PLACEBO: Males que se curan con nada...(II)

En junio de 2004 THE WALL STREET JOURNAL publicó el siguiente comentario referente a la intención de algunas compañías farmacéuticas (Lilly en este caso) de excluir a los "placebo responders" de los protocolos de investigación clínica.

Many antidepressant trials fail because the placebo effect can be so powerful and highly variable. Somewhere between 30% to 50% of patients in depression trials get better when given fake pills, and that number has increased and become more volatile over time, making it more difficult to prove that a drug works. In comparison, only about half of patients taking antidepressants find their symptoms relieved by 50% or better.

"The placebo response has plagued psychiatric clinical trials," says Steven Paul, head of research and development at Lilly. If drug companies could sort out the placebo responders, it "would greatly help us in the short term in drug development."

But some clinical-trial experts worry that excluding placebo responders to facilitate drug development could lead to the approval of ineffective drugs. Kay Dickersin, a Brown University professor who teaches courses on clinical trials, says such winnowing "allows bias to enter in" and constitutes "a subtle manipulation" of trial results.

The companies dismiss the criticism that they will use the information to gain approval of ineffective drugs. They say the techniques would be used only in early trials, not for trials done for FDA approval.