Examination of Witnesses (Questions 40
- 59)
THURSDAY 9 SEPTEMBER 2004
DR FELICITY
HARVEY, DR
JIM SMITH,
PROFESSOR SALLY
DAVIES, PROFESSOR
KENT WOODS
Q40 Siobhain McDonagh: Is it in the
public's interest and that of the scientific community that all
results are not published? Is it in the interests of Government
and NHS patients to be secretive and permit secrecy about much
of industry's research data?
Dr Naysmith: Just before you answer that,
you did say in answer to the question that Siobhain just put that
you thought you should get all the information, you thought you
are getting it now, but there have been one or two recent examples
where pharmaceutical companies have suppressed some information
and not provided it. In answer to Siobhain's question, I would
be grateful if you took that into account.
Professor Woods: If we have any
evidence that there has been a breach of the regulations, then
we have an inspection and enforcement division which will take
the necessary action to pursue investigations; the legal framework
is clear, that we must have for the assessment process all the
data which the applicant possesses.
Q41 Dr Naysmith: Have you ever used
that power or has it ever been used?
Professor Woods: Yes, we have
had occasion to involve our enforcement group where there has
been some evidence to suggest that we have not been given data
at the appropriate point. This is not simply at the point of licensing,
but if any additional data arrives which is relevant to the safety
of a product, again there is a legal obligation on the authorisation
holder to tell us about it.
Q42 Dr Naysmith: I think Siobhain's
question was do we think it is in the public's interest that some
of the results are not published?
Professor Woods: The question
of public access to trials data is quite a vexed and controversial
one. It is probably best to think of it in two areas: firstly,
the data which we as a regulatory agency receive in confidence,
should that be in the public domain? There are, within the Freedom
of Information Act provisions, exceptions—this Act will
come into force of course next January—where data submitted
in confidence which are trade secrets, which are commercially
in confidence, are exempted from the provisions of the Freedom
of Information Act. There is a wider question, however, whether
the information on a drug once it has received its product licence
should then be publicly made available by the manufacturer? That
is an area where I think opinions are moving quite quickly and
there has been a much greater willingness on the part of the industry—there
have been several notable examples recently—to put their
trials data into the public domain once the regulatory decision
has been made.
Dr Naysmith: We indeed had further discussion
about this with NICE when they last were before us and no doubt
we will be reviewing it later on. Siobhain, have you anything
else to ask?
Siobhain McDonagh: No, thank you.
Q43 Mr Dowd: Can I just look at the
questions of promotion of pharmaceuticals and information? According
to my figures, the pharmaceutical industry employs some 83,000
people directly, of whom one in 10 approximately are drug representatives
visiting health professionals and others, and there is also growth
of people who are now called regional medical advisers as well,
so it is a substantial part of their operation. We have received
many submissions expressing concern at the activity of this army,
but from your submission the Department seems pretty sanguine
about the current arrangements. In the Medicines Advertising Regulations
it states all of the principles behind it, and it all seems fine—except
it uses terms like "reasonable" and "appropriate"
which of course keep lawyers in work for generations. Who actually
enforces this and how often are there prosecutions under this?
Professor Davies: I think in terms
of the regulations themselves, they are actually enforced by the
MHRA, but in addition to that there is also guidance to the NHS
as to management responsibility. Would it be worth talking about
the regulations first, and then possibly say something about the
management responsibility within the NHS?
Professor Woods: You mentioned
two things, one was advertising and the other was the sales force;
perhaps we could start with the advertising. There is a mixture
of self-regulation and legislation to regulate the advertising
of medicines. The formal legal framework goes back to the Medicines
Advertising Regulations of 1994 and a clear distinction is made
between advertising directed towards patients and advertising
directed towards persons qualified to prescribe or supply drugs,
in other words doctors and pharmacists. The voluntary framework
on advertising is a self-regulatory system which is run separately
for the over the counter medicines and for the generics and innovative
areas. By and large, that is a very effective system for scrutiny,
but we do have powers within the agency to back that up and we
do so in three ways: firstly, we will pre-vet advertising material
under certain circumstances—that is to say, if we have concerns
about the direction in which advertising claims might be slanted,
perhaps it is a new drug, newly marketed in a new therapeutic
category, perhaps it is a drug which has shifted in its classification
so that it is available over the counter. So there is the pre-vetting
facility which we use, and in the current year I think there are
something like 17 products which are under that pre-vetting of
advertising. The second area where we will act is if there has
been a complaint about an advertisement thought not adequately
to represent the drug in question, and of course the advertiser
is expected to produce advertising material which accurately reflects
what is in the summary product characteristics which we had agreed
with them. So we will investigate complaints and, of course, we
maintain surveillance of advertising ourselves in our own unit
to look for things that might have slipped through the self-regulation
process.
