Another issue: The Vascepa trial focused on a specific population — patients with high triglyceride levels plus elevated risk of cardiovascular disease or diabetes who were already taking a daily statin. That means any proof of benefit is limited to that group.
Dr. Woloshin and Dr. Schwartz both suggested that nuance could get lost in translation. “It is this much narrower, high-risk population,” Dr. Schwartz said.
Dr. Woloshin added, “The fear is [the message] would generalize to anyone with high triglycerides.”
This concern is amplified by a 2016 court settlement in which the FDA permitted Amarin to market Vascepa to audiences for whom it hasn’t been specifically approved – so long as the company doesn’t say anything untrue about the drug.
Mr. Thero said Amarin’s marketing of Vascepa has stayed, and will remain, consistent with what is factual and relevant.
“We are proceeding consistently with what the FDA has guided,” he said.
But, some experts said, the 2016 settlement could unlock the door to wider marketing of Vascepa’s off-label use, implying the pill benefits more people than it actually does.
“They’ll take pains to show how different this is from everything out there ... and its results in these populations,” said Ameet Sarpatwari, MD, JD, an epidemiologist and lawyer at Harvard Medical School, Boston, who studies the pharmaceutical industry. “What they can’t do is say it will be beneficial to these other populations. But they can hint at that.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.