Examination of Witnesses (Questions 600
- 619)
THURSDAY 16 DECEMBER 2004
MS MARGOT
JAMES, MR
MIKE PALING,
MR RICHARD
HORTON, MS
JENNY HOPE
AND MS
LOIS ROGERS
Q600 Dr Naysmith: Have you ever come
across the need to argue or discuss that with a client, or you
just accept it?
Mr Paling: Not at all, no. The
ultimate responsibility for a campaign rests with the doctor inside
the companies and I think they could not be more careful, stringent
and totally honest with what they are doing in my experience and
in the work we do, which is advertising and sales promotion, as
you know.
Q601 Dr Naysmith: Ms James, do you
have anything you want to add to what Mr Paling has said?
Ms James: I would like to reiterate
the seriousness with which the code of practice is taken by our
clients and by ourselves. I was amazed to hear Dr Horton say earlier
that it has no teeth, it is just words because that really is
not the case. I have also noticed that over the time I have been
in the business—over 15 years—that the seriousness
in which it is taken has significantly increased. When I started
in the business the code was a bit over there and although it
was taken seriously the top directors would pay lip-service to
how important it was and the product managers would just turn
a blind other eye. Now that is most certainly not the case. Even
the product managers now go in fear of breaching it.
Q602 Dr Naysmith: Why do you think
that has happened?
Ms James: I think it is partly
a societal trend overall in business. I think the whole trend
of corporate social responsibility is having an effect and that
effect is being felt within pharmaceutical companies just as in
any other industry. That would be my first comment. I think also
the regulatory situation is becoming tighter around the world
and companies that start to get a bad reputation for breaching
ethical guidelines are probably going to feel the heat from the
regulators.
Q603 Dr Naysmith: Dr Horton, you
were talking to the Chairman earlier on and you were talking about
the rules that The Lancet has for conflicts of interest
for authors and editors and reviewers. In general terms do you
think your rules are effective? You told us about one example
where you discovered that you were being deliberately misled about
a paper, but do you think in general that they are effective and
you can be sure that you are not publishing anything that you
would not really want to be publishing?
Dr Horton: As you rightly point
out, the system is voluntary; it depends upon trust; it depends
upon good faith between ourselves and the authors who work with
us. Clearly there is room for great exploitation in that relationship.
I think that over the last four or five years we have made our
procedures much more robust. We have changed the conflict of interest
disclosure now so that you actually have to actively lie if you
are going to deny that you have had a conflict if you have in
fact had a conflict. We insist that we have a description of the
role of the funding source in the research: did they take part
in the design, the conduct, the analysis, the writing up and submission
of the paper. We did not used to do that. We insist on the naming
of all contributors to the paper including those who might have
been ghost authors of the paper. I think within the voluntary
nature of this we have done all that we can do. We have tried—that
is the editors of journals—have tried to strengthen this
and so the Committee on Publication Ethics that was created in
1997 was created largely out of a failure amongst us to persuade
those in medicine at the General Medical Council and some of the
other colleges and organisations that run medical research that
we need to actually go a step further and to create what we call
the Council for Research Integrity. This is a body that is a place
where complaints about the way research was done and reported
could be taken to that had legal teeth. If you look in some European
countries—particularly the Scandinavian countries—they
have statutory bodies where these kinds of issues can be referred
where there has been a breach of practice and sanctions can be
made against individuals, against sponsors and against universities
that have taken part in these malpractices. We have been singularly
unsuccessful—our failure—to persuade anybody that
we need such a body. There is great scepticism within the science
community because they feel this would be another layer of bureaucracy
and regulation and that is the last thing science needs. However,
from where I sit we desperately need it because we do not have
the teeth that we need to enforce these voluntary regulations.
Q604 Dr Naysmith: Do you think that
similar voluntary regulations apply to other journals of the standard
of The Lancet?
Dr Horton: : When the code was
introduced about 1997 it was the BMJ, The Lancet and one
or two other journals that came together to create this and we
tried to draw in many other journals in the last five or six years
to make them part of this process. Again, it only goes a small
step of the way; this is really just a scratch on the surface.
