Hopkins admits flaws, adjusts to new rules

Med school swallows bitter pill of criticism

September 27, 2001|By Jonathan Bor | Jonathan Bor,SUN STAFF

Stung two months ago by a four-day shutdown of its research program, the Johns Hopkins School of Medicine is showing signs of an institution on the mend.

The university has reviewed and restarted nearly half of the 2,700 experiments suspended by federal investigators after the death of a young woman in an asthma experiment. With more review boards devoting more time than ever before, Hopkins officials hope all studies will resume by November.

Restoring the nation's most richly funded research program could be the most tangible sign of recovery. Just as telling, however, is the conciliatory tone being set by administrators and doctors, who appear to be getting past their initial anger toward the federal agencies that disciplined them.

Dr. Chi Dang, the vice dean for research, acknowledges that Hopkins had wrongly convinced itself that its esteemed research program was beyond reproach. Now, he is calling for a "new culture" in which Hopkins not only accepts criticism but actively seeks it.

"Obviously, we went through a little denial stage, as we all do when we have bad news," said Dang in a recent interview. "The spirit of the place changed very rapidly from denial to saying, `We want to achieve excellence, and how do we achieve excellence?' It becomes a challenge rather than a burden."

While Hopkins is working to improve protections of human subjects, it is also planning to hire an outside auditor to monitor its performance. Dang said he also wants academic departments to evaluate and criticize each other.

All this, he said, should help to break down a complacency that had settled over Hopkins, which was perhaps caught up in its distinguished history. He hasn't been shy about communicating this message to employees.

"We have to get over our thinking that we had the best possible system," Dang said in a newsletter circulated throughout the campus. "There's plenty of room for improvement."

Dr. Lewis Becker, a cardiologist who heads one of the institutional review boards, agrees that the school had grown overly confident.

"It's just a normal human tendency to think that you're doing things in the best way," he said. "There's now an attitude that we definitely need to change. We want to do whatever it takes to make this system as good as possible."

Jolt to institution

Dang admits that it took a tragedy - the death June 2 of a research volunteer - to jolt Hopkins into taking a new look at itself.

Ellen Roche, 24, died a month after inhaling a chemical in an experiment that doctors hoped would show them how healthy lungs defend against asthma attacks. The substance, hexamethonium, was supposed to provoke a temporary airway constriction - but in her, it produced a cascade of symptoms that began with a cough and ended in respiratory failure. Roche, who lived in Reisterstown, had worked as a technician in another laboratory within the asthma center.

A Hopkins panel found that the chemical probably killed her, and it faulted researchers and the review board that approved the study for failing to properly warn volunteers of the risks. Doctors had mistakenly called hexamethonium a medication, even though it had lost its status as a federally approved drug in the 1970s.

Hopkins officials reacted angrily when the federal Office for Human Research Protections found widespread flaws in its system of protecting volunteers and, on July 18, suspended virtually all experiments involving humans. Four days later, the agency said Hopkins could resume experiments once its review boards re-evaluated their safety.

Last month, a panel of outside experts recruited by Hopkins said the school's system of protecting human subjects was inferior to those at most other universities and that Hopkins' researchers too often resist regulation.

Though Dang doesn't agree that Hopkins doctors are inherently hostile to oversight, he said that some bristle at the paperwork that is required of them.

"Anything administrative just seems to be a barrier to getting things done," Dang said. Soon, he said, doctors will be able to communicate electronically with the review boards, making the process less burdensome.

To speed the massive review of studies, Hopkins increased the number of review boards from three to six. Members have quadrupled the amount of time they ordinarily spend in session, meeting twice a week for two or three hours each. Added time is spent reviewing protocols on their own or in subcommittees.

"The reviews are absolutely rigorous," said Dr. Constantine Lyketsos, a psychiatrist who serves on one of the IRBs. "Suddenly, there's a whole lot more work being done in a short time frame. We're juggling a lot of things."

Lyketsos said he has endured brief interruptions of his studies in Alzheimer's disease. He has asked colleagues to see some of his clinic patients so he can devote enough time to the IRB.

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