Examination of Witnesses (Questions 580
- 599)
THURSDAY 16 DECEMBER 2004
MS MARGOT
JAMES, MR
MIKE PALING,
MR RICHARD
HORTON, MS
JENNY HOPE
AND MS
LOIS ROGERS
Q580 John Austin: Do you have examples
of where they might have been giving misleading information? For
example, on the testosterone patches you said in your evidence
that there is also an increased risk of raised cholesterol and
heart disease as well which presumably the company—Proctor
and Gamble—manufacturing it are aware of. Have they at any
time attempted to suppress that information?
Ms Rogers: I cannot recall having
asked the direct question when I eventually got through to someone
who was put up as the company spokesman; they were too junior
to deal with that sort of question anyway so I never went down
that track particularly. There have certainly been other occasions
at regular intervals where people ring you up and tell you things.
As a journalist you do not want to miss anything so if somebody
tells me something that sounds phenomenal and plausible then you
have to check it out. If it turns out to be completely and utterly
untrue then I would make the time to ring back the source and
tell them that they have wasted however much of time and also
make it clear that any subsequent approach would not be looked
on favourably. It is a give and take relationship. If people are
helpful and truthful you build up a relationship with them where
you respect them. If they say you are wasting your time on this,
whatever you have been told is actually not quite how it is, then
you know not to pursue it.
Q581 John Austin: You have the luxury
of not being a daily driven by embargos and having the time to
investigate. I wonder if Ms Hope has a similar experience.
Ms Hope: I am sorry to disappoint
you; I cannot think of any specific examples of active obstruction.
As Lois says, it is more the case that they might not get back
to you or they might be economical with their answers and that
could be because you have asked the wrong question. That happens
even when I ask some government departments; I might not get the
right answer because I have not asked the right question. I just
want to add to the testosterone patches story because we published
a story saying that testosterone patches offered some relief to
symptoms in eligible women based on a paper given at the American
Society for Reproductive Medicine. I think it was in October.
I was there and saw the paper being given, looked at it, went
to the press conference where they presented the details again.
I asked about side effects, side effects were included in our
story. They had a company spokesman there, very upbeat and, as
is to form, I included one quote from him saying, "I hope
to get marketing approval" but I did not feel I was a particular
target of the marketing campaign but obviously, as Lois suggests,
they are getting papers together, presenting them at conferences,
putting them into journals and then they become a potential news
story.
Q582 Chairman: You went to the States
for that.
Ms Hope: Yes.
Q583 Chairman: Your paper paid for
that presumably.
Ms Hope: Yes.
Q584 John Austin: Since the other
question I was going to ask has already been asked, I want to
go back to something that Dr Horton said earlier about the food
chain. I am not sure whether you are prepared to name names as
to those publications which are lower down the list, but reference
was made earlier to general practitioners and general practitioners,
by their very nature, are generalists. The Lancet publishes
very specialised and specialist articles which perhaps general
practitioners might not have the time to study in detail. What
they do get weekly is a whole range of magazines, presumably sponsored
by advertisements and the pharmaceutical industry which gives
them easily readable information or mis-information. Would you
say that the presence of those magazines was overall helpful or
a malign influence?
Dr Horton: Definitely a malign
influence.
Q585 John Austin: Would you name
the magazines? What are these magazines?
Dr Horton: There are many magazines
that get given out to general practitioners and it would almost
be invidious to name one because it would put a focus on one rather
than another but you are right, I can probably count on the fingers
of one hand the number of general practitioners who read The
Lancet in the UK; you are quite right, nobody is going to
read The Lancet, it is not written for them.
Q586 John Austin: That is not a criticism.
