The National Institutes of Health (NIH) states it is no longer “for or against” ivermectin for the treatment of COVID-19, but NIH will still prevent the anti-parasitic drug from being an accepted standard of care, says a group of published critical care specialists from major academic centers.
The NIH upgraded its recommendation on January 14 after a presentation of data on the drug to the NIH’s Treatment Guidelines Panel by three physicians, Paul Marik, M.D.; Pierre Kory, M.D., of the Front Line Critical Care Alliance (FLCCA); and Andrew Hill, M.D., a consultant to the World Health Organization. Previously, the NIH stated Ivermectin should not be used for treating COVID-19 patients outside a clinical trial.
The panel stated there is “insufficient data” to offer more specific guidance on Ivermectin for COVID-19 and “results from adequately powered, well-designed, and well-conducted clinical trials” are needed for a more encouraging recommendation.
FLCCA states NIH has given similar “neutral” stances to monoclonal antibody treatment and treatment using convalescent plasma.
“Ivermectin is the ONLY one of these therapies that has multiple randomized controlled trials and a meta-analysis of RCT’s that demonstrate statistically significant large reductions in mortality rates, shorter duration of hospital stay profound reductions in the infectivity rate in both pre-and post-exposure prophylaxis studies, faster times to clinical recovery and faster times to viral clearance,” FLCCA stated in an open letter.
NIH – Too Much Influence
NIH agreed to hear the evidence on Ivermectin after hearings in November and December before the U.S. Senate Committee on Homeland Security and Governmental Affairs. Kory was one of several physicians who testified that existing, inexpensive drugs like Ivermectin and cocktails of vitamins are keeping people from getting deathly ill from COVID-19. Often, patients recover in a matter of days at home.
Ivermectin has been used around the world for decades, primarily for fighting diseases caused by parasites. Researchers believe ivermectin stops the SARS-CoV2 virus that causes COVID-19 from quickly replicating in the body and causing life-threatening complications.
If the NIH offered more encouraging guidance on ivermectin, it could turn the tide on COVID-19 case counts and death, Kory says.
“Since the neutral stance, more and more doctors are prescribing Ivermectin but much of that is anecdotal,” Kory told Health Care News. “It hasn’t been a systematic change. By softening the recommendation, it has reduced some of the fear and resistance” by physicians and institutions.
The NIH holds considerable influence over providers, and the guidelines can become impediments to the practice of medicine, Kory says.
“These recommendations are not really guidelines borne of the intuition and experience of experts, but simply scorecards of the amount and quality of evidence-based data, and NIH will only give a high score if you have a massive multi-centered double-blind placebo and randomized controlled trial,” Kory said. “Without that, they won’t make a recommendation for anything. And with that, they end up recommending things that, although backed by such studies, are novel, pharmaceutically engineered, expensive and have near-zero clinical benefits, like remdesivir and monoclonal antibodies.”
Institutions are too afraid to go outside the guidelines, Kory says.
“Liability may explain part of it, but you don’t get sued for telling your patients to take vitamin D or when you use good clinical judgment,” Kory said. “Physicians can defend what they do if well-reasoned and considerate of a risk/benefit analysis. This doesn’t mean a doctor should abandon a patient because of fear of being sued.”
Against the Tide
Kory has seen first-hand the resistance to conventional thinking in medicine, often directed by regulatory agencies.
In May, Kory testified at a U.S. Senate hearing on the use of corticosteroids in treating COVID-19.
“I was attacked repeatedly for weeks and weeks for my testimony supporting the use of corticosteroids until the Recovery Trial came out over a month later that said corticosteroids were life-saving for COVID-19, ” Kory said.
After his testimony, Kory resigned from his job as chief of critical care and medical director of an intensive care unit at a major academic medical center.
“The institution was blocking me from using corticosteroids, more aggressive anti-coagulation protocols, and intravenous ascorbic acid,” Kory said. “It was morally unacceptable to me to watch patients die due to being offered what is called ‘supportive care only’ approaches consisting essentially of fever control, IV fluids, and oxygen or ventilatory support.”
Kory said that since that time, he joined a new institution who then claimed he violated the terms of his contract after his second testimony in December.
“I did no such thing,” Kory said. “There was no language forbidding me from testifying before the Senate. In fact, as a former associate professor, one of your societal responsibilities is to share your knowledge and expertise with the public, which is what I was doing.”
According to Kory, the institution wanted him to agree to eight restrictions on his ability to speak publicly, which Kory decided was unacceptable.
Support from around the world has poured in, Kory says, and his views on early COVID treatment have received wide coverage in conservative media outlets. Kory says he has also been invited to speak by Eric Goosby, M.D. a member of President Joe Biden’s COVID-19 Task Force.
Kory says there has been less interest in ivermectin by the mainstream media, and his organization has had to avoid using the word “Ivermectin” in social media platforms to keep posts from being taken down—two realities he finds frustrating.
“Our opinion is not ‘conservative,’ Kory said. “We are scientists, not politicians. This is about data. It’s funny, we are going against the grain and the conservatives welcome us more than the liberals, and many of us are liberal and Democrats. It’s really kind of stupid.”
AnneMarie Schieber (firstname.lastname@example.org) is the managing editor of Health Care News.
FLCCC Alliance Response to the NIH Guideline Committee Recommendation on Ivermectin Use in COVID-19 Dated January 14, 2021,” January 18, 2021: https://covid19criticalcare.com/wp-content/uploads/2021/01/FLCCC-Alliance-Response-to-the-NIH-Guideline-Committee-Recommendation-on-Ivermectin-use-in-COVID19-2021-01-18.pdf