Source: New York Times
Date: 13 December 2006

Panel to Debate Antidepressant Warnings


Public health officials, psychiatrists, grieving parents and outraged former patients will fill a hotel ballroom in Silver Spring, Md., this morning to argue the most bitterly divisive question in psychiatry: do the drugs that doctors prescribe to relieve depression make some people more likely to attempt suicide?

The hearing, called by the Food and Drug Administration, will be the first time a government panel has addressed the question since 2004, when impassioned testimony resulted in the agency requiring antidepressant drugs to carry strong warnings that they could increase suicidal thinking or behavior in some children and adolescents.

Today’s hearing is expected to be even more contentious. The panel will hear testimony on whether to recommend that the F.D.A. require labels carrying similar warnings for adult patients.

The meeting marks the latest chapter in a controversy that began in the late 1980s, soon after Prozac was introduced as the first in a new generation of antidepressants. Over the last 15 years, the debate has come to transcend questions about side effects and labeling. It is now a clash of cultures.

Psychiatrists say the debate has scared patients and their families away from the very medications that could save their lives. Critics say psychiatry relies too much on drugs that pose a danger to public health, and too much on drug company money.

“It’s like a religious war,” said Edward Shorter, a medical historian at the University of Toronto and author of the definitive “History of Psychiatry.”

“The only time I can remember when people argued over an issue with this kind of fervor,” Professor Shorter said, “was back in the 1960s and 1970s, when scientists were challenging psychoanalysis,” the therapy based on Freudian principles.

The fervor has spread beyond academia, to doctors in private practice who now have more trouble than ever getting their depressed patients to try medication; and to people who have any reason to distrust psychiatry.

“Sitting up there and having the public yell that you’re killing their children is no fun,” said Dr. Andrew Leon, a psychiatric researcher at Weill Medical College of Cornell University, in New York City. “But I suppose that has become a part of the process now.” Dr. Leon was a member of the 2004 panel and is on the panel conducting today’s hearing.

Dr. Leon said he was a paid scientific adviser for government and the pharmaceutical industry.

At one level, the debate is about science, which has not provided clear answers. Studies linking antidepressant use to suicide rates appear to point in opposite directions.

“The bitterness or confusion, at least within academia, stems from divisions over what the evidence means,” Dr. David Healy, a psychiatrist at the University of Cardiff, Wales, wrote in an e-mail message.

Dr. Healy, who has argued that the suicide risk is higher than psychiatrists have acknowledged, has worked for drug makers and for plaintiff’s lawyers in cases brought against pharmaceutical companies.

An analysis by F.D.A. scientists of data from drug trials, released last week, found that adults under 25 who took antidepressants were more than twice as likely as those who took dummy pills to report having made suicide attempts or preparations for suicide — about the same increase in risk found in minors.

But other studies have found that adolescent suicide rates tend to be low in areas of the country where antidepressants are most widely prescribed. Autopsy studies of adolescents who committed suicide found that few had antidepressants in their system, Dr. Leon said. Last week, researchers reported that in the Netherlands the suicide rate in children and adolescents had increased by more than 40 percent since 2003, when prescription rates of antidepressants began to drop. According to the federal Centers for Disease Control and Prevention, the suicide rate among teenagers in the United States rose slightly in 2004, for the first time in more than a decade.

Many psychiatrists interpret such findings as evidence that benefits of antidepressants far outweigh the risks, and say they worry about the fact that prescriptions by American doctors have dropped since 2003.

“This is evidence that our worst fears could come true, that these labeling changes and reductions in prescriptions are in fact having an adverse impact on suicide rates,” said Kelly Posner, an assistant professor of child psychiatry at Columbia University and the New York State Psychiatric Institute.

But others insist, with Dr. Healy, that the establishment has been in denial about the drugs’ most serious side effects, in part due to the influence of drug company money.

“All along, it has been too easy to blame the victim, or the underlying disease, without acknowledging that there might be some kind of synergistic effect between the drugs and whatever problems the person has,” said Sara Bostock, of Atherton, Calif., whose daughter committed suicide at age 25, shortly after starting to take the antidepressant Paxil. Ms. Bostock testified at the 2004 hearing and plans to do so today.

In some ways, the debate has changed little over the years. In 1990, Dr. Martin Teicher, a Harvard researcher, reported that six of his patients “developed intense, violent, suicidal tendencies and preoccupations” after starting on Prozac. A scattering of similar reports followed, and in 1991 the F.D.A. convened a panel of experts to review the evidence.

But the panel concluded that the data showed no link between the drugs and suicide. By the mid-1990s, the Prozac era was in full swing, similar drugs like Paxil and Zoloft would soon be on the market, and antidepressants were being prescribed not only for severe depression but also to people with modest mood problems.

In the late 1990s, two psychiatrists, Dr. Healy and Dr. Joseph Glenmullen at Harvard, wrote books that revived the suicide debate and put the questions about increased risk back in the air. And in late 2003, after reviewing previously unpublished data from drug company trials, British regulators effectively banned the use of most antidepressants in children and adolescents, citing a possible suicide risk, and the climate surrounding the issue changed drastically.

At today’s hearing, scientists are likely to discuss mechanisms that could set off suicidal behavior: if the risk is real for some people, what is happening in the brain?

Theories abound. Some people taking antidepressants have reported a feeling of restlessness, called akathisia, that in extreme cases is thought to be so unbearable that people want to end their lives. Others might have bipolar disorder, which is characterized by alternating high and low moods, and may become dangerously manic on an antidepressant, feeling reckless, grandiose, perhaps more willing to risk their lives. Still others have said they had experienced withdrawal effects that sparked self-destructive impulses. And some experts argue that genetic variations could put some people at increased risk. But no one knows how these processes work.

Dr. David Shaffer, a professor of psychiatry and pediatrics at Columbia University who receives no money from drug makers but has consulted with them in the past, said the study of suicide must change before clear answers emerge.

One suicidal teenager who came to Columbia for help improved quickly with a combination of antidepressant treatment and talk therapy, Dr. Shaffer said. But after what the boy perceived to be a humiliating incident at his part-time job — well after he was considered recovered and out of danger — he bought a bottle of painkillers on the way home and swallowed an overdose. Doctors later saved his life.

“What caused that attempt?” Dr. Shaffer said. “It was a combination of his emotional state at the time and his reaction to this environmental factor.”

Perhaps the only way to understand suicide is from the point of view of those who make a genuine attempt, successful or not.

Suicide is “a closed world with its own irresistible logic,” wrote the British poet and literary critic A. Alvarez, a failed suicide himself, in “The Savage God.”

“Once a man decides to take his own life,” Mr. Alvarez wrote, “he enters a shut-off, impregnable but wholly convincing world where every detail fits and each incident reinforces his decision.”

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