“This Is What It Has Come To”: Amid Fears of Politicization at FDA, Big Pharma Pledge to "Stand With Science" Is Met With Skepticism
September 9, 2020
Pennsylvania Commonwealth microbiologist Kerry Pollard performs a manual extraction of the coronavirus inside the extraction lab at the Pennsylvania Department of Health Bureau of Laboratories (governortomwolf)
By Julia Conley
Public health experts reacted with cautious optimism on Tuesday after nine major pharmaceutical companies signed a pledge saying they won't seek approval for a coronavirus vaccine until after Phase 3 trials are completed, in an attempt to allay fears that the release of a vaccine will be politicized.
The companies—including Pfizer, Moderna, AstraZeneca, and GlaxoSmithKline—released the statement as concerns mounted that President Donald Trump will pressure the industry and the Food and Drug Administration to approve a vaccine in time for the November 3 general election.
Pledging to "stand with science," the CEOs of the companies wrote that they will "only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA."
The pledge comes amid speculation, driven by Trump's repeated statements pushing for the approval of treatments and vaccines for Covid-19, that the FDA is under pressure from the White House to release a vaccine to the public before the completion of Phase 3 trials—the standard randomized and controlled studies used to test a drug's efficacy and safety.
On Monday, Trump said in a news conference without citing any scientific data that he believes "we're going to have a vaccine very soon. Maybe even before a very special date. You know what date I'm talking about." Privately, Trump campaign advisors reportedly refer to a pre-Election Day vaccine as "the holy grail," and last month, CDC Director Robert Redfield called on states to be ready to distribute a vaccine by November 1. The push led the World Health Organization to warn last week that no approved vaccine for Covid-19 is expected until mid-2021.
Fears of the politicization of public health have intensified as the FDA has reacted to the White House's recent statements; days after Trump suggested on Twitter that "the deep state" had infiltrated the agency and was stopping officials from approving Covid-19 treatments until after the election, FDA Commissioner Stephen Hahn joined the president at the press conference and claimed that convalescent plasma improved outcomes for 35% of patients who received it.
Soon after, Hahn apologized for overstating the effects of plasma, which, according to British physician Dr. Rachel Clarke, showed a mortality reduction rate of 3.5% "at most" in a single study.
The public's reliance on pharmaceutical CEOs who say they won't seek vaccine approval until randomized, controlled studies are completed is a sign of regulatory breakdown, suggested Dr. Ali Nouri, president of the Federation of American Scientists.
"When was the last time we had to place more faith in pharma than the FDA?" wrote Dr. Eric Topol of the Scripps Research Translational Institute.
"It is simply remarkable and beyond dangerous that President Trump has so politicized the vaccine process to the point that drug corporations—the least trusted industry in America—are now the messengers on vaccine safety," said the public health advocacy group Lower Drug Prices Now. "It is the job of elected officials and government regulators, not corporations, to police safety for consumers. Yet, Donald Trump continues to prioritize his own narrow political goals over the needs of the American people, undermining public health and ignoring his responsibility as president."
The pledge was released on the heels of several polls which show Americans are wary of taking a Covid-19 vaccine which hasn't been rigorously tested.
A survey taken last week by STAT-Harris showed that 78% of respondents believe the push for vaccine approval is being dictated by politics, not science.
In May, 31% of respondents in an AP-NORC poll said they were "unsure" if they would take a Covid-19 vaccine once one becomes available, and vaccine researcher Dr. Natalie Dean wrote in a New York Times op-ed that the hesitancy was understandable, considering the White House's insistence on finding a vaccine at "warp speed."
"I'm a vaccine researcher, and even I would place myself in the 'not sure' bucket," wrote Dean. "The evidence that would convince me to get a Covid-19 vaccine, or to recommend that my loved ones get vaccinated, does not yet exist."
Epidemiologist Eric Feigl-Ding tweeted last week as news broke that the pharmaceutical companies' pledge was forthcoming that he was "hopeful" the statement would ensure no vaccine would reach the public until it is sufficiently tested.
"But given every crazy batshit unprecedented thing Trump has done, I'm worried," he tweeted, writing that the president could launch "a Nixon-era Saturday Night Massacre to force this vaccine in October."
At STAT News, columnist Ed Silverman wrote that Pfizer, unlike the rest of the companies which signed the pledge, has stated it may complete Phase 3 trials by the end of October, potentially triggering a vaccine approval far ahead of the schedule global public health experts have put forth. At a press conference last Friday, Trump called the company's CEO a "great guy" and said Pfizer was a "leader" in the race to find a vaccine.
Considering the visible politicization of the vaccine research upon which millions of Americans are relying, wrote Silverman, "The pharmaceutical industry is keenly aware that its reputation is also at stake."
"These public pronunciations are not simply altruistic attempts to take the moral high ground," wrote Silverman. "With each tweet and off-the-cuff remark about the vaccine timeline, Trump is eroding whatever confidence the public may have in vaccine makers, which is already questionable as far as some people are concerned...And simply put, that's not good for business."
Lower Drug Prices Now agreed, calling on Democrats in Congress to make sure Americans are not offered an insufficiently-tested vaccine.
"In the middle of the biggest public health crisis of our lifetimes, Americans need concrete assurance that a vaccine is safe, affordable, and effective from the government, not gimmicks from corporate executives," said the group. "A vaccine is the only way out of the pandemic. Since President Trump has made clear that his priority is winning the election whatever the cost, it’s up to Democrats in Congress to safeguard Americans' health and pass the long-overdue reforms we need to ensure access to affordable, safe Covid medicines.”
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