Chief executives of multinational pharmaceutical companies have much to
celebrate this week. They saw spending on prescription drugs in the
USA soar by a remarkable 17% in 2001, according to figures recently
released by the National Institute for Health Care Management
Foundation. As bonuses for corporate leaders ratchet upwards, so does
the unalleviated financial pressure on the elderly, the largest users
of these drugs. Direct-to-consumer advertising campaigns for
cholesterol-lowering agents, anti-ulcer medications, anti-arthritics,
and antidepressants have been strikingly successful. Total retail
spending on prescription drugs was US$155 billion in 2001, almost
double what it was in 1997.
The escalating influence of big pharma in medicine persuaded
editors of medical journals to come together last year and agree
strict rules on reporting sponsorship and conflicts of interest (see
Lancet
2001;
358:
854-56). While this consensus sets the highest standards yet for
disclosing commercial influences in medical research, there are signs
that it does not go far enough--or, at the very least, that this
guidance is not being fully heeded.
A study of the interactions between authors of clinical practice
guidelines and the pharmaceutical industry, published in JAMA
in February, found serious omissions in declarations of conflicts of
interest. Almost 90% of authors received research funding from or
acted as consultants for a drug company. Over half had connections
with companies whose drugs were being reviewed in the guideline, and
the same proportion indicated that there was no formal procedure for
reporting these interactions. The guidelines studied covered all
fields where prescription drug use has seen the greatest increases.
An especially corrosive example of such a commercial influence,
involving one of the most respected US specialist societies--the
American Heart Association--was described in the BMJ last
month. Was the AHA sensible to accept US$11 million in donations from
Genentech while at the same time producing guidelines about
thrombolytics in stroke? Genentech is the US producer of one such
thrombolytic, which was recommended for use in the AHA 2000 guidance
on stroke management.
Prestigious institutions are also not averse from mixing research
with commercial gain from industry partnerships. The Seattle Times
has conducted one of the most thorough investigations of how such
relations threaten to poison patient care. In a series of articles
published last year, staff reporters Duff Wilson and David Heath
claimed to reveal how investigators at the Fred Hutchinson Cancer
Research Center completed experiments with biotechnology products in
which they had a direct financial interest. The journalists allege
that doctors did not tell patients that others had died using these
products and that there were safer alternatives available. The Center
denies these allegations but admits that it "could have handled
better" perceptions of conflict of interest.
These concerns extend to journal editors, especially those who edit
part-time while continuing to work in clinical practice and research.
The rules issued by the International Committee of Medical Journal
Editors state that, "Editors who make final decisions about
manuscripts must have no personal, professional, or financial
involvement in any of the issues they might judge". However, the
editor of the British Journal of Psychiatry was recently
questioned about his membership of a drug-company sponsored
"educational organisation", for which he received £2000 annually,
together with his decision to publish a paper favouring a drug
manufactured by the same company. Only after receiving the letter
questioning his behaviour did the editor change his journal's
procedure, excluding himself from decisions about work sponsored by
that same company. He avoided the issue about whether he should have
any commercial liaisons while acting as editor of a supposedly
independent medical journal. The Lancet's policy is that
editors should divest themselves of all such links upon assuming their
new duties.
To return to our first question: how tainted by commercial
conflicts has medicine become? Heavily, and damagingly so, is the
answer. A more important question arises: do those doctors who support
this culture for the best of intentions--eg, to undertake important
research that would otherwise remain unfunded--have the courage to
oppose practices that bring the whole of medicine into disrepute?
The Lancet