APPENDIX 32
Memorandum by Dr Julian Colledge (PI 113)
INTRODUCTION
I graduated in Medicine from Bristol University
in 1972 and have gained post-graduate qualifications in psychiatry,
general practice and obstetrics and gynaecology. During the past
25 years as a General Practitioner I have always had an interest
in cost-effective prescribing. For eight years I was a manager
of an out-of-hours co-operative for 300 doctors and was responsible
for managing the medicines and dealing with the complaints.
HEALTH NEEDS
AND NHS SPENDING
1. The priorities of NHS spending are distorted
by overwhelming demands for medication. We are using too many
drugs and too many expensive medicines with little certainty that
they are benefiting our patients.
2. Massive financial savings could be made
by cost-effective prescribing using a "Core National Formulary."
3. There is no doubt that the pharmaceutical
industry has produced some drugs which have been of immense benefit
to humanity over the past 50 years. However, also it would be
reasonable to say that many drugs have not been of benefit and
definitely some have been harmful. Iatrogenic illness is a significant
cause of morbidity and mortality.
4. Of the thousands of drugs available on
the NHS very few save lives.
5. Pharmaceutical companies generate needs
and markets.
A GP'S PERSPECTIVE
The role of the doctor should primarily be one
of health education to prevent illness, support, and encouragement
of self reliance in the management of disease. All of us should
remember that the title of doctor is derived from the latin docere—to
teach, and that one of the basic tenets of the Hippocratic Oath
is—"first do no harm". Unfortunately the provision
of prescriptions has become institutionalised in modern health
care—"the quick fix."
Working at the coal face, I have seen so far,
more than a quarter-of-a-million patients and yet only saved a
few lives. Prompt administration of penicillin to patients with
meningitis, and other inexpensive antibiotics to patients with
overwhelming infections and early referral for surgery of patients
who had life-threatening surgical conditions have been the main
factors in saving lives in general practice. Of course, good management
of chronic conditions, such as hypertension, does have an impact
on morbidity and mortality, however again medication used does
not have to be vastly expensive.
From the Black Report and other research you
will know that poverty and ill-health are closely linked. Clean
water, sanitation, employment, reduction of poverty, vaccination
programmes, avoidance of environmental pollution are all major
factors in the improved health of the nation. To promote individual
versus state responsibility for health and endeavouring to prioritize
and achieve the right balance of spending is immensely difficult.
The pharmaceutical industry is basically driven
by the profit motive. 47% of my patients are on some form of repeat
medication and 14% of my patients are on four or more repeat medicines.
My Practice is fairly average for rates of prescribing. These
statistics seem shocking and one has to question the health benefits
(and financial implications) of such a large proportion of the
population taking regular medication. My practice prescribing
costs are 16% below the local average and 17% below the national
average. The practice is meeting all the requirements of the new
GMS Contract and is achieving the maximum number of points. The
Practice makes less than average referrals to secondary care.
Data confirming these figures is available upon request.
MISTAKES OF
THE PAST—HARMING
OR KILLING
PATIENTS WITH
DRUGS
As a junior doctor in the 1970's working for
a cardiologist I prescribed Practolol, a beta-blocker that was
subsequently withdrawn as it caused retro-peritoneal fibrosis
and death. Also, I also prescribed Clofibrate to lower cholesterol,
which subsequently was withdrawn because it caused an increased
rate of bowel cancer. In November 2004 Vioxx (Rofecoxib) used
in arthritis was withdrawn from the market as it caused a significant
increased rate of deaths from heart problems. For many years,
I was convinced by the research data, general medical opinion
and the information from pharmaceutical companies that HRT was
good for my menopausal female patients. In the early 90's many
GPs had "Well Woman Clinics" and a very high proportion
of menopausal women were put on HRT in the belief that it reduced
their risk of heart disease and osteoporosis. These beliefs were
supported by some very large trials from the USA. At the time,
some of the media encouraged patients to think that HRT was the
path to eternal youth. In an editorial article in the British
Medical Journal about 18-months ago the conclusion was "That
HRT is good for symptoms but bad for health".
Initiatives such as NICE, working on evidence
based medicine should reduce future risks. But serious mistakes
continue to be made. Why does this still happen?
DRUG INNOVATION
From the general practice perspective over the
past 30 years, the following categories of drugs have been major
advances and made very positive impacts on health care:
— PPI's (proton pump inhibitors) have
dramatically reduced the mortality and morbidity from peptic ulceration.
