Lanham Act Peer Review on Trial

Scientific opinion has special protection under the First Amendment, but does that give pharma a free pass to BYOD – build your own dataset – publish a peer-reviewed article based on the data, and then promote it for competitive advantage?

The dividing line between fact and fiction becomes increasingly blurry in the age of prolific data. In the digital age, platform trumps product, or as the poet and artist Kenneth Goldsmith says – in an update to Marshall McLuhan’s famous dictum – “context is the new content.”

In the Ony v. Cornerstone Therapeutics, Chiesi Farmaceutici et al federal appeals court case, the context was a peer-reviewed journal article, and whether or not the promotion of that article constitutes false advertising. Interestingly, the scientific merits of the article, and the dataset it was built upon, were not addressed directly by the court.  The courts, in fact, “are ill-equipped to undertake to referee such controversies,” wrote 2^nd US Circuit Judge Gerard Lynch. “Instead, the trial of ideas plays out in the pages of peer-reviewed journals, and the scientific public sits as the jury.”

Publishing clinical data in a peer-reviewed academic journal, and promoting the article to physicians is not a new commercial approach or strategy for pharma – it’s the hallmark of professional marketing. So what makes this case interesting? After all, pharma companies routinely sue each other for false advertising under the Lanham Act, and the Office of Prescription Drug Promotion reviews promotional materials based on clinical data to make sure advertising claims don’t go beyond what the data shows. The Ony v. Cornerstone Therapeutics case is interesting because it signals the court’s unwillingness to distinguish between scientific fact and opinion under the First Amendment.

If data is generated and then stamped with the peer-review seal of approval, then marketers can do what they wish with it – as long as they don’t misrepresent or distort what the data purports to show. But datasets aren’t always comparable on equal scientific grounds; differing participants, data sources, survey questions and methodologies give rise to differing conclusions. At issue in the Ony v. Cornerstone Therapeutics case was whether Cornerstone Therapeutics and Chiesi Farmaceutici committed false advertising by promoting an article based on a dataset that didn’t include what Ony felt was a key data point – length of hospital stay – in assessing the value of its own directly competing product (the other key endpoint for both Chiesi and Ony’s products is mortality rate, which the Chiesi-commissioned data focused on).

But the Journal of Perinatology, which published the article, didn’t find fault with the researchers’ methodology and conclusions. And the authors openly acknowledged the limitations of the data, and disclosed the study’s sponsors: Chiesi Farmaceutici, and indirectly, Chiesi’s US marketing partner, Cornerstone Therapeutics.

Paul Llewellyn, partner and co-head of Kaye Scholer’s trademark, copyright and false advertising group, says the case is an important one, destined to be cited in a lot of new cases going forward. But he says pharma shouldn’t assume that any dataset it builds – or pays someone else to build – provides immunity against false advertising charges. “This decision should not be read as a free pass to say whatever the scientists will say in a journal article.” Llewellyn acknowledges that the limits to the decision aren’t yet clear, but the ruling “does suggest that at least in some circumstances, courts aren’t going to start refereeing the scientific process.”

What is fact today might be fable tomorrow, despite all efforts to produce data that’s objectively true – that is the nature of scientific progress. There’s always another variable. But when it comes to marketing a product, it’s difficult to anticipate the extent to which a court of law will insert itself into an ongoing scientific argument. The 2^nd US Circuit Court of Appeals is the same court that handed down the Caronia decision at the end of last year, which suggests that at least some justices are leaning toward a greater permissiveness in scientific discourse, under the banner of free speech. Context matters, and the peer-review process, unlike the FDA drug label, remains safe for now as a context for and arbiter of truth, at least in terms of marketing and product claims.