nothing good comes out of approving treatments ‘on the run’



Less than a month ago, the United States Food and Drug Administration (FDA) said hospitals could use remdesivir, a drug manufactured by Gilead Sciences, to treat COVID-19 patients.

Remdesivir, sold under the brand name Veklury, is said to shorten recovery times and reduces the need for ventilators to facilitate breathing. Yesterday, the World Health Organization (WHO) stepped on the brakes: it recommended that doctors avoid using the drug altogether.

« There is currently no evidence that remdesivir improves survival and other outcomes in these patients, » the WHO noted. citing detailed studies he sponsored.

« The evidence did not suggest any significant effect on mortality, the need for mechanical ventilation, time to clinical improvement, and other important patient outcomes, » he detailed.

A group of experts brought together by the Organization agreed, reporting their findings in a reputable medical journal. Remdesivir offers « small and uncertain benefits » outweighed by the « possibility of major damage, » they wrote.

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Gilead responded, stating that it supports remdesivir and citing other studies that support its efficacy.

Speed ​​is appreciated in the race to beat the pandemic, as it should be. The world is also fortunate to have dedicated and innovative public and private researchers capable of producing coronavirus vaccine candidates in record time, but the WHO’s refusal to remdesivir it is also a reminder that Rushed drug development and approval are risky. It highlights why the FDA has to do more than put its ‘seal of approval’ on novel coronavirus treatments in the face of strong pressure from the White House to act quickly.

As my colleague Max Nisen recently observed, it is puzzling that the FDA formally approved remdesivir as a treatment for the SARS-CoV-2 virus in October. The drug was already available to hospitals and patients under a federal emergency use authorization granted in May. Since then, the data that supports its benefits they have become confused, and an FDA approval is unlikely to significantly expand its use.

As I pointed out in a previous column, remdesivir it is also expensive, perhaps not as expensive as other blockbuster drugs sold by the pharmaceutical industry, but still high in price.

Two Science magazine writers, Jon Cohen and Kai Kupferschmidt, offered some answers to these mysteries in a highly interesting article published late last month. They found that the FDA and the European Union had approved the use of remdesivir despite some glaring procedural gaps.

The FDA did not consult with the outside experts it keeps available to review approvals for complex antiviral drugs. The EU approved the price of remdesivir just a week before the results of a major WHO trial on the drug were released, and then it seemed to have no idea of ​​the new data. (Gilead was aware: had donated drugs to the trial and knew the results were bad).

The Science writers noted that the FDA’s inaction around remdesivir « stands in stark contrast to its handling of potential COVID vaccines. » For remdesivir, the agency failed to convene a notice to study the drug. Several prominent medical researchers expressed skepticism about remdesivir in the Science article, including Martin Landry of the University of Oxford, who commented that the drug was useless in treating the sickest patients. In any case, most people with COVID-19 recover without medical treatment.

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« The argument that the sooner you use it, the better, is excellent until you realize the implications of that – it won’t save many lives and you will have to treat a lot of patients, » Landry told Science. « It is very inconvenient and will cost you a fortune. »

Perhaps it was inevitable that Gilead receive special treatment. In May, when remdesivir received its emergency use authorization, the company’s CEO, Daniel O’Day, was greeted in the Oval Office for a photoshoot with President Donald Trump and FDA Commissioner Stephen Hahn. .

Trump, who was treated with remdesivir after contracting COVID-19, described it as one of the few drugs he received that were like « miracles that descended from God. »

Hospitals have been less enthusiastic and have drastically reduced the use of remdesivir due to its cost and value only to the most seriously ill patients, making the FDA’s enthusiasm for the drug and its manufacturer even more curious. The FDA approved remdesivir based on three trials, the most important of which was conducted by the National Institutes of Health. Both the NIH and the FDA are affiliated with the Department of Health and Human Services (HHS).

Perhaps it was okay that the FDA relied on what was essentially an in-house trial to approve remdesivir and that Hahn has been unusually responsive to Trump’s demands to approve incomplete treatments for the novel coronavirus. And maybe it’s okay that Alex Azar, a former pharmaceutical executive and lobbyist for Big Pharma who is loyal to Trump, run HHS and supervise Hahn.

In case any of this is not right, we need to take that into account, as HHS and the FDA continue to play a critical role in overseeing the approval, launch, and regulation of the most crucial drugs – COVID vaccines. -19 that Pfizer and Moderna have put on the table.

* This column does not necessarily reflect the opinion of the editorial board, Bloomberg LP and its owners. Not from El Financiero.

* The author is a senior columnist for Bloomberg Opinion.

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