JHU researcher found to have violated rules

FDA proposes restrictions

study resulted in death

April 18, 2003|By Julie Bell | Julie Bell,SUN STAFF

Nearly two years after the death of a research volunteer at the Johns Hopkins School of Medicine, the Food and Drug Administration has concluded that the physician conducting the experiment violated federal regulations and asked that he restrict his research.

Dr. Alkis Togias has given a copy of the FDA's March 31 warning letter to the school. Togias is negotiating with the FDA over terms of a settlement, and his once-suspended research has been restarted, according to a statement from the school.

"Dr. Togias has cooperated fully in all aspects of this matter and anticipates reaching an appropriate agreement with the FDA regarding research activities falling within that agency's jurisdiction," the statement said. It described the restrictions the FDA has proposed on Togias' research as "limited."

Hopkins spokesman Trent Stockton said neither the school nor Togias would have additional comment. Togias' lawyer, Daniel A. Kracov, also declined to comment.

The federal government briefly shut down all human experiments at Hopkins seven weeks after the death of Ellen Roche in June 2001, citing widespread safety lapses. Roche had inhaled the chemical hexamethonium bromide in an experiment designed to help scientists understand how the lungs of healthy people protect against asthma attacks.

Within six months after the shutdown, the university had reapproved almost all the 2,600 halted experiments except those led by Togias. It was unclear yesterday when his research began again or how many people it involved. The warning letter cited Togias for failing to apply to the FDA before using hexamethonium bromide, failing to get the approval of a university oversight board before changing aspects of the experiment and failing to properly warn volunteers who participated in the study of its risks.

Vanderbilt University Assistant Vice Chancellor Alastair Wood, a member of an external committee Hopkins appointed to review its human experiments after Roche's death, said yesterday that it is still unclear when researchers who aren't developing drugs need FDA clearance for human tests.

For years, he said, many researchers have used substances already present in the human body to trigger reactions such as the raising or lowering of blood pressure without seeking FDA approval. The studies, known as "challenge" studies, are the precursors to later, FDA-approved studies in which drugs are tested in people to see if they counter those reactions. Hexamethonium bromide is not naturally present the body.

Wood said, "I think clarity would be useful."

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