Q44 Mr Dowd: I accept it is extremely
difficult, but what mechanism do you employ to monitor what individual
drug company representatives are saying to individual prescribers?
Professor Woods: That again comes
under the same Regulations of 1994, the Promotion of Medicines.
It is a little bit more complicated than simply the legal framework:
for instance, there are ethical standards for drug marketing,
but there is also a role for the NHS as an employer to have codes
of practice as to what its employees may accept, for instance,
by way of inducements, by way of freebies, by way of incentives.
There are also professional standards, the General Medical Council
have said something about this in good medical practice, so it
is a complex set of constraints. Perhaps Dr Harvey might be able
to enlarge on some of the NHS constraints.
Q45 Dr Naysmith: Of course, employees
of the NHS would be bound by that, but of course GPs are contractors
to the National Health Service. How would that slight but very
important difference affect it?
Dr Harvey: Could I just say that
actually in terms of the guidance that the NHS has, that does
also include contractors to primary care trusts. In fact, the
two pieces of guidance that the Department put out was, firstly,
in 1993 the Standards of Business Conduct for NHS Staff, and then
later in November 2000 Commercial Sponsorship: Ethical Standards,
and that includes a draft code of practice. Within that guidance
it is fairly clear about the responsibilities within NHS trusts,
PCTs, within management to make clinicians who are prescribing
aware of these issues, and it does include in the same way that
the regulations do quite a lot of detail in terms of the sorts
of things that NHS trusts should put in place. That includes things
like declarations of interest, and in terms of gifts that if people
have had gifts and things they should be declared, also limits
in terms of gifts or support—for example, support for travel
to international conferences. That is all laid out very clearly
within the guidance and it is the responsibility of NHS management
to make sure that all of their clinicians are aware and indeed
are abiding by that guidance. As Professor Woods said, it is also
covered within good medical practice within revalidation for the
GMC that there are codes of practice, it is the duty of the clinician
to ensure that when they prescribe they prescribe based on the
evidence base and in the best interests of their patient. That
is very clear, both within the NHS guidance and also very much
within the self-regulatory mechanisms for medical professionals.
Q46 Mr Dowd: Within your submission
here you have mentioned the points you have just made, certainly
with regard to the standards of business conduct and commercial
sponsorship. You say: "If an agreement is entered into the
clinician's judgment should always be based upon clinical evidence
that the product is best for the patient . . . "That is what
you said, but it also goes on to say "and value for money."
I thought that was NICE's job.
Dr Harvey: That comes from the
evidence base that we provide for clinicians through the outputs
of NICE in terms of the NICE appraisals. As you are aware, the
NICE appraisal is both clinical and cost-effectiveness jointly,
and in fact much of the information that we put out to the NHS
is support in making decisions around effective prescribing to
the best needs of their patients.
Q47 Mr Dowd: Can I just take that
further, because we have received information that NICE- approved
products, when they had been promoted to prescribers, actually
showed a distinct increase amongst those who had received such
submissions as opposed to those who had not. Do you think that
was just making them aware of something they were previously unaware
of, or is it the effect of promoting directly to prescribers?
Dr Harvey: Sorry, could you repeat
that?
Q48 Mr Dowd: We have received information
that representative promotion of NICE-approved products can have
a supportive effect. The growth in prescriptions in those doctors
who had received calls from representatives was larger than in
those who had not received any calls.
