Patients often ask two questions about every medical treatment: Will it help me? Will it hurt me? The Food and Drug Administration knows many of the answers. It wants patients to know them, too.
After years of deliberation, the FDA has proposed giving patients a simple one-pager for every prescription drug with the information needed for safe and effective use. The new form will supplement the long package insert that patients currently get with their prescriptions — and which, we imagine, most people throw away without reading, just as we all tend to click on “Agree” on lengthy privacy policies online.
But we are afraid that the FDA will blow the opportunity with poor design and inadequate testing of the one-pager.
Companies seeking FDA approval for their products submit reams of documents, with minute detail on how drugs work, how well they work, what harms they can do, and how good their evidence is. FDA staff examine this material intensively, and then, if they conclude that the likely benefits outweigh the expected harms for patients, FDA approves the drug for marketing in the United States. The FDA summarizes its findings in review documents posted on their website. However, these reviews are effectively useless to the public: inaccessible, lengthy, poorly organized, and weakly summarized.
A decade or so ago, the FDA took a big step toward transparency, by producing tabular summaries of the key issues informing their approval decisions, called the Benefit-Risk Framework. These summaries, which are not included in public-facing documents, are intended to guide expert decision-making — think, a doctor or health plan wondering about a newly available treatment.
The FDA is now proposing the next leap forward: requiring a standard, easy-to-read, easy-to-access disclosure of what the FDA believes patients need to know in order to decide whether a drug is a good choice for them. The report describing the FDA’s long consultative process is lengthy, but surprisingly readable for a regulatory document.
This new FDA requirement is a once-in-a-generation opportunity to support patients and physicians in making better informed health decisions. The FDA is asking what patients and physicians want in that one-pager. You can see the proposed design here. If you have an opinion on what should be in it or how it should look, you can register your opinion.
We will be registering our own opinion. When we do that, we will urge the FDA not to fall prey five myths that often undermine health communications — and could waste the years of effort that have gone into creating the new proposal:
Myth No. 1. People don’t need numbers to understand how well drugs work.
Reality: People need to know how big the expected risks and benefits are. The FDA’s proposed design does not contain any numbers. How can people decide about a drug if all they get are lists of good and bad things that might happen? We know from research that people can understand numbers — when they are clearly presented. Further, we know that people are confused by “verbal quantifiers,” such as “rarely” and “likely.” Unfortunately, experts often prefer such mumbling words, conveniently claiming that their audience is innumerate. We urge the FDA to include clear numeric estimates of risks and benefits in its one-pagers.
Myth No. 2. People need to be told about a drug’s side effects but can be assumed to know its benefits.
Reality: People can take drugs that are wrong for them if they overestimate the benefits, as well as if they underestimate the risks. In a national survey, 40% of respondents believed, erroneously, that the FDA approves only drugs that are “very effective,” while 25% believed that approved drugs would not have serious side effects. However, many approved drugs have marginal benefits and/or significant side effects. To make informed decisions, consumers need to know both the good and the bad effects of drugs. We urge the FDA to include scientific evidence of benefits, as well as risks.
Myth No. 3. People can’t handle uncertainty.
Reality: Patients need to know how much experts know, so that they understand what kind of gamble they are taking. The FDA’s current proposal does not require telling patients how sound the evidence is. However, the FDA often approves drugs with the stipulation that the vendor conduct further research into their benefit or harm. We urge the FDA to be transparent about uncertain evidence.
Myth No. 4. People understand what experts are trying to say.
Reality: Experts use everyday terms in exotic ways. Many people might be surprised to learn that “FDA-approved” does not mean “FDA-recommended.” Or that a “breakthrough drug” need not involve innovative science. We urge the FDA to require the empirical research and user testing needed to ensure that the one-pager is clearly understand.
Myth No. 5. Experts can tell when a message is clear enough.
Reality: People overestimate how well they understand one another. The gap grows with the differences in their life experience. By that criterion, pharmaceutical experts should be especially bad at evaluating their own communications. Message testing is an ethical responsibility that is remarkably easy to fulfill: Ask some people from the intended audience to think aloud as they read successive drafts and share what they think the message is. Not testing is communication malpractice. We urge FDA to require drug companies to test their messages until they get them right.
We hope that the FDA will stay its course in relying on evidence, and not be derailed by the folk wisdom expressed in these myths. See what you think — and then let the FDA know.
Baruch Fischhoff is a university professor at Carnegie Mellon University and a member of the National Academy of Sciences and the National Academy of Medicine. Steven Woloshin is a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice and director of the Lisa Schwartz Foundation for Truth in Medicine. Tamar Krishnamurti is an assistant professor of medicine at the University of Pittsburgh. Barry Dewitt is an independent researcher specializing in medical decision-making.