Early this year, a placebo study found that, as placebos go, expensive beats cheap. Testing the power of the sugar pill--or in this case, saline solution--researchers told a group of Parkinson's disease patients they were testing two versions of a new "dopamine agonist," one that cost $100 per dose, and the other at $1,500.
The results confirmed that placebos do, indeed, have an effect. But they also showed that patients thought their results on the pricier placebo trumped the benefits of the cheaper one.
The point of the study was to prove the utility of the placebo effect. It might just as well have told us that skyrocketing drug prices could be a good thing, if not for payers, then for the patients who think the expensive meds are working better than older, cheaper alternatives. And for drugmakers, of course.
But drugs aren't placebos. When it comes to actual treatments, price is far from the only difference. Benefits, side effects--the whole package varies from drug to drug, class to class. So, the FDA wants to know how price comparisons in advertising affect people's perceptions of drug quality. According to Regulatory Focus, the agency's Office of Prescription Drug Promotion is planning a new study to assess how diabetes patients and their doctors react to direct-to-consumer advertisements that feature price info.
In the main study, participants will view one of three versions of a DTC ad for a diabetic neuropathy treatment, Regulatory Focus reports. One version will compare the price of the featured drug to a competing treatment. Another will include price comparison info, plus additional information on differences in safety and efficacy between the two meds. The third will include pricing info about the featured drug, but won't compare it to any other product.
The FDA says it's worried that, even with additional information on differences in side effects and benefits of the two alternatives, viewers might get the wrong idea. The added info might not be enough to "correct the impression that the products are interchangeable and that price is the main factor to consider," the agency said in a Federal Register notice (as quoted by Regulatory Focus).
As RF points out, the FDA's drug-ad police have rolled out plans for a series of studies designed to gauge how different patients respond to different types of advertising. For instance, in November, the agency said it wanted to determine whether consumers perceive a drug differently if it's in heavy rotation, ad-wise.
One of the FDA's advertising studies has already prompted potential changes in the rules. In February 2014, the agency said it wanted to study whether paring down the litany of side effects in DTC ads would actually help patients better understand a drug's risks. This February, the agency advised drugmakers to use a "capsulized" version of potential side effects, rather than the full page of fine print that accompanies most magazine ads. So far, the industry seems amenable to idea.