While pharmaceutical companies sponsor much credible medical education, mishandling of this opportunity can be a potent portal for fake news.
Reviewed by Mark Domke, MLIS, Pharmaceutical Information Specialist, Prescott Medical Communications Group.
Rumor, propaganda and sensationalism have been used for centuries to manipulate public opinion. “Fake news” is a 21st century neologism that gained attention during our recent presidential election. But the attention is well deserved, because sophisticated marketing techniques and social media have increased the power of disseminated information, regardless of factuality. Although science and medicine are disciplines ostensibly built on fact, they are affected by their own specialized purveyors of fake news.
The ethics of scientific publication have recently come under increased scrutiny. While politics has always played a role in widespread acceptance of research conclusions, definitions of research quality by “evidence level” and of journals by “impact factor” were attempts to increase objectivity. These definitions gradually influenced the nature of publications in high-impact-factor journals. Increasingly, only level I (meta-analyses) or level II (multicenter, randomized, controlled trials) are deemed worthy of space in these periodicals. However, these types of studies are intrinsically multifaceted, expensive and dependent on collaborative relationships between industry and clinician investigators. Data analysis is often performed by an industry sponsor; authors are selected by variable criteria (e.g., the highest number of subjects enrolled); and manuscripts are drafted by professional ghost writers, with variable amounts of input by the authors.
It is much more difficult to find a publication venue for small cohort studies or case series. Although the level of evidence for these reports is considered inferior (IV-VI), they can provide a nidus for higher-level investigation.
The need for additional publication opportunities, coupled with technologic advances in the setting of net neutrality, helped inspire a new business model. The new venue, termed “open access” (OA), allows authors to retain copyright, but shifts the costs from subscribers and advertisers to authors and institutions. OA manuscripts are available online, without charge to the reader.
The success of this model is reflected by the exponential growth in the number of OA journals to ~10,000, and by professional standards, as developed by the Open Access Scholarly Publishers Association (OASPA). Unfortunately, the OA process has been compromised by an exploitative paradigm, dubbed “predatory publishing” by Jeffrey Beal, a University of Colorado librarian and researcher, who began compiling a so-called “Beall’s List” in 2008 that grew to include over 1,000 offending journals.
Beall’s “predatory” OA journals do not adhere to good publishing practices as defined by organizations such as the International Council of Medical Journal Editors. They widely solicit manuscripts, manipulate authors with flattery and coercion, lack editorial services and have looser quality standards. A common predatory maneuver is to bill authors sometimes exorbitant fees that are hidden until after the manuscript has been completed and accepted, and then to refuse the author’s request to withdraw, preventing submission to another journal.
The most vulnerable victims of these practices are investigators from developing countries and, of course, the many naïve readers who have limited access to subscription-only peer-reviewed literature.
In 2016, the U.S. Federal Trade Commission recognized the problem and initiated legal action against an India-based firm that was also accused of organizing fraudulent conferences.1 Beall’s list was voluntarily withdrawn last January amid backlash from the same firm (including a threatened $1 billion defamation lawsuit). However, the process has been resurrected by Stop Predatory Journals.2
While pharmaceutical companies sponsor a tremendous amount of credible medical education, mishandling of this opportunity can be a potent portal for fake news. The FDA Office of Prescription Drug Promotion (OPDP) has responded with a wide array of laws, regulations, guidances, and enforcement actions.3 Among these is the “Bad Ad Program” designed to alert healthcare providers about misleading drug promotion and to allow easy reporting of this activity to the agency.4
It is common industry practice to identify and recruit clinicians and clinical investigators as “thought leaders” (aka “key opinion leaders” or “KOLs”) to help educate colleagues about new treatments. These often well-respected individuals are also paid for their services and expertise (including consulting, live lectures, webinars and manuscripts), prompting the alternative insidious acronym “HOL” (Highly Paid Opinion”).
For many well-meaning and objective KOLs, the ethical ambiguity of accepting honoraria for these teaching activities compels them to decline invitations. But in the complex world of human interaction, the consequences of this rejection may be to jeopardize the relationship between the clinical and pharmaceutical investigators, along with subsequent opportunity for input into pipeline projects. For those who do participate in promotional endeavors, a facsimile of their earnings is public record on two websites.
The newest website is a government-sponsored result of Section 6002 of the Affordable Care Act.5 This law (aka the “Open Payment” or “Sunshine Act”) requires reporting of payments and other transfers of value (“TOV”) from all manufacturers of medical products to physicians and teaching hospitals, starting in 2013.
This system was designed to be impartial and allows physicians to dispute erroneous reports, but it is characteristically complex, and navigation (as explained in a 474-page User Guide) is difficult. After several attempts made over several hours, I was finally able to register.
Unfortunately, an unintended consequence of this requirement has been, in some cases, to obfuscate rather than authenticate pharmaceutical support. For example, my profile included all payments made to my university for clinical trials in which I served as principal investigator, suggesting personal gain, rather than additional unpaid effort. (I am awaiting reply to my dispute.) And because the rules do not apply to trainees or non-physician prescribers, payments TOV to them are reported under the physician’s name.
Furthermore, interpretation of the rules is not consistent among pharmaceutical companies, such as reporting the cost of providing medical literature as TOV. I believe most clinicians would be pleased if the millions of dollars spent on food for office lunches were redirected to programs that help defray patients’ out-of-pocket costs for drugs. But, as designed, the public record will simply give the impression that physician decisions are manipulated by pharmaceutical companies.
The provocatively titled “Dollars for Docs” is a precedent-setting public website sponsored by ProPublica, a nonprofit, multi-Pulitzer-Prize-winning newsroom focused on “the public interest.”6 It originally based its data on payments disclosed by 17 pharmaceutical companies between 2009 and 2013, without mechanism for physician dispute.
Eli Lilly reported the highest total payment amount ($811.7 million), perhaps reflecting Lilly’s conservative corporate culture.7 Lilly also sponsors an FDA OPDP Regulatory Pharmaceutical Fellowship designed to train selected candidates about regulatory aspects of drug advertising and promotion, and to “maintain and enhance a scientific link among the FDA, academia, and the pharmaceutical industry.”8
It appears that, despite ProPublica’s efforts and other attempts to oversimplify and impugn the importance of these relationships, their value is also recognized and supported.
Like the fake political news that affected on our presidential election, fake medical news and fake medical publishing become real if enough people believe the statements they present. Dissemination of fake information is a threat to the clinical scientific community and the physician-patient relationship. The best way to overcome the challenges is to stay informed and help educate colleagues, trainees and patients.
4. To make a report, e-mail BadAd@fda.gov or call 855-RX-BADAD.