open access: PLoS Medicine: Challenging Medical Ghostwriting in US Courts - eg. ethics, legal liabilities, patient harm..... Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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Tuesday, January 24, 2012

open access: PLoS Medicine: Challenging Medical Ghostwriting in US Courts - eg. ethics, legal liabilities, patient harm.....



Introduction

"Complaints about the ethics of medical ghostwriting have increased in the last decade, but little has changed [1][14]....."

Summary Points

  • Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.
  • In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
  • For example, when an injured patient's physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.
  • In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.
  • Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.
  • Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud.

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