Examination of Witnesses (Questions 360
- 362)
THURSDAY 25 NOVEMBER 2004
MS MELINDA
LETTS, PAUL
FLYNN MP, MR
PHIL WOOLAS
MP AND MR
CLIFF PRIOR
Q360 Dr Naysmith: This will probably
be the last question. There have been questions about the reliability
of summaries of product characteristics. I know you have strong
views on these, Paul.
Paul Flynn: From listening to
what has been said, it is revealing—and I think we are all
used to this—that the person who actually writes the documents
is the one who has the power and it is the pharmaceutical industry
that writes these documents now. Then there is approval by the
CSM. What is significant is that neither the CMS nor the MHRA
nor the industry has exposed the scandals that we have had and
the dangers of the terrible side-effects. Recently drugs have
been exposed by programmes like Panorama. One patient organisation,
not one in the pay of the pharmaceutical industry but MIND, did
the heroic job on the MHRA by resignation on this, together with
groups elsewhere in the world. We have to look at the position
we are in where the might of the pharmaceutical industry is enormous,
where their tentacles of power go through the whole of the medical
establishment, including the regulatory bodies and into the patient
organisations. We need a stronger voice and transparency to defend
the patients' interests.
Q361 Dr Naysmith: In a way, that
is the nub of this whole question. There have been suggestions
that the drug manufacturers use the summaries of product characteristics
to mislead readers about their products. This might be a question
for Melinda Letts. How can this happen when SPCs are jointly produced
by the company and the regulator and in law have to be consistent
with the licence?
Paul Flynn: I think they are very
resourceful in ensuring that their case gets across. We would
all share what I think is behind your questions, the view that
the advice given is not adequate and masks the potential side-effects
in many cases. They are often written in a way that is not readily
understandable to most of the patients who receive them, and certainly
they have a long history, which is part of their nature, it is
endemic to pharmaceutical companies, to deny the danger, the "addictivity",
of their products. Over the 150 years that I mentioned all these
drugs were all sold as harmless drugs that were non-dependent.
Every one of them proved to have little utility, be damaging and
addictive or encourage dependence in some way. We cannot ignore
where we are now with a history of pharmaceutical companies behaving
in this way for 150 years. There has not been some change. With
new drugs we are still conducting experiments on a massive scale
on the public. They might have been tried on animals and trials
might have taken place but the whole confidence we have in trials
has been undermined by what has happened with GlaxoSmithKline
and Seroxat. The duty of all of us I believe, and I am sure it
will come out in your report, is to make a stand for organisations
to be strengthened to defend themselves against the insatiable
greed of the pharmaceutical industry.
Q362 Dr Naysmith: You have made your
case very strong.
Mr Prior: Leaving aside the specific
cases where evidence has been concealed or distorted or whatever,
I think it is also true to say that no amount of pre-marketing
studies on medications will reveal what the large-scale use, once
they are on the market, will reveal. We need to be much more ready
to go out proactively to check for side-effects in the first couple
of years of marketing and be prepared to hear those messages and
proactively ask people, "What are you experiencing?"
There is a deeper malaise here. There is a myth, particularly
in the British public that I do not find elsewhere in the world,
that there is one set of nice, clean, effective drugs with no
side-effects and there is a nasty set of toxic stuff that evil
pharmaceutical companies adopt and peddle to us. This is a complete
myth. There is nothing that you take by way of a drug which does
not have risks attached to it. All drugs carry some benefits and
some adverse effects. We can know some of that before things are
marketed; we can know a bit more afterwards, but everybody has
their own body and their own mind and will have different experiences.
We need to enter into this with a much greater degree of scepticism.
Ms Letts: I simply wanted to add,
in response to your question, that one of the things the working
group is looking at is improving the readability guideline and
introducing much better ways of communicating about risk, as well
as introducing some supplementary information about side-effects.,
for precisely the reason that Cliff Prior has referred to, that
people often do not understand that there are likely to be side-effects
with anything that you take. With my 13 years background of working
for people with long-term conditions of one kind or another, what
I have to bear in mind all the time is that for many of those
people it is a matter of having to weigh up the benefit of the
drug against the side-effects that they may have to put up with.
The public find it very difficult to understand how to weigh up
risk and benefit. We have been looking at that on the working
group. I do think it is relevant here to say, and it is one of
my recommendations to this Committee, that patients should have
the absolute right to inspect the evidence that led the regulators
to license the drugs in the first place. It is wrong that that
is not the case.
Chairman: May I thank you, Ms Letts and
gentlemen, for a very interesting session. We are most grateful
for your co-operation.
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