Examination of Witnesses (Questions 152
THURSDAY 14 OCTOBER 2004
Q152 Chairman: Colleagues, we have
one further witness who will be with us in a moment or two. Can
I welcome our second group ? We are grateful for your cooperation
with the inquiry. Can I begin with apologies that I and my colleague,
Mr John Austin, will have to leave at 12.30. In my absence Dr
Doug Naysmith will be called to take the Chair. We mean no discourtesy;
unfortunately we both have other commitments, but I hope we can
get through the business by then. Can I ask you to introduce yourselves
briefly, starting with you, Mr Brook?
Mr Brook: Yes. My name is Richard
Brook. I am Chief Executive of Mind, the mental health charity.
Professor Healy: I am David Healy.
I work in what used to be University of Wales College of Medicine,
which has just recently changed into Cardiff University.
Q153 Mr Amess: As you know, gentlemen,
this inquiry is called "The Influence of the Pharmaceutical
Industry", but what we would like to hear from you about
is are there differences between the way the major pharmaceutical
industries display their influence and actually operate? Perhaps
if you could name a few of the companies and enlarge on the way
you perceive their influence to happen in practice?
Mr Brook: I am happy to start
,Chairman. My experience is limited to what has obviously been
a very high profile issue around anti-depressants, and I have
seen, I think, quite clearly through my time sitting on the Expert
Working Group which is part of much of the SSRI's investigation
of the last two years into this, very clear influences, I think.
You only have to look at, for instance, the Committee on Safety
of Medicine's declaration of interest which has been recently
updated to see three-quarters of the committee actually have defined
a personal or non-personal interest, not defined by size, and
you only have to realise that that raises a whole issue of transparency,
and, as you have already heard in evidence today, the relationship
between those members and the drug companies and what is going
on. I do not want to make any allegations, but you just do not
knowthe transparency is not there. You ask for two very
specific examples. The two that I would give at this point would
be GlaxoSmithKline in terms of the issues of Seroxat and Wyeth,
which I do not think has been generally mentioned before in relation
to venlafaxine and Effexor. Both of those companies had at least
two years before the information went to the MRHA, evidence in
relation to paediatric trials, and neither of them bothered to
place that evidence into the MRHA's domain, and in both cases
those drugs were subsequently contra-indicated. I do not know
about the other SSRI drugs because the dates on their trial data
was never given to me as part of that expert group, but the two
that have got dates related to them, both of them had information
two years prior to the MHRA having that information. I have raised
that issue several times, it has been very high profile, and to
be honest, to this date, as far as I know, nothing has been done
about that; and particularly in relation to Wyeth, which, I think,
is of particular concern, it has never actually been acknowledged,
despite correspondence between myself and the MRHA, that there
is an issue: because they claim it is investigated, they claim
it is secret under the 1968 Medicines Act and they threaten prosecution
if someone like me says that they will actually raise those issues
Mr Amess: Mr Brook has chosen to be negative
about two companies, but, the other two gentlemen, do you want
to say some nice things about any
Chairman: I am not sure Professor Herxheimer
heard your question. He came in part way through your question,
so perhaps you could briefly repeat your question, and perhaps
I could ask him to introduce himself as well.
Q154 Mr Amess: Thank you Chairman.
Would you tell the Committee who you are?
Professor Herxheimer: I am Andrew
Herxheimer. I am a medical pharmacologist.
Q155 Mr Amess: As you know, this
is an inquiry into the influence of the pharmaceutical industry,
but there would appear to be differences in the way the major
pharmaceutical companies go about influencing general matters.
Mr Brook has just decided to be a bit negative about two companies.
Would you gentlemen want to praise any of these major pharmaceutical
companies or have you got some axes that you would wish to wield
Professor Herxheimer: I have had
interactions with many pharmaceutical companies and I cannot recall
one that I would wish to praise.
Q156 Mr Amess: Right. Well, that
is that! What about you, Professor Healy?
