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Goodbye blues.

Only five drugs have billion-dollar sales. Eli Lilly's wonder drug for depression could be the next.

Not since Valium hit the market has a drug achieved such widespread, instant name recognition among consumers. From the covers of Newsweek and New York magazine to television and radio features, the media are touting Indianapolis-headquartered Eli Lilly and Company's new weapon against depression.

For Lilly, which developed and manufactures Prozac, the resulting hype has meant a 7 7/8 point jump in stock in one day and an estimated $300 million in revenues for 1989. It is estimated that sales of Prozac could top the billion dollar mark by the mid90's. Is Prozac worth all the hoopla? It depends upon whom you ask, but most physicians, patients and financial analysts agree that it definitely merits the lavish attention it's getting.

Ellie D., a 42-year-old businesswoman, began taking Prozac more than a year ago. "I was clinically depressed. If I'd been any more depressed, I would have been hospitalized," she says. "My business failed and I was facing bankruptcy. Shortly after that, my teenage son who had lived with me all his life suddenly decided to leave and move across country to live with his father. All I ever wanted to do was sleep and escape. I had no feelings at all. Everything looked hopeless."

According to Dr. Richard Rahdert, medical director at Wabash Valley Hospital in West Lafayette, Ellie exhibited many of the classic symptoms of depression: too much or too little sleep, appetite loss or gain, crying easily for no reason, a feeling of hopelessness, lack of energy, suicidal thoughts, a loss of self-esteem and poor concentration.

Ellie's friends arranged for her to see a therapist who suggested she try Prozac to treat her depression. "It was a subtle drug for me," she recalls. "I began feeling stronger and things stopped bothering me as much. I was up doing things, taking care of my problems one at a time and able to work with the therapist. I'll never forget the day the therapist looked at me and said, 'The sparkle's come back into your eyes.'"

Ellie stayed on Prozac for four months and shortly after that, was dismissed by her therapist. One year later, most of her problems have been solved. "My son moved back," she says, "and I was able to find a job that paid well. I can't attribute my success to Prozac, but the medication gave me the right frame of mind to start working on my problems."

Although the efficacy of the treatment in Ellie's case was dramatic, not all patients respond to the drug so positively. The success rate at present stands at 60 percent, though with further research and development this figure could improve. And no one, furthermore, has a handle yet on Prozac's long-term effects.

According to Dr. David Giles of Gallahue Mental Health Center in Indianapolis, the incidence of depression is much higher among women. "The chance of a woman's having an episode of depression within her lifetime is 15 percent as compared with 10 percent for men," he says.

Antidepressants first appeared on the market in the 1950s and came in basically two varieties: tricyclics, such as Elavil and Tofranil, and monoamine oxidase inhibitors (MAOIs), such as Nardil and Parnate. In treating depression, these drugs work on the action of the serotonin and norepinephrine, which are chemicals that transmit impulses through the nervous system. Low levels of norepinephrine or serotonin have been connected with depression.

Enter Prozac.

Put simply, the drug provides for accumulation of serotonin. According to Dr. Stephen Dunlop, associate professor psychiatry at Indiana University Medical School, Prozac acts as a serotonin uptake inhibitor, increasing the effectiveness of neurotransmission by blocking the uptake, or removal, of serotonin. "Prozac slows down the vacuuming of the neurotransmitter," he says.

"It's critically important that people understand that antidepressants are not mood-elevating drugs, as distinct from amphetamines and uppers," stresses Dr. Thomas Kuich, medical director of the Psychiatric Medical Center at Ball Memorial Hospital in Muncie.

All antidepressants work by preventing the breakdown of serotonin using the body's natural chemistry, but Prozac is the first drug on the market that is serotonin-specific. The problems with antidepressants in the past have not necessarily been the efficacy of the drugs, but their side effects.

"With the MAOIs, patients had to be able to follow a fairly detailed, rigorous regimen in what they ate," says Dunlop. "If they ate certain kinds of cheese, aged meats, pickled herring, or drank alcohol, they could have a stroke, a severe headache, be paralyzed or even die."

Tricyclics caused unpleasant side effects such as dry mouth, constipation, sluggishness, dizziness and weight gain. They also caused low blood pressure and heart disturbances, which made their use for treating depression in the elderly inadvisable.

The side effects of Prozac seem to be fewer in number. Dr. Gerald Kauffman, clinical director of adult inpatient services at Oaklawn Psychiatric Center in Goshen, cites side effects of anxiety and gastrointestinal problems in some patients. Once the medication is stopped, however, the side effects dissipate.

