Examination of Witnesses (Questions 340
- 359)
THURSDAY 25 NOVEMBER 2004
MS MELINDA
LETTS, PAUL
FLYNN MP, MR
PHIL WOOLAS
MP AND MR
CLIFF PRIOR
Q340 Dr Taylor: I do want to focus
a little more on the fault of the medical profession. I remember
that when the first worries about the addictive properties of
these came out, I hoped many of us actually stopped prescribing
them, but they were prescribed for a long time after the first
worries were made known. Should we not be investigating the conduct
of the medical profession in going on prescribing after the first
hints of trouble were known?
Mr Woolas: Yes, very much so.
Q341 Dr Taylor: I will move on to
regulation. Many of you have already said that the charities need
strict regulation. Just one point to Mr Flynn: in the table of
the charities that are in receipt of funding, in your paper, I
think it is fairly significant that those that do not receive
funding, apart from MIND, are probably the ones that the pharmaceutical
industry would not be able to make any money out of in any case?
Paul Flynn: I think that is probably
true.
Q342 Dr Taylor: So it is not that
they are declining it because they are very well-minded and good-hearted
charities; it is probably because they cannot get it?
Paul Flynn: No, that is not true
of MIND, for instance, and YoungMinds as well, another splendid
organisation. I believe there are some charities that look like
a public relations group for a drug, and I think we are very suspicious
of them. I am not inclined to go into too much detail on this
but there are so many of the charities that appear whose only
purpose seems to be pushing drugs and emphasising the advantages
of drugs. There was an example with a group called In Vivo Communications
where they had, as part of disease mongering, a whole group set
up to popularise or to identify irritable bowel syndrome as a
specific concrete disease. There was a drug available, which has
now been withdrawn because it had fatal side-effects, but there
was a whole campaign by a pharmaceutical company that was exposed
the public. There were various stages of the campaign. The first
was to persuade the medical press and the medical establishment
that this was indeed a problem that affected many millions of
people. Then part of their campaign was to set up patient organisations
in order to push the need for the use of this drug. I believe
we have evidence that the pharmaceutical industry, knowing that
they cannot in this country advertise directly to the public,
used the patient organisations, set them up or used existing ones
deliberately to put their case. We know ourselves from the letters
we have from individual constituents. Handwritten letters are
far more convincing than something from a drug company.
Q343 Dr Taylor: Can I just go back
to regulation and pull together all your ideas on regulation because
this has to be one of our huge recommendations? I think Mr Flynn
mentioned that the Charity Commission, so that is one organisation
that should be strengthening its act. Is that right?
Paul Flynn: I made a list of suggestions
at the last part of my report, which I will not read to you now,
on pages 6 and 7. Many of those are to strengthen organisations
like the one represented by the witness here, the LMCA, and other
organisations that are certainly benign and have no axe to grind
as far as maximising the sale and use of drugs.
Q344 Dr Taylor: It is primarily the
Charity Commissioners and the MHRA?
Paul Flynn: Yes. Action has been
taken on the LMCA.
Ms Letts: Mention has been made
of patient organisations set up by pharmaceutical companies. Such
organisations certainly do exist and I think that is one of the
reasons why I think we need to have a clearer way through something
like the LMCA of being able to establish the bona fides
of patient organisation. That would be a great help to the existing
ones.
