Give It to Me Straight! - Pharmaceutical Executive

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Give It to Me Straight!


Pharmaceutical Executive


Conducting research on any topic always leads to new questions. At some point action should be taken, especially when it comes to health outcomes. "One can always improve upon something, but you'd have to be able to claim that your research is going to produce powerfully different results, to justify delaying implementation of something which I think serves everybody," says Fischhoff. "Given the amount of work that's gone into the facts box, and the evidence that supports it, it's hard for me to believe that alternate design [studies conducted by HHS/FDA] would justify a delay of a couple of years." Fischhoff describes the facts box as having a "sound design, both analytically and empirically ... it follows the theories of risk communication, it has demonstrated efficacy in its field trials, and is clearly much better than what we have out now."

The November RCAC meeting set out to answer the two key questions by identifying perceived gaps in the literature. It quickly turned into a gap-a-thon, with participants identifying gaps everywhere they looked. "What about the consumer's literacy levels, and cultural diversity issues?" asked RCAC member Sokoya Finch Nealy. "Is that a gap?" Sure, "that's fair to say," answered another member. "What about graphs; are those really non-numeric? Some of them have numbers in them," said Nananda Col. "That's a gap," someone else declared. At one point, a member who only recently joined the committee asked, "What are we aiming to do with this exercise ... is it to review and critique the study?" Someone else answered, "To give advice and pointers to FDA on regulatory policy." Craig Andrews identified "two major gaps," including "the external validity of the various findings in realistic settings, like broadcast and print," and the fact that "people bring biases to [drug ads], different moods and emotional states ... the 'magic bullet' effect, etc. They may process these things differently." Valerie Reyna wondered if "it is even possible to get a script for a standardized presentation." Gap, gap, gap ...

Yolanda Fultz-Morris, a public affairs spokesperson at the FDA, said the November RCAC meeting reflects "what we need to know for the types of actual cases that are really quite common in drug regulation, where there is not a single applicable number, or where the meaning of numbers may vary based on the [clinical] studies producing them," such as when a product has different indications; was studied in different populations; contains differing endpoints, such as composite endpoints or surrogate markers; or when some products are notably more dangerous than others. "FDA does indeed wish to facilitate good communication of the efficacy and risks of prescription drugs, but we also wish to avoid unintended consequences that could cause a worse understanding. The only way we know to avoid unintended consequences—as much as possible at least—is to take the time to attend to the practical variations from the theoretical ideal," says Fultz-Morris. Short of implementing the facts box, though, it's hard to say how they would perform in a practical, real-world setting.

In an editorial piece commenting on Schwartz and Woloshin's 2009 facts box article in the Annals of Internal Medicine, titled "Communicating Drug Benefits and Risks Effectively: There Must Be a Better Way," authors Jerry Avorn and William Shrank call the current risk presentation in consumer drug ads "a virtual museum of poor communication: the print is tiny; the prose is usually dull, stiff, and hard to understand; and vital facts are buried in a sea of less-relevant data. The format of the information can mask important side effects, as well as—ironically—numb the reader with so many worries that a perfectly worthy treatment may seem too toxic to take." Even so, it seems FDA is at least three more years away from implementing a standardized, quantitative summary of a drug's risks and benefits.

Woloshin says he hasn't looked into broadcast media applications for the facts box, but suggests that certain warnings, such as approval on the basis of a surrogate outcome, or the main efficacy finding for a drug, could be easily inserted into broadcast spots. For broadcast, "we imagine the primary goal would be to point people to a drug [facts] box, either in print or online ... We have not tested these ideas, but hope to in the future," he says.

PhRMA, for its part, is taking a measured approach to the issue. "Careful thought must be given to how to convey risk-benefit information in a simplified format, in a way that remains relevant to the real-world practice of medicine and patients," says Matthew Bennett, PhRMA's senior vp of communications, in an email. "The desire to present simple 'facts' should not trump the overriding goal of ensuring that information about a drug's benefits and risks is accurate, and not misleading." Most people don't have a problem with facts, particularly when they're presented in a readable format. But perhaps more research is needed, to know for sure.


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