E-DRUG: Drug company sues Spanish bulletin over fraud claim
--------------------------------------------
[E-drug reported earlier (9 January 04) about this case. Here is more info,
copied as fair use from the BMJ.
BMJ 2004;328:188 (24 January), doi:10.1136/bmj.328.7433.188.
The BMJ site offers free connections to the original articles. WB]
Drug company sues Spanish bulletin over fraud claim
by Liza Gibson, London
One of Spain's independent drug bulletins, Butllet� Groc, is being sued by
Merck Sharp & Dohme for an article that claimed that the company committed
scientific fraud in a trial of its cyclo-oxegenase-2 (COX 2) inhibitor
rofecoxib (Vioxx). The case opened in Madrid last week.
The company wants the bulletin to retract its article on the Vioxx
gastrointestinal outcomes research (VIGOR) trial and publish a new one
reproducing text prepared by the company. However, Professor Joan-Ramon
Laporte, the bulletin's editor, refuses to do so.
He said: "I feel this is an attack on independent information on drugs. The
pharmaceutical industry has almost a monopoly on information on drugs and
therapeutics." Professor Laporte claimed that the company's text was "mainly
propaganda" for rofecoxib.
The article, entitled "The so called advantages of celecoxib and rofecoxib:
scientific fraud," was published in the July-September 2002 issue of the
bulletin ( 2002;15: 13-5) but was not based on new material. It summarised
earlier commentaries in the Lancet ( 2002;360:
100-1)[CrossRef][ISI][Medline] and the BMJ ( 2002;324: 1287-8)[Free Full
Text] on irregularities in the conduct and analysis of the VIGOR trial and
the celecoxib long term arthritis safety study (CLASS). These large trials
compared the gastrointestinal safety of two COX 2 inhibitors, rofecoxib and
celecoxib (Celebrex), respectively, with traditional non-steroidal
anti-inflammatory drugs.
In the VIGOR trial, which was published in the New England Journal of
Medicine in November 2000 (343: 1520-8)[Abstract/Free Full Text], rofecoxib
was found to be associated with significantly fewer upper gastrointestinal
events than naproxen but with a higher incidence of myocardial infarction.
The finding has been the subject of much debate in medical journals.
The bulletin said the results of the VIGOR trial generated doubts on the
cardiovascular effects of rofecoxib. It referred to a Lancet commentary that
had "raised the possibility that the company was already aware of the
likelihood of this adverse effect, and suggests that a selection bias may
have been introduced which may have led to an underestimation of rofecoxib
cardiovascular toxicity."
Merck Sharp & Dohme, however, disagrees with many aspects of the Lancet
article.
The general conclusion of the bulletin's article, which referred to both
trials, said that the assessment and financing of the drugs was based on
distorted information presented to the European regulatory body, the
European Agency for the Evaluation of Medicinal Products�unlike the
information that was available to the US Food and Drug Administration.
It said that the obvious commercial interests that led to the manipulation
of the scientific results and the disregard of patients' health undermined
trust in the scientific rigour of the published studies.
It also added that there were serious ethical transgressions in the design,
analysis, and publication of the results of the studies.
The company said it would not accept this "most serious accusation of fraud
and data manipulation." It demanded "rectification" of the comments, which
they claimed were defamatory, adding that such "rectification" was its
constitutional right.
The company said that its legal action against Professor Laporte and the
Catalan Institute of Pharmacology, the publisher of the bulletin, comes
after unsuccessful discussions with the editor for more than a year.
It originally sought action in October 2002, but this was rejected by a
lower court. The company then applied to a higher court, which overturned
the earlier decision. The company says the lower court had not accepted the
case because of a technicality.
Professor Laporte believes that the use of the words "scientific fraud" in
the title of the article and its conclusion that the drug industry was more
interested in profits than health could be part of the reason why the
company was taking the journal to court. The manufacturer of celecoxib,
Pfizer, unlike Merck Sharp & Dohme, did not take legal action against the
bulletin. Professor Laporte believes that Pfizer felt that taking action
would lead to worse results for the company.
The bulletin has received some 700 signatures of support�from countries in
Latin America that use the bulletin and from European centres. One signatory
is Professor Michael Rawlins, chairman of the National Institute for
Clinical Excellence.
Professor Joe Collier, president of the International Society of Drug
Bulletins, of which Butllet� Groc is a member, has also pledged support. He
has written to the court saying that "large transnational pharmaceutical
companies have a history of unjustified bullying of their critics" and that
the bulletin accurately reflected the irregularities of the trials, noting
that this had been described in various publications, including the
society's newsletter in July 2002.
The matter has also become an issue for the World Health Organization, as
the Catalan Institute of Pharmacology is a WHO collaborating centre.
"Indirectly, this is an attack on the WHO," said Dr German Velasquez,
coordinator of WHO's drug action programme. "It is a pity it is going to the
courts, because they are not competent to debate technical issues. [It is
best left] to scientific medical journals," he said.
This is the first time that a Spanish drug bulletin faces a court trial. A
hearing took place on 16 January, and a decision is expected in the next two
weeks.
The issue of the cardiovascular safety of rofecoxib has an EU-wide
dimension. In November 2003 the European Agency for the Evaluation of
Medicinal Products' scientific advisory body, the Committee for Proprietary
Medicinal Products, concluded that the risk-benefit ratio of the two drugs
remained positive. However, it recommended that warnings on the drugs should
be added or strengthened, in particular for patients with underlying
gastrointestinal and cardiovascular risks.
The European Commission has yet to issue a response to the committee's
safety review, which was initiated by France in July 2002, around the time
when the safety of the drugs was being debated.
A spokesman for Merck Sharp & Dohme said that on the basis of all available
data it stands by the efficacy and safety profile of Vioxx.
[picture omitted]
Professor Joan-Ramon Laporte: "I feel this is an attack on independent
information on drugs"
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