The Prozac question

An OdEd peice from the Frederick News Post

Prozac is a brand name for fluoxetine, a drug primarily used to treat conditions such as depression, eating disorders, premenstrual mood disorder and anxiety disorders.

Fluoxetine stimulates the brain's levels of the neurotransmitter serotonin; inadequate amounts of that chemical are linked to depression. The medicine blocks unused serotonin from being absorbed by a nerve cell, sending it to another nerve cell and facilitating transfer of the chemical along the brain's synapses.

At first, the drug was heralded as a wonder treatment, with Newsweek giving the pill cover story treatment on March 26, 1990, titling one article "The Promise of Prozac."

But Benjamin Garris wasn't alone in believing something was wrong while he was on Prozac. Long before he consumed the drug, a grassroots movement spread a message that Prozac made people worse -- specifically, more violent and suicidal.

In 1989, Joseph T. Wesbecker killed eight of his co-workers and injured 12 others with an assault rifle before killing himself in Louisville, Ky. Mr. Wesbecker was taking Prozac. The drug's manufacturer, Eli Lilly, reached a settlement over the effects of the drug when a lawsuit was filed on behalf of the people killed by Mr. Wesbecker.

The scientific community also began to weigh in. In the March 1991 edition of the Journal of the American Academy of Child and Adolescent Psychology, researchers from the Yale University School of Medicine described how six out of 42 patients ages 10 to 17 with a history of psychological problems worsened while being treated with fluoxetine.

On Sept. 20, 1991, about three years before Garris was prescribed Prozac, the Department of Health and Human Services, Public Health Service of the Food and Drug Administration met with the Psychopharmacological Drugs Advisory Committee in Rockville.

The purpose of the meeting: To hold a "scientific investigation into suicidal ideation, suicidal acts, and other violent behavior reported to occur in association with the pharmacological treatment of depression."

Although all makers of antidepressants were invited to the meeting, only Eli Lilly sent representation.

A clear divide developed during the session.

The committee heard stories from people about how they or their friends or relatives changed while under the influence of Prozac and antidepressants:

"After being on Prozac for 21 days, my wife shot and killed both of these two boys right there. She turned the gun to herself and shot herself twice. Now she's in jail for murder. This is the kind of lady that never took a drug, no mixed drinks, no alcohol, no reason to be depressed, just some nerve problems, like everybody else from time to time."

However, members of the professional psychological and psychiatric community said they believed introducing a warning system or other punitive measures for anti
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depressants would pose a serious risk for the larger community of people who are stricken with depression:

"We have certainly heard some very sad, troubling, and tragic stories and anecdotes this morning. We also know that when depression is untreated, some 15 percent of patients will kill themselves, additional tragedies, and many more suffer from untreated depression who do not suicide. But depression is eminently treatable. Once recognized and appropriately managed with combinations of pharmacotherapies and psychotherapies, the vast majority of individuals with depression can be treated effectively and lead useful and productive lives."

Representatives from the U.S. Food and Drug Administration and Eli Lilly testified that studies and trials of Prozac, which they said encompassed more than 8,000 patients, showed only a small number of adverse events and no direct connection between increased suicide or violent risk.

"Taken all together, with these anecdotal data one has to raise the obvious question. It seems likely that what we have here is a situation that we are taught in medical school," said Dr. Charles Nemeroff of Emory University, on behalf of Eli Lilly. "Things can be true, (or) true and unrelated. Patients can be suicidal, patients can be being treated with an antidepressant, yet there is no cause-and-effect relationship.

"At best, these are anecdotal reports."

In the end, the committee agreed with Eli Lilly, the FDA and the medical community, voting that no credible evidence supported a conclusion that antidepressants cause or increase suicidal or violent behaviors, and no labeling change should be made.

In September 2004, the FDA approved a warning label for antidepressants, including Prozac. The warning states the drugs can cause suicidal actions in patients under the age of 18.