THE PROMOTION OF DRUGS
76. Worldwide, there has been a marked trend to substantially
increased expenditure on marketing. In the US, major pharmaceutical
companies spend of the order of 24% to 33% of sales on marketing,
about twice as much as on R&D.[55]
Exact comparisons are complicated because of uncertainties about
the dividing line/overlap between marketing and related activities,
notably provision of drug information and professional education
programmes. We have not been presented with UK figures, but direct
promotional expenditure in this country is proportionately lower
than in most European countries, reflecting the dominance of the
NHS as the major drug purchaser and the terms of the Pharmaceutical
Price Regulation Scheme (PPRS, see Paragraph 113)
77. Prescription-only medicines may be promoted only
to healthcare professionals, except in very specific cases such
as Government-endorsed vaccination programmes. Promotion to prescribers
may take many forms:
a) Drug company representatives. Approximately.
8,000 drug company representatives operate in the UK and play
an important role in information provision and medicines promotion.
Many doctors cite them as one of the main sources of information
on the use of new drugs.[56]
b) Sponsored attendance at industry-organised
events or medical conferences. Travel and accommodation costs
are often met by the company. Other forms of hospitality are also
provided.
c) Journal articles and supplements supporting
use of the company's drug. These are distributed free to prescribers
and are available at conferences and on the Internet.
d) Direct advertising. Advertisements
are placed in medical journals and magazines. Direct mailing to
healthcare professionals often takes the form of informing prescribers
of changes in drug delivery systems or the availability of new
drug formulations. Approximately 80% of medicines advertising
is aimed at doctors, with an increasing amount targeting nurses
with new prescribing powers.[57]
78. Public relations and marketing agencies are often
used by the pharmaceutical industry to assist with the promotional
activities described above. 'Medical communications' play an important
role in the marketing of medicines. The main aim is to improve
sales figures and there are dedicated agencies that often form
part of enormous, multinational PR and communications companies,
such as Ogilvy, Burson-Marsteller, Edelman and Ketchum. Medical
communications agencies may be involved in all or some of the
following:
a) Pre-marketing of drugs;
b) Identification of disease areas;
c) Disease awareness campaigns;
d) Consumer education and marketing;
e) Publications and papers;
f) Conferences, meetings and hospitality;
g) 'Product lifecycle management';
h) Regulatory and policy issues;
i) Grassroots communications;
j) Key opinion leader development; and
k) The production of 'educational' materials
aimed at prescribers.
79. A critical element of the work of medical communications
companies is the recruitment and training of key opinion leaders
(KOLs), who are usually 'authoritative third parties' such as
physicians at the top of their field. These individuals may be
paid to speak and write on behalf of the sponsoring pharmaceutical
company. They attend medical conferences, for example, and may
present research papers, take part in panel debates or field questions
in oral sessions. The 'development' of KOLs, we were told, is
a well-worked process involving all types of doctors (hospital
consultants, clinical academics and GPs).
80. A major part of the work of medical communications
agencies involves liaison with the lay media and a significant
proportion of their activities may be directed towards building
relationships with journalists.
81. In addition to building relationships between
KOLs and journalists, medical communications agencies commonly
have links with patient organisations. Such groups provide information
to their members and the general public and often campaign for
increased access to a particular medicine or procedure. Many are
powerful lobbying groups, working both through the lay media and
in specialist settings. As such, their interests may coincide
to some degree with those of the pharmaceutical industry, and
the communications company may be used as a mediator in the relationship
between the two.
82. PR companies and communications agencies have
expanded their work in recent years. They are increasingly involved
with research and the design of clinical trials. A well-documented
trend is for large medical communications groups to buy into the
infrastructure of drug testing by taking over CROs that conduct
clinical trials and generate evidence for licensing approval.
83. Increasingly creative methods are used in the
promotion of drugs by Industry. Which? cited a financial donation
made by the manufacturers of Cipralex (escitalopram, an antidepressant
manufactured by Eli Lilly) to Depression Alliance when GPs completed
and returned a feedback leaflet relating to their drug[58]
and a spoof Mr Man book ('Mr Sneeze') that was sponsored by a
drug company and carried information about its anti-allergy product.[59]
84. The direct advertising of prescription drugs
to patients is prohibited. Direct-to-consumer advertising (DTCA)
of prescription-only medicines is permitted only in the US and
New Zealand. Moves towards extending DTCA to Europe proposed by
the European Commission were quashed by the European Parliament
in October 2002 by a majority of 494 to 42. Only over-the-counter
(OTC) medicines may be advertised to the UK general public. The
Medicines (Advertising) Regulations 1994, amended in 1999, govern
the advertising of these medicines. There are specific regulations
relating to promotional methods that could lead to the unnecessary
or excessive use of medicines.
85. Complaints regarding advertising material are
handled by a variety of bodies. The Proprietary Association of
Great Britain (for OTC medicines), the Prescription Medicines
Code of Practice Authority (PMCPA, for prescription-only drugs)
and the Advertising Standards Authority operate as self-regulatory
schemes and take responsibility for handling advertising complaints
alongside the MHRA. Corrective statements are rarely mandatory,
although a recent increase in the number of such statements required
by the MHRA has been observed.
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