The authors of an article published on January 24, 2012 in the medical journal PLoS (Public Library of Science) suggest that prominent physicians (also known as Key Opinion Leaders or “KOLs”) who lend their names to ghostwritten, industry-financed medical articles that convey fraudulent misinformation resulting in harm to patients should be held legally liable.
The article, entitled “Challenging Medical Ghostwriting in the US Courts,” was co-written by Baum Hedlund attorney Bijan Esfandiari along with Dr. Xavier Bosch from the University of Barcelona and Dr. Leemon McHenry from California State University, Northridge.
The authors describe the practice of improper medical ghostwriting as, not only infringing on academic standards, but, in many cases, they argue it “contributes to fraud.” They explain the practice as “industry-financed writers generating articles that either promote the sponsor company’s products or discredit competing ones, with eventual authorship credited to academic researchers who provide little or no input, thereby concealing industry involvement and contributing to distorted drug profiles.” Marketing messages are “planted in the ghostwriter’s first draft well before a nominal author is selected” according to the authors, and often “falsely tout the purported benefits of the drug and fail to disclose the side effects.” They argue the practice, which has “long tainted journal content and jeopardized patient safety,” should be outlawed.
“Prominent physicians who lend their names to ghostwritten articles containing fraudulent representations resulting in harm to patients should be held legally liable.“
Numerous examples of medical ghostwriting have been uncovered in lawsuits involving drugs
such as Neurontin, Paxil, Zoloft, fen-phen, Vioxx and Prempro where courts have unsealed formerly confidential internal company documents. In other cases, the extent of medical ghostwriting remains under court seal (e.g., Avandia, Zyprexa, Seroquel, Bextra and Celebrex).
Although the issue of medical ghostwriting has received wide-ranging attention in recent years with universities and medical journals instituting new policies against ghostwriting, the practice persists. Esfandiari et al. argue the only sure remedy is through litigation.
The legal remedies the authors suggest will serve as a deterrent to the practice include:
Personal Injury Lawsuits — “Guest authors” or “KOLs” are rarely if ever named as defendants in personal injury cases. However, where a doctor relies on a ghostwritten article containing false or manipulated safety and efficacy data and his patient is injured, the patient could not only sue the drug manufacturer, but the physician who lent his/her name to the fraudulent article.
Federal False Claims Act (FCA or Whistleblower Statute) — The KOL could be named as a co-conspirator in a False Claims Act (Whistleblower) lawsuit, along with the manufacturer, for inducing the United States government, relying on the ghostwritten article, to reimburse prescriptions under false pretenses, particularly for off-label uses of the drug.
Anti-Kickback Statute — The KOL could be charged with receiving kickbacks in exchange for appending his/her name to a ghostwritten paper, accepting hefty speaker’s fees and costs of “educational “ trips at lavish resorts, resulting in his clinical judgment being influenced, placing patients at risk by misrepresenting risk-benefit, all resulting in increased health care costs. The Department of Justice could even bring a criminal action against violators of the Anti-Kickback Statute.
Esfandiari et al. counter the argument that ghostwriting is protected by the First Amendment by pointing out that commercial speech (e.g., promoting the safety and efficacy of a drug) is not entitled to the same protection as other types of speech. Moreover, the Supreme Court has firmly held that “the First Amendment does not shield fraud.”
The authors of the PLoS article call the current state of the medical literature a “crisis of credibility” and argue “the courts now have the task of restoring the integrity of the medical literature.”
About Baum, Hedlund, Aristei & Goldman, P.C.
Baum, Hedlund, Aristei & Goldman has successfully represented clients harmed by medications in over 4,000 individual personal injury and wrongful death cases, in addition to representing consumers in multiple pharmaceutical class actions against major pharmaceutical companies such as Alpha Therapeutic, Armour Pharmaceutical Co., Baxter Health Care Corp, Bayer Corp., A.H Robins Company, Eli Lilly, GlaxoSmithKline and Pfizer.
In the course of discovery and litigation in its pharmaceutical cases, Baum Hedlund’s team of lawyers and researchers have uncovered multiple examples of pharmaceutical companies using ghostwritten articles as part of their marketing plans, including the now-infamous study 329, which falsely touted the efficacy and safety of Paxil for adolescents, and GSK’s CASPPER ghostwriting program, which was used to promote Paxil and Avandia.