“Can I trust that that is now in the past? Can data and information change your opinion or will you only look for data supporting a predetermined conclusion?” That’s what Sen. Bill Cassidy said of Robert F. Kennedy Jr.’s anti-vaccine views during a confirmation hearing for Kennedy’s nomination to lead the Department of Health and Human Services.
The Senate confirmed Kennedy after Cassidy’s deciding vote to advance his nomination. To justify his support, the Louisiana Republican cited multiple commitments he had secured from Kennedy. “If confirmed, he will maintain the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices without changes,” Cassidy said of the key federal panel responsible for vaccine recommendations.
But on Monday night, Cassidy released a statement calling for that committee to delay its scheduled meeting this week after Kennedy blew up the panel earlier this month, replacing all 17 members with a much smaller group consisting mainly of vaccine skeptics and individuals with little experience in immunology, epidemiology, or vaccine development. The move is Kennedy’s latest in a series of actions targeting vaccines’ status as a longstanding pillar of American public health.
Kennedy justified the wholesale sacking of the Advisory Committee on Immunization Practices (ACIP) as necessary to restore public trust in vaccines, alleging that the committee was irredeemably corrupted by members’ ties to vaccine manufacturers. But the secretary has not substantiated the allegations, and several of the new members have the same types of conflicts that he assailed. Health policy scholars and former committee members see the move as simply a pretext to seed vaccine skepticism rather than improve public trust in the credibility of the panel.
“I fired people who had conflicts with the pharmaceutical industry,” Kennedy said in testimony before the House Committee on Energy and Commerce on Tuesday. In statements and interviews, Kennedy has repeatedly pointed to two decades-old reports to justify his claims.
In 2000, the staff for the Republican chair of the Committee on Government Reform produced a report on conflicts of interest among ACIP members and a separate Food and Drug Administration vaccine advisory panel. Democrats on the committee strongly contested the reports’ claims of conflicts influencing the committee’s decisions and noted that the committee members complied with what the ACIP disclosure rules were at the time. (The committee chair, Rep. Dan Burton, held a series of hearings throughout the early 2000s elevating vaccine skepticism, including more than a dozen on the supposed links between vaccines and autism—he has two grandchildren, including one who is autistic, that he believes were harmed by vaccines.)
Kennedy has also frequently cited a 2009 HHS Office of Inspector General report claiming the office found 97 percent of ACIP members didn’t complete full conflict-of-interest disclosures. In reality, the report examined more than a dozen CDC advisory committees’ 2007 records, not just ACIP. It found a 97 percent rate of omissions on a complex disclosure form but noted that many of the omissions involved information not being listed in the proper section or information that was left out of the form but included in other material, like a committee member’s CV. Seven of the 246 panel members examined in the report, or 3 percent, voted on issues that conflict-of-interest rules should have precluded them from voting on, but it’s unclear whether those members were even part of ACIP. The report noted that all seven were on a single committee but did not name the body.
“What we’re getting is a total misrepresentation of a 20-year-old report, about a process that was already being improved before that report was issued,” said Tom Frieden, who served as CDC director when the report was released. The CDC had already begun working on tightening its disclosure processes to address the errors and moved to implement all the recommended improvements.
Regardless of how Kennedy has portrayed the dated reports, he has not presented evidence of undisclosed or compromising conflicts of interest that resulted in a corrupted ACIP recommendation in the nearly two decades since, let alone for the recently dismissed ACIP panel members.
ACIP’s current rules prevent any member or immediate family member from being employed by a vaccine manufacturer, holding stock in any manufacturer, or receiving royalties or other compensation for any vaccine or vaccine component that the committee may consider during their tenure. Members also must resign from any consulting or advisory roles with manufacturers during their tenure on the committee—exceptions are made for participating in clinical trials or serving on safety data monitoring boards for manufacturers. Members are also prohibited from serving as consultants or paid witnesses in vaccine litigation during their time on the committee.
The CDC may grant waivers to members who have a conflict of interest to allow them to participate in discussions related to a particular vaccine (e.g., a member is serving on the data board for the vaccine), but they are not allowed to vote on any recommendations involving that vaccine. Former ACIP members have noted that the panel’s disclosure practices are more stringent than any other advisory committee they’ve served on.
“The idea that these advisory committees need to be independent, need to avoid the appearance of bias that could compromise trust in their decisions, is something that the committee and CDC, and FDA as well, have been thinking about really at the top of their mind for literally decades,” Jason Schwartz, a professor at the Yale School of Public Health who researches vaccine policy-making, including the work of ACIP, told The Dispatch.
In March, HHS released a searchable database of the conflicts and appearance of conflicts disclosed by ACIP members during their public meetings over the last 20 years, part of the secretary’s pledge to increase transparency. Rather than backing Kennedy’s claims, the disclosures, which were already public, detail how members have followed the disclosure requirements and recused themselves from votes when appropriate. “This was very carefully crafted over 30, 50 years, and the procedures gradually improved, and they improved in ways to make sure that the science was excellent, and they also removed any taint on the science,” Myron Levin, who served as ACIP chair in the early 2000s, told The Dispatch.
