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March 2016

Free Speech and Pharmaceutical Regulation—Fishy Business

Author Affiliations
  • 1Yale Law School, New Haven, Connecticut
JAMA Intern Med. 2016;176(3):295-296. doi:10.1001/jamainternmed.2015.8155

Recent research has not been kind to fish oil salesmen, or the value of ω-3 fatty acid supplements for the secondary prevention of cardiovascular disease.1 Amarin Corporation, in particular, has been hit hard. The company’s only approved product is icosapent ethyl (Vascepa), a prescription-based derivative of fish oil. In 2012, the US Food and Drug Administration (FDA) approved the drug to treat patients with very high triglyceride levels, but the company has long wanted to promote its use in a much larger group of patients: those with lower triglyceride levels and cardiovascular disease who were already being treated with statins. In 2013, an FDA advisory committee voted 9 to 2 against approval for this use, in part because several recent studies of other drugs with similar effects on blood lipids showed no clinical benefit when they were added to statins.2 Amarin’s stock price plummeted, and investors brought suit claiming that they had been misled about the promise of the drug.

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    2 Comments for this article
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    Off-label prescribing is not harmful, if it is backed by science
    David L. Keller, MD | none
    Eguale and colleagues concluded in these pages last month that off-label prescribing of medications (for other than their FDA-approved indications) is not more harmful than on-label prescribing for an FDA indication if the off-label use is backed by strong scientific evidence. Further, they demonstrated that electronic health records can be programmed to identify off-label prescriptions which have or which lack strong evidence. The lack of strong evidence for an off-label indication will expose drug companies to lawsuits for adverse events, whereas strong evidence will protect companies marketing drugs for those indications. The question of FDA regulation versus over-regulation is not properly a debate about freedom of speech, but of free access to effective and safe drugs which have strong scientific evidence of benefit but do not have sufficient profit potential or patent life to warrant an FDA indication application. The problem is not off-label prescribing, it is unscientific prescribing.
    CONFLICT OF INTEREST: None Reported
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    JAMA's statist point of view
    Richard A. Crane, M.A., M.A., M.D. | no affiliation
    The author propounds the statist point of view typical of JAMA. She notes that drugs prescribed for \"unproven indications\" can cause harm. What does she mean by \"unproven?\" If she means unapproved by the FDA, then she should also note that drugs prescribed for unapproved indications do more good than harm, and are sometimes the preferred drugs for a given indication. Doctors in clinical practice are trained and licensed to evaluate available medications. Having the author, or JAMA, or the FDA limit the information available to the medical community causes net harm, not net good. Science progresses through the free expression of ideas, not through bureaucrats regulating the communication of information.
    CONFLICT OF INTEREST: None Reported
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