Depression Drugs Safe, Beneficial, Studies Say

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Depression Drugs Safe, Beneficial, Studies Say

Suicide Risk Rejected, But Critics Question Validity of Findings

By Rob Stein and Marc Kaufman

Washington Post Staff Writers

Sunday, January 1, 2006; A01

Antidepressants, such as Prozac and similar drugs, help many

patients overcome their often disabling psychiatric disease and do

not increase the risk for suicide in adults, according to two large

studies being published today 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 reevaluate 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 A. 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 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 another 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. "

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 in the hopes of

clarifying their safety further, 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, " Temple 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

today's issue of the American Psychiatric Association's American

Journal of Psychiatry.

In one study, E. Simon of the Group Health ative, a

large, private nonprofit health insurance company based in Seattle,

analyzed data from 65,103 patients who took antidepressants between

Jan. 1, 1992, and June 30, 2003, comparing the rate of suicide

attempts and death from suicide attempts before and after treatment

began -- the first such study to track patients over time. Previous

studies had examined reports of suicidal thoughts among patients.

The researchers found that the risk of attempted suicide was 60

percent lower in the month after treatment began and that it

continued to decline. While the overall risk for suicide was higher

for adolescents than adults, the reduction in risk was about the

same for both groups. When the researchers specifically examined 10

of the newest antidepressants, such as Prozac -- the ones that have

come under the most suspicion -- they found that the risk was even

lower.

While some people may react negatively to the drugs, the findings

indicate that for most patients the medications do not increase the

risk of suicide, Simon and others said.

" There may very well be individuals who are sensitive to these

medications, and doctors should monitor their patients carefully, "

Simon said. " But on average most people are not at higher risk. If

anything, they appear to be at lower risk for a serious attempt at

suicide or dying of suicide. "

The second study involved the first analysis of data from a $35

million ongoing trial known as Star-D, which is designed to provide

the first large-scale analysis of various depression treatments in

real-life settings.

The analysis involved 2,876 adults around the country who took the

antidepressant Celexa at 41 sites representing different types of

settings, including clinics, psychiatrists' offices and primary care

providers' offices, for up to 14 weeks. Within an average of eight

weeks, 28 to 33 percent of patients experienced a complete

remission, and 10 to 15 percent experienced some improvement, the

researchers found.

Although the response rate in some previous studies has been better,

researchers said the findings were encouraging because drugs often

fail to perform as well in real-world settings, where many of the

patients also have other mental or physical problems and treatment

is often more complicated. There was no indication the drugs

increased the risk for suicide.

" This is very good news, " said psychiatrist Rush of the

University of Texas Southwestern Medical Center at Dallas, who led

the study. " We were able to achieve a significant level of remission

in a group of patients who are difficult to treat in a real-world

setting. That's encouraging. "

The study will continue to evaluate how best to treat patients who

do not respond, including whether other drugs or a combination of

drugs and therapy may be effective. The current FDA review of

suicidal thinking in adults taking antidepressants will ultimately

analyze much of the existing clinical data on the subject. It is

scheduled to be completed this summer.