CAN the companies or individuals responsible for publishing an article in a peer-reviewed journal be sued for false advertising? Yes, says a patients鈥� group in the US that is taking on a major pharmaceutical company. But an association of the major medical journals in the US is now trying to halt the lawsuit, claiming it will compromise the publication of scientific results.
Last year the Congress of California Seniors, a patient advocacy group based in Sacramento, California, filed a lawsuit against Pharmacia, and its owner, Pfizer. It claims that the company made unlawful use of an article in a leading journal to promote an unapproved use of a painkiller called Bextra.
The FDA approved Bextra to treat long-term pain in October 2001; it did not sanction its use for acute pain because of safety and efficacy concerns. Despite this ruling, Pharmacia paid another firm, part-owned by one of the largest advertising companies in the world, to conduct clinical trials. The report of these trials, published in the Journal of the American Dental Association in May 2002, concluded that Bextra was effective for acute pain. The lawsuit alleges that this paper was misleading, and was used by Pharmacia sales representatives to illegally promote the prescription of Bextra for acute pain.
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But the threat that peer-reviewed studies could be considered 鈥渇alse and misleading commercial speech鈥� and thus liable to litigation 鈥渕ay well eviscerate鈥� the science journal system, says a letter sent to the judge by law firm Wiley, Rein and Fielding in Washington DC. It is acting on behalf of the Association of Medical Publications (AMP), which includes prestigious journals such as The New England Journal of Medicine. 鈥淚t鈥檚 a problem for journal publishers who don鈥檛 care about the interests of a company but want to report on new developments in their fields,鈥� says company attorney Rosemary Harold. If the case is allowed to proceed, publishers might be sued for false advertising, she says. Just the thought of being involved in a lawsuit may deter scientists, reviewers or journals from publishing results on novel uses for drugs, Harold argues.
Lawyers acting for the Congress of California Seniors, however, say this argument is misguided. 鈥淭he case is a case that attacks the drug company鈥檚 marketing activities鈥t鈥檚 not a case against the authors of the article or the publishers,鈥� says Tom Sobol, an attorney with the law firm Hagens Berman in Boston. 鈥淭he use of scientific efforts by the drug companies to manipulate the prescription behaviour of physicians: that鈥檚 what we think is the problem.鈥�
The lawsuit is one of several being brought against drug companies alleging scientific papers have been misused for marketing.