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Johns Hopkins stops study after fatality

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BALTIMORE — Johns Hopkins University has suspended all human research studies by the doctor whose asthma experiment went awry in June, causing the death of a healthy, 24-year-old participant.

The university also said Monday it is imposing additional supervision on the hundreds of studies it conducts each year, and said an external investigation of the fatal research will begin later this month.

The actions were contained in a report to the federal Office of Research and Protection on the case of Ellen Roche, who died June 2.

"While we will never know the exact cause of her death . . . we accept full institutional responsibility," Dr. Edward Miller, dean of the medical school, said Monday. "We're going to have to increase our scrutiny of our procedures and look at all processes involved."

Miller said Monday that Roche likely died from inhaling the drug hexamethonium, which restricts airways. But he said the ruling was not definitive.

Hexamethonium was used widely as a tablet in the 1940s and 1950s to treat hypertension, but the Food and Drug Administration later withdrew its approval. It never was approved as an inhalant, which was the way it was used in the Hopkins study, the FDA has said.

Earlier this month, a preliminary federal report said researchers should have sought that FDA approval for experimental use of hexamethonium.

Since Roche's death, 10 other human studies led by Dr. Alkis Togias have been stopped. He remains on staff and does not face disciplinary action.

Togias' asthma study was intended to help doctors learn how the body fights asthma by inducing asthmatic symptoms in healthy lungs.

Roche, a lab technician in the Johns Hopkins Asthma and Allergy Center, was one of three subjects who inhaled hexamethonium. The first developed a cough lasting a week. The third had no symptoms.

Roche also began coughing and died a month later while hospitalized.

An internal review board was mixed on whether Togias should have stopped the experiment after the first subject developed symptoms.

"It's a lot easier to judge things in retrospect and hindsight than it is to know what the investigator should have done at the time the experiment was in progress," said Johns Hopkins cardiologist Lewis Becker, who led the investigative panel.

His report detailed other criticisms as well, saying existing information about the danger of the drug wasn't published in the research subject consent forms.

Despite this, Becker said disclosing the information may have had little effect on the outcome.

Also, the report said the study deviated from protocol for administering hexamethonium by diluting it in water instead of saline. But Becker stopped short of blaming Togias for Roche's death, saying the experiment was well-supervised.

Togias, 44, could not be reached for comment. He came to Hopkins as a research fellow in 1983 and received an award in 1989 for excellence in postdoctoral clinical sciences.

Dr. Chi Van Dang, vice dean for research at the institution, said the hospital will wait for the findings of an external investigation before deciding whether to discipline Togias.

That external investigation will begin later this month.

Johns Hopkins officials would not disclose details of settlement proceedings with Roche's family.