When President Trump advertised an experimental drug as a “cure” for Covid-19 in a video on Wednesday, it seemed like he was back at it: promoting a questionable solution to a deadly pandemic, similar to his earlier enthusiasm for the malaria drug hydroxychloroquine or even disinfectant at one point.
But the treatment that Mr Trump praised and given by doctors last week after being diagnosed with Covid-19 is not a by-product. It’s a promising late-stage drug developed by a respected biotech company, Regeneron. Infectious disease experts have been closely following the treatment, as well as a similar product from Eli Lilly, in the hope that the therapies could represent real advancement in the fight against Covid-19.
Drug companies often pay well for celebrities, but this patient testimonial was like no other. It came from a polarizing president who, just weeks before an election and after he and his White House was at the center of an outbreak, wants to show that his administration is doing something about a pandemic that killed more than 212,000 Americans.
Although there was no way he could have known whether Regeneron’s treatment had helped him – or whether he was still out in the woods – Mr. Trump praised the video, calling it “incredible,” and saying it was moments away from widespread use authorized. In doing so, Mr Trump reminded critics of the many times over the past nine months – from reopening schools to approving hydroxychloroquine and blood plasma – that he has incorporated politics into the decisions of independent health authorities.
Regeneron, who filed an application with regulators within hours of the president’s video, is now forced to guide its antibody treatment through a politically tense approval process, where the president’s over-approval has likely sharpened the profile of his product, but could also sow suspicion , if it works.
“I don’t see what will be good for a pharmaceutical company,” said Ronny Gal, a pharmaceutical analyst for Wall Street company Bernstein. “Once you’ve become a political opinion, that’s not great.”
Regeneron is already asking messy questions about how its treatment was tested with cells originally from an aborted fetus – a line of research Mr Trump has spoken out against – and the president’s relationship with Regeneron’s executive director.
Mr Trump has further complicated the possible introduction of these treatments by pledging – first on Wednesday and again in another video on Thursday – that the drugs would be free and soon available in hundreds of thousands of doses.
However, Regeneron said there would only be enough doses for 50,000 patients initially, with a plan to have enough for about 300,000 people by the end of the year. Regeneron has received more than $ 500 million in federal funding to develop and manufacture the treatment. Through this deal, the company announced that it would make the products available to Americans free of charge.
Even so, this is a small number, given the scale of the outbreak in the United States and the fact that treatment is believed to work best soon after infection. More than 50,000 Americans tested positive for the virus on Wednesday alone.
“This is like running a massive direct marketing campaign for a product where we have limited supply and treatment capacity. This is a nightmare for companies in the industry,” said Geoffrey Porges, analyst at SVB Leerink, a Boston investment bank.
There is no way to know if Regeneron’s antibodies helped Mr. Trump. The president was given several drugs at Walter Reed National Military Medical Center, including the antiviral remdesivir and the steroid dexamethasone, which have been shown to help patients with Covid-19.
Mr Trump has said he is feeling better, but his doctors have provided sparse and conflicting details about his health, and he’s only just entered the second week of the illness when some patients are turning for the worse.
Dr. Mark Mulligan, director of NYU Langone Vaccine Center who is involved in studies on Regeneron’s and Eli Lilly’s antibody products, said the president’s claim that he was cured was premature – if not impossible.
“We know that sometimes people get better and then they get worse,” said Dr. Mulligan. “I would reserve my right to judge and hope that he is on the right track.”
The only way to tell if a treatment is working is to test it in large groups of patients and compare those who received the drug to those who received a placebo.
Monoclonal antibodies, the treatments developed by Regeneron and Eli Lilly, are believed to give patients powerful antibodies that help fight the virus. Like Regeneron, Eli Lilly recently asked the Food and Drug Administration for an emergency permit for her treatment.
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Oct. 10, 2020, 12:25 p.m. ET
Although the companies’ studies are not exhaustive and have not published their results in medical journals, early data showed promising results. Eli Lilly is testing two treatments: one with a single antibody and one with two. Both have shown evidence that they reduced the hospitalization rate in patients who received the treatments shortly after testing positive.
Regeneron recently released data showing that its drug, a cocktail of two antibodies, appeared to help the body clear the virus when it was given at the onset of the disease.
“We believe that the early signs of antiviral activity and possible implications for the clinical course of the disease are very promising,” said Dr. Janet Woodcock, who oversees federal efforts to accelerate the time-to-market of coronavirus treatments, speaking to reporters Friday. She said the emergency application is now in the hands of the FDA
While waiting for the government’s decision, Eli Lilly and Regeneron now face the challenge of maintaining their credibility, even as the president continues to make baseless and exaggerated claims.
“If he comes out and says, ‘Good news, I’m cured,’ it can only be seen through the political lens of his re-election,” said Arthur L. Caplan, professor of medical ethics at NYU Grossman School of Medicine.
Regeneron now has to prepare for a possible surge in demand. “You are in a thicket of ethical difficulties waiting for what I think is a fairly large rush of further inquiries,” said Dr. Caplan.
All the attention has raised the profile of Regeneron, a lesser-known drug company based in Westchester County that sells the eye medicine Eylea and the asthma medicine Dupixent.
Since the president received the experimental treatment last Friday, a company spokeswoman has said that requests for the drug outside of clinical trials – through so-called “compassionate use” – have increased, although she did not provide details. Participation in the studies has also increased, she said: In the past two weeks, the company has enrolled 500 participants for a total of 2,500 people.
However, the exam was not all positive. Some have raised questions of fairness, such as why the president should have been given access to an unavailable drug when tens of thousands of Americans contract the virus every day.
“I cannot offer it to my patients,” said Dr. Matthew G. Heinz, a hospital physician at a major medical center in Tucson, Arizona, who acknowledged that the benefits of the treatment are still not proven. “That’s the most frustrating thing for me as a doctor.”
Others have the President’s relationship with Dr. Leonard S. Schleifer, the co-founder and chief executive officer of Regeneron who was a member of Mr. Trump’s golf club in Westchester County, was questioned. The two have known each other casually for years, and Dr. Schleifer has told employees that Mr. Trump is calling him to inquire about the status of the coronavirus treatment.
Dr. Schleifer is also a frequent donor of Democratic candidates, and his son Adam Schleifer ran unsuccessfully this spring in the Democratic Elementary School in New York for the seat vacated by Rep. Nita Lowey.
The company also had to ask questions this week about using cells from fetal tissue to test the antibody cocktail. The cell line developed decades ago has been used to test many other drugs, including remdesivir and some of the coronavirus vaccines in studies.
Contrasting Mr. Trump’s boosterism with his opposition to the use of fetal tissue in scientific research found his critics rich in hypocrisy. But the president’s avid marketing of Regeneron’s antibodies may at least have drawn public attention to treatments that may eventually emerge.
“The fact that he received any of these therapies raised awareness about them,” said Dr. Mulligan. “I think in a way it’s a good thing. We need some success. “
Gina Kolata and Noah Weiland contributed to the coverage.
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