Schwitzer health news blog

Growing scrutiny of drug studies and drug co. claims

"When Eli Lilly & Co. wanted to get the big California health-maintenance organization Kaiser Permanente to use its new antidepressant, it ran straight into Debbie Kubota." That's how the Wall Street Journal begins its piece on how insurers are scrutinizing drug studies and drug company claims.

The story continues: "Two studies published in psychiatry journals described the new drug, called Cymbalta, as 'superior' to the older antidepressants Prozac and Paxil. But Dr. Kubota, a Kaiser pharmacist here, observed that in both studies the patients who did the best on Cymbalta received a higher dose of it than recommended on the label. Although each article mentioned the superiority of Cymbalta in its abstract, or summary, both acknowledged lower down that the studies weren't designed to show whether one drug was better than another.

Dr. Kubota's conclusion: The claim of superiority was 'speculative.' She issued a negative report to Kaiser's physician committees, which agreed and ruled that Kaiser would bar Cymbalta from its list of favored drugs for its biggest regions, Northern and Southern California.

As the cost of drugs in the U.S. approaches $250 billion a year, pharmaceutical companies are running up against a growing breed of detective trained to see through marketing spin. Working for insurers, state Medicaid programs and nonprofit bodies, these detectives cast a wary eye on published studies in medical journals, once considered an unimpeachable source. They search for subtle aspects of clinical-trial design that might show the drugs are not all they're cracked up to be."