UnitedHealth Group, one of the nation's largest health insurers, will begin mining its huge patient database for signs of drug side effects.
The company wants to speed up the discovery of side effects that sometimes go undetected before drugs reach the public, such as the concerns about heart attacks and strokes that led to the removal of Vioxx from the market last year. Critics say the Food and Drug Administration hadn't done enough to track drugs once they're approved.
As the nation's second-largest managed-care company, UnitedHealth, Minnetonka, Minn., has both prescription and treatment records for its members. The company said its database of nearly 11 million patients includes enough information to look for patterns even in less commonly prescribed drugs.
Private databases exist, but many have records on fewer than a million patients.
UnitedHealth is testing its records by looking at four recently introduced drugs -- Cialis, an impotence drug; Spiriva, for chronic bronchitis and emphysema; Ketek, an antibiotic; and the antidepressant Cymbalta.
Results comparing the use of those four drugs to the healthcare received by patients will be available in June, and the database should be ready for outside use by the end of 2005, said Donato Tramuto, chief executive officer of i3, the UnitedHealth subsidiary running the drug project.
Individual patient identities are stripped out of the data, the company said.
UnitedHealth is getting the information from insurance claims, rather than observations reported directly by doctors. That could skew it because of practices such as "upcoding," where doctors report performing a costlier procedure than the one they really performed to get more insurance money.
But UnitedHealth has a good idea which procedures are more likely to be upcoded and can adjust for that, said Arnold Chan, M.D., associate professor of epidemiology at the Harvard School of Public Health, who has been working with i3 on the project.
UnitedHealth spokesman Mark Lindsay said the company will merely mine the data -- not reach its own conclusions.
"We do not do the analysis and say 'This is safe, this is not safe," he said.
Steven Galson, M.D., acting director of FDA's Center for Drug Evaluation and Research, said it's soliciting proposals from UnitedHealth and other drug researchers for data the FDA could use to increase its tracking of drugs once they're released to the public.
"I think that the type of database that United is offering is a very important tool for the FDA to be able to evaluate post-marketing safety issues related to marketed products," he said.