Examination of Witnesses (Questions 320
- 339)
THURSDAY 25 NOVEMBER 2004
MS MELINDA
LETTS, PAUL
FLYNN MP, MR
PHIL WOOLAS
MP AND MR
CLIFF PRIOR
Q320 Chairman: Mr Prior, a lot of
the pharmaceutical companies make donations to charities. Would
it not be a more appropriate way of patient organisations receiving
income to get it from those charities rather than directly from
the companies?
Mr Prior: I think a balanced range
of funding would be highly desirable. At Rethink we are in a much
stronger position in that we have over £40 million a year
in alternative sources of income, which makes us very robust against
any influence from pharmaceutical companies who provide less than
1% of our income. Many patient organisations struggle to survive.
They do not have alternative sources of income.
Q321 Chairman: If it is less than
1%, in view of the suggestions from Mr Flynn that you are possibly
compromised as a consequence of receiving that money, why, with
it being only such a small amount, do you continue to receive
it?
Mr Prior: I think all sources
of funding bring strengths. I know it has been suggested in previous
sessions before this committee that government funding, for example,
should replace pharmaceutical funding of patient organisations,
but I am afraid that anybody who thinks that government funding
comes without strings or without influence is being exceedingly
naïve. All sources of funding bring their biases. Even raising
funds direct from the public brings a bias. It is much easier
to raise funds for attractive conditions, if you like, cuddly
conditions, rather than for difficult and edgy causes, like severe
mental illness, our own area, and in addition, to raise funds
from the public you have to stay in the public eye. If you stay
in the public eye you are more tempted to make controversial statements.
All sources of funding bring bias. What is important here is to
know that patient organisations are, as in our own case, genuinely
controlled by the people they are there to represent. We have
a shareholding membership made up of people living with the conditions
we are about and their passion and energy would not allow us to
tell anything other than their experience in our campaigns. Secondly,
patient organisations should have a balanced range of funding
which is fully declared, not just a declaration of money that
comes from the pharmaceutical industry; that is important, but
also a declaration of what other sources of funding they have,
government funding and so on. It would be wonderful if charitable
trusts were prepared to put more funds specifically into allowing
patient organisations to survey the experiences of the people
they represent and campaign on that basis. However, even then
most charitable trusts have their own agenda. They set their own
criteria. Again, that can distort the message that is heard from
patient organisations. Balance and transparency and accountability
are what are important here.
Q322 Chairman: Ms Letts, do you have
any comments on Mr Flynn's opening remarks?
Ms Letts: I would not disagree
with anything that Cliff Prior has just said. What I would like
to add is that I think that all patient organisations should have
guidelines for all the funding that they accept and particularly
guidelines that they have with pharmaceutical companies. These
should include an absolute insistence on independent governance,
on editorial control, on independent decision-making and so on,
and an absolute ban on promoting any company's products, whatever
those products are. I have written these policies myself for a
National Asthma Campaign in the past and LMCA and most recently
for Ask About Medicines Week. I would like to supplement what
Cliff Prior said about patient organisations struggling to survive.
It is one thing if you are running an organisation such as I did
with asthma where you are running a national charity dealing with
an emotive issue where it is easy to make your case and get your
funding, even though public fundraising, as Cliff has suggested,
does drive you sometimes into doing things or emphasising things
that perhaps you would not want to emphasise. However, if you
run a small support group for a rare condition affecting a small
number of people, none of whom is particularly cute or cuddly
then it is difficult, or, as in my most recent experience, if
you are leading an umbrella body whose interaction is at policy
level, not directly at patient level, it is very difficult, and
finding core funding for organisations like these is a constant
and exhausting struggle. Government does stubbornly refuse to
understand this. Government funding tends to come either with
explicit or implicit strings attached, or it tends to be in the
form of project funding which is no use at all if you have not
got an infrastructure to support the projects. I think that what
we need to see is much clearer standards to establish the bona
fides of a patient organisation. The patient organisation that
I chaired until recently, the Long-Term Medical Conditions Alliance,
discussed this quite frequently but, ironically, we never had
the core funding available to get the infrastructure that we needed
built up in order to introduce such a system. We need to introduce
these standards to establish the bona fides of patient organisations.
What I would add to what Cliff has said about the need for balance
in funding is that indeed you are influenced from all sides when
you accept funding and what is absolutely essential—and
this is very difficult again for a lot of small organisations
who have not got the staff or the infrastructure—is to be
very clear about your objectives, your policies, your strategies
and the things on which you will not compromise. One of the things
on which you have to be absolutely clear is that you will declare
all sources of funding. I have been on the receiving end on one
occasion of an attempt by a company to persuade me not to declare
in an annual report some funding that we had received. I think
you have to have the courage to stand up to that kind of pressure.
