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The Perils of Excluding the Depressed From Clinical Trials

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Reuters reports:

"Doctors have long known that depression often coincides with other disorders, such as addiction and heart disease. Yet clinical trials for these related conditions routinely exclude patients with depression.

"This strategy may benefit drug companies during the early testing stages, but it can backfire once the treatment is released into the real world."

By eliminating those with depression, drug-makers hope to gain faster FDA approval -- though the American Council on Science and Health says they may be "shooting themselves in the foot" by doing so.

Case in point: Pfizer.

The company faces a civil lawsuit by at least 1,200 patients who blame the company's smoking-cessation drug Chantix for causing erratic behavior -- including reports of suicide -- and is being called on the carpet for not including the depressed in its safety studies.

Dr. Gilbert Ross of ACSH says, “Smoking -- similar to other types of addictions -- is to some extent a genetic propensity, and similar linkages exist with depression and suicidal risk. Therefore, how can you justify barring them from a clinical trial relating to smoking cessation?”

ACSH adds that "The FDA is now requiring that Pfizer complete a large follow-up study for Chantix to include a reasonable proportion of participants with mental health problems as the agency works to draft guidelines for assessing suicide risk during clinical trials."

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