When is a mental health clinic not a mental health clinic? Drug trial abuses reach social work.

The HOPE Clinic In May 1999 the New York Times published a series about the abuses resulting from drug companies paying private practice doctors to refer patients as experimental subjects (Eichenwald & Kolata, 1999a, 1999b). The series provided an intriguing history of the economic events and policy decisions that created this situation. According to Eichenwald and Kolata (1999a), it began in the early 1990s, with managed care providers pressuring drug companies to reduce the price of their products and drug companies, in turn, strategizing to compensate for lost revenues by expanding their product line. Reforms at the FDA accelerated the process of bringing new drugs to market, but more experimental subjects were needed to test the new drugs. Drug companies began to solicit private practice doctors as researchers, reasoning that they would have easier access to subjects than academic researchers. Anyone with an MD degree is technically qualified to conduct research. Certain private practice doctors, who were meanwhile losin g income as a result of managed care payment cutbacks, greeted these incentives--as much as $1,000 per patient-- with enthusiasm. The number of private doctors involved in drug studies increased 300 percent (4,307 to 11,662) between 1990 and 1997. This practice of payment per subject led to numerous abuses, endangering patients and jeopardizing the validity of research findings (Eichenwald & Kolata, 1999a). As a clinical social worker, I assumed such matters fell outside the scope of my practice. Then I received a form letter announcing the opening of a new psychiatric clinic for adolescents in a nearby city. Although I teach full-time at a school of social work, I also maintain a small clinical practice working mostly with adolescents, which was how my name came to be on the mailing list. As social workers we have an ethical duty to "discourage, prevent, report, expose, and correct" what we perceive as unethical conduct (NASW, 2000, p. 18, section 2.1la). However, because the Commentary column in Social Work is not intended for investigative reporting but rather for discussions of current professional issues, I refer to the program as the HOPE clinic. The letter I received bore the imprimatur of a prestigious New England medical school; let us call it the "New England College of Medicine." The clinic, according to the letter, was "an exciting new, investigational program" offering assessment and treatment for teenagers who "might be at risk for developing mental illness." The letter claimed that the HOPE clinic was "the first initiative in this country to study the prevention of serious mental illness." A vague reference was made to "international data" that suggested a psychosis could be delayed or prevented through early identification and intervention, although no specific studies were cited. The remainder of the letter included a symptom list to help identify which clients might be appropriate for treatment and an offer of $400 to be paid to the recipient of the letter for every client referred and accepted into the study. Although no specific intervention was described in the letter, an accompanying brochure mentioned a "newly approved drug." A clinic representative, contacted by phone, identified the drug in question as Zyprexia, and explained that treatment would consist in every case of one year of psychodynamic therapy in conjunction with either Zyprexia or a placebo, randomly assigned. Although the clinic representative would neither confirm nor deny that the program was a drug trial, he did say that one of the funders of the clinic, and perhaps the sole funder of the clinic, was Eli Lilly and Company, the manufacturer of Zyprexia. Nowhere was this acknowledged in any of the literature I received. According to a fact sheet published by NAMI (the National Alliance for the Mentally Ill), Zyprexia is one of the new "atypical" antipsychotic medications. …