- The Washington Times - Sunday, May 7, 2000

After a breakup with a girlfriend, Patrick, a 36-year-old Los Angeles man, told his primary care physician he was feeling a little down. The physician wrote him a prescription for Wellbutrin, a selective serotonin-re-up-take-inhibitor (SSRI) anti-depressant.

Patrick took the drug and became one of the estimated one in 10 Americans who has taken SSRIs which include the more popular Zoloft, Prozac and Paxil since the medicines were approved by the U.S. Food and Drug Administration in 1987.

Almost immediately, Patrick began to suffer side effects. He became nauseous and dizzy and "was flying higher than a kite," he says. He went to a psychiatrist, who tried a variety of other SSRIs over a period of several months. Patrick never did feel better about the breakup. In fact, after a while, he was physically ill.

"I was tired and craved sugar," he says of his experience with Luvox, another SSRI. "I lost all emotions; I had no interest in sex. I abruptly quit the drug after five weeks, then my whole mind and body fell apart. I had nerve pain in my arms, hands and legs. I felt like something was happening to the left side of my brain. I believe a little therapy and talking would have helped me. This opened up a while can of worms and created more problems for me."

Though millions of Americans have credited SSRIs with correcting the chemical imbalances that cause depression, a vocal group of mental health professionals and patients are opposed to both the drugs and the easy way they are prescribed.

Critics say patients are not warned adequately of serious side effects, especially debilitating ones that can occur when a patient discontinues the medication. They also take issue with the availability of prescriptions, many of which are written by primary care doctors with little mental health training, and they say patients who stay on the drugs for longer than a year or two are facing unknown risks to their health.

However, drug manufacturers, physicians and millions of people who have used SSRIs say the benefits of the drugs far outweigh the side effects, which, for most patients, are not that troublesome. Thus far, extensive testing has not shown use of SSRIs to be linked to violent or suicidal behavior or proved it to be a long-term health risk.

Still, detractors say SSRIs are given out like aspirin by busy medical professionals who may not have a clear picture of a patient's health.

"I would go further than to say they are overused," says Bethesda psychiatrist Peter Breggin, author of the books "Talking Back to Prozac" and "Your Drug May Be Your Problem."

"It is an approach that has gotten out of hand by sound medical standards. We have been sold a bill of goods that emotional disturbances are biological and genetic when, in fact, they are not. No drugs correct a biological imbalance. In fact, they all cause them.

In "Your Drug May be Your Problem," Dr. Breggin cites dozens of medical-journal articles that detail the effects from SSRI use and withdrawal.

When SSRIs are given, the brain fights the drug and kills off its own capacity to respond to serotonin," Dr. Breggin says. "The brain now has to compensate, and you wind up with an abnormal brain. Everyone who takes these drugs is really an experiment, but [health maintenance organizations] and preferred provider networks prefer them. It is easier and cheaper for them to put people on drugs, whereas people tend to like therapy and keep coming back."

A magic bullet?

In simple terms, SSRIs increase the supply of serotonin, the neurotransmitter that is critical to mood regulation and well-being. That means the drugs are effective for a number of afflictions, from long- or short-term depression to anxiety disorders, obsessive-compulsive disorder, eating disorders and panic disorder.

"SSRIs are like broad-spectrum psychiatric antibiotics," says Dr. Brian Doyle, clinical professor of psychiatry at Georgetown University School of Medicine. "They are useful for a lot of things."

Sharon, a 46-year-old British woman who declined to give her last name, says: "I have been taking Prozac for over two years for depression I have suffered since adolescence. Over the years, I have taken various medications, and Prozac helps a great deal. My mood swings have decreased, and I definitely feel that I need to take Prozac for perhaps the rest of my life."

Sharon says the small number of side effects a loss of libido and slight fatigue are worth it for her.

Dr. Doyle says those side effects, along with weight gain, are common in people taking SSRIs.

"These drugs are not magic bullets," he says. "All of them have side effects. The most common are weight gain and sexual dysfunction. Approximately 50 percent of patients notice some side effects. Paxil seems to be the worst for weight gain. About 25 percent of patients gain 10 pounds or more."

However, Dr. Joseph Glenmullen, a Harvard Medical School professor of psychiatry and author of "Prozac Backlash," says those minor side effects are only the ones for which the drug companies will take responsibility.

Dr. Glenmullen maintains that SSRIs cause damage to brain cells and that the notion of a serotonin deficiency is a sales pitch to promote the use of medications. He also says side effects can include greater depression, mania, psychosis, even suicidal tendencies.

