Former Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb told CNBC on Friday that he believed the White House had carefully considered all of its treatment options decided to give up president Donald Trump the experimental coronavirus antibody cocktail Regeneron Pharmaceuticals.
“It was a perfectly reasonable decision to give him active therapy, and then it simply became a choice of therapy,” said Gottlieb “Quick money,” before Trump be forgiven to Walter Reed Medical Center “out of caution” after his diagnosis of coronavirus.
“I wouldn’t conclude that they chose the Regeneron product over any other – other than that given the data they knew, they were probably the most effective of the products when they looked at the Regeneron product data.” added Gottlieb, who headed the regulator under Trump from May 2017 to April 2019.
Not everyone in the medical community agrees with Gottlieb about the decision to give Trump experimental treatment. Some shared concerns about the president’s preferential treatment as the drug wasn’t approved by federal regulators, and others pointed to the limited data available.
On Twitter, a doctor said: “V.I.P. medicine does not mean better medicine if there is no data.”
Regeneron confirmed that it was providing a single 8 gram dose of its REGN-COV2 treatment for use by the President, whose Coronavirus diagnosis was announced just before 1 a.m. ET Friday. Regeneron’s antibody drug is still experimental and has not been approved by the FDA for emergency use. However, it was provided in response to a compassionate use request.
CNBCs Meg Tirrell It was reported Friday that a “limited number of patients” had also received the drug on this basis after talking to Dr. George Yancopoulos, Regeneron’s scientific director, had spoken.
On Tuesday, Regeneron said its REGN-COV2 treatment improved symptoms and reduced viral load in non-hospitalized patients with mild to moderate Covid-19. This was based on the results of the first 275 study patients. At the time, the company stated so plans to discuss “quickly” the first results with regulatory agencies, including the FDA.
Regeneron’s REGN-COV2 is an experimental recording of antibodies generated in the laboratory that mimics how the body would react to a foreign intruder. The goal is to strengthen the immune system’s defenses instead of waiting for human biology to do its job.
In a White House memo on Friday, Trump’s doctor, Dr. Sean Conley, the president received Regeneron’s antibody cocktail “as a precaution.” Conley also wrote that Trump “remains tired but in good spirits”.
Trump has one too light feverNBC News reported Friday afternoon, citing three people familiar with his condition.
The White House did not immediately respond to CNBC’s request for comment on the decision to give Trump the antibody drug.
Gottlieb said he thought if Trump received early treatment for Covid-19 it would be was likely be Gilead Sciences‘remdesivir. The antiviral drug was approved by the FDA in an emergency, but for patients with coronavirus in the hospital who are seriously ill.
“I would have thought that they would use remdesivir as there is more data on this drug at this point and we are seeing the drug being used earlier and earlier as the disease progresses,” said Gottlieb, adding that he was “optimistic” opposite Regeneron is drug, but it’s still very early.
“You could get a lot of use, but you just don’t know,” he said.
Gottlieb, however, pushed back on any suggestion that Trump, who is receiving Regeneron’s treatment, should be a cause for concern. He said virtually every other American at this point in his coronavirus diagnosis would only be monitored by medical professionals in the hopes that symptoms would not worsen.
“For a President of the United States, if you have available therapy, I think you will deliver it, especially if you understand the safety profile of these products and believe that they are otherwise safe and will not make his condition worse,” Gottlieb said.
However, some doctors are skeptical of the decision to treat Trump with the antibody drug. “It’s bad science, bad medicine, and bad ethics to give unproven things to powerful people,” wrote Dr. Vinay Prasad in a Twitter post. Prasad is an associate professor of medicine and a practicing hematologist-oncologist at the University of California at San Francisco.
“I will say that in no case have I heard from a patient, particularly the importance of the president receiving an experimental infusion of an antibody cocktail,” added Seattle-based pulmonologist Dr. Vin Gupta added on MSNBCwho also urged more information from the White House.
In addition to Regeneron’s antibody cocktail, the president also takes zinc, vitamin D and the histamine blocker famotidine.
Treatment with famotidine was “speculative” at the time, although there are studies looking to see if it might be beneficial in coronavirus patients, Gottlieb said.
“There are studies to suggest that vitamin D supplementation can be beneficial when you are low on vitamin D, but you should take vitamin D before you get sick,” he added. “I don’t think any of these drugs are problematic or harm. I just don’t know that they will have any treatment effect in this situation.”