Pharmacologist wins legal battle with Merck over Vioxx article

[Guest guest]

Rheumawire

Feb 5, 2004

Pharmacologist wins legal battle with Merck over Vioxx article

Madrid, Spain - A Spanish pharmacologist who was sued by Merck Sharp &

Dohme (MSD) for writing an article alleging that the VIGOR study [1] of

Merck's COX-2 inhibitor, rofecoxib (Vioxx®), minimized the

cardiovascular side effects of the drug, has won his case.

Prof Joan-Ramon Laporte wrote the article, entitled " The so-called

advantages of celecoxib and rofecoxib: Scientific fraud " in the drug

bulletin Butlleti Groc [2], published by the Catalan Institute of

Pharmacology, which was also sued by Merck.

The article summarized commentaries that had previously appeared in the

Lancet [3] and BMJ [4] on irregularities in the conduct and analysis of

the VIGOR trial (with rofecoxib) and the CLASS study (with celecoxib

[Celebrex®, Pfizer]). It alleged that commercial interests had led to

the manipulation of the scientific results and that there were serious

ethical transgressions in the design, analysis, and publication of the

study. In its lawsuit, Merck maintained that these comments were

defamatory and that the article contained " biased interpretations of

third parties' opinions, and serious false accusations against

rofecoxib. " Pfizer did not take any legal action against the bulletin.

The judge in the case, which was heard on January 22, cleared both

Laporte and the Catalan Institute of Pharmacology. According to an

article in the Scientist [5], Judge Salcedo Ruiz said that the

Lancet and BMJ editorials referred to by Laporte had commented on

irregularities surrounding the VIGOR trial and that the Lancet editorial

reported that Merck " was already aware of the cardiovascular risks of

[rofecoxib] and suggested a possible bias in trial patient selection. "

The verdict also noted that the US FDA had warned the company against

its promotion activities minimizing the cardiovascular risk, the

Scientist reports.

However, the judge did say that one comment made by Laporte regarding

information submitted to the European Medicines Evaluation Agency (EMEA)

was " insufficiently justified. " But she added that this comment occupies

just three lines in Laporte's article, while the rectification requested

by Merck 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.

The Catalan Institute of Pharmacology described the ruling as " 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 verdict

also echoed the FDA warnings to Merck on the rofecoxib promotional

material, " which minimized the risk of adverse cardiovascular effects, "

it said.

The institute goes on to say: " We believe that the design, conduct, and

analysis of research done by pharmaceutical companies are not adequately

supervised by independent bodies. " It adds: " Many new medicines are

presented as improvements over those already available but do not show

any real relevant clinical advantage in terms of safety, efficacy,

convenience, or cost. Independent information and interpretation are

needed in order to ensure that this does not harm patients' health or

the financial health of the National Health System, " it adds.

MSD issued a statement acknowledging that the judge had decided not to

grant MSD's rectification request. But it added: " However, it is

important to note that the court did not find that MSD engaged in the

conduct alleged in the Butlleti Groc. "

Merck noted that: " Dr Laporte's statements were based almost entirely on

a non-peer-reviewed commentary published in 2002. There were several

inaccuracies in that commentary regarding the design, conduct, and

reporting of the VIGOR trial. The principal investigator, the heads of

the data and safety monitoring board, the cardiovascular event

adjudication committee, and Merck addressed these errors in the

commentary, in a letter to the editor. Unfortunately, that letter was

not published, " the company continued.

" MSD has always been and will always be fully committed to the highest

standards of scientific integrity, ethics, and protection of patient

well-being in our research efforts. The VIGOR trial reflects these high

standards of scientific rigor, and we reject any and all allegations to

the contrary, " the company statement said. " The trial was sponsored by

MSD, with a steering committee responsible for the scientific conduct of

the trial, and a data and safety monitoring board, both drawn from the

academic research community. It is unacceptable that MSD and these fine

scientists who collaborated on the VIGOR trial should have their conduct

challenged in Butlleti Groc with no opportunity for MSD to respond to

Prof Laporte's claims, " it added.

Sue

Sources

1. Bombardier C, Laine L, Reicin A, et al. Comparison of upper

gastrointestinal toxicity of rofecoxib and naproxen in patients with

rheumatoid arthritis. VIGOR Study Group. N Engl J Med 2000;

343:1520-1528.

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

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

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

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

4. 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.

5. Bosch X. Spanish scientist cleared: Scientific freedom of speech seen

as winner in suit between drug firm and pharmacologist. Scientist

February 3, 2004. Available at:

http://www.biomedcentral.com/news/20040203/02.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org