A new study shows the majority of drug studies fail to provide key information that doctors need to prescribe drugs. Further, most studies use drugs that are not available to patients.
The first extensive examination of drug effectiveness studies shows that less than one-third of the studies published in major medical journals assist doctors in finding the best patient treatments. "Research on new therapies is critical for scientific advancement, but we also need data that will help doctors use existing therapies appropriately," said Michael Hochman, MD. "We need research that addresses questions such as: Which of the more than 30 blood pressure medications on the market works best and in whom? Are certain diets and exercise regimens as good as medications for controlling cholesterol? Is it safe to aim for normal blood sugar levels when treating patients with diabetes? Such information is critical for day-to-day medical decision-making."
Last year, Congress appropriated $1.1 billion in funding for comparative effectiveness research. The researchers said head-to-head studies of different drugs have dominated comparative effectiveness research to date, while other types of studies that might be equally useful have been neglected. Of 104 drug effectiveness studies published recently in major journals, 45 pitted one drug against others, 11 compared drugs with nonpharmacologic treatments and 16 examined different dosing schedules.
The new study, published in the March 10 issue of the Journal of the American Medical Association, was conducted by researchers at Harvard Medical School/Cambridge Health Alliance and the University of Southern California. The study had no external funding. The new report found that only about one-third of the studies involved medicines currently available to patients. The rest were drugs in development or available drugs compared against no treatment or a placebo. The studies were in leading medical journals between June 2008 and September 2009.
The authors said studies that would be of major practical benefit to clinicians and patients are not getting enough attention from funding sources and researchers. They called on the Food and Drug Administration to require more active comparator studies for treatments it regulates. This move, they said, would improve understanding of new treatments, reduce the amount of taxpayer funds spend on comparative effectiveness research and could even reduce healthcare costs.
The authors conjecture that medication research provides limited information about existing therapies because the pharmaceutical industry - which funds the majority of major clinical trials - focuses its research on the development of new, marketable products rather than on available medications. "Many of our nation's research priorities are driven by the pharmaceutical industry," said Dr. Hochman, an assistant professor of clinical medicine at the University of Southern California. "These companies, not surprisingly, focus most of their attention on new therapies. If we hope to increase the amount and improve the quality of comparative effectiveness studies, the funding will most likely need to come from government institutions."
About the author: Pat Elliott is a journalist and blogger who has written about health issues for more than 20 years. She is also a cancer survivor who coaches people on how to manage their transition and take control of their new future.
Resource: Journal of the American Medical Association
Hochman M, et al "Characteristics of published comparative effectiveness studies of medications" JAMA 2010; 303: 951-58.
O'Connor A, "Building comparative efficacy and tolerability into the FDA approval process" JAMA 2010; 303: 979-80.