HHS faults Hopkins research procedures

The government has suspended all federally funded research on human subjects at Johns Hopkins School of Medicine following the June death of a healthy volunteer

WASHINGTON (CNN) -- A government letter suspending all federally funded research projects involving human subjects at Johns Hopkins says the institution failed in several instances to follow proper procedures.

The Department of Health and Human Services Office of Human Research Protections ordered that enrollment of new participants stop immediately, and said research involving previous enrollees can continue "only where it is in the best interests of individual subjects."

The suspension follows the death of a healthy volunteer during an asthma study of why irritants trigger asthma in some people and not in others. After inhaling the airway-constricting drug hexamethonium in May, Ellen Roche, 24, developed a cough, then flu-like symptoms and organ failure. She died June 2.

Johns Hopkins officials were outraged that the studies were suspended. Hopkins receives more federal research dollars than any other medical school. Last year, it received $301 million in federal support.

Ellen Roche died June 2, a month after inhaling the drug hexamethonium during an asthma study conducted by Hopkins

"Patients who are receiving therapies, come here for hope, are not going to be able to receive that because of this issue," said Dr. Edward Miller, dean and CEO of Johns Hopkins Medicine.

The head of a cancer research organization also criticized the move, saying it could reduce the chance of developing medical breakthroughs.

"If we shut down a research enterprise such as the one at Hopkins, it will take years to recreate that enterprise," said Carolyn Aldige, president of the Cancer Research Foundation of America.

Review Board oversight criticized

Of particular concern to Health and Human Services were the actions of the institutional review boards, or IRBs.

Officials with the OHRP found during their review that "IRB chairs, IRB members and IRB administrative staff displayed a sincere commitment to the protection of human subjects," according to the letter.

However, minutes and tapes of IRB meetings, along with IRB members and administrators "indicate that no review takes place at convened meetings for most protocols," the July 19 letter said. It noted that minutes of IRB meetings do not yet exist for 18 of the last 21 meetings dating back to October 2000.

But Miller defended the institutional review boards.

"Our IRBs are excellent, the people who are on it are excellent, and they do a very good job," Miller said. "And to make it sound like they are not reviewing these things, I don't understand where they're coming from."

He also reiterated Johns Hopkins' history of safe research practices.

"We have done clinical trials over 100 years here at Hopkins. We have had one death in all of these years in a human healthy volunteer," Miller said.

More concerns cited

In its letter, Health and Human Services also said:

•  An informed consent document for participants failed to indicate that the drug was experimental or to describe the "reasonably foreseeable risks and discomforts" associated with the research.

•  Investigators failed to promptly report the cough, shortness of breath and decrease in pulmonary function experienced by the first subject in the study. The HHS' Office for Human Research Protections "is particularly concerned that the investigators continued to expose additional subjects to inhaled hexamethonium before the symptoms in the first subject were resolved."

•  The IRB and investigators failed to ensure that risks to participants were "minimized and reasonable."

•  The findings suggest the IRBs may be overburdened by the volume of research they must oversee.

Johns Hopkins officials outlined Monday the results of their internal investigation into why Roche died.

While they said they don't know specifically what caused her death, they believe it is related to the drug and accept full responsibility for her death.

Their internal investigation found several problems, including that the IRB was unaware earlier studies had shown a side effect of lung toxicity with this drug. Also, a cough developed by the first volunteer was never reported to the IRB by the lead researcher of the trial.

All of the studies by the lead researcher have been put on hold.

Christy Feig of CNN's Medical Unit contributed to this report.