Q323 Chairman: The company did not
want you to declare money that they had given?
Ms Letts: They had not given it.
They had paid for something that we had carried out so, because
they had not given it directly to us, it had not gone through
our books, the suggestion was that it should not be declared and
I insisted that it must be declared.
Q324 Chairman: Do you want to mention
the company?
Ms Letts: Yes. It was Glaxo Wellcome.
Q325 John Austin: If I could stay
with Ms Letts, nothing in my questioning should be taken as implying
any criticism of your integrity. We know that you have always
argued for a relationship with the pharmaceutical industry and
that it should be restrained by a code of practice. During your
period with the Long-Term Medical Conditions Alliance and, as
you say, you have always been open in your declarations, you were
working for or did undertake some consultancy work for a number
of organisations, including one of the companies which was involved
in the drug launches of Viagra and Celebrex. We now understand
that Celebrex is one of those—
Ms Letts: Sorry—which company
was that?
Q326 John Austin: With the Chandler
Chicco agency.
Ms Letts: Ah, Chandler Chicco,
yes.
Q327 Chairman: Who were working for
the pharmaceutical industry and involved in the drug launch of
Celebrex, about which I think there are considerable safety concerns
and questions at the moment. In that capacity did possible conflicts
of interest ever occur and, if so, how did you handle them?
Ms Letts: I had no idea that Chandler
Chicco was even involved with that drug. In fact, I have ever
heard of that drug, Celebrex, that you mentioned. They commissioned
me to write a report on something which I was happy to write a
report on for them. They are a communications consultancy and
I had absolutely no involvement in any of their direct work with
any of those drugs that you mentioned. I simply wrote a report
for them. It was a research report that I put together for them
on the current European situation and current European campaigning
about direct-to-consumer communications, and I put both sides
of the story very clearly in that report. No, I do not think there
is any possible conflict of interest that I can think of there.
Q328 John Austin: You mentioned the
GSK incident to the chair. Have there been other occasions when
pharmaceutical companies have tried to influence you in some way?
Ms Letts: When you are running
a patient organisation this word "influence" bears a
little bit of examination. Of course, another word for "campaigning"
is "influencing", and we are all involved in influencing.
That is what you do when you meet with people, so of course any
company that one is dealing with wants one to understand their
point of view. I have been sometimes what could be called a bit
bloody-minded in resisting it. Anyone who tries to influence me
will probably get a counter-productive reaction from me. I am
not very susceptible to that kind of approach. The important thing
is that what you have to have in your mind is who it is you are
there for, who it is you are working for. What I always ask myself
is, what is going to be in the best interests of the patients
whom I am ultimately here to speak or work for? I believe, as
I think you have alluded to already, that the best interests of
the patients who I have always worked for, those people with long
term conditions, are served by maintaining a dialogue with pharmaceutical
companies because those companies make products on which in many
cases people depend, sometimes on a day-to-day basis and sometimes
periodically but they make those products and it is important
to remain in contact with them. That is what I believe. I do not
believe that it means you have to adopt lock, stock and barrel
the agenda of the pharmaceutical company. You have to go into
such relationships knowing full well that they have a commercial
imperative, and that is what one would expect in the world that
we live in. If you are clear about who you are there for and,
as I said, what your non-negotiables are, then I think you can
conduct a fairly robust dialogue. I am certainly aware, in the
time I have been doing this, because I have both seen and been
given explicit feedback, of having influenced companies themselves
and persuaded them that it is not a very good idea to try to capture
a patient organisation, for example.
Q329 John Austin: The difficulties
for some organisations have been explained. Some organisations
are more cuddly than others and more easy to raise funds for.
Some conditions it is more difficult to raise funds for. If there
were no funding from the pharmaceutical industry what sort of
impact do you think that might have on the patient's voice generally?
Mr Prior: Some would really struggle.
Some patient organisations would close altogether and then support
would not be available to people living with those conditions.
