Cochrane at crossroads over drug company sponsorship

Only indirect funding to the Collaboration (eg central offices,
website, publishing efforts) would be acceptable and uncompromising. Any
means of individual funding to reviewers would instead undermine
reviewers' independency and credibility in an irreversible way.

Competing interests:
None declared

Sua Cuique Voluptas

(Everyone Has His Own Pleasures)

Competing interests:
Dr Joseph Chikelue Obi MBBS MD MPH DSc FRIPH FACAM is also the Chairman of the General Wellness Assembly (GWA); an International Professional Body for Independent Wellness Consultants.

Sir,
the scenario depicted by Moynihan (1) resembles the discussions within the
Catholic Church on permitted contraceptive methods: both are out of touch
with what is going on in the real world.

In few years, the concepts put forward by the EBM movement
revolutionized the philosophy and practice of medicine. A key factor in
this dramatic change was the development and refinement of the methodology
that enables to systematically evaluate and summarise all the available
information, usually fragmented in many trials of varying size, quality,
reliability and accessibility. However, in the near future, there may be
little left to meta-analyse.

Big Pharma, where the majority of new treatments come from, is
increasingly adopting the one-shot-trial strategy, aimed at bringing new
drugs into the market as soon as possible. A large -sometimes oversized-
randomised trial, resulting from international, even worldwide,
prestigious though often occasional co-operation, faultless from a
methodological and documental viewpoint, and initiated soon after (and
sometimes before) the completion of phase I-II trials, is worth its costs
(few millions) if it warrants the licensing of a (marginally?) effective
drug just a couple of years earlier. Replication of these trials is seldom
possible, both in the case of positive results, for ethical reasons, and
in the case of negative results, because nobody is interested in
replicating a large, good quality, negative trial. Furthermore,
skyrocketing trial costs make it increasingly difficult to run trials not
sponsored by pharmaceutical companies.

As a consequence, medical practice and guidelines will be
increasingly relying on the results of just one trial, valid as it may be
(see, as an example, ref. 2 and the accompanying editorials). As new
treatments progressively replace the old ones, the role of standard
systematic reviews in the building of medical knowledge will become more
and more marginal, and nobody (including the industry) will care who pays
for them.

The discussion within the EBM community should focus instead on the
development of methodologies to help clinical decisions in a world where
these are to be more explicitly based on extrapolations or indirect
evidence. More important, the medical community as a whole should decide
whether its present role in the setting of clinical research priorities is
satisfactory. When discussing these issues, my suggestion is to leave the
industry out of the door.

1) Moynihan R. Cochrane at crossroads over drug company sponsorship
BMJ 2003; 327: 924-926
2) Goss PE, M.D., Ingle JM, Martino S. A Randomized Trial of Letrozole in
Postmenopausal Women after Five Years of Tamoxifen Therapy for Early-Stage
Breast Cancer. Published as an early release of the N.E.J.Med. at
www.nejm.org October 9, 2003

Competing interests:
Paolo Bruzzi, in the past 20 years, accepted in several instances from no less than 12 pharmaceutical companies one and/or another of the following:
Reimbursement for attending a symposium - Fee for organising education - Funds for research - Funds for a member of staff - Fees for consulting. Unfortunately, he was never offered a fee for speaking, nor does he hold any stocks or shares in any pharmaceutical company.