The U.S. Department of Health and Human Services in July halted all federally financed medical studies on human subjects at the Johns Hopkins University School of Medicine, and other medical programs within the university. The action followed the death in June of a healthy volunteer participant in an asthma study.
After Hopkins officials worked furiously to develop a plan to correct the problems identified by the government, the federal agency agreed last week to let about 750 of the studies resume.
The Johns Hopkins medical college consistently draws more federal research money than any other medical school in the country. Last year it received $301-million in federal research grants. “This will have a significant adverse impact on our research,” said Gary Stephenson, a spokesman for Hopkins. “But the full impact won’t be known for months.”
The suspension was the first in more than a year to be ordered by the department’s Office of Human Research Protections, and the first under the tenure of Greg Koski, who has been the office’s director since September.
Mr. Koski had strongly advocated working with universities to help them comply voluntarily with department rules on the protection of research subjects. Prior to his arrival, the office had suspended research at eight institutions between October 1998 and June 2000.
The contested research at Hopkins had involved exposing human subjects to the drug hexamethonium, which induces wheezing in people with asthma, in order to study the physiological response in the lungs. Complications stemming from the experiment led to the death of Ellen Roche, 24, who did not have asthma.
In a letter to Johns Hopkins administrators, the research-protections office said it had found that the medical college and its institutional review board had “failed to ensure that risks to subjects were minimized and reasonable,” as required by federal regulation.
In particular, the office noted that researchers had “failed to obtain published literature about the known association between hexamethonium and lung toxicity” and that the substance was not currently approved by the U.S. Food and Drug Administration for use in humans. It also faulted Hopkins investigators for not having reported an earlier volunteer’s unanticipated coughing and shortness of breath.
Federal officials originally said the suspension would last until Hopkins officials developed plans for improving research protocols and human-subject protections.
Under the “corrective action plan” approved by the research-protections office last week, studies eligible for expedited review, and those that had been reviewed by Hopkins’s institutional review board within the last year, were immediately allowed to resume. But implementing the new plan means that about 2,000 studies will remain on hold while the Hopkins board assesses them, a process that will take months to complete, a university spokesman said.
“We strongly believe that this action was taken in utter disregard of patients’ health and potentially of life,” Joann Rodgers, a spokeswoman for the medical school, said on the day of the suspension. “Even a temporary interruption in therapeutic clinical trials, such as those involving cancer patients, could be devastating.”
A few days before the suspension, Hopkins officials issued an internal report in which the university took blame for Ms. Roche’s death and acknowledged many of the problems cited in the federal office’s letter. The university also announced that it had suspended all research conducted by Alkis Togias, the investigator who oversaw the experiment that led to Ms. Roche’s death.
But after the government announced its action, Hopkins officials called it “unwarranted, unnecessary, paralyzing, and precipitous.”
“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,” Ms. Rodgers said. “We agree that this is one too many.”
http://chronicle.com Section: Government & Politics Page: A25