Regeneron Asks F.D.A. for Emergency Approval for Drug That Trump Claimed Cured Him – The New York Times

Thanks! Share it with your friends!

Close

Drugs are not generally considered to be proven safe or effective until they undergo rigorous clinical trials that compare one group of people who received the treatment with those who receive a placebo.

The company has received more than $500 million from the federal government to develop and manufacture its experimental treatment as part of Operation Warp Speed, the federal effort to come up with viable vaccines and treatments for the virus and to help distribute them once they are available.

The company said that it expects to have doses available for 300,000 patients in the next few months. Under the agreement with the federal government, it said those doses would be made available free of charge. In August, it announced a partnership with the pharmaceutical company Roche to ramp up production to about 250,000 doses a month by next year.

Mr. Trump received the antibody cocktail on Friday, but it is not the only drug that he was prescribed. He has been taking the antiviral drug remdesivir, as well as the steroid dexamethasone, which the World Health Organization and National Institutes of Health recommend only for people who have severe or critical cases of Covid-19.

In an interview on Wednesday before the company’s announcement, Dr. George Yancopoulos, Regeneron’s president and chief scientific officer, said it was possible that Mr. Trump responded to the treatment and that the level of virus had declined. “That’s a logical conclusion,” Dr. Yancopoulos said. “Based on his symptomology, that has to have happened.”

But neither Dr. Yancopoulos nor Mr. Trump can definitively say whether the treatment worked. Any number of factors could complicate the picture, including the fact that most people who are infected with the virus recover. That is why drugs are typically tested in large clinical trials with hundreds and sometimes thousands of people.

Dr. Peter Chin-Hong, an infectious disease specialist at U.C.S.F. Health in San Francisco, said in his opinion, there was “one million percent no” chance that the Regeneron treatment could have cured Mr. Trump in 24 hours, as the president claimed.

Source Article from https://www.nytimes.com/2020/10/07/health/trump-covid-regeneron.html

Comments

Write a comment