The recent passing of Francis Kelsey served as a cautionary reminder of the critical role the FDA plays and the importance of its staffers being freed of political and business pressures.
Kelsey was the Canadian-born FDA examiner who in 1960 withstood considerable pressure to approve the anti-nausea drug Thalidomide because she determined there was sufficient data linking the product to birth defects. Kelsey was ridiculed as a “bureaucratic nitpicker,” but she wouldn’t back down and was ultimately proved correct. Kelsey’s stubbornness averted a national U.S. tragedy, but the drug was marketed and sold in Canada, Europe, Japan, and elsewhere. It is estimated that 100,000 babies worldwide were born with defects because of the drug. More than 7,000 died.
The FDA, whose approvals influence health agencies round the world, is facing an unprecedented test of its expertise and integrity. In addition to being pressured to approve in record time Covid vaccines that were developed with unrivaled speed, the FDA must also approve emergency treatments that possibly could save millions from dying. There are few people who can claim they carry the weight of the world on their shoulders. The folks at the FDA are among them.
That is why the medical world, and the public should be alarmed by a rash of resignations of FDA senior officials and advisors in recent months, including the agency’s two top vaccine experts whose pending departures were disclosed Tuesday. The only science one needs to understand what’s going on is the political kind.
The New York Times and other publications reported that Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, and her deputy, Phil Krause, have resigned. According to the Times and other reports, Gruber and Krause were angered that the Biden Administration promoted vaccine booster shots without the FDA having approved them.
The departures of Gruber and Krause come in the wake of the resignation last month of veteran drug expert Ellis Unger, who was known for his outspokenness and willingness to call out FDA decisions he deemed questionable. One of the decisions Unger questioned was the FDA’s approval of Biogen’s controversial Alzheimer’s disease drug, Aduhelm (aducanumab), which the FDA blessed despite an agency advisory panel recommending that it be rejected. Within three days of the approval, three doctors on the advisory panel resigned.
The FDA’s Aduhelm approval was supported by acting Commissioner Janet Woodock, who was installed by President Biden. Jeffrey Zients, who co-chaired Biden’s transition committee and now oversees the Administration’s Covid response, likely played a role in Woodcock’s appointment. I’ll explain the significance in a moment.
Although the Times and other publications downplayed the loss of Gruber and Krause, trade publications that follow the FDA understood the significance. Endpoints News, which covers Biopharma, called it a “massive blow to confidence in the agency’s ability to regulate vaccines.”
The publication said FDA’s former chief scientist Luciana Borio noted on Twitter, “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service . . . These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave.”
Endpoints said Rick Bright, former director of Biomedical Advanced Research and Development Authority, tweeted, “Dr. Gruber is much more than the Director. She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-cov-2, many others.”
In addition to their possibly unrivaled experience, the educational credentials of Gruber and Krause are impressive. According to Gruber’s LinkedIn profile, she graduated magna cum laude with a PhD in microbiology and immunology from the University of Kiel in Germany and holds a master’s degree in biology from Ulm University, also in Germany. According to Krause’s LinkedIn profile, he holds an MD degree from Yale, an MBA from Florida State, and a MS computer science degree from the University of Illinois Urbana-Champaign. (Gruber and Krause interestingly have only 233 and 147 respective connections on LinkedIn.)
If ESPN covered the FDA, they’d be all over the resignations of Gruber and Krause and demanding answers who’s responsible for the agency losing its two superstar vaccine players in the midst of a Super Bowl pandemic. Unfortunately, America’s pandemic response is covered by Washington reporters, more concerned about protecting sources who give them “scoops” than serving as a watchdog against questionable public policy involving Democratic Administrations. This likely explains the Times’ docile coverage of Gruber’s and Krause’s resignations.
The Biden Administration leaked to the Times that it planned to promote booster shots, and you can rest assured that if Zients wasn’t directly responsible for the leak, he supported it. The leak came while President Biden was under fire for the disaster in Afghanistan and was intended to distract from the bad publicity. That’s not only my opinion but also that of Marty Makary, professor of surgery and health policy at Johns Hopkins University School of Medicine.
In its story about the resignations of Gruber and Krause, the Times quotes Zients as saying “we announced our (booster) approach in order to stay ahead of the virus, give states and pharmacies time to plan, and to be transparent with the American people.” The story notes Zients said the booster strategy was contingent on FDA approval and that acting Commissioner Woodcock supported it.
The Times neglected to mention that the Biden Administration apparently doesn’t have all the much confidence in Woodcock because it leaked to Bloomberg that it doesn’t plan to nominate her to hold her job permanently. As for boosters being contingent on FDA approval, I know of many instances of people assuming boosters are safe and rushing out to get them. Many doctors are on record saying there isn’t sufficient data to justify boosters, but the Biden Administration hasn’t taken any measures or issued any warnings about getting them.
The media has yet to explain why the Biden Administration wants to throw Woodcock under the bus. In another curious twist, Woodcock has asked the inspector general overseeing the FDA to investigate the agency’s approval of Biogen’s Alzheimer’s drug. The request came after a report that Biogen executives met with FDA officials to discuss a regulatory pathway for getting the company’s Alzheimer’s drug approved. While we would all like to believe the FDA is staffed by people beyond ethical reproach, for some it’s a stepping stone to a lucrative Big Pharma job.
I’ve previously written about Zients and why he is unqualified and failing leading America’s pandemic response. In addition to possibly being responsible for the FDA losing its most capable vaccine experts at the height of the pandemic, the Biden Administration’s singular focus getting all of America jabbed is questionable.
Even experts who support vaccinations say vaccines alone won’t combat the pandemic. One of those experts is Ran Balicer, who is a doctor and public health expert and chairman of an advisory committee to the Israeli government. Balicer in May published a paper warning that even if most of Israel was vaccinated, it would be imperative that other restrictions remain in place. Balicer’s recommendations were ignored, and Israel is at the brink with Covid again.
Robert Carnahan, associate director of the Vanderbilt Vaccine Center, also insists that relying solely on vaccines is misguided.
“It is clear that we need additional solutions beyond vaccines to protect those most vulnerable members of our society, such as the immunocompromised,” Carnahan was quoted in a news release this week announcing the discovery of a monoclonal antibody “cocktail” that protects immunocompromised and chronically ill adults exposed to Covid by 77%.
Vanderbilt said it would apply for regulatory approval, but one must wonder if the FDA has the qualified talent and resources to review and approve promising applications in a timely matter. Recruiting qualified people to join the agency will be a challenge given the mounting adverse publicity.
The public should be demanding an expedited inquiry into the FDA’s affairs. Something clearly is amiss.