Public health experts are concerned that, if confirmed, Donald Trump’s choice for secretary of the Department of Health and Human Services (HHS) – Robert F Kennedy Jr – could upend access to pharmaceutical drugs in favor of more experimental treatments.
Kennedy, who the president-elect picked earlier this month, has repeatedly expressed distrust for pharmaceuticals, and criticized the FDA for its “aggressive suppression of psychedelics”. On his podcast, he called the US “the sickest country in the world”, blaming its healthcare system for devoting billions to “the pills and the potions and the powders rather than on actually getting people healthy, building their immune systems”.
Kennedy is a surprising choice for a number of reasons. He’s an attorney who lacks government public health experience and has criticized Trump harshly during his own independent presidential campaign.
But, like Trump’s other cabinet picks, Kennedy has expressed a conspiratorial mistrust for the agency he has been tapped to run. Matt Gaetz, who had been tapped to become attorney general before withdrawing himself from consideration on Thursday, believes the January 6 insurrection was a government sham intended to cover a stolen election while Tulsi Gabbard, Trump’s national intelligence pick, has parroted Russian propaganda about US intelligence.
Kennedy has likewise promoted conspiracy theories about the healthcare system he would oversee, including the debunked theory that vaccines cause autism. Even the New York Post, which has praised Kennedy in the past, warned in an editorial board opinion that Kennedy’s confirmation would be disastrous for public health, citing a 2023 interview when “he told us with full conviction that all America’s chronic health problems began in one year in the 1980s.”
Reshma Ramachandran, a physician and director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, says that Kennedy’s theories are “tricky”, because they often contain a mix of truth and conspiracy. Like Kennedy, her team has raised concern about “the corporate influence at federal agencies, and how that might unduly affect regulatory decision making”. Similarly, there is some scientific evidence behind Kennedy’s concerns about the health impact of processed foods – but not his claims that a better diet would solve a plethora of physical and mental health issues.
Ramachandran says Kennedy’s seeming disregard for scientific evidence is deeply concerning.
“Having a healthy skeptic [as HHS secretary] is totally fine,” she said, “but that skepticism needs to come with at least some humility.”
During his campaign, Kennedy repeatedly villainized Adderall and SSRIs, and claimed that, if elected, he would legalize cannabis and use the tax revenue to create “wellness farms” where “we’re going to repair people” with addiction, including to “psychiatric drugs” such as “Adderall”. People who rely on Adderall and SSRIs are worried Kennedy might criminalize their medications.
As HHS secretary, Kennedy would have “quite a bit of power” to upend the healthcare system, says Ramachandran.
While traditionally, HHS defers to agencies such as the FDA, “there may be instances where they have the authority to override agencies.” Ramachandran explained that Kennedy would face legal challenges if he attempted to change the legal status of Adderall, for example, but that he is an expert in liability law and theoretically, he could do it.
Ramachandran is especially concerned that Kennedy will overturn recent FDA decisions he has criticized: in 2020, the FDA pulled hydroxychloroquine as a Covid-19 treatment, citing safety concerns and lack of evidence. This year, the agency rejected Lykos Therapeutics’ MDMA-assisted therapy for PTSD. Some trial participants described adverse effects, including suicidal thoughts and attempts, which they attributed to the trial, but which they say Lykos hid in their clinical trial results – including phase 2 trial results originally published in the journal Psychopharmacology. Psychopharmacology retracted those results as well as two other papers this year by MAPS (the Multidisciplinary Association for Psychedelic Studies, which founded Lykos and conducted the trials). That earlier 2015 Phase 2 trial was already plagued with ethical issues, including a sexual relationship between a therapist and a trial participant, who alleged it was assault. MAPS released a statement condemning this conduct in 2019, four years after it happened. Notably, MDMA increases suggestibility.
A spokesperson for Lykos said it was confident all data was correctly reported. They told the Guardian: “Suicidal thoughts and actions were monitored throughout the trials to check on participant safety using the Columbia-Suicide Severity Rating Scale (CSSRS). If a participant’s CSSRS score rose above their baseline, it was reported to the FDA as an adverse event.” The spokesperson added that those conducting the interviews “were trained to spot when a participant either played down or overplayed symptoms”.
Neşe Devenot, a bioethics researcher affiliated with Johns Hopkins University and the psychedelic harm reduction non-profit Psymposia, organized opposition to Lykos’s treatment. Their research, which has not yet been published, found “the therapy component was based on pseudoscience very similar to Facilitated Communication,” a discredited technique ostensibly intended to help disabled people communicate, that actually gives their “facilitator” power to speak for them.
Kennedy boosted claims that Devenot’s opposition stemmed from hatred toward veterans, and blasted the FDA’s decision, suggesting it illustrated collusion with the pharmaceutical industry.
But Lykos actually has close ties with the established pharmaceutical industry. Jeff George, Lykos’s chairperson, is also on the board of Amneal Pharmaceuticals, a company that makes a variety of traditional drugs, including generic Adderall.
Much of Kennedy’s rhetoric on psychedelics and the pharmaceutical industry echoes that of Elon Musk’s, who Trump has also tapped to join his cabinet. Devenot thinks that Kennedy is heavily influenced by Silicon Valley’s “move fast, break things” ethos around psychedelics – which Musk and others in the tech industry claim are superior to traditional mental health treatments.
Both Devenot and Ramachandran believe psychedelic therapies do have potential – but need more rigorous research.
Ramachandran says if Kennedy chooses to rush approval of Lykos’s therapy or other psychedelic treatments, it could backfire, because accelerated approvals lead to more safety issues.
Devenot can see why it’s appealing to think that psychedelics could be a “miracle solution” for all mental health ills, if only men like Kennedy and Musk could get the FDA out of the way.
“It’s a very reductive way of looking at mental health,” Devenot said, “the reality is a lot more complicated.”
• This article was amended on 26 November 2024 to clarify that references to suggested adverse effects of the MAPS-sponsored Lykos trials were as described by some participants, and to include a response from Lykos. It was also clarified that the ethical issues concerning a sexual relationship and alleged assault arose in the 2015 Phase 2 trial; a link to a statement in response from MAPS was added.
