President Trump
Donald John Trump Federal Judge approves Texas declaration of one ballot drop-location per county, nine participants in Trump rally in Minnesota agree to coronavirus shiff: ‘Will Trump do anything different if Trump wants more infection?’ MorePraise for experimental coronavirus antibody treatment is putting new pressure on the Food and Drug Administration (FDA) that the drug it called a miracle could be approved immediately.
Doctors believe the drugs promise a possible cure for COVID-19, although Trump has also created confusion by quickly moving them to treatment.
“They call them therapeutic, but for me it wasn’t therapeutic,” Trump said in a video he tweeted Wednesday, five days after receiving experimental treatment from biotech company Regeneron.
Trump said he feels better immediately after taking the drugs.
He said, “I call it cure. “It’s a cure.”
But by putting himself in the middle of the drug assessment process, Trump is once again ignoring concerns that politics is engulfing science at a crucial time.
This pressure threatens to erode confidence in government regulators and turn the science of drug evaluation into another political controversy, confusing Americans and creating distrust about supportive therapies.
Former FDA Commissioner Scott Gottlieb said the agency should allow an emergency for antibody treatment, such as the treatment Trump took, and people should not be so quick to attack such promising treatment.
“I hope people don’t shoot at these drugs because they lead to political boycotts. We just need scientific qualifications,” Gottlieb told CNBC on Friday.
Gottlieb also said that the safety band for antibody treatment is lower than those vaccines because the science for antibodies is better understood.
“These drugs, based on data we’ve seen publicly, probably meet the bar for authorization of use. They’re different from a vaccine for safety, a vaccine for which you have a lot of safety.” Gottlieb said.
In the past week, two companies have applied for emergency use authorization for antibody drugs: Regeneron and Ally Lilly. Alley lilies are treated with a single monoclonal antibody, while regeneration is treated with a cocktail of antibodies.
Monoclonal antibodies are lab-generated versions of one of the main defenses of the human body against pathogens.
Doctors and health experts believe that antibody drugs may be a bridge to a COVID-19 vaccine, but warn that today’s results are too preliminary and require a long study.
“I think there’s an efficacy signal here. But it’s a very selective segment of the patient population,” said Jesse Goodman, a professor at Jersetown University who was the FDA’s chief scientific officer during the Obama administration.
Regeneron made a press release considering its preliminary results, but did not disclose any data to the public. According to the company, high doses of the drug reduced the level of the virus in non-hospitalized patients with mild to moderate symptoms.
Eli Lilly’s presentation was based on a study that showed her had antibiotic treatment and serious complications with hospitalization.
There is no evidence that Regeneran’s antibody therapy was responsible for Trump’s apparent recovery.
But in the days following his Covid-19 diagnosis, Trump has seized on the promise of treatment and claimed they will be available to the public, mostly for free.
“We are going to make them available immediately; “We have an emergency use authorization that I want to sign immediately,” Trump said in a separate video posted Thursday.
Yet the companies themselves have said that only a limited amount will be available there. Regeneron will have only 300,000 doses available by the end of the year, which is enough for just one week given the current infection rate.
Eli Lilly has said it will be equally limited with 1 million doses.
On Friday, federal officials said they were confident the administration would be able to purchase enough drugs to treat vulnerable people if the emergency was allowed.
“We feel comfortable after that [emergency use authorization] “We need enough to provide Americans with the medical care they need from a clinical perspective,” said Paul Carey, deputy chief of staff for policy at the Department of Health and Human Services.
Trump’s fixation on antibody treatment is reminiscent of his promotion of convulsant plasma and hydroxychloroquine.
In both cases, the FDA approved emergency use for non-Provenance therapy after coming under clear pressure from the White House.
While antibody drugs may be effective, Trump’s applause and pressure campaign run the risk of drawing people to believe that the FDA’s decision was driven by politics, not science.
“I think there are concerns, especially with things from the past, that undermine people’s perceptions of the FDA’s independence and the credibility of its decisions.”
Medical groups led by the Infectious Diseases Society of America urged the FDA not to rush into its decision, and assured that any recognition or approval is based on “established scientific standards.”
The groups said in a joint statement that “promising approaches to antibody therapy in the number of patients is not a substitute for a rigorous scientific review that is needed to ensure the safety and efficacy of the drugs.”
“Patients are at risk of adverse events relying on such limited data, and the EUA may reduce the ability to conduct clinical trials necessary to evaluate the safety and efficacy of antibody treatment.”
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