January 1, 2006 in Nation/World

Study boosts use of Prozac

Rob Stein and Marc Kaufman Washington Post
 

WASHINGTON – Antidepressants, such as Prozac and similar drugs, help many patients overcome their often disabling psychiatric disease and do not increase the risk for suicide, according to two large studies being published Sunday that counter recent concerns about the popular medications.

The findings from two independent, federally funded studies – the first of their kind – spurred some psychiatrists to call for the Food and Drug Administration to re-evaluate its warnings about the drugs, which have been blamed for a decline in their use.

“The take-home message from these studies is that we have treatment that is effective and that the risk from depression is far greater than the risk of treatment,” said Darrel Regier, director of research for the American Psychiatric Association, a group that has been critical of the warnings. “These studies are very important.”

Some other medical professionals, however, questioned the results, saying they failed, for example, to show that the drugs were more effective or safer than a placebo.

“The big bulk of the response to antidepressants is the placebo response,” said Irving Kirsch, a psychologist at the University of Plymouth in England. “I don’t think these studies are very informative.”

Critics also said the findings indicate that most patients do not benefit from the drugs. “These pills can be useful pills, but they don’t match up to the hype we’ve had that they really cure the illness,” said psychiatrist David Healy of Cardiff University in Wales, who added that the research could not rule out the possibility that the medications increase the risk for suicide among some patients. “As far as the risk for suicide, this sheds very little light on that issue,” he said.

One of the new studies, of nearly 3,000 adults suffering from major depression, found that about one-third experienced a full remission within weeks of taking an antidepressant, while 15 percent experienced some improvement – meaning nearly half got at least some benefit. The second study, of more than 65,000 patients, found that the risk of suicide for both adults and teenagers drops after treatment begins, with the newest drugs appearing to be the safest.

Regier said the new studies provide strong evidence for the safety and effectiveness of the drugs. And he said he fears that the FDA warnings, which were issued in 2004 and 2005, could lead to an increase in suicides because psychiatrists may be reluctant to prescribe the antidepressants.

“What the FDA initiated was in some ways a natural experiment,” Regier said. “This is the kind of rigorous scientific information the FDA should consider in evaluating its decisions.”

Robert Temple, the FDA’s director of medical policy, called the findings “reassuring” but said they do not settle the issue. The agency was continuing to study the drugs’ safety, he said. “There’s no question that many psychiatrists are worried that the public fuss about suicidality will lead to the failure of some patients to use antidepressants when appropriate. We are very worried about that, too,” he said.

After rapidly increasing in use for a decade, the number of prescriptions for antidepressants dropped 2 percent for the first 10 months of 2005, according to IMS Health, a pharmaceutical consulting company.

Antidepressants such as Prozac transformed the treatment of depression because they were considered highly effective and safe, allowing many more patients to use them. As a result, they quickly became among the most widely used prescription medications. The drugs, however, fell under a cloud when reports indicated they increased the risk for suicidal thinking, particularly among teenagers.

Those reports led some critics to press for stronger FDA action, and in 2004 the agency ordered companies to include a “black box” warning saying that antidepressants could increase suicidal thinking in young people. That warning was followed by a July 2005 public advisory that said adults beginning on antidepressants should be closely watched because of preliminary studies suggesting that they, too, could be at greater risk of suicidal thinking and behavior.

The new studies are the first large-scale efforts to independently evaluate the drugs without using data from drug companies’ studies. Both were funded by the National Institute of Mental Health and conducted by independent scientists. They are being published in Sunday’s issue of the American Psychiatric Association’s American Journal of Psychiatry.


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