Dr Horton: No, it is just that
that is not who we are; that is not what we do. So you have theses
intermediaries and the intermediaries may be through a promotional
campaign or advertising, a drug representative visiting where
the work that is published in general is completely distorted—I
have examples if you want me to go into that—so that the
general practitioner would see the results of a study and be completely
misled as to the efficacy and safety of a particular drug. Or
what happens is that with these controlled circulation free newspapers
that will come to doctors the reporting of the studies there or
the presentation of those studies at meetings again often is filtered
through company PR systems. To take an example, if you have a
big meeting—a research conference—where work is presented
many of the journalists who will be attending—I am not talking
about Lois or Jenny here, but journalists on these sorts of free
newspapers—will have had their travel and hospitality paid
for by industry.
Q587 Chairman: Which is why I asked
that question, obviously.
Dr Horton: Exactly. They will
go with the express purpose of covering the conference but particularly
to cover the conference about the products made by the company
which is paying for their travel. It may not be the company that
has taken them; it may be a PR company working on behalf of the
pharmaceutical company involved. They will go, they will go to
the satellite symposium, they will write up the story and that
will then get published in their newspaper. That is what the general
practitioner will read. Again, there is no identification that
the travel was paid for by the company, no identification that
this journalist was there for just 24 hours to go to the sponsored
satellite symposium, no indication that the way that study has
been reported is misleading. The quality control here is appalling.
Q588 John Austin: Does this also
lead to unnecessary prescribing?
Dr Horton: I think you have examples
of that. You have examples—whether it is SSRIs, Vioxx or
other drugs—where you can see that the prescribing rate
has gone up hugely and then you have a public health disaster.
Ken Woods, Chief Executive of MHRA, said only the other day—I
think last week—that there had been over-prescription of
SSRIs. Yes, the way drugs are marketed and the way that information
gets seeded in the pseudo literature as well as advertising material
has enormous impact on prescribing habits.
Q589 John Austin: Could I raise one
which has not had a great deal of publicity and is costing the
NHS an enormous amount of money at the money, and that is the
prescription of proton pump inhibitors—PPIs—when there
are much cheaper remedies which are applicable to most people
who might turn up at their general practitioner's surgery. Has
that been influenced by marketing campaigns by the pharmaceutical
industry?
Dr Horton: Yes, and the classic
case example that we talk about a lot is the way AstraZeneca very
successfully took omeprazole to Nexium which had a little bit
of fiddling with its formulation but was essentially the same
drug, got marketing approval for what was a new branded drug—supposedly—and
kept the patent life for that supposedly new drug when in fact
it had no competitive advantage on now what was a generic medicine.
Yes, there are very good examples.
Q590 John Austin: Does Mr Paling
share your concerns?
Mr Paling: When you were talking
about the issue of PPIs—proton pump inhibitors—unless
I am wrong I thought that NICE had recently deliberated on the
treatment of oesophageal reflux and said that these were the treatments
to use. They did put the caveat in that it should be the cheapest
and I do not think that is a negative issue at all; I think that
is important. I think that proton pump inhibitors have made a
tremendous difference.
Q591 John Austin: In that specialist
area?
Mr Paling: In the treatment of
all the conditions that they are involved in. Their big impact
has been on ulcers, first of all the H2 days of Zantac and so
on and these treatments have literally wiped out the need for
surgery for the treatment of ulcers. I think they have value;
I am not arguing the case for them one way or the other but I
think they have value and I think we have to be careful not to
make too many sweeping statements as I said before because I think
there are drugs which have brought tremendous benefit over the
last years where appropriately used and used in the right patients
and used in the right way. I do not want to swing the pendulum
too far the other way. I do take issue with something that Dr
Horton said when he said that drug representatives are there to
feed doctors rubbish. I do not know whether he means the information
they are giving them or that the products are rubbish, but given
that journals—including The Lancet—carry advertising
for pharmaceutical products, I do not know whether that is vetted
by The Lancet before the adverts are allowed to appear,
but advertising is an important function of all of these publications.
I would also say that when we are talking about what general practitioners
read whether this is right or wrong the bulk of the readership
to my knowledge seems to be in news-based publications not pseudo-scientific
or scientific publications. They are not reporting on clinical
trial results; they are giving doctors other information whether
it is political or news or whatever. That is where the bulk of
the advertising goes in my experience.
