The Food and Drug Administration (FDA) is feeling a bit of pressure to release clearance to an experimental drug to treat COVID-19. President Donald Trump has been publicly praising a coronavirus antibody treatment he calls a “miracle.”
Many doctors believe the drug shows great promise to combat COVID-19. Although Trump’s claims have added much confusion to the drug’s abilities.
They call them therapeutic, but to me it wasn’t therapeutic… I call that a cure, It’s a cure.
FDA Feels Pressure From Trump’s Claims to Approve Drug for COVID-19
Trump’s comments about the drug have raised many concerns about politics trespassing into science. These concerns have caused people to lose confidence in whether or not anyone knows what they are talking about.
Scott Gottlieb, the former FDA Commissioner, believes that the FDA should grant the emergency authorization to use the COVID-19 antibody medication. He is also a firm believer that people should not be quick to judge the promise these therapies may hold.
The former Commissioner stated that he feel s there is a better understanding of antibodies than in the past. Due to this, he feels the safety bar for antibody treatments is lower than it is for vaccines.
The FDA is Working on Getting Medications to Americans
On Oct. 7, the drugmaker Regeneron said they had submitted an application to the FDA for the experimental antibody medications that Trump has repeatedly praised. The company announced that at first there would be a limited amount of doses available.
The plan is to start off with enough doses for roughly 50,000 patients. This number is much lower than Trump has claimed to be available. In a five minute video, the President released saying that he thought that contracting COVID-19 had been a “blessing from God.”
Trump further stated that after taking the medications developed by Regeneron he has suddenly felt better. At this time there is no evidence the medication is the fact the President felt better. He has even hinted that he was going to push the FDA to approve the drug.
The FDA has Yet to Comment
The treatment Regeneron has created is a cocktail of two powerful antibodies. These antibodies are believed to boost the body’s immune response to the virus. The company claims that their cocktail lowers virus levels — particularly in those who had not made their own antibodies.
Clinic trials of this medicine have not been completed. At this time the company has not released any data to prove their claim. A few other pharmaceutical companies have also begun creating medications to combat COVID-19. The FDA has not made any comments about the situation.
Written by Sheena Robertson
The New York Times: Regeneron Asks F.D.A. for Emergency Approval for Drug That Trump Claimed Cured Him; Katie Thomas
The Hill: Trump sparks new FDA concerns with praise of ‘miracle’ treatment
The New York Times: As New York City’s Covid-19 Lockdown Nears, Confusion and Anger Reign; James Estrin
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