Vioxx - Spanish drug editor wins case brought by Merck, Sharp & Dohme

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BMJ 2004;328:307 (7 February), doi:10.1136/bmj.328.7435.307-b

News

Spanish drug editor wins case brought by Merck, Sharp & Dohme

Liza Gibson

London

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 (24 January,

p 188).

The company had wanted a statement-which it had prepared-to be published

in the bulletin and on the institute's website 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, 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 MSD'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.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org