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Safeguarding Patient Welfare: Who's In Charge?

Jane E. Henney, MD
[+] Article, Author, and Disclosure Information

From University of Cincinnati, Cincinnati, OH 45267.

Potential Financial Conflicts of Interest: Employment: University of Cincinnati; Consultancies: AstraZeneca, Cigna Corporation, MPM BioVentures, AmerisourceBergen Corporation; Honoraria: Deutsche Bank, CIBC World Markets, Northwestern University, American Council on Consumer Interests; Stock ownership or options (other than mutual funds): AstraZeneca, Cigna Corporation, AmerisourceBergen Corporation.

Acknowledgment: The author thanks Robin Dreisigacker, JD, for her assistance with the background research for this editorial.

Requests for Single Reprints: Jane E. Henney, MD, Office of the Senior Vice President and Provost for Health Affairs, University of Cincinnati Academic Health Center, PO Box 670663, Cincinnati, OH 45267-0663; e-mail, henneyje@UCMAIL.UC.EDU.

Ann Intern Med. 2006;145(4):305-307. doi:10.7326/0003-4819-145-4-200608150-00013
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Over the course of my career, I have been privileged to serve in a variety of roles, including that of oncologist, principal investigator, study manager, senior academic administrator, Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA), and as board member for 3 Fortune 500 and Global 500 companies (AstraZeneca PLC, 2001 to present; AmerisourceBergen Corporation, 2002 to present; and Cigna Corporation, 2004 to present). I have been regulated and a regulator, and I have led institutions striving to develop and advance new investigational therapies within a heavily regulated environment. This experience has afforded me a unique view of the various controversies in drug marketing, particularly those related to off-label uses of drugs. Steinman and colleagues' article (1) on the marketing of gabapentin guides my discussion of off-label use, changing FDA regulatory power, the role of industry, the involvement of the medical profession in promoting off-label use, and our fundamental obligation to protect the best interests of our patients.

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Realigning incentives in off-label promotion and prescription
Posted on September 10, 2006
Arturo Pereira
Hospital Clinico of Barcelona
Conflict of Interest: None Declared

The article on the gabapentin case (1) and the accompanying editorial (2) appeal to more stringent regulatory oversight and ethics-based self- regulation by industry and physicians in order to eradicate off-label promotion and prescription from the health care scene. I would like to put forward a market-oriented approach that may help achieve this goal by realigning the incentives of all the involved actors.

Since off-label prescription is not supported by the high quality studies that are required for drug approval, it should be regarded as a non-scientific medical practice, much in the same manner as herbal medicine or homeopathy is. Physicians must retain freedom to prescribe whatever they believe can help their patients, irrespective of whether or not it is scientifically sound, but society must exercise the right not to waste limited health care resources in interventions whose therapeutic margin is unknown. Therefore, off-label prescription should not be automatically reimbursed by third-party payers, as any other medical intervention of unknown efficacy shouldn't either. Lack of automatic reimbursement would transmit the right signal to every actor involved in off-label promotion and prescription. Physicians will have to make explicit the cost-effectiveness balance to their patients in order to convince them that the expected benefit is worth the money they will have to pay out of their pockets. As patients are getting better informed about health issues and can seek second medical opinion, this will strongly discourage off-label prescription. Falling revenue from off-label uses will signal to the pharmaceutical industry that they must reallocated resources from murky marketing tactics toward activities that create real value for patients and third-party payers (e.g. conducting the studies that are necessary to achieve approvals for new drug indications).

Reimbursement of off-label uses is a kind of protectionism in which inefficient pharmaceutical firms that fail to accomplish their mission (i.e. developing useful drugs and selling them for a profit) are subsidized with health care dollars. Removing this subsidy will free health care dollars enough to properly finance regulatory agencies, so that they will be able to speed up the approval of really valuable drugs in the benefit of patients, physicians and the pharmaceutical industry. There is no reason to believe that developing useful drugs and selling them at a price commensurate with their value is an unprofitable business. Profit came hand-in-hand with innovation and product value for most of the past century, just until marketing replaced research as the main source of revenue. Reversing this situation would not only benefit patients and the society as a whole but, as Marcia Angell has put it (3), would also help a valuable industry be saved from itself.


1. Steinman MA, Bere LA, Chren M-M, Landefeld CS. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med 2006; 145: 284-93.

2. Henney JE. Safewarding patient welfare: who's in charge? Ann Intern Med 2006; 145: 305-7.

3. Angell M. The truth about the drug companies. Random House Inc., New York, 2005: 237.

Conflict of Interest:

None declared

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