BALTIMORE — The government has suspended federally funded research on human subjects at Johns Hopkins University following the death of a healthy volunteer during an asthma experiment, the school said Thursday.
The move comes just three days after the university suspended human research by the doctor whose experiment went awry in June, causing the death of 24-year-old Ellen Roche.
Officials with the federal Office of Human Research Protection did not immediately return a call seeking comment. Hopkins called the agency’s decision “unwarranted, unnecessary, paralyzing and precipitous.”
“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. The school said the effect could be devastating for ongoing clinical trials. Hopkins receives more federal research dollars than any other medical school – $301 million last year, making it No. 1 for the ninth straight year.
The university has acknowledged full responsibility for Roche’s death June 2 and suspended 10 projects led by Dr. Alkis Togias. Togias remains on staff and faces no other disciplinary action.
Medical school officials said Roche likely died from inhaling the drug hexamethonium, which restricts airways.
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 said.
Earlier this month, a preliminary federal report said researchers should have sought FDA approval for experimental use of hexamethonium.
Togias’ study was funded by the National Heart, Lung and Blood Institute, a division of the National Institutes of Health. It 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 was mixed on whether Togias should have stopped the experiment after the first subject developed symptoms.
The panel noted that existing information about the danger of the drug wasn’t published in the research subject consent forms, but said disclosing the information may have had little effect on the outcome.
The report stopped short of blaming Togias for Roche’s death and said the experiment was well-supervised.
On Monday, the university said it is imposing additional supervision on the hundreds of studies it conducts each year. An external investigation of the fatal research is expected to begin later this month.
Some members of Congress have suggested requiring new standards and reviews for researchers who want federal funding. Others have called for the establishment of an accreditation system for researchers.
Pressure for added protections has been building since the 1999 death of Jesse Gelsinger, 18, at the University of Pennsylvania four days after he was injected with a genetic drug designed to correct a liver disorder.
Researchers said he died because the protein used to carry new genes into his damaged liver triggered a major immune system response.
A federal investigation found researchers enrolled ineligible patients such as Gelsinger and had failed to warn patients that two monkeys used in the same experiment had to be put to death because they developed serious side effects.
On the Net:
Johns Hopkins Medicine: http://www.hopkinsmedicine.org
Office of Human Research Protection: http://ohrp.osophs.dhhs.gov