Drugs

Eight months before Roach’s sentencing, Rosemary Heinen, an employee of Starbucks, was arrested for allegedly embezzling $3.7 million from her employer. Heinen’s job consisted, in part, of reviewing and approving invoices that came into the company’s information-technology department. Heinen reportedly created a bogus consulting company, which for a little under a year billed Starbucks for nonexistent services.

When investigators searched the Heinen’s suburban house, they reported finding it crammed with hundreds of boxes of Avon cosmetics, Barbie dolls and Franklin Mint products, all unopened. The hallways were clogged with piles of clothes and rooms were filled floor to ceiling with television sets, satellite receivers, Steinway pianos, stuffed animals and commemorative mugs. Also found were two motorcycles, a $200,000 powerboat and 31 cars — including a 2001 911 Porsche Turbo and an inconspicuous yet practical Model T. Heinen agreed to repay $2.5 million and the items found her home have since been auctioned off to pay back Starbucks.

Roach and Heinen fit the criteria for compulsive shopping, which falls under the category of “Impulse-Control Disorders, Not Otherwise Specified,” in the Diagnostic and Statistical Manual of the American Psychiatry Association. Researchers have characterized the ailment more specifically as “a preoccupation with purchasing unneeded items that causes marked distress, social or occupational impairment and/or financial problems.” According to a variety of estimates, based mostly on limited university studies, 2 to 8 percent of Americans are believed to be compulsive shoppers; women who suffer from this condition outnumber men 9 to 1. And as is so often the case with newfangled disorders, the statistics have led to self-help books, which have paved the way, inevitably, to a pill.

Last year, a team of researchers at Stanford University School of Medicine conducted a study on the effects of a drug called Celexa on compulsive shoppers; the initial results were published last fall. Dr. Lorrin Koran, a professor of psychiatry and the director of the obsessive-compulsive disorder clinic at Stanford University Medical Center, led the inquiry, which established that citalopram (Celexa is the brand name), a selective serotonin reuptake inhibitor, or SSRI, helped curb the urge to purchase in compulsive shoppers.

Compulsive shoppers are described by Dr. Koran as a group of people “motivated by ‘irresistible’ impulses, characterized by spending that is excessive and inappropriate, has harmful consequences for the individual, and tends to be chronic and stereotyped.”

The study concluded that “results suggest that citalopram may be effective for compulsive shopping. Additional research is needed to examine the role of mood symptoms in the initiation, continuance and relief of this disorder. Acute and long-term, double-blind, placebo-controlled trials of citalopram and other SSRIs for the treatment of compulsive shopping are indicated.” In a statement, the researchers added, “Citalopram produced marked improvements on both the Yale/Brown Obsessive-Compulsive Scale Shopping Version and the Clinical Global Impressions of Improvement Scale.”

The media loved the story. Celexa was both lauded and pilloried as the “anti-shopping pill.” The findings of the study were widely publicized in articles that included sentences like, “But help is on the way — in the form of a pill.” Coverage of the study — prominently featuring the brand name Celexa — helped put both the buying disease and its potential cure on the map.

Five months after some of the initial results of the study were published, Business Week ran a breathless article on Forest Labs, the makers of Celexa, mischievously titled “No Need For a Mood Enhancer.” The magazine credited the company with “revolutionizing the way drugs are sold.” The company has done this by making significant investments in direct-to-consumer advertising, sending out, as Business Week described it, “a small army of well-versed sales reps, trained to call on every prescribing doctor in a defined territory.”

According to Business Week, Celexa has gained 12 percent of the market since it was first introduced in 1998. The drug’s sales reached $190 million two quarters ago, making up 61 percent of the company’s $310 million in total quarterly revenue, according to the magazine. Forest’s share price has more than doubled in the past two years; the company’s CEO, Howard Solomon, exercised stock options last year valued at $230 million.

“Investor exuberance over Celexa,” concluded Business Week, “largely has to do with the way in which Forest was able to grab a modestly successful drug in Europe and make it into an American blockbuster.”

Celexa’s success, of course, is due to much more than just the result of one Stanford study. Like other SSRIs, Celexa also has been used to treat depression, obsessive-compulsive disorders, phobias, bulimia, pain in fibromyalgia, bipolar disorders, anxiety disorders and any condition for which an SSRI might be prescribed. But media-friendly studies like this one certainly don’t hurt a company’s efforts to market a drug, especially when they provide a specific link to the treatment of an exotic new disorder. In a roundabout way, studies can help build the kind of buzz and brand positioning that, it turns out, money can buy after all.