— The low dose combined oral contraceptive
Pill is effective, safe and inexpensive.
— Beta-blockers, statins and ACE-inhibitors
and diuretics have all made major contributions in the care of
hypertension and cardiovascular disease.
— SSRI anti-depressants are safe in
overdose and have been a major advance in the treatment of depression.
— Many anticancer drugs have been enormously
beneficial to humanity.
Within these categories there are now many off
patent generic medicines which are inexpensive and very cost-effective.
However, there are many expensive "me-too" drugs which
have no real benefit over the ground breaking original drugs.
All too often misleading research and advertising are used to
boost drug company profits. Eso. and des. molecular variations
of former drugs are blatantly misleading and a method of profiteering.
NICE and regulatory bodies should contribute
towards identifying needs and approving research at a national
and international level.
Hopefully the mapping of the human genome and
other advances in human biology will inspire and enrich future
unbiased research and then pharmaceutical innovation.
THE CONDUCT
OF MEDICAL
RESEARCH
Nowadays a very large amount of research is
sponsored by drug companies and clearly is biased. Important negative
findings are often withheld. These should be published, for example
the manner in which the data was presented with regard to Cox-2
inhibitors. The British Medical Journal has expressed concerns
about this over a period of several years (Abbasi K. Editors Choice.
BMJ 204:329.27.11.04). Similar problems have arisen with the conduct
of research and marketing of a group of drugs called A2-blockers,
used in heart disease and hypertension (Verma S and Strauss M.
Angiotensin Receptor Blockers and Myocardial Infarction, BMJ 329.27.11.04
Page 1248-1249). This article illustrates how confusing the research
is relating to these particular drugs and how they may be positively
harmful to patients. Currently the NHS spends vast sums of money
on these drugs on an evidence base which is very shaky and will
probably result in litigation. Twenty-five years ago the Medical
Research Council undertook a large amount of pure research, the
funds for the MRC were whittled down. Surely the NHS and universities
should be undertaking non-sponsored pure research.
THE PROVISION
OF DRUG
INFORMATION AND
PROMOTION
"There is no such thing as a free lunch".
Advertising works. With the best will in the world, accepting
educational grants, sponsorship or hospitality will inevitably
compromise the prescribing of individual doctors. My own opinions
have been inappropriately swayed by pharmaceutical representatives
and promotional information.
Safe, unbiased and useful sources of information
include medical journals such as the British Medical Journal,
Drugs and Therapeutics Bulletin and Current Problems published
by the Committee of Safety of Medicines, The Department of Health
bulletins and other independent medical journals and locally produced
prescribing information. Many websites, such as the British Hypertension
Society, produce balanced and well-considered information about
prescribing with appropriate evidence based links.
REGULATORY REVIEW
OF DRUG
SAFETY AND
EFFICACY
The controversy surrounding many drugs, for
example HRT (hormone replacement therapy), Cox-2 inhibitors (anti-inflammatory
drugs for arthritis) and angiotensin receptor blockers (for raised
blood pressure, heart disease and prevention of renal disease
in diabetics), illustrates the immense difficulties for any regulatory
authorities. The research is often very controversial and contradictory.
Vested interest and immense profits hinder truth.
With respect to the most recent controversy, to quote David Graham,
the United States Food and Drug Administration Associate Director,
"The dangers of Rofecoxib were apparent eight years ago and
not acted upon, the harms suppressed. What has now unfolded may
be the most serious example of regulatory failings about drug
related harm since the thalidomide scandal". Please see
Advisory Briefing of the Food and Drug Administration, NDA, 20-757(S-021),
www.fda.gov.
PRODUCT EVALUATION,
VALUE FOR
MONEY
Please see a GP's perspective above and attached
document entitled "Cost Effective Prescribing—Saving
Millions for the NHS".
CONCLUSION
— Enormous financial savings to the
NHS could be made by adopting an evidence based "Core National
Formulary" without compromising safety or efficacy.
— The positive and negative influences
of the pharmaceutical industry should be recognised and constantly
scrutinised.
— Pure academic research must be encouraged
and adequately funded from unbiased sources.
— Negative research findings should
be published.
— Health promotion and encouragement
of personal responsibility for health must be encouraged.
— Please see separate document entitled
"Cost Effective Prescribing—Saving Millions for the
NHS." for specific details of how to achieve significant
financial savings.
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