Dr Harvey: I think that in addition
to what you were referring to in terms of calls that they might
have from representatives, one needs to remember that there also
is quite a lot of contact with the PCT mechanism in terms of prescribing
advisors, the Area Prescribing Committee etc. In an Audit Committee
review in 2003 on primary care prescribing, they found that the
areas of greatest growth within prescription medicines were actually
in those areas that were NSF areas (National Service Framework
areas) and indeed those where we had NICE guidance—that
is particularly in areas such as CHD, diabetes and also mental
health. So, as you would expect there are many sources of information
that prescribers receive. Yes, they may well get visits from representatives
of the pharmaceutical industry; it will be up to them as to whether
or not they see those representatives, but anyway they get a great
deal of information through the mechanisms that we alluded to
earlier in terms of supporting prescribing and supporting evidence-based
prescribing for increasing the quality of care for patients.
Q49 Dr Taylor: Really it is on the
same sort of topic, because it staggered us I think with the information
we have received to see the proportion of drug firms' revenue
that does go on promotion, so obviously promotion must work. There
are all sorts of suspicions that drug reps and promotional meetings
do influence prescribing doctors, sometimes in the wrong way.
Is there any evidence of inappropriate or uneconomic prescribing
of a specific medicine, following on particular events or drug
reps visits?
Dr Harvey: I wonder if I could
possibly ask Dr Smith to answer.
Dr Smith: Thank you. I think it
is true to say that there has been that kind of evidence—it
is difficult to find, it is in the research literature, and the
people who would really know of course are the companies themselves
or maybe the advertising industry, who I do not think put that
information into the public domain. There is evidence in the research
literature, but it is a few years ago and it is mainly American;
I think the point I would like to make is that prescribing now
takes place in a much more managed environment, and over the last
five or ten years there has been a sea change in organisation
and individual professional approach to prescribing. We have different
drug and therapeutics committees, we have prescribing advisers,
all primary care trusts are required to have a code of conduct
and there are a couple of examples in the Audit Commission report
which Dr Harvey referred to of East Yorkshire PCT and Amber Valley
PCT who have particularly robust policies for working with the
industry. We have come a long way and, without having objective
evidence, my take would be that there is a much more level playing
field, in fact a playing field much more tilted in favour of the
NHS and NHS professionals. That is not to say that influences
are not out there, but we are much better equipped to handle them
and to make sure professionals prescribe effectively.
Q50 Dr Naysmith: Do you think that
a drug firm taking a bunch of young GPs off to Switzerland during
the ski-ing season and carrying out a promotion at that time,
would that be caught by any ethical requirements? The promotion
was fine, it was just that it was accompanied by the ski-ing—and
this was not American and it was not a long time ago, it was last
year.
Dr Smith: Superficially it would
appear to be in breach of the principles that we have very clearly
set out in guidance to the NHS, and the 1994 Regulations.
Q51 Dr Taylor: If you are right,
the drug firms would be countering this by either increasing their
expense on promotion or decreasing their expense on promotion.
Have we any evidence of that? We will have to ask the drug firms.
Dr Smith: I think you will, yes.
I am not aware of that.
Q52 Mrs Calton: Can I pick up on
just a couple of points because we have had answers which have
indicated that malpractice, as such, is pretty well covered by
existing practice and existing controls, but in our briefing notes
Herxheimer has said that it may be more to do with the extent
and volume of influence rather than actual malpractice going on.
What is your view of that, do you believe that the sheer volume
of influence, the extent of it and the pervasive nature of it
may actually have more influence than actual malpractice which
most of us would recognise?
Dr Harvey: I think it is very
much down to individual NHS trusts as to the sort of relationship
they might have with an individual pharmaceutical company, be
it in support of education, in support of information etc. I think
what we would say is that within not only the guidance that has
gone out to the NHS, both in 1993 and 2000, but also within the
code of practice that the ABPI itself has through the Prescription
Medicines Code of Practice Authority, that is actually fairly
heavily dealt with, within the mechanisms that we have, and if
there are any concerns around the particular practices of an individual
company or individual representatives, there are mechanisms going
to the Prescription Medicines Code of Practice Authority, or indeed
through to the MHRA. If there is a concern about a clinical professional
then that concern goes through the NHS trust and the mechanisms
there. What we would say is that we do have mechanisms in place,
we are providing a large amount of information through various
very good sources—for example NICE Drug and Therapeutics
Bulletin, and the BNF—we have mechanisms through the prescribing
advisers, the area Prescribing Committees, drugs and therapeutics
committees. There are lots of structures and information sources
within the NHS now and, indeed, monitoring of prescribing to see
whether what we are actually prescribing at the end of the day
is what we would expect in terms of increasing quality of care
and evidence-based practice. The prescribing evidence that we
have is indicating that that is the case. We do have an issue
around getting NICE positive appraisals into practice and the
government responded to that in terms of how we can make that
more robust earlier this year, but I think there are a lot of
mechanisms that we now have within the NHS that actually support
prescribers in trying to ensure that they are prescribing in the
best interests of their patients and quality of care.
