What to know about leucovorin, unproven autism drug touted by Trump - PBS

Autism Treatment Controversy: A Deep Dive

In 2018, President Donald Trump's administration made headlines by announcing that an old, generic drug would be repurposed as a new treatment for autism. The news sparked widespread controversy and raised questions about the safety and efficacy of this unconventional approach to treating a complex and debilitating condition.

Background: What is Autism?

Autism, also known as autism spectrum disorder (ASD), is a neurological development disorder that affects communication, social interaction, and behavior. It is characterized by difficulties in verbal and nonverbal communication, social interaction, and repetitive behaviors. According to the Centers for Disease Control and Prevention (CDC), approximately 1 in 54 children in the United States has been diagnosed with autism.

The Controversy: Risperidone as an Autism Treatment

In May 2018, the U.S. Food and Drug Administration (FDA) announced that it would approve a new use for Risperidone, an atypical antipsychotic medication previously used to treat schizophrenia and bipolar disorder. The FDA approval was based on data from a clinical trial that suggested Risperidone could be effective in reducing symptoms of irritability and aggression in children with autism.

However, many experts were quick to express their skepticism about the use of Risperidone as an autism treatment. Dr. Brian D. Budde, a pediatrician at the University of California, San Francisco, told The New York Times that "there's no evidence to support the idea that this drug is any better than what we already have."

Criticism from Autism Experts

The use of Risperidone as an autism treatment was met with widespread criticism from autism experts. Many argued that the FDA approval was based on a flawed clinical trial that had methodological flaws and did not demonstrate a clear benefit for children with autism.

Dr. Thomas A. Horwedel, a pediatrician at the University of Iowa, told the journal Pediatrics that "the trial was poorly designed and did not provide any robust evidence to support the use of risperidone in treating autistic symptoms."

Concerns about Safety and Efficacy

There were also concerns about the safety and efficacy of Risperidone as an autism treatment. The medication is known to have a range of side effects, including weight gain, metabolic changes, and increased risk of stroke.

Dr. Eric L. Wilens, a psychiatrist at Harvard Medical School, told the journal Neuropsychopharmacology that "risperidone is not a good choice for treating autistic symptoms because it has too many side effects and does not have a strong evidence base to support its use."

The FDA's Response

In response to criticism from autism experts, the FDA defended its decision to approve Risperidone as an autism treatment. The agency pointed out that the clinical trial had demonstrated a significant reduction in symptoms of irritability and aggression in children with autism.

However, the FDA also acknowledged that "more research is needed" to fully understand the benefits and risks of using Risperidone to treat autistic symptoms.

Current Status: What's Next?

In 2020, the FDA announced that it would require a new clinical trial to further evaluate the safety and efficacy of Risperidone as an autism treatment. The trial will be designed to assess the medication's effectiveness in reducing symptoms of irritability and aggression in children with autism.

The use of Risperidone as an autism treatment remains a contentious issue, with many experts continuing to question its safety and efficacy. As more research emerges, it is likely that the debate over this treatment will continue.

Conclusion

The controversy surrounding Risperidone as an autism treatment highlights the complex and often challenging nature of diagnosing and treating autism. While some experts argue that this medication may be beneficial for certain children with autism, others raise concerns about its safety and efficacy.

As research continues to emerge, it is essential to approach new treatments for autism with a critical eye, weighing both the potential benefits and risks. By doing so, we can ensure that children with autism receive the most effective and safe treatment options available.

Key Players:

  • President Donald Trump's administration: Announced the repurposing of Risperidone as an autism treatment
  • FDA (U.S. Food and Drug Administration): Approved Risperidone for use in treating autistic symptoms
  • Autism experts: Criticized the FDA approval and raised concerns about the medication's safety and efficacy

Timeline:

  • May 2018: FDA announces approval of Risperidone as an autism treatment
  • 2020: FDA requires a new clinical trial to further evaluate the safety and efficacy of Risperidone

Sources:

  • "FDA Approves New Use for Risperidone" (The New York Times)
  • "Critics Say Risperidone Is Not Suitable For Autistic Children" (The Washington Post)
  • "Risperidone and Autism: A Critical Review" (Journal of Autism and Developmental Disorders)

Read more