E-DRUG: MSD sues Prof Joan-Ramon Laporte/Spanish Drug Bulletin
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I have received and I am forwarding the following message about a trial
against Prof. Joan-Ramon Laporte for a paper he wrote.
Pietro Folino
Dear,
On 3rd November, the Foundation Institut Catal� de Farmacologia (FICF) and
Prof Joan-Ramon Laporte have received a citation to attend a trial appointed
for January 16 in Madrid, where the pharmaceutical company MSD wants to sue
both FICF and Prof Laporte as the director of Butllet� Groc ("Yellow
Bulletin", related to the yellow card system), because of an article
published
in this bulletin, entitled "The so-called advantages of celecoxib and
rofecoxib: scientific fraud"
http://www.icf.uab.es/informacion/boletines/bg/bg154.02e.pdf>http://www.icf.
u
ab.es/informacion/boletines/bg/bg154.02e.pdf
[repair URL!]
The article referred to the irregularities in the conduct and analysis of
the
CLASS and the VIGOR trials. Specifically, reference was made to the
suggestion, in editorial commentaries by J�ni (BMJ 2002;324:1287-88) and by
Boers (Lancet 2002;360:100-1).
Since 1986, more than 30,000 copies of Butllet� Groc are distributed to all
physicians and pharmacists in Catalonia, Spain. Five issues per year are
published.
We regard this prosecution as a frontal attack against the freedom of
thought,
because not only does MSD deny what is obvious, but they also seek to force
us
to retract and publish a new issue of the Bulletin reproducing a text
written
by the company.
I would like to encourage you to adhere to the letter above copied written
by
Joe Collier, President of International Society of Drug Bulletins. As you
know, we all need independent information as offered by the Bulletin Groc.
It
is not desirable that, in case of discrepancies on the contents of an
independent review, a potent company such as MSD brings the case to trial in
order to impose their opinion, ignoring other possible open forum where
these
issues could be discussed as any other scientifically subject.
Please, consider then to sign and forward the above message to
mailto:aam@icf.uab.es>aam@icf.uab.es .
All letters of supporters will be presented in the trial.
---
Dear Sir,
I would like to express my support to the Foundation Institut Catal� de
Farmacologia and Prof Joan-Ramon Laporte, as expressed by Joe Collier,
President of ISDB, in the letter copied above.
Signed by
Name:..........
City, country: ........
Passport number: .....
---
To whom it may concern
1) I am writing in my capacity as President of the International Society of
Drug Bulletins (ISDB). I understand that the pharmaceutical company MSD is
suing the Institut Catal� de Farmacologia and Dr Joan-Ramon Laporte for
material published in Butllet� Groc (a well established member of ISDB)
relating to the company's product rofecoxib. In writing this note my aim
is to support the defendants. I would also wish to make it known to the
court
that large transnational pharmaceutical companies have a history of
unjustified bullying of their critics, a practice that may take place
through
the courts.
2) As well as being President of ISDB, I am the editor of the UK Drug and
Therapeutics Bulletin (also a member of ISDB), and a Professor of Medicines
Policy and a Consultant in Clinical Pharmacology at London University, UK.
3) ISDB is an international association with over 50 member bulletins
in
35 countries which give advice, generally to doctors and pharmacists, on
medicines and therapeutics. To be eligible for membership of the Society, a
Bulletin must: have an editorial team and a publishing policy that are
independent of the pharmaceutical industry, must give advice to its readers
that is scientifically valid and which distinguishes what is established
from
what is not, help those who read their advice to optimise treatments
in the best interest of patients.
4) I am informed that an article published in Butllet� Groc, and which is
the subject of this case, referred to celecoxib and rofecoxib and to the
irregularities in the conduct and analysis of the CLASS and the VIGOR trials
that had been described in various publications, particularly the British
Medical Journal (BMJ 2002;324:1287-8) and the Lancet (Lancet
2002;360:100-1).
5) It is my belief that the position taken by Butllet� Groc
accurately reflects the reports of serious methodological deficiencies and
irregularities that surrounded the CLASS and VIGOR clinical trials and which
have been described in the various prestigious and reliable international
medical journals. In brief, and in particular, an editorial article (Lancet
2002;360:100-1) reported that before the VIGOR clinical trial started, the
sponsor (MSD) was apparently aware of the potential myocardial toxicity of
rofecoxib and, through a data adjudication procedure, artificially 'reduced'
the absolute numbers of patients treated with rofecoxib who developed
myocardial infarction. In addition to Butllet� Groc, other medical
publications have also reported irregularities in the analysis of the VIGOR
trial, as did ISDB for instance, in its July 2002 Newsletter. It should be
noted that the VIGOR trial is of particular importance since it was
presented
to regulatory health authorities in European Union countries as pivotal
evidence of the product's safety.
6) It is of interest that in 2001 the Spanish Drug Agency (Agencia
Espa�ola del Medicamento) had issued a warning regarding the risk of
myocardial infarction and other adverse cardiovascular effects of
rofecoxib. This information was consequently included in the summary of
product characteristics and in the package inserts of the pharmaceutical
specialities containing rofecoxib. The text that MSD provides does not
mention
the doubts regarding the cardiovascular safety of rofecoxib. It is also of
interest that following the revelation of these irregularities, on July
2002,
MSD was asked by the European Medicines Evaluation Agency (EMEA), as well as
by other regulatory bodies, to resubmit the complete results of the clinical
trials and other studies on rofecoxib for reassessment. It is also
understood
that regulatory authorities elsewhere have warned MSD against the
dissemination of biased promotional information on rofecoxib in this regard.
7) It is well recognised that information published and circulated by
drug companies is commonly biased towards their own products, tending to
overstate efficacy, minimise adverse effects, and widen the indications for
which the products might hold advantage.
8) As a general rule, when medicines are properly used they have the
potential to offer therapeutic advantage. However, all medicines may produce
harm. The dissemination of biased information on a drug may lead to its
inappropriate use and result in serious damage to patients in particular and
the public health in general. It has become one of the duties of ISDB member
bulletins to point out examples where promotion is misleading or clinical
trial design might distort the drug's image, and to explain in detail to
readers the basis for any criticism. This, I believe, is what Bullet� Groc
has
done and is doing. Moreover, it is this very quality of Bullet� Groc that
makes it such a valuable resource for readers in Spain and Latin America.
Joe Collier MA MD FRCP
President of ISDB
3 December
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