When President Trump promoted experimental medicine as a “cure” for Covid-19 in a video Wednesday, it seemed like it could come again: a questionable determination for a fatal epidemic, not in contrast to his previous enthusiasm for malaria. The drug hydroxychloroquine or even, one at a time disinfectant.
But the treatment that Mr. Trump presented last week after doctors diagnosed Covid-19 is not a fringe product. This is a promising drug in the final stages of testing developed by the respected biotech company, Regeneron. Infectious disease specialists are closely following the treatment, as well as following a similar product of Ally Lily, in the hope that the treatment can be a real breakthrough in the fight against covid-19.
Pharmaceutical companies often pay beautiful money to support a celebrity, but this patient testimonial was like no other. It came from a polarizing president who, just weeks away from the election, and who found himself and his White House at the center of the outbreak, is eager to show that his administration is doing something about the epidemic that has killed more than 212,000 Americans. Is. .
Although he probably didn’t know if Regeneron’s treatment helped him – or even though he’s not out of the woods yet – Mr. Trump sings his praises in the video, suggesting it’s “unbelievable” that he’s just Was away from the moments. Authorized it for widespread use. In doing so, Mr. Trump has repeatedly reminded critics – from reopening schools to authorizing hydroxychloroquine and blood plasma – that in the last nine months he has entered politics into the decisions of independent health agencies.
Regeneron, who pleaded with regulators within hours of the president’s video, must now compensate for his antibody treatment through a politically-charged approval process, where the president’s overwhelming support boosted his product profile, but also sowed. Doubts about whether it works.
“I don’t see how it’s going to be good for the pharma company,” said Ronnie Gale, a pharmaceutical analyst at the Berlin-based Street Pay firm. “Once you become a political opinion, it’s not great.”
Already, Regeneron is raising unsettling questions about how abortion was treated using cells taken from an abortion fetus – a line that Mr. Trump objected to – and the president’s relationship with Regeneron’s chief executive.
Mr. Trump has further complicated the potential rollout of these remedies by promising – first Wednesday and again in another video – that the drugs will be free of charge and will soon be available in thousands of doses.
But Regeneron said there are enough plans for about 300,000 people by the end of the year, with enough doses for 50,000 patients at the beginning alone. Regeneron has received more than 500 500 million in federal funding for the development and production of the treatment, and through that deal, the company has said it will make products available to Americans free of charge.
Still, given the scale of the outbreak in the United States and the fact that it will work best in treatment immediately after infection, it is believed that it is a small number. On Wednesday alone, more than 20,000,000 Americans tested positive for the virus.
“It’s like a comprehensive direct-to-consumer advertising campaign for a product where we have a limited supply and limited capacity for treatment, which is a nightmare for companies in the industry,” said Geoffrey Porge, an analyst at SVB Lynch. “Bank in Boston.
There is no way to know if Regeneran’s antibodies helped Mr. Trump. The president was given a number of drugs, including antiviral remedivisor and steroid dexamethasone, at the Voter Reed National Military Medical Center, which has been shown to help patients with Covid-19.
Mr Trump has said he feels better, but his doctors have given sporadic and conflicting details about his health, and he has just entered the second week of illness when some of his patients are getting worse.
Dr. Y. Mark Mulligan, director of the NYUU Langone Vaccine Center, which is involved in the study of antibody products from both Regeneron and Ally Lilly, said the president’s claim that he had recovered seemed premature – though not impossible.
D We. “We know that sometimes people get better and worse,” Mulligan said. “I want to reserve judgment and hope it is on the right track.”
The only way to know if a treatment works is to test it in large groups of patients who have received a placebo compared to those who have received the drug.
The treatment, developed by monoclonal antibodies, Regeneron and Ally Lilly, is believed to work by giving patients powerful antibodies that help fight the virus. Like Regeneran, Eli Lee Lilly has recently asked the Food and Drug Administration for immediate authorization of his treatment.
Although the companies ’trials are not complete and they have not published the findings in a medical journal, preliminary data have shown promise. Eli Lilly is testing two treatments: one in which one antibody is used and the other in which two are used. Both have shown evidence that they reduce hospitalization rates in patients receiving treatment immediately after a positive test.
Regenero recently showed information on his medication, a cocktail of two antibodies, to help the body clear the virus when given the drug as early as possible.
“We believe that the early signs of antiviral activity and the potential impact on the clinical course of the disease are very promising,” said Dr. John O’Brien, who oversees federal efforts to accelerate coronavirus treatment in the market. Janet Woodcock said in a call with reporters on Friday. . He said the emergency use application is now in the hands of the FDA
While they await the government’s decision, Eli Lilly and Regeneron are now facing the challenge of maintaining their credibility, even as the president continues to make unfounded and exaggerated claims.
“When he comes out and says, ‘Great news, I’m fine,’ he can only be seen through the political lens of his re-election,” said Arthur L., a professor of medical ethics at the NYU Grossman School. Said Capla. Medicine.
Now Regener will need to prepare for a potential surge in demand. D They. “They’re struggling with moral dilemmas, I think waiting will be a big attack of more requests,” Caplan said.
All eyes are on the profile of Regeneron, a lesser-known pharmaceutical company based in Westchester County that sells the eye drug Ilia and the asthma drug Dupixant.
Since the president received the experimental treatment last Friday, a company spokesman said he had seen it outside of clinical trials for drug requests – known as “pathetic use” – although he did not give details. Enrollment in the tests has also increased, he said: In the last two weeks, the company has enrolled 50,000 participants in its experiments, for a total of 25,000 people.
But the test has not been all positive. Some have raised questions of fairness, such as, why should the president be given access to drugs that are not yet available when tens of thousands of Americans are infected with the virus every day.
“I can’t offer this to my patients,” said Dr. Matthew G. Hospital. Heinz, a hospitalist at Tucson, a major medical center in Arizona, admitted that the benefits of the treatment have not yet been proven. “That’s the most frustrating thing for me as a therapist.”
Others say Dr. Questions have been raised about the president’s relationship with Leonard S. Schliffer, a billionaire co-founder and chief executive of Regenron, who has been a member of Mr. Trump’s golf club in Westchester County. The two have known each other casually for years, and Dr. Schliffer has told colleagues that Mr. Trump calls them to ask about the status of coronavirus treatment.
But Dr. Schleifer is also a frequent donor to Democratic candidates, and his son, Adam Dum Schleifer, in New York’s Democratic Primary, Rip. Nita Lowe ran unsuccessfully for the vacant seat.
The company also had to raise questions this week about the use of cells taken from fetal tissues to test antibody cocktails. The cell line, which was developed decades ago, is used to test many other drugs, including remedivisors and some coronavirus vaccines.
Mr. Trump’s intoxication of boosterism with opposition to the use of embryonic tissue in scientific research enriched his critics with hypocrisy. But the president’s enthusiastic treatment of regeneron antibodies would have at least drawn attention to the treatment of people who might eventually get out.
“The fact that he was given one of these remedies has increased his awareness,” said Dr. Muligan. “I think that’s a good thing. We need a little success. ”
Gina Kolata and Noah Veland contributed to the report.
