[ad_1]
(Bloomberg Opinion) – Less than a month ago, the Food and Drug Administration said hospitals could use remdesivir, a drug made by Gilead Sciences Inc., to treat patients with Covid-19. Remdesivir, sold under the brand name Veklury, has been said to shorten recovery times and reduce the need for ventilators to aid breathing. Yesterday, the World Health Organization slowed down: 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 it sponsored. “The evidence suggests no significant effect on mortality, the need for mechanical ventilation, the time to clinical improvement, and other important patient outcomes.”
A group of experts convened by the WHO concurred with this assertion, reporting its findings in a reputable medical journal. Remdesivir offers “modest and uncertain benefits” outweighed by “the possibility of significant harm,” they wrote. Gilead backed down, saying it supports remdesivir and citing other studies supporting its effectiveness.
Speed is prized in the race to beat Covid-19 – as it should be. The world is also fortunate to have innovative and dedicated public and private researchers capable of producing coronavirus vaccine candidates in record time. But the WHO’s rejection of remdesivir also serves as a reminder that the early development and approval of drugs is risky. It shows why the FDA must do more than just approve Covid-19 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 officially approved remdesivir as a Covid-19 treatment in October. The drug was already available to hospitals and patients under federal emergency use authorization granted in May. Since then, the data supporting its benefits had become obscure, and an FDA approval was unlikely to significantly expand its use. As I noted in a previous column, remdesivir is also expensive – perhaps not as expensive as other successful drugs sold by the pharmaceutical industry, but still expensive.
Two writers for Science magazine, Jon Cohen and Kai Kupferschmidt, offered answers to these mysteries in a high-profile article published late last month. They found that both the FDA and the European Union had approved the use of remdesivir despite some glaring procedural shortcomings. The FDA has not consulted the outside experts it maintains to analyze the approvals of complex antiviral drugs. The EU approved the price for remdesivir just a week before the mediocre results of a major WHO trial on the drug were published – and seemed unaware of the new data at the time. (Gilead knew about it; he had donated trial drugs and knew the results were poor.)
Science editors pointed out that the FDA’s inaction around remdesivir “contrasts sharply with its handling of potential Covid-19 vaccines.” For remdesivir, the agency failed to convene an advisory to study the drug. Several prominent medical researchers expressed their skepticism about remdesivir in the Science article, including Martin Landry of the University of Oxford, who said the drug was useless in treating the sickest patients. Either way, most people with Covid-19 recover without medical treatment.
“The argument that the sooner you use it the better is great until you realize what the implications are: you won’t save a lot of lives and you will have to treat a lot of patients,” said Landry at Science. “It’s very inconvenient and it will cost you a fortune.”
Perhaps it was inevitable that Gilead would receive special treatment. In May, when remdesivir received its EUA, 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 himself, described it as one of the few drugs he received that looked like ‘miracles from God’.
Hospitals were less enthusiastic and sharply reduced their use of remdesivir because of its cost and value only for the most seriously ill patients – making the FDA’s enthusiasm for the drug all the more curious and its manufacturer. The FDA has approved remdesivir based on three trials, the largest of which was conducted by the National Institutes of Health. The NIH and FDA report to the Department of Health and Human Services.
Perhaps it was very good that the FDA relied on what was essentially an internal trial to approve remdesivir and that Hahn was exceptionally receptive to Trump’s requests to approve summary treatments for Covid-19. And maybe it’s good that Alex Azar, a former pharmaceutical executive and Big Pharma lobbyist who’s a stalwart of Trump, runs HHS and oversees Hahn.
In case all of this does not go well, we must keep it in mind as the HHS and FDA continue to play a central role in overseeing the approval, deployment and regulation of more critical drugs: vaccines. Covid-19 that Pfizer Inc. and Moderna Inc. have put on the table.
This column does not necessarily reflect the opinion of the Editorial Board or of Bloomberg LP and its owners.
Timothy L. O’Brien is a senior columnist for Bloomberg Opinion.
For more articles like this, please visit us at bloomberg.com/opinion
Subscribe now to stay ahead with the most trusted source of business news
© 2020 Bloomberg LP
[ad_2]
Source link