1 Introduction
"After careful consideration of the evidence
laid before them your Committee find:
(1) That there is a large and increasing sale in
this country of patent and proprietary remedies and appliances
and of medicated wines.
(2) That these remedies are of a widely differing
characters, comprising (a) genuine scientific preparations; (b)
unobjectionable remedies for simple ailments; and (c) many secret
remedies making grossly exaggerated claims of efficacy…
(3) That this last-mentioned class (c) of remedies
contains none which spring from therapeutical or medical knowledge,
but that they are put upon the market by ignorant persons, and
in many cases by cunning swindlers who exploit for their own profit
the apparently invincible credulity of the public.
(4) That this constitutes a grave and widespread
public evil…"[2]
Select Committee Report on Patent Medicines, 1914
1. The consumption of medicinal drugs[3]
is vast and is increasing. Purchase of medicines currently accounts
for about 12% of the NHS budget. 650 million prescription items
were dispensed in England in 2003, an average of 13.1 prescription
items per head of population. This represents a 40% increase over
the previous decade. The cost[4]
of prescriptions dispensed in England has risen remorselessly
with year-on-year increases well above inflation. In 1993 the
cost was £3.1 billion. In 2003 it was £ 7.5 billion,
an increase of 9.7 per cent or 6.4 per cent in real terms on 2002.[5]
In addition, £1.8 billion was spent on over-the-counter medicines.[6]
2. The drugs are produced by a very large and successful
industry. It employs 83,000 people directly and many more indirectly,
and makes a huge contribution to the balance of trade each year.
Overall, the industry represents the country's third most profitable
economic activity, after tourism and finance. It is of great importance
to the UK economy.
3. Drugs have produced many benefits. They have an
important, sometimes vital, role to play both in saving lives
and improving the quality of life. No one should take these benefits
for granted: at some time or other, most people need drugs and
are grateful for them. Our recent report on venous thromboembolism
underlines this Committee's recognition of the need for appropriate
pharmacological interventions.
4. However, the increasing consumption of drugs has
also brought disadvantages. Two stand out. One is a syndrome which
has been described as 'medicalisation', that is an unhealthy
reliance on, and over-use of, medicines - the view that there
is a pill for every ill. There is a strong and growing tendency
to believe that life's problems are best dealt with as medical
conditions. Diagnostic labels are readily applied and drug intervention
follows. People hope for health solutions, and come to rely on
the inspiration of 'get well' messages from commercial and professional
sources rather than focus on sometimes grim realities. Medicalisation
could lead to unsustainable demand on the NHS, a confused vision
of how good health is maintained and a failure to ensure preventative
public health measures are at the forefront of health policy.
5. The second disadvantage arises from the first.
Excessive use of medicines leads to increased exposure to the
risk of drug-induced illness and harm. No figures for the economic
burden of drug-induced illness yet exist, but it is feared that
it could amount to several billions of pounds per year. The adverse
drug reactions, which account for some 3% to 5% of all hospital
admissions in the UK, cost in the order of £500 million per
year. No estimates have yet been made of the presumably greater
cost of adverse drug reactions which do not lead to hospital treatment
at all, nor of those experienced by perhaps 15% of all hospitalised
patients.
6. These problems are not caused by the pharmaceutical
industry, but do reflect its influence. People have been taking
ineffective and harmful medicines for centuries. However, there
is reason to fear that the industry has positively nurtured anxieties
about ill-health. The fundamental problem, it is alleged, is that
the industry is increasingly dominated by pressure from its investors
and the influence of its marketing force and advertising agencies
rather than its scientists. The industry is hugely influential,
affecting every aspect of the medical world, including prescribers,
patients, academics, the media, and even the institutions designed
to regulate it. Its influence in Parliament is extensive. The
Annex lists the All-Party Groups the pharmaceutical industry supports.
It is claimed that pharmaceutical companies encourage us to see
ourselves as 'abnormal' and thereby requiring (drug) treatment.
They have a powerful incentive to do so. The more people who see
themselves as suffering from a medical condition, the larger the
market and the greater the profits.
7. The timing of this Inquiry coincided with an investigation
by the medicines regulator into the safety of the newer 'SSRI'
antidepressant drugs, and we refer to these drugs to illustrate
some concerns. Depression can be a severely disabling and life-threatening
condition, when urgent treatment is needed, but only about 5%
of all prescriptions are written for 'severe' depression, and
about two-thirds are for forms of depression classified as 'mild'[7]-
i.e. mainly for people who are unhappy and distressed by difficult
situations and circumstances. Although it is often suggested that
antidepressant drugs will help these people, there is no good
evidence that they will. Most people prescribed SSRIs in such
circumstances can expect modest benefits, but are exposed to substantial
risks of harm.
8. Government has a dilemma: it has to balance the
need to promote the competitiveness of this industry with the
need to address health concerns and to promote the effectiveness
of the NHS. The Department of Health has constantly to balance
trade imperatives and health priorities. This is a hard task.
Sometimes, it means serving two masters at the same time.
