Fallout from a Research Tragedy

The federal government dealt a blow to Johns Hopkins University last week when it suspended human-research trials there following the death of Ellen Roche, a volunteer in a Hopkins asthma study. While the move had dramatic public-relations value, it left many in the medical community confused over how the government is regulating such research.

Roche volunteered for a trial in which she took hexamethonium, a compound not currently approved by the FDA for use in humans. In these cases, the FDA requires that researchers obtain the agency's approval before administering such compounds. But because of the huge number of academic trials and the accompanying paperwork, the FDA had got into the habit of quietly discouraging universities from applying for approval, assuming that safety issues could be dealt with by the universities. Then, in 1999, the feds abruptly cracked down, stopping human research at Duke University Medical Center. One infraction they cited: the improper recording of minutes of a meeting. Frustrated critics say what is needed is a regulatory middle ground.

Hopkins officials note that hexamethonium was approved in the 1950s for treating high blood pressure, and was pulled only when other drugs proved more effective. "The decision to go ahead was based on the fact that this was not a new investigational drug," says Dr. Edward Miller, dean and CEO of Johns Hopkins Medicine. "On similar compounds, the FDA had ruled that their approval was not needed." Doctors, heal thyselves.