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E N Q U I R E R   L O C A L   N E W S   C O V E R A G E
Sunday, May 09, 1999

Controversial UC studies




        Sources have identified four psychiatric studies at the University of Cincinnati and Cincinnati VA Medical Center that are being investigated:

Schizophrenia study
        Title: “Biology of Schizophrenic Subtypes — II,” conducted 1981 to 1984

        Lead researcher: David L. Garver, UC department of psychiatry

        Purpose: To define subgroups of schizophrenic-like illnesses. Potentially, the information would allow psychiatrists to predict who will respond to a given medication. This study included Shalmah Prince as a subject.

        Methods: Sought 35 patients a year for three years, selected from the emergency ward of the Cincinnati General Hospital (University Hospital), from other psychiatric wards and by referral.

        Criticism: The study deprived participants of medication without detailing the consequences, even though the research protocol states there was a “distinct possibility of spontaneous remission.” Participants were recruited from the emergency room, when their ability to give informed consent could be impaired. Also, apomorphine — a chemical that can cause psychosis — was used to differentiate between patients.

       

Post-traumatic stress study
        Title: “Cerebrospinal Fluid and Plasma B-Endorphin in Combat Veterans with Post-Traumatic Stress Disorder,” published in 1997

        Lead researcher: Thomas Geracioti Jr., Cincinnati VA Medical Center

        Purpose: To determine whether the spinal fluid of patients with Post-Traumatic Stress Disorder contains higher endorphin concentrations than normal volunteers. In theory, people with PTSD have hyperactive fear responses even in the absence of stress. Potentially, the research could lead to a test to detect PTSD or to a treatment.

        Methods: Spinal fluid was withdrawn via catheter over a six-hour period from 10 male combat veterans and nine “normal” male volunteers. One normal volunteer dropped out. The fluid was then tested to measure B-endorphin levels.

        Criticism: Lumbar puncture, commonly known as a spinal tap, is a potentially painful and risky medical procedure. Critics question the ethics of asking patients to accept the risks for a test that offers no therapeutic benefit to them, and whether low-income participants were improperly enticed by cash payments offered to all participants.

Sensitization study
        Title: “Lack of Enhanced Response to Repeated d-Amphetamine Challenge in First-Episode Psychosis: Implications for a Sensitization Model of Psychosis in Humans,” published in 1997

        Researcher: Stephen M. Strakowski, UC department of psychiatry

        Purpose: To determine whether patients with new-onset psychosis would be more sensitive to amphetamines than “normal” volunteers. The information could lead to new treatment for manic depression or schizophrenia.

        Methods: Researchers chose 13 patients with first-episode manic or schizophrenic psychosis. The four-day study included daily doses of amphetamine or a placebo. Researchers measured eye blinks, mood, level of activity, rate of speech and severity of psychosis.

        Criticism: Patients were psychotic, yet simultaneously presumed to be rational enough to sign a consent form. Patients who needed hospitalization were denied treatment for their illness for five days to complete the study. Researchers anticipated from the outset that the amphetamines would worsen the patients' symptoms.

Bipolar disorder study
        Title: “Olanzapine versus Placebo in the Treatment of Bipolar Disorder, Manic or Mixed,” conducted in 1998

        Lead researcher: Paul Keck Jr., UC department of psychiatry

        Purpose: To investigate whether olanzapine, the generic name for Zyprexa, is effective in treating manic depression. This was the study that recruited Patricia Reynolds.

        Methods: After a week in the hospital, patients who had improved sufficiently could be released to go home, taking either the medicine or a placebo. Criticism: Researchers recruited study subjects in agitated states from the emergency room. Study participants also had a chance of receiving a placebo instead of treatment for their illness.

       



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