Government Agency Caves in to Johns Hopkins pressure
July 21, 2001
In its July 19 letter to Johns Hopkins, the Office of Human Research Protection (OHRP) outlined serious violations beyond those in the experiment that killed a healthy volunteer. Those violations raised concerns about the safety of ALL human subjects currently in clinical trials at Johns Hopkins University (JHU). OHRP found that research protocols had not been properly evaluated for safety by the institutional review board prior to its rubber stamp approval process.
If the Government agency (OHRP) succumbs overnight to pressure from the biomedical research lobby, then the agency's lack of resolve will jeopardize the safety of ALL human subjects everywhere. Its mixed signal to the research community will be interpreted as a green light for others to disregard safety requirements when they conflict with expediency or commercial interests. The agency will be viewed as delivering empty threats of no real consequence to violating institutions. The only adverse consequences are borne by the human beings who are victimized in unsafe experiments, and the families that mourn them. If this is an about face by OHRP, it demonstrates how Government agencies-- whose mandate is to protect individual citizens--can be persuaded overnight to act against the public interest.
The issue is not about a vote of conscience, but about a powerful special interest group using bullying tactics to extract Government waivers (pardons) when found violating human protection regulations that resulted in preventable death.
Agency To Hasten Hopkins Review
University Allowed To Continue Studies
By Susan Levine
Washington Post Staff Writer
Saturday, July 21, 2001; Page B01
Johns Hopkins University officials said yesterday that the government agency responsible for suspending the school's federally funded medical trials with human subjects had agreed to "very rapidly expedite" its review of proposed corrective action so that all research can resume as quickly as possible.
One day after the U.S. Office for Human Research Protections' bombshell letter to the Baltimore institution, which identified a host of problems and shortcomings in medical studies there, the impact of its order seemed far less sweeping because federal regulators may allow numerous study protocols to continue during the suspension.
An e-mail sent throughout the university medical community said agency Director Greg Koski had informed Dean Edward D. Miller that clinical trials can proceed if investigators decide that doing so is in the "best interests" of their subjects.
Additional subjects still can be enrolled in studies when the same circumstances apply, Miller said. On Wednesday, the Office for Human Research Protections had warned Hopkins that new volunteers could be signed up only in "extraordinary cases" that it would approve in advance.
Bill Hall, a spokesman for the Department of Health and Human Services, which includes the Office for Human Research Protections, said the agency had indicated from the start that no patients were to be put in jeopardy because of the research shutdown. Regulators agree that the faster problems are resolved, "the better for everyone. . . . Our ultimate goal is to protect the people who volunteer in studies," Hall said.
Hopkins conducts hundreds of clinical trials annually involving more than $300 million in federal funding. It was unclear yesterday how many trials might be exempt from closure.
In many Hopkins offices yesterday, it was far from business as usual. Child psychiatrist Mark Riddle said half a dozen appointments for young protocol patients were canceled, although their parents were reassured that the schedule should be back to normal by next week.
"Given that our studies are all treatment studies and all include potential benefit for the subjects, in addition to the potential knowledge we may learn, I believe they will fit under the 'best interests' umbrella," Riddle said.
Interrupting research in midstream, which is what Wednesday's letter ordered, is action that can have drastic consequences for scientists and subjects, Riddle said. If a trial is testing a potential medication, for example, patients receiving it have to be identified and switched to a different drug, which effectively ruins the controlled double-blind structure required in medical studies.
No appointments were interrupted at Hopkins's bone marrow transplant program, which has more than 225 patients enrolled in clinical trials, program director Richard Jones said.
"Most of the people we're treating have potentially fatal diseases for which bone marrow treatment is not only a curative therapy but one of only a few therapies available," he said.
After calling the federal suspension an "extreme example of regulatory excess" on Wednesday, the university took a more conciliatory approach yesterday.
"We're going to work with [government officials] throughout the weekend if necessary," Hopkins spokeswoman Joann Rogers said. "We're very pleased that is happening."
The Office for Human Research Protections acted after the June 2 death of Ellen Roche, a 24-year-old woman involved in an asthma study. Its letter faulted the principal investigator conducting the project, as well as the institutional review board that approved it, for failing to obtain critical information on the risks of hexamethonium. Participants were asked to inhale the chemical, which the Food and Drug Administration considers an experimental use.
The federal alert to Hopkins also criticized the university broadly for the way its review boards evaluate and monitor the huge volume of research underway there. Correspondence between government officials and school leaders showed that some issues had been pending for years, although it was not explained yesterday what triggered regulators' concerns.
Last summer, the Office for Human Research Protections was moved from the National Institutes of Health to HHS headquarters. Koski was appointed director and vowed an era of tighter oversight.
The office, Hall said, "has been working very hard to educate institutions of the importance of these regulations. This is not a paperwork process. We're talking about protecting human lives."
Staff writer Rick Weiss contributed to this report.
© 2001 The Washington Post Company
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