1:49 PM
 | 
May 23, 2017
 |  BioCentury  |  Regulation

Misalignment in autism

FDA workshop reveals diversity of priorities among autism patients, caregivers

FDA’s Patient-Focused Drug Development meeting on autism revealed two different stakeholder groups with rather different priorities. Individuals with autism who were able to speak on their own behalf said their primary concerns are not autism per se, but depression, anxiety, communication, self-harmful behavior and quality of life -- and they don’t necessarily expect much help from drugs.

At the May 4 meeting, they said FDA and companies developing drugs have focused too heavily on improving repetitive behaviors or restricted interests. In fact, they said, reducing repetitive behaviors -- such as stimming, or engaging in repetitive motions like hand-flapping or rocking -- would deprive autistic people of a coping mechanism without necessarily alleviating the underlying problem.

“Therapies that suppress autistic traits hurt autistic people,” said Kathleen Mead, an autistic adult who spoke at the meeting.

These individuals do not think of autism as a disease that needs to be treated. They just want help with the aspects of autism and the mood disorders that come with it that make their lives difficult.

“If something gives me the flexibility in the world to interact as a person who doesn’t have a neurodevelopmental disability, but also allows me to think the way I do now, I would sign up for that quickly,” said an autistic meeting participant named Michael.

“Oftentimes it’s the way we ask the questions.”

Christina Nicolaidis, Oregon Health & Science University

This group also was uninterested in, and in some cases offended by, therapies aimed at treating irritability in autism -- the specific indication on the label of the only two drugs approved for an autistic population.

However, a second group of stakeholders who are caregivers for autistic children or adults placed a high priority on reducing disruptive, problematic or harmful behaviors.

“Our children are suffering and nothing isolates them more in our society than physical aggression towards others,” said Jeannie, the mother of an autistic daughter.

Caregivers aligned with the autistic speakers on wanting a way to improve communication. They thought many of their loved ones’ behavioral problems were caused or exacerbated by inability to communicate...

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