WASHINGTON (AP) — President Trump’s administration has faced sharp criticism following its decision to approve leucovorin, an old generic drug, as a new treatment for autism. While the news shocked many experts, Dr. Richard Frye, the pediatric neurologist who proposed the drug, acknowledged that he didn't expect the government to move forward so quickly without further research.
Frye expressed his surprise to The Associated Press, noting that systemic studies were necessary before validating leucovorin as a credible treatment for autism, a complex neurological condition.
This hasty announcement has many professionals and leading autism organizations distancing themselves from the FDA's endorsement, emphasizing that the evidence backing leucovorin's efficacy is minimal at best.
David Mandell, a psychiatrist at the University of Pennsylvania, stated, “We have nothing resembling even moderate evidence that leucovorin is an effective treatment for autism symptoms.” Furthermore, Mandell pointed out that current research indicates that autism is largely genetic, with additional factors potentially affecting its onset.
Despite the lack of substantial proof, leucovorin is being prescribed by a growing number of practitioners, with some administering versions used in chemotherapy, or developing new formulations. Medical professionals, however, stress the importance of conducting controlled clinical trials to ensure patient safety and treatment effectiveness.
Research into leucovorin's potential began over two decades ago when low folate levels in autistic individuals were noted. However, skepticism remains high as previous theories linking folate deficiency to autism have lost traction due to conflicting evidence.
While appetite for leucovorin has surged, driven by anecdotal success stories from parents discussing their children's improvements, experts urge caution, asserting that the drug should only be utilized within strictly regulated clinical environments. As the situation unfolds, the ongoing debate regarding the approval and promotion of unproven treatments raises ethical questions about the healthcare of vulnerable populations.
