ver, implementation of these regulations has
given by the youthful graphic designer in the
been lax and patients may well have suffered
Legislation, as it applies to the advertising
existence there have been only four prosecu-
of medicines to doctors, is contained in the
tions for breaches of the Medicines Act as it
relates to advertising. All have been brought
(Advertising to Medical and Dental Practi-
instance the plaintiff was an individual work-
provisions of this legislation include that
product sold on a small scale. Despite the
that claims made should reflect available
numerous breaches, and despite the statu-
The regulations clearly indicate what gov-
adherence to the Act, it would appear that
ernment requires of the pharmaceutical in-
dustry and yet breaches of them are common
prepared nor willing to confront the larger
place. In a study reported to the British
Pharmacological Society in 1984 by a mem-
ber of the Department of Health, over half of
leave the control of advertising to the indus-
the full page advertisements published in the
try's own code of practice committee, and
previous year had breached the regulations
has abrogated its responsibility to such an
rejected over half the complaints referred to
and consist, for example, of a failure to give a
proprietary name. These the industry dismis-
ses as 'legal technicalities' and of no signifi-
cance. Others see minor breaches as a symp-
selected by the industry, is run for and on
tom of a widespread and sinister disregard
behalf of the industry, uses a code indepen-
dent of the law, has no enforceable sanc-
tions, has no legal status and has no public
advertisement appear, such as that for the
accountability. Indeed many assume that the
False Claims
cardiac drug amiodarone, which claimed
primary role of the committee is to shield the
that the drug was essentially devoid of side
industry from the public scrutiny of the law
Safety of Medicines and articles in the British
dominates the prescribing habits of doctors
Furthermore, until recently the committee
Medical Journal and Lancet were all advising
and so essentially determines the medicines
that the drug's side effects were such that it
that patients receive. The main target for
should be given only with special care and
probably best by a specialist? How could an
who each month receives kilos of unsolicited
attention by outside agencies. It therefore
advertisement for the antibiotic keflex be
had no capacity to prevent misleading adver-
published which falsely implied that the drug
fronted by pages of advertising in medical
tisements appearing in the first instance.
journals. An obvious aim of such promotion
Accordingly, in general, by the time it has
is to persuade the doctor to prescribe the
In most instances, but not all, some indica-
deliberated (which takes several months) the
tion of the misleading nature of such claims
company's campaign will have achieved its
can be obtained by scrutinising the warnings,
ends, and possibly patients will have suf-
of the market (this year the NHS will spend
precautions and side effects printed at the
fered. Furthermore, breaches of the law will
about £1.5 billion on prescribed medicines),
bottom of the advertisement. Unfortunately
escape prosecution, doctors are unlikely to
promotion also strives to increase the size of
however, the printing of such information is
learn of the nature of the false claim, and
patients will certainly have no chance of
in which there is a greater reliance of society
unquestioned. In a study of the advertise-
on medicines for normal life (half of the
ment for xanax, six out of 18 doctors were
It is difficult to see how ministers can justify
healthy adults in the UK take some sort of
unable to read the small print unaided, and
either their continued abrogation of respon-
sibility to a body that has manifestly failed to
would not have persevered in other circumst-
adequately control advertising. Where leg-
£ 180m each year, an amount only just short
ances, only continuing as they did for the
islation exists perhaps the situation will be
of its annual expenditure on research. Pre-
sake of the investigation. There is no legal
improved once the Department successfully
sumably in an attempt to counter possible
definition of 'legibility' and one assumes that
abuse by the industry with consequent dan-
in a court of law it would be dependent upon
its senior member(s) for publishing a mislead-
gers to patients, legislation was introduced
whether it could be read by the judge. His
to control advertising. Unfortunately how-
findings might be rather different from that
How to Use an Article about Harm Mitchell Levine, Stephen Walter, Hui Lee, Ted Haines, Anne Holbrook, Virginia Moyer, for the Evidence Based Medicine Working Based on the Users' Guides to Evidence-based Medicine and reproduced with permission from JAMA. (1994;271(20):1615-1619). Copyright 1995, American Medical Association. • I. Are the results of the study valid • III.What are t
GUARDIAN Faithful till the End By TibbieB Chapter Seven By the time they reached the house, the pain shot had kicked in, leaving Hutch drowsy and relaxed—so much so, he couldn’t stand on his own two feet and walk from the car to the house. After three failed efforts, Starsky decided he’d just have to carry him. Sam sat patiently in the back seat of the car, watching