The Amarin Decision: Free Speech Or Truthiness?

Amarin, which makes the prescription fish oil product Vascepa, won a big victory last Friday in its ongoing battle against the FDA. The bottom line: a federal judge ruled that the FDA can’t restrict Amarin’s first amendment right to disseminate off-label information about Vascepa providing it is neither false nor misleading. (You can read a detailed description of the entire case on the FDA Law Blog.).

The ruling basically affirms and slightly expands the 2012 Caronia ruling, which first broadened the right of free speech for pharma representatives. The judge in the Amarin case said that this right applies “across-the-board to all truthful and non- misleading promotional speech. Indeed, the speech on which the Caronia prosecution itself was based involved the very types of statements promoting off-label use that the FDA most disfavors: proactive oral statements to a doctor by a manufacturer’s sales representative.”

According to Fierce PharmaMarketing, the fear is that the ruling “could unleash a flood of off-label promos,” . For now it remains unclear just how much damage will be done, or what the FDA’s strategy in the wake of the decision will be.

I think the Caronia and Amarin decisions are quite dangerous, but I’m guessing the practical impact will be somewhat limited, at least in the near future. For one, it bears remembering that Vascepa is a nutritional supplement. Safety concerns about the pill are minimal. Because of the greater potential for safety concerns with other drugs, traditional drug manufacturers may be more reluctant to engage in aggressive off-label marketing. (One important side note in the new decision is that Amarin can now make the same claims for its product that are made for non-prescription fish oil products.)

Truth or Truthiness? Science or Scienciness?

A central element in the case is Amarin’s wish to distribute literature to doctors that support the use of Vascepa for an off-label indication, in this case the prevention of coronary disease. The decision contains a list of 13 papers that Amarin specifically sought to distribute. In his decision the judge accepts without question the assertion that these are “peer-reviewed” “scientific publications.”

In fact, the FDA had already conceded that Amarin was within its rights to distribute these papers. But I think its worthwhile to take a closer look at some of these papers. It has long been clear that “scientific publications,” even when ostensibly “peer-reviewed,” do not always meet the highest, or even minimal, scientific standards.

Consider just the first paper on Amarin’s list:

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A quick look at the paper reveals that 3 of the 5 authors are Amarin employees and that a commercial company was paid by Amarin for editorial assistance. The other two authors, including well-known KOL Christie Ballantyne, received funding from Amarin. The ProPublica Dollars For Docs database shows that in 2013 the first author, Harold Bays, received $4,823 and Ballantyne received $8,155 from Amarin.

In addition, the acknowledgements section at the end of the paper includes the following statement:

Editorial assistance was provided by Peloton Advantage, LLC, Parsippany, NJ, and funded by Amarin Pharma Inc. Dr Harold Bays (Principal Investigator) wrote the first draft of this report, with subsequent drafts revised and edited by the other authors, who vouch for the accuracy and completeness of the data and approved the final version for submission.

This means, in case you’re not familiar with the way these things work, that the paper was almost certainly the product of an elaborate publication plan funded by Amarin. Regarding the role of Peloton Advantage, let me put it this way: it is highly unlikely their role was restricted to proofreading and copyediting.

It’s one thing for Amarin to say they want to freely disseminate scientific information. That of course doesn’t sound objectionable. It’s another thing entirely for them to manufacture and control that scientific information. It’s tipping the scale. What is the likelihood that Amarin would have paid for the publication of papers with negative conclusions or would have provided support to researchers who had a critical view of the expanded indication for Vascepa? Who is going to pay for their papers? This is why we need the FDA to carefully scrutinize scientific claims  from drug makers. We need to know if we’re dealing with science or scienciness?

One question for the FDA: is it possible for the FDA to use the discovery process in this ongoing case to find out the degree to which Amarin has put its thumb on the scientific scale by heavily supporting all these papers?

 

Comments

  1. Henry Greenspan says:

    Strongly concur with Larry. We know from the more infamous cases from which litigation surfaced internal documents–Zyprexa, Neurontin, et al–that, even within the limits of the law at that time, peer review meant little against the ghost/guest publication mills. Still, we can read Lilly’s internal memos hoping for the last straw–that the Washington Legal Foundation would prevail in court so that Zyprexa could be hawked for pretty much everything. Now we begin slipping down the slope pretty much to the valley, i.e., the bottom.

  2. Gordon Titcomb says:

    Apparently Mr. Husten is unaware of the difference between a dietary supplement and an FDA approved drug, as evidenced by his statement: “For one, it bears remembering that Vascepa is a nutritional supplement. ” Before issuing an alarmist, Henny-Pennyesque article claiming that the sky is about to fall, Mr. Husten would have been well served by reading the entire 71 page decision by Judge Englemeyer and parsing out the fact that the injunction does not give license to any drug company to disseminate untruthful or misleading (including acts of omission) information.

    • Larry Husten says:

      I actually did read the entire decision and I am of course completely aware of the distinction between a dietary supplement and an FDA approved drug. But a key point in the ruling is that the judge agreed that Amarin can promote Vascepa with the same claims made by the makers of non-prescription fish oil supplements. The key distinction here is that the burden of proof for nutritional supplements is much lower than for prescription pills.

      • It’s really simple Larry. You said Vascepa was a nutritional supplement and it’s not. Critics of Vascepa have been using belittling name-calling for years. You’re just another rock on that pile.

      • Larry Husten says:

        This is a silly discussion. It *IS* a nutritional supplement– it is composed of purified EPA and, in fact, could be sold simply as a nutritional supplement, as the FDA has indicated. But Amarin chose to pursue Vascepa as a drug and has performed and is performing the necessary trials to obtain approval as a drug, the key advantage of which is that the drug is then eligible for reimbursement and they can charge a higher price.

  3. So those authors were biased? And I’m sure you’re not “editor”?

  4. Henry Greenspan says:

    Bottom line is that FDA does not regulate journals but it does regulate marketing. In a short DTC ad or slim jim and certainly labels, it can be relatively clear about what is required and what counts as reality. In the enormous realm of journals, it is essentially powerless re: what counts as “truthful.” Even if a case for fraud is brought, it would be tied up in the courts for months or longer. By then, the damage is done.

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