E-DRUG: Prof Joan-Ramon Laporte wins the case against MSD
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[E-drug earlier reported on 9 and 23 Jan about this case, under the title
"Drug company sues Spanish bulletin over fraud claim". Congratulations to
Prof Laporte for winning the case! WB]
Dear all,
Let me congratulate from e-drug Prof Laporte and Foundation Institut Catal�
de
Farmacologia (FICF) as you know sued by MSD, because of an article published
in their bulletin, entitled "The so-called advantages of celecoxib and
rofecoxib: scientific fraud".
After the trial in Madrid the 16th January, the verdict confirms now that
Prof
Laporte was right. MSD must now pay the expenses.
Congratulations to all of us really, since we all win when independent
information wins.
Carmen P�rez Casas
(See BMJ 24 January 2004 for more information
http://bmj.bmjjournals.com/cgi/content/full/328/7433/188?etoc)
[This 24 Jan text was already circulated to E-drug on 23 Jan.
Below 2 responses by Prof Laporte and MSD to complete the picture. WB]
---
[message to BMJ by Prof Laporte]
The Fundaci� Institut Catal� de Farmacologia (FICF) is glad to announce that
the District Court n� 37 in Madrid has pronounced sentence with regard to
the lawsuit brought by the MSD company against the FICF and the editor of
Butllet� Groc, Dr Joan-Ramon Laporte. The lawsuit has been rejected, the
defendants have been absolved, and MSD has been ordered to pay the trial
costs.
FICF wishes to declare the following:
1) The judgment is 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.
Pharmaceutical companies should not pretend that a single way of thinking on
their products exists. The debate on scientific issues is only possible if
there is no pressure or intimidation. Hence the need for freedom of speech
for the progress of science and of medical care.
2) The sentence confirms that the facts described in Butllet� Groc were
true. It also reflects the debate on the ethics of reports and publications
on medical research, and it echoes the US FDA warnings to the MSD company on
the contents of rofecoxib promotional material, which minimized the risk of
adverse cardiovascular effects.
3) The results of scientific research are always subject to interpretation.
We believe that the design, conduct and analysis of research done by
pharmaceutical companies are not adequately supervised by independent
bodies. The lack of transparency in these issues raises doubts on its trust.
4) Many new medicines are presented as improvements over those already
available, but do not show any real relevant clinical advantage in terms of
efficacy, safety, convenience or cost. Independent information and
interpretation are needed in order to ensure that this does not harm
patients� health nor the financial health of the National Health System.
5) We wish to express our gratitude and that of all those working in
independent medicines and therapeutics information to all the institutions,
scientific societies, organizations and thousands of health professionals in
Spain and in more than 30 countries who have given us their support.
Barcelona, January 28, 2004
Competing interests: No competing interests, except that MSD sued me
---
[MSD response]
To the editor:
We read with interest and concern your recent news article about Dr.
Joan-Ramon Laporte�s allegations against MSD (Merck & Co., Inc.) and his
refusal of our requests to respond in Butllet� Groc [British Medical
Journal, January 24, 2004, �Drug company sues Spanish bulletin over fraud
claim.�]
Dr. LaPorte's statements were based almost entirely on a non-peer reviewed
commentary published in 2002 (ref 1). There were several inaccuracies in
that commentary regarding the design, conduct, and reporting of the VIGOR
trial (ref 2). The principal investigator, the heads of the Data and Safety
Monitoring Board and 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.
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. We have a long tradition of partnership with
leaders in the academic research community, as evidenced by the CONSENSUS,
4S, FIT, ELITE II, RENAAL, OPTIMAAL, and LIFE trials, among others. The
VIGOR trial reflects these high standards of scientific rigor, and we reject
any and all allegations to the contrary. The trial was sponsored by MSD,
with a Steering Committee responsible for the scientific conduct of the
trial, and a Data & 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
Butllet� Groc with no opportunity for MSD to respond to Prof. Laporte's
claims.
Merck's commitment to open scientific debate is demonstrated by our rapid
disclosure of the results of the VIGOR trial, which have been thoroughly
examined, discussed, debated and studied by the medical, regulatory and
scientific communities over the past three years.
Peter Honig, Senior Vice President, Worldwide Regulatory Affairs and Product
Safety, Merck & Co., Inc.
1 Boers M. Seminal pharmaceutical trials: maintaining masking in analysis.
Lancet 2002; 360 (9327): 100-1.
2 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(21):
1520-1528.
Competing interests: None declared
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