Correspondence
Pharmaceutical Promotion and First Amendment Rights
N Engl J Med 2008; 359:536-537July 31, 2008
- Article
To the Editor:
Kesselheim and Avorn (April 17 issue)1 dramatically understate the robust, sound constitutional protection the U.S. Supreme Court affords truthful, nonmisleading commercial communication such as that embodied in reprints of scientific articles discussing off-label uses.2-4 Their suggestion that physicians need protection from the very journal articles they receive through subscription or library services is utterly at odds with the Court's forceful rejection of government paternalism.
Appropriate off-label use that informs proper patient care is fostered by more, not less, communication of truthful, nonmisleading information. It is unclear how articles published in the Journal lose their educational benefit and public health value (never mind constitutional protection) when manufacturers buy them as reprints from the Journal and distribute them to information-seeking physicians.
Daniel E. Troy, J.D.
Sidley Austin LLP, Washington, DC 20005
dtroy@sidley.com Scott Gottlieb, M.D.
American Enterprise Institute, Washington, DC 20036Mr. Troy reports representing manufacturers who submitted comments to the Food and Drug Administration (FDA) on its draft reprint guidance. No other potential conflict of interest relevant to this letter was reported.
4 References1
Kesselheim AS ,Avorn J . Pharmaceutical promotion to physicians and First Amendment rights. N Engl J Med 2008;358:1727-1732
Full Text | Web of Science | Medline2
Cincinnati v. Discovery Network, 507 U.S. 410 (1993).
3
Edenfield v. Fane, 507 U.S. 761 (1993).
4
Ibanez v. Florida Dept. of Business & Professional Regulation, 512 U.S. 136 (1994).
Author/Editor Response
Troy and Gottlieb's logic would suggest there is no need for the FDA; anyone could market a drug, and physicians would then seek out relevant information to decide which treatments are safe and effective for particular diseases. This is clearly untenable. There are important public health reasons for regulating the ability of companies to promote off-label uses of drugs for which the data have not been reviewed by the FDA. Manufacturers' communications to physicians exist to increase product sales and heavily shape the choices of prescribers. Commercial distortions of the medical literature are well documented, including omission or underemphasis of safety data,1 presentation of negative or questionable findings about efficacy as being positive,2 selective publication of results,3 and industry-sponsored ghostwriting of seemingly academic papers.4 The Supreme Court's recent skepticism regarding similar regulation results from the Court's current composition and the political decisions leading to it. Perhaps additional promotion-driven drug debacles that affect public health will help the Court return to the view that the special complexity and extremely high stakes of decisions regarding medication use — and the associated problems with commercial speech in this area — warrant enhanced government oversight.
4 ReferencesAaron S. Kesselheim, M.D., J.D.
Jerry Avorn, M.D.
Harvard Medical School, Boston, MA 02115
akesselheim@partners.org 1
Curfman GD ,Morrissey S ,Drazen JM . Expression of concern reaffirmed. N Engl J Med 2006;354:1193-1193
Full Text | Web of Science | Medline2
Turner EH ,Matthews AM ,Linardatos E ,Tell RA ,Rosenthal R . Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008;358:252-260
Full Text | Web of Science | Medline3
Ridker PM ,Torres J . Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005. JAMA 2006;295:2270-2274
CrossRef | Web of Science | Medline4
Ross JS ,Hill KP ,Egilman DS ,Krumholz HM . Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 2008;299:1800-1812
CrossRef | Web of Science | Medline
