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Kennedy’s Lawyer Has Asked the FDA to Revoke Approval of the Polio Vaccine
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By The New York Times
Published 6 months ago on
December 13, 2024

Del Bigtree, founder of the Informed Consent Action Network, during an anti-vaccine rally outside the New York State Capitol in 2019 in Albany on May 14, 2019. Bigtree is Robert F. Kennedy’s Kennedy’s former campaign communications director. (Desiree Rios/The New York Times)

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The lawyer helping Robert F. Kennedy Jr. pick federal health officials for the incoming Trump administration has petitioned the government to revoke its approval of the polio vaccine, which for decades has protected millions of people from a virus that can cause paralysis or death.

That campaign is just one front in the war that the lawyer, Aaron Siri, is waging against vaccines of all kinds.

Siri has also filed a petition seeking to pause the distribution of 13 other vaccines; challenged, and in some cases quashed, COVID-19 vaccine mandates around the country; sued federal agencies for the disclosure of records related to vaccine approvals; and subjected prominent vaccine scientists to grueling videotaped depositions.

Much of Siri’s work — including the polio petition filed in 2022 — has been on behalf of the Informed Consent Action Network, a nonprofit whose founder is a close ally of Kennedy. Siri also represented Kennedy during his presidential campaign.

Kennedy, President-elect Donald Trump’s choice for health secretary, has said he does not want to take away access to any vaccines. But as he prepares for his confirmation hearing and plans a fresh health agenda, his continuing close partnership with Siri suggests that vaccine policy will be under sharp scrutiny. It is a chilling prospect to many public health leaders, especially those who recall the deadly toll of some vaccine-mediated diseases.

At the Trump transition headquarters in Florida, Siri has joined Kennedy in questioning and choosing candidates for top health positions, according to someone who observed the interactions but insisted on anonymity to disclose private conversations. They have asked candidates about their views of vaccines, the person said.

Kennedy has privately expressed interest in having Siri serve in the Health and Human Services Department’s top legal job, general counsel. However, Siri has suggested he may have more influence outside the administration. At his law firm, Siri & Glimstad, he oversees about 40 professionals working on vaccine cases and policy.

“Somebody on the outside needs to be petitioning them,” he said on a podcast in late November.

Either way, it’s clear that his voice will be heard at the highest levels.

“I love Aaron Siri,” Kennedy said in a clip played on a recent episode of a podcast hosted by Del Bigtree, who is Kennedy’s former campaign communications director and the founder of the Informed Consent Action Network, which describes itself as a “medical freedom” nonprofit. “There’s nobody who’s been a greater asset to the medical freedom movement than him.”

Won’t Take Away Vaccines for Those Who Want Them

Like Kennedy, Siri insists he does not want to take vaccines away from anyone who wants them. “You want to get the vaccine — it’s America, a free country,” he told Arizona legislators last year after laying out his concerns about the vaccines for polio and other illnesses.

He did not mention the petitions he has lodged on behalf of ICAN with the Food and Drug Administration, asking regulators to withdraw or suspend approval of vaccines not only for polio, but also for hepatitis B.

Siri is also representing ICAN in petitioning the FDA to “pause distribution” of 13 other vaccines, including combination products that cover tetanus, diphtheria, polio and hepatitis A, until their makers disclose details about aluminum, an ingredient researchers have associated with a small increase in asthma cases.

Siri declined to be interviewed, but said all of his petitions were filed on behalf of clients. Katie Miller, a spokesperson for Kennedy, said Siri has been advising Kennedy but has not discussed his petitions with any of the health nominees. She added, “Mr. Kennedy has long said that he wants transparency in vaccines and to give people choice.”

If the Senate confirms Kennedy as health secretary, he will oversee the FDA. In that capacity, he could take the rare step of intervening in the FDA’s review of the petitions.

Vaccines undergo extensive testing before they are approved, and are monitored for safety after they come on the market. The process of taking an established drug off the market can be lengthy. The FDA would need to outline a new safety concern in writing and give the vaccine’s maker a chance to respond. The FDA would then hold a hearing and render a decision. If the company did not agree with the outcome, it could sue.

Trump and Kennedy have spoken about vaccines, the president-elect told Time magazine in an interview published Thursday. Trump pledged to do “very serious testing” and to get rid of some vaccines “if I think it’s dangerous, if I think they are not beneficial.”

During an appearance last weekend on NBC’s “Meet the Press,” Trump said he was open to a review of vaccines and autism. But he singled out the polio vaccine as a potential exception.

“The polio vaccine is the greatest thing,” Trump said. “If someone told me get rid of the polio vaccine, they’re going to have to work really hard to convince me.”

Public health experts describe the polio petition as troubling. In 2022, an unvaccinated man in New York became paralyzed after contracting polio, and experts say the virus is still circulating worldwide.

“It’s an airplane ride away,” warned Dr. Kathryn Edwards, a Vanderbilt University vaccine scientist who was subjected to one of Siri’s lengthy depositions.

Some vaccine scientists credit Siri for drilling into the details of vaccine research that he cites to make his arguments. In some cases, he aligns with vaccine scientists, including a team that in 2004 called for an independent body to review vaccine safety outside agencies that fund or approve them.

Daniel Salmon, director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health, said Siri raises “points that are worthy of exploration,” such as his concern about the safety of aluminum in vaccines.

“There are issues that he raises, such as this one, that really deserve to be studied carefully,” Salmon said. “But it’s got to be done carefully — it’s hard to do.”

Yet Siri’s ascent is concerning to some doctors, who note that it comes at a time of falling vaccination rates in the United States and a rise in cases of measles and whooping cough. His detractors say he twists snippets of science to make questionable claims that will deepen vaccine hesitancy, threatening the system of childhood vaccines that is credited with saving millions of lives.

One critic is Dr. Stanley Plotkin, who in the 1960s invented the vaccine that eliminated rubella, a disease that killed thousands of newborns. Plotkin, who was subjected to a nine-hour deposition as an expert witness in a lawsuit brought by Siri, said having Siri in a position of influence “would be a disaster.” He added: “I find him laughable in many ways — except, of course, that he’s a danger to public health.”

The Placebo Issue

One of Siri’s arguments against vaccines is that some, including the polio and hepatitis B vaccines, have not been tested against placebos in randomized, double-blind clinical trials — the gold standard for medical research, in which some patients get inert vaccines and doctors don’t know which patients get which.

He has called in his petitions for the shots to be pulled from the market until placebo-controlled trials — which would deny some children polio shots — can be completed. Given the known risks of polio causing paralysis that can seize major organs and kill people, such work is considered unethical.

“You’re substituting a theoretical risk for a real risk,” said Dr. Paul A. Offit, a vaccine expert at the Children’s Hospital of Philadelphia. “The real risks are the diseases.”

Siri has indicated he has no intention of stopping. This week, on behalf of ICAN, he sent an “official demand” letter to Xavier Becerra, the current health secretary, instructing the health agency and all of its divisions, including the Centers for Disease Control and Prevention and FDA, to “preserve all documents.”

It ended with a warning: “Note that we will contact the Department of Justice and the inspector general if there is any evidence that any records are destroyed, deleted, modified in any manner before Jan. 21, 2025.”

This article originally appeared in The New York Times.

By Christina Jewett and Sheryl Gay Stolberg/Desiree Rios
c. 2024 The New York Times Company

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