Commentary
In a recent interview, Dr. Robert Califf, the commissioner of the Food and Drug Administration, admitted to helping Pfizer promote its antiviral drug “Paxlovid.”
“I felt that I had an obligation as a public health official, to point out that the evidence was strong,” Dr. Califf said during the medical ground round
discussion at UCSF.
Dr. Califf acknowledged that it wasn’t accepted practice for the FDA to promote products the agency regulated but said the world was undergoing extenuating circumstances.
“I don’t think any FDA commissioner alive has been through a pandemic like this. I think this is a very unusual situation,” he said.
“In normal times, the FDA should not be a cheerleader, the FDA is a referee calling balls and strikes ... but in this case, we were in the middle of a pandemic, people were dying at very high rates,” he said.
Dr. Califf explained that Pfizer wasn’t able to advertise Paxlovid because, under section 564 of the Federal Food, Drug & Cosmetic Act, drug companies cannot advertise their products unless they are fully approved.
At the time, Paxlovid had only emergency use authorization (EUA).
“Remember with an EUA the company can’t advertise,” Mr. Califf explained. “The purchasing is not done by sales reps selling in hospitals and practices; it’s bulk purchasing by the government.”
Consequently, Dr. Califf took to social media to promote Paxlovid based on his observation that “almost everyone who was dying or getting severely ill was not up to date on vaccination and had not been given the opportunity to take an antiviral.”
It’s not clear why Dr. Califf felt the need to promote the use of Paxlovid given the U.S. government had already committed to
purchasing 10 million treatment courses at a cost of $5.29 billion.
Dr. Califf cited a single
clinical trial that found an 89 percent relative reduction (6 percent absolute reduction) in the risk of hospitalization and death in people who took the drug compared with people who didn’t.
But what Dr. Califf did not say was that the trial was conducted between July 16 and Dec. 9, 2021, which was before the emergence of the omicron variant that was less virulent than the progenitor virus.
He also did not mention that the clinical trial of Paxlovid recruited only unvaccinated people who had never previously been exposed to COVID-19.
Knowing how Paxlovid would perform in “real world scenarios” was unproven since most Americans had already been vaccinated and had
prior exposure to COVID-19. By
May 2022, 76 percent of U.S. adults were vaccinated, and an estimated 58 percent already had COVID.
An
observational study from Israel supported Dr. Califf’s proposition that Paxlovid could reduce hospitalizations and deaths among high risk patients aged 65 and over, but these types of studies have
major limitations, making it difficult to draw causal inferences.
Pfizer did actually commence a randomized clinical trial of Paxlovid in vaccinated people at lower risk of COVID-19. This represented the best opportunity to obtain high-quality evidence rather than relying on confounded observational data.
However, Pfizer
abandoned the trial in December 2022 “due to a very low rate of hospitalization or death observed in the standard-risk patient population.”
Jessica Adams, an FDA regulatory affairs expert, said, “Something is really wrong with public health ‘leadership’ that thinks every norm can be thrown out the window in an emergency.”
“I wish the heads of our public health agencies could reflect more deeply with the benefit of hindsight. It seems to be that Califf somehow doesn’t see how off-putting it was to watch him promote Paxlovid the way he did,” Ms. Adams said.
“The FDA has learned nothing during the pandemic and is setting terrible precedents for future emergencies,” she added.
In fact, FDA’s own drug advisory committee was
requesting further data about which populations would benefit from Paxlovid over others, but this did not temper Dr. Califf’s enthusiasm for promoting the drug.
Dr. Califf boasted on social media that he took Paxlovid after contracting COVID and said the drug could
reduce the risk of “long COVID” even though that was never validated by robust trials, leading
some to criticize him for being “a billboard for Pfizer.”
Dr. Califf understood that his comments have attracted criticism but said someone had to make tough decisions during an emergency.
“You have to make decisions more like an ICU doctor than a doctor in a situation who can give advice and have the patient come back three months later,” Dr. Califf said.
“You’re going to be wrong some of the time and criticism is fair. I feel like I was right in this case,” Dr. Califf insisted.
In October 2022, the FDA quietly
relaxed its rules regarding the promotion and advertising of drugs under EUA, including Paxlovid.
Dr. Califf has continued to promote Paxlovid despite multiple reports of COVID “rebound” in people after taking the drug, something that he has tried to dismiss as a “distraction.”
But it’s been hard to ignore when high-profile figures such as former Centers for Disease Control and Prevention Director Dr.
Rochelle Walensky, former director of the National Institute of Allergy and Infectious Diseases Dr.
Anthony Fauci, and President
Joe Biden have all experienced a Paxlovid rebound.
In May this year, Paxlovid received
full FDA approval for managing mild to moderate COVID-19 infections in adults who are at high risk of developing severe disease—more than 11.6 million treatment courses of the drug have been prescribed in the United States alone.
Update from reader: “Paxlovid showed no significant reduction in the risk of all-cause mortality on day 28 and the duration of SARS–CoV-2 RNA clearance in hospitalized adult COVID-19 patients with severe comorbidities.” (published in THE LANCET Regional Health, April 2023) Views expressed in this article are opinions of the author and do not necessarily reflect the views of The Epoch Times.
