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.

PLoS Medicine: Being the Ghost in the Machine: A Medical Ghostwriter's Personal View

"Introduction

Ethical concerns about medical ghostwriting have been directed primarily at “guest” authors and the pharmaceutical companies that pay them. One voice that is largely missing is that of the ghostwriters themselves who, after all, create the documents that are in the ethical and legal crosshairs. Without them, one could argue, there can be no fraud, because it is they who create the fraudulent product.
For almost 11 years, I worked as a medical writer, creating a variety of pieces including the occasional ghostwritten article. For the most part, I never saw the finished paper, nor did I care to. This article describes what I did, why I did it, why I stopped doing it, and what I think might be done about the problem of fraud in authorship......"cont'd

full free access: PLoS Medicine: How Industry Uses the ICMJE Guidelines to Manipulate Authorship—And How They Should Be Revised

"The ICMJE guidelines will always be a work in progress, but the adjustments proposed here have the potential to end the self-concealment and authorial misrepresentations that mar industry's contributions to the literature. Furthermore, they have the potential to help industry achieve the enhanced respect its beneficial contributions to medicine deserve. Industry publications will always have a commercial valence alongside their scientific and medical content: this should henceforth be truthfully displayed, and no longer downplayed or concealed."