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(2005; 165 pages)
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Spanish drug editor wins case brought by Merck, Sharp & Dohme
A victory for all independent drug bulletins was declared last week when Professor Joan-Ramon Laporte, the editor of Spain's Butlletí Groc, won a district court case brought against it by the pharmaceutical company Merck, Sharp & Dohme.
The multinational firm had sued the editor and the publisher of the bulletin, the Catalan Institute of Pharmacology, over an article that the bulletin had published in 2002. The company said that the article had contained false and inaccurate information about the trial of one of its drugs, the Vioxx gastrointestinal outcomes research (VIGOR) trial, which looked at the safety of its arthritis drug, rofecoxib.
The company had wanted a statement - which it had prepared - to be published in the bulletin and on the Institute's web site under Spain's 1984 "rectification" legislation, which allows anybody the right to rectify any information they consider to be incorrect and whose distribution could cause them harm.
However, the judge, Maria Victoria Salcedo, rejected the demands of the company, absolved Professor Laporte and the Institute, and demanded that the company pay the court costs.
In her judgment on 27 January, she said the contents of the bulletin were accurate as they were based on a series of articles published in journals such as the Lancet and the BMJ, which had mentioned the irregularities surrounding the publication of the VIGOR trial, including a commentary that had said the company knew of the cardiovascular risks in relation to rofecoxib and suggested a bias in the selection process of the trial.
However, one aspect of the bulletin's article was found to be not correct. Judge Salcedo said the institute had not supplied enough evidence to show that distorted information on rofecoxib had been submitted to the EU regulator, the European Agency for the Evaluation of Medicinal Products, unlike that presented to the US Food and Drug Administration. But she said this had taken up only a few lines in the bulletin's article, while the company's rectification text was twice as long as the article, making this disproportionate.
The judge also said the company's text did not limit itself to the contents of the article, and its coverage exceeded what it wanted rectified. The text said, for example, that rofecoxib had better gastrointestinal safety compared with other drugs, but the bulletin had looked only at cardiovascular risk; it had also claimed that Merck, Sharp & Dohme had an ethical tradition, but this too had not been questioned in the bulletin.
Professor Laporte said the judgment "echoes the international debate which took place (in the literature) regarding the irregularities in the VIGOR trial and the omission of cardiovascular adverse effects in Merck, Sharp & Dohme's promotional materials."
The Catalan Institute of Pharmacology said the judgment was a "victory for all those involved in independent information on medicines and therapeutics."
A spokesman for Merck, Sharp & Dohme said after the ruling, which the company is reviewing, that the bulletin's article was almost completely based on a commentary that appeared in the Lancet in 2002 (360:100-1) on the design and conduct of the VIGOR trial. It claims that there were several inaccuracies in the commentary, but a letter to the Lancet's editor spelling these out was not published.
Source: BMJ 2004;328:307 (7 February).