Donald Trump believes he “cured” Covid-19 with an experimental treatment made by Regeneron Pharmaceuticals that he now promises to approve fast. Even if the drug is considered promising, these constraints cast doubt on the scientific integrity of the U.S. Food and Drug Administration (FDA), not to mention a future decision on the approval of a vaccine.
Since the beginning of the pandemic, Donald Trump has passionately advocated purely pharmaceutical solutions to coronavirus, ignoring public health measures such as masking and physical distancing. He had openly lobbied the FDA to approve, for example, hydroxychloroquine. It was a fiasco: the former antimalarial drug was the first to receive conditional approval for Covid-19 in the United States at the end of March 2020, but after several large studies that failed to prove its efficacy, the approval was revoked.
The treatment he himself received on Friday, October 2, 2020, is more credible than hydroxychloroquine: the synthetic antibodies developed by the U.S. biotechnology company Regeneron have shown promising results in preliminary clinical trials involving 275 patients. The pharmaceutical company Eli Lilly is developing its own “monoclonal” antibodies, which have been shown to help patients fight moderate infections and recover faster. These antibodies, which are produced in the laboratory and transfused in a single dose, are intended to replace the immune system in neutralizing coronavirus.
Like other biopharmaceutical companies, Regeneron tested its antibodies with cell lines derived from an aborted fetus in the Netherlands in the 1970s (HEK293T); these “immortal” cells are widely used in the industry, but the issue has come back to the forefront due to traditional resistance from American conservatives to the use of cells derived from abortions. The two companies filed an emergency application with the FDA on Wednesday, whose experts will now review the data submitted by the manufacturers. The scientific community was not able to independently verify them as the results were only announced in press releases and were not published by a peer-reviewed journal.
“It was my idea.”
But Donald Trump made it clear that his own experience, not the data, determined his decision. “I heard about this drug, I asked for it, it was my idea,” he said on Wednesday. “Had I not noticed it, it would have been just one drug among others,” he added. “I want you to have what I have,” he said. “I have approved it,” he said, although the FDA has not yet announced anything.
In comparison, the other two recommended treatments for COVID-19, the antiviral drug Remdesivir and the corticosteroid dexamethasone, are supported by studies in thousands of patients (Donald Trump also received both). Experts are worried that the president is trumpeting that Americans should not fear Covid-19 on the pretext that the disease did not kill him. “He has said from the beginning that everything is exaggerated,” Jeremy Konyndyk, a researcher at the Center for Global Development, told AFP. “He is not sure, but if he survives without side effects, he will believe that based on a sample of one person when 210,000 people have died.”
How high is the risk?
Until this week, there was concern that the FDA would compromise its standards and prematurely approve a vaccine ahead of the November 3 election. But the agency on Tuesday set criteria for the duration of the trials that make it materially unlikely that a conclusion will be reached in the next four weeks, pleasantly surprising, even the most critical experts who thought the FDA would give in to presidential pressure. “Neither the FDA nor I will give in to pressure from anyone,” said Stephen Hahn, “we will fight to defend the integrity of the agency. Donald Trump himself seemed to have given up: “They’re playing their games, it’ll be right after the election”.
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