President Trump Obtained Regeneron Experimental Antibody Remedy

President Trump Received Regeneron Experimental Antibody Treatment

President Trump has been given a dose of an experimental antibody cocktail developed by drug maker Regeneron, in addition to several other drugs including zinc, vitamin D, and the generic version of the heartburn treatment Pepcid. This emerges from a letter from his doctor released by the White House on Friday afternoon.

Mr Trump and the first lady, Melania Trump, announced early Friday morning that they had tested positive for the coronavirus. According to two people close to Mr Trump, the president has a mild fever, nasal congestion and cough.

In the letter, Mr. Trump's doctor, Dr. Sean P. Conley, "he completed the IV with no incident" and that he "remains tired but in good spirits".

There are no approved treatments for Covid-19, but Regeneron treatment is one of the most promising candidates along with another antibody treatment developed by Eli Lilly. Both are being tested on patients across the country. Initial results suggest that if given early in the course of the infection, they can lower the levels of the virus in the body and potentially shorten hospital stays.

Although Regeneron's product has not been approved for emergency use by the Food and Drug Administration, companies can grant access to their experimental treatments through compassionate use, for example when all other options have failed and a patient may die without trying the drug.

In an interview on Friday afternoon, Regeneron's CEO Dr. Leonard S. Schleifer that Mr. Trump's medical staff had asked the company for permission to use the drug and that it had been approved by the Food and Drug Administration.

"All we can say is that they asked to be able to use it and we were happy to do it," he said. He said that so-called compassionate use cases – when patients are given access to experimental treatment outside of a clinical trial – are decided on a case-by-case basis and he is not the first patient to be given permission to use the treatment that route. "Of course, if it's the President of the United States, that gets our attention, of course."

Dr. Schleifer has known Mr. Trump casually for years and has been a member of his Westchester County golf club.

A Regeneron spokeswoman Hala Mirza said that for coronavirus treatment, "our first priority is to maintain adequate supplies to conduct rigorous clinical trials" in certain exceptional circumstances on a case-by-case basis. "

Dr. George Yancopoulos, President and Chief Scientific Officer of Regeneron, said the company was already preparing for an expected influx of inquiries.

"This certainly puts us in a difficult position," said Dr. Yancopoulos. The company also plans to assign the product if it is approved or approved for use in an emergency. Regeneron has an agreement with the Department of Defense to distribute the first 300,000 cans as soon as they become available. "We didn't want to decide who would get a limited number of doses," he said.

"I've obviously been in conflict, but I probably know the science and the data and everyone in the world," he added. "If it were me, I would take it."

During the pandemic, Mr Trump promoted a number of unproven or scientifically questionable treatments for the virus, including himself taking the malaria drug hydroxychloroquine in hopes that it could prevent infection. The Food and Drug Administration approved emergency hydroxychloroquine this spring and then revoked its approval after determining that the drug's potential benefits did not outweigh its risks.

Mr. Trump has also enthusiastically endorsed the use of convalescent plasma and supported the F.D.A. Approve emergency treatment, although there is still no good evidence that it works. He suggested that injecting a disinfectant like bleach might help fight the virus, although he later said he was kidding.

Other treatments – an inexpensive steroid, dexamethasone, and remdesivir, an antiviral drug developed by Gilead – have shown in clinical studies to help patients with Covid-19 who are sick enough to be hospitalized. None of the drugs have the strict F.D.A. Approval process to determine if it is safe and effective, although dexamethasone is widely used for other uses and remdesivir has received emergency approval.

Dr. Conley said in his letter that in addition to Regeneron treatment, Mr. Trump was also taking zinc, vitamin D, melatonin, a daily aspirin, and famotidine, the generic name for the heartburn drug Pepcid. Some of these products, which are widely available, have been studied to treat Covid-19, although none have been shown to be effective.

Dr. Clifford Rosen, professor of medicine at Tufts and co-editor of the New England Journal of Medicine, said there weren't any rigorous clinical studies showing that vitamin D, zinc, or famotidine help fight the virus.

Mr. Trump signed the Right to Experiment Act in 2018, which allows patients and their doctors to request experimental treatment directly from a company without first obtaining approval from the F.D.A. obtained, which usually approves the vast majority of these requests. However, the right to try is seldom applied, as most doctors and hospitals prefer to use the existing process to apply for a corporate and then government approval.

Some ethics experts said it was not surprising that Mr Trump received an experimental drug because it passed safety studies.

"The President's medicine is and was unique," said Arthur L. Caplan, professor of medical ethics at the N.Y.U. Grossman School of Medicine. "If his doctors believe that an intervention could be helpful, and if this judgment is confirmed by outside experts they speak to, and if things look bad or serious, the President has access to all agents."

Regeneron and Eli Lilly are among several companies and research teams furthest away from the development of so-called monoclonal antibodies against Covid-19. The researchers identify strong antibodies that fight infections and then produce them in large quantities. They are then given to sick patients or those who have been exposed to the virus in hopes that they will help boost the body's immune response.

Antibody treatments have shown promise against other viruses, including Ebola.

In an interview prior to announcing that Mr Trump was taking the Regeneron drug, Dr. Daniel Skovronsky, chief scientist at Eli Lilly, said the company only granted access to its experimental coronavirus treatment through a clinical trial that patients could get a placebo to test if the product worked.

"We are committed to clinical trials," said Dr. Skovronsky, adding that patients who dispense the drug too freely do not want to participate in these studies.

This spring after the F.D.A. Having established a major convalescent plasma access program and promoting Mr Trump's benefits, researchers have had difficulty enrolling participants in clinical trials on a placebo.

On Tuesday, Regeneron said its treatment, a cocktail of two antibodies, accelerated recovery time and reduced the amount of virus in the nasal cavities of a small number of volunteers in its ongoing study.

The new results come from a study of 275 volunteers treated after being diagnosed with Covid-19. Those who didn't make their own antibodies at the start of the study benefited the most, Regeneron reported. Their symptoms resolved in an average of 6 to 8 days, compared with 13 days for those given a placebo.

The dose Mr Trump received is the higher of two doses Regeneron is testing in its study of outpatients with Covid-19.

Despite their early promise, monoclonal antibodies are difficult and expensive to make, and some have raised questions about whether companies will be able to earn enough to meet global demand if they are found to work.

Regeneron received more than $ 500 million from the federal government to develop and manufacture its product prior to the completion of clinical trials. In August, the company announced that it would team up with a larger company, Roche, to ramp up production.

Maggie Haberman and Michael D. Shear contributed to the coverage.


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