For some, like us, there would be a bit of a hit but it would
not be anything tremendously significant, so there would be a
range of different effects. Then organisations would be more open
to influence from other directions. If I can give you an example
of this, our main interest is with people affected by psychoses
and over the last five or 10 years there has been a major debate
about two different classes of anti-psychotic medication—an
old class which was cheaper and a new class which was more expensive—and
obviously the pharmaceutical companies wanted to sell the new
class and there was very clear direct evidence from surveys that
we conducted of NHS agencies that government agencies wanted to
control the prescribing of these because they were more expensive
and cost was a major factor restricting prescription. The way
we tackled that was by going out to people who were taking medications
on a very large scale and surveying them about their experiences
and the benefits and disbenefits that they found. We produced
a report which was presented to NICE and actually was the line
that NICE very much followed, which was not to say, "New
drugs good, old drugs bad". It was to say, "They have
both got benefits and side effects. The range of side effects
is different. People need an informed choice in order to arrive
at the best treatment for them". That was possible only through
the most intense job of trying to raise absolutely neutral funds.
We could not touch government funds because they were biased against
spending more money. We could not touch pharmaceutical funds because
obviously they would be biased in favour of selling more of the
new drugs. We found there were almost no sources of funding to
support that sort of neutral inquiry into the experiences of patients.
We were very fortunate to find two trusts, King's Fund and the
Gulbenkian Foundation, which were prepared to support it, but
even then it came with strings. I think the strings were right.
The King's Fund's condition was that a full data set of the survey
must be published on our website, and good on them for insisting
on that. That is the sort of influence I like, but it is incredibly
difficult and simply removing pharmaceutical funding would damage
patient organisations and the work that they do. Replacing it
with government funding would create disproportionate influence
from one party. We need a more balanced approach. We need to see
more charitable trusts contributing to this field, but we also,
as patient organisations become more influential, need to defend
their position—and I think this is in our own interests—by
introducing standards. Governments or regulatory agencies should
fund these developments under umbrella bodies for patient organisations
Patient organisations would then be expected to adhere to publication
of interests, accountability, showing how they are controlled,
how they get the views of their beneficiaries, before their evidence
is taken seriously by bodies like NICE or the CSM, or indeed by
the media who are all too prone to report the controversial comment
rather than the one that is well-founded in evidence from large
numbers of people with that condition.
Paul Flynn: We already have the
umbrella body, of course. The problem with it is that it cannot
enforce its recommendations. There is no way of monitoring what
is going on and it is described as being a distant dream, the
possibility that it can impose any sanctions. The evidence is
that only 26% of the UK groups that were surveyed recently had
any kind of conflict of interest statement on this. There is no
disagreement with the Long-Term Medical Conditions Alliance's
guidelines and aims. There is also a problem with the Charity
Commission because the suggestion that they have absolute control
is another fallacy. In a letter to me they said that under the
Charity Accounting Regulations there is no general requirement
for charities to disclose the sources of their donations and the
kind of control they have is very weak, as I mentioned in my written
statement. We do need some kind of tightening up on this. They
said that the requirements to provide information on the source
of donations are less stringent than those relating to the expenditure
of a charity. There is a great dispute about those charities and
patient organisations saying they have no choice but to accept
money that is given to them and those who very successfully resisted
money that they thought was tainted because it was intended to
influence their policies.
Ms Letts: As we are talking about
the umbrella organisation I assume that Mr Flynn was referring
to LMCA. As I said, our wish when I was in the Chair to introduce
such a system was hampered by the fact that we did not have the
money to fund the infrastructure to make it work. I think, and
in fact one of my recommendations to this committee would be,
that there should be core funding provided without any strings
attached by government to the LMCA or some other such umbrella
body to set up such a system so that it becomes a matter for anybody
who wants to join in the Alliance. I am sure a lot of people would
still want to join it, in fact probably more. There would be some
kind of standard attached to it to recognise the bona fides of
member organisations. One of those standards I absolutely agree
should be that all interests should be very clearly declared in
annual reports and so forth and not simply pharmaceutical industry
funding. In answer to the question what would happen if there
were no pharmaceutical industry funding, I think that unless there
was a lot of work done to counterbalance this potential outcome,
there would probably be undue influence exerted by other funders,
including government. Both Cliff Prior and I have referred to
the notion that government funding comes without bias as being
really untenable.
Paul Flynn: It is biased by government
but I think all that is in the government's interests is the wellbeing
of the patients and the pharmaceutical industry's interest is
to maximise their profits. I believe that if we did see withdrawal
of all the funding, it would liberate the patients' organisations,
give them a new respectability and credibility, and would certainly
help those who have properly resisted all funding from pharmaceutical
companies over the years and have led the campaigns to expose
the dangers of pharmaceutical drugs and the benefits of pharmaceutical
drugs.
Q330 Chairman: Mr Woolas, could you
say a bit about how you became involved? Obviously you are here
as a constituency MP and not as a minister. Can you say a little
about what has happened in your constituency that made you become
involved in this whole area?
