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PHOTOS BY DIANA WATTERS
By Beth Hawkins
In a year of tumbling stock prices, accounting scandals, and shaky consumer spending, the British pharmaceutical giant GlaxoSmithKline has had remarkably good news to report so far. More than eight million prescriptions have been written for Advair, its asthma medication, in the year and a half it has been on the market; Trizivir has become the most frequently prescribed drug for new HIV patients; and despite competition from a new generic version, the antibiotic Augmentin is still selling well.
But it is the antidepressant drug Paxil that seems to be GlaxoSmithKline's unstoppable star. During the first half of this year, the drug's sales were up 18 percent in the United States. Every day an estimated 3,000 to 5,000 Americans begin taking Paxil. In 2001 alone, 25 million new scripts were written for the drug. Paxil's strong sales--$2.1 billion last year--are often cited by Wall Street analysts as one reason GlaxoSmithKline's stock remains an attractive prospect in an otherwise gloomy market.
Indeed, during the past 15 years the antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, have revolutionized mental health care. And for tens of millions of Americans, Paxil and its pharmaceutical cousins--Prozac, Zoloft, Celexa, and Luvox--have proven a godsend. They boast far fewer side effects than their predecessors and it's virtually impossible to take a lethal quantity of the new pills. Most people know someone who has been on one of the drugs for years.
The SSRIs have been a boon to the pharmaceutical industry, too, becoming the third most commonly prescribed type of drug, with sales of more than $13 billion a year worldwide. A bonus: Many patients use SSRIs for years, which takes some of the sting out of the cost of bringing a new prescription drug to market.
For years Eli Lilly's Prozac was the most widely prescribed SSRI. Pfizer's Zoloft has likewise taken a turn as the top seller. But it's Paxil that has shone as a marketer's dream. When the drug was introduced in 1992, the market seemed so saturated with antidepressants that it was hard to imagine Paxil would ever catch up. A decade later, it's poised to become the world's best-selling SSRI. GlaxoSmithKline has steadily and energetically added to the list of disorders Paxil can be used to treat, and spent billions of dollars to make sure the buying public knows where to turn in case anxiety or melancholy sets in.
Unfortunately GlaxoSmithKline leaves out one little detail: For thousands of people, it seems that Paxil could well be addictive.
The chemical serotonin is present throughout the human body. Among other places, it exists in blood, in the mucous membranes of the gastrointestinal system, and in certain kinds of tumors. Serotonin plays a vital role in regulating sleep, appetite, sensory perception, body temperature, pain, and mood.
In the brain, serotonin acts as a neurotransmitter, a chemical messenger that facilitates communication between two nerve cells. Serotonin molecules are released from a "sender" cell into the space between nerve cells known as the synapse. From there, they are scooped back up by a "receiver" cell.
When physicians describe depression as an illness resulting from a chemical imbalance in the brain, one of the possibilities they speak of is an interruption in the supply of serotonin in the synapses. Perhaps too little of the chemical is being manufactured, for instance, or too little of its chemical precursors--the molecules used to make the neurotransmitter. Sometimes there aren't enough receptor sites, and sometimes serotonin is taken back up before it can get to those sites.
Research into serotonin's role in mood disorders has been going on for decades. Physicians have long known that in many instances, depression is caused by a lack of another chemical important to brain function, norepinephrine. Perhaps, they posited, a lack of serotonin somehow caused or allowed a dip in norepinephrine. If that were the case, the manipulation of serotonin levels would indirectly raise norepinephrine.
Before Prozac came on the U.S. market in 1988, depression was often treated with a class of drugs known as tricyclic antidepressants. These drugs were quite effective at manipulating both serotonin and norepinephrine but caused a wide range of bothersome side effects.
"In the old days, the pre-Prozac days of tricyclic antidepressants, you were told to treat endogenous depressions for six to 12 months and then to taper off," explains Kevin Turnquist, a psychiatrist with the Hennepin County Mental Health Initiative. "In most cases, it worked well for those people; in fact, the tricyclics worked slightly better. The problem was the side effects. A week's dose was lethal."
As a consequence, tricyclics were not widely prescribed. The advent of Prozac, Paxil, and the other selective serotonin reuptake inhibitors changed that. Although each is a slightly different chemical cocktail, the SSRIs all work in roughly the same way: They slow the action of brain cells that take serotonin out of the synapses, raising the amount of the chemical circulating in the brain. And they do it with relatively few side effects. "Plus," notes Turnquist, "you could just give one dose, start a patient on 20 milligrams and let them stay on it. It's much easier and safer for the doctor to prescribe."
