In September of 2020, the CDC issued guidance relating to safety measures on attending religious services that omitted a warning about singing and choirs. The omission was demanded by the Trump Administration despite CDC findings that chanting prayers and singing hymns could spread the Covid virus and be especially deadly.
“I am very troubled on this Sunday morning that there will be people who will get sick and perhaps die because of what we were forced to do,” Dr. Jay Butler, then head of the CDC’s coronavirus response, said in an email after the agency issued guidance it knew to be incomplete.
This anecdote was included in a ProPublica feature published last October about how political pressure and other influences demoralized the CDC, an agency that eradicated smallpox globally and polio in the U.S. ProPublica recounted other incidents CDC insiders considered “hills to die on” but invariably they surrendered. CDC insiders, despite their principals and well-meaning intentions, let the Trump Administration roll over them.
I mention this not to cast judgment on the CDC insiders, but rather to provide context in understanding the bravery and character of Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and a 32-year veteran of the agency, and her deputy, Phil Krause. Gruber and Krause resigned three weeks ago reportedly because of undue political pressure from the Biden Administration and Dr. Fauci to approve Pfizer vaccine boosters for all Americans 16 and over.
FDA’s vaccine advisory panel, comprised of the leading vaccine experts in the U.S., on Friday validated the positions of Gruber and Krause, voting overwhelmingly 16-2 not to authorize the boosters, except for people who are 65 and older or at risk of severe disease. The decisive vote gave me hope that doctors and scientists still have some measure of control and influence over America’s pandemic response, although the FDA isn’t bound by the independent panel’s decision. The agency is temporarily overseen by Janet Woodcock, under whose watch an Alzheimer’s drug was approved despite the recommendation of an independent advisory panel. Woodcock is a Biden Administration appointee.
It’s alarming that politics would figure into decisions impacting the health of Americans and others around the world, as the FDA’s decisions carry considerable weight with regulatory agencies of other countries. Biden’s closest advisor and vaccine czar is Jeffrey Zients, a former Obama aide whose only education credential is an undergraduate degree in political science. Zients made millions serving as a healthcare consultant, an industry rife with conflicts and ethically challenged behaviors. A company Zients oversaw owned a controversial anesthesia outsourcing firm that was involved in so-called surprise billing and other questionable practices. Zients isn’t remotely qualified to make scientific determinations. More on Zients can be found here.
Even more alarming is that by Dr. Fauci’s own admission, there’s little science backing up his aggressive advocacy for boosters. As recently as last week, Fauci admitted at a conference that U.S. data so far revealed only an “inkling” that Pfizer’s vaccine lost substantial efficacy after six months. Fauci was relying on Israeli data, which leading experts warn might not be representative of the U.S. experience.
Fauci admittedly is a physician-scientist and immunologist, but interpreting scientific data is a highly specialized function and requires an expertise that the National Institutes of Health, whose infectious disease unit Fauci oversees, doesn’t have.
“It’s no secret that FDA doesn’t have the disease experts in the way that the NIH does,” Diana Zuckerman, a former senior advisor to Hillary Clinton and president of the nonprofit National Center for Health Research in Washington, D.C., told Kaiser Health News. “And it’s no secret that the NIH doesn’t have the experts in analyzing industry data.”
KHN, a nonprofit news service, is on to Fauci in a very big way. After the Biden Administration and Fauci advocated for boosters weeks ago – a move critics say was intended to distract from the Administration’s debacle in Afghanistan – KHN posted an article quoting experts on-the-record questioning the move.
“I think we’ve scared people,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the National Institutes of Health and the Food and Drug Administration, told KHN. “We sent a terrible message . . . We just sent a message out there that people who consider themselves fully vaccinated were not fully vaccinated. And that’s the wrong message because you are protected against serious illness.”
Dr. Nicole Lurie, a former senior Health and Human Services official in the Obama Administration, told KHN it was irresponsible for the White House to promote boosters before the FDA approved them.
“(The Biden Administration and Fauci) have completely and unfairly jammed FDA. They’ve left them no choice. If there’s no booster program, FDA gets blamed and that’s not appropriate,” Lurie said.
KHN on Thursday posted a feature that revealed Fauci was scheming as early as January to promote boosters, even before Covid vaccines were widely available. In February, scientists working under Fauci organized an international group of epidemiologists, virologists and biostatisticians to track and sequence covid variants. In March, Fauci’s scientists were experimenting with monkeys and reviewing early data from humans showing that booster shots provided a rapid increase in protective antibodies — even against dangerous variants.
Fauci’s initial thesis was that boosters would be required and he was determined to stick with it regardless of whether real world data supported it.
Among the reasons Fauci is so popular with journalists is his delight spreading fear, the bread and butter of America’s corporate media. It’s a skill Fauci honed from his AIDS crisis days. In May 1983, after a scientist published a paper in the medical journal JAMA that an infant had contracted AIDS, Fauci created panic with his speculation that the disease could be contracted through household contact, a theory the New York Times and others reported on.
The infant contracted AIDS through pregnancy, but Fauci’s reckless speculation resulted in gays being ostracized because of fears one could contract AIDS from routine contact. Phillip Magness, of the American Institute for Economic Research, has more insights on this. (Be forewarned: the corporate media dismisses the AIER as an irresponsible right-wing think tank. Magness provides links that confirm his allegations.)
The media promotes the narrative that the FDA is overly cautious and moves too slowly. That’s how Big Pharma regards the agency, but I’ve seen little to back up the claim. A newsletter I subscribe to is chock full of warnings about FDA approved drugs and is very critical of the agency. I’m forever mindful of Frances Kelsey, the FDA reviewer who was maligned as a “bureaucratic nitpicker” for refusing to approve Thalidomide, a drug that caused more than 100,000 babies and killed more than 7,000.
Gruber and Krause, the FDA examiners who resigned because of political pressure, strike me as adhering to the caution of Frances Kelsey. Little has been written about them, which underscores how good a job they’ve done. FDA drug examiners would only attract public attention and scrutiny for a drug they blessed and proved quite harmful.
An industry trade publication called the pending departures of Gruber and Krause a “massive blow to confidence in the agency’s ability to regulate vaccines.” It’s heartening that ACIP withstood political pressure and supported the positions of Gruber and Krause, but it’s tragic they had to resign to make their positions known.
It’s Jeffrey Zients and Dr. Fauci who should resign for playing politics with American lives and promoting boosters based only on a scientific “inkling.”