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The NIH study may settle the debate over ivermectin as a covid-19 treatment



LaFond said the demand for pasta declined late last year after she voiced her concerns during an interview with local television. But elsewhere, interest in ivermectin is growing, despite insufficient evidence that it acts as a treatment for covid-19. and sometimes the dangerous consequences when people take the animal version. The Food and Drug Administration said at least three people were hospitalized in February after taking the veterinary staff. He warned that high doses could cause allergic reactions, seizures, liver damage and even death.

Experts say some people steal animal drugs because they are easier to obtain than those intended for humans. This formula is approved for tropical diseases and requires a prescription. And although ivermectin is advertised on social media as something that can end pandemic is not approved for use against covid-1

9, a disease caused by the new coronavirus.

“It’s like the new hydroxychloroquine,” said Angela Rasmussen, a virologist at the Center for Global Health Science and Security at Georgetown University, referring to a malaria drug pushed by President Donald Trump that has proved ineffective against covid-19. “It would be great if ivermectin really works – it’s been around for years and it’s cheap. But as far as I know, there is no evidence to suggest that it is good for covid-19. “

Ivermectin is highly effective in treating devastating parasitic infections such as river blindness and is safe when used in the recommended doses. In the 1970s, Japanese and American scientists discovered the compound that led to its development, and in 2015 they received the Nobel Prize. But against covid-19 there is no “significant evidence” of efficacy, according to Merck, which makes the version with the brand. And the leading national organization of infectious disease physicians recommends not using ivermectin outside of clinical trials.

But Pierre Corey, a critical care doctor, is not embarrassed. Kory, co-founder of Front Line Covid-19 Critical Care Alliance, a group of doctors and scientists from several countries, says studies from around the world show that ivermectin is a “miracle drug” for covid-19 and should be introduced immediately. He opposes waiting for data from large randomized clinical trials to allow its use, saying too many people are dying from covid-19.

Now the National Institutes of Health may run into controversy. A randomized clinical trial is planned to see if older, already approved drugs can be reassigned to reduce covid-19 symptoms, according to three individuals who spoke on condition of anonymity because the plans were not announced. Ivermectin is considered the best candidate for the test, although the details are not final, people said. Other options include fluvoxamine, an antidepressant for decades, and famotidine, the generic name for Pepcid, according to outside scientists. The goal would be to get results within months.

A British study called Recovery provided important information on older medicines, finding that hydroxychloroquine did not help hospitalized patients with covid-19, while the steroid dexamethasone could be a lifesaver. However, the United States is lagging behind in conducting such trials due to the fragmentation of the health care system and the lack of financial incentives for pharmaceutical companies to continue researching old, cheap drugs.

Interest in ivermectin for covid-19 grew last spring after a small Australian study found that the drug inhibited coronavirus replication in laboratory tests. But many scientists have warned that it will be impossible for people to take high enough doses of the drug to cause an antiviral effect.

Sales of the veterinary version accelerated, making it difficult for pet owners to find ivermectin for pets and livestock. Tractor Supply, a national agricultural trader, has temporarily suspended the sale of a form of animal medicine to prevent misuse. He has since resumed sales of the product – “carefully labeled”, the company said in a statement.

“We currently have no solid evidence” for the drug, said Janet Woodcock, acting FDA commissioner, during a recent seminar on covid-19 treatment sponsored by the American Medical Association. “We have had hints of ivermectin for a long time, but again we have hints of many of these agents and many of them are not exposed.”

Patti Gilliano, a 56-year-old nurse who lives near Houston, believes ivermectin contributed to her recovery from covid-19 last summer. After she was hospitalized, she said she was treated with the antiviral drug remdezivir. But it wasn’t until she got home and found a doctor to prescribe ivermectin that she said the brain fog, night sweats and gastrointestinal problems were gone.

However, scientists warn that such anecdotes do not prove that the treatment works, as most people who receive covid-19 eventually recover.

Corey, of the Alliance for Critical Care, said the group of doctors was set up at the start of the pandemic to trade information on potential treatments and was an early proponent of steroid use, now part of the standard of care for critically ill patients. Last fall, she began focusing on ivermectin, as several studies have emerged from countries in Southeast Asia and South America that suggest it may be useful in the treatment of covid-19.

In an emotional statement to the Senate Homeland Security Committee in December, Corey praised drugs as a “potential global solution” to the pandemic. After his testimony attracted widespread attention, Corey said, his employer, Aurora St. Luke’s Medical Center in Milwaukee, tried to impose new restrictions on the contract that he said would impede his freedom of expression. He refused to accept the restrictions and left. The hospital declined to comment.

He previously worked in the health system for the University of Wisconsin-Madison, but left that job last May, he said, because his superiors refused to follow his recommendation that patients with covid-19 be treated with steroids. That was a month before the first major clinical trial – the British Recovery Study – showed the value of the steroid dexamethasone. The health system declined to comment.

Corey said he now works as a “locum tenens” doctor – a doctor who works in temporary jobs – and as president and chief medical officer of the Front Line Covid-19 Critical Care Alliance.

Last August, the NIH committee, which issued guidelines for covid-19 treatment, recommended against the use of ivermectin outside of clinical trials. But after a presentation by Kory and colleagues in January, the panel took a neutral stance, saying there was “insufficient data to recommend either for or against the use of ivermectin for the treatment of covid-19.” According to him, some studies show benefits and others do not. But he noted that most of the studies “have incomplete information and significant methodological limitations that make it difficult to rule out common causes of bias.”

A few weeks later, the American Society of Infectious Diseases, made up of infectious disease physicians, said most studies of ivermectin were too small, not properly randomized, or had other deficiencies, and said the drug should not be used outside of studies. Adarsh ​​Bhimraj, an infectious disease physician at the Cleveland Clinic and a member of the treatment guidelines group, described what he described as a well-designed, randomized, placebo-controlled study in Colombia that found the drug did not help patients. with light covid-19. The study was published in the Journal of the American Medical Association in early March.

The speed of embracing unapproved therapies reflects an understandable desire to find a silver bullet for the viral threat, Bhimraj said. Although some progress has been made in covid-19 treatment, there have been no changes in the game, such as the ability of penicillin to kill streptococcal bacteria, he noted.

Against the background of the debate, some doctors are trying to reduce the temperature.

In a blog post earlier this year, Paul Sachs, an infectious disease doctor in Brigham and Boston Women’s Hospital, admitted that the debate over ivermectin, with its echo of the battle for hydroxychloroquine, provoked a “tired feeling of déjà vu” doctors. But he warned doctors not to assume that “because we were burned by hydroxychloroquine, it means that all other repaired antiparasitic drugs will also fail.”

He expressed cautious optimism that the drug could benefit, based mainly on a recent meta-analysis – a statistical analysis based on several studies – from the University of Liverpool. The data, Sachs said, “seem stronger than ever for hydroxychloroquine, but we’re still not at the level of a ‘change of practice.’

Alice Crites contributed to this report.


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