News that Federal Trade Commission’s assertions against the makers of the brain health supplement Prevagen were dismissed last week should be a values statement check-in for the supplement industry.
Surely some will celebrate that the Commission, joined in the suite by New York Attorney General Eric Schneiderman, lost its case against Quincy Bioscience in federal court. FTC actions against supplement companies are both expensive and damaging to companies that contend they have a legitimate claim and are being held to a stricter standard based more on the magnitude of their success than questions of science. When Bayer won out over FTC in 2015, with Bayer attorneys calling out the Commission for effectively inventing new rules to suit the case, there was a huge sigh of relief across the industry and probably more than a few high-fives.
Celebrating U.S. District Judge Louis Stanton’s decision in FTC vs. Quincy Biosciences case, however, may be misguided. There are matters of principle in the Prevagen case. The judge held that Quincy Bioscience could make claims based on its analysis of “subgroups” in a study group rather than results across the entire sample. But companies should not see that as a green light to interpret data to suit their claims. This already happens all too often. Clearly, the success of Prevagen made it a target—$165 million in sales and $59 bottles will certainly trigger regulatory attention—but squinting at the science to make a claim is a scar on the industry no matter how big the company.
The Prevagen case looks a lot like winning on a technicality. The science was widely viewed as sketchy. The Madison Memory Study it points to was published in a journal described by one expert as, “about as low quality as you can get.” A regulatory and science consultant to the industry called the study “so selective and incomplete it was hard for me to know how they did it.” That the company attacked the FTC action as a partisan matter, charging that the two commissioners who authorized the study were “both democrats” and railing against a “lame duck” FTC (the case was filed in January) raises the question of how much the science even mattered to the company.
This is a “just because you can, doesn’t mean you should” moment. Science can’t be based on what you can get away with. Because the judge accepted the Quincy Bioscience study doesn’t mean the public should.
This is a low standard, not a gold standard. In the case of cognitive health, the standards should be stratospherically high.