Institute for Nearly Genuine Research
You've heard the hype: New psychiatric drugs like Zyprexa and Risperdal, called atypical antipsychotics, are a vast improvement over old drugs like Haldol.
Whether or not the new drugs work any better, they make a lot of money for the drug companies. While a month's supply of an old drug like Haldol costs less than $30, a month's supply of Zyprexa can cost well over $500.
To determine if these drugs are worth their outrageous price, the National Institute of Mental Health conducted one of the largest and longest independent studies ever, the Clinical Antipsychotic Trials of Intervention Effectiveness, or CATIE. Four years and $44 million later, the CATIE study, published in September 2005, reached a startling conclusion: the new drugs "have no substantial advantage" over the old ones.
Atypical antipsychotics, it turns out, are a massive rip-off. They're no better than old drugs which weren't very good to begin with.
Government programs like Medicaid pay for over 90 percent of all antipsychotic prescriptions. Across the nation, state budgets are being squeezed by Medicaid, and Medicaid is being squeezed by the high cost of prescription drugs. Atypical antipsychotics are among the most expensive.
Studies by Mark Duggan, professor of economics at the University of Maryland, reveal these facts:
* Among the top 30 drugs by total U.S. revenue, Zyprexa has the highest price per prescription.
* Between 1996 and 2001, while Medicaid spending on prescription drugs doubled and spending on psychiatric drugs tripled, Medicaid spending on atypical antipsychotics jumped over 600 percent.
* Looking at the rate of hospitalization and side effects like movement disorders, diabetes, and weight gain, Duggan concluded that atypical antipsychotics "have not led to significant improvements in the health of schizophrenia patients... If anything, the results suggest that health outcomes decline following the shift to the new drugs." (Does Medicaid Pay Too Much for Prescription Drugs? A Case Study of Atypical Anti-Psychotics, 2003.)
We're paying all this money for high-priced drugs, yet patients are getting sicker, not healthier. It's a scandal of monstrous proportions.
From the minute CATIE's results were announced, the pharmaceutical industry and front groups like the American Psychiatric Association (APA) and the National Alliance for the Mentally Ill (NAMI) have rushed to defend their favorite drugs: the most profitable ones.
APA's medical director, James Scully, said it would be a "dire mistake" to restrict doctors from prescribing certain drugs "based on cost." The APA apparently believes taxpayers should pay for any drug no matter how expensive and ineffective, so long as doctors follow APA guidelines approved by the drug companies.
NAMI responded to CATIE in predictable fashion, blaming the study's unexpected results on patients who participated in the study. Many patients dropped out or discontinued medication, NAMI said, because they suffer from a co-occurring disorder called anosognosia, or "lack of insight" into the need for treatment.
NAMI also complained that CATIE "only lasted for 18 months." Curiously, NAMI has never criticized drug company clinical trials lasting 12 weeks or less. Such trials provide the basis for claiming new drugs are safer and more effective than old ones.
Drug companies themselves have responded to CATIE, bending over backwards to find a silver lining inside a dark cloud. Pfizer boasted that its drug, Geodon, is less likely to cause weight gain than Zyprexa, not mentioning other side effects which caused 79 percent of those on Geodon to stop taking it.
Johnson & Johnson, maker of Risperdal, followed NAMI's lead and blamed the patients. "The CATIE study reinforces the overwhelming need for greater medication compliance," the company web site says. In 2003 Janssen Pharmaceuticals introduced the first atypical "long-acting injectable," which allows doctors to forcibly inject the drug whether patients want it or not. This guarantees compliance.
Business goes on as usual, and CATIE appears to have changed nothing. Drugmakers and mental health professionals have a long history of ignoring the results of scientific studies they don't like.
In December 2000, the British Medical Journal published a systematic review of 52 randomized trials comparing atypical antipsychotics with older drugs, concluding there was "no clear evidence that atypical antipsychotics are more effective or better tolerated than conventional antipsychotics." The study was ignored.
In November 2003, the Journal of the American Medical Association published the results of a two-year randomized trial comparing patients on Zyprexa with patients on Haldol, concluding there were "no significant differences" between the two groups. Zyprexa had no advantage over Haldol in terms of compliance, symptoms, or overall quality of life. The study was ignored.
In October 2005, one month after CATIE was published, the Journal of the American Medical Association published a meta-analysis of 15 randomized trials of more than 5,000 elderly patients treated with atypical antipsychotics. Patients taking the drugs had a 54 percent increased chance of dying within 3 months, compared with patients taking placebo sugar pills. The study was ignored.
Atypical antipsychotics continue to be prescribed in growing numbers not only to patients diagnosed with schizophrenia, but also to nursing home residents, prison inmates, and even schoolchildren labeled with learning disorders.
Judging by third quarter 2005 profits, business is booming:
* Sales of Risperdal, Johnson & Johnson's biggest-selling drug, reached $916 million, up 23 percent.
* AstraZeneca's Seroquel, $706 million, up 32 percent.
* Bristol-Myers Squibb's Abilify, $206 million, up 58 percent.
* Pfizer's Geodon, $148 million, up 18 percent.
* Eli Lilly's Zyprexa, $1.035 billion, up 1 percent.
Eli Lilly said the company's diabetes drugs earned $653 million, up 13 percent. Among all drugs studied by CATIE, Lilly's Zyprexa was most likely to cause weight gain and high blood sugar leading to diabetes.
Now that CATIE has been published in the New England Journal of Medicine, will our government take action to punish drugmakers and mental health professionals who deceived the public, harmed patients, and defrauded taxpayers? Don't bet on it.
What happens when expensive drugs are found to be unsafe and ineffective? Not much.
This article was originally published December 2005 in Ragged Edge Magazine.
© 2012 Bonkers Institute for Nearly Genuine Research