Examination of Witnesses (Questions 400
- 406)
THURSDAY 25 NOVEMBER 2004
MR JIM
THOMSON, MR
GLYNN MCDONALD,
DR HELEN
WALLACE AND
MS JENNY
HIRST
Q400 Dr Naysmith: How can you achieve
the balance that we were just talking about between informing
sick people of, say, a new medicine and making sure that people
know about it and get its benefits and inadvertently increasing
the number of the worried well who are not depressed? I know people
can feel unhappy and miserable periodically and not necessarily
be clinically depressed. That was the basis of the conversation
we were having in the House of Commons a few weeks back. How do
you get the balance right?
Mr Thomson: I am not sure I understand
the question.
Q401 Dr Naysmith: You have new products
and people recognise that they are useful and functional and have
a benefit to confer for people who suffer from a disease but at
the same time you could convince quite a lot of people that they
would be happier if they were on this product as well if you were
not careful. Is it not a problem?
Mr Thomson: I suppose it could
be. I fail to see how, in what we do, it would be an issue because
what we are predominantly doing is raising awareness of a condition
which I hope we all accept exists. I can see how raising awareness
of that issue by definition is likely to convince people that
they have it, but that is for the doctor's diagnosis to confirm.
Q402 Dr Naysmith: None of these people
are rushing along to see GPs with bits of paper off the web or
what they have read in The Guardian or The Telegraph
saying, "I think this applies to me. Can I have some of it?"?
Mr Thomson: I hope they do because
it is a vastly under-diagnosed condition. On average, it takes
nine visits to the GP in this country to get a diagnosis of depression.
There is a legitimate job there to raise awareness of the symptoms.
There are 2.9 million people with a diagnosis of depression in
this country. There are several million more who probably have
that condition and have it undiagnosed, largely because of the
stigma still surrounding the condition. In terms of what we produce,
the link between new treatments is way further down the line and
any new treatment, once it had been approved by regulators, would
come into our literature and stand or fall alongside all the other
treatments. We do not recommend any treatment at all.
Dr Wallace: One thing that would
help would be to involve a wider constituency of people in decisions
that are made. For example, NICE is starting to do that with its
consultative panel. Then you would involve not only the people
who are at risk and get ill but also the people who have been
told they are at risk and do not get ill, often a much larger
number of people. You would change the interests, if you like,
of the people informing the decisions.
Q403 John Austin: I want to come
back to the regulatory process. Clearly it is in the interests
of the pharmaceutical industry to get its new products on the
market as quickly as possible. In that they may be aided and abetted
by pressure from patient organisations and patient groups. Over
the last decade, do you feel there is any evidence that patients
have been put unnecessarily at risk by an acceleration of the
process?
Ms Hirst: Yes. I do not think
there is sufficient evidence to warrant the speedy acceptance
of some of the drugs. I accept that with certain conditions getting
a drug on the market as quickly as possible is essential but if
we take the insulin issue there is no urgency about getting a
new insulin onto the market, so why does it go through the regulatory
process quite so fast without, in my view, the evidence being
strong or being looked at sufficiently?
Mr McDonald: In terms of the disease-modification
and finding therapies for multiple sclerosis, the issue is not
so much the idea of risk with things being brought to the market
quickly but of the possible long term benefits. This is why we
have the 10 year monitoring scheme which is agreed with the Department
of Health. There is an issue around drugs which are licensed on
the basis of relatively short term evidence, if they are going
to be used in some cases for decades. That 10 year monitoring
study which is underway at the moment is intended to look at the
longer term benefits in addition to the shorter term benefits
which have been demonstrated for those drugs, but obviously it
also has the benefit that, if there are risks attached to taking
the drugs over a longer period than is usual in clinical trials,
that will tend to emerge from that study as well.
Mr Thomson: There are two parts
to the question. It is not something I have considered before
but, off the cuff, the condition I represent is one which, if
left untreated, will lead people to kill themselves. I would be
in favour, as long as due diligence is observed, if there is a
new treatment which is effective, and I would want to see it on
the shelves as soon as possible and being in a GP's armoury. Where
Mr Flynn and I agree—those are not words I have ever said
before—is that, once a drug is in use, I would like to see
regular monitoring of it and we leave ourselves open to criticism
as a society if we do not implement that, certainly in the first
few years of its introduction. I agree with him also that the
yellow card scheme in the vernacular is a bit of a pup. I would
certainly support any moves to strengthen that, which would incur
more cost for the industry, but I do not think it falls to industry
to do that. I think it falls to us as a society to implement those
things.
Ms Hirst: I support that. If there
was proper monitoring over the long term, a lot of concerns would
go away. It is the fact that a drug comes onto the market and
then what happens? We often talk about long term benefits, forgetting
that all drugs have long term risks as well and I think that is
key to having proper monitoring.
Q404 John Austin: Some drugs and
therapies will react differently with different people. A drug
which is very beneficial to one group of patients may cause severe
harm to others. Does a patient organisation have to be particularly
wary of the influence of the pharmaceutical industry in those
circumstances and perhaps need to bring pressure on the pharmaceutical
company to present that remedy as a therapy of last resort?
Mr Thomson: We are almost coming
back to the issue of patient information leaflets. I would support
a crystal mark or a far simpler method of producing patient information
leaflets that a patient with that condition can read and understand.
The litigious nature of the business is such that these patient
information leaflets run to several pages. Companies are forced
to produce them in that way. I have some Neurofen here which I
had to take earlier on, having over indulged after the Arsenal
match last night. The patient information leaflet in that would
dissuade me from ever taking it and yet I take it routinely because
I digest the information and take it with a pinch of salt. Antidepressants
are powerful medicines and I would like to see sensible patient
information on there that people understand and can use to exercise
choice. It is simply not there at the moment.
Q405 Dr Taylor: I was so interested
that you said you thought it was society's responsibility to monitor
for side effects after the explosive sales when drugs are released,
because so far everybody has told us that they thought it was
industry's responsibility in that phase immediately after the
preliminary release, when it is released to the wider population.
How should society do this?
Mr Thomson: Society is probably
wrong. I think it is your responsibility. Once a drug is approved
for use and licensed, you may well want to involve industry because
they are likely to have the data but, as we have heard, that data
is often called into question so I think it is the regulatory
body's responsibility to ensure that that ongoing monitoring carries
on. The regulatory body is woefully under-resourced. How many
people work in the MHRA to police this activity? 60 odd? It is
preposterous.
Q406 Dr Taylor: Do you think there
should be a limited release to begin with, limited prescribing?
If it is a really major advance like the anti-TNF drugs, they
are only allowed to be prescribed by NICE guidelines and by limited
people, whereas something like Vioxx was released to everybody.
Ms Hirst: We did have at one time—I
do not know whether it still exists—a post-marketing surveillance
body which was independent. It seems to me that it would be unrealistic
to expect drug companies to be open, above board and totally transparent
in monitoring their own products. I am sorry if I sound cynical
but I really do think that is unrealistic. An independent body
like that could monitor.
Chairman: Can I thank our witnesses for
a very helpful session? We appreciate your cooperation with our
inquiry. Thank you very much.
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