Autism groups and researchers have reacted with alarm to a federal research roadmap drawn up by advisers handpicked by the US health secretary, Robert F Kennedy Jr, fearing it will promote unproven fringe therapies at the expense of promising genetic research.
A slew of scientific bodies and groups within the autism community are warning that the 336-page plan risks deflecting federal dollars away from potentially groundbreaking genetic research in favor of unreliable alternative therapies.
There is little or no evidence, they say, that many of the proposed treatments work, or that they even fit the definition of autism.
“So much of the plan is fringe science that is absolutely not ready for prime time,” said Helen Tager-Flusberg, an emeritus professor at Boston University and founder of the Coalition of Autism Scientists.
Alliances of autistic people are especially worried that the plan could make it easier for them to be sent to institutions. The plan calls for government agencies to try out “supported-living models” such as “farmstead or campus-based communities”, which the groups fear could revive forms of institutional confinement.
The strategic plan is the work of the Interagency Autism Coordinating Committee (IACC), a body that for 25 years has advised US health secretaries on federal efforts related to autism.
In January, Kennedy overhauled the panel, replacing prominent experts with several anti-vaccine advocates who have promoted dangerous remedies for autism including the heavy-metal removal process known as “chelation therapy” and the use of industrial bleach.
The strategic plan completed its public consultation last week, inviting comments from the autism community, researchers and clinicians. On Thursday, the committee formally adopted the roadmap, with several of the federal agency representatives on the panel abstaining, some arguing they needed more time to review the details.
The plan ostensibly runs for three years, but its significance could be much more long-lasting. It proposes almost doubling federal spending on autism services, to $760m annually, and if its outline is adopted by the Trump administration it could reframe the way research is done in this area for years to come.
Among the plan’s proposed $270m target specifically for research spending is $15m towards studies of folate biology. This follows a surge of interest in leucovorin or folinic acid, a derivative of vitamin B9 that is commonly prescribed for cancer patients.
double quotation markHere is [a] strategic plan proposing $15m of research money into something that is completely disconnected from the direction of scienceHelen Tager-Flusberg
Last September, Donald Trump and Kennedy jointly embraced leucovorin as “an exciting therapy that may benefit large numbers of children who suffer from autism”.
Leucovorin prescriptions instantly shot up by 71%, as concerned parents rushed to get onboard. But a fierce backlash from scientists also followed, with many experts pointing out that there is scant evidence that folinic acid has any beneficial impact on autism beyond a very small subset of people.
In March, the FDA approved leucovorin only for that subset – those with the extremely rare condition cerebral folate deficiency.
Tager-Flusberg, who herself sat on the IACC until Kennedy’s arrival as health secretary, said that “there is simply no evidence that autistic people suffer from abnormalities in metabolizing folate. Yet here is the strategic plan proposing $15m of research money into something that is completely disconnected from the direction of science.”
A member of Kennedy’s repurposed IACC, Dr Dan Rossignol, runs a private practice, the Rossignol Medical Center, that is a leading provider of leucovorin to autistic people. One of the physicians based at that center, Dr Richard Frye, told NPR that he prescribes the medication to about 80% of his autistic patients.
Rossignol also acts as unpaid chief clinical adviser to Eletala, a company developing folinic acid therapies for autism. He has a 1% equity stake in the enterprise.
The Guardian reached out to Rossignol to ask whether there was a potential conflict of interest in his role advancing leucovorin use for autism and his membership in a group that has just proposed major research funding for the therapy. He said he had complied with all federal ethics guidelines “and any potential conflict was disclosed and addressed through the required ethics process”.
The IACC’s strategic plan was purely advisory with no grant-giving powers, he said. Should the research go ahead, it would be independent of his medical center and of Eletala.
“I contributed to the strategic plan as one member of the IACC, but I did not independently determine the $15m figure, select a funding recipient, or propose that the research be conducted at Rossignol Medical Center,” he said.
Trump and his health secretary have been pushing misinformation and controversial approaches to autism throughout the second Trump administration. Earlier this month, the president signed an executive order that would make sweeping changes to childhood vaccinations, including breaking up the triple MMR vaccine.
The move stems from the debunked and retracted research of the disgraced British doctor Andrew Wakefield, who claimed falsely to have found a link between MMR vaccines and autism.
Emily Hilliard, press secretary for the US Department of Health and Human Services, said that autism affects one in 31 children. More than a quarter of autistic children having profound needs, she said, adding: “Under the Trump administration, IACC believes the scale and complexity of autism demand more than treating it solely as a research topic or a single service category. A challenge of this magnitude requires a plan that connects evidence to federal authority, authority to agency responsibility, and responsibility to measurable results.”
Some aspects of the plan, including its emphasis on providing support for autistic people through their lifetimes and focusing on those with high support needs, are welcomed by scientific and autism groups. But other specific suggestions are raising concerns.
The IACC panel calls for “rigorous testing” of fecal microbiota transplantation (FMT). The experimental procedure would involve small samples of feces from a person with a healthy colon being passed to autistic people with gastrointestinal problems.
The roadmap highlights such gastrointestinal problems as a common challenge for individuals with autism spectrum disorder, that can cause other knock-on difficulties such as lack of sleep, irregular feeding and behavioral issues. It proposes fecal transplants as one potential solution, though it accepts that not enough is yet known to make this a “general autism intervention yet”.
The plan says this should be done through controlled trials. But scientists are concerned that such experiments may not be fully transparent or correctly conducted.
In 2019, the Food and Drug Administration (FDA) issued an official alert that has since been taken off the agency’s website: it warned of the dangers of fecal transplant clinical trials after a patient died and another was severely infected by drug-resistent bacteria contained in the feces.
Another controversial proposal is that autistic people who are non-speaking should be able to access “text-based and letter-based communication”, which the plan says can have “meaningful benefit”. The idea is that a partner – often a parent or an aide – can with training help an individual to express themselves.
That idea is heavily criticised by the Independent Autism Coordinating Committee (I-ACC) that was set up in March by leading autism researchers as a counterweight to Kennedy’s handpicked panel of advisers. It includes several former IACC chairs.
The I-ACC’s public response to the plan is skeptical about “partner-assisted communication”. In backing that approach, the panel departs from its own evidentiary standards, the group says.
“Every rigorous study has found that these methods convey the thoughts and words of the partner, not the autistic person,” the I-ACC objects.
Fears have also been raised that, were the proposals to become policy, they could see a return to the grim history of institutionalized care in which large numbers of people in need of support were warehoused away from the rest of society. For almost 30 years, autism advocates, alongside other disability groups, have fought to have isolating institutional homes closed and people returned to their communities.
In June, the justice department provoked consternation when it released a memo saying that states no longer have to provide community-based care for people with disabilities. The American Association of People with Disabilities told NPR that such a shift would “drag our nation back to a dark and shameful era of ignorance and cruelty”.
The roadmap calls on federal agencies to build supported-living models on at least 10 sites across rural, suburban and urban areas of “small specialized homes, enhanced behavioral-support residences, intentional communities, farmstead or campus-based communities”.
The Autistic Self Advocacy Network (ASAN), a national disability rights organization run by and for autistic people, has objected to the plan on grounds that “it says policies should change to put more autistic people in institutions”.
ASAN is also scathing about the proposal to build more farmsteads, saying: “Farmsteads are still institutions. They still keep autistic people separate from non-disabled people. They still take away autistic people’s freedom.”