Detractors of SSRIs point out that Kip Kinkel, who shot his parents and schoolmates in Oregon in 1998, and Eric Harris, one of the gunmen in the Columbine High massacre last year, were both on SSRIs.

"Some people are particularly sensitive to drugs," Dr. Glenmullen says. "They become overstimulated and agitated. Death would be a welcome relief. The drug companies continue to deny this happens."

Eli Lilly and Co., which manufactures Prozac the oldest and most popular SSRI maintains the drug's link to suicide has been studied and no link has been shown.

"There is no credible scientific evidence that establishes a link between Prozac and violent or suicidal behavior," says Laura Miller, spokeswoman for Eli Lilly and Co. "There is, to the contrary, scientific evidence showing that Prozac and medicines like it actually protect against such behavior. In 1991, a panel of experts appointed by the FDA found no credible evidence of a causal link between the use of anti-depressant drugs and suicidal and violent behavior."

Critics of the drugs also say the risks of taking SSRIs for years are unknown because most clinical trials lasted less than 12 weeks.

"Physicians who prescribe psychiatric drugs for long-term use believe that the drugs are useful, but their views are based on personal impressions and unproved assumptions rather than scientific evidence," Dr. Breggin says.

Says Dr. Doyle: "We don't know of the long-term impact of these medications, and I tell patients that. However, [SSRIs] have been around for 12 years. The evidence to date shows sex and weight problems, but no lasting effects. The clinical data shows no long-term effects on the heart, lungs or mental function. New data is suggesting it is safe for use in pregnancy."

Jeff Stier, spokesman for the American Council of Science and Health, a New York consumer group, says the only way to test the long-term effects is to have the drugs on the market.

"You can't have a 10-year clinical trial," he says. "No drugs would ever make it to market. There is a very responsible post-marketing system in place. Companies must report to the FDA side effects, complaints and further research. Just because something is FDA-approved doesn't mean it is out there freely. It means it is at a stage to have more long-term numbers."

Easy to get

Another criticism is that anti-depressants are given out hastily and without monitoring.

"A lot of doctors give out anti-depressants like candy," Dr. Breggin says.

Says Dr. Glenmullen: "Antidepressants are overprescribed. Seventy percent are written by a primary care doctor, who are under pressure not to refer a patient to a psychiatrist. You can go to a doctor, and in 20 minutes or less, get a prescription to last six months to a year. People taking SSRIs should be monitored by a psychiatrist."

Dr. Doyle says primary care doctors often are quite skillful at recognizing and treating depression. That, along with the innovation of SSRIs, has changed the mental health profession for the better, he says.

"There are more depressed patients than psychiatrists can take care of," he says. "In the last few years, there has been a massive effort in primary care to recognize and treat depression."

Ideally, however, a combination of psychotherapy and medication is the best approach, according to guidelines of the National Institute of Mental Health.

Dr. Doyle says, in fact, that not enough people who could benefit from medication are taking it. He cites a recent Yale University study that surveyed 7,500 people ages 17 to 39. Of that sample, 312 subjects met the criteria for current, major depression, but only 23 were taking medication for it. An additional 216 people met the criteria for lifetime depression (having episodes in the past), but only 17 were on medication.

"The point, according to the study at Yale, is that less than 10 percent of those who should be getting medicine are," Dr. Doyle says.

Tough to stop

Doctors on both sides of the SSRI debate agree on one thing: If a patient is going to stop taking drugs, he or she needs to go about it very, very slowly. Some of the worst side effects occur with sudden withdrawal.

"I took Zoloft for six weeks, and the prescription ran out," says Mendy, a 32-year-old Arizona woman who asked that her last name not be used. "I didn't realize you couldn't just stop taking it. I had a bad panic attack. I had a really bad migraine headache. I felt like I was going to vomit. I was nauseous and dizzy."

Withdrawal effects sometimes can be confused with the return of depression symptoms, leading some patients to get right back on the drug, Dr. Breggin says. Other withdrawal side effects include balance and coordination problems, fatigue, insomnia, flulike symptoms and tingling. The symptoms could last days, weeks, even months.

Dr. Breggin recommends "the 10 percent method" for weaning off a drug reducing the dosage by 10 percent every seven to 10 days until the goal is reached.

Then again, Dr. Breggin, who says scientists have never proved the theory of a serotonin imbalance, advises that some people not even take drugs.

"Life is difficult," he says. "Often it requires psychological and spiritual guidance, not tooling our brain.

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