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David has beaten Goliath again, this time in Spain. Joan-Ramon Laporte, the Spanish pharmacologist who was taken to court on January 16 by the giant Merck Sharp and Dohme (MSD) for an article in which he commented on the irregularities surrounding the company's VIGOR trial has been cleared of wrongdoing.
MSD sued Laporte because his article, “The supposed advantages of celecoxib and rofecoxib: a scientific fraud,” allegedly contained a series of “falsities, biased interpretations of third parties' opinions, and extremely serious false accusations against rofecoxib.”
The article was published in the Yellow Bulletin (Butlleti Groc) newsletter, whose editor-in-chief is Laporte himself. Its publisher, the Catalan Institute of Pharmacology, was also sued by MSD. In his article, Laporte criticized the VIGOR study for allegedly minimizing the cardiovascular side effects of rofecoxib.
But the judge in the case, Victoria Salcedo Ruiz, on January 22 cleared both Laporte and the Catalan Institute of Pharmacology on the basis of four facts. First, she said it was a fact that two editorial articles published in the Lancet and British Medical Journal—and referred to by Laporte in his article—“commented on irregularities surrounding the VIGOR trial.”
Second, it was also true that “these publications triggered a scientific debate about drugs' properties as well as an ethical debate about biomedical research publications.”
Third, continues the verdict, the Lancet editorial article reported that the company “was already aware of the cardiovascular risks of [rofecoxib] and suggested a possible bias in trial patient selection.” It is also the case that the “FDA had warned the company against its promotion activities minimizing the cardiovascular risk,” the judge ruled.
Finally, in the sections of his article titled Commercial interests at the expense of patients' health and Conclusions, the author “fundamentally [writes] opinions, which may be or may not be shared,” Salcedo Ruiz noted.
However, the judge considered Laporte's comment that the information released to the European Medicines Evaluation Agency was false, in contrast to that available in the FDA, was “insufficiently justified”. But this comment occupies just three lines in Laporte's article, she argued, while the rectification requested by MSD would have been almost twice as long as the original article.
On the basis of these points, “I must acquit Joan-Ramon Laporte and the Catalan Institute of Pharmacology,” the verdict ends. It orders MSD to pay for the trial costs.
In a January 28 statement, the Catalan Institute of Pharmacology called the ruling “a victory for all those involved in independent information on medicines and therapeutics with regard to any past, present, or future attempt by pharmaceutical companies to meddle in these activities.”
The institute adds that “debate on scientific issues is only possible if there is no pressure or intimidation. Hence the need for freedom of speech for the progress of science and of medical care.”
References
| 1. | | [http://www.the-scientist.com/news/20040123/03/]
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| | | X. Bosch, “Scientist, drug firm in court,” The Scientist, January 23, 2004.
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| 2. | | M. Boers, “Seminal pharmaceutical trials: maintaining masking in analysis,” Lancet, 360:100-101, July 13, 2002.
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| 3. | | P. Juni et al, “Are selective COX 2 inhibitors superior to traditional non steroidal anti-inflammatory drugs?” British Medical Journal, 324:1287-1288, June 1, 2002. Erratum in: British Medical Journal, 324:1538, June 29, 2002.
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