Rethinking Antipsychotics - Part II

In an earlier blog I noted that there may be a sea change in how psychiatry thinks about prescribing new-generation (atypical) antipsychotics such as Zyprexa and Risperdal.

Originally approved for treating schizophrenia, over the last several years the FDA has approved their use for treating short-term mania. Zyprexa also has a long-term indication.

(Seroquel and a combination Zyprexa-Prozac pill known as Symbyax also have an FDA indication for treating bipolar depression.)

In recent years, atypicals have moved up to a first choice option in various treatment guidelines in treating patients in the initial phase of their mania. These are generally your 911 situations - where the patient poses a clear threat to himself and others and where pharmaceutical overkill is acknowledged as best practice.

Long-term treatment is far more problematic. Owing to the risk of tardive dyskinesia (chronic muscular spasms), the American Psychiatric Association does not recommend its long-term use for mania unless there is a valid clinical reason. Right from the very beginning, patients complained to their deaf psychiatrists about the weight gain side effects. A 1997 study found that patients on Zyprexa gained 27 pounds in one year, and a 1999 study found a nine-pound gain on the drug over 10 weeks.

In medical practice, a seven-percent weight gain from baseline is considered clinically significant. In 2001, the US Surgeon General declared an obesity epidemic, reporting that approximately 300,000 US deaths a year are associated with obesity and overweight compared to more than 400,000 deaths a year from cigarette smoking.

With weight gain comes diabetes risk. In 2002, studies appeared documenting diabetes risk in patients on atypicals. In 2003, a joint panel of the American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity issued a consensus statement advising that doctors screen and monitor their patients on atypicals, including taking blood samples and other measures.

In 2003, the drug companies added a diabetes warning to their product labeling.

With weight gain also comes cardiac risk, depression risk, and a host of potential medical problems. According to endocrinologist Judith Korner MD PhD of Columbia University at a session of the 2004 American Psychiatric Association's annual meeting, "Obesity hits every organ system in the body."

But an $18 billion a year worldwide market in atypicals indicates that psychiatrists were paying far more attention to the carefully-rehearsed sales pitches of well-groomed pharmaceutical detailers than to either their own patients, scientific studies, drug labeling, or medical common sense.

According to an article in PLoS this year, the drug industry spent $15.7 billion on promoting prescriptions drugs in the US in 2000, $4.8 billion spent on detailing. According to the article, trainee drug reps are told: "When you're out to dinner with a doctor, the physician is eating with a friend. You are eating with a client." Reps then use "the friendship" to request favors in the form of prescriptions.