A submission made by the author which she wrote while in grad school.
Atypical Antipsychotics are the New SSRIs
A women walks along a beach, the sky is grey, the waves hit the shore with a tumultuous splash. She tugs her jacket just a bit closer to fend off the chill.
“Bipolar Disorder is challenging, and can affect your job, family, and friends,” begins the woman’s narration. “For years, I had severe mood swings, racing thoughts, unusually high energy, and was extremely irritable.”
Then suddenly, the sun begins to shine and the woman, who looks to be in her late 20s or early 30s, cracks a smile.
“My doctor and I discussed my options. He prescribed Abilify,” continues the narration as she walks over a dune to meet a handsome man who is reading a newspaper and has evidently been waiting for her.
“Hundreds of thousands of patients have been prescribed Abilify,” an official male voice promises enthusiastically.
With its 2.3 million diagnoses a year, bipolar disorder may very well be the “new” depression. For pharmaceutical marketing, atypical antipsychotics drugs are the new SSRIs, or selective serotonin reuptake inhibitors, an older form of antidepressants that were big business in the 90s.
Abilify, made by Bristol-Myers Squibb, the third largest pharmaceutical company in the US, was approved in November 2002 for the treatment of schizophrenia, the psychiatric illness marked by auditory and visual hallucinations, delusional thoughts, and the inability to connect with other people.
But Abilify didn’t really transform into a wonder drug—at least not in sales—until it was approved by the FDA and marketed for the everything-that-ails-you psychiatric indications, such as pediatric schizophrenia and bipolar disorder, and supplementary aid for depression, but mainly, as a treatment for bipolar disorder.
Atypical antipsychotics, including Abilify, will lose their patent in 2015. Clinical Psychology and Psychiatry, a trade blog, estimated that the overall sales of atypical antipsychotics will plummet from $5.4 billion in 2005 to $4.8 billion in 2015. This means that pharmaceutical companies must do all they can to keep the drug selling right now, which is done through approval of new indications and aggressive marketing.
“There’s a pattern with the atypical medications. They come along, the first indications are psychosis, then they move on from there,” said Allan Coukell, the director of policy at the Prescription Project, an independent nonprofit policy institute, which produces research and information about the health care industry, and is funded by the Pew Charitable Trusts.
With these new indications Abilify has gone on to become the company’s second bestselling drug—right after the heart disease medication Plavix—according to Bristol-Myers Squbb’s earnings report from October 2008. But how the public has fallen for their campaign is more surprising.
In 2004, journalist Vanessa Grigoridas, writing about “mild bipolar disorder” for New York magazine, said it best: “As much as depression was the illness of nineties, mild bipolarity has become the new diagnosis for a slice of society that includes hard-to-treat depressives and some with a personal disposition that perhaps hedges into ordinary moodiness.”
Many can remember that period in the mid-90s when it appeared that everyone, young and old, was popping SSRIs to combat a depressive disorder. But soon many of the medications in this drug class, such as Paxil, Prozac and Zoloft, were subject to class action suits. There turned out to be not only a high rate of side effects—such as apathy, dizziness, tremors, renal impairment, and sexual side effects. Most serious, however, was the higher risk of suicide or death in some patients taking the medications. Pharmaceutical companies producing SSRIs were eventually forced by the FDA to include a black box warning, to caution consumers about the risk of suicidal thinking and behavior associated with SSRIs, especially in children and adolescents.
In the case of Bristol-Myers Squibb, its SSRI, called Serzone, was pulled off the market in April 2004 after it caused liver damage in dozens of patients and was linked to the deaths of 20 people, the Associated Press reported. In the world of psychotropic drugs, SSRIs developed a bad reputation; the money and marketing efforts needed to go elsewhere.
Enter atypical antipsychotics. Abililfy was the sixth atypical put on the market, when the world of psychiatric medicine was ready for an alternative to the “typical antipsychotics,” the first class of drugs from the 1950s used to treat psychosis in schizophrenics. While these older medications were a breakthrough for many, they caused what is known as tardive dyskinesia, an often irreversible condition of uncontrollable twitching and involuntary muscle movement. The mark of a psychiatric patient taking Thorazine, one of the most commonly administered typical antipsychotics, for example, was said to be the “Thorazine shuffle,” since an attribute of tardive dyskinesia was a distinctive, shuffling walk.
But complications with the newer class of antipsychotics, which also include the popular drugs Seroquel, Zyprexa, and Risperdal, remain plentiful. Most notably, they can cause a patient to put on tremendous amounts of weight, which leads to many long term health problems over the years.
“These newer medications are proven to be better in terms of risk of tardive dyskinesia, but they are not necessarily as good at controlling psychosis,” said Margaret Weiss, a psychiatrist who is the director of Women’s and Children’s Health Centre in Vancouver, Canada, where she uses many of the atypical antipsychotics to treat patients. She added that Abilify and others in the same class have been linked to diabetes and adult metabolic syndrome, but as a clinician, she has seen remarkable improvement among her bipolar patients. “You really trade one set of side effects for another,” Weiss said.
However, the warning and indications label for Abilify mentions that tardive dyskinesia still remains a risk of using the drug. The label says: “Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.”
The National Institute of Mental Health (NIMH) also questioned the efficacy compared to the older class of antipsychotics. In the mid-1990s, NIMH re-conducted a series of trials known The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Study, to compare the two classes of antipsychotics. They had last conducted such studies in the 1950s, when the older class of medications hit the market. NIMH noted that atypicals cost roughly ten times more than the older drugs, but were not always as effective. Studies done on the new medications were conducted only by the pharmaceutical company that produced them and for only four to eight weeks. In a $42.6 million study which lasted for 18 months and involved more than 1,400 subjects, the NIMH noted the trade-offs evident between the two different medications, but they only examined the atypical antipsychotics for its oldest indication: schizophrenia.
