Merck & Co sues Spanish drug bulletin over Vioxx story

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Rheumawire

Jan 28, 2004

Merck & Co sues Spanish drug bulletin over Vioxx story

London, UK - Pharmaceutical giant Merck & Co is suing a Spanish

publication, Butlleti Groc, over a story it ran about the company's

COX-2 inhibitor, rofecoxib (Vioxx®). A hearing took place on January 16,

2004, and a decision is expected in the next 2 weeks.

The article, which appeared in the drug bulletin's July-September issue

2002 [1], was entitled: " The so-called advantages of celecoxib and

rofecoxib: scientific fraud. " It summarized commentaries that had

previously appeared in the Lancet [2] and the BMJ [3] on irregularities

in the conduct and analysis of the VIGOR trial (with rofecoxib) and the

CLASS study (with celecoxib).

The story concluded that the assessment and financing of both drugs was

based on distorted information presented to the EU regulatory agency,

the European Medicines Evaluation Agency (EMEA), and that commercial

interests had led to the manipulation of the scientific results. It also

said there were serious ethical transgressions in the design, analysis,

and publication of the results of the studies.

Merck & Co has demanded rectification of the comments, which it says

were defamatory, and has taken legal action against the bulletin's

editor, Prof Joan-Ramon Laporte, and the Catalan Institute of

Pharmacology, which publishes Butlleti Groc. The maker of celecoxib

(Celebrex®), Pfizer, has not taken any legal action against the

bulletin.

" I feel this is an attack on independent information on drugs. The

pharmaceutical industry has almost a monopoly on drugs and

therapeutics, " Laporte said last week, in an interview with the BMJ [4].

According to the BMJ, the bulletin has received 700 signatures of

support from Europe and Latin America, including Prof Rawlins,

chair of the UK drug watchdog, the National Institute for Clinical

Excellence (NICE).

The WHO has also become involved because the Catalan Institute of

Pharmacology is a WHO collaborating center. " Indirectly, this is an

attack on the WHO, " Dr German Velasquez (WHO drug action program)

commented to the BMJ. " It's a pity it is going to the courts because

they are not competent to debate technical issues. [That is best left]

to scientific medical journals, " he said.

Nainggolan

Sources

1. [No authors cited]. Las supuestas ventajas de celecoxib y rofecoxib:

fraude cientifico. Butlleti Groc 2002; 15:13-15.

2. Boers M. Seminal pharmaceutical trials: maintaining masking in

analysis. Lancet 2002 Jul 13; 360(9327):100-1.

3. Juni P, Rutjes AW, Dieppe PA. Are selective COX 2 inhibitors superior

to traditional non steroidal anti-inflammatory drugs? BMJ 2002 Jun 1;

324(7349):1287-8.

4. Gibson L. Drug company sues Spanish bulletin over fraud claim. BMJ

2004 Jan 24; 328(7433):188.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org