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Study Raises Hopes for Adhd Medical Test, more about PET Scans

New York Times Syndicate, Naomi Aoki, March 14, 2001

Boston Life Sciences Inc. Monday said results from a second study have confirmed earlier findings that identified a clear-cut chemical abnormality in the brains of people with attention deficit-hyperactivity disorder, raising hopes for a long-sought medical test to diagnose the disease.

Such a test would go far to resolve an intense controversy about whether medications such as Ritalin are being overprescribed as a treatment for ADHD, a condition estimated to affect as much as 7 percent of U.S. schoolchildren and 5 percent of adults.

The study of the Boston company's diagnostic agent, dubbed Altropane, is the second of three test phases generally required by the U.S. Food and Drug Administration before a company can seek approval to market a product. Lanser said the company plans to start the final phase of testing in three or four months.

If proven effective, it could become the first medical test to diagnose the psychiatric disorder. While other tests such as PET scans and MRIs have detected slight differences in the brain function of ADHD patients, none have been specific enough to hold promise as a diagnostic test.

"This is the first time that we've had the promise of an objective lab measure for ADHD," said Russell Barkley, who researches the condition at the University of Massachusetts Medical Center and was involved in the study. "We still have a lot of work to do, but we've never been this close before."

Currently, ADHD is diagnosed based on a patient's history and psychological testing, lending an element of ambiguity to the diagnosis. People with the disorder tend to be overly active, distractible, unfocused and impulsive, making everyday activities such as work, school and social gatherings difficult.

But over the years, the condition has come under increasing scrutiny, with critics alleging the disease is overdiagnosed and drugs like Ritalin overprescribed. The most ardent of critics have even dismissed the disease as a figment of psychiatric imaginations.

"Parents are concerned about it, and professionals are concerned about it," said Dr. Marc Lanser, founder and chief scientific officer of Boston Life Sciences. "Society has a right to be concerned about unnecessarily treating adults and children with behavior-modifying drugs."

The recently completed study confirmed earlier research that patients with ADHD have a chemical abnormality in a part of the brain that uses the nerve messenger dopamine, providing scientific evidence of the disease and a possible way to diagnose it. Dopamine helps regulate attention and inhibits impulsive behavior.

Twenty adults in the study who had been diagnosed with ADHD using standard tests had much more of a protein called the dopamine transporter than did the 20 people in the study without the condition, Lanser said.

Altropane is a radioactively tagged chemical agent that attaches itself to dopamine transporters, making them readily apparent on brain scans. The diagnostic agent was developed to help diagnose Parkinson's disease. Boston Life Sciences, a tiny biotechnology company located on Boston's Newbury Street, plans to file for regulatory approval for that use later this year.

But researchers at Massachusetts General Hospital came up with the idea of studying it as a possible diagnostic tool for ADHD since drugs such as Ritalin had been shown to work by blocking dopamine transporters. The findings of the initial study, published in December 1999, were promising but needed to be repeated in a separate study to gain scientific merit.

The company's study is exciting because it did that, said Dr. Alan J. Fischman, an MGH nuclear medicine specialist and senior author of the initial study. But there are still many scientific and regulatory hurdles to overcome, Fischman said. And even if all goes well, an approved test is at least a couple years away.

The company needs to test Altropane in a large-scale study before it can be sure of the diagnostic agent's usefulness in diagnosing the disorder. And most importantly, Fischman said, it needs to test the agent in children, the group at the center of the most heated controversies surrounding ADHD.

The company has plans to begin testing Altropane in adolescents with ADHD and later in younger children, Lanser said. Although Lanser said Altropane is safe at the current level of radioactivity, the company is researching ways to lower the dosage without compromising the effectiveness of the test.

Despite the cautions, Fischman and Barkley said, they are optimistic about prospects for developing a diagnostic test based on Altropane. Genetic research has also uncovered a possible link between the dopamine transporter gene and patients with ADHD, Barkley said.

"So you see the pieces of the puzzle are all beginning to fit together, which is why I think this is absolutely fascinating," Barkley said.

One day, the diagnostic agent might even become the basis of a better drug to treat the disease. Lanser said a drug similar to Altropane will enter human clinical trials this year to test it as a possible treatment for Parkinson's disease. If it proves safe, the company will also pursue it as a treatment for ADHD.

"I think this news is very important, for us obviously, but also for the world at large," Lanser said.

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