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Hard to Swallow

Read the ads and you'll think relief from the black cloud of depression is just a pill away. But if you consult the scientific record and look at the medical trials the pills have gone through, you'll see a much scarier story.

By Thomas J. Moore

Thomas J. Moore is the author of four books about health and medical care. His book, Prescription for Disaster, (published by Simon & Schuster, 1998) focuses on the risks of the most widely used prescription drugs.
"Prozac seemed to give social confidence to the habitually timid, to make the sensitive brash, to lend the introvert the social skills of a salesman."

So writes psychiatrist Peter Kramer in his book Listening to Prozac. Such glowing accounts have helped make antidepressants such as Prozac, Paxil, Zoloft, Effexor, and Serzone among the best-selling drugs in the world.

Yet here, in similar language, is how Johns Hopkins psychiatrist Kay Redfield Jamison describes an episode of mania in An Unquiet Mind, a memoir of her long battle with mental illness:

"Shyness goes, the right words and gestures are suddenly there, the power to captivate others a felt certainty. There are interests found in uninteresting people."

These statements are so strikingly alike because both describe a serious mental illness, no matter how attractive Kramer makes it sound. During manic episodes, the habitually timid may attack a police officer; armed with new social confidence, an introverted woman may brazenly solicit men in a bar. A serious episode of mania typically ends in a locked psychiatric ward.

In fact, according to their manufacturers, Prozac, Paxil, Zoloft, Effexor, Serzone, and other antidepressants may trigger mania, or less severe hypomania.

Fortunately, mania is an infrequent side effect of drugs for depression. What is distressingly common, though, is the tendency of both doctors and patients to overestimate the benefits of these drugs while ignoring their risks.

How does the hype about antidepressants compare to the scientific record?

The drugs are touted as effective for the vast majority of depressed patients. Yet they routinely fail to produce a measurable benefit in clinical testing.

Prozac especially is claimed to be relatively free of side effects. Yet in reports to the Food and Drug Administration, Prozac has been linked to more serious adverse reactions than any other drug in America over the past decade. And other antidepressants are little safer.

Antidepressants are said to be non-habit-forming. Yet in the first large study, more than one out of three patients experienced withdrawal effects.

The safety of antidepressants is supposedly proven by the fact that they have been taken by more than 20 million Americans. Yet virtually no meaningful research has been conducted on their long-term risks.

The danger of suicide is widely cited as a reason to treat depression with these drugs. Yet there is no evidence that antidepressants prevent suicide--and dark hints that they may even encourage it.

With antidepressants, side effects are more common than success stories. Here is what a patient named Greg had to say about Zoloft:

"Side effects? Just about all of them. The ones that stick around? Dry mouth, some hot flashes. I still get unusual cases where I'll wake up at three in the morning sweating. I have drowsiness and difficulty focusing for the first five hours after taking a dosage." (Greg's comments and those of some of the other patients quoted in this article were obtained through the Internet. To protect privacy, last names have been omitted.)

The fact is that antidepressant drugs are overrated by many consumers and doctors, overprescribed because of aggressive marketing, and among the most toxic drugs in widespread use as measured by the number, variety, and severity of adverse effects.

What's more, millions of Americans who think they can testify to the benefits of antidepressants are being misled by their own feelings. Doctors, if they rely on their clinical experience, are similarly deceived.

Why? Because in the treatment of depression, the placebo effect is very large. Scientific testing shows that roughly two out of three people who report a "marked" improvement on an antidepressant drug would have done equally well on a harmless placebo--and they wouldn't have to suffer such side effects as sexual dysfunction, anxiety, insomnia, sweating, and nausea.

An objective appraisal of antidepressants would be easier if global pharmaceutical companies didn't depend so heavily on their sales. Take Eli Lilly: Last year, Prozac accounted for about 30 percent of its total sales and probably an even larger share of its profits.

Like tobacco and beer companies, the pharmaceutical industry spends more for advertising and promotion than for manufacturing or research. This means billions are available to polish the image of products--and to combat critics.

For the facts about antidepressants, the best place to look is the Food and Drug Administration. By law, drugs have to be extensively tested before being marketed. The tests are evaluated by FDA doctors, chemists, and statisticians.

This article focuses on two of the newest drugs for depression, Serzone and Effexor, because--as new drugs--they ought to be tested to high standards and might offer advantages over Prozac, now in its tenth year. But what does the record say?

An examination of the risks and benefits of a drug must begin with a look at the medical problem it is intended to combat. Those who have not personally experienced major depression should not underestimate the severity of the disorder. Few afflictions are so capable of causing suffering. Here's how Charlotte Brontë described an episode of depression in her novel Villette:

"Indescribably was I torn, racked, and oppressed in mind: Galled was my innermost spirit with an unutterable sense of despair about the future. Motive there was none why I should try to recover or wish to live; and yet quite unendurable was the pitiless and haughty voice in which Death challenged me to engage his unknown terrors."

Modern psychiatry has reduced Brontë's poetic account of a dark cloud over the human spirit into a dry list. A "major depressive episode" is defined as a period of two weeks or longer in which a person loses pleasure in all or almost all activities. To this may be added fatigue, a feeling of worthlessness, inappropriate guilt, anxiety, difficulty sleeping or excessive sleeping, indecisiveness, inability to concentrate, or thoughts of suicide. By the medical criteria, just one of these episodes justifies a diagnosis of "major depressive disorder."

The number of people who suffer from this mood disorder has been poorly studied and is often exaggerated, either to sell drugs or to advance depression to a more prominent position on the list of disorders worthy of media attention, aggressive medical treatment, and public funds.

In a survey of 18,000 people funded by the National Institutes of Health, 1.5 percent of the population was suffering from major depression when interviewed, and 4.5 percent had experienced major depression at some point. At any time, about 4 million people in the United States suffer from the disorder. Millions more suffer less-severe episodes, often in connection with bereavement, divorce, or other life stresses.

The oppression of the human spirit that is called depression may be measured by a numerical scale of symptoms that ranges from 0 to 52. Called the Hamilton Depression, or Ham-D, scale, it consists of 17 scored items. A person with a Ham-D score of less than 6 is roughly normal. A Ham-D score of 20 or higher indicates major depression.

The strength of this approach is that psychiatrists everywhere can use the same protocol to evaluate patients and ought to get at least similar results. Under controlled conditions, raters agreed on diagnoses about 80 percent of the time. The scale isn't perfect, but Ham-D is a reasonably precise tool for diagnosing depression and measuring improvement or deterioration.

From the December 1997 issue.

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