JOHNS HOPKINS' studies involving human subjects suspended following healthy volunteer's death

Friday, July 20th 2001, 12:00 am
By: News On 6

BALTIMORE (AP) _ Johns Hopkins University said the government's decision to suspend nearly all its federally funded experiments involving human subjects is ``unwarranted'' and could be devastating for ongoing clinical trials.

The ban came Thursday, nearly seven weeks after a 24-year-old healthy volunteer died during an asthma study at the school, one of the nation's top research centers. The university had already voluntarily halted human research by the doctor whose experiment went awry.

``We strongly believe that this action was taken in utter disregard of patients' health and potentially of life,'' Hopkins Medical School spokeswoman Joann Rodgers said about the suspension.

In a letter to the school, the Office of Human Research Protection said researchers did not sufficiently warn subjects in the asthma study of risks, and did not promptly report another subject's symptoms after the drug hexamethonium was administered.

``OHRP is particularly concerned that the investigators continued to expose additional subjects to inhaled hexamethonium before the symptoms in the first subject were resolved and before reporting the event'' to a university review board, the agency said.

Hopkins receives more federal research dollars than any other medical school _ $301 million last year, making it No. 1 for the ninth straight year. A week ago, U.S. News & World Report ranked Johns Hopkins Hospital the country's best for the 11th straight year.

The suspension means Hopkins cannot recruit new subjects without OHRP approval, and research involving previously enrolled subjects ``may continue only where it is in the best interests of individual subjects.''

In a statement, the school called OHRP's action ``unwarranted, unnecessary, paralyzing and precipitous.''

Dr. Edward Miller, dean of the school, said the government was taking ``draconian measures against an institution that has cared for thousands of patients in clinical studies.''

``This is very important for people,'' Miller said. ``They need to have these therapies available.''

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

Roche began coughing, was hospitalized and died June 2, a month after inhaling the drug. Medical school officials said Roche likely died from inhaling the hexamethonium, which restricts airways.

The study, funded by the National Heart, Lung and Blood Institute, was intended to help doctors learn how the body fights asthma by inducing asthmatic symptoms in healthy lungs.

The university has accepted responsibility for Roche's death and suspended 10 projects led by Dr. Alkis Togias, who remains on staff and faces no other disciplinary action. The internal review stopped short of blaming Togias and said the experiment was well-supervised.

Craig Schoenfeld, a lawyer for Roche's family, declined comment on the suspension.

Hopkins said it will supervise the hundreds of studies it conducts each year more closely. An external investigation of the fatal research is expected to begin later this month.

Some members of Congress want new standards and reviews for researchers seeking federal funding. Others have called for an accreditation system.

Hexamethonium tablets were used widely in the 1940s and 1950s to treat hypertension, but the Food and Drug Administration later withdrew approval. The drug never was approved as an inhalant.

Miller said Hopkins hoped to have the ban lifted within days.

``I think 110 years of tradition is not going to be jeopardized by one agency of the government,'' he said.