Science by litigation

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    A company's lawsuit against researchers should not be allowed to intimidate others.

    The curious case of Biopure versus Natanson pits a struggling biotechnology company against a biomedical researcher in a libel case (see Nature News doi:10.1038/news.2008.1219; 2008). Historically, such attacks on the scientific literature have been given short shrift by the courts. The case is dangerous nevertheless.

    Biopure of Cambridge, Massachusetts, is attacking an analysis performed by Charles Natanson, a senior investigator at the US National Institutes of Health, and his colleagues, and published in The Journal of the American Medical Association (JAMA — C. Natanson et al. J. Am. Med. Assoc. 299, 2304–2312; 2008). Natanson's article was a meta-analysis: a statistical lumping together of several small clinical trials. Such analyses can be complex and problematic. A bad meta-analysis has the power to needlessly frighten or groundlessly assure consumers, but a good meta-analysis can protect the public from a previously unrecognized — or unpublicized — safety risk. Regardless of quality, a well publicized meta-analysis can cost a firm millions in lost sales.

    Biopure alleges that this analysis was not sufficiently sound to warrant one of the paper's conclusions: that a blood substitute produced by the company is not safe.

    Natanson and his colleagues combined data for different blood substitutes that share a mechanism of action; Biopure says this means that the results could not be applied specifically to its product. The researchers also lacked access to critical data — a common lament of the meta-analyser, and an inevitable result of companies refusing to disclose the results of their clinical trials. JAMA's editors — who have declined to comment — and their reviewers presumably felt that the evidence as described justified the conclusions.

    There is a traditional forum, in science, to air such grievances: the journal itself. And indeed, after the article was published, JAMA published numerous critiques from readers and the authors' response. Biopure elected to put its questions about scientific quality into the hands of the law. It claims that it has suffered financial loss and that its corporate mission, financed to the tune of $600 million, has been put at risk.

    The US legal system has historically treated scientific publications with respect under the US constitution's first amendment, which protects freedom of the press. That does not mean that scientists are exempt from laws on libel and slander simply because they are scientists. But those involved should be aware that this action potentially threatens public trust in the very industry of which Biopure is a part, which is founded on open scientific analysis and debate. Researchers (and their editors) must never forget what is at stake in a meta-analysis, but above all must not be intimidated by this action.

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    Science by litigation. Nature 456, 142 (2008) doi:10.1038/456142b

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