WASHINGTON (AP) — When President Donald Trump’s administration announced it would repurpose an old, generic drug as a new treatment for autism, it came as a surprise to many experts — including the physician who suggested the idea to the nation’s top health officials.
Dr. Richard Frye told The Associated Press that he had been in discussions with federal regulators about developing a customized version of leucovorin for children with autism, assuming further research would be necessary.
“We were kinda surprised that they were just approving it right out of the gate without more studies or anything,” Frye remarked, noting his work within the realm of experimental treatments.
This announcement adds to the controversy surrounding the Trump administration's approach to autism treatments, with critics arguing that the drug needs significantly more study before it can be considered a viable treatment option.
The nation’s leading autism groups and researchers quickly distanced themselves from the decision on leucovorin, labeling the supporting studies as “very weak” and “very small.” David Mandell, a psychiatrist at the University of Pennsylvania, expressed that there is currently no reasonable evidence indicating that leucovorin effectively treats autism symptoms.
Mandell emphasized the prevailing consensus that autism primarily originates from genetic factors, complicating the justification for using leucovorin as a treatment option. Despite this skepticism, a growing number of doctors have begun to prescribe the drug, which poses the risk of many patients experiencing unwarranted side effects.
Frye and his colleagues have paused their development of a new version of the drug after the FDA announcement merely updated the label on the generic formulation to include information about boosting folate levels in autism patients. Experts say this may encourage further prescriptions without comprehensive understanding or evidence of its effectiveness.
Many in the medical community advocate for further research on the potential effects of leucovorin for patients with folate deficiencies. However, they urge that such studies be conducted in controlled environments before widespread application in treatment protocols.
As discussions around this controversial treatment continue, it remains paramount for experts to scrutinize and validate any proposed therapies to ensure patient safety and care.