Q605 Dr Naysmith: The point you made
just now was a very good on. The last thing science needs is more
bureaucracy and more regulation. Where do you feel the balance
lies now, having laid out the case for it and then pointed out
why it is not going to happen or is very slow to happen? What
would you like to see happen?
Dr Horton: What we do not see
is an office of research integrity like they have in the US, a
huge superstructure of bureaucracy looking over science and interfering
in the conduct of research. We do want something very light. There
are models—and I would look to Norway, Sweden and the Netherlands
as very good models—of lightweight oversight but which have
some sort of legal statutory teeth. I think there are models that
we can draw on and that is what I would go for.
Q606 Dr Naysmith: Turning to Ms Hope
and Ms Rogers, are there any kind of voluntary regulations that
apply to The Daily Mail and The Sunday Times?
Ms Hope: Speaking for myself I
feel I have personal ethics that I abide by in reporting. I have
been a reporter for a very long time and I am a trained reporter,
but because I knew this question was coming up when I rang yesterday
I specifically went and looked at the code of practice for the
National Union of Journalists (of which I am a member) and I was
delighted to see, for example, point eight: "A journalist
shall not accept bribes nor shall he/she allow other inducements
to influence performance of his/her professional duties"
which I feel is just taken as read by journalists, let alone those
who are members of the NUJ. Certainly in this context, talking
about the pharmaceutical industry, I feel it is important to highlight
and I can confirm that I have never personally felt that I have
been unethically lobbied or offered a bribe or inducement to run
a story or not run a story. I have to say that I cannot imagine
a drug company or a PR company would have the temerity or the
stupidity to approach me with that kind of offer.
Q607 Dr Naysmith: You have never
had such an offer?
Ms Hope: No.
Q608 Dr Naysmith: Travel or gifts
or hospitality of that sort? Nothing like that?
Ms Hope: Do you think that going
out to dinner with somebody is an inducement? I do not.
Q609 Dr Naysmith: I think many MPs
would have difficulty answering that question.
Ms Hope: It is likely to go both
ways. I take doctors out and I get taken out by doctors or occasionally
by PR companies. For example, I had an offer to go to a dinner
last month which I leapt at because sometimes PR companies run
supper attached to a kind of educational programme—about
an hour's worth of press briefing—and it was on heart disease
and the Government's heart tsar was speaking. It is not often
you get the chance to spend 20 minutes listening to him talking
about heart disease and then questioning him. I leapt at it and
so did other journalists on national papers and broadcasting organisations.
I was also going to make the point about advertising that we should
not lend ourselves to the suppression of truth because of advertising
considerations. For example, I think I am correct in saying that
ours is the only national newspaper that has actually written
stories about the potential detrimental consequences of putting
statins over the counter, of re-classifying them for pharmacy
use. We were a paper that ran stories about how the Royal College
of General Practitioners and the Consumer's Association had produced
evidence that they were against this on safety grounds and other
grounds. We ran stories about this on at least two occasions.
It did no good whatsoever; it just went through on the nod as
far as I can see. That is another opaque system that I feel you
should address because we do not get to see the information on
which these decisions have been made. It appears to me that new
classification is now a big deal for the health service. It has
all sorts of unforeseen consequences that may come from it. The
point I am making is that we now run enormous full-page ads for
statins that you can buy from your pharmacy. If I had given it
one single minute's worth of thought and thought whether this
would affect our future advertising if we wrote stories which
actually ended up with statins not going over the counter, but
it just does not come into your thinking and it would not do at
our paper.
Q610 Dr Naysmith: Ms Rogers, do you
share the opinions we have just heard from Jenny Hope?
Ms Rogers: Yes, I do but I do
think that the issue of hospitality is one that should be looked
at not just a propos of journalists but MPs even because the drugs
industry does spend an enormous amount on it. As Jenny just said,
there are often occasions when there are government advisors or
people you cannot normally get to because the Department of Health
is very protective about its advisors. All journalists have to
go through the press office in a way which is peculiar to the
Department of Health; other government departments are less protective.
