Examination of Witnesses (Questions 960
- 979)
THURSDAY 3 FEBRUARY 2005
LORD WARNER,
DR FELICITY
HARVEY AND
DR JUNE
RAINE
Q960 Dr Naysmith: I do not want to
give that impression.
Lord Warner: No, no, but it is
important. It is just worth bearing in mind that the national
average for generic prescribing is round about 78%. That figure
itself is a telling figure in my view, compared with many other
countries, which does suggest that the GPs do take a great deal
of notice of some of these other sources of information. It is
also worth bearing in mind my second statistic. The Audit Commission
did a study a couple of years ago and they estimated that wasteful
prescribing was round about 2% of prescription expenditure in
2003 and that compared with a 1994 estimate of 14%. So the Audit
Commission, which again is pretty independent, were saying that
wasteful prescribing had dropped significantly in 10 years. I
would not want to claim that there is no GP in this country who
may not be unreasonably influenced by some of the literature,
but I think there are quite a lot of powerful checks and balances
in that, and there is also a good deal of self-regulation and
control over the way the pharmaceutical industry itself can produce
its own literature. I do not know whether Dr Raine would like
to give a couple of examples.
Q961 Dr Naysmith: Just before that,
minister, might I ask you whether you think the majority of drug
adverts encourage the rational use of medicines by presenting
information objectively and without exaggerating the properties
of the advertised product, which is what it is supposed to be?
Do you think that is true?
Lord Warner: We would be catching
a very large number of people out if it were true. I would say
that the number of examples where we have had concerns is relatively
small and that is why I was going to get Dr Raine to talk about
the systems we have for checking that kind of behaviour.
Dr Raine: Certainly the self-regulatory
system is one which has stood the test of time, but the MHRA is
ready to back up with investigation and enforcement, any complaint,
any problem advert which is discovered on scrutiny and also increasingly
by pre-vetting advertising before it is issued. In the light of
ongoing vigilance in the area, we have overhauled our systems
in the last couple of years to focus on pre-vetting precisely
because of the concerns that the Committee has expressed, that
preventing misleading adverts going out is actually where we ought
to be, rather than catching them once they have gone. I am pleased
to say that the number of pre-vetted adverts has been steadily
increasing since we did that.
Q962 Dr Naysmith: We have had evidence
that it sometimes takes a long time after a component is made
for it to be withdrawn. Are you saying that is now a thing of
the past and will not happen any more?
Dr Raine: I can say that with
confidence. We now have very tight time targets in place, with
the team which operates here to act in response to complaints,
to have misleading advertising withdrawn.
Q963 Dr Naysmith: In the very complex
negotiations that go on for determining the price, there is an
allowance for promotion, is there not, in the formula which enables
companies to benefit? That is so, is it not?
Lord Warner: Within the PPRS system?
Q964 Dr Naysmith: Yes.
Lord Warner: Yes, that is correct.
Q965 Dr Naysmith: Do you ever use
that as any kind of mechanism for saying someone has a bad record?
Can that be done? Can individual companies be treated in that
way? You are saying there is no bad record any more, but just
if there were?
Lord Warner: No, I am not saying
there are no errors, no bad behaviour at all. Not everybody is
a saint in this particular area, if I may put it that way. What
I think I am saying and I think Dr Raine was saying is that we
have certainly tightened up the system for dealing with complaints,
so they are dealt with more speedily. I think the Committee wanted
to have, and we shall make it available to you, the data on the
MHRA staff who are dealing with this particular area. We brought
copies along and I will not go through what is in that, we will
give that to you. It sets out which particular staff, what their
qualifications and experience are, and I think that will be helpful
to the Committee to have that. We have focused much more on pre-vetting
as Dr Raine was saying. No human system is perfect in all respects,
but it is a stronger version of what was there before and we do
think we are hitting the nail on the head much more than may have
been the case in the past. I certainly do not want to give the
impression that we are complacent about this and it is an area
which does require continuing vigilance.
Q966 Dr Naysmith: That would deal
with the quality aspect, what is said in adverts. What about the
quantity, which I was raising at the beginning in terms of the
amount of material that comes from the producers of drugs versus
the very small amount of information that comes from you, I suspect?