Mr Woolas: Thank you for the opportunity
to do so. It might be helpful to you and your Committee if I referred
you to the Westminster Hall debate of 7 December 1999, column
186, in which I outlined the case of the benzodiazepine campaign.
Essentially, my constituency has an estimated 5,000 involuntary
addicts to benzodiazepine drugs; that is an estimate from our
primary care trust.
Q331 Chairman: Is there some specific
reason why that is such a high figure, or would you say that is
not uncommon elsewhere?
Mr Woolas: It is not uncommon
elsewhere. There are particular reasons to do with the area of
Greater Manchester in which my constituency falls, but it is not
an uncommon figure. What is perhaps special about my area is that
there is a very well-developed support group for the involuntary
addicts of benzodiazepine drugs, and that support group has indeed
grown up, over the last five years, into what is now a nationwide
support group. We have the first primary care trust funded treatment
service for withdrawal from benzodiazepine addiction, but we are
dependent, as a national organisation, on voluntary funding from
individuals. In particular, our efforts to bring legal cases have
been hampered by the lack of legal aid, the lack of funding for
advocacy, and of course the enormous resources of the particular
companies that have provided benzodiazepines over the last 30
years.
Q332 Chairman: Can I ask you specifically:
to what extent do you believe that the drug manufacturers were
responsible for the current levels of use and the dependence on
benzos?
Mr Woolas: That goes to the nub
of the problem. I have referred the Committee to two submissions
of written evidence to this inquiry: first, from my constituent,
Mr Barry Haslam, who has submitted his evidence to you; and, secondly,
from a constituent of Clive Soley, Mr Michael Behan. In addition,
those two documents provide the historical record of how Wyeth
Brothers and Roche in particular we believe in our campaign withheld
information showing that the addictive levels of these drugs were
much higher than the prescription guidelines stated. Indeed, as
you will know, Mr Chairman, I wrote to you on 13 October of this
year suggesting that a number of documents that we have become
aware of in our research for legal action in this country and
in other countries would show, in my view beyond doubt, that that
deliberate withholding of the information was intentional.
Q333 Chairman: You feel the Committee
could help you in this respect?
Mr Woolas: I think the Committee
could be an enormous help if the documents referred to in the
memorandum from Mr Behan were requested by this Committee because
I believe that would show evidence existed that the addictive
effects of these drugs were much greater than was known to the
regulatory authorities in this country, and therefore of course
to patients. In particular, I believe the statements issued by
ex-medical directors of Wyeth—Dr Dipak Malhutra and Thomas
Harry who were responsible for the development of Ativan—show
that what I am saying is the case.
Q334 Chairman: Can you say a bit
more about the initiative by the PCT in terms of helping people
with this problem in your area? Has this been funded entirely
by the local PCT or has there been some help from national government?
Mr Woolas: The situation is that
our campaign does not advocate immediate withdrawal from benzodiazepines.
We believe that would be very dangerous. Our campaign is to have
the prescription guidelines enforced. Unfortunately, they are
not being enforced. There are some 20 million repeat prescriptions
in this country. Therefore, availability of facilities for withdrawal
treatment from these drugs is extremely important. I would point
out that in the evidence that has been presented, the Home Office
statistics, the number of deaths by poisoning from benzodiazepine
involuntary addiction in this country is 1,800. This is some nine
times greater than the number of deaths from heroin misuse. The
funding for the withdrawal treatment is exclusively from our primary
care trust. The difficultly we have is, of course, that the withdrawal
treatment is not a central part of the national drug withdrawal
strategy, and nor therefore is it one of the five priorities given
to primary care trusts by national policy. In other words, it
is a local decision by the board of our PCT to commission a service
in conjunction with the North-West.
Q335 Chairman: It is locally funded,
basically?
Mr Woolas: It is therefore locally
funded but it is government funded, of course.
Q336 Chairman: Barry Haslam, in his
evidence on page 6, makes a number of recommendations for action.
Mr Haslam has fought hard on this over many years. He writes to
me at least once every week and, to his credit, he has worked
very hard. I will not go into one of his recommendations, and
you will not want that either, which is to sack the Health Minister
Rosie Winterton and her special advisers forthwith and appoint
Phil Woolas MP in her place. You probably do not want to comment
on that and I will not ask you to do so. His first recommendation
is that there should be an independent and full public inquiry
to be ordered by the Government as a matter of urgency into benzodiazepine,
SSRIs and "Z" drugs. Is that something that you personally
would support and, if so, how do you feel that might address some
of the issues you have raised with the Committee?
