Examination of Witnesses (Questions 363
THURSDAY 25 NOVEMBER 2004
Q363 Chairman: We express our thanks
to the second group of witnesses for your co-operation with our
inquiry. Could you each briefly introduce yourselves to the Committee?
Mr Thomson: I am Jim Thomson and
I am Chief Executive of Depression Alliance. In the interests
of declarations of interest, I should start by making one and
that is that although I have been with Depression Alliance for
three years, in my immediate previous incarnation I also came
into contact with the pharmaceutical industry. I was Director
of Fundraising and Marketing for the largest anti-vivisection
organisation in this country. Part of my role there was to play
an active part in undercover investigations into that industry
and its suppliers.
Ms Hirst: I am Jenny Hirst. I
am Co-Chairman of the Insulin-Dependent Diabetes Trust and as
such I am a volunteer with no conflicts of interest.
Mr McDonald: I am Glynn McDonald,
Head of Policy and Campaigns at the Multiple Sclerosis Society.
I am also a trustee of the Disability Alliance. The Multiple Sclerosis
Society provides the secretariat for the All-Party Parliamentary
Group on MS.
Dr Wallace: I am Helen Wallace,
Deputy Director of GeneWatch UK, which is a not-for-profit organisation
whose aim is to ensure genetic technologies are used in the public
interest. Our funding at the moment is largely charitable foundations.
Q364 Chairman: I think several of
you were here for the earlier session. You will probably be aware
oaf some of the written evidence we have received and you will
have had a chance to look at that written evidence. You will be
aware of something mentioned in the previous session, the suggestion
that patient organisations are the ground troops of the pharmaceutical
industry. I do not know whether any of you feel that that description
applies to your organisation?
Mr McDonald: No.
Mr Thomson: My organisation has
spoken to you several times in this and previous sessions. I do
not recognise the organisation from anything I have heard, so,
Q365 Chairman: To be fair to you,
may I give you the opportunity to respond to Paul Flynn's comment.
As you are aware, he was talking about the specific SSRI issue
and suggesting that there had been a courageous campaign pursued
by MIND, who receive no contribution from any company, but silence
from SANE and Depression Alliance who accept donations. Would
you all respond to that? Is that an unfair criticism?
Mr Thomson: I would love to respond
to that. He says in his memorandum that there is worldwide alarm
because of the effects of SSRIs. There is not worldwide alarm
but there is an investigation ongoing in this country, which I
believe is going to report back soon. There was alarm caused by
the so-called heroic (I think that was the word he used) coverage
by Panorama. May I say for the record that I do not find
it particularly heroic when a programme goes to air and the principal
resource offered to people that it is going to alarm is a help-line
that has been shut for a month. I spent all day the previous day
before that programme on Panorama went out trying to get
Panorama to put another resource up there and not to broadcast
a number that had shut, but there we are. He further says that
there has been silence from SANE and Depression Alliance who accept
donations. As he well knows, there has not been silence from Depression
Alliance. In fact I have written to Paul Flynn on four occasions
and he has written back to me on a number of occasions. I gave
up the correspondence when it became clear that the points I was
making about the role of a charity as opposed to the role of the
regulator were falling on deaf ears. It is not Depression Alliance's
role to campaign in that way. In fact, a political campaign of
that type is strictly prohibited under charity law. We have not
Q366 Chairman: You would strongly
refute his argument that your organisation has in some way been
compromised on this issue?
Mr Thomson: On five separate occasions,
one in person and four in writing, I have asked Mr Flynn to provide
one piece of evidence of where my organisation has been in any
way influenced by the pharmaceutical industry and he has been
unable or unwilling to do so. In fact, for the purposes of the
Committee, I have brought a copy of everything that we produce
here and I repeat that offer. If anybody can show me one example
of pharmaceutical industry bias, and given what I told you about
my previous incarnation I suggest I am the last person to not
recognise bias, then I am quite happy to offer my resignation.
Q367 Chairman: We discussed in the
previous session the difficulties that some organisations have
in functioning without support from the industry. Mr McDonald,
what impact would it have on your organisation if the resourcing
you receive from the industry was no longer available?
Mr McDonald: The effect would
not be so much upon our organisation as upon people with MS. May
I explain the way in which we receive money from the pharmaceutical
industry? Our turnover is about £28 million a year. We are
involved with a scheme which receives donations from three manufacturers
of disease-modifying drugs for people with MS where those companies
each put in £350,000 over three years, which is matched by
£350,000 from the MS Society. We act as an independent administrator
for that money. It goes direct to the NHS to fund MS nurses. That
arose out of the risk-sharing scheme for provision of disease-modifying
drugs. The Department of Health wanted the industry to contribute
towards development of infrastructure for delivering those drugs.
At the request of the Association of British Neurologists and
the UK MS Specialist Nurses Association, the Society stepped in
and offered to act as an independent broker for that money to
put a gap between individual companies and individual nurses.
If that money was withdrawn, the effect would not be on our organisation
because we do not actually benefit from that money directly; it
would be on people with MS who would have less access to MS nurses.
Q368 Chairman: Do you think that
more could be done to develop that kind of principle whereby there
is not the direct connection between the patients' organisation
and the company? Have you other ideas on how that might evolve?
Mr McDonald: I think what causes
some discomfort, and there are numbers of specialist nurses around,
is the idea that there might be direct link between those individual
practitioners and individual companies. We were quite happy to
act in the role which was requested of us, to act as an independent
intermediary. If I can give you an example of how that works,
we receive the money from the companies; there is then an advisory
panel which decides where the money should go. There is a bidding
process and a panel decides in which areas that money should be
allocated. There is no drug company representation on that group,
and so there is no suggestion that nurses are being put in areas
where the drug companies see an opening for their market. They
are going to places purely decided on the basis of need.