The results of the relatively small (only 21 people), relatively short (12 weeks) and non placebo-controlled Stanford study were never intended to be the last word on the subject. The researchers have continued to monitor the success of members of the first group — some of whom chose to continue on the medication, some who did not — over time, and there is little to report in the way of conclusive long-term results at this point.

“I know some people are doing well, some aren’t,” says Dr. Kim Bullock, a fourth year resident at the Stanford School of Medicine’s department of psychiatry and behavioral sciences, who conducted the study with Dr. Koran, “but I can’t say there’s some general trend.”

Dr. Bullock and her colleagues are still trying to determine the precise role of the drug in the patients’ improvement. The initial study involved other forms of cognitive-behavioral therapy, which may have had an effect on results. Specifically, says Dr. Bullock, patients were asked to keep spending logs as a means to examine and confront their behavior, in some cases, for the first time. Also, visits with the psychiatrists may have also had an effect.

In fact, in a follow-up study, the team has taken away the shopping logs. “We thought that their having to confront [what they bought and how often] was having some therapeutic effect,” says Dr. Bullock. “We’re also following them over a long period of time to see if there’s a drug effect and we’re still doing follow-up on the people from the first study. We also have a cognitive therapy group, so eventually we’ll compare them.”

Initial improvement was measured by Stanford researchers on the Yale/Brown Obsessive-Compulsive scale, which they modified to work with compulsive shopping. Questions on the scale were broken down into obsessions (thoughts and urges about shopping) and compulsions (actual shopping behavior). The questions asked things like, “How much do you think about shopping?” “How much anxiety does it cause you?” “How much does it interfere with your life?” “How much do you resist it?” “How often are you successful at resisting?”

“There were dramatic life changes,” says Dr. Bullock of the initial results. One woman, who was deeply in debt, now has savings and is preparing to make investments for her retirement, says Bullock. “She’s now also much more interested in her relationships. But we don’t know why. Is it the drug? Is it something that happens when they come to visit us? Is it the shopping log they’re keeping? Are they responding to placebo?”

Bullock explained that there is some evidence to suggest that people with impulse-control disorders respond to placebos because “their locus-of-control beliefs are external.” In other words, they are highly suggestible. The study also found that shopaholics are unusually responsive to visual cues, a phenomenon that seems to occur most consistently in women, who as the primary shoppers in our society are relentlessly courted by the advertising industry. Ironically, medical researchers are courted just as aggressively by drug-makers.

“They woo us, basically, ” says Bullock. “They come and pick the brains of the investigators and find out about what’s going on. It’s very interesting. Doctors give talks and get great dinners.”

This is not to suggest that the Stanford study’s hypothesis was driven by the pharmaceutical company. Doctors commonly prescribe Celexa, as well as other SSRIs, to treat mood disorders, and compulsive shopping may well be related to this type of disorder. But which brand of drug a doctor chooses to include in a study depends on the doctor’s discretion — as well as the drug company’s enthusiasm for funding studies.

“A few other studies involving SSRIs and compulsive shopping had been done before and Dr. Koran had the idea of using an SSRI in a study,” Bullock says. “Then, of course, Forest Labs said ‘We’ll finance this.’ So that’s how Celexa was chosen.”

“I’m still a resident, so I’m trying to figure out how the academic world works,” she adds. “But from what I see they come and form relationships with the primary investigators and find out what they’re excited about. Dr. Koran was interested in the subject anyway, but they’ll come and brainstorm and say ‘Can we help you do this study?’ or ‘You’re thinking about SSRIs, why not Celexa? And if you use Celexa then we’ll pay for part of that study.’ That’s kind of how it works on an informal basis.”

When a company donates money to the university to finance a study, it has to go through the university to make sure that it will not influence the study in any way. The primary investigator still decides how to conduct the study, and companies are prohibited from trying to influence results. “But they do give a lot of money,” Bullock says. “It’s amazing.”

And then, of course, there’s the irony of the drug company selling a pill to a group of people who will literally buy anything. How hard can it be to convince a compulsive shopper to buy a fix-it pill? For that matter, how difficult would it be to convince researchers to take money for research they are anxious to do? The drug salespeople come to campus bearing gifts of lavish lunches, conferences, pens, and clocks and, of course, the funding that pays their salaries.

“I think the [the drug companies] are getting way too much influence,” says a researcher who asked not to be named. “They’re here, and that doesn’t seem right, because they are money-driven and the fear is they’ll bias us in some way. On the other hand, it’s so hard to get funding, there’d be no research if they weren’t here.”

“Doctors at the attending level would be even less likely to say how they feel about it, because their research money and salaries are coming from the drug companies,” she adds. “My fellow residents and I are kind of sickened by it. It kind of disillusions you a little bit. So you try to separate it and try not to be biased by it, but the temptation is there all the time.”