Free Anatomy of an Epidemic by Robert Whitaker Page A

on a very particular question: How could psychiatry adapt, for its own use, a scientific tool that had recently proven its worth in infectious medicine: the placebo-controlled, double-blind, randomized clinical trial? 10
    As many speakers noted, this tool wasn’t particularly well suited for assessing outcomes of a psychiatric drug. How could a study of a neuroleptic possibly be “double-blind”? The psychiatrist would quickly see who was on the drug and who was not, and any patient given Thorazine would know he was on a medication as well. Then there was the problem of diagnosis: How would a researcher know if the patients randomized into a trial really had “schizophrenia”? The diagnostic boundaries of mental disorders were forever changing. Equally problematic, what defined a “good outcome”? Psychiatrists and hospital staff might want to see drug-induced behavioral changes that made the patient “more socially acceptable” but weren’t to the “ultimate benefit of the patient,” said one conference speaker. 11 And how could outcomes be measured? In a study of a drug for a known disease, mortality rates or laboratory results could serve as objective measures of whether a treatment worked. For instance, to test whether a drug for tuberculosis was effective, an X-ray of the lung could show whether the bacillus that caused the disease was gone. What would be the measurable endpoint in atrial of a drug for schizophrenia? The problem, said NIMH physician Edward Evarts at the conference, was that “the goals of therapy in schizophrenia, short of getting the patient ‘well,’ have not been clearly defined.” 12
    All of these questions bedeviled psychiatry, and yet the NIMH, in the wake of that conference, made plans to mount a trial of the neuroleptics. The push of history was simply too great. This was the scientific method now used in internal medicine to assess the merits of a therapy, and Congress had created the NIMH with the thought that it would transform psychiatry into a more modern, scientific discipline. Psychiatry’s adoption of this tool would prove that it was moving toward that goal. The NIMH established a Psychopharmacology Service Center to head up this effort, and Jonathan Cole, a psychiatrist from the National Research Council, was named its director.
    Over the next couple of years, Cole and the rest of psychiatry settled on a trial design for testing psychotropic drugs. Psychiatrists and nurses would use “rating scales” to measure numerically the characteristic symptoms of the disease that was to be studied. Did a drug for schizophrenia reduce the patient’s “anxiety”? His or her “grandiosity”? “Hostility”? “Suspiciousness”? “Unusual thought content”? “Uncooperativeness”? The severity of all of those symptoms would be measured on a numerical scale and a total “symptom” score tabulated, and a drug would be deemed effective if it reduced the total score significantly more than a placebo did within a six-week period.
    At least in theory, psychiatry now had a way to conduct trials of psychiatric drugs that would produce an “objective” result. Yet the adoption of this assessment put psychiatry on a very particular path: The field would now see short-term reduction of symptoms as evidence of a drug’s efficacy. Much as a physician in internal medicine would prescribe an antibiotic for a bacterial infection, a psychiatrist would prescribe a pill that knocked down a “target symptom” of a “discrete disease.” The six-week “clinical trial” would prove that this was the right thing to do. However, this tool wouldn’t provide any insight into how patients were faring over the long term.Were they able to work? Were they enjoying life? Did they have friends? Were they getting married? None of those questions would be answered.
    This was the moment that magic-bullet medicine shaped psychiatry’s future. The use of the clinical trial would cause