Healthy Skepticism Library item: 19676

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Gale EAM
Conflicts of interest in guideline panel members
BMJ 2011;

Abstract:

It has been said that “it is difficult to get a man to understand
something when his salary depends upon his not understanding
it,”1 and the medical profession has been slow to understand the
importance of conflicts of interest. The linked study by Neuman
and colleagues (doi:10.1136/bmj.d5621) reports the prevalence
of financial conflicts among guideline panel members in the
United States and Canada. Of the 14 guidelines considered, six
came from government sponsored organisations, six from
specialist or professional organisations, and two from private
non-profit organisations; three were from Canada and the
remainder from the US. Five (four government sponsored)
guidelines provided no conflict of interest statement, but their
participants had presumably been screened, because only four
of 77 panellists seemed to have a conflict. Six of 12 named
chairpersons had a conflict, as did 138 of the 211 panellists who
provided a disclosure statement; 12 more failed to disclose an
interest, and 10 others received research funding from industry.
Only 61 (29%) had no potential financial ties.2
The guidelines in question related to the management of diabetes
and hyperlipidaemia, therapeutic areas that accounted for sales
of $70.8bn (£44.3bn; €50.4bn) worldwide in 2010, or 8.9% of
the worldwide drug market.3 Patent protected agents generate
most of the profit, but they enter the market in competition with
established treatments that are not only cheaper but have more
evidence to support their use. Outcome data are rarely available
for a new agent at the time of launch, and unexpected safety
concerns may still come to light.
Clinical guidelines can bridge this gap, and inclusion has become
the passport to marketing success. Guidelines are supposedly
evidence based, but the published evidence has usually been
provided by the company and is rarely sufficient to fill the
evidence gap. The gap is plugged by expert opinion. Evidence
based review, in the words of one guideline, “[must] also be
supplemented by value judgments, where the benefits of
treatment are weighed against risks and costs in a subjective
fashion.” 4 Because provisional approval by a panel of experts
implies the existence of a body of evidence sufficient to justify
the use of the drug, a guideline easily becomes a substitute for
the evidence it is supposed to represent and offers a disincentive
for the collection of better data. Last but not least, guidelines
can have a big financial impact. The committee cited above
commented unfavourably on rosiglitazone and wrote 20% off
the share price of GlaxoSmithKline in the process.5
With billions of dollars at stake, a company has every motive
to encourage potential guideline panellists to view its product
in a favourable light, and a virtually limitless budget to support
this objective. Established and would be opinion leaders are
cultivated with tactics ranging from flattery, career promotion
(names on papers is one device), and gifts of money
euphemistically described as honorariums. Some of these gifts
pass under the table—for example, when an arrangement risks
a conflict of interest, companies have offered to transfer the
money in ways that cannot be traced.6
Although the proportion of guideline committee members
declaring a conflict of interest has risen over time, the proportion
of members affected has not changed.2 One suggested remedy
is that guideline committees should be composed of only those
who have no conflicts of interest. There is a charming sense of
unreality about this suggestion—money from drug companies
is the oxygen on which the academic medical world depends.
The income of the professional societies that publish guidelines
largely derives from their annual conferences, which depend
on the rents charged to exhibitors and the registration of
company sponsored delegates.
Medical journals are not exempt; a past editor of the BMJ wrote
that they have become “an extension of the marketing arm of
pharmaceutical companies,” while noting that published studies
funded by a company are four times more likely to reach a
conclusion favourable to the product than those funded
independently. Publication of such a trial can earn the journal
up to $1m in reprints.7 Professional training and publishing
derive financial support from an industry whose influence
extends to academic institutions, national representative
committees, and the behaviour of politicians. Money from drug
companies, and the influence it buys, is integral to the way
medicine is done, and the carefully nurtured belief that clinicians
can navigate all this amid the odour of sanctity and scientific
objectivity is mere illusion.
Let us therefore forget the hand wringing and confront the reality
of the world in which we live. Academic and non-academic
medicine are pervaded by conflicts of interest, and too many
people benefit from the situation for this to be openly
acknowledged. How much simpler it is to locate the problem
in the conscience of individual clinicians. Meanwhile, and at a
time when the US economy staggers under the burden of
healthcare, the public purse continues to pour a river of gold
into the revenues of the drug industry. Legislation will not
change the situation, for the smart money is always one step
ahead. What is needed is a change of culture in which serving
two masters becomes as socially unacceptable as smoking a
cigarette. Until then, the drug industry will continue to model
its behaviour on that of its consumers, and we will continue to
get the drug industry we deserve.