Examination of Witnesses (Questions 520
- 539)
THURSDAY 16 DECEMBER 2004
MS MARGOT
JAMES, MR
MIKE PALING,
MR RICHARD
HORTON, MS
JENNY HOPE
AND MS
LOIS ROGERS
Q520 Chairman: You talk in your evidence
about editorial kick-backs. You have actually had situations where
you have been offered substantial sums of money to publish certain
research studies. Money from the industry. Tell us about it. Who
has offered you money? Be precise because we are interested to
know how it works.
Dr Horton: The way it works is
that an investigator will give you a call and say they have a
paper that they would like to submit to us and ask us if we are
interested in it. On the telephone I would ask them to tell me
about it. If they describe it I would say we are interested. Then
the conversation might go: "It is likely that the company
will want to buy several hundred thousand reprints" and of
course several hundred thousand reprints might translate into
half a million pounds, a million pounds revenue to the journal.
There is an implicit connection between the submission of a paper
and the revenue that comes into a journal.
Q521 Chairman: To be clear, it is
the reprint where the money is offered.
Dr Horton: Absolutely. Then at
various stages after a paper has been submitted there may be interventions
by either the authors or the sponsors to try to move the peer
review process in a direction that is less critical. I could give
you some examples of that if you want me to.
Q522 Chairman: Please do.
Dr Horton: All the examples I
will give are very recent, within the last six to 12 months. Over
the summer we received a paper on a Cox-2 inhibitor which we fast
tracked to publication. In the process of peer review there was
a substantial level of criticism against this paper: over-interpretive,
reducing the impact of the adverse reactions. So we put these
questions to the authors and in the middle of the peer review
process as we were trying to get the paper right for publication
we received a call from the sponsor of the company saying: "Stop.
Pull back. Stop being overly critical because if you carry on
like this we are going to pull the paper and if we pull the paper
that means no re-print income for the journal." We then went
back to the authors and said, "You need to pull these guys
off the journal because if they continue to put pressure on us
we do not want your paper". After a few more days the company
backed off; the authors were willing to change the way they had
interpreted the paper and report more accurately the data in the
paper. That is just one example—and it is not an uncommon
example—of how there is this constant continuing conflict
(and conflict in the peer review process) between the journal
and the sponsor and the authors get caught right in the middle
of that.
Q523 Chairman: How do you then determine
what you publish? If there are all these influxes how do you come
to a decision that you feel it is okay to associate your journal
with a particular article?
Dr Horton: We are very lucky because
in the last 10 years or so we have been able to set out a series
of independent guidelines which have provided some force when
we go to negotiate with authors about the quality of their work.
We are a member of the International Committee for Medical Journal
Editors which has a very detailed list of guidelines about the
way research should be reported which we can appeal to. The Committee
on Publication Ethics, which is a UK Committee, does exactly the
same. It is a forum which has a list of guidance about the reporting
of research and it is also a place where we can take difficulties
that we have encountered as editors and place that before colleagues
to work out a way forward. The third set of guidelines about the
reporting of clinical trials again enables us to force authors
and sponsors to disclose information about the results of the
search. These are not statutory; these are all voluntary codes
so I am the first to admit that they are not perfect but they
at least allow a benchmark that we can appeal to in order to do
our best to improve the quality of reporting.
Q524 Chairman: You have learned some
lessons from problems that have occurred. The Andrew Wakefield
study is an issue; do you want to say a bit about that?
Dr Horton: The Andrew Wakefield
study is not related to the pharmaceutical industry as such but
I think the lesson that I took from the paper on MMR was the way
a story which has the potential to be enormously controversial
can get put in a crucible of publicity with a rather maverick
investigator and controlling that message in the public domain
becomes almost impossible. The issue that eventually came out
this year, as you know, was the conflict of interest issue that
he had, although that was related to the Legal Services Commission
rather than the pharmaceutical industry.
Q525 Chairman: Which of course you
were not aware of at the time.
Dr Horton: At the time of submission
we were not aware of it and also the recent information that came
out on the Channel 4 Dispatches programme about the patent, we
were not aware of that.
Q526 Chairman: Would your guidelines
now perhaps be able to take that into account? Would that ensure
that you are aware when you publish of any kind of conflict of
interest?
Dr Horton: The evolution of the
robustness of our own journal's guidelines has developed very
quickly in the last four or five years so that now we are much
stricter than we were back in 1998 about disclosure statements;
much stricter about insisting on the responsibility of the funding
source to disclose its role in the research: was it responsible
for writing the paper? Was it responsible for doing the analysis?
Was it responsible for limiting access to data for the authors?
We take those kinds of issues point by point in the process of
peer review. Prior to 2001 we did not so this whole evolution
of quality control is on a very rapid conveyor belt of change.
Q527 Chairman: Going back to the
point about the initial question I asked you in terms of the quote
in your evidence and about your comments on medicine being tainted
and its integrity being compromised, from your knowledge of the
time you have been around as a doctor obviously you have just
become aware of this particularly in your current role, but do
you feel that something significant has changed in recent times
that has reinforced the concerns that you have expressed? If so,
what has happened?
Dr Horton: I think the competitive
environment in which industry works now is ever greater. It is
almost an asymptotic relationship. Its progress maybe from the
mid-1960s to the mid-1980s was really quite rapid in terms of
developing new drugs and then as time has gone on it has become
ever more difficult. Once you have two or three classes of drugs
to treat high blood pressure thinking of the next class and the
next class and the next class then becomes very hard. The potential
gain for research and development investment is diminishing. The
pressure then comes—and we have seen that, the numbers of
new drugs that have been licensed have gone down with time—and
in that almost intolerable pressured competitive environment the
emphasis then switches from research more to market. With the
marketing focus such as it is the gain that can be got from even
1 or 2% market share, and the great example, of course, is the
statin portfolio of drugs and the entry of Crestor for AstraZeneca.
