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Death Halts Human Tests at University

July 20, 2001|AARON ZITNER | TIMES STAFF WRITER

WASHINGTON — Johns Hopkins University of Baltimore, the nation's largest recipient of U.S. government medical research money, was ordered to cease all federally funded research on humans Thursday after the June 2 death of a volunteer in an asthma experiment.

About 2,400 experiments are underway at the university, said Bill Hall, a spokesman for the U.S. Department of Health and Human Services. He did not know the number of volunteers involved. He said no experiment would be stopped if the suspension would endanger research participants.

But the university, in a written statement, called the federal action "unwarranted, unnecessary, paralyzing and precipitous."

"We strongly believe that this action was taken in utter disregard of patients' health and potentially of life," the statement said. "Even a temporary interruption in therapeutic clinical trials, such as those involving cancer patients, could be devastating."

Gary Stephenson, a university spokesman, said he did not know how many experiments or patients were covered by the suspension order. "We're still trying to assess the full impact of this."

Johns Hopkins, one of the nation's preeminent research institutions, received $301 million in federal research money last year. It has received more money than any other research institution for nine straight years.

The university must take several steps before it can resume research, federal officials said. They include writing a plan to correct deficiencies and restructure the system for protecting research participants. The plan must include setting up additional research review boards.

Research suspensions are uncommon but not unprecedented. In 1999, federal regulators briefly suspended 2,000 human experiments at Duke University Medical Center for alleged violations of ethics and safety rules.

Johns Hopkins has already acknowledged responsibility for the death of the asthma research volunteer, Ellen Roche, a 24-year-old laboratory technician at the university. She became ill in May after inhaling an experimental drug as part of research into how the body fights asthma attacks. She had been paid $365 to participate.

A university report released Monday said the researcher and the oversight committee involved in the experiment did not take adequate measures to prevent injury to research subjects. All 10 studies conducted by the researcher, Dr. Alkis Togias, had been suspended by the university.

But the federal Office of Human Research Protection said Thursday that it had found a wide range of deficiencies in the university's system for evaluating research projects and protecting volunteers.

"They went in and found problems in this asthma study and said, 'We also need to look systemwide at this institution,' " Hall said. "They did that and they found problems severe enough that warranted suspending all clinical research."

Regarding the asthma experiment, federal investigators determined that researchers, as well as a Johns Hopkins review board that approved the research, failed to obtain published information about the drug Roche took and its effect on lung functioning. It said data on the drug, hexamethonium, were available through "routine" Internet and database searches, as well as in textbooks.

In a letter Thursday to Johns Hopkins, federal investigators also said hexamethonium is not now approved by the Food and Drug Administration for use in humans, and it has never been approved for administration by inhalation.

Investigators said the review board approved the research without requesting information about the toxicity of the drug. Moreover, they said, the informed consent form did not give participants a clear understanding of the research plan, and the researcher changed the plan without notifying the review board. They noted that Johns Hopkins itself had come to some of the same conclusions after a review that followed Roche's death.

Investigators also cited deficiencies in the review board's meeting procedures, written policies and record keeping.

In its written statement, Johns Hopkins said that officials had addressed some of the federal investigators' complaints about review board procedures last year.

"Despite the passage of seven months, we never received any indication--not a word--that our responses did not in all respects satisfactorily address the agency's concerns," the university said. It said that its research review boards study each proposal thoroughly.

Stephenson said the suspension order covers the university's two major hospitals, its nursing school and other facilities, but not its hospital in Singapore.

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