Give It to Me Straight!

Dec 01, 2011

If you've ever flipped through a magazine in a checkout line, or even on your iPad, then you've probably seen a print DTC advertisement. If you bothered to look beyond the images and actually read the text, you may have noticed a marked absence of numbers. Instead, descriptive, non-numeric language such as "some," "frequently," "rare," or "common" is used to describe the drug's side effects, in combination with blunt statements like, "It may cause harm to your heart or brain," (from a recent Sanofi ad for Lantus), or "Serious allergic reactions may occur," (from a recent Eisai/Janssen ad for Aciphex).

As a defense against failure-to-warn claims, this qualitative, laundry-list articulation of a drug's risks and benefits may be smart, but as a way to communicate clearly with consumers and patients, it's obviously lacking. Enter the drug facts box, a concise, quantitative, easy-to-read format for sharing numeric information about a drug's efficacy and side effects. The goal, according to proponents of the facts box, is to make it easier for consumers and physicians (facts boxes would also appear in a drug's promotional labeling) to parse the underlying clinical data for a given product, which would in turn facilitate a more informed decision about treatment.

This theory has been tested directly by academic researchers, and a body of literature has emerged; the methodologies, participants, and objectives vary, but the resulting consensus in the academic community is that a standardized facts box or table is superior to current presentations of risk and benefit. Indeed, the current members of FDA's Risk Communication Advisory Committee (RCAC) released an extensive literary review in preparation for its most recent meeting, held Nov. 17 to 18 in Washington, DC. The report, titled "Quantitative Summary of the Benefits and Risks of Prescription Drugs," analyzes the findings of 52 journal articles, with a focus on answering two stated questions: 1) "What is the value of quantitative information or summaries about the risks and benefits of medical interventions for consumers, patients, and clinicians?" and 2) "How does presentation of the quantitative information influence consumers,' patients,' and clinicians' processing and understanding of the risks and benefits of medical interventions?"

These seem like pretty straightforward questions, but as anyone who has personally witnessed an RCAC meeting knows, very little is straightforward in the realm of risk communication theory. As the famed analytical psychologist Carl Jung once wrote, "The shoe that fits one person pinches another; there is no recipe ... that suits all cases." This point is very well taken, given the RCAC November session, but first, it's important to understand what happened the first time the drug facts box went to Washington.

In 2009, the FDA's RCAC—then chaired by Baruch Fischhoff, professor of social and decision sciences and of engineering and public policy at Carnegie Mellon University—took a vote on whether a standardized drug facts box should be adopted by FDA for use in pharmaceutical print advertising and promotional labeling. The committee said yes, unanimously. Then nothing happened for two years. When the Patient Protection and Affordable Care Act passed, it contained a mandate (Section 3507) ordering the US Department of Health and Human Services (HHS) to review the evidence for or against a quantitative summary of a drug's risk and benefit, "such as a table or drug facts box," and to make a judgment. HHS responded by filing a report to Congress last March, requesting at least three more years for additional research.

Lisa Schwartz and Steven Woloshin, a wife and husband team of professors at Dartmouth Medical School, and two of the primary contributors to the body of literature around facts boxes, don't get it. Asked about the justifications for another three years of research, Woloshin says he's "completely baffled," an opinion he made known in a New York Times editorial printed on July 4. "It's crazy that people—doctors, patients, tax payers—don't have ready access to summaries of [a drug's efficacy and risks] in a way that we've shown can help them make better decisions," says Woloshin. "No one has published any important criticism of the [facts box] studies."