Lord Warner: I am just going to
ask Dr Harvey to say something about the way this gets taken account
of in the PPRS system which I think is where we left that.
Q967 Dr Naysmith: That would be one
mechanism of dealing with it, if someone transgressed.
Lord Warner: Yes.
Dr Harvey: In fact within the
new PPRS scheme which came into force on 1 January of this year,
the 2005 agreement, the sales promotion allowance of the 1990s
scheme is now the marketing allowance and that does limit the
amount of advertising literature etcetera the NHS pays for in
the price of medicines; there is also an information allowance
in a similar manner to the information allowance within the 1999
scheme. It is fair to say that in terms of the marketing and information
allowances within the 2005 PPRS scheme, there is a reduction in
the allowed expenditure on the promotion side and more of an increase
in terms of the allowances around the actual information itself,
although the overall allowance, if you take it all together, is
the same as it was in the 1999 scheme.
Q968 Dr Naysmith: How do you measure
the amount of promotion that goes on, or is it just assumed this
is a kind of chunk that everybody takes, a box is taken, you have
promoted therefore you get the allowance.
Dr Harvey: In terms of the PPRS
itself, the PPRS, as you probably know, works in terms of annual
financial returns which companies send to the department on a
confidential basis which include their expenditure on promotion.
The Department also receives information on how they are making
what is now a 7% reduction in prices across their portfolio of
branded medicine to the NHS. Those are looked at, those are audited,
but they are looked at on an annual basis as part of the return.
Q969 Dr Naysmith: On an individual
company basis?
Dr Harvey: On an individual company
basis.
Q970 John Austin: May I move on to
the issue of the medicalisation of society, the society in which
there is a pill for every purpose and a capsule for every condition?
Earlier on the Chairman used the phrase disease-mongering. In
evidence earlier in the inquiry, we had a suggestion from the
organisation No Free Lunch that disease awareness campaigns were
undermining our collective sense of well-being so that we were
all instinctively reaching for the medicine chest. In their evidence,
the Royal College of General Practitioners referred to the invention
or creation of diseases, the categorisation of normal behaviour
or conditions as abnormal requiring drug treatment. One of the
examples given was mild depression, conditions where drug therapies
may be either ineffective or inappropriate. We have had evidence
as well which quoted an article in the BMJ which said one of the
recent examples of the corporate sponsored creation of disease
involves an emergent condition called female sexual dysfunction
(FSD). Highly inflated and misleading statistics about the prevalence
of FSD are being promoted by some drug companies and misleading
information is being reported in many media stories. Do you have
any fears about this popularisation or creation of disease? What
are the implications, not only for drug consumption but implications
for public health?
Lord Warner: Gosh, is my reaction.
Certainly, if I may put it this way, as a citizen and a father,
I have some concerns that sometimes we do, as a society, wish
to put labels on things which are just part and parcel of the
human condition which can lead in the sorts of directions I suppose
that you are saying. Particularly in the area of depression we
did ask the National Institute for Clinical Excellence to look
into this particular area and their guideline on depression did
advise non-pharmacological treatment for mild depression. What
we are trying to do is strike some balance here as a society,
not ignoring the pain, discomfort, concerns which people have
about their health and, clearly, as employment changes, society
changes, disease conditions may themselves change. It would be
a surprising phenomenon if the disease conditions now were the
same as they were 200 years ago, because patterns of society have
changed a great deal and we just have to recognise that. A great
part of the government's White Paper Choosing Health is
about trying to encourage people to think more about some of the
lifestyle choices they make which may adversely affect their health.
There is not a lot of doubt that many of those lifestyle choices
are injurious to health. There is some pretty good evidence around
some of those which the Committee is well aware of. Exercise is
a good example where lifestyles have changed over time, where
taking exercise in the normal course of events is less common
now than perhaps it was 30 or 40 years ago. These are good examples
of where it does not need clever marketers to say that the social
forces have actually changed the way people live their lives,
sometimes with adverse consequences for their health. If you ask
me whether we have an answer, I do not think the Department of
Health has any more of an answer than anybody else about this
very broad phenomenon other than that we try to strike a balance
in many of the areas and I cited the NICE guidelines. I know doctors
try to strike a balance between the pharmacological response and
the non-pharmacological response.
