercount.

Similar issues were raised with hydroxychloroquine and chloroquine early in the pandemic — and some used the antimalarial drug off-label for COVID-19, too. Nature published a meta-analysis of randomized trials from an international collaborative that said mortality increased for COVID-19 patients treated with hydroxychloroquine. Chloroquine had no apparent benefit.

Nonetheless, Sen. Rand Paul, R-Ky., said at a town hall last week that “hatred for Donald Trump” had made researchers biased against ivermectin. “I don’t know if it works, but I keep an open mind,” Paul said.

When medical options collide

Mental illness is often more clear-cut. In Arizona, a patient who doesn’t want to undergo mental health treatment can be forced to by the court if there’s “clear and compelling evidence” of need and the person would not voluntarily seek or accept it. Any adult who is concerned can ask the court system to consider the need for treatment and order an evaluation. Other states have similar laws regarding mental illness evaluation, treatment and hospitalization.

It’s far more common for the courts to get involved when parents reject a treatment option the medical community generally agrees will save a minor child’s life. The parens patriae doctrine only applies, though, when a decent quality of life could be expected from the treatment. With terminal illness, a parent can choose to let nature take its course, according to Cornell Law School’s Legal Information Center.

States can side with parents of a severely ill child if they choose a different treatment than health care providers recommend if the risks and chance of survival are similar.

Or states can take action through the courts. The Nevada Supreme Court recently upheld removing a 4-year-old child who had cancer from his parents’ custody after they decided not to complete a lengthy course of chemotherapy, though doctors gave him a 60% chance of survival with the treatment and said he’s likely to die within six months without it, according to the Omaha World-Herald.

“Other parents have stood trial over the deaths of their children for refusing treatment. In 2008, 11-year-old Madeline Kara Neumann died as a result of untreated juvenile diabetes. Her family believed prayers would heal their daughter and prayed over her as she died without seeking help. Madeline’s parents were convicted of second-degree reckless homicide in 2009,” according to KXTV in Sacramento.

In 2003, a Utah boy, Parker Jensen, 12, was diagnosed with a rare and aggressive cancer, Ewing’s sarcoma in the form of a small growth on his tongue. His family rejected the diagnosis and the recommended chemotherapy. The boy was ordered removed from his home because of medical neglect, but his family had moved to Idaho, which led to further charges. Eventually, the child welfare case was dropped and Parker never did undergo chemotherapy. Criminal charges were settled or dropped.

When the Parkers sued the doctor and several officials, the Utah Supreme Court ruled that none of the Parkers were entitled to money damages, as doctors and state officials named in the suit had the boy’s best interests at heart. Parker later served a mission for The Church of Jesus Christ of Latter-day Saints and married, according to KSL.

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