Q369 Dr Naysmith: This question is
to Helen Wallace. The issues that GeneWatch is concerned with
tend to be technical and have a different kind of applicability
to what we have been talking about this morning, the side-effects
and so on, and very laudable they are. Do you think they are of
concern to any other patient organisations? Have any other organisations
come in behind you on that?
Dr Wallace: Yes. We have done
some work with the Consumers' Association, for example, on the
direct marketing of genetic tests to members of the public. Our
particular concern and the issue I have raised in my submission
is about healthy people; it is not so much about patients but
about disease mongering, if you like, to people who are told they
are at risk of becoming ill in the future. One of our concerns
is that there is not an organisation really that will represent
the views of those people in government policy or in regulation
and that we therefore need to consider new mechanisms to get the
broader public involved in this debate.
Q370 Dr Naysmith: have you ever come
across any opposition from patient organisations or consumer organisations
to the kinds of thing that you are doing with the idea that you
might be blocking progress for them or their supporters?
Dr Wallace: We have been criticised
by one of the patient organisations, the Genetic Interest Group,
yes, for work that we have done.
Q371 Dr Naysmith: What sort of group
Dr Wallace: They represent groups
of people with genetic disorders mainly, a collection of different
charities. They do play a role in a lot of consultative meetings
and they do take pharmaceutical industry funding.
Q372 Dr Naysmith: Do you think the
pharmaceutical industry has any role to play in this kind of negative
Dr Wallace: I can certainly say
that the industry is not happy with the kinds of things that we
are advocating in terms of regulation of genetic tests. They have
told me, of course, that they are opposed to increased regulation
of genetic tests. I am not aware of any action that they have
specifically taken to try to prevent us from raising these issues.
Q373 Dr Naysmith: Could I turn to
Mr McDonald and mention something from your submission? The Society
states: "Where the Society is in partnership with the industry,
publication of results is always expected." Why do you think
that is so important?
Mr McDonald: That is purely for
reasons of transparency. With any research which we as an organisation
finance, and at the moment we have about £12 million of research
commitments, it is an absolute that all the results of those trials
or research projects are published. We would expect that to apply
if we did any joint work with the pharmaceutical company. Equally,
we would expect it if it was something being done entirely independently
by a pharmaceutical company. We want publication of all results
Q374 Dr Naysmith: Would you take
that as far as terminating your partnership with a pharmaceutical
company if it refused to publish something, and publish something
in a timely way as well?
Mr McDonald: In practical terms,
that would happen before any joint work took off if it became
apparent that there were any kinds of restrictions on publication.
Once we had set out an agreement, if it then appeared that there
was a reluctance to publish, we would not continue with that arrangement.
Q375 Dr Naysmith: Turning to Jenny
Hirst now, you have been quite critical in your submission and
you suggest that the commercial influence of the industry and
the culture of secrecy in UK drug regulation leads to "largely
poor quality research". What do you mean by that? Can you
justify that statement? Why is the research of poor quality?
Ms Hirst: Relying on the evidence
of the Cochrane reviews, which we certainly class as independent
and good quality reviews, for insulin, for instance, the genetically-produced
insulin, at least 80% of the research was funded by the drug industry
and both Cochrane reviews have shown that it was methodologically
poor. It has not it looked into the long-term effects of the insulin
and obviously for people with diabetes that is key. It concerns
us that this sort of research has been relied upon for the approval
of drugs and for people to make decisions upon.
Q376 Dr Naysmith: Yet there have
been some amazing advances in using different forms of insulin
in diabetes compared with even 10 or 15 years ago.
Ms Hirst: Have they, in fact?
There is really not the evidence to show that. What we have actually
got now are genetically-produced insulins where there is no evidence
to show that they are better or more reliable, but they are far
more expensive. The cheaper animal insulins, which have a long
history of safety, are not even advertised and doctors and diabetes
specialist nurses tend to think that animal insulins are not available
any more because they are not advertised, again an influence that
the drug companies are having.
Q377 Dr Naysmith: Would you tend
to say that these influences are such that drug regulation is
failing to protect and promote patients' health? Is that a statement
you would agree with? If things were better regulated, it would
be better for your patients?
Ms Hirst: Yes, and I am unhappy
about the relationship between the drug companies, the MHRA, and
the role that patients cannot play in all of that.
Q378 Dr Naysmith: How would you rectify
the situation? What would you expect your organisation and other
patients' organisations to do to improve this? What would you
be able to do?
Ms Hirst: What would we like to
be able to do? We would like to be better represented within the
regulatory authorities; to ensure that there is greater transparency;
be allowed, as it were, to look at the research properly; to have
access to the yellow card scheme and the adverse reaction reports
and be able to report. I realise that that is supposed to happen,
that patients are going to be able to report, but I think patients
need all of that information. They need to be able to access it
if that is what they want.
Q379 Dr Taylor: May I go on along
that tack just for a moment? You are content that there is no
advantage of the genetically-produced insulin over the others
and the only rationale for them is that they make more money for
the drug firms? Am I over-stating you?
Ms Hirst: You are over-stating
me. A wide variety of insulins need to be available to suit all
needs, but what we have now got is increasing pressure from the
industry to make us believe that the genetically-produced ones
are better for everybody, which I do not believe.