Ivermectin hovers over COVID ‘Right-to-Try' law passed by Michigan House

“Ivermectin” doesn’t appear in the text of a proposed Michigan law intended to support the right of dying COVID patients to try last-ditch medications.

Its sponsor has bristled at the drug’s mention, saying she doesn’t want the effort limited to a single drug.

But proponents of the bill, which the Michigan House approved 56-48 Wednesday, say the measure is necessary to give cover to doctors who are hesitant to prescribe drugs like ivermectin, a controversial parasite drug some patients continue to demand, despite the lack of compelling evidence that it prevents serious illness from COVID. 

“I think we should truly respect the decision between a patient and a doctor with a willing manufacturer and get politics and government out of that relationship,” State House Rep. Mary Whiteford, the bill’s sponsor, told Bridge Michigan last week.

Whiteford’s bill, which now goes to the Senate for approval, is similar to measures being introduced in other Republican-run legislatures. It would specifically add COVID patients to Michigan’s 2014 Right to Try Act. That law allows dying patients to access not-yet-approved drugs that have cleared at least a first phase of a clinical trial. Patients must have an advanced, life-threatening illness and have exhausted other treatment options.

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Supporters of right-to-try laws note they protect healthcare providers from licensing sanctions, and absolve the manufacturer and provider from civil liability. President Donald Trump signed those rights into federal law in 2018.

That and the state’s 2014 law raise questions about whether the current bill, which specifically mentions COVID, is even necessary. Ivermectin is an approved drug that already can be prescribed off-label and, as a recent study confirmed, is still being reimbursed at times by insurers.

Even so, many doctors refuse to prescribe ivermectin for COVID, despite campaigns promoting its effectiveness by prominent Republican politicians including Wisconsin Sen. Ron Johnson and conservative media personalities like Fox News host Laura Ingraham. 

In humans, ivermectin is traditionally used to treat parasitic worms, head lice and skin conditions such as rosacea. In treatment of parasites in animals, it can be formulated as pour-on medications, injections, and paste. The drug is cheap and accessible.

And, early in the pandemic, doctors theorized it could work against COVID.

The first studies suggested as much. But a mounting stack of research since then has found no significant difference in survival rates between COVID patients treated with ivermectin and others. 

One review, published last year in the peer-reviewed Cochrane Database of Systematic Reviews, examined 14 studies involving 1,678 patients, determining the studies to be “small,” with “few … considered high quality.” 

Another study released a few days ago, found that, among 490 patients at 20 hospitals, “ivermectin treatment during early illness did not prevent progression to severe disease.”

The Centers for Disease Control and Prevention and the World Health Organization have warned against ivermectin’s use for COVID patients, and the American Medical Association and two national pharmacists associations “strongly oppose” its use as a COVID treatment outside a clinical trial. 

The Michigan Department of Health and Human Services also warned against ivermectin’s use, and the Michigan Poison and Drug Information Center issued an advisory as well. Even the drug’s manufacturer, Merck, last year cautioned against its use for COVID, saying studies to that point lacked “meaningful evidence” and safety data.

While “ivermectin” isn’t in the Michigan’s bill language, it’s been clear since the bill’s first hearing in January that the controversial drug was top-of-mind for lawmakers considering its passage out of the House Health Policy Committee — so much so that Whiteford repeatedly asked that the word be taken out of the discussion when fellow lawmakers brought it up.

“I just request that we don’t even talk about this drug,” she said, when State Rep. Laurie Pohutsky, D-Livonia, began questioning ivermectin’s safety for COVID. “I don’t want this committee hearing to be about one drug.”

When Pohutsky persisted, Whiteford turned to chairwoman Bronna Kahle, R-Adrian, repeating, in part, “I request this subject is not brought up.”

Pohutsky again started to get to her question, at which point Kahle replied that “it was going in a direction that didn’t pertain to this legislation before us.”