Mr Prior: If I may comment specifically
on that, I think the MHRA and the medicines regulatory bodies
are probably a better channel than the Charity Commission, which
of course has the whole panoply of all sorts of different charities
to regulate and is unlikely to have the specific focus on this
area that would be needed. I would like the medicines regulatory
agencies to have a strategic relationship with patient organisations,
not only co-operating with them on regulation, transparency, accountability
and so on of patient organisations but also working with them
on early indications when problems are starting to emerge with
treatments. I do say "treatments" because it is not
just pharmaceuticals that have caused problems. Herbal medicines
have caused problems, non-medical therapies, technologies and
so on, all sorts of things have caused problems. Patient organisations
are often aware of the early anecdotal evidence, the buzz that
"well they told us this was not addictive but we did not
half have problems coming off it". It can take years, 10
and sometimes 20 years, for that early patient information to
be taken seriously by the regulatory bodes. We have to move towards
the yellow card system being opened up to direct reporting by
patients. Evidence from other countries suggests that that is
not a very strong method unless you are proactive about it. I
would like the MHRA to have a channel that hears about what we
are observing with antipsychotics, whatever it might be—cardiac
risks, weight gain risk—and, in view of that, say, "All
right, we hear enough news from you on this to fund you to conduct
an informal patient survey". If that comes back saying, "This
seems to be a more common problem", then they go to a full-scale
clinical trial to try and lift the lid on that and to shorten
this terrible period, this very long period, between the early
news and so on. Whilst the other witnesses are saying things that
are absolutely true, there is a real problem here. There is even
more of a problem on the European front for patient organisations
where the sources of alternative funding are almost nil and the
European front, of course, is becoming increasingly important
in medicine regulation. This is only one of the influences on
patient organisations. Certainly, if I were to list the undue
and improper influences brought to bear by different funders,
government and NDPBs would be at the top of the list, followed
closely by non-pharmaceutical corporate interests. Almost all
corporate fundraising, apart from the pharmaceutical industry,
which is regulated, is direct cause related marketing; it is directly
to sell their product. In the course of looking at undue influences,
we have to recognise that removing one undue influence from the
scene may simply serve to influence the undue influence of other
parties. Balance, transparency, accountability and regulation
are needed on this across the board. I am astonished by the fact
that in joining the Medicines Commission I was required to declare
interests in the pharmaceutical industry and nothing else. Personally,
I am much more influenced by the fact that I would not be alive
without advanced antibiotics than I am by any financial grant
to the organisation.
Q345 Dr Taylor: I am extremely worried
about writing this report because we have already heard from many
witnesses previously that the vast amount of research is funded
by drug firms; the vast amount of postgraduate education is funded
by drug firms; these patient groups are funded by drug firms.
Some of you have actually implied that some of this money is absolutely
essential and cannot come from other places. How do we make the
compromise? Is there possibly an argument, as has been put to
us, that if drug firms reduced their prices because they were
not spending all the money on these other things, then the drugs
would cost less, they would have more money and then things could
be government funded. Is that cloud cuckoo land?
Ms Letts: I do not think we would
want to be entirely government funded in any case.
Q346 Dr Taylor: I do not mean entirely,
but more?
Ms Letts: Sometimes there are
just as many pressures, as we have already alluded to, for patient
organisations in resisting the pressures that government or NDPBs
or other people want to put on them. Therefore, I think it is,
as we have said, it is a matter of establishing the bona fides
of the organisations and perhaps, through such a process, being
able to offer training and support to some of the less well-resourced
organisations in how to deal with these influences. I have always
believed it does not have to be the case that taking money from
somebody means that you have to do what they say. That has not
been the case in my experience. You take the money; if they do
not like what you did, then you may not get it again but at least
you have had it for the time being and you did something that
you thought was good with it. If you have the courage of your
convictions and say what you believe to be right and do what you
believe to be right with the money that you have, then very often
you will find that the funders will not go away because in some
way you have all moved on and their understanding of your agenda
has developed, just as your understanding of their agenda has
developed.
Q347 Dr Taylor: You can take the
money without being influenced?
Ms Letts: I have actually explicitly
resisted pressure from companies and I have not failed to have
a grant renewed.
Q348 Dr Taylor: Many of the research
doctors who have spoken to us have said that they have not been
influenced by the money they have had to do the research, but
they admit that other people are influenced.
Ms Letts: That may be the case.
I cannot speak for other people. I said earlier on that you have
to know absolutely what your objectives are, what your strategy
is, what your non-negotiables are, what are the things on which
you will not compromise.
