President Donald J. Trump has repeatedly tried to undermine the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (F.D.A.) and now, with just two weeks until Election Day, the world is learning more about the behind-the-scenes battles that have shaken these governmental entities to the core.
Approximately two weeks after Trump's release from Walter Reed Medical Center, there is no "cure," as the president stated, and he is not "immune." No one is immune - and there is no successful vaccine, regardless of how much Trump claims one will arrive before Nov. 3. The F.D.A. published the guidelines in briefing materials to an advisory committee that will discuss them on Thursday, effectively making them official. To be clear, the F.D.A.has not approved Trump's miraculous cure of a cocktail - even though he has claimed differently.
A senior administration official, who spoke to The New York Times on condition of anonymity, denied that Dr. Stephen M. Hahn and the president’s chief of staff, Mark Meadows, were deeply at odds over the vaccine guidance, saying “the two have a good relationship.” According to the source, Meadows’ only concern was that changing the guidance in the middle of ongoing clinical trials could confuse vaccine makers, who noted that the White House eventually approved it.
“The White House has always encouraged the F.D.A. to follow the science and their expert medical viewpoints while also encouraging the F.D.A. to work around the clock to help advance therapeutics and ultimately a vaccine that will save American lives," said White House Communications Director Alyssa Farah.
An F.D.A. spokesman also told the Times that the White House and the Department of Health and Human Services “continue to support the science-based decisions of the agency’s career professionals.”
“It’s better late than never, but I do think we can see a lot of damage has been done,” said Dr. Jesse L. Goodman, the F.D.A.’s chief scientist from 2009 to 2014. “And I don’t think they are out of the woods yet.”
In the past, Trump has openly accused the F.D.A. of engaging in politics to harm his re-election campaign. For this and other reasons, Hahn has tried to shield his staff and White House officials from the drama created by the commander-in-chief, asking that all calls be routed directly to him and not to his staff. Alex M. Azar II, the secretary of health and human services and Hahn’s direct superior, has also questioned Hahn’s motives in some conversations with the White House, multiple officials told the Times.
Hahn is an oncologist and former hospital administrator with no experience in Washington. Under his command, the F.D.A. authorized hydroxychloroquine for hospitalized COVID-19 patients despite a lack of evidence, only to reverse the decision once the drug was tied to severe side effects. In August, Hahn also made a significant error at a news conference with Trump announcing the approval of plasma treatments for COVID-19. The commissioner greatly exaggerated the benefits of the treatment, angering the scientific community. He publicly corrected the record.
“I think that was really a wake-up call about the legacy of his leadership,” said Goodman.
A month later on Sept. 11, a group of career scientists at the F.D.A. released a rare joint letter with a promise to continue their work unimpeded and independent of political influence.
“We absolutely understand that the F.D.A., like other federal executive agencies, operates in a political environment,” they wrote. “That is a reality that we must navigate adeptly while maintaining our independence to ensure the best possible outcomes for public health... We and our career staff do the best by public health when we are the decision makers, arriving at those decisions based on our unbiased evaluation of the scientific evidence.”
Hahn agreed and shared this tweet:
In an op-ed today, career FDA leaders took the initiative to independently express their steadfast trust in the exp… https://t.co/a7orKYNDoc— Dr. Stephen M. Hahn (@Dr. Stephen M. Hahn)1599745607.0
In an interview on Oct. 15, Hanh addressed the public outcry for a valid vaccine, saying that data from clinical trials would first be evaluated by an independent monitoring board and that when the F.D.A. reviews the data, it will not “cut corners."
The F.D.A. has committed to "ensuring that data from COVID-19 vaccine trials is reviewed in a transparent, deliberative manner. To this end, the agency intends to convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) when data from trials becomes available. VRBPAC is one of the many advisory committees at FDA, and is composed of independent experts in the fields of vaccine safety and infectious disease. By convening VRBPAC, FDA will ensure public transparency around discussions of vaccine safety and effectiveness tp provide a window into its decision-making process and help address potential concerns from vaccine-hesitant populations. As trials reach completion in the coming months, we are committed to ensuring the agency impartially reviews the evidence and reaches decisions based on established regulatory standards."