DDMAC is conducting a study of how consumers and physicians understand the information in print ads and drug labels. But it’s got a fatal flaw – it’s not double blind.
In comments on the proposed study design, Merck suggested removing statements from the draft physician questionnaire that the drug is fictitious on the grounds that this might bias the results and instead label it a "potentially new drug." FDA rejected this idea for physicians, though it agreed to a bit of deception on the consumer questionnaire. And they’re right. Alas, the FDA disagrees.
"FDA had many internal discussions regarding this issue and decided that because of the particular [physician] sample, it is necessary to be upfront with them about the nature of the drug," the agency states in a notice scheduled to be published in the Federal Register on Dec. 23.
"Physicians will be more savvy about the particulars of the chemical entities and the realism of the clinical benefits and we do not wish to make them skeptical of our purposes," FDA states. "We agree that this approach is preferable for consumers and so we will inform them that this is a potentially new drug in that part of the study."
The consumer survey will present identical safety information under one of two randomly chosen headlines - "Important Safety Information" or "Important Risk Information" - to see whether that makes a difference in the respondents' understanding.
General practitioners will be asked to look at a label for one of the fictitious drug and answer questions designed to show how they use the prescribing information - which sections of the label they choose to read, for how long, and in what order. They will be asked how they perceive the drug's efficacy and how well they can recall the claimed benefits, and their answers will be compared with those of the consumers.
In other words, the GPs will know this is a test. Isn’t it likely then, that they will pay closer attention to the details? Isn't it just as important to learn how much (or how little) physicians really understand the information presented in the P.I.? In fact -- isn't it more important since they are the "learned intermediaries?"
Comments from Eli Lilly & Co. suggested that benefits and risks be viewed together and in a similar format so as not to bias the results. FDA agreed that "the benefits and risks should be evaluated together and [we] have several measures to investigate both. ...[but] because of the complexity of DTC ads, we cannot manipulate both benefits and risks at the same time."
Hm.