Dunlop, who helped test the drug, reports that rashes are one of the more severe side effects and are probably related to individual allergies. Other side effects can be weight loss, a decrease in sexual function usually among men), or an increase in sexual desire (usually among women). In rare instances, people taking Prozac actually get worse, not better. They develop a condition known as the "caffeine syndrome," which results in tremors and jitteriness.

According to Dr. Thomas W. Riley at St. Vincent Stress Center in Indianapolis, however, the side effects of Prozac are so minimal that it probably will replace all the other antidepressants. "Where Prozac fails, we may try others, but so far, it seems equal to the others without the side effects," he says. The only side effects I've seen have been nausea and restlessness at night."

The drug's actions are subtle, says Riley. People say they are not improved and feel the same, but I see a difference. I had one patient who was cutting up with me and joking and suddenly he stopped and said, "I'm just as depressed as before." I looked at him amazed and said, "You weren't joking or gaining weight before.'"

Another advantage of Prozac over other antidepressants is the fairly standard dosage prescribed. Prozac is usually given in 20 milligram doses once a day, making it easier for patients to remember. Since individuals react differently to other antidepressants, patients have to be monitored carefully to determine the correct dosages.

Steve Rauch, director of the counseling center at St. Francis Hospital Center in Beech Grove, thinks the easy dosage makes Prozac especially useful in an outpatient clinic. We have fewer concerns about people overdosing on this drug," he says. Because we only see people weekly and biweekly, we don't want to have people on medicines that we're worrying about." This also makes it an easy drug for general practitioners to prescribe.

The major criticism physicians have about Prozac focuses on its cost. At $1.50 a pill, Prozac is by far the most costly antidepressant. Raymond Diggle, a financial analyst with Raffensperger, Hughes & Co. in Indianapolis, says that Lilly charges for Prozac what the market will bear. "There's no way of knowing what their profit margins are, but I would guess they are in the 60 percent-plus range," he speculates. "Sure, they're making a lot of money, but look at all the risks they're taking and the social benefits."

Kuich agrees. "It's expensive, but so is the disease," he notes. "It's important that the pharmaceutical companies be able to do the research."

Most psychiatrists agree that Prozac is a good drug, but stress that it is only one in an arsenal of antidepressants. What will work for one patient will not necessarily work for another. The biggest fear that physicians have about Prozac is that patients will regard it as a panacea for all ills. The media has made it a boom, which is a little dangerous," Rauch warns. There is also the fear that people will start believing they can go in, take the medicine and not deal with the depression. It's not a cure-all, but it's a good support in conjunction with therapy."

Although Prozac has been approved by the U.S. Food and Drug Administration to treat depression only, researchers also are looking into possible uses for problems with weight loss, bulimia, Tourette's syndrome, compulsive-obsessive disorders, borderline personalities and, possibly, addiction. Riley had a patient who used it successfully to cure a facial tic.

Research results are not yet in, but physicians in the field report both positive and negative effects with bulimia and compulsion. Ball Memorial's Kuich says he used the drug successfully in treating a man for compulsive checking.

"The patient checked to make things were turned off and doors were secure. it took him 10 or 15 minutes to leave the house every day as he redid everything. After having been on Prozac for nine months, he had a complete resolution of this problem," says Kuich. Other physicians, however, report seeing little or no benefit from prescribing Prozac to manage compulsive-obsessive disorders.

There is evidence that serotonin plays a part in regulating the food intake in animals, says the IU med school's Dunlop. There is no statistical change in weight with a dosage of 20 milligrams, but with an increased dosage, there is some weight loss, he says. "The weight loss is proportional to the weight and body mass index of a person," he explains. He cautions, though, that this could be similar to other weight-loss drugs. If lifestyle remains unchanged, the weight returns once the drug is stopped.

Research certainly will continue at Lilly, where last year alone more than $600 million was spent on research and development. "Only a handful of companies in the world can match Lilly," says Diggle. A few years ago, a small company could develop something, but that's not possible now."

Lilly likely will funnel profits from Prozac back into research to determine whether Prozac can cure anything else. "Lilly is clearly expanding onto this turf," Diggle says. "I think they'll be concentrating on three areas: antidepression or neurological products, cardiovascular products and the medical-device area. They are big in anti-infectives, but the trouble is that these are either old products or there is a lot of competition."

Dorothy E. doesn't care much what Lilly's future is, as long as it continues making Prozac. She knows it helps her chronic depression. "I was on Prozac for nine months and loved it. Then I went off for a while. Now, my husband is begging me to go back on it. If the drug works, I'm for it."
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Title Annotation:Eli Lilly Co.'s new anti-depressant drug Prozac
Author:Partington, Marta
Publication:Indiana Business Magazine
Date:May 1, 1990
Words:1794
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