"There certainly is an unmet need out there," says UCLA's Leuchter, who has conducted extensive research on antidepressants' effectiveness. "Only about half the patients [on antidepressant drugs] will improve, and fewer than a third will get well with the first antidepressant they try."
That "unmet need" represents a potentially huge business opportunity for drug firms. Each year, as many as 10 million to 12 million depressed Americans could still be seeking relief after trying an antidepressant -- many more than the number who suffer from schizophrenia (2.4 million adults) and bipolar disorder (5.6 million adults). About 6.8 million adults suffer from generalized anxiety disorder.
"The story's pretty clear, and pretty embarrassing for the profession of psychiatry, which has allowed itself to be led by marketing," says Robert Rosenheck, a psychiatrist at Yale University who has studied the effectiveness and expanded use of the atypical antipsychotics. "We know now what these companies' strategies are: The number of people with schizophrenia is limited, so the road to profitability goes through soccer moms. They need to market these drugs to ordinary people who have dissatisfactions in life."
Side effects
In the run-up of use across the nation, weight gain and metabolic changes quickly emerged as a worrisome side effect. And in August 2008, the FDA, responding to a flurry of new research, required all antipsychotics to carry the agency's most urgent warning: The drugs' use in geriatric patients with dementia (by then very common) would raise their risk of dying from any cause.
Recent research has darkened the drugs' safety profile even further.
* Early this year, a Lancet Neurology study concluded that Alzheimer's disease patients given the drug to control aggression were nearly twice as likely to die of any cause than those not given the drug.
* Another study published in August 2008 -- this one in the British Medical Journal -- concluded that taking any antipsychotic medication raises a patient's likelihood of suffering a stroke, and added that "the risk of stroke might be higher in patients receiving atypical antipsychotics."
* Then, in January, the New England Journal of Medicine delivered a further blow to the new class of drugs. A federally funded study compared the rate of fatal heart attacks in patients taking the newer class of antipsychotic drugs, those on the older class, and patients taking neither. Patients on any antipsychotic drug -- new or old -- were twice as likely to die of a heart attack as those not on such medications.