Hopkins failed to resolve safety issues, FDA says

September 08, 2001|By Jonathan Bor | Jonathan Bor,SUN STAFF

An internal board that approved the Johns Hopkins asthma experiment in which a 24-year-old woman recently died never addressed safety questions that had been raised by its own members, the U.S. Food and Drug Administration said yesterday.

In a preliminary report, the FDA said the review board failed to forward written questions raised by several members to the scientists who proposed the study - and failed to discuss the issues before voting to approve the study last September.

On June 2, Ellen Roche of Reisterstown died of respiratory failure about a month after inhaling a chemical that doctors administered to help them understand how healthy lungs defend against asthma attacks.

"Issues that were raised were not being properly forwarded to the clinical investigator or discussed across the group," said Dr. David Lepay, FDA senior adviser for clinical sciences.

Two members had asked if the FDA had approved the use of the chemical, hexamethonium. One member wanted to know how the drug's potency would be determined. One asked why the dose was chosen.

In addition, the FDA said six board members didn't receive or review the consent form that explained safety precautions to volunteers.

In a previous report, the FDA faulted Dr. Alkis Togias, a Hopkins asthma specialist, for conducting the study without asking the FDA's approval.

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