Mr Woolas: I support that and
it is something that the Government of the Republic of Ireland
has undertaken with significant success. There are two reasons
for this. One is that to address this issue requires cross-departmental
policy co-ordination. Our campaign in particular has lobbied the
Home Office on the scheduling of the drugs, that is the rules
that pertain to the storage of drugs, because there is a street
trade in temazepam in particular. Obviously, that involves the
Health Department, the ODPM and a number of government departments
in having that policy, which is needed to enforce the prescription
guidelines, to give confidence to doctors and patients in the
independence of the regulatory authorities, and to provide the
treatment that the addicts require. Incidentally, for example,
the prison service in its guidelines does recommend this for prisoners,
but not for the general public.
Q337 Dr Naysmith: I have been asking
questions about the use of benzodiazepine and SSRIs for the last
few years. It looks, quite clearly, as if benzodiazepine use is
dropping and being replaced by SSRI use. Is that something on
which you have any views?
Mr Woolas: I do not believe that
to be true. The number of benzodiazepine prescriptions has dropped
slightly, but it runs into tens of millions. There is a fallacy
in the Western world that the benzodiazepine problem was addressed
in the 1980s, particularly by the high profile campaigns, the
That's Life programme and other legal actions. In fact,
the prescription guidelines have not been enforced for the past
20 or 30 years. What has happened is that the media, understandably,
have paid attention to SSRIs, and Seroxat in particular. Personally,
I am supportive of the campaign of Paul Flynn and others but that
has not replaced the problem of benzodiazepines; it has supplemented
it and, in my view, made it worse.
Paul Flynn: It is alarming that
the level of prescriptions of SSRIs has now reached 25 million,
which is approaching the peak levels for benzodiazepines. It is
so depressing to look at the answers for treating depression,
including mild depression, over the past 150 years. The miracle
drug for Sigmund Freud, of course, was cocaine, which he used
himself and recommended for his patients. Heroin was then introduced
as an answer to opium addiction. Then the bromides were introduced;
again, those did enormous damage at the time of the First World
War. We have gone through a succession of drugs and now the benzodiazepines,
the tricyclics and the SSRIs have all been introduced as non-addictive
drugs with great utility that will be very successful in treating
depression and in treating addiction. In fact, all of them have
been used as the answers, the cures, to problems that they themselves
have created. This is an uncanny repetition of the same mistake
being made by the medical establishment over a period of 150 years
of introducing cures that turn out to be curses and problems.
We now know the difficulties with the SSRIs, which were introduced
because they did not have the effects of the tricyclics. Those
are now being exposed. The awful part of this, and this comes
from someone who like most of us has had scientific training,
is that we always believed in the integrity of scientific trials
but we realise, to our horror, that the scientific trials have
been fixed; they have been suppressed; data has been found, as
in the Lancet report of April of this year, that the conclusions
of the trials were different from the data. We know that organisations
as eminent as the MHRA rely not on the data of the trials but
only on the conclusions. I believe that a great confidence trick
has been perpetrated on the world by the pharmaceutical industry
which has behaved in a disgraceful way. I hope the case that is
going on in America now about the trials of SSRIs will bring the
pharmaceutical industry back to a position where they behave with
honour and integrity. There is certainly a wealth of evidence
that they are not doing that now.
Q338 Dr Taylor: I do apologise. Mr
Austin's declaration of interest means that I have to make one
as well. I am one of the Vice Chairs of the Associate Parliamentary
Health Group, which is funded by a wide range of industries. This
is still dealing with benzodiazepines. I am horrified to hear
from Mr Woolas that they are still prescribed in millions. Short-term
injections of benzodiazepines are still used for surgical procedures
and to enhance local anaesthetics. Are they still prescribed in
millions as tablets to patients?
Mr Woolas: Yes, they are. The
estimate of the mental health charity MIND is that 1.2 million
people in the United Kingdom are affected by addiction to benzodiazepines,
including Valium, Ativan and lorazepam.
Q339 Dr Taylor: So these millions
of prescriptions are all for the people who are already addicted?
Mr Woolas: That is exactly the
point. The difficulty is that because the drugs are so addictive,
particularly Ativan, and because the prescription guidelines were
not toughened until 1988, some 25 years after the introduction
of the drugs, and because even today the prescription guidelines,
which essentially limit a prescription to three weeks, are not
enforced and because the difficulties of withdrawal from the drug
make the problem worse in many cases, the easy solution is for
the doctors to carry on prescribing and for the patients to keep
taking them. That results in over 20 million repeat prescriptions
and over 1.2 million addicts in the country, many of whom are
elderly people living in residential and nursing care, but by
no means exclusively.
|