If you want to speak to an advisor in an informal way often you
might have to go to an event which is sponsored by a pharmaceutical
company which they are also attending. I think you could argue
that that is problematic, that the influence of the industry is
so all-pervasive and tight.
Q611 Chairman: Ms Hope would not
have gone to that function that she described—the dinner—had
it not been for the fact that the heart tsar was going to be there.
Ms Hope: The fact that I am going
to get something out of it, that is the point. It really was very
interesting, I have to say. He made the point just in passing
that you might be interested in, which is that he felt that heart
drugs had got to such a state of good effect at bringing down
heart disease and heart attacks that now studies were being devised
that were aiming to produce non-inferior outcomes but with improved
side effect profiles. I think this is a fascinating development,
that you cannot now look forward in some areas of medicine to
getting black and white answers any more.
Q612 Chairman: Lois Rogers is making
the point that in a sense you are in the company of the industry.
Ms Hope: No, I have better things
to do with my time.
Q613 Chairman: Let me finish the
question. You are in the company of the industry and having the
hospitality of the industry on the basis that that is a mechanism
for you getting access to these people you would not otherwise
have access to.
Ms Hope: I just think it is an
added bonus. If I really pushed for it I could probably get to
talk to Roger Boyle on the phone at some point but it is more
interesting if he is giving a presentation where you actually
have the opportunity to question him in company of other journalists
which always has an impact on the kind of story you get. Also,
it is public; whoever is running it, it is public forum. Other
journalists are there and a story is more likely to emerge that
you might be able to report on. I thought you were going to ask
me I would have gone if it had not been Roger Boyle, if I just
thought I was going to get a free supper" and quite frankly
I have better things to do with my time.
Q614 Chairman: Of course; I was not
going to say that. Lois Rogers was saying that she probably has
access to special advisors at some function where the pharmaceutical
industry is involved. That is the impression I got.
Ms Rogers: That is correct.
Q615 Chairman: It just struck me
that that was rather strange that you could not get access to
them without being in the company of the industry.
Ms Rogers: If you go big conferences
around the world—the heart disease and cancer conferences
in particular—I have often found myself the only person
who is not in the thrall of one or other drug company. There will
be all the leading specialists from around the world at these
functions and every minute of their time is timetabled by whichever
drug company has sponsored them to go so you can hardly get to
talk to them because they are going straight from the session
on whatever to the drinks party to the white water rafting event
the next day or whatever. It is like that. There are all these
jolly activities that are bolted on to their whole stay in whichever
resort it happens to be; they not necessarily resorts but they
tend to ferry them out to nice places around wherever the city
is. Every minute of the time they are there can be absolutely
timetabled so you hardly get to talk to them.
Ms Hope: To pick up on a point
that Lois was saying about access to people via the Department
of Health, I can only concur that it is incredibly difficult.
You just cannot get to speak to people there; you cannot get any
sort of meaningful dialogue going from anybody involved in the
drug regulatory system, for example. I am going to see Ken Woods
next week and this is quite frankly an earth shattering occasion;
I have never had access to the MHRA before. The only other time
I have come into contact with the system, as I said in my written
evidence, was when I was invited by Jeremy Metters—along
with some other journalists—to comment on the yellow card
system. A fat lot of good that did, quite frankly. The point is
that there is some movement because the MHRA for example, is appointing
its own press office, but it all comes back to the point that
we have hardly touched on which is the regulatory system: how
little access journalists have to the information being discussed
there and how we are in an impossible position when it comes to
looking at whether or not data has been corrupted by lack of evidence
being put forward or it being distorted because we—and anybody
else who asks to look at the data—just cannot get to it.
Ms Rogers: That is a very good
point.