On Wednesday, the House passed the legislation after representatives painted two starkly different pictures of the bill — backers touted it as providing hope for dying patients, while opponents dismissed it as a gateway for rogue doctors promoting “snake oil” treatments and patients to bully clinicians into dispensing unproven treatments.

State Rep. Julie Alexander, R–Hanover, supported the bill.

“During any health emergency, severely sick patients should be able to consider a variety of treatment options to reduce their chances of death,” she said. 

But Pohutsky, the Livonia Democrat, argued that Michigan’s Right To Try Act already covers COVID patients and access to drugs such as ivermectin that have been approved for other conditions.

Pohutsky said the new law would “encourage people to pressure, harass, intimidate, or even harm medical professionals in an attempt to convince them to prescribe a treatment they (the professionals) may feel as inadequate or inappropriate or as simply unavailable,” she said.

William Sowerby, D-Clinton Township, said the bill “provides a pathway for unscrupulous physicians to act without oversight and treat patients as test subjects.”

Still under study

Ivermectin has been as much a subject of political debate during COVID as scientific.

Health leaders and many doctors have said conservative efforts to promote unproven drugs like ivermectin and hydroxychloroquine have given patients and their families false reassurance about COVID treatments that have not been shown to work — to the point where some have threatened doctors if they don’t give them the drugs.

But ivermectin supporters, including some doctors, counter that it’s politics that has kept ivermectin out of reach of desperate patients. They still see promise in ivermectin, despite disappointing results in peer-reviewed research so far.

Dr. John Bizon, an ear, nose and throat doctor and Republican state senator from Battle Creek, said large studies in ivermectin have been flawed. That’s because the drug was used on very sick patients who had been infected for days or weeks with the coronavirus — too late for ivermectin to work, he said.

Those studies forced hospitals to abandon the use of the drug, even if their own doctors still believed in it. That, combined with political rhetoric and worry about possible sanctions against doctors, has shaken the trusted doctor-patient relationship, said Bizon, who said he took ivermectin when he had COVID.

“That's what made a doctor a doctor — it was your relationship with an individual and it was you and him against the world,” Bizon said.

Short of clearer evidence that it works, though, ivermectin should not be used for COVID treatment outside a clinical trial — pure and simple, said Dr. Bobby Mukkamala, chairman of the board of trustees at the American Medical Association and immediate past president of the Michigan State Medical Society.

“The jury's still out on ivermectin,” he said.

Mukkamala is a Flint-based ear, nose, throat doctor, but as an early and vocal advocate of COVID vaccines, he also gets lots of questions about ivermectin, he said. His response to those who ask?

“They shouldn't rely on that as being what's going to save their lives, and instead, they should try to prevent getting sick. And if they do get sick, what has been shown to save their life is monoclonal antibodies” treatment, he said.

Also authorized are so-called COVID pills. Both the pills and antibodies are limited in who has access to them, and both which must be administered in the first few days of infection to be most effective.

Still, Mukkamala and others say, the Whiteworth bill is misdirected if its aim is to reassure doctors about ivermectin, which is already approved for other diseases, and is available to doctors to prescribe off-label — in other words, for another approved purpose.

Lawmakers in other states have considered passing additional right-to-try laws in the context of ivermectin, but have appeared to have dropped the efforts after discussion, said Naomi Lopez, Director of Healthcare Policy at the conservative Goldwater Institute.

The Phoenix-based institute helped pass Right to Try laws and continues to work on the issue, she said.

But when it comes to ivermectin and COVID?

“It’s already legal for a physician to prescribe an FDA-approved drug for an indication that's not the label,” said. “This is absolutely not a right-to-try issue. There's a lot of confusion about it.”

Some mistakenly see “right to try” as a law that would force doctors into prescribing drugs they otherwise would not, Lopez said, speaking in general, and not about the Michigan-specific law.

“What I think a lot of the lawmakers are interested in is compelling physicians to prescribe” something they don’t feel comfortable with, she said. “And that is not something that we would ever, ever support.”