Kennedy’s Lawyer Has Asked the F.D.A. to Revoke Approval of the Polio Vaccine

Kennedy’s Lawyer Has Asked the F.D.A. to Revoke Approval of the Polio Vaccine

 

Aaron Siri, who specializes in vaccine lawsuits, has been at Robert F. Kennedy Jr.’s side reviewing candidates for top jobs at the Department of Health and Human Services.

 

Christina Jewett Sheryl Gay Stolberg

By Christina Jewett and Sheryl Gay Stolberg

Dec. 13, 2024

https://www.nytimes.com/2024/12/13/health/aaron-siri-rfk-jr-vaccines.html

 

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.

 

Mr. Siri has also filed a petition seeking to pause the distribution of 13 other vaccines; challenged, and in some cases quashed, Covid 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 Mr. 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 Mr. Kennedy. Mr. Siri also represented Mr. Kennedy during his presidential campaign.

 

Mr. Kennedy, President-elect Donald J. Trump’s choice for health secretary, has said that 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 Mr. 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-mitigated diseases.

 

At the Trump transition headquarters in Florida, Mr. Siri has joined Mr. 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.

 

Mr. Kennedy has privately expressed interest in having Mr. Siri serve in the Health and Human Services Department’s top legal job, general counsel. However, Mr. 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,” Mr. Kennedy said in a clip played on a recent episode of a podcast hosted by Del Bigtree, who is Mr. 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.”

 

Like Mr. Kennedy, Mr. 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.

 

Mr. Siri is also representing ICAN in petitioning the F.D.A. 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.

 

Mr. Siri declined to be interviewed, but said all of his petitions were filed on behalf of clients. Katie Miller, a spokeswoman for Mr. Kennedy, said Mr. Siri has been advising Mr. 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 Mr. Kennedy as health secretary, he will oversee the F.D.A. In that capacity, he could take the rare step of intervening in the F.D.A.’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 F.D.A. would need to outline a new safety concern in writing and give the vaccine’s maker a chance to respond. The F.D.A. would then hold a hearing and render a decision. If the company did not agree with the outcome, it could sue.

 

Mr. Trump and Mr. Kennedy have spoken about vaccines, the president-elect told Time magazine in an interview published Thursday. Mr. 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,” Mr. 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,” Mr. 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 Mr. Siri’s lengthy depositions.

 

Some vaccine scientists credit Mr. 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.

 

Dr. Daniel Salmon, director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health, said Mr. 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,” Dr. Salmon said. “But it’s got to be done carefully — it’s hard to do.”

 

Yet Mr. 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. Dr. Plotkin, who was subjected to a nine-hour deposition as an expert witness in a lawsuit brought by Mr. Siri, said having Mr. 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.”

 

A fruitful alliance

Mr. Siri first made news in a vaccine case in New York City in 2015, challenging a rule that required preschool children to get an annual flu shot. He delayed the rule for several years, but lost the case on appeal.

 

The work caught the attention of Mr. Bigtree, a former television producer who was winding up a national bus tour for the movie “Vaxxed: From Cover-Up to Catastrophe,” which was pulled from the Tribeca Film Festival over the concerns of public health leaders.

 

Mr. Bigtree has said on his podcast that he had realized that he needed a capable lawyer to advance his campaign challenging vaccine safety. Through his nonprofit, which flourished during the coronavirus pandemic, Mr. Bigtree began funding Mr. Siri’s legal efforts, paying his law firm $5.3 million in 2022, the most recent year records are available.

 

Over the years, Mr. Siri has helped clients avoid vaccination requirements. He won a case seeking a religious exemption from vaccines in Mississippi schools, and convinced a judge to strike down a Covid vaccine mandate in San Diego public schools.

 

In 2017, Mr. Siri and Mr. Bigtree joined with Mr. Kennedy to meet with the government’s top vaccine experts, including Dr. Anthony S. Fauci, who has since retired from government service, and Dr. Francis Collins, then director of the National Institutes of Health.

 

Afterward, N.I.H. leaders worked through Mr. Kennedy’s relatives to introduce him to Dr. Peter Hotez, a vaccine expert who had a daughter with autism. Dr. Hotez said he tried to explain that researchers believe autism is largely genetic and is observed in early fetal development, before vaccines are administered. “R.F.K. Jr. was deeply dug in,” Dr. Hotez said. “He wasn’t interested in information and the science.”

 

In 2018, Mr. Siri’s star rose with vaccine skeptics after he deposed two renowned vaccine scientists: Dr. Plotkin and Dr. Edwards, who helped create vaccines for whooping cough and flu and one to prevent infection with a deadly bacterium, Haemophilus influenzae type B.

 

Mr. Siri grilled them each for more than eight hours for two separate cases, one in Tennessee, the other in Michigan. Mr. Bigtree later posted snippets of both depositions online, which made the doctors pariahs among vaccine skeptics.

 

“You’re taking the leaders in vaccinology,” Dr. Edwards said, “the people that have spent their whole lives studying these vaccines and seeing their impact, you’re marginalizing and making them look like they are prostitutes of pharma.”

 

Mr. Kennedy, who is also a lawyer, joined Mr. Siri and others in pushing the Tennessee case forward, accusing a doctor of malpractice for giving a boy a measles, mumps and rubella shot in 2001 that they claimed caused his autism. They sought $75 million to cover his lifetime care.

 

Mr. Kennedy sat through the trial and at the end, in early 2022, delivered closing arguments to the jury. He lost: The jury ruled in favor of the doctor.

 

As Mr. Kennedy campaigned for the presidency in 2023 and this year, Mr. Siri remained at his side as his personal lawyer, exhorting federal officials to provide Mr. Kennedy with a security detail and working to remove Mr. Kennedy’s name from ballots in the final days before the election.

 

The placebo issue

One of Mr. 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.”

 

Mr. Siri’s petition to withdraw the polio vaccine also claims that the manufacturer “only assessed safety for up to three days after injection,” and therefore did not meet the F.D.A.’s standard for safety.

 

Ayman Chit, head of vaccines for North America at Sanofi, which makes the polio vaccine that is subject to the petition, said the vaccine has been widely used in North America and Europe and studied carefully in trials with as long as six months of safety follow-up.

 

Dr. Chit said development of the vaccine began in 1977 and included more than 300 studies before and after it was approved. He said more than 280 million people had received the vaccine worldwide.

 

Mr. Siri has also pushed to eliminate secrecy around government decision making. Last week, in response to a lawsuit he filed in 2021, a federal judge ordered the F.D.A. to turn over records related to authorization of the Pfizer Covid shot.

 

The agency said in court filings that it has processed more than 1.2 million pages of records, spending more than $3.5 million on “unprecedented and extraordinary operations” to comply with Mr. Siri’s requests.

 

“This is a way to hobble a public health agency like the F.D.A. — you can just drown them in paperwork so they can’t do their work,” said Lawrence O. Gostin, an expert in public health law at Georgetown University.

 

Mr. 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 C.D.C. and F.D.A., 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 January 21, 2025.”

 

Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy. More about Christina Jewett

 

Sheryl Gay Stolberg covers health policy for The Times from Washington. A former congressional and White House correspondent, she focuses on the intersection of health policy and politics. More about Sheryl Gay Stolberg