If the articles include false or manipulated data on marketed products, “guest authors” could face litigation under several federal statutes, according to Xavier Bosch, MD, PhD, of the University of Barcelona in Spain, and two U.S.-based colleagues.
They suggested that such lawsuits may be the last hope for putting a stop to ghostwriting in medical journals.
“Stakeholders, including universities, journals, pharmaceutical companies, and academic key opinion leaders, have largely failed to heed public calls for honesty in reporting clinical research. Since these complaints have fallen on deaf ears, we believe the courts now have the task of restoring the integrity of the medical literature,” Bosch and colleagues wrote.
Three types of litigation could be pursued against the nominal authors of ghostwritten articles, they indicated — although, in each case, the articles must contain false or misleading information for lawsuits or prosecution to succeed.
One type of litigation involves individuals suffering adverse effects from medical treatments described favorably in such articles suing for personal injury — or when outcomes are fatal, families could sue for wrongful death.
According to Bosch and colleagues, such cases could be winnable if, for example, the ghostwritten article describes a study in terms that omit primary endpoints showing poor efficacy or safety and instead emphasize more favorable post-hoc outcome measures.
“We argue that when an injured patient’s physician directly or indirectly relied upon a journal article containing false/manipulated safety and efficacy data, then … the authors of that article, including guest authors, are legally liable for patient injuries and could be named as defendants,” Bosch and colleagues wrote.
A second form of vulnerability relates to the federal False Claims Act, if — as has typically been the case — the misleading ghostwritten article was funded by a pharmaceutical company.
To the extent that such articles are used to support payment of insurance claims, off-label prescribing, or inclusion in drug formularies, the False Claims Act comes into play, Bosch and colleagues argued.
A guest author could be considered a conspirator under the law, they noted.
And if the guest author receives payment for allowing his or her name to be used on such an article, then the Anti-Kickback Statute could apply.
This law makes it a crime for prescribing physicians to take payments for “induc[ing] … the prescribing, purchasing, or recommending of goods or services reimbursable by any federal health care program,” according to Bosch and colleagues.
They contended that the same law could also be used against authors of misleading journal papers, including guest authors.
Neither these authors nor the drug-company sponsors can hide behind the First Amendment, Bosch and colleagues added.
“The U.S. Supreme Court has firmly held that ‘the First Amendment does not shield fraud’ and courts have consistently rejected such First Amendment arguments in cases in which drug companies have been sued for fraudulent or off-label promotion,” they wrote.
Although most of the documented cases of pharma-sponsored ghostwriting occurred in the 1990s and early 2000s — brought to light in the course of product liability litigation — Bosch and colleagues asserted that they had created a “crisis of credibility” that persists to this day.
“The situation is so dire that the public is forced to seek judicial intervention to curb dangerous, unethical medical ghostwriting,” they concluded.
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