However, by 2004, Bristol-Myers Squibb had already pushed ahead with its big plans to expand the market. The FDA gave approval for treating bipolar disorders in adults, and the company waited for FDA approval for several other indications including treatment for bipolar disorder and schizophrenia in children and adolescents and adjunctive therapy for treating bipolar disorder as well as depression in adults. Abilify would be the first psychiatric medication approved for adjunctive therapy, the concept of using an additional medication to supplement a patient’s current less effective medication. In this case, Abilify got approved as a supplemental medication to the oldest mood stabilizers on the market—lithium and Depakote—and both old and new antidepressants.
During the period of 2002 to 2005, the company received several allegations that they were illegally marketing Abilify for the off-label uses of pediatric bipolar disorder and schizophrenia, as well as for psychosis due to dementia in the elderly. The allegations came from former employees of Bristol-Myers Squibb, who said that company offered kickbacks in the form of consulting fees and paid-resort stays to physicians who prescribed Abilify for these indications. The federal lawsuit was settled out of court for $500 million dollars. The FDA also forced the company to include a black box warning, describing the risk of death among elderly patients taking the drug for dementia, though later the agency approved the drug for use in children in 2007 and 2008.
Bristol-Myers Squibb needed to repair its reputation and make up financial losses due after the civil suit. It got back into the marketing game, pushing Abilify heavily for the treatment of bipolar disorder for the 20-and-30-something-year-old market, especially targeting women. According to the Journal of Clinical Psychiatry, “although bipolar disorder is equally common in women and men, research indicates that approximately three times as many women as men experience rapid cycling,” which meant that young women were an especially large market, since Abilify had been shown clinically to aid in the control of manic, depressive, and mixed episodes. For the most part, young, Caucasian women dominate Abilify’s ads.
Women have always been the target of drug advertisements, especially psychiatric medications. The rock band, The Rolling Stones immortalized the problem in their song “Mothers Little Helpers,” about women’s addiction to benzodiazepines: “Mother needs something today to calm her down/ And though she’s not really ill/ There’s a little yellow pill/ She goes running for the shelter of a mother’s little helper/And it helps her on her way, gets her through her busy day.”
The 2007 launch of Bristol-Myers Squibb’s splashy bipolar campaign was the epitome of rebranding in the pharmaceutical world. Most notably, it was marked by an unprecedented attempt at guerilla marketing, by placing advertisements in unexpected places. Thousands of posters were taped to the sides of public phone booths in neighborhoods of cities heavily populated with young people, including Seattle’s University District, and the East Village of New York City. On the poster, a woman stood alone, looking out in the distance. “Treating bipolar disorder takes understanding,” read the advertisement. At the bottom of the advertisement, viewers were urged to visit this website about “managing bipolar,” which redirected the consumer directly to one of the Abilify websites, which marketed specifically to consumers with a diagnosis of bipolar disorder.
In 2006, Bristol-Myers Squibb spent $329 million dollars on advertising and marketing of its drug, rolling out the preliminary stage of the bipolar disorder indication campaign. By 2007, it was the third most recommended atypical antipsychotic drug for the treatment of bipolar disorder, just below Zyprexa and Seroquel. Twenty-three percent of psychiatrists recommended the drug regularly for bipolar disorder, according to Pharmalot, a blog about pharmaceutical marketing. However, in the same study, Abilify was only recommended by three percent of the psychiatrist interviewed for schizophrenia, its primary indication. During the third quarter of 2008, Abilify earned the company $564 million, which was a nearly 35% more from the last quarter, according to Pharma Marketletter, a trade publication for the pharmaceutical industry.
Some experts attribute this spike to the memorable commercials.
“The implication I get from the commercial,” said Douglas Bremner, MD, author of “Before You Take That Pill: Why the Drug Industry May be Bad for Your Health,” “is maybe you aren’t in a good relationship, so you take this medication and it will abilify you to have a good relationship.”
Bremner noted that none of the commercials for Abilify ever call the medication an “antipsychotic,” since the word would most likely scare the average consumer. In all of its TV commercials, Abilfy isn’t even a “drug” or a “medicine,” it is simply: “Abilify,” a magic solution to make the sun shine once again, “for the road ahead,” as the drug’s slogan says.
“Also, who wants to go on a date with someone taking lithium,” said Brenner, referring to the mood stabilizer, a chemical salt, that has been the old faithful in keeping manic episodes at bay since the early 20th century, but has a reputation as a drug for crazy people.
For “D,” who started the website “Bipolar Chicks Blogging” several years ago with her friend when they were both diagnosed with bipolar disorder, a pharmaceutical ad is just another pharmaceutical ad. The two follow the advertisements for psychiatric medications, and blog their reactions.
“All psych meds are being marketed as ‘pop this little pill and . . . .,’” said D, who asked to remain anonymous. “Antidepressants are marketed to people in the same way. They are a group of symptoms that could very well be temporary, caused by ‘life’ and the promise of normalcy. The average person has no idea about the seriousness of these medications,” she said, adding that she noticed similar marketing tactics between atypical antipsychotics and the antidepressants.
For more info on Abilify in particular as well as some stuff on antipsychotics in general see here.
For a damning video on Abilify made by and ex-pharma sponsor and drug user see here.