FDA Wins ‘Trump versus Science’
[Editorial essay by David McFarland and Jim Dickinson] President Trump may have bent other federal agencies to his will, but FDA’s win 10/7 in getting the White House to back away (see earlier story) from threats to block a Covid-19 emergency use authorization (EUA) guidance showed that the agency’s internationally recognized “gold standard” in science remains unscathed – for now. Hours after FDA formally released the guidance making a vaccine EUA all but impossible until after the 11/3 elections, a peeved commander-in-chief posted a Tweet openly hitting his own appointee, commissioner Stephen Hahn. It read: “New FDA rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA.”
Executive repercussions apparently included a decision not to contact-trace the cause of Covid-19 infections in the White House. Former commissioner Scott Gottlieb told CNBC’s Squawk Box 10/7 he was “surprised” by this development. Gottlieb, who now serves on the boards of Pfizer, Tempus and contact-tracing biotech company Illumina, hypothesized that there are two possible explanations, one innocent and the other deliberate: (1) that the White House had been just too busy on other priorities, or (2) that it simply did not want to know the cause because that might expose other positive cases and further feed media Covid-19 distractions in the weeks before Election Day.
FDA’s new EUA guidance recommends that manufacturers seeking EUAs follow participants in late-stage clinical trials for at least two months starting after they receive a second vaccine shot. That's important because most severe adverse reactions occur within two months after receiving a vaccine. The new EUA standards will allow science to take its course as FDA data review proceeds, even when expedited, over weeks and possibly months, including the holding of an advisory committee meeting, commissioner Hahn told a Senate Health Education Labor & Pensions Committee hearing recently.
FDA – and more importantly, science and safety – needed this win, and it may signal a tipping point involving a diverse tsunami against political interference and in support of science. After several earlier missteps by Hahn involving EUAs for hydroxychloroquine and convalescent plasma, with both touted by Trump as practically Covid-19 miracles, the commissioner this time held his ground against the political interference and supported decisions by career employees. Allowing continued interference could “misinform the public and distort policy decisions,” a Washington Post editorial board opinion piece reminds us. “Worst of all, it could lead people to lose faith in these public health agencies, cascading into dangerous distrust of a vaccine or drug therapy. It is hard to see the political profit in that.”
FDA officials have been steadfast with agency recommendations to reassure the public that any vaccine authorized for early use will be as safe and effective as possible. Opinion polls about pending Covid-19 vaccines have been worrisome, and they have seen a decline in the share of Americans willing to try a first-generation vaccine as Trump has hyped suggestions that one could be ready before the election. Voter polls are equally disturbing, showing that the majority of voters are concerned about how the Covid-19 pandemic is currently being handled. Backed into a corner and without FDA budging, White House advisors probably had no choice but to recommend backing down to prevent further political damage.
Other health agencies, former FDA and health officials, academia, and industry organizations are fighting hard to support science during the pandemic and their efforts are likely wearing down a depleted White House. No official is more prominent on the airwaves than National Institute of Allergy and Infectious Diseases director Anthony Fauci, who diplomatically and regularly corrects science untruths advanced by Trump, his administration and allies. On the day the FDA guidance was issued, Fauci made media rounds to contradict a Trump tweet suggesting seasonal flu was more deadly than the coronavirus. “It is not correct to say it’s the same as flu,” the government’s top infectious disease expert said. Trump’s much-used social media platforms took the issue a step further. Facebook removed his post, and Twitter added a label warning about the misinformation before a user could click to view it and blocked it from being shared. Increased opposition to these types of science untruths seem to be taking hold and are increasingly recognized by the public.
Writing recently in a Washington Post op-ed, seven former FDA commissioners warned that the perception of political influence in FDA’s science-based decisions matters and say “political intrusion only prolongs the pandemic and erodes our public health institutions.” The op-ed was signed by Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan, and Andrew von Eschenbach. The seven say that a Covid-19 vaccine is urgently needed to reduce the virus’ health impacts and help the country return to normalcy. “But a safe and effective vaccine will not be enough,” they write. “People will also have to choose to take it. This depends on widespread confidence that the vaccine approval was based on sound science and not politics. If the White House takes the unprecedented step of trying to tip the scales on how safety and benefits will be judged, the impact on public trust will render an effective vaccine much less so.” The op-ed also reviewed FDA history as an independent, science-driven agency that has created a worldwide model for evidence-based public policy and also looks at some of the recent issues with political interference in the agency’s work.
With less than one month before Election Day and Covid-19 on the majority of voters’ minds, more attempts at political interference and attacks against science could be expected.