Friday July 20 8:18 AM ET

U.S. Cuts Off Medical Research Aid to Leading School

By Will Dunham

WASHINGTON (Reuters) - Faulting one of the world's top medical research centers in the case of a healthy volunteer who died in an asthma experiment, the U.S. government has suspended all federally funded research on people at Johns Hopkins University School of Medicine in Baltimore.

The Office for Human Research Protections (OHRP), part of the Department of Health and Human Services (HHS), sharply criticized the prestigious university for failing to outline possible risks to volunteers and neglecting promptly to report that an earlier volunteer also became ill.

HHS officials notified the institution of the action in a letter written after the June 2 death of Ellen Roche, 24, of Reisterstown, Maryland.

Roche died of lung damage and multiple organ failure after inhaling the drug hexamethonium, which had been linked to cases of fatal lung disease in the 1950s and 1960s and was no longer approved for human use by the U.S. Food and Drug Administration.

In a statement on Thursday, the school condemned the funding suspension as an ``unwarranted, unnecessary, paralyzing and precipitous action.''

Johns Hopkins gets $301 million a year in grants from the National Institutes of Health (NIH), more than any other medical school. The research that triggered the suspension was funded by the NIH.

``UTTER DISREGARD OF PATIENTS' HEALTH''

``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. In addition, the OHRP letter forbids us from enrolling new, sick patients in these trials.''

The HHS letter said the government was particularly concerned that investigators involved in the study continued to provide the drug despite the persistence of coughing and shortness of breath in the first volunteer. Roche became ill within days of taking part as the third subject in the study.

Government officials faulted the school for failing to tell volunteers the drug was no longer FDA approved. OHRP also criticized the school for allowing changes in the experiment that did not have the approval of an independent review board.

OHRP said the Johns Hopkins investigators failed to obtain published literature about the association between lung damage and hexamethonium prior to receiving the go-ahead for the study from an institutional review board. The letter said such information was ``readily available'' on the Internet.

A Johns Hopkins review committee on Monday released a report saying the cause of Roche's death likely will remain uncertain, but probably was due to exposure to inhaled hexamethonium. The drug was first used 50 years ago to treat high blood pressure, but the FDA in 1972 pulled it from the market because of its lack of effectiveness.

The school has suspended studies with human subjects conducted by Dr. Alkis Togias, who led the ill-fated research at the Johns Hopkins Asthma and Allergy Center. Roche was an employee at the center when she volunteered for the study.

Dr. Edward Miller, dean of the medical school, has said the school ``takes full responsibility for what did happen.''

``To the best of our knowledge, in our entire history, we have had only one death of a healthy research volunteer out of tens of thousands who have participated in such research,'' the school's
statement said.

``We agree that this is one too many, and that is why we announced earlier this week the steps we are taking to strengthen our processes. In light of this, the OHRP's action seems to us to be an extreme example of regulatory excess.''

(Lisa Richwine contributed to this story)

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