Trump sparks new FDA concerns with praise of ‘miracle’ treatment

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 about politics 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 that the agency should grant emergency authorization to antibody treatments such as the one Trump took and that 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.

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 preliminary and that 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 the 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 nonhospitalized patients with mild to moderate symptoms.

Eli Lilly’s submission was based on studies showing that its antibody treatment reduces hospitalizations and serious complications.

There’s no evidence Regeneron’s antibody therapy was responsible for Trump’s apparent recovery.

But in the days since his COVID-19 diagnosis, Trump has seized on the promise of the treatments and claimed they will be broadly available to the public for free.

“We’re going to make them available immediately. We have an emergency use authorization that I want to get signed immediately,” Trump said in a separate video posted Thursday.

Yet the companies themselves have said there will be a limited number of doses available. Regeneron will have just 300,000 doses available by the end of the year, which is enough to last one week, given the current rate of infections.

Eli Lilly has said it will be similarly limited, with 1 million doses.

On Friday, federal officials said they are confident that if emergency authorization is granted, the administration will be able to purchase enough of the drugs to treat vulnerable populations.

“We feel comfortable that upon an [emergency use authorization] being granted that we will have enough to take care of the Americans that need that from a clinical perspective,” said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services.

Trump’s fixation on the antibody treatment is reminiscent of his promotion of convalescent plasma and hydroxychloroquine.

In both cases, the FDA issued an emergency use authorization for unproven therapies after coming under apparent pressure from the White House.

Even though antibody drugs may be effective, Trump’s effusive praise and pressure campaign run the risk of leading the public to think the FDA’s decision was driven by politics, not science.

“I think there is the concern, especially with the past things that happened, that this undermines public perception on the independence of FDA and the credibility of their decisions,” Goodman said.

Medical groups, led by the Infectious Diseases Society of America, urged the FDA not to rush its decision, and to make sure any authorization or approval is based on “established scientific standards.”

“Promising results among small numbers of patients to approaches that include antibody therapies are not a substitute for the rigorous scientific review that is essential to ensuring the safety and effectiveness of medicines,” the groups said in a joint statement.

“Relying on such limited data can put patients at risk of adverse events, and an EUA can reduce the ability to conduct the clinical trials that are needed to assess the safety and efficacy of antibody treatments,” they added.

Tags antibodies Coronavirus COVID-19 Donald Trump Regeneron treatment Vaccine
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