Atypical Antidepressants

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Primary-care doctors are prescribing the antipsychotics for a range of mental illnesses, including "off-label" uses such as severe depression and dementia. While not officially approved by the FDA, off-label application is legal and common in the drug business.
Sue G. Decotiis, an internist with a large practice in New York City, says she has started several of her patients on antipsychotics, including a 30-year-old woman who works in human resources. "She was acting out at work, showing up late all the time," says Dr. Decotiis. Dr. Decotiis says she spotted signs that the woman had an undiagnosed bipolar condition: She was irritable, sexually irresponsible, and had a history of alcohol abuse.
Dr. Decotiis put the woman on Symbyax, Lilly's new combination antipsychotic and antidepressant. A month later, the woman was doing much better, Dr. Decotiis says. "More primary-care doctors need to realize we can do this," she says. "I think it's easy for us to do."
Dr. Decotiis learned how to use the drugs to treat bipolar disorder from continuing-education courses funded by the drug companies. Such programs are common and permitted by federal regulators.
Two companies in particular, Eli Lilly and J&J, have been particularly active in courting primary-care doctors with the new drugs. Karla Birkholz, who runs a four-doctor family practice in Phoenix and has treated a handful of patients with antipsychotic drugs, says drug-company reps visit her office once or twice a month. A survey of 700 high-prescribing doctors by ImpactRx, which tracks drug promotions, found that the total number of sales visits rose to 607 in November 2003 from 364 in January 2002.
J&J says its sales force only calls on the some one-third of primary-care doctors who already prescribe atypical antipsychotics "to provide them with important information about Risperdal."
Lilly says its salespeople visit general physicians because they are the first line of defense in diagnosing and treating bipolar disorder.
The companies also use continuing-education courses to encourage general physicians to prescribe antipsychotics. J&J sponsored the publication of a journal titled "Using Atypical Anti-psychotics in Primary Care," which was sent to 38,000 primary-care doctors. Lilly, meanwhile, funded a continuing-education program on bipolar disorder for primary-care doctors that was held in 29 cities last year.
Psychiatrists say there are some cases in which general doctors can safely treat patients with antipsychotics. They include patients who are getting refills for prescriptions that were started by a psychiatrist, who have responded well to initial drug or therapy treatment, or whose doctors have invested a significant amount of time learning about mental health.
Risk Factor
Side effects of some of the new antipsychotic drugs
DRUG: Zyprexa
MAKER: Eli Lilly
COMMENT: The most costly drug of the group. Side effects include weight gain and adverse impact on blood fats, including cholesterol.
DRUG: Risperdal
MAKER: Johnson & Johnson
COMMENT: When taken at high doses, Risperdal can lead to jerky movements.
DRUG: Seroquel
MAKER: AstraZeneca
COMMENT: Some people taking Seroquel can experience sleepiness, dizziness.
DRUG: Geodon
MAKER: Pfizer
COMMENT: Not widely used partly because the FDA required warning labels about the drug's possible triggering of irregular heart rhythms.
DRUG: Abilify
MAKER: Bristol-Myers Squibb
COMMENT: Physicians are increasingly prescribing Abilify because they believe it doesn't cause as much weight gain as some other antipsychotic drugs.
Thanks in part to such marketing strategies, sales of the new atypical antipsychotics have soared. Unlike antidepressants -- which have been marketed to huge audiences almost as lifestyle drugs -- antipsychotics are aimed at a small but growing market: schizophrenics and people with bipolar disorder. Atypicals are profitable because they are as much as 10 times more expensive than the old antipsychotics, such as Haldol. In 2004, atypical antipsychotics were the fourth-highest-grossing class of drugs in the United States, with sales totaling $8.8 billion -- $2.4 billion of which was paid for by state Medicaid funds.
At a time when ethical questions are dogging the pharmaceutical industry and algorithm programs in Texas and Pennsylvania, President Bush's New Freedom Commission on Mental Health has lauded TMAP as a "model program" and called for the expanded use of screening programs like the one at Aliah Gleason's middle school. The question now is whose interests do these programs really serve -
THE TEXAS MEDICATION ALGORITHM PROJECT got under way in the mid-1990s just as the new generation of antipsychotic drugs was coming on the market. For some 40 years before, medications like Thorazine, Haldol, and Mellaril were given to patients with schizophrenia or psychosis to silence their voices and calm their agitation. But they caused terrible side effects, including sedation, social withdrawal, and tardive dyskinesia, which causes muscle and facial tics and strange jerking movements like those in people with Parkinson's disease. Many patients would refuse to take them -- when they had a choice. Some sued drug companies and doctors for failing to warn them about the side effects and won large awards.
Into that environment, drug companies brought out the new atypical antipsychotics and began describing them in almost miraculous terms. The drugs -- including Janssen Pharmaceutica's Risperdal, Eli Lilly's Zyprexa, Pfizer's Geodon, AstraZeneca's Seroquel, and Bristol-Myers Squibb's Abilify, as well as a slightly older drug, Clozapine by Sandoz -- were said to be more effective than the first-generation antipsychotics and less likely to cause motor problems and other side effects. "A potential breakthrough of tremendous magnitude," Stanford University psychiatrist Alan Schatzberg gushed to the New York Times. Laurie Flynn, executive director of the National Alliance for the Mentally Ill, added that now "the long-term disability of schizophrenia can come to an end."
Despite the hoopla, not all doctors immediately embraced the new drugs, and many patients bounced haphazardly between the old and new antipsychotics. "They complained that whenever they got new doctors, their whole medication regimen usually changed," says Dr. Steven Shon, the medical director for behavioral health for the Texas Department of State Health Services (DSHS).
In 1995, Shon began talking with researchers at the UT-Southwestern Medical Center in Dallas about the use of algorithms to address these random prescribing practices. From the start, the process of creating the algorithms reflected the extensive ties between academic psychiatrists and the pharmaceutical industry. UT-Southwestern was a major research center stocked with investigators conducting drug trials paid for by pharmaceutical companies.
One of Shon's key collaborators was Dr. John Rush, a nationally known psychopharmacologist who has extensive ties to industry. Rush declined to speak for this article, but according to a disclosure statement appended to one of his published articles, he has received grant and research support from 14 pharmaceutical companies, has served as a consultant to 11, and has been a member of 10 drug company speakers' bureaus.
Together, Shon, Rush, and the then-chair of UT-Southwestern's psychiatry department convened panels of experts who drew up "consensus guidelines" for schizophrenia, bipolar disorder, and major depression -- ...