Monday, May 17, 1999

UC called leader for ending controversial research




BY TIM BONFIELD and ANNE MICHAUD
The Cincinnati Enquirer

        The University of Cincinnati has grabbed attention among scientists and patient advocates nationwide for its decision this month to suspend a controversial type of psychiatric research known as challenge studies.

        Such research uses chemicals to induce psychosis, a severe form of mental illness, to study the disease or potential treatments. On May 5, UC decided to no longer participate in challenge studies — at least until a new advisory committee that includes the mentally ill can help set a permanent policy.

        UC, along with several other research centers nationwide, faces a federal investigation of how it oversees medical research involving human subjects, especially people with mental illness. In question are two challenge studies UC researchers performed in the early 1980s and in 1997.

        But now, consumer advocates and research experts say UC has become the nation's first research center to voluntarily stop performing challenge studies.

        UC officials say they hope their action, combined with its new advisory committee sys tem, will become a national model. However, some leaders in the field say it will take tougher federal regulations, not just voluntary actions, to properly protect research patients from abuse.

        “One of the research methods that raised significant concern for our commission were challenge studies. To hear that an institution has chosen on its own to take forceful steps is something to be welcomed,” said Eric M. Meslin, Ph.D., executive director of the National Bioethics Advisory Commission.

        “Whether in the long term voluntary steps alone will be sufficient, only time will tell. Our report suggests that more regulations need to be implemented,” Dr. Meslin said.

        The bioethics commission made 21 recommendations to the White House in January to improve oversight of medical research involving people with mental disorders powerful enough to affect their ability to provide informed consent. The Clinton administration has asked various federal agencies that provide research grants to comment on the report before taking regulatory action or seeking reforms through Congress.

        Reform at UC was sparked in part by criticism by local advocates. Allen Buettner, a Northside resident with bipolar disorder, or manic depression, said he is saddened to see UC criticized.

        “I must have cutting-edge medications. They empower me to keep a good job — and to function at all,” said Mr. Buettner, whose conversations with UC researchers have convinced him they are “authoritative, ethical and honest.”

        UC and local advocates held an inaugural meeting of the advisory committee this month. Of the 12 members, nine will be mental health consumers or people interested in mental health, and three, members of UC's psychiatry department: Thomas Geracioti, Paul Keck and Loren Friedman.

        Several advocates for the mentally ill praised the developments.

        “This is not happening in the rest of the country,” said David Oaks, co-coordinator of Support Coalition International, which comprises 70 advocacy organizations in 11 countries.

        “The people (in Cincinnati) are way ahead of the rest of the country in demanding that the people who experience the psychiatric system have a direct voice in this research.”

        E. Fuller Torrey, a psychiatrist and director of the Stanley Foundation in Bethesda, Md., said “getting the patients and families involved is the right thing to do.”

        The private foundation gives away about $20 million annually. It funds half of all U.S. research on manic depression and a quarter of the studies of schizophrenia. The foundation does not fund challenge studies.

        Challenge studies and “washouts,” which require patients to discontinue their medication, are harder to justify today than 10 years ago, Dr. Torrey said.

        “We know more now, so what we are likely to learn is less valuable,” he said.

        Others said suspending challenge studies doesn't fully address their concerns about psychiatric research. Washout studies, problems with informed consent and non-therapeutic research — which does not treat patients' illnesses — remain under concern.

        “We're just starting to talk about the ethical questions,” said Mike Fontana, president of the Mental Health Association, a Cincinnati advocacy organization.

        UC's reforms will not hold without federal mandates, predicted Vera Sharav, president of Citizens for Responsible Care in Psychiatry and Research, a New York consumer group that claims many patients are being abused in clinical trials.

        “There is so much money at stake, this is simply not going to work as a gentlemen's agreement,” she said. “The temptation to cut corners and to slide back is just too great.”

        Patient advocates should be on the institutional review board itself, she said, which is responsible for reviewing all research for scientific merit and ethics.

        Dr. David Shore, associate director for clinical research at the National Institute of Mental Health, said UC's actions go beyond the changes his agency has recently made.

        The NIMH is the largest federal source of psychiatric research grants, conducting some of its own studies in Bethesda, Md., and providing more than $500 million a year to other centers. UC received about $700,000 from NIMH last year for five studies.

        NIMH has formed a group that will start meeting in June to conduct an extra review of any proposed challenge studies or washout studies.

        “We're not saying we'll never fund these studies. We just want to make sure adequate safeguards are in place,” Dr. Shore said.

        Scientists may think UC's action, although temporary, goes too far, Dr. Shore said.

        “Some scientists feel we already make it too difficult to carry out these studies,” Dr. Shore said. “We're a little concerned about closing off a potentially valuable area of research.”

        The actual number of challenge studies going on in the United States is not clear.

        Dr. Randy Hillard, chairman of UC's Department of Psychiatry, said he believes “hundreds” of challenge studies are going on nationwide.

        However, UC won't be taking much of a financial hit for suspending its challenge studies. Since publishing results from a 1997 study, UC has no active challenge studies and had no immediate plans to launch any, Dr. Hillard said.

        “We've got tons of other cool research to do,” Dr. Hillard said.

- UC called leader for ending controversial research
National commission finds rules too loose
Studies elsewhere found sloppy in ethics standards and consent



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