罗伯特·肯尼迪的律师已要求 FDA 撤销对脊髓灰质炎疫苗的批准
【中美创新时报2024 年 12 月 13 日编译讯】（记者温友平编译）帮助罗伯特·肯尼迪 (Robert F. Kennedy Jr.) 为即将上任的特朗普政府挑选联邦卫生官员的律师已请求政府撤销对脊髓灰质炎疫苗的批准，该疫苗几十年来保护了数百万人免受可能导致瘫痪或死亡的病毒的侵害。《纽约时报》记者克里斯蒂娜·朱厄特 (Christina Jewett) 和谢丽尔·盖伊·斯托尔伯格 (Sheryl Gay Stolberg)对此作了下述详细报道。
这场运动只是律师亚伦·西里 (Aaron Siri) 针对各种疫苗发起的战争中的一个战线。
Siri 还提交了一份请愿书，要求暂停分发其他 13 种疫苗；挑战并在某些情况下撤销了全国范围内的 COVID-19 疫苗强制令；起诉联邦机构披露与疫苗批准相关的记录；并让著名的疫苗科学家接受严酷的录像作证。
Siri 的大部分工作（包括 2022 年提交的脊髓灰质炎请愿书）都是代表知情同意行动网络 (Informed Consent Action Network) 进行的，该网络是一个非营利组织，其创始人是肯尼迪的亲密盟友。Siri 还在肯尼迪的总统竞选期间代表他。
肯尼迪是当选总统唐纳德·特朗普 (Donald Trump) 选择的卫生部长，他表示不想剥夺任何疫苗的获取途径。但在他准备确认听证会并计划新的健康议程时，他与 Siri 的持续密切合作表明疫苗政策将受到严格审查。对于许多公共卫生领导人来说，这是一个令人不寒而栗的前景，尤其是那些记得某些疫苗介导疾病的致命损失的人。
据一位观察了互动但坚持匿名披露私人谈话的人说，在佛罗里达州的特朗普过渡总部，Siri 与肯尼迪一起询问和选择高级卫生职位的候选人。这位人士说，他们询问了候选人对疫苗的看法。
肯尼迪曾私下表示有兴趣让 Siri 担任卫生与公众服务部的最高法律职位——总法律顾问。然而，Siri 暗示他在政府之外可能拥有更大的影响力。在他的律师事务所 Siri & Glimstad，他负责管理大约 40 名从事疫苗案件和政策工作的专业人员。
“需要有人从外面向他们请愿，”他在 11 月下旬的播客中说道。
无论如何，很明显，他的声音将被最高层听到。
“我喜欢 Aaron Siri，”肯尼迪在最近一集播客的片段中说道，该播客由 Del Bigtree 主持，他是肯尼迪的前竞选通讯主管，也是知情同意行动网络的创始人，该网络自称是一个“医疗自由”非营利组织。“没有人比他对医疗自由运动的贡献更大。”
和肯尼迪一样，Siri 坚称他不想从任何想要疫苗的人手中夺走疫苗。 “你们想接种疫苗——这是美国，一个自由的国家，”去年，在阐述了他对脊髓灰质炎和其他疾病疫苗的担忧后，他告诉亚利桑那州的立法者。
他没有提到他代表 ICAN 向食品和药物管理局提交的请愿书，要求监管机构撤回或暂停批准不仅针对脊髓灰质炎的疫苗，还针对乙型肝炎的疫苗。
Siri 还代表 ICAN 向 FDA 请愿，要求“暂停分发”其他 13 种疫苗，包括涵盖破伤风、白喉、脊髓灰质炎和甲型肝炎的联合产品，直到它们的制造商披露有关铝的详细信息，研究人员认为这种成分与哮喘病例的小幅增加有关。
Siri 拒绝接受采访，但表示他的所有请愿书都是代表客户提交的。肯尼迪的发言人凯蒂米勒 (Katie Miller) 表示，Siri 一直在为肯尼迪提供建议，但尚未与任何健康提名人讨论他的请愿书。她补充说，“肯尼迪先生，他是一位非常优秀的医生，他是一位非常优秀的医生。”肯尼迪长期以来一直表示，他希望疫苗透明化，并给予人们选择权。”
如果参议院批准肯尼迪担任卫生部长，他将负责监督 FDA。以这种身份，他可以采取罕见的措施，干预 FDA 对请愿书的审查。
疫苗在获得批准前要经过广泛的测试，上市后还要接受安全性监控。将一种成熟药物从市场上撤下的过程可能很漫长。FDA 需要以书面形式概述新的安全问题，并给疫苗制造商一个回应的机会。然后，FDA 将举行听证会并做出决定。如果该公司不同意结果，它可以起诉。
当选总统特朗普在周四发表的《时代》杂志采访中告诉《时代》杂志，他和肯尼迪谈到了疫苗。特朗普承诺进行“非常认真的测试”，并取消一些疫苗，“如果我认为它很危险，如果我认为它们没有好处”。
上周末在 NBC 的“与媒体见面”节目上露面时，特朗普表示他愿意接受对疫苗和自闭症的审查。但他指出脊髓灰质炎疫苗是一个潜在的例外。
“脊髓灰质炎疫苗是最伟大的东西，”特朗普说。 “如果有人告诉我要放弃脊髓灰质炎疫苗，他们就必须非常努力才能说服我。”
公共卫生专家称脊髓灰质炎请愿书令人不安。2022 年，纽约一名未接种疫苗的男子在感染脊髓灰质炎后瘫痪，专家表示这种病毒仍在全球传播。
“只需坐飞机就能到达，”范德比尔特大学疫苗科学家凯瑟琳·爱德华兹博士警告说，她曾接受过 Siri 的一次冗长的证词。
一些疫苗科学家称赞 Siri 深入研究了疫苗研究的细节，并引用这些细节来论证自己的观点。在某些情况下，他与疫苗科学家站在一起，包括一个团队，该团队在 2004 年呼吁一个独立机构审查疫苗安全性，而这些机构不是资助或批准他们的机构。
约翰霍普金斯大学彭博公共卫生学院疫苗安全研究所所长丹尼尔·萨蒙表示，西里提出了“值得探讨的观点”，比如他对疫苗中铝的安全性的担忧。
“他提出的一些问题，比如这个问题，确实值得仔细研究，”萨蒙说。“但必须小心谨慎——这很难做到。”
然而，西里的崛起让一些医生感到担忧，他们指出，这发生在美国疫苗接种率下降、麻疹和百日咳病例增加的时候。他的批评者说，他扭曲科学片段，做出可疑的断言，这将加深人们对疫苗的犹豫，威胁到儿童疫苗体系，而该体系被认为挽救了数百万人的生命。
一位批评者是斯坦利·普洛特金博士，他在 20 世纪 60 年代发明了一种疫苗，消灭了风疹，这种疾病曾导致数千名新生儿死亡。普洛特金在 Siri 提起的诉讼中作为专家证人接受了长达九小时的质证，他说让 Siri 处于有影响力的位置“将是一场灾难”。他补充说：“我觉得他在很多方面都很可笑——当然，除了他对公众健康构成威胁之外。”