Professor Davies: Perhaps I could
make that alive for you. Speaking as a doctor who still does clinics,
if we take a condition where patients who have had cancer or leukaemia,
have been treated with chemotherapeutic drugs and have no white
cells then get a fever, they have probably got an infection. There
is a myriad of very expensive antibiotics that we could use and
I am sure the drug companies each would like us to use their own,
but we have a protocol for the hospital—almost every hospital
does have—where the infectious diseases people, the microbiologists,
the clinical pharmacologists have sat down and agreed what is
right for the patient in this situation, and then we have bulk
purchasing to ensure a sensible buy. So I have a protocol, I do
not even have to think at two in the morning, I just say yes,
the protocol says those drugs at that dose, we start with that.
We change if the situation changes. Another example was a few
weeks ago I prescribed a particular iron syrup for an infant who
was iron-deficient; 10 minutes later the phone goes, it was pharmacy:
"We do not stock that, we will be prescribing the following
[ferrous sulphate] the same dose, the same concentration, but
a lot cheaper." So in practice it is beginning to change.
Q53 Mrs Calton: Another point in
our briefing notes and something that I have had some personal
concern about, which the Royal College of General Practitioners
has brought to our attention, is the categorisation of an increasing
number of individuals as "abnormal" and that therefore
they will need a drug to put them right. I have heard this personally
from a practising consultant, that large numbers of children need
Ritalin, for example, to put right what nature has put wrong.
I wonder whether this is a concern that you might have.
Dr Harvey: In terms of clinical
areas, clearly there is a lot of guidance and clinical guidelines
from all of the professional medical royal colleges, other professional
bodies etc, but that is also another function of NICE. It does
have its appraisal process, but it also has a clinical guidelines
arm to the work that it does as well. That is very important in
terms of looking at particular conditions and giving an evidence-based
approach to not only the treatment but the diagnosis. What is
the most efficacious method of diagnosing and then treating a
particular condition? As we are developing the quality strategy
within the NHS, more and more of these guidelines are out there
in the NHS to inform doctors, and we also support that through
decision support, one of the facets that will also be developed
further within the national programme for information technology.
Q54 Mr Dowd: If I could just pull
it together, I would just say that I am sure it is the experience
of most of the members around this table that the pharmaceutical
industry is one of the best-organised representative lobbying
groups that we have to deal with—not anything improper I
would hasten to add and certainly not trips to Switzerland to
learn about what they are doing. One question you did not answer
was how often action is taken under the regulations governing
this. I would not expect precise figures but is it frequently,
infrequently, rarely, not at all?
Professor Woods: I can give you
some figures for advertising, for instance, because this is something
we looked at—in fact it was the precursor organisation,
the Medicines Control Agency, which started an internal review
of the investigation of advertising complaints. We have continued
that, and what we have been doing since December last year is
to put on our website the outcome of the investigation of the
complaint made about medicines advertising. Between December last
year and June this year, 16 complaints were put on the MHRA website,
including description of what the complaint was, what the adjudication
was and what corrective action was being taken. We use that as
a way of helping to reinforce the messages about what is acceptable
advertising, and of course we also have a guideline document "Advertising
and Promoting Medicines in the UK" which is on our website.
There is no ambiguity about what the ground rules are.
Q55 Mr Dowd: Of those 16 would you
know how many were upheld or are the determinations not as clear-cut
as that?
Professor Woods: The determinations
are on the website, I cannot give you that statistic here.