Professor Healy: Okay, if I can
come in on this. One of the things I do is I go round and try
and work on the history of the field, which means that I interview
people who were working in the area during the Sixties, the Seventies,
the Eighties, people who worked within the industry, people who
worked clinically whatever, and there was a feeling, I think,
up to about 10 to 15 years ago that the practices of pharmaceutical
companies based over in the US were somewhat sharper than perhaps
the practices of the pharmaceutical companies based over here.
I think that has changed now, and I think, broadly speaking, all
of the companies take much the same approach. I would not, like
Andrew Herxheimer, say that this is always a bad thing that he
would not wish to praise. If you hold shares with pharmaceutical
companies you want your drugs marketed most effectively, and I
think almost all the companies take the same approach to these
issues these days which involve an increasing proportion of the
articles on which physicians like me actually depend being ghost-written,
which involve those articles not actually reflecting the raw data
from clinical trials that people like you, or your wives, families,
get involved in, take risks with or are injured by these pills.
The hazards that come out in these clinical trials do not get
translated through to the articles that shape "formularies".
The issue was actually raised earlier: would we not be able to
really sort this all out if we just had a decent "formularies".
No; you would not, because the problem is not the ad', the problem
is not the free, kind of like . . . Because what you find these
days is people like me are brought to the Caribbean. We come out
of the meeting halls with our arms stuffed full of bags of free
gifts, free rulers, free pens, free mugs, that have the name of
the drug on them. We have had our massage done, portrait painted
Q157 Mr Amess: You have had your
Professor Healy: People have a
massage done, their portrait painted, and are ambushed by the
media who hold up the mike and say, "Doctor, are you not
influenced by this?", and the answer from people like me
and almost all the physicians you would meet is, "No, we
are not." The media say, "What does influence you then?",
and the answer is we are influenced by the articles we read, the
articles in the BMJ, the articles in the the Lancet.
If you look at the BMJ these days you will see an advert
on the left-hand page and an article, or the first page of an
article, which appears to be a randomised controlled trial on
the opposite page, and we all look at these things and think,
"If only the BMJ did not have the adds in it, things
would be fine, and if they had more of these articles which are
controlled clinical trials, this is the way we need to move forward."
But industry twenty odd years ago or so actually began to realise
that, "Yes, if physicians say they are influenced by the
evidence, what we are going to use to influence them is the evidence",
and they began to ghost write up the trials, and increasingly
the articles that are written in the BMJ and the Lancet will not
just be ghost-written but will not represent the raw data from
the clinical trials that they purport to represent; and this can
lead to the kind of situation where, if you make "formularies",
the drugs that you will put on the "formularies" that
appear to be the most evidence-based will actually be less effective
than the ones that you are actually removing from the "formularies".
Q158 Mr Amess: Before moving to my
next question, you have got an awful lot off your chest; you want
to have a get together with the free lunch chap! Did you enjoy
your time in the Caribbean?
Professor Healy: Well, yes, I
am in a position to speak to all these things, and the issue was
raised earlier, having worked very closely with the industry,
having been a person who has actually spoken for the industry;
so I know just what the practices are. The issue, the interesting
issue for me has been just the issue of what is going on here.
You hear very clearly from the industry that actually the sales
department who want to give the free pens, the free mugs, they
know that these do not have quite the influence that you think,
and they even play on the fact that physicians like me know that
we are not really going to be influenced by this, or at least
we think we are actually not going to be influenced by this, but
that we are going to be influenced by the articles. So the drug
reps when they come round to see me will have the free pen and
the free mug and the sheaf of articles, and the article is the
advert these days.
Mr Amess: This is all very interesting.
Members of Parliament could never be influenced in such a way!
Q159 Mr Naysmith: The pharmaceutical
industry is not going to be terribly pleased with what you are
saying today. I just want to know what produced the road to Damascus
moment for you?
Professor Healy: Nothing in particular.
I have actually been writing about these issues for the last fifteen
years or so. There has been no particular change in the issues
that I have actually been writing about.