Ghostwriters: Medical Research or Paid Endorsers (and are they mutually exclusive?)

When Merck was busy battling lawsuits emanating from the pain medication Vioxx, the Wall Street Journal, among other news organizations that were reporting on the proceedings, also reported on the practice of “ghostwriting,” alleging that five out of the six authors of a study published in the Journal of the American Medical Association were paid consultants to Vioxx lawyers! An editorial accompanying the studies in JAMA opined that manipulation of publications in the promotion of drugs by paid ghostwriters might not be such an uncommon occurrence. The Washington Post even went so far as to report that the JAMA studies essentially “accuse” the drug manufacturer of “scientific fraud.”

Merck responded to the Wall Street Journal article expressing disappointment at reports that trial lawyers might have made payments to authors whose work found their way into medical journals. While a majority, if not all, of the Vioxx cases have been settled, inquiries into the practice of ghostwriting—payments by pharmaceutical manufacturers for articles frequently extolling the virtues of one drug or another and appearing in medical journals—seems to be a continuing, and problematic, means of promoting pharmaceuticals.

As they say, timing is often everything. A few weeks ago, I had prepared a presentation for an international gathering of lawyers at Limerick University in Ireland, describing the use of testimonials and endorsements in advertising. You can read my previous post and obtain a .PDF copy of the presentation. In briefing the assembled professionals—mainly from the United States and Europe—my presentation and their interest focused heavily on the Federal Trade Commission’s proposed updates and revisions to its Guides that were last revised in 1980.

One of the items clearly on the FTC’s agenda is DISCLOSURE—specifically, disclosure of material connections between those who promote and endorse products and services, and the advertisers and companies that create, manufacture, distribute and sell these products and services. Indeed, the FTC is considering extending liability to endorsers themselves who promote goods and services, if the claims being made are found to be false, deceptive, or misleading, or if they represent unfair competition. While much of the discussion surrounding these revisions has focused heavily on new social media and digital distribution—buzz, viral and word-of-mouth marketing, social networks, bloggers, vloggers, sploggers and virtual worlds—and both traditional and revised Guides (as well as specific advertising guidelines for regulated pharmaceuticals), all focus on the potential for misleading consumers as to the credibility of the speaker or writer, where a material connection to the sponsor is not clearly disclosed. Whether a physician who reads an article that is authored by a paid ghostwriter and that appears in a medical journal, would be considered a “consumer” under these circumstances; or whether an independently peer-reviewed article would be considered advertising or promotional activity, are separate questions. But clearly these are topics that have created “buzz.”

Well, here we go again. Just recently, the reported that Wyeth paid ghostwriters for articles published in medical journals—in this case promoting certain replacement hormone therapy in menopausal women. You can read the full article here. While proponents (or should we say “defenders”) of payments made to authors assert that if the medical professional is qualified; if the content is subject to rigorous peer-review by independent experts; and if the authors retain complete editorial control over the content and the views that are expressed; it should not be a problem and should be considered perfectly fine.

Assuming, as both the pharmaceutical companies and the individual authors assert, that the content of these articles is scientifically accurate, many questions arise. For example, is disclosure even necessary under these circumstances? Could failure to disclose these payments be construed as deceptive or misleading—always, or only under specific circumstances, and if so, what circumstances? What criteria will be used to determine if a payment is “material,” and if disclosing (or not disclosing) that fact that would affect the reader’s perception of the credibility or impartiality of the authors? Is this even a “consumer” regulatory issue or does this belong to the FDA or another regulatory body relevant to the medical profession, since this isn’t really “consumer” advertising? These are questions perhaps that that FTC and David C. Vladeck, its new Director of the Bureau of Consumer Protection, may well decide to focus upon.