President Trump’s public praise for an experimental coronavirus antibody treatment is putting new pressure on the Food and Drug Administration (FDA) to quickly give emergency clearance to a drug he has touted as a “miracle.”
Doctors think the drugs show promise as a potential treatment of COVID-19, though Trump has created confusion by quickly elevating them to a cure.
“They call them therapeutic, but to me it wasn’t therapeutic,” Trump said in a video he tweeted on Wednesday, five days after receiving the experimental treatment from the biotech company Regeneron.
Trump said that he felt better immediately after taking the drugs.
“I call that a cure,” he said. “It’s a cure.”
But by placing himself in the middle of the drug evaluation process, Trump is once again igniting concerns that politics is encroaching on science at a crucial time.
The pressure threatens to undermine confidence in government regulators and turn the science of drug evaluation into yet another political dispute, confusing Americans and sowing distrust about helpful therapies.
Former FDA Commissioner Scott Gottlieb said the agency should grant emergency authorization to antibody treatments like the one Trump took, and people shouldn’t be so quick to attack such a promising therapy.
“I hope people don’t shoot at these drugs because there’s this political veneer over access to this. We should just look at the scientific merits,” Gottlieb said Friday on CNBC.
Gottlieb also said the safety bar for antibody treatments is lower than it is for vaccines because the science for antibodies is better understood.
“These drugs, based on the data we’ve seen publicly, probably meet the bar for an emergency use authorization. They’re different from a vaccine, a vaccine you’re going to have a much higher threshold for safety,” Gottlieb said.
Two companies have filed for emergency use authorization for antibody drugs in the past week: Regeneron and Eli Lilly. The treatment from Eli Lilly consists of a single monoclonal antibody, while the treatment from Regeneron consists of a cocktail of antibodies.
Monoclonal antibodies are lab-generated versions of one of the human body’s main defenses against pathogens.
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Doctors and health experts think antibody drugs could be a bridge to a COVID-19 vaccine, but have cautioned that the results to date are very preliminary and longer studies are needed.
“I think there’s an efficacy signal here. But it’s a very selective part of the patient population,” said Jesse Goodman, a professor at Georgetown University who was FDA’s chief scientific officer during the Obama administration.
Regeneron issued a press release touting its preliminary results, but has not publicly released any data. According to the company, a high dose of its drug led to reduced levels of the virus in non-hospitalized patients with mild to moderate symptoms.
Eli Lilly’s submission was based on studies showing that its antibody