Cochrane at crossroads over drug company sponsorship
BMJ 2003; 327 doi: https://doi.org/10.1136/bmj.327.7420.924 (Published 16 October 2003) Cite this as: BMJ 2003;327:924
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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
Competing interests: No competing interests
We should be afraid that the Cochrane Collaboration becomes a tool of
pharmaceutical industry but not only because of direct sponsoring.
With all the main clinical trials decided, performed and analysed by the
industry, what else is left to review?
Even if strictly independent, reviews can only review the issues that drug-sellers decide to investigate.
Evidence Based Medicine is increasingly "working for" the pharmaceutical
industry as the mainly (and soon the one and only) "evidence maker".
In fact, it must be acknowledged that the highly-paid, industry-driven
trials almost monopolize the capacity of the clinical researchers
community all over the world, with research issues decided in accordance
with commercial interests that are seldom coincident with the public-health real questions.
Therefore, a strictly independent, non-industry-sponsored, Cochrane
Colaboration, forced to review the only evidence available, should be much
more useful to the pharmaceutical companies than a "suspect" one funded by
them.
To counteract this, other players (governments, regulatory bodies,
academic institutions, insurance companies, social security, etc.) should
commit themselves much more deeply to fund and/or perform research on
health questions that are "orphan" in the eyes of the pharmaceutical
industry but of utmost relevance to obtain health gains and to preserve
the economic survival of health systems even in developed countries.
Competing interests:
Direct participation in industry-sponsored trials from 1988 to 2001.
Since 2001, participation in decisions concerning research contracts between my Institute and pharmaceutical companies.
Competing interests: No competing interests
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.
Competing interests: No competing interests
As a first step, and perhaps as an alternative to funding the production of reviews, pharmaceutical companies could help improve access to reviews.
The Web is a vital source of information, and search engines are a popular means of finding information on the Web - a recent survey of British students found that 45% used Google as their first port of call when looking for information. Until Cochrane Reviews are visible in search engines such as Google the impact of Cochrane Reviews will always be less than the funding agencies and review authors would wish.
The easiest way to do this would be for pharmaceutical companies to work with the Cochrane Collaboration and Wiley Interscience to remove the barriers to Cochrane Reviews.
Competing interests:
None declared
Competing interests: No competing interests
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.
Competing interests: No competing interests
Governments who pay for health care for their populations, and health
insurers who pay for health care for their clients--"Payors"--and the
patients they cover--have the greatest interest in determining the truth
about cost-effective health care. I would have no problem with, in
addition to public funding sources, Cochrane receiving significant funding
from the health insurance industry. I completely agree with those who
maintain that all of the available evidence suggests that pharmaceutical
industry funding would bias the results of reviews in favor of the
sponsor's drug. The bias of payors in favor of spending less has not been
as clearly shown to influence study results, and is in any case a
healthier bias in an era of exponentially rising health care costs.
--Chris Hogness, M.D.
Competing interests:
None declared
Competing interests: No competing interests
The Cochrane Collaboration is the foundation for many efforts to
improve health care. Drug company sponsorship would tilt the foundation
making the whole house of health care reform unsafe.
Healthy Skepticism's work to improve health by reducing harm from
misleading drug promotion depends on the Collaboration for a gold standard
comparator for promotional claims. ( www.healthyskepticism.org ) If we
could not rely on the Collaboration, where could we go?
The Collaboration's most priceless asset is a reputation for
reliability. Companies spend billions trying to achieve such a reputation
without success because a small scratch can ruin the whole record. If the
Collaboration accepts drug company sponsorship then we will not know which
reviews we can trust. If we can't trust the Collaboration why should
anyone support it? If we can't trust it why should taxpayers fund it?
Andrew Moore "strongly defends" tarnishing the gold standard by
taking money from Pfizer. He asserts that: "We had explicit rules to
ensure independence." Clearly he was not financially independent. The
only way to ensure independence of judgement is to refuse funding from
vested interests because any gift can lead to unintended unaware
bias.<1,2,3> The best defence is to sign the NoFreeLunch pledge (
www.nofree.lunch.org )
There are three main ways that drug companies can increase the funds
available for Cochrane reviews: pay their taxes, lower their prices and
quit their misleading promotion. Consequently we need to change our
systems for paying drug companies to enable them to have good returns on
investment without tax avoidance, high prices and misleading promotion.
The key to that is to reduce wasteful competition that increases their
costs. Having companies compete to tilt the Collaboration their way would
just make everyone's problems worse.
1. Katz D, Caplan AL, Merz JF. All gifts large and small: toward an
understanding of the ethics of pharmaceutical industry gift giving. Am J
Bioethics 2003;3(3):39-46.
2. Dana J, Loewenstein G. A social science perspective on gifts to
physicians from industry. JAMA 2003;290:252-255
3. Mansfield PR. Bribes for doctors: a gift for bioethicists? Am J
Bioethics 2003;3(3):47-8.
Competing interests:
I have recieved gifts from drug companies in the past but signed the NoFreeLunch pledge in 2001.
Competing interests: No competing interests
Cochrane Colloquium in Barcelona. A view from the debate in Spain
Congratulations for your interesting paper. It's being sent to our
evidence based mental health's list for Spanish Psychiatrist to open a
debate.
In Spain the drugs industry sales and puts its nose in "everything". But
in Spain there's not enough funds to carry on research from the
Goverment, compared with the well-setled Northern European areas. I think
that some unsolidarity, selfish or chauvinist views appear.
Maybe they do not understand what is the meaning of the saying: "to be on
other's shoes".
The drug industry implies a way to help us with our CME, which it is going
to be a benefit for our best practice, in the best profit for our
patients.
Since Hippocrates there have been ways to learn and improve Medicine, and
our Jury clearly explains what are the ethics which each of us, -from
North to South- West and East we must keep our ethics and morals in mind, applying it in order to improve our learning ever.
Competing interests:
None declared
Competing interests: No competing interests