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Healthy Skepticism Library item: 19883

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Media Release

Key Opinion Leaders Who Lend Their Names to Ghostwritten Medical Articles Should Be Held Legally Liable, Article States
Baum, Hedlund, Aristei & Goldman 2012 Jan 24


Full text:

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.

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.”

Link to article

 

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...to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.