Photo: Photo For The Washington Post By Al Drago
WASHINGTON - In another era, what happened Wednesday might have been viewed simply as good news. Two companies, Regeneron Pharmaceuticals and Eli Lilly, have independently developed therapeutic drugs, called monoclonal antibodies, that in preliminary testing appear to reduce symptoms for coronavirus patients. They applied for emergency use authorization from the Food and Drug Administration.
The positive development immediately became entangled in election-year politics, with President Donald Trump repeatedly making false and exaggerated claims about the new therapeutics. He called them a cure, which they're not. He said he was about to approve them - a premature promise given that the FDA's career scientists are charged with reviewing the applications.
Politics has thoroughly contaminated the scientific process in 2020. The result has been an epidemic of distrust, which further undermines the nation's already chaotic and ineffective response to the novel coronavirus, which causes the illness covid-19.
The White House has repeatedly meddled with decisions by career professionals at the FDA, Centers for Disease Control and Prevention and other science-based agencies. Many of the nation's leading scientists, including some of the top doctors in the administration, are disturbed by the collision of politics and science and bemoan its effects on public health.
"I've never seen anything that closely resembles this. It's like a pressure cooker," Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview.
Trust has been damaged by White House intrusions and the FDA's mistakes. This year, the agency granted emergency authorization to hydroxychloroquine, the malaria drug wrongly touted by Trump as a treatment for covid-19, then reversed course when it became clear that the medication could cause dangerous complications. In August, FDA Commissioner Stephen Hahn drew criticism for inaccurately describing the benefits of convalescent plasma, statements for which he later apologized.
Millions of Americans have embraced some version of a conspiracy theory that imagines the pandemic as a wildly exaggerated threat, or even an outright hoax, pushed by politically motivated scientists and the mainstream media to undermine the president. This is a form of science denial that leads many people to refuse to wear masks or engage in social distancing.
Scientists, meanwhile, worry that the politicization of the regulatory process could undermine the rollout of a vaccine even if it is approved by career professionals at the FDA. This is shaping up as a communications challenge for the government: Many people will want to know who, exactly, is approving a vaccine.
"If the public health professionals, if Dr. Fauci, if the doctors tell us that we should take it, I'll be the first in line to take it. Absolutely," Sen. Kamala Harris, D-Calif., the Democratic nominee for vice president, said in Wednesday's debate with Vice President Mike Pence. "But if Donald Trump tells us that we should take it, I'm not taking it."
Moments later, Pence said it is "unconscionable" for Harris "to undermine public confidence in a vaccine." He added, "Stop playing politics with people's lives."
The scolding by Pence was remarkable given that Trump has repeatedly framed the vaccine effort in terms of the November election - including just hours before Wednesday's vice-presidential debate, when he came close to accusing his own government's scientists of trying to delay a vaccine.
"We're going to have a great vaccine very, very shortly. I think we should have it before the election, but frankly the politics gets involved. And that's OK. They want to play their game. It's going to be right after the election. But we did it," Trump said in a video taped at the White House and posted on social media.
Trump said it was a blessing that he had fallen sick with covid-19, and he implied that no one would have recognized the potential of the laboratory-brewed antibodies without his insight. But medical experts point out that the president was given a suite of drugs, including a powerful steroid, and that it is impossible to know what role the antibodies may have played in his recovery, or even whether he is fully recovered.
The president said these antibodies would soon be available to everyone in the country - another falsehood. Regeneron has said it could produce about 300,000 doses by the end of the year. That is roughly how many new cases of the coronavirus are being reported nationally every week.
Two administration officials who spoke on the condition of anonymity to discuss internal matters said the White House has pushed Hahn to approve the monoclonal antibodies. The applications are being handled by the FDA's Center for Drug Evaluation and Research, which is led by career scientists. Hahn could potentially short-circuit the normal review process, but in a keynote address to the Food and Drug Law Institute conference on Tuesday he said decisions are made by civil service professionals.
Still, Hahn has to answer to Health and Human Services Secretary Alex Azar, who in turn has to answer to Trump, who is vigorously pushing a false narrative about the imminent end to the pandemic.
"I'm telling you, we have a cure. More than just a therapeutic. We have a cure," Trump said Friday on Rush Limbaugh's syndicated radio show.
Scientists are not naive enough to think they can operate in a politics-free zone. But Trump and his allies have continued to deliver messages at odds with the guidance from the administration's own experts. The result is a government that chronically sends mixed messages, adding to the incoherence of the response to the pandemic.
Fauci, who did not directly criticize Trump or other administration officials, noted the historically unfortunate timing of the pandemic overlapping with the 2020 election. The vaccine "kind of slipped into the timing of a very politically charged season at a time when there's extraordinary divisiveness that seems to permeate our society at every level," he said.
Francis Collins, director of the National Institutes of Health, said that it would be "a tragedy" if the nation turned its back on a safe and effective vaccine, and that "we won't be able to put this behind us even though we have the scientific tools to do that. That is an absolutely terrible outcome for a technologically advanced society."
On Friday, Collins addressed the potential breakthrough with monoclonal antibodies and lamented that the issue already has a political tinge.
"If you're looking for a therapeutic success story, this I think is shaping up very well. But now it is overshadowed," Collins said. "If it does get approved for scientific reasons, everyone will be suspicious that it is because of political manipulation. And that makes me sad. I'm absolutely confident that FDA will not allow that to happen."
Fauci and Collins have reason to worry: Polls show trust in a potential vaccine has plunged. A Pew Research poll in September found that 21% of respondents said they would definitely get a coronavirus vaccine if it were available immediately, down from 42% in May.