Q56 Mr Dowd: Finally, then, to pull
it all together from what you have said, are you satisfied that
there are sufficient mechanisms in place—I think actually,
Dr Harvey, you alluded to this—to make sure prescribers
can make the most effective prescribing decisions?
Dr Harvey: I think this is obviously
something that we always keep under review, but I think from the
information that we have there is a lot of information to prescribers.
We also, as I said earlier, have a generic prescribing rate now
of 78%, 85% in a few PCTs. And again if you look at the Audit
Commission's report in 2003 of the areas of growth in the drugs
budget in terms of prescription medicines, they are in the areas
that we would expect that growth to be because of the clinical
priority areas that are very important in terms of increasing
quality of care in the community. The evidence would indicate
I am sure we can always do better, but at the moment we do have
mechanisms which are informing clinicians of the sort of evidence-based
decisions coming from many different sources, NICE being one of
them, that they might make. Clearly, there is clinical freedom
and this is actually something which, at the end of the day, is
an issue for an individual clinician in their consultation with
an individual patient.
Q57 Mr Dowd: Finally, finally, is
there anything that you can say succinctly to convince the more
sceptical or cynical citizen who believes that the army of drug
company representatives are actually just out to sell products
rather than to improve public health?
Dr Harvey: I think in terms of
the pharmaceutical industry also they are very conscious of the
important public health priorities that we have, and they are
also working to support those.
Q58 Mr Jones: This evidence session
is of course about exploring the relationship between the industry,
its customers and its regulators, and I think when the Committee
looks back upon the evidence of the session one of the most striking
features is that despite great pressing from colleagues, in the
last hour and a half none of you have given one example of any
single company or any single product that has been improperly
provided, so either things are going marvellously well or there
is a certain reluctance. Perhaps in answer to future questions,
from me or from somebody else, there are some specific examples
of products improperly provided that you might give. I want to
ask some questions about the role of education. One of the other
unique features of this industry is that the industry is effectively
the educators of professionals who provide the products. Over
half of further education training for doctors is funded by the
industry; the industry extensively provides hospitality and courses
on training for its products. That may be inevitable in this industry,
but do you recognise, Professor Davies, that it is an unsatisfactory
position and maybe we should look to see if we could have safeguards
or whatever in other ways, so that those providing the products
were not actually the ones who were educating and providing most
of the material that goes into the journals on their product?
Professor Davies: I can only pick
up on the research side. I do believe that people are educated
through the journals, individual studies are better put through
the more complex manipulation of metra-analysis and systematic
review and we are working hard to make those available to clinicians.
The Cochrane Collaboration have a whiter than white policy about
their relationship with the pharmaceutical industry and will accept
no sponsorship, even with a firewall between it in this, so we
are left as a government to fund significant amounts.
Dr Harvey: In terms of education
generally the Department itself invests some £4 billion in
MPET and, as you know, that very much funds undergraduate and
postgraduate medical education. We also have the deaneries and
the Workforce Confederations that are actually looking to training
needs of individuals. Within the new frameworks we have for appraisal
and revalidation—and this is both for the consultants and
indeed for general practitioners it is important for every individual
clinician and every doctor And it is not just doctors, it is for
other health care professionals as well, to have a personal development
plan. That personal development plan is part and parcel of their
appraisal, and will be in discussed with their employer.
Q59 Mr Jones: Sorry, can I go back
to my question again? I acknowledged in my question that maybe
there is nothing else we can do. You cannot say that industry
providing huge sums of money to help educate doctors is a bad
thing, and it would be ridiculous to reject that, but what my
question was trying to pull out of one of you is would you acknowledge
that there may be occasions where some of that produces bad effects
and what could we do to try and mitigate it?
Dr Harvey: I think our position
is that in terms of the guidance and regulations that we have
got, those actually do give an environment where there is great
clarity for the NHS in terms of what sponsorship, what relationships
in terms of education it might have with the industry. There is
obviously, separately from that, a relationship which is not subject
to government guidance, for example, the medical royal colleges
or other professional bodies might have and what that might mean
in terms of education. I think that is outwith our brief, although
I am quite sure they have codes of conduct around that as well.
Clearly, some education, yes, is through the NHS, but there are
also education requirements that the individual professional bodies
put upon their clinicians.
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