To gild the lily, the pharmaceutical industry touted the SSRIs as non-habit-forming. "Paxil is not a controlled substance," explains GlaxoSmithKline's promotional literature. "Paxil belongs to a class of medications called SSRIs, which have not been shown to be associated with addiction." The claim is repeated in all of the ads for Paxil, and in the drug information GlaxoSmithKline gives to doctors.
Kevin Murphy found all of this information comforting when he and his wife struggled with the decision to put their 11-year-old daughter Kelly on medication. She'd been having panic attacks for a while and had tried several kinds of therapy. Nothing worked, so the Murphys, who live in Lino Lakes, swallowed their concerns and took Kelly to see a psychiatrist. "He prescribed a couple of medications that didn't do anything," Kevin Murphy recalls. "He switched her over to Paxil, and Paxil worked pretty quickly.
"We had talked to the doctor and said what we'd really like to do is have her on it for a year and then take her off of it in the hope that her body would have unlearned the panic response," he continues. "As we drew near the end of that year, her doctor said very casually that it's always a good idea to taper off of this very gradually. She was already cracking a 10-milligram tablet in half, then she started cracking that in half, too, to get to 2.5 milligrams.
"Finally, she was off of it altogether for a couple of days and then she started to have panic attacks. Her heart would just race, and then she'd think she was going to be sick--and she hates being sick. So we called the doctor, and he said to put her back on it."
For the next three-plus years, they tried other tactics for weaning her off the drug. They tried switching her to Celexa, another SSRI. That failed. They tried the same tactic, but using Prozac. They tried anti-nausea drugs, acupuncture--"everything," Murphy says, "but nothing helped."
In addition to excruciating stomach pain, Kelly was so nauseated she couldn't sleep or eat. Doctors examined her upper gastrointestinal system. She had a CT scan, an ultrasound, and countless other tests. Each showed her to be healthy. And yet each time she stopped taking Paxil, she found herself homebound. And each time, she went back on Paxil--at a higher dosage.
Kelly's mother, Maureen Murphy, was forced to quit her job to stay home with her. She missed months of school. "We had to get a tutor for her so she wouldn't fail school," Kevin Murphy says. "She lost 10 pounds. She would be up until 1:00, 2:00, 3:00 a.m. trying to sleep.
"And all the while her psychiatrist said, 'This is really weird. I'll check with the drug company and see what's going on.' And they told him that nothing like this happens with this drug," he recalls. As for Kelly, he adds, "She told me several times she wished she were dead."
Right now she's trying one more time to taper off Paxil. On the advice of a psychiatrist, she switched to a liquid form of the drug so she could decrease her dose by one milligram each month.
Last fall, Murphy became one of 34 named plaintiffs in a class-action lawsuit filed in U.S. District Court in Los Angeles. Since then, some 6,000 people have joined the suit. Several other law firms are pursuing similar suits in the United States. In addition, suits have been filed in Canada (in British Columbia, Ontario, and Quebec) and in England.
20/20 hindsight: Kevin Murphy wishes he'd never agreed to put his daughter Kelly on Paxil
Before SSRIs, anxiety had been treated mostly with psychotherapy. In the most serious cases, psychiatrists turned to Valium and other benzodiazepines--again, drugs with a host of serious side effects. Just as Prozac had revolutionized the treatment of depression, SmithKline promised to change the treatment of anxiety disorders by providing a safe alternative.
The company quickly secured permission to market Paxil for the treatment of panic disorder and obsessive-compulsive disorder. By mid-1995, Paxil had become the fastest-growing SSRI in the United States. In 1996, sales of the drug had climbed 54 percent to $291 million.
Impressive though those numbers may be, SmithKline was on the verge of a much bigger marketing coup: The company had been working to win approval from the U.S. Food and Drug Administration to market Paxil as a treatment for the first of a series of little-known mental health ills. In 1999, the FDA agreed to allow Paxil's prescription for the previously rare "social anxiety disorder."
SmithKline hired a New York public relations firm to raise awareness about the syndrome. According to the trade journal PR News, Cohn & Wolfe "developed a plan to educate reporters, consumers, and, in some cases, physicians, in an effort to encourage diagnosis and treatment."
All indications are that the agency earned its fee. "Paxil's reintroduction secured nearly 1.1 billion media impressions in 1999, with 400 million generated in the month that the drug was granted FDA approval," raved PR News. "Media highlights included the cover of U.S. News and World Report, The Howard Stern Show, Parade, National Examiner, the New York Times, Good Morning America, and Vogue. Ninety-six percent of media coverage delivered the key message, 'Paxil is the first and only FDA-approved medication for the treatment of social anxiety disorder.'"
Earlier studies had suggested that perhaps two percent of the population suffered badly enough from social phobia to warrant treatment. Far worse than simple shyness, these people harbored "persistent irrational fear and the need to avoid any situation in which one might be exposed to scrutiny by others and potentially embarrassed or humiliated," according to one medical dictionary.
