Kentucky scientist says FDA "confused" when his autism treatment called unapproved

From the Chicago Tribune:

A Kentucky scientist whose company has been selling a chemical developed for industrial purposes as a dietary supplement said July 12 that the U.S. Food and Drug Administration may have been "confused" when it called his product an unapproved new drug.

The agency last month sent a letter to Boyd Haley, a popular figure in the autism recovery movement, warning him that sales of his product, OSR#1, violate federal law. Some parents and physicians have embraced OSR#1 as a treatment for children with autism.

In an op-ed piece published Monday in the Lexington Herald-Leader, Haley wrote that his product's complex chemical name, N1,N3-bis (2-mercaptoethyl)-isophthalamide, may have misled the FDA.

He called OSR#1 a combination of naturally occurring substances — benzoate and cystamines — that are found in cranberries and meat. "It might be that the chemical name we placed on the label has confused this issue," he wrote.

The FDA declined to comment, stating: "We await the company's response through proper channels."

Experts interviewed by the Tribune said the argument by Haley, a retired chairman of the University of Kentucky's chemistry department, defies elementary principles of chemistry.

OSR#1 "is indeed a complex chemical entity," said Dr. Arthur Grollman, director of the Laboratory for Chemical Biology at State University of New York at Stony Brook. "He should have stopped there."

Grollman and other experts say any molecule can be broken down to chemical groups found in nature, but that doesn't mean the molecules are natural or they are a sum of their parts.

For example, the illegal drug Ecstasy contains a benzene ring and an amine group, both of which are found in OSR#1, but Ecstasy is not a dietary supplement.

Creating a new molecule out of old ones results in an entirely new substance that will have different effects on the body, experts said.

"Once you connect them together, they have very different properties," said Chuan He, professor of chemistry at University of Chicago. "That is why they are different molecules."

The FDA's June 17 letter detailed several violations of the Federal Food, Drug and Cosmetic Act. Failing to correct such violations can result in fines, seizure of products and even criminal prosecution.

Haley has not responded to the letter, and the FDA has granted him an extension, a spokeswoman said. Haley did not respond to requests for an interview.

The Tribune reported in January that Haley's compound had been developed to treat mining wastewater and it had not undergone rigorous testing to ensure it is safe and effective.

J.B. Handley, a founder of the advocacy group Generation Rescue who has a child with autism, said parents using alternative treatments for the disorder are more likely to listen to one another than to mainstream institutions, which they feel have abandoned or betrayed them. And OSR#1 has not raised concerns, he said.

"We don't trust the FDA or the CDC. We don't trust you. We don't trust most doctors. We only trust each other," he said.