Health Secretary Robert F. Kennedy Jr. has pledged to purge conflicts of interest from the government agencies he's now in charge of, alleging close ties between employees and the pharmaceutical industry.
In his confirmation hearings for the role, he took aim at Centers for Disease Control and Prevention committee that in setting policies around vaccine schedules and access, the Advisory Committee on Immunization Practices, or ACIP.
on Jan. 29 of the committee: "I think 97% of the people on it had conflicts. I think we need to end those conflicts and make sure that scientists are doing unobstructed science." He was citing an older government report on ethics disclosures, which he said came from a "government oversight investigation committee."
NPR tracked down , spoke with those involved with the CDC's vaccine advisory committee at the time, and learned that Kennedy's statement about it is inaccurate.
"Right now, 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," says , CDC director from 2009 to 2017. He signed the agency's to the report in 2009.
Kennedy reiterated his view, asserting that the agency's federal advisory panels are filled with members that have "severe, severe conflicts of interest" in a subsequent appearance .
These statements have raised concerns with public health advocates that Kennedy may be laying the groundwork to kick members off the CDC's vaccine advisory committee, and replace them with members more aligned with his past advocacy work against vaccines. Prior to his current role, Kennedy founded the anti-vaccine organization Children's Health Defense and served as the group's chairman .
If the panel members are replaced with others less committed to preventing diseases with vaccines, "you could get worse recommendations or you could make vaccines less accessible," says Dr. Walter Orenstein, who served as director of the U.S. immunization program at the CDC from 1988 to 2004 and is now professor emeritus at the Emory School of Medicine.
Conflicts of interest have always been declared and documented at public vaccine advisory committee meetings, but on Friday, Kennedy's team pulled together the last 25 years of conflicts and posted it to the CDC website.
"Rather than conflicts of interest being buried within meeting minutes, this tool quickly provides the public with ACIP members' conflicts of interest," Andrew Nixon, spokesperson for the Department of Health and Human Services, wrote to NPR in an email.
In response to a request for comment on this story, Nixon said: "Secretary Kennedy is committed to ensuring radical transparency across HHS."
Most problems on disclosures were paperwork errors
The 2009 report, titled "" comes from the Office of Inspector General for HHS.
It's an audit of ethics paperwork filed in 2007. It covers all 17 CDC advisory committees at the time, comprising around 250 members who gave guidance on topics like smoking, tuberculosis, and improving clinical labs.
The review, contrary to Kennedy's characterization, it did not find serious conflicts among most members.
What it found was problems with committee members' disclosure paperwork: 97% of the financial disclosure forms filed contained errors or omissions, such as people putting information in the wrong section of the form or incompletely filling out a section, or reviewers forgetting to initial and date amendments to the pages.
Dr. Dale Morse, who chaired the CDC's vaccine advisory committee from 2007 to 2009, remembers working through .
"It was a painful process — like doing your taxes but worse," he says. "You had to list every single category that was listed in [each] portfolio," such as naming each stock or mutual fund held in a retirement account.
Compared to other committees he's served on, Morse says that he thinks ACIP "would be the most complete," in terms of compliance with ethics requirements, Morse says.
But it's hard to say for sure because the report does not break down the analysis by specific committee, and that information is not accessible, said Melissa Rumley, public affairs specialist in the HHS Office of Inspector General, in response to an inquiry from NPR.
She added that she "cannot confirm" that Kennedy's statement about ACIP "was true at the time of our review."
To Frieden, the way that Kennedy characterizes the report amounts to "classic misinformation."
"You start with something that has a kernel of truth — that there was a problem with completing these forms," he says. "And you conflate that [by saying] there are conflicts of interest, which in this case, is absolutely false."
When it comes to actual conflicts of interest that should have been addressed, the number in the report is dramatically less than Kennedy alleged.
The report finds that seven out of 246 members across the CDC's advisory committees voted on issues they were explicitly not allowed to vote on. All were on the same committee, though the report does not name which one.
"I believe that the report is accurate, but when you get down to things that might have been a problem, it's down to 3%," says Dr. Carol Baker, a member of the vaccine advisory committee from 2006 to 2012, who served as chair after Morse.
That is a clear policy violation, so the Office of the Inspector General investigated these cases — and determined that they "did not rise to the level of criminal violations" but stemmed largely from CDC's "systemic lack of oversight" at the time, according to the report.
The report also faulted CDC for not identifying potential conflicts of interest for 58% of committee members. In response, the agency said that the report overstated the problem since it counted a category that was considered exempt: researchers employed by an institution that has any grants related to committee matters, even if they're run by other researchers in different departments.
Taking conflicts of interest seriously
The vaccine advisory committee was strict, in enforcing ethics rules, Baker recalls. Back in 2006, she was an hour or two into her first public meeting as a new voting member, when a CDC staffer interrupted the proceedings. "She tapped me on the shoulder and said, 'Come with me now.' I said, 'Should I bring my purse?' — 'No, bring nothing.' It was dramatic being asked to leave the meeting," Baker says.
The staffer from CDC's legal team erroneously believed that Baker had a "serious conflict" of interest based on the forms she had submitted, and escorted her from the meeting. "It turned out it was just a clerical error," Baker says, but the fact that she was nearly kicked out of her first meeting because they thought she had a conflict of interest reflects how seriously they took the issue, she says.
Several recent ACIP members who have gone through the process within the past five years told NPR the process is intensive. They've filled out those forms for themselves and their family members, and had interviews with CDC staff tasked with managing conflicts of interest.
"There's been such a public eye on the committee — even more so in the past decade," said one former member, who requested anonymity to avoid retaliation. "The process was very, very rigorous."
Members must declare financial ties and relationships they have with vaccine companies, and sever those that conflict with their ability to serve on the advisory committee, which is a voluntary, unpaid position.
Those past ties often exist for valid research purposes, says the former ACIP member: "We're not shilling for the manufacturer — we're trying to answer scientific questions." Researchers sometimes work with manufacturers to test their products in studies, or to give advice on best practices.
Baker, who is known by her peers as the "" recalls giving up her involvement with a company developing a vaccine against the bacteria to serve on ACIP.
"It was a big sacrifice personally," Baker says. She had made a key scientific discovery that led to the vaccine. "I was very emotionally involved, and they felt I was the best person to give them advice and they paid me for my time, which I think is fair."
On joining the vaccine advisory committee, she cut ties with the company for six years. Serving the public mattered more: "I thought I could do more good in my life to prevent children from getting sick or being damaged or even dying by my work on ACIP," she says.
Misleading statements could sow doubt about vaccines
Frieden, the former CDC director, agrees that conflicts of interest are cause for concern. "It is important to avoid impropriety and the appearance of impropriety. It is important that any potential conflict of interest that may unduly influence a recommendation be investigated," he says.
But, Frieden says Kennedy's misleading statements "can undermine confidence in what is a very transparent, fact-based process," in which the committee debates and makes vaccine policies in .
Kennedy's team has already postponed or canceled some public meetings and committees that would have addressed topics such as "how to protect infants from meningitis, which travelers should get a new vaccine that would prevent severe prolonged joint pain," and how flu vaccines should be updated, Frieden says.
Sowing doubts on the integrity of vaccine policymaking could lead to fewer people getting routine vaccines, says Orenstein at Emory. "It really scares me. I've seen measles, I've seen polio cases," he says. "I am very, very concerned that what is happening now will lead to more decreases in vaccine uptake and the return of these diseases."
It also hampers the development of new and better vaccines that could have led to a healthier future, Orenstein says.
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