Spinning the Doctors

The ads running in trade journals promised something psychiatrists desperately wanted: a safer antipsychotic. But like so much that comes from the pharmaceutical industry, they present a story of spin.

For years, psychiatrists had been giving mentally ill patients drugs that triggered horrific neurological side effects known as extrapyramidal symptoms (EPS). In the 1990s, pharmaceutical companies led by Janssen Pharmaceutica introduced a new class of "atypical" antipsychotics with eye-catching claims: Not only were they less toxic, their neurological impact was minimal.

"Incidence and severity of extrapyramidal symptoms were similar to placebo," claimed an ad for Janssen’s Risperdal in the April 1994 American Journal of Psychiatry. A placebo, of course, is a sugar pill with no active ingredients that can cause no side effects. What was missing was context.

The studies these claims were based on were conducted with mentally ill patients who were, to start with, on old generation antipsychotics, usually Haldol. To begin the study, all the patients were abruptly taken off their meds. The placebo group went through Haldol withdrawal, a process known to trigger side effects. The others got Risperdal.

"It’s a huge trick," claims David Cohen, a professor of social work at Miami’s Florida International University, who has written widely on psychiatric medication. "In the group yanked off Haldol and left with nothing, the extrapyramidal symptoms worsen. Of course they do. They’ve just been yanked off Haldol and their brains are going haywire!"

In fact, many patients on Risperdal in Janssen-sponsored studies did experience EPS—just not at a greater rate than those withdrawn from Haldol.

Doug Arbesfeld, a spokesman for Janssen Pharmaceutica, said there was nothing misleading about the ads for Risperdal. Few schizophrenic patients available for trials are not already on medications, he noted. "Anyone who understands how these studies are constructed would understand that."

In fact, researchers at McMaster University in Ontario did test patients not previously treated with antipsychotics and found that 59 percent on Risperdal developed Parkinsonism, compared to 52 percent on Haldol.

Risperdal, wrote Richard Horton, editor of the British medical journal, the Lancet, was "a marketing success if nothing else."