Q592 Dr Naysmith: I want to explore
the area of voluntary regulation that all of you are under in
terms of putting out the information that you put out and so on.
I am going to start by asking Mr Paling a question. The kinds
of bottom end of the market that Dr Horton was talking about in
terms of journals are often described as "the comics"
by GPs and I think quite a few of them understand that they may
not be fully scientific. What I wanted to ask Mr Paling was, you
say you adhere to the ABPI code of practice and guidelines and
that you are satisfied with the existing standards relating to
the quality of drug promotion. Why do you think there is such
concern about the practices of companies such as yours? Why do
you think that people do not have a particularly high opinion
of the work that companies like yours are performing?
Mr Paling: Just one comment first
of all about the journals, in terms of comics they are news based
publications, as I say. I think the ones that we have both got
in our minds are actually the highest readership amongst general
practitioners so it would suggest that it is their choice.
Dr Naysmith: They are given free or they
are sent through the post freely.
Q593 Chairman: If nobody else will
name names, will you name names? We are in the dark you see.
Mr Paling: Almost all of the publications
are free.
Q594 Dr Naysmith: There are so many
of them that if you name one or two or three then you are sort
of picking them out. Things like the GP and Hospital
Practice and things like that.
Mr Paling: In terms of how materials
are regulated for prescription products through the ABPI code
of practice—which is what we adhere to and obviously our
clients adhere to—the process there is a self-regulating
one and you are quite right to point that out. When we are talking
about pharmaceutical products it is a vast amount of knowledge
base, it is not like regulating advertising in FMCG consumer sector
where you may be looking at other things but you are not looking
at the same amount of data and I think it is important that a
large part of the self-regulation goes on at the company where
the highly responsible people—one of whom has to be a doctor—have
to regulate all the output. We have worked with client companies
on that basis for many years now and I think it is the most stringent
and incredibly accurate place to verify the output of the material.
The code of practice is very clear; the products can only promote
within their licence and their summary of product characteristics.
The checks and balances I think are very tight and I think if
a company does breach the code—and I am not saying there
are not breaches; there are breaches, I think about a hundred
a year and about 70% of those are upheld (the ABPI would be able
to give you that data)—that is taken very, very seriously.
It causes all sorts of problems within companies, not least of
which from a commercial point of view is loss of time while advertising
is removed, the cost of replacing it, which we obviously feel;
it has an impact on us as well. I do not think it is taken at
all lightly; it is a very detailed stringent system.
Q595 Dr Naysmith: Do you have any
worries about the length of time the advertising complaints procedure
takes from the time of a complaint being put in before there is
an adjudication?
Mr Paling: I cannot give you an
accurate answer on that I am afraid. I would imagine it is a matter
of weeks.
Q596 Dr Naysmith: It can take longer
than that; sometime six months. That is a disincentive. Why can
they not adjudicate much more quickly than that?
Mr Paling: I would have thought
they would be able to adjudicate much more quickly than that.
As I said, there is not a vast amount of complaints so there are
not a thousand complaints sitting waiting. I would imagine that
is something you would have to take up with the ABPI. I think
if there is a complaint, particularly if it is going to be upheld,
it should be adjudicated and sorted out very quickly.
Q597 Dr Naysmith: If one of your
adverts was found to be misleading would you be penalised in any
way or would this cause any problems for you?
Mr Paling: For our company directly?
Q598 Dr Naysmith: Yes.
Mr Paling: We have had a misleading
advertisement through the ABPI and it created a great deal of
difficulty between ourselves and the company concerned. Both of
us had to be carefully audited and monitored to see how that process
had occurred. It is important. Our relationship with our clients
is a very important one and we do not want issues like that to
get in the way, plus the fact that we do not want to be breaking
the code full stop.
Q599 Dr Naysmith: Have you ever withdrawn
from negotiations with a drug company because you felt that a
campaign they were asking you to undertake might be unethical
or misleading?
Mr Paling: No, never.
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