Johnna Munsen, a 20-year-old college student who lives in Los Angeles, said she wants a vaccine for herself and her parents, who are in their 50s. But she said she has been alarmed by Trump's repeated predictions that a vaccine would be available by the Nov. 3 election, and by his assertions during the presidential debate that government scientists were wrong in saying it would take longer.
"If it gets pushed to coincide with the election, I don't know that I would trust the safety of it," Munsen said.
The vaccine approval process "should be based on the highest quality science and discussion, and involve a thoughtful balancing of benefits and risks," said Aaron Kesselheim, a professor of medicine at Harvard University's medical school. "But there are substantial concerns it is being hopelessly tarnished by impulsive comments from somebody who is only thinking about his personal political implications."
To try to counter such concerns, medical experts emphasize the nation's long-standing, rigorous process of clearing vaccines, starting with randomized clinical trials and including reviews by independent data and safety monitoring boards and a panel of outside advisers to the FDA. They say the system is set up to protect it from political or financial interference. They insist any nefarious effort to push through an unsafe or ineffective vaccine would be blatantly obvious and would surely fail.
Vaccine makers, which include large pharmaceutical firms and biotechnology companies, have powerful corporate incentives to avoid producing and selling a flawed or dangerous product, medical experts point out.
Still, even those who are expressing confidence in the process worry about public opinion. Mistrust - toward Congress, Wall Street, the pharmaceutical industry, the news media - has been endemic in the United States for many years.
More recently, it has been weaponized by Trump as part of his populist appeal and his argument that there is a "deep state" opposing him.
Democrats, meanwhile, have also responded to the crisis in ways that could undermine the FDA, agency backers say. Senate candidate Cal Cunningham, D-N.C., said last month that he would hesitate to take a vaccine approved before Election Day, though he later softened his comments.
New York Gov. Andrew Cuomo, a Democrat, said recently that he would commission an expert panel to review the FDA vaccine decision, something his office characterizes as a way to bolster public confidence. But Eric Topol, director of the Scripps Research Translational Institute, called the idea of states reviewing FDA decisions "ridiculous."
Topol on Friday directed his consternation at Trump's hyping of monoclonal antibodies as a cure for covid-19: "It's ruined in a way, because he says he's going to get it out before the election. This was the most promising thing in the hopper, a glowing opportunity. Now, it's contaminated."
The nation has long relied on an unseen army of government professionals - scientists, doctors, engineers, technicians, statisticians - to safeguard public safety amid a freewheeling market-based economy. But trust in government expertise has shown itself to be fragile.
An Axios-Ipsos poll in mid-September found more than 40% of Americans have either not very much trust in the FDA or none at all to look out for their interests.
The implications of such falling trust "are potentially dire," wrote seven former FDA commissioners in a recent Washington Post opinion article that called on the Trump administration to stop meddling in the FDA's sensitive decisions.
Inside the agency, officials realize they have a daunting challenge. They have to persuade the public that, even in a crisis atmosphere in which a vaccine is desperately needed, the procedures supervised by the FDA are sufficiently sturdy that they can withstand the political pressures in an election year.
"The most important thing that I think I can do . . . in the coming months is to help generate trust, regain trust in vaccines," Peter Marks, the FDA career official who oversees vaccines, said at a virtual meeting held by the advocacy group Friends of Cancer Research recently. "Vaccines have saved public health previously. They will save it again. We just are going to have to believe in them."
Vaccine development is happening globally. In the United States, four companies have started Phase 3 trials, the final phase, involving 30,000 to 50,000 volunteers each: AstraZeneca, Johnson & Johnson, Moderna and Pfizer. AstraZeneca's trial remains on hold in the United States as regulators try to determine whether a serious side effect experienced by a participant in Britain was caused by the vaccine. Another company, Novavax, has begun a late-stage trial in Britain and is scheduled to start one this month in the United States.
These are randomized trials in which participants don't know whether they've been given the vaccine candidate or a placebo. The data is reviewed by independent groups - data safety monitoring boards - when a certain number of people in the trial get covid-19. If more of the people who became infected come from the placebo arm of the trial, in a statistically significant way, that is a signal the vaccine is working.
The FDA has said a vaccine must be at least 50% effective to get approval, though a higher protective effect is greatly desired.
But this process cannot be rushed. For ethical reasons, researchers cannot intentionally expose volunteers to the coronavirus. The participants have to go about their ordinary lives. Researchers monitor the volunteers who received the vaccine candidate to make sure there are no side effects.
If the data safety monitoring board concludes that the vaccine candidate is effective and safe, it will alert the manufacturer, which would then decide whether to seek a standard licensing approval or emergency use authorization from the FDA. Given the urgency of the coronavirus crisis, the FDA is expected to clear the first coronavirus vaccines on an expedited, emergency basis.
But before the agency makes a decision, it will consult with its own panel of outside experts in a public meeting, FDA officials have said.
Such guardrails, and other parts of the regulatory process, make it hard - though not impossible - for the White House to subvert the FDA's judgment. When Trump officials recently objected to the planned release of an FDA guidance detailing rigorous standards for the vaccine, agency officials made clear that they would stick to the criteria and had already conveyed them to vaccine makers.
It is difficult for the FDA to win widespread public confidence amid the "steroidal level" of today's political pressure, said Daniel Carpenter, a professor of government at Harvard University and an expert on the FDA.
"You have a deeply polarized electorate, an authoritarian president who wants to use the levers of government to give himself an advantage electorally and a pandemic in the middle of the campaign," Carpenter said.
Fauci said scientists, such as Collins and himself, and others in the scientific community would be watching the approval process closely.
"If someone tries to mess with that, politically, it will be obvious," he said. "And then you will hear the shouts go up."
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The Washington Post's Carolyn Y. Johnson contributed to this report.