富有成效的联盟
Siri 首次登上新闻是在 2015 年纽约市的一起疫苗案件中，他对一项要求学龄前儿童每年接种流感疫苗的规定提出了质疑。他推迟了这项规定几年，但在上诉中败诉。
这项工作引起了比格特里的注意，比格特里曾是一名电视制片人，他当时正在为电影《疫苗接种：从掩盖到灾难》的全国巴士巡演做准备，这部电影因公共卫生领导人的担忧而被从翠贝卡电影节撤下。
比格特里在他的播客中表示，他已经意识到他需要一位有能力的律师来推进他挑战疫苗安全性的活动。通过他的非营利组织（该组织在冠状病毒大流行期间蓬勃发展），Bigtree 开始为 Siri 的法律工作提供资金，并在 2022 年向他的律师事务所支付了 530 万美元，这是有记录的最近一年。
多年来，Siri 帮助客户避免了疫苗接种要求。他赢得了一场寻求密西西比州学校疫苗接种宗教豁免的案件，并说服法官推翻了圣地亚哥公立学校的新冠疫苗强制令。
2017 年，Siri 和 Bigtree 与 Kennedy 一起会见了政府顶级疫苗专家，包括现已从政府部门退休的 Anthony Fauci 博士和时任美国国立卫生研究院院长的 Francis Collins 博士。
之后，美国国立卫生研究院的领导通过肯尼迪的亲戚，将他介绍给了彼得·霍兹博士，霍兹是一位疫苗专家，他的女儿患有自闭症。霍兹说，他试图解释说，研究人员认为自闭症主要是遗传性的，在接种疫苗之前的胎儿早期发育中就已发现。“罗伯特·肯尼迪非常固执，”霍兹说。“他对信息和科学不感兴趣。”
2018 年，Siri 在疫苗怀疑论者中声名鹊起，因为他罢免了两位著名的疫苗科学家：普洛特金和爱德华兹，他们帮助研制了百日咳和流感疫苗，以及一种预防致命细菌 B 型流感嗜血杆菌感染的疫苗。
Siri 就两起不同的案件对他们分别进行了 8 个多小时的质询，一起发生在田纳西州，另一起发生在密歇根州。后来，比格特里在网上发布了两份证词的片段，这让这两位医生在疫苗怀疑论者中成了弃儿。
“你们把疫苗学领域的领军人物，那些花了一生研究这些疫苗并看到其影响的人边缘化，让他们看起来像是制药公司的妓女。”
肯尼迪也是一名律师，他与 Siri 等人一起推动田纳西州的案件，指控一名医生在 2001 年给一名男孩注射麻疹、腮腺炎和风疹疫苗，这是医疗事故，他们声称这导致了他的自闭症。他们要求 7500 万美元支付他的终身护理费用。
肯尼迪参加了审判，并在 2022 年初向陪审团发表了结案陈词。他输了：陪审团裁定医生胜诉。
在肯尼迪 2023 年和今年竞选总统期间，Siri 一直陪伴在他身边，担任他的私人律师，敦促联邦官员为肯尼迪提供安全保障，并在选举前最后几天努力将肯尼迪的名字从选票中删除。
安慰剂问题
Siri 反对疫苗的理由之一是，包括脊髓灰质炎和乙肝疫苗在内的一些疫苗没有在随机双盲临床试验中与安慰剂进行对比测试——这是医学研究的黄金标准，在这种试验中，一些患者接种的是无效疫苗，医生不知道哪些患者接种的是哪些疫苗。
他已呼吁将这些疫苗撤出市场，直到完成安慰剂对照试验——这将拒绝一些儿童接种脊髓灰质炎疫苗。鉴于脊髓灰质炎可能导致瘫痪、夺走主要器官并导致死亡的已知风险，此类工作被认为是不道德的。
“你用理论风险代替了实际风险，”费城儿童医院的疫苗专家 Paul A. Offit 博士说。“真正的风险是疾病。”
Siri 撤回脊髓灰质炎疫苗的请愿书还声称，制造商“仅评估了注射后最多三天的安全性”，因此不符合 FDA 的安全标准。
赛诺菲公司北美疫苗负责人艾曼·奇特 (Ayman Chit) 表示，该疫苗已在北美和欧洲广泛使用，并在长达六个月的安全跟踪试验中进行了仔细研究。
奇特表示，该疫苗的研发始于 1977 年，在获批前后进行了 300 多项研究。他说，全球已有超过 2.8 亿人接种了该疫苗。
Siri 还推动消除政府决策的保密性。上周，作为对他在 2021 年提起的诉讼的回应，一名联邦法官下令 FDA 移交与辉瑞 COVID 疫苗授权相关的记录。
该机构在法庭文件中表示，它已经处理了超过 120 万页记录，花费超过 350 万美元进行“前所未有的非凡行动”，以满足 Siri 的要求。
“这是束缚 FDA 等公共卫生机构的一种方式——你可以让他们淹没在文书工作中，让他们无法开展工作，”乔治城大学公共卫生法专家 Lawrence O. Gostin 说道。
Siri 表示他无意停止。本周，他代表 ICAN 向现任卫生部长 Xavier Becerra 发送了一封“正式要求”信，指示卫生机构及其所有部门，包括疾病控制和预防中心和 FDA，要“保留所有文件”。
信的结尾是一条警告：“请注意，如果有任何证据表明任何记录在 2025 年 1 月 21 日之前以任何方式被销毁、删除或修改，我们将联系司法部和监察长。”
本文最初刊登于《纽约时报》。
题图：罗伯特·肯尼迪 (Robert F. Kennedy Jr.) 汤姆·布伦纳 (Tom Brenner)/《华盛顿邮报》
附原英文报道：
RFK Jr.’s lawyer has asked the FDA to revoke approval of the polio vaccine
By Christina Jewett and Sheryl Gay Stolberg New York Times,Updated December 13, 2024
Robert F. Kennedy Jr.Tom Brenner/For the Washington Post
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.”
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.”
A fruitful alliance
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 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.