Paul Flynn: The main problem is
that we look at the problems of the planet and find that the third
largest cause of death and illness is medical intervention. There
is a deliberate campaign by the pharmaceutical industry to medicalise
all society and convince us all that we cannot get through life
without their support. It is extraordinary that this has been
so successful. The great problem is that it has made us a dependency
culture. Giving us the idea that there is no answer to our problems
except a pill that gnaws away at our self-confidence and our ability
to cope in the way we have for thousands of years.
Ms Letts: That is exactly why
every organisation that I have been involved in and am involved
in puts out the message that drugs are only one part of treatment;
they are only one aspect of treatment. In fact, "Ask about
Medicines Week", of which I am a director, has, as a fundamental
message of the week, that patients must have the right to participate
in the prescription decision and to choose whether to have that
drug or whether to have any drug at all or to have some different
form of treatment.
Mr Woolas: In our support group
I would say that we do receive funding from the state in the form
of legal aid, which we have on occasion received. I think I would
want to distinguish between state funding and government funding.
I think state funding can be independent. The Opposition parties
receive state funding. I would say that I would want to distinguish
the funding for treatment from the funding for advocacy and support.
I think there are ways that we can guarantee independence on that
front by a combination of funding that in our case would not involve
the pharmaceutical companies.
Q349 Dr Taylor: This is a question
for Mr Woolas. For the record, could you tell us the source of
your statement that 1,800 patients have died from benzodiazepine
use.
Mr Woolas: It is contained in
the memo from Mr Behan. The figures are based on Home Office figures.
Part of our campaign is to ensure that coroners' and pathologists'
reports actually test for benzodiazepines. The media phrase is
"a cocktail of other drugs". That normally refers to
benzodiazepines. The figures are contained in the written evidence
that I have given quoting the Home Office that resulted from a
series of parliamentary questions.
Q350 Chairman: It is sourced in that
evidence to us?
Mr Woolas: Yes.
Q351 Dr Naysmith: Given what Richard
Taylor and John Austin have said, I had better admit to the fact
that I am an officer of the All Party Stroke Group. I have no
idea whether that is funded by the pharmaceutical industry or
not. Maybe they are, so I had better admit it. I am active on
lots of other backbench health groups as well. I want to ask Mr
Prior about something he has really referred to quite a lot already,
but I would like to clarify it. In your written evidence, you
recommend that the drug regulatory process should be opened up
to include all stakeholders and you expanded on that a bit. Is
it just in terms of side-effects of drugs or do you want them
involved much more than that? Is it just patients you are talking
about or does "all stakeholders" mean other people as
well?
Mr Prior: I am particularly thinking
of people who take the medications and, where people are too ill
to speak for themselves, the carers of the people who take the
medications. I think it is on the positive side as well as the
negative side. I work in a field where for many years people were
really trying to treat the wrong problem. They treated the problem
that doctors thought was the problem rather than asking the people
taking the medications, living with the condition, what they saw
as the major problem. It is about the positives as well as the
adverse effects. We do need more patient/user/carer representation
throughout the medicines regulatory system. Of course, once you
do that, patient organisations become yet more important. It is
additionally important to follow up on the concerns, and there
are real problems out there, which can deflect patient organisations.
We stand on our track record for transparency and openness on
this, but, for every one of us, there is always some other organisation
that perhaps is prepared to cut a corner. Regulation defends good
patient organisations. It is to the benefit of good patient organisations.
We need that additional level of regulation, that transparency
and that openness and the balance. When we survey our members
about what they see as most important in this field, they do not
want the pharmaceutical industry hobbled. They want the development
of better medicines with fewer side effects. They also want the
development of alternatives to medicines as well. They want a
balanced range, but they do not want the pharmaceutical industry
hobbled. They do want the patient voice to come through loud and
clear throughout the regulatory system.
Paul Flynn: They want the patient
voice uninfluenced by donations from the pharmaceutical industry.
It is not true to defend the yellow card system, which has vastly
under-reported the effect of adverse reactions. It was alarming
to hear a government minister recently in a debate defending the
idea that the only people who should be on the MHRA and taking
on this very important body are people with years of experience
in the pharmaceutical industry as they are the only people who
could make these decisions when many lay people and others with
a scientific background can make the decisions there. I think
we have suffered from a preponderance of people on the MHRA over
the years with 20 or 30 years in the pharmaceutical industry;
their mindset is very different from that of other people who
examine these things.
