223. We were told that advertising to prescribers is conducted
on a huge scale; it is targeted and orchestrated to increase prescription
of particular drugs in particular groups. According to Dr Herxheimer,
the influence of the industry:
by the huge volume of pharmaceutical promotion,
direct and indirect
and intense public relations activity.
Competition in the industry is based far more on innovative
marketing methods and public relations than on the effectiveness
and safety of its products.
224. The main concerns are not so much to do with the accuracy
of individual advertisements but with the scale of medicines advertising,
as Dr Herxheimer indicated, and the process and duration of the
complaints procedure, which was frequently referred to during
225. Which? cited the following case to illustrate
the inadequacy of the current pre-vetting and complaints system
for prescription-only medicines advertising:
In April 2002, Schering Health Care (Schering) launched
Yasmin in the UK, claiming, in an advertisement to healthcare
professionals, that the medicine was "the pill for well-being"
and that "Yasmin is different in many ways. It has been
shown repeatedly to have no associated weight gain. In addition,
Yasmin has a demonstrable effect on PM (pre-menstrual) symptoms
and on skin condition
Women feel well on Yasmin. Make a
difference to their lives and prescribe Yasmin."
DTB published a review
of Yasmin in August 2002, which concluded that "we believe
that the claim that Yasmin 'is the pill for well-being' is unjustified
and misleading and should be withdrawn." In response, Schering
threatened (on September 9 2002) to sue DTB for defamation.
Prompted by DTB's article, the PMCPA began
an investigation into the promotion of Yasmin and concluded (on
September 18 2002) that Schering had breached the Authority's
Code of Practice on several counts. As a result, the company withdrew
its threat to sue DTB. The PMCPA later confirmed its initial
findings (after rejecting an appeal by Schering), in concluding
(on 22 November 2002) that the company had breached the PMCPA's
Code of Practice on 11 separate counts.
The Yasmin advertisement had originally been vetted
by the MCA (now the MHRA) in late Spring 2002. The MCA told Schering
(in a letter dated 13 June 2002) that its promotional claims for
Yasmin were acceptable. The findings of DTB (subsequently
echoed in the PMCPA investigation) suggest a serious failure in
the MCA's original vetting of the advertisement.
Although the PMCPA first ruled against the Yasmin
advertisement in September 2002, the delayed action by the MCA
allowed the company to continue the misleading promotion unchecked
for around two months after DTB first highlighted the misleading
advertisement (and in total, for around six months from the product's
226. The MCA did not know that the PMCPA was investigating
DTB's concerns until alerted by DTB itself, indicating
a lack of coordination or communication between the two. Following
DTB's article in August 2002, the MCA undertook a second
assessment of Schering's claims for Yasmin, the results of which
were released in a letter to DTB on 6 December 2002. This
time, the MCA found Schering's claims unacceptable and asked the
company to withdraw the advertising and to publish a corrective
statement in the journals that had carried the original advertisement.
The correction appeared in February 2003, which was around 10
months after the launch of Yasmin.
227. The ABPI stated that, "like the House of
Commons, the pharmaceutical industry works well within self-regulation,"
but the examples cited to us of breaches of advertising regulations,
cover-up of negative medicines information and provision of misleading
information to prescribers suggest that self-regulation is not
228. The delay in investigation and issue of corrective
statements, which are not always mandatory, is clearly unacceptable.
Where such statements are issued, their effect on the original
impact of the campaign is usually limited. Patients may be already
taking the new medicine and are therefore unlikely to be switched
back to their original treatment. Mr Mike Paling, the director
of a large advertising company, stated:
I would have thought they would be able to adjudicate
much more quickly than that. As I said, there is not a vast amount
of complaints so there are not a thousand complaints sitting waiting.
I think if there is a complaint, particularly if it is going
to be upheld, it should be adjudicated and sorted out very quickly.
229. Small alterations to advertising slogans may
also be requested - from, for example "Protection for hearts"
to "Help protect your heart". This case, involving Zocor
Heart-Pro, was one on which the MHRA took a "very serious
do not consider this a very serious sanction.
230. Promotional activity takes place on a huge scale.
Nevertheless, it is impossible to solely blame the industry because
some doctors do not take enough care when prescribing. Although
doctors are taught clinical pharmacology at medical school, the
quality of teaching on evaluation of clinical trial data and drug
marketing techniques seems to be highly variable and prescribers
often lack the time or skills to distinguish between weak and
strong clinical studies and to evaluate critically the claims
made. The 'How to use a drug' lectures that form part of the Clinical
Pharmacology course at UCL Medical School include essential information
about the processes needed to evaluate data on new medicines fairly
and effectively. Areas covered include the power of the trial
and size of treatment effect as well as factors such as conflicts
of interest, the use of 'rentaquote' doctors and how new treatments
are reported in the lay press.
However, it would not be safe to assume that all doctors receive
231. The volume of information received by prescribers
and the accuracy (data interpretation, completeness, comparison
with existing treatments) of the information provided were questioned
by many witnesses..
However, some doctors' failure to recognise that promotional techniques
used by the pharmaceutical industry have any effect on their decision-making
suggests a dangerous complacency that needs to be addressed. The
enormous variation in prescribing of some medicines illustrates
232. The aggressive
promotion of medicines shortly after launch, the sheer volume
of information that is received in its many forms by prescribers
and the "promotional hospitality masquerading as education",
in the absence of effective countervailing forces, all contribute
to the inappropriate prescription of medicines.
in conjunction with suppression of negative trial results, is
harmful. If prescribers do not have access to fair and accurate
accounts of clinical trials they cannot be expected to make informed
prescribing decisions. Guidelines on the subject of authorship
and the role of professional medical writers (quoted in Paragraph
199) must be followed.
234. At the
same time, the blame for inadequate or misinformed prescribing
decisions does not only lie with the pharmaceutical industry,
but with doctors and other prescribers who do not keep abreast
of medicines information and are sometimes too willing to accept
hospitality from the industry and act uncritically on the information
supplied by the drug companies.