Bigtree has said on his podcast that he had realized he needed a capable lawyer to advance his campaign challenging vaccine safety. Through his nonprofit, which flourished during the coronavirus pandemic, Bigtree began funding Siri’s legal efforts, paying his law firm $5.3 million in 2022, the most recent year records are available.
Over the years, 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, Siri and Bigtree joined with Kennedy to meet with the government’s top vaccine experts, including Dr. Anthony Fauci, who has since retired from government service, and Dr. Francis Collins, then director of the National Institutes of Health.
Afterward, NIH leaders worked through Kennedy’s relatives to introduce him to Dr. Peter Hotez, a vaccine expert who had a daughter with autism. Hotez said he tried to explain that researchers believe autism is largely genetic and is observed in early fetal development, before vaccines are administered. “RFK Jr. was deeply dug in,” Hotez said. “He wasn’t interested in information and the science.”
In 2018, Siri’s star rose with vaccine skeptics after he deposed two renowned vaccine scientists: Plotkin and Edwards, who helped create vaccines for whooping cough and flu and one to prevent infection with a deadly bacteria, Haemophilus influenzae type B.
Siri grilled them each for more than eight hours for two separate cases, one in Tennessee, the other in Michigan. Bigtree later posted snippets of both depositions online, which made the doctors pariahs among vaccine skeptics.
“You’re taking the leaders in vaccinology,” 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.”
Kennedy, who is also a lawyer, joined 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.
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 Kennedy campaigned for the presidency in 2023 and this year, Siri remained at his side as his personal lawyer, exhorting federal officials to provide Kennedy with a security detail and working to remove Kennedy’s name from ballots in the final days before the election.
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’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 FDA’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.
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.
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 FDA 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 Siri’s requests.
“This is a way to hobble a public health agency like the FDA — 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.
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.