9. In view of these concerns, in June 2004 we announced
our decision to undertake an inquiry. Our terms of reference were
as follows:
The Health Committee is to undertake an inquiry
into the influence of the pharmaceutical industry on health policies,
health outcomes and future health priorities and needs. The inquiry
will focus, in particular, on the impact of the industry on:
- drug innovation
- the conduct of medical research
- the provision of drug information and promotion
- professional and patient education
- regulatory review of drug safety and efficacy
- product evaluation, including assessments
of value for money
In doing so, the Committee will examine the influence
of the pharmaceutical industry on the NHS; National Institute
for Clinical Excellence (NICE); regulatory authorities and advisory
and consultative bodies; prescribers, suppliers and providers
of medicines; professional, academic and educational institutions;
the (professional and lay) press and other media; and patients,
consumers, the general public and representative bodies.
10. The pharmaceutical industry includes companies
which differ hugely in size, work in many different spheres, and
do quite different things. There are giant international companies
and medium, small and modest enterprises. The people who work
for them may be engaged in research, academic medicine, clinical
practice, production and quality control, public relations (PR),
administration, law and more. Our main focus was on the companies
that lead the industry, and on the driving forces behind them.
11. This was a major inquiry, but we acknowledge
that we have not touched on every detail of what is an enormous
subject. The written and oral evidence presented, however, allowed
us to gain a strategic sense of the influence of the pharmaceutical
industry and of the implications of its significance and impact.
12. We have taken oral evidence on nine occasions.
We have heard from Ministers and officials from the Department
of Health and the Department of Trade and Industry; health professionals
and academics; the pharmaceutical industry; journalists; PR companies;
patient organisations; medical charities; Phil Woolas MP and Paul
Flynn MP[8]; NICE and the
MHRA. We received well over 100 written memoranda. We would like
to thank all who provided us with oral and written evidence.[9]
13. During the inquiry we made several visits. In
Australia, in September, we had the opportunity to observe the
operation of a different medicines regulatory system than exists
in the UK. We were able to explore the benefits of their National
Drugs Policy and also heard evidence regarding the regulatory
mechanisms in New Zealand.[10]
We received invaluable information from many experts. We much
appreciated our visits to GlaxoSmithKline (GSK) and AstraZeneca,
where we were able to inspect modern manufacturing plants. In
December, we went to Brussels and met representatives from the
Enterprise Directorate-General (DG), the Directorate sponsoring
the pharmaceutical industry, who explained the role of the EU
in drug regulation and sponsorship. Unfortunately, no representative
from DG Sanco (responsible for health) could be present. We were
also fortunate in being able to visit Pfizer at its impressive
facilities in Sandwich. Finally, we went to the Use of Medicines
Committee at University College Hospital, where we received a
very useful briefing on how mechanisms can be put in place to
ensure effective prescribing. We much appreciated the time that
all the people we met on these visits gave us.
14. We are also very grateful for the expert guidance
we received from our specialist advisers. They were: Professor
John Abraham, Department of Sociology, University of Sussex; Professor
Joe Collier of St George's Medical School; Professor Gerard Hastings,
University of Stirling; Charles Medawar, Executive Director of
Social Audit Ltd; and Dr Harriet Scorer, an independent consultant
to the pharmaceutical industry.
15. The report is organised as follows. The next
five chapters provide brief descriptions of the industry and the
difficulties it faces, the process of developing and licensing
a drug, the arrangements for controlling the industry and the
control of access to medicines. Chapter 7 examines what level
of influence the industry should have. Chapter 8 looks at the
evidence we received about the industry's influence on key groups.
Finally, we present our main conclusions and recommendations in
Chapter 9.
16. This is the first major study of the pharmaceutical
industry by a Select Committee since the Select Committee on Patent
Medicines reported on 4th August 1914. We trust that
it will not be another century before the next.[11]
2 Report from the Select Committee on Patent Medicines,
Session 1914, HC 414. Back
3
The terms 'medicine' and 'drug' are used interchangeably throughout
the report. Back
4
Net ingredient cost Back
5
Prescriptions dispensed in the community. Statistics for 1993-2003:
England. http://www.publications.doh.gov.uk/prescriptionstatistics/index.htm Back
6
Figures provided by PAGB Back
7
Martinez C, Rietbrock S, Wise L et al. BMJ 2005;330:389,
doi:10.1136/bmj.330.7488.389. See http://bmj.bmjjournals.com/cgi/content/full/330/7488/389
Back
8
Phil Woolas MP appeared as a trustee of the Beat the Benzos campaign.
Paul Flynn MP has a long-standing interest in the activities of
the pharmaceutical industry and submitted a memorandum detailing
particular concerns. Back
9
Some of the written evidence is published in Volume 2 of the Report.
Volume 2 also contains a list of unprinted written evidence which
has been reported to the House but, to save printing costs, has
not been printed. Copies will be placed in the House of Commons
Library, where they may be inspected by Members. Other copies
are in the Record Office, House of Lords, and are available to
the public for inspection. Back
10
We received valuable written and oral evidence from Prof Les Toop
and Dr Dee Richards from the University of Otago in Christchurch,
New Zealand. We are very grateful to them for travelling to Melbourne
to meet with us. Back
11
Report from the Select Committee on Patent Medicines, Session
1914, HC 414. Back
| 