Following SmithKline's PR and advertising campaigns, however, sufferers were presenting themselves for medication in record numbers. "Paxil sales surpassed those of Zoloft," PR News reported, "and tied those of Prozac for the first time in history, and the Social Anxiety Disorder Coalition received nearly 12,000 calls to its 800 number."
A support group funded by the pharmaceutical industry, the coalition recruited patients to share their sagas with the media. Donny Osmond--diagnosed with the condition by the head of one of the coalition's member groups--recounted his struggles with the disorder on network television. "Never underestimate the power of a celebrity to invigorate a tired media story," observed PR News. A few weeks later, PR News recognized Cohn & Wolfe's campaign with its Platinum PR Award.
"Every marketer's dream is to find an unidentified or unknown market and develop it," Barry Brand, SmithKline's product director for Paxil, told Advertising Age. "That's what we were able to do with Paxil."
Last year, GlaxoSmithKline won FDA approval to sell Paxil for generalized anxiety disorder, a diagnosis that was created by psychiatrists as something of a catchall entry in the Diagnostic and Statistical Manual of Mental Disorders. Sales shot up 17 percent to $2.1 billion. A few months later, post-traumatic stress disorder was added to the list.
SmithKline's so-called public-awareness campaigns were just one half of a coordinated strategy, though. In 1997, the FDA relaxed its rules on pharmaceutical advertising to let the pharmaceutical industry bypass healthcare providers to market its wares "direct-to-consumer" (DTC in marketing shorthand). In 1996, drug companies spent $595 million on advertising. Within a year, spending rose to $843 million. By 2000, the amount had shot up to nearly $2.5 billion.
Paxil was the first central-nervous-system drug to be advertised by name on television, according to Advertising Age. With such tag lines as "Your life is waiting" and "What if you were allergic to people?", the spots targeted 18-to-34-year-old professionals.
In the weeks following the attack on the World Trade Center, Glaxo positioned Paxil as the perfect antidote to post-9/11 anxiety. "Your worst fears," agonized one woman, seated at a kitchen table, "the what-ifs... I can't control it." "I'm always thinking something terrible is going to happen," another woman fretted. "It's like a tape in my mind," a third confessed. "It just goes over and over and over."
"DTC is a great way to create demand," the trade journal Drug Topics quoted one marketing VP as saying. "Advertisers are trying to help consumers recognize a specific symptom and then recognize that something can be done to alleviate the symptom."
The ads pay off for drug companies. Ninety-one percent of people surveyed in 2000 by Prevention remembered seeing a drug ad; one third of them then asked their doctor about the medicine. Seventy-one percent of patients who asked for a drug they had seen advertised left with a prescription.
The statistics don't surprise the Mental Health Initiative's Turnquist. "I get phone calls from people who've seen the ads and they may be doing okay, but they say, 'Hey, I want to try this new drug,'" he says. "The patient sees an ad on TV, and there's a smiley, happy face bouncing across the screen, and they aren't feeling that well." It seems like it's worth a try, especially because the drug is billed as harmless.
The FDA's new rules on promotions freed drug companies from listing all of the side effects associated with every drug in every ad, but they still require accurate and balanced information about a drug. Nonetheless, the FDA frequently reprimands drug companies for TV and magazine ads that downplay a drug's risks, misstate its benefits, or wrongly characterize it as better than another.
In November 2000, for example, the agency took Eli Lilly to task for a TV spot for Sarafem, the name given to Prozac when it is sold as a treatment for premenstrual dysphoric disorder (PMDD). "Think it's PMS?" the voiceover asks, as a frustrated woman tries to wrestle a shopping cart. "It could be PMDD." The FDA complained that the ad made no distinction between PMS and the much more rare and serious PMDD; that jumpy graphics distracted viewers' attention from the list of side effects and risks; and that other vital information was listed in type that was all but invisible.
Poor compliance aside, the pharmaceutical industry has begun a campaign to have the FDA's authority over advertising loosened even further. The companies want to use much shorter lists of possible side effects in magazine ads, for instance. Leading the FDA's review of the rules is the agency's chief counsel, Daniel Troy, an attorney with a history of challenging the FDA on marketing issues, including attempts to restrict tobacco advertising.
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About Beth Hawkins
From the Archive
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- The Yo-Yo Files Why did it take three investigations, two trials, and one year of legal ups and downs to convict Alfred Flowers of sassing a cop? He may never know: Minneapolis, Hennepin County, and the FBI have declared the records top-secret. (Cover Story - Mar 29, 2000)
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- S is for Spriegl One jury sent Dameion Robinson to prison for life. The other said he was not guilty. Confusing? Not to the state Supreme Court. (City Beat - Feb 2, 2000)
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