Q971 John Austin: May I move on to
an area which perhaps might be appropriate, the area of raised
cholesterol levels and the possible long-term consequences of
that? There is a drug available called Simvastatin, which I understand
can be highly effective in advanced conditions, although—we
were talking earlier about risks and benefits—there are
certain potential side effects of the use of that medication,
but it is now being made available in much lower dosage off prescription,
over the counter and is being sold as a good preventative medicine
for people with raised cholesterol levels. However, as far as
I am aware, there has been no evidence, no research to show that
this drug, in its lower levels, is effective in any way in preventing
further coronary, arterial or heart disease. Is it really in the
public interest to permit drugs, which we know are effective in
certain conditions, to be sold over the counter in lower dosages
when there is no clinical evidence to suggest that they are effective
in any way?
Lord Warner: It might be helpful
if I just talked the Committee through what actually happened
in the case of that particular drug. Certainly, the safety profile
of Simvastatin has been established over a period of about 15
years and the medicine has been prescribed to millions of patients.
The safety profile of the very low dosage, the 10 milligram dosage,
was thoroughly reviewed, not has been but was, also before the
classification of the drug was changed; that was reviewed very
thoroughly by the Committee on Safety of Medicines and the pharmacy
protocol for supplying the product included multiple safeguards
to target its use appropriately to patients for maximum benefit
and minimum risks. We did not just decide one day to change the
basis for getting the 10 milligram version of Simvastatin; that
followed scrutiny by the Committee on Safety of Medicines. It
went through that kind of process before it was made available
over the counter.
Q972 John Austin: I think we will
need to look at the other evidence that has been given to us on
that.
Lord Warner: Certainly, if it
would help, we can give you more detailed chapter and verse about
the timings of the meetings, and the process that was gone through.
We should be very happy to do that.
Q973 John Austin: I was putting it
in the climate of the marketing machine which is suggesting to
us that there is a pill for every condition when, as you have
acknowledged, the public health agenda would suggest that there
may be much more effective ways essentially of looking after our
health.
Lord Warner: I certainly would
not want it to be interpreted, because we had a process for Simvastatin,
that I think there is a pill for every eventuality. I do think
that we do have a robust process before we move drugs to an over-the-counter
basis and in that particular case we can give you some reassurances
and we will send you the details.
Q974 John Austin: We should like
to see the published evidence because the information we were
given was that there was no published evidence.
Lord Warner: Yes; fine.
Q975 Dr Taylor: This is really just
a request for straight information which, if you do not have it
now, we should like later. It is really about drug-induced illness.
Do you have up-to-date figures for admission rates to hospital
for that, the costs of that, the death rates of drug-induced illness?
We are told that the figures are more readily available in some
other countries and I cannot really believe that; I am sure these
figures must be available.
Lord Warner: We can send you more
details, but there was certainly a study by the MHRA which looked
at admissions in hospitals in Merseyside in 2001-02 and it was
published in the BMJ in July 2004. It showed that 6.5% of admissions
related to an adverse drug reaction. The median bed stay was about
eight days, which accounted for about 4% of hospital bed capacity
and that, as I understand it, was broadly in line with the findings
in some overseas countries.
Q976 Dr Taylor: So 6.5% of admissions.
Any deaths? Any figures on deaths?
Lord Warner: I do not have that
information, but Dr Raine may be able to give you more.
Dr Raine: Certainly the study
did look at deaths and I think it was 0.15%. We shall give you
full details.
Q977 Dr Taylor: And costs?
Dr Raine: The cost to the NHS
projected annually would be £466 million, from that study.
Q978 Dr Taylor: Could you extrapolate
that and give us a global figure?
Lord Warner: I think we would
need notice of that particular question.
Q979 Dr Taylor: Could we ask you
to try to get it for us?
Lord Warner: We will go away and
ponder the question and try to give you the best answer we can
give you, that is all I can promise. I certainly left my abacus
at home.
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