‘Political Intrusion Prolongs the Pandemic’: Op-Ed
Writing in a Washington Post op-ed, seven former FDA commissioners warn 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 reviews 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.
They say the recent shift in public opinion of FDA has potentially dire implications. “When a new drug for cancer or heart disease is approved,” they write, “will clinicians and families trust it to work? And more urgent for today: When FDA approves a Covid-19 vaccine, will Americans accept it?”
If FDA makes available a safe and effective vaccine that people trust, the former commissioners say, “we could expect to meaningfully reduce Covid-19 risk as soon as next spring or summer. Without that trust, our health and economy could lag for years.”
The commissioners say they still have confidence in the integrity and high-quality scientific work of FDA staff. “Following defined practice,” they explain, “each vaccine clinical trial will continue until independent oversight boards and the sponsoring manufacturers stop them. FDA has already effectively communicated its strict standard for evidence from these trials to the manufacturers, despite comments from the White House. The health professionals whom people still trust won’t recommend a vaccine that hasn’t met FDA’s standards. Drugmakers have also pledged to use FDA’s scientific standards….With more than 750 Americans on average dying a day from Covid-19, FDA must be supported to play its unique and essential role. Scientists should make decisions based on data, unfettered by political pressure or the intrusions of ideology or vested interests.”