Q352 Dr Naysmith: We have seen quite
a lot of evidence that people are pleased with the extension of
the yellow card system and it can go further?
Paul Flynn: Yes.
Q353 Dr Naysmith: To pick up on one
or two other things that we need to clear up before we finish
this morning, over the last three weeks, we have heard a lot about
patient information leaflets and their shortcomings. Why has it
taken so long for there to be any serious attempt to improve these
leaflets? Perhaps Melinda Letts could start?
Ms Letts: I do not know why it
has taken so long. I am very glad that there is a serious attempt
because I think many of us know the shortcomings of patient information
leaflets. I have heard a lot about that over the years, which
is why I was very glad to be asked to chair the working group.
Q354 Chairman: Mr Woolas has to leave
as he has government duties to perform. We appreciate his attending
today.
Ms Letts: They have been compulsory
since 1 January 1999. Among the shortcomings are not only the
layout and the contents, which as you probably know are heavily
regulated, but also the fact that not everybody does get them,
even though it has been compulsory, supposedly, since 1 January
1999. There are various problems leading to this, including splitting
packs. I find it almost impossible to believe, but apparently
it is true, that the reason why pharmacists cannot photocopy them
when splitting packs is to do with copyright. I cannot understand
why that has not been able to be sorted out by now. In any case,
my working group is charged with looking at improving their quality.
We have been working for a year and we are focusing on that.
Q355 Dr Naysmith: Are you finding
co-operation from the pharmaceutical industry? Do they really
want this information to be much more widely available in a readable
form?
Ms Letts: It is a little difficult.
There are two pharmaceutical industry representatives on my working
group. I certainly have not detected any resistance to improving
the readability and quality of the leaflets from those members.
I am aware that for the industry generally there is a certain
amount of apprehension on a procedural and logistical basis, particularly
as there are changes that we are suggesting should be introduced
now in advance of some legislative changes coming into practice.
There is a concern that if we have to change what we are doing
at one time, is there going to be another new guideline issued
a short time later that is going to make us change everything
all over again? The working group is quite clear that the interests
of the patient must come first.
Q356 Dr Naysmith: Do you produce
drafts of these leaflets to improve them?
Ms Letts: We do not produce drafts.
If we did, we would be very busy indeed I think. The drafts are
written by the companies. They do not have to be approved by us
either. They have to be approved by the CSM, the Committee on
Safety of Medicines, as part of the licence application. Some
leaflets have come to us for comment where there are thought to
be special cases. For example, in a recent statin that was going
over the counter, the leaflet was brought to us for comment, but
we are not the body that actually approves them or drafts them
or writes them.
Q357 Dr Naysmith: Do you think there
has been improvement?
Ms Letts: No, I do not think there
has so far. It is far too early to say there has been any improvement.
The changes in European legislation are only coming on stream
early next year. For example, one thing that is going to happen
is that the order of information is going to change.
Q358 Dr Naysmith: You are saying
that in some special cases you have seen some examples. Do you
think they are going in the right direction or do you think it
is too early to say?
Ms Letts: I could not say I was
hugely impressed by any of them. What we need is a wholesale improvement.
We need these new guidelines that we are working on. One of the
important things that is going to come in is a requirement for
user testing to take place. That has been mentioned in guidance
since 1999 but it has had a minuscule take-up and it now going
to become compulsory.
Q359 Dr Naysmith: Why is that? Is
there any reluctance to involve users in the testing?
Ms Letts: I really cannot speak
for the industry. I am not involved on their side, but I imagine
that if it is not made compulsory, then it is simply another stage
that they have to go through in this long and complicated procedure
of getting an approval. It does not rise to the top of the priority
list. I am simply speculating. I really cannot say. It is not
something I am responsible for, but I am glad that it is becoming
compulsory because it seems an obvious thing to do, if you are
writing leaflets for people about something as important as their
medication, to test them out on potential users.
| 
