Safeguarding Patient Welfare: Who's In Charge?

  title={Safeguarding Patient Welfare: Who's In Charge?},
  author={Jane E. Henney},
  journal={Annals of Internal Medicine},
  • J. Henney
  • Published 15 August 2006
  • Medicine
  • Annals of Internal Medicine
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… 

Evaluating Off-Label Uses of Anticancer Drugs: Time for a Change

  • H. Sox
  • Medicine
    Annals of Internal Medicine
  • 2009
This editorial will contrast the present system for off-label indications with existing alternatives and end with several proposals to judge how Medicare evaluates off- label uses of cancer drugs.

Sorrell v. IMS Health: issues and opportunities for informaticians

As states, courts, regulatory agencies, and federal bodies respond to Sorrell, informaticians' expertise can contribute to more informed, ethical, and appropriate policies.

Who needs another journal?

Pharmaceutical promotion to physicians and First Amendment rights.

The authors argue that public health concerns make pharmaceutical promotion different from other commercial speech and that more stringent regulation should be permitted.

Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints

Aaron Kesselheim and colleagues analyzed unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing, and

Pharmacotherapy of Schizophrenic Patients: Preponderance of Off-Label Drug Use

Data from this cross-sectional study of community based schizophrenic patients are consistent with the recognition of the therapeutic limitations of both first and second generation antipsychotic drugs.

Indication creep: physician beware

A systematic review of the use in critically ill patients of erythropoietin, a drug that is widely promoted without an approved indication in this patient population, features a systematic review.

L'expansion des indications : médecins, attention

Ce numero du JAMC presente une critique systematique (page [725][1]) portant sur l'utilisation, chez les patients aux soins intensifs, de l'erythropoietine, medicament dont on fait la promotion


: Gabapentin, sold under the brand name Neurontin among others, is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain. It is a first-line medication for the



Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents

How marketing strategies and tactics for gabapentin were developed and used in the mid- and late 1990s are described, focusing on how certain groups of physicians were targeted as recipients of and vehicles for promotion.

Guidelines for interactions between clinical faculty and the pharmaceutical industry: one medical school's approach.

Yale guidelines, which are presented as an Appendix here, ban faculty from receiving any form of gift, meal, or free drug sample (for personal use) from industry, and set more stringent standards for the disclosure and resolution of financial conflict of interest in Yale's educational programs.

Off-label prescribing among office-based physicians.

Off-label medication use is common in outpatient care, and most occurs without scientific support, so efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use.

New federal guidelines for physician-pharmaceutical industry relations: the politics of policy formation.

The draft Guidance questioned the legality of many arrangements heretofore left to the discretion of physicians and drug companies, including industry-funded educational and research grants, consultantcies, and gifts.

Shalala, 130 F.Supp

  • (D. DC
  • 2001