Kennedy and his allies often portray any interaction or tie to a pharmaceutical manufacturer as inherently suspect. For instance, critics claim that panel members from universities or research institutions that receive funding from pharmaceutical companies are biased even when the funding is not tied to projects members are working on or their positions; to avoid the appearance of inappropriate conflicts, members publicly disclose institutional funding ties at ACIP meetings in addition to disclosing them internally to the CDC as part of the committee membership’s vetting process.
“These disclosures were portrayed inaccurately as evidence of wrongdoing but actually reflected a process that had been [protecting] against real or perceived conflicts of interest,” Frieden, the former CDC director, said in an analysis of the disclosure data he coauthored this week.
Former ACIP members emphasized that individuals best qualified to evaluate vaccines are often those who have worked in vaccine development, including clinical trials. “If you’re looking for individuals who have never had any interaction with a vaccine manufacturer at any point in decades-long careers, you’re not going to find that among the committee,” Schwartz said, “but also it would call into question whether you would want experts who wouldn’t have had [that] kind of expertise.”
Several of Kennedy’s picks for the reconstituted ACIP have had the same kind of conflicts he argued were disqualifying for past committee members.
Martin Kulldorff, one of the newly appointed members, has served as a paid expert witness in litigation against the pharmaceutical manufacturer Merck regarding its HPV vaccine. As recently as January, he has produced reports on behalf of plaintiffs suing Merck, and he’s listed as a witness in court filings for a separate case that is still pending, according to court documents first reported by Reuters. It’s unclear whether Kulldorff has removed himself from participation in ongoing vaccine litigation as previously required for ACIP members. The appearance of either such a recent or ongoing conflict would have almost certainly fallen under the public disclosures requirement for each meeting. Kulldorff said at the outset of Wednesday’s meeting that he had no conflicts of interest to disclose.
Robert Malone, another new panel member, has also served as a paid expert witness in a separate whistleblower lawsuit over Merck’s mumps, measles, and rubella vaccines, producing a report on behalf of the plaintiffs. After his announcement as a new ACIP member, Malone said that his consultation work for that case “ended in 2018/2019,” but he also noted “my hourly rate at that time was $350. My hourly rate for expert witness work is now $450,” potentially suggesting he has provided paid testimony more recently in other cases. At Wednesday’s meeting, he said that he had no conflicts of interest and that “any potential conflicts of interest have been analyzed and vetted and declared lacking” by CDC staff. Malone has also worked and consulted for multiple pharmaceutical companies and vaccine manufacturers over the course of his career.
Michael Ross, a licensed physician and a partner at a health care private equity fund, was one of the original eight new members named by Kennedy. Ross removed himself from the committee, apparently as a result of the financial vetting process, but his financial and professional ties to the medical and biotech industry were already clear and even highlighted in Kennedy’s initial announcement. What is unclear is why Kennedy selected Ross in the first place. His medical background is in obstetrics and gynecology, and he was once a member of the CDC’s Advisory Committee for the Prevention of Breast and Cervical Cancer. Ross was a signatory to an open letter criticizing a 2021 study published in the Journal of the American Medical Association that found ivermectin was not an effective COVID treatment.
Another new member calls into question Kennedy’s “clean sweep” to rid ACIP of members with connections to vaccine manufacturers. He appointed Cody Meissner, a well-respected vaccine expert and pediatrician who previously served on ACIP from 2008 to 2012. Meissner previously disclosed ties to multiple vaccine manufacturers and participated in several vaccine clinical trials funded by manufacturers, but he also supported Kennedy’s recent unilateral decision to remove the COVID vaccine recommendation for pregnant women and healthy children.
The controlling criteria for Kennedy appear not to be a lack of industry ties but proximity to his personal views on vaccines.
Kennedy’s own words hint at what the conflict-of-interest claims seem to really be about. “The problem isn’t necessarily that ACIP members are corrupt,” he wrote in a Wall Street Journal op-ed earlier this month. “Most likely aim to serve the public interest as they understand it. The problem is their immersion in a system of industry-aligned incentives and paradigms that enforce a narrow pro-industry orthodoxy.” He was sharper in his House testimony on Tuesday, saying, “That committee has been a template for medical malpractice for 30 years.”
As the ramifications of replacing ACIP’s former members with a group of Kennedy’s choosing become fully realized, medical associations and state governments have already begun to look elsewhere for credible guidance and recommendations on vaccines, moves that will likely accelerate if the new panel seems to be advancing the secretary’s vaccine skepticism.
Sen. Cassidy said during a confirmation hearing Wednesday for the Trump administration’s CDC director nominee, Susan Monarez, “The people on [ACIP], although scientifically credentialed, no one has the experience with immunizations, the kind of already [held] knowledge, to say, ‘Well, wait a second, the evidence that you’re presenting, there’s a lot more evidence to say it’s not true.’”
Cassidy said he trusted that she would help ensure the integrity of the panel. Time will tell whether, if confirmed, Monarez will depart from Kennedy’s agenda for ACIP. But Cassidy’s currently 0-for-1 on placing his trust in HHS nominees.
