For Release: October 21, 2009, 5 p.m.
Contact: Deborah Kimbell, director of communications and external relations, The Dartmouth Institute for Health Policy and Clinical Practice, 802-236-6934
Prescription: Better Labeling
Lebanon, N.H.— Drug labels—the main way that the Federal Drug Administration (FDA) communicates the prescribing information physicians need—frequently don't include basic information required to fully understand the harms and benefits of these products, two Dartmouth Medical School (DMS) professors declare in the Oct. 29 edition of the New England Journal of Medicine.
Authors Lisa M. Schwartz, M.D., and Steve Woloshin, M.D., argue that the FDA needs to improve its drug labeling information. Specifically, the FDA needs to systematically improve access to the results of its internal drug reviews to foster informed decision-making about prescription drugs. While FDA reviewers—independent experts—spend as much as a year evaluating data on benefits and harm from drug trials, they write, "in many cases, information gets lost between FDA review and the approved label."
Associate professors of community and family medicine at DMS, Schwartz and Woloshin also teach at The Dartmouth Institute (TDI) for Health Policy and Clinical Practice and treat patients at the Veterans Affairs Medical Center in nearby White River Junction, Vt. They note that the FDA approves drug labels that the pharmaceutical companies write in pages and pages of dense text to go with prescription. But a full summary of the results of the studies reviewed in these lengthy documents may be missing in the approved label.
The authors, who with TDI colleague H. Gilbert Welch, M.D., cowrote the book Know Your Chances: Understanding Health Statistics, cite the example of Zometa, a drug prescribed for patients with an abnormal amount of calcium in their blood, an important complication faced by some cancer patients. In two clinical trials that the FDA analyzed, eight milligrams of Zometa proved no more effective than four milligrams in reducing calcium levels. Moreover, the higher dose led to a greater likelihood of kidney damage and death. Although FDA reviewers noted both of these serious risks in their review, the Zometa label makes no reference to the higher death rate.
"FDA has known about problems with drug labeling for some time," Woloshin said. "We are very hopeful that FDA's new leadership will try and take on this issue. Better labeling is critical: Clinicians—and their patients—need access to credible, complete information about prescription drugs without the filter of industry. FDA is the logical choice to provide this information".
In the article, Schwartz and Woloshin recommend that the FDA introduce a standardized executive summary of every drug review, to include data tables of main clinical trials results, highlight any reviewer uncertainties (often expressed in the body of the reviews, but absent from product inserts) and whether approval was conditional on further study. They encourage the FDA to use the structured approach they have developed and tested—called the "drug facts box"—a simple, standardized table presenting benefit and harm data for prescription drugs.
In February of this year, FDA's Risk Advisory Committee unanimously recommended that the FDA adopt drug-facts boxes as its format for communications to the public. Also, health-reform legislation that the U.S. Senate is now considering includes a proposal to incorporate drug-facts boxes into the labels.
"Whatever approach the agency adopts, it needs a better way of communicating drug information to clinicians," the authors conclude. "We don't need to wait for new comparative-effectiveness results in order to improve practice. We need to disseminate what is already known."
Schwartz and Woloshin have written widely about the importance of understanding risks and benefits of health procedures and treatments. The NEJM article, "Lost in Transmission—FDA Drug Information That Never Reaches Clinicians," is viewable at http://nejm.org.
-DMS-
