https://www.wnd.com/2020/11/tells-doctors-not-prescribe-covid-19-treatment-approved-fda/

[Editor’s note: This story originally was published by Real Clear Health.]

By James K. Glassman
Real Clear Health

In a baffling decision that could harm the poorest patients, the World Health Organization (WHO) told global physicians Friday not to prescribe remdesivir – even though it is the only COVID-19 treatment approved by the world’s top pharmaceutical regulator, the U.S. Food & Drug Administration (FDA).

The WHO, under fire for its slow start against the global pandemic, decided to shun the FDA and base a decision on its own study. That study, still incomplete, used methods inferior to the National Institutes of Health (NIH) trial that confirmed the efficacy and safety of the COVID drug, now called in many countries by its brand name Veklury.

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While the WHO recommendation is not binding, it is part of a “living guideline” project giving advice to doctors. The decision probably will not affect the use of Veklury in the U.S. and other developed countries, but it could prevent the medicine from getting to people who need it in low-income nations.

The FDA granted Veklury emergency use authorization in May and final approval on Oct. 22 as the sole therapeutic authorized for patients with COVID-19. The European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency have granted approval as well.

Veklury has become accepted as the standard of care for people with serious cases of coronavirus, and 2 million treatment courses will be produced this year with several million more in 2021, if needed. The European Commission signed a Joint Procurement Agreement on Oct. 8 with Gilead Sciences, the Silicon Valley biotech that developed the drug, for up to 500,000 treatment courses for 37 countries. Gilead made 650,000 treatment courses – about 150,000 of them free – available to the federal government for U.S. distribution. The company now sells the medicine directly to hospitals.

The big question is why the WHO decided to conduct a study that came up with this controversial recommendation. The answer lies in the criticism the organization has received over the past year that led to the U.S. serving notice it will withdraw from the WHO in July 2021. Officials in other countries, including Japan and France, have also condemned WHO’s deference to China and delay early in the pandemic.

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“Scientists and health experts,” said a New York Times article in July, have “criticized the WHO for being slow to update its guidance and keep step with science as understanding of the virus rapidly evolves.”

In trying to recover from this criticism, the WHO, despite its limited experience in running pharmaceutical trials, is clearly trying to reach for new relevance in the pandemic by becoming a drug researcher and arbiter. But that attempt is backfiring. Its research pales in comparison to the NIH trial on which the FDA relied and which was complemented by two other studies.

The randomized, placebo-controlled, double-blind clinical trial – the gold standard for drug evaluation – was conducted by NIH’s Institute of Allergy and Infectious Diseases. In contrast to the open-label WHO trial, the 1,062 hospitalized patients did not know whether they were getting remdesivir or a medicine with no therapeutic value.

The NIH study, reported in a peer-reviewed article in the New England Journal of Medicine on Nov. 5, found that, with remdesivir, the median time to recovery was five days shorter than with the placebo group, “a statistically significant difference,” said the FDA. The article concluded the drug was “beneficial in the treatment of Covid-19.”

Based on cost alone, the results were highly significant. According to a study released this month by FAIR Health, a non-profit, the cost of a COVID hospital stay of 11 to 15 days for a patient over 60 years old was $152,388 while the cost of a stay of 6 to 10 days was $89,973 – a difference of more than $60,000 for a drug which, according to the Department of Health and Human Services, has a cost of approximately $3,200 for a full five-day course.

By comparison with the NIH study, the WHO’s trial, called Solidarity, tracked patients in 405 hospitals in 30 countries “in record time” without controls. WHO concluded that all four drugs studied, including remdesivir, “appeared to have little or no effect,” but it called the finding “conditional” and said that “more research is needed.”

The WHO recommendation leaves many developing nations in a bind. Gilead has issued licenses, free of royalty charges for the duration of the epidemic to manufacture remdesivir in India, Pakistan and Egypt for distribution to 127 mainly low-to-middle-income countries. Many of those nations have limited regulatory capacity and depend on WHO recommendations or on donations of WHO pre-qualified drugs distributed by international global health organizations. Without remdesivir, they have few, if any, effective treatment alternatives for COVID patients.

Rather than second-guessing the best drug evaluators in the world, the WHO should stick to what it was created to do. As the organization’s website says, “Our primary role is to direct and coordinate international health.” That’s a big enough job in itself, especially during the worst pandemic in a century.

James K. Glassman, former Under Secretary of State for Public Diplomacy, is an advisor to health care companies and non-profits.

[Editor’s note: This story originally was published by Real Clear Health.]

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