Q616 Mr Jones: We have heard what
you have said about your reluctance to accept hospitality from
organisations. We have three professions represented here—doctors,
journalists and politicians—and there seems to be an inverse
relationship in terms of public trust. Doctors come right up there;
the only people below politicians in public trust are journalists
but we appear to be the other way round in the way in which we
accept hospitality. From the evidence we have had doctors seem
to accept hospitality at the drop of a hat.
Ms James: Can I make a point on
behalf of the advertising and PR profession which you did not
mention.
Q617 Mr Jones: I assumed everyone
understood you were below journalists.
Ms James: I like and respect Lois
very much but she must have been to different conferences than
the ones we run. The code of practice that we abide by now precludes
any excessive entertaining of the sort of white water rafting,
glossy resort hotels and all of that. I would concede that those
kinds of activities were more common place in the past but now
we have very strict rules that we abide by: no spouses are paid
for; no accommodation is booked in four and five star hotels;
no accommodation is booked in any kind of spa or resort type of
hotel. The guidelines for entertaining costs are: lunch, no more
than £30 a head; dinner, up to a limit of £70 a head.
These are very strictly supervised by our clients. I appreciate
I am saying something which is in direct contravention to what
you have heard, but that is our experience and we are one of the
biggest companies laying on these kinds of conference and events.
I am quite happy to send you after this meeting typical examples
of conference programmes so that you can see for yourselves.
Q618 Jim Dowd: I am sure that is
true from your end of the operation but we get too many reports
from the way that companies operate themselves for them all to
be simply disregarded and I think there is a difference there.
If you could send us an outline of the programme it would be very
helpful. I want to move on now to direct to consumer advertising
particularly of prescription drugs, drugs that can only be obtained
through a general practitioner. Certainly we had evidence—very
alarming evidence—of how this works in New Zealand and it
is also prevalent in other parts of the world. Is it your view
that this is opening up information to the lay person and to the
man and woman in the street in the face of professional jealousy,
the gatekeepers wanting to keep all the information to themselves
and this is actually a liberating feature for ordinary citizens,
or is this going to lead to disease mongering, to over-subscription,
to increased prices and to a perversion of the prescription market.
Ms James: Are you suggesting that
that is going to happen in the UK?
Q619 Jim Dowd: I am trying to assess
what the effect might be if it were to; it does in the US and
there is similar pressure on the EU to accept it. I do not want
to argue about it; I just want to know what your assessment of
it is.
Ms James: I will give you my assessment
of it; it is an individual point of view and the pharmaceutical
industry in the most part is actually now against bringing in
this form of advertising into the UK. They might have had a more
open mind about it a few years ago. I sat on the ABPI's informed
patient initiative task force which looked at this issue for four
years. There is no appetite among pharmaceutical companies for
bringing that kind of advertising to the UK. My own opinion of
it is that largely I think it has had a positive health effect
in the US. The most recent FDA research was actually published
last month and it showed that by and large the public (they interviewed
doctors and patients) felt that it did prompt them to seek information.
Most of the information that it prompted them to seek was actually
about side effects and risks rather than benefits—which
questions the competence of the advertisers, possibly—by
quite a large margin. On the benefit:risk ratio 60% of the public
felt that the advertising did not provide enough information about
risk which might explain why they sought the information independently.
However, 44% did say also that it did not provide enough information
about benefits. In terms of the doctors' viewpoints, slightly
under half—41%—said it was beneficial and only 18%
said it caused problems. I think that the main benefits really
are that people get more informed about diseases and both professionals
and patients are able to enter into a more productive dialogue
as a result of the DTC advertising in the States. I think it has
also had a positive effect on prescribing. I know that the branded
advertising that AstraZeneca did for tamoxifen over there led
to doctors getting up to speed on the benefits of that drug as
well as patients asking about it.
Mr Paling: I think something else
that came out of that research was that the FDA concluded that
it had had no noticeable increased effect on prescribing. I know
that is very difficult to judge because there is no control on
that, but I think that was the biggest worry, that it was having
an increased effect. Whether, in the long run, even in the United
States, this will be seen as a good way forward I personally doubt.
I am certain that we will not have it in the UK and that was definitely
not the intention of the ABPI.
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