Academics who lend their names to medical and scientific articles ghostwritten by the pharmaceutical industry should be charged with fraud under the the Racketeer Influenced and Corrupt Organizations Act (RICO), according to two University of Toronto Faculty of Law professors.
The pharmaceutical industry often conducts research, but allows academic experts to submit it to scientific journals under their own name. Although medical professionals and academics have called for these "guest authors" to be sanctioned by journals, academic institutions and regulatory agencies, their recommendations have not been widely embraced.
"It's a prostitution of their academic standing," Professor Trudo Lemmens said. "And it undermines the integrity of the entire academic publication system."
In an article published Tuesday in PLoS Medicine, Professors Simon Stern and Trudo Lemmens argued that, "guest author's claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act."
"Guest authorship is a disturbing violation of academic integrity standards, which form the basis of scientific reliability," they claimed. "Pharmaceutical sponsors borrow the names of academic experts precisely because of the value and prestige attached to the presumed integrity and independence of academic researchers."
Academics who lend their names to ghostwritten studies give false respectability to claims of safety and effectiveness that threaten to undermine the integrity of medical research and patient care, according to Stern and Lemmens. This false respectability extends to the courtroom as well, when the studies are used as evidence in lawsuits to support pharmaceutical companies' claims.
"Expert witness testimony comes into court through the agency of lawyers, who are officers of the court," they explain. "When a pharmaceutical company helps to produce ghostwritten articles and its lawyers cite them in court, the lawyers are, at the very least, reckless about the falsehood and they have a duty to disclose the truth."
Pharmaceutical lawyers who to treat ghostwritten articles as legally valid evidence should be charged with "fraud on the court."
"They are often used in litigation to support the manufacturer's arguments about a drug's efficacy and safety, or to establish a record of scientific acceptance for Daubert purposes, or to credentialize an expert witness," Stern and Lemmens wrote. "Each of those uses, if attempted by a party that had helped to create the article, could risk sanction."
Ghostwriting only one facet of pharmaceutical companies aggressive marketing tactics
Ghostwriting is part of larger marketing strategy by pharmaceutical companies, which has been shown to affect drug recommendations - potentially harming patients - and even expanding the criteria for mental illness.
A study published in January in the American Journal of Public Health found drugs that pharmaceutical companies marketed most aggressively to physicians and patients tended to offer less benefits and more harm to patients.
"This is not a random occurrence, but rather a repeating, planned scenario in which drugs, discovered with good science for a specific set of patients, are marketed to a larger population as necessary, beneficial and safer than other alternatives," Howard Brody, a professor and director of the Institute for the Medical Humanities at UTMB Health and co-author of the study, said.
"Marketers are just doing their jobs. However, the reality is that for most new drugs, safety and efficacy are scientifically proven for only a small subset of patients. It’s time for physicians to take a stand and not prescribe them so readily."
Pharmaceutical companies have exaggerated safety and efficacy claims and encouraged unapproved uses of drugs, according to the authors of the study.
For example, a study by researchers at the Stanford University School of Medicine and University of Chicago found a lack of strong evidence that atypical antipsychotic medications, a top-selling class of drugs, actually helped most patients. The study was published January 7 in Pharmacoepidemiology and Drug Safety.
"There is an unintended, but direct conflict between pharmaceutical marketing and public health," Brody said. "Physicians should approach commercial marketing by pharmaceutical companies with a critical eye. Future reform polices should look to reduce, minimize and limit these practices. Patients can also play an important role by being more skeptical of drug ads."
Brody and his colleagues said the writing of usage guidelines should be restricted to groups free of commercial conflicts of interest and that research focused on safety and efficacy should be independently funded. In addition, the authors called for a neutral agency, such as a branch of the National Institutes for Health, to conduct drug trials.
"Further funding from governments or other sources not affiliated with the pharmaceutical industry for the development of such information would promote rational prescribing and better outcomes while reducing the need for prescription fees," Kesselheim added. "Most physicians would be happy to receive additional information about the proper use of drugs that is both effective and free of bias, but the medical community needs to do a better job of creating and disseminating this information without the influence of pharmaceutical advertising."