Johns Hopkins Works to Repair Patient Safety Problems
July 20, 2001 (Washington) -- Johns Hopkins University, considered one of the nation's finest, finds itself in the unlikely position of negotiating with federal regulators over when it can restart its human research program.
At stake is some $277 million in government funding and perhaps the future of the institution itself, some experts suggest.
"Our understanding is that over this weekend, the OHRP [Office for Human Research Protections] and Hopkins are working to resolve the concerns that OHRP has, and I have no reason to believe they will not be resolved very quickly. And I hope that's the case, because we need Hopkins to continue to fulfill its noble mission," Jordan Cohen, MD, president of the Association of American Medical Colleges, tells WebMD.
Art Caplan, PhD, director of the medical ethics center at the University of Pennsylvania, put it more bluntly. "Hopkins will get itself back into compliance within 48 hours. Otherwise, there won't be a Hopkins," he tells WebMD.
"It's in everyone's best interest that the suspension is lifted as expeditiously as possible, but we've got to make sure they're in compliance. Protecting people's lives is the bottom line here," OHRP spokesman Bill Hall tells WebMD.
Meanwhile, Cohen says patients can be assured that the system overall operates at a "high level of safety."
Taxpayer-funded research ongoing at Johns Hopkins was suspended beginning Thursday because of the recent death of Ellen Roche. The 24-year-old lab technician died mysteriously on June 2 after taking part in an asthma study. While it's not clear what happened, Johns Hopkins officials concede her death was linked to inhaling hexamethonium, a drug used in the study.
A review by federal officials found numerous safety problems. One being that the consent form was "difficult to understand." A review committee at Johns Hopkins agreed that the consent form inadequately described the risks of the study.
The federal reviewers also found that Johns Hopkins' institutional review boards, which review the safety of human experiments, are "overburdened" by the large volume of material they must analyze and are not trained adequately to determine that experiments are ethical.
The Hopkins reviewers also complained that the primary investigator, Alkis Togias, MD, didn't follow all the rules required of clinical investigators.
In a letter to Johns Hopkins, the federal reviewers said, "all federally supported research projects ... must be suspended. ... [E]nrollment of new subjects must cease immediately except in extraordinary cases."
Johns Hopkins responded with a statement calling the federal move "outrageous, unwarranted, unnecessary, paralyzing, and precipitous."
"We strongly believe that this action was taken in utter disregard of patients' health and potentially of life. ... Even a temporary interruption in therapeutic clinical trials ... could be devastating," says the statement. Johns Hopkins did not return WebMD's calls.
A number of research programs have been shutdown in recent years, including the University of Pennsylvania and Duke University. These instances shook the scientific community, but the Johns Hopkins case seems certain to have more potential impact.
Vera Hassner Sharav, president of the Alliance for Human Research Protections, a New York-based advocacy group, says the message is that it's time for a tougher approach to ensuring patient safety.
"There's no incentive [for research institutions] to comply with safety requirements, because we don't have the legal restraints. We don't have the independent oversight to make sure that these rules are enforced," Sharav tells WebMD.
Ethicist Caplan agrees. "If you're only looking hard when you get a death, you're not sending the right message," he says. "You need to fix the system."