Tom McKillop said that this drug is going to be the make or break
for AstraZeneca. There was a billion dollars of investment which
seems a huge amount of money but when it could be a two, three,
four billion dollar a year return it is actually not that huge
an investment. That is the kind of environment that has changed.
The marketing pressure has been ramped up enormously.
Q528 Chairman: I was interested in
what you said because Richard Smith, who used to edit the BMJ
is quoted as saying that "marketing and promotional activity
has increased inversely to innovative drug production in recent
years. Since 1995 research staff numbers have fallen by 2% while
marketing staff numbers have increased by 59%." That, in
a sense, ties in with what you have just said.
Dr Horton: And the problem we
have at journals is that the great tool for marketing are the
papers we publish so that has led to the swathe of ghost-writing,
public relations attached to research papers, using the research
that we publish as a marketing tool and not as an educational
tool. We get caught in that vice.
Q529 Jim Dowd: The main question
I want to ask relates directly to what was just mentioned by the
chair, but I think I think I missed something. In the case you
gave where you came under pressure from the company and went back
to the authors, what was the conclusion of that and, if you feel
able, could you mention the company?
Dr Horton: It is probably better
that I do not mention the company. Do you mind if I do not? The
reason being that the negotiations we have with authors are somewhat
like doctor/patient relationships; we say that they are confidential.
I can give you generic examples but I would prefer not to give
it on the record. In that particular instance the authors themselves
had come under huge pressure from the sponsor and were very grateful
that we were then saying that we would not publish this paper
unless they had full disclosure about adverse reactions and considerably
toned down the spun message in the research. We were able to be
allies with the authors. So often what happens is that the authors
are caught between these forces of the sponsors who they need
to do the research. Let us be clear, you would not have this research
done if it were not for industry. Then industry owns the message
as a result and the authors fail to win the argument about how
the research gets reported. I give some more examples in my written
evidence. In that particular case I think we were able to win
although we did publish an editorial to go with that paper that
was highly critical of the way the paper had been reported and
the way the study had been designed. That is often our only come-back,
to run a critical editorial pointing out the weaknesses in the
study design.
Q530 Jim Dowd: The pharmaceutical
industry generally and individual companies put a great deal of
resources into promotional activities, advertising and public
relations et cetera which clearly they regard as being in their
individual commercial interest. Is the net effect beneficial in
promoting public health?
Ms James: I think usually it is
beneficial in promoting public health. I think as I said in my
evidence most of the programmes that we undertake involving public
relations are to meet various objectives: very much to improve
awareness of certain conditions and treatment choices, also to
improve diagnosis, identification and management of patients with
those conditions and also such a way as does provide a commercial
return for our clients. Occasionally those goals are difficult
to marry but I would say that was the exception rather than the
norm. In the vast majority of cases I believe that public health
benefits in terms of our reaching the first two of the objectives
I outlined in addition to the third. We do not always achieve
the third.
Q531 Jim Dowd: Does anybody demur
from that point of view?
Dr Horton: I would put a slightly
difficult emphasis on it. As we were talking about earlier, I
think that the influence of industry on education, for example,
one has to conclude if you look at the work that is put out under
the mask of education it is largely marketing dressed up as education.
One can understand why; that is perfectly reasonable. This is
about getting market share. However, let us be clear: this is
not education. Again the regulatory environment—despite
the ABPI code of practice—is such that while they are fine
words they have absolutely no teeth whatsoever.
Ms Rogers: The only other thing
I would say is that in general you could reasonably argue that
the whole agenda is skewed by the commercial potential of a particular
product so we, the media, and in turn the public are influenced
in our perception of the relative importance of different diseases
by the commercial possibilities of marketing a treatment for it.
If there are a lot of people who suffer from something which you
can produce a lucrative treatment for, then the perception of
that condition will grow. Sorry, I meant the perception of the
seriousness of that condition will become more significant.
Q532 Mr Jones: Going back to Dr Horton's
reluctance to reveal the name of the organisation that put him
under pressure, you ably describe the difficult position that
you are in and your research publication but the reality is that
it is increasingly important as a marketing tool. As well as putting
you under all sorts of pressure it also provides with you an opportunity—because
you are an enormously important marketing tool—and if you
should so choose you have power over that company.
Dr Horton: Yes, that is true.
Q533 Mr Jones: It may be that you
are unduly reluctant to use the powers you have in order to solve
the problems that you are under.
Dr Horton: I think that is a very
fair point and it is an issue that is underestimated in not just
The Lancet but across the whole range of journals. There is a
bit of a food chain with journals and you have some of the general
journals like the BMJ and The Lancet that you hear a lot about
but there are thousands of others. These journals are often very
good places to drop articles which are clearly promotional on
behalf of a particular company. A very good example, to be very
specific, is this whole story surrounding SSRIs. I know you have
had evidence from David Healy about this but it is probably the
best example where the companies have been very clever at seeding
the literature with ghost-written editorials and review papers
that promote off-label use of these drugs. You can dress up in
an academic argument about "would this drug X be quite useful
for this condition; why?" and have an interesting debate
about that. What it does in the mind of the prescriber is to think
"Hah, this patient with this condition, perhaps I will try
it". It is an off-label use and that is how you had two and
a half million scripts a couple of years ago for SSRIs in under-18s
with no licensed indication for it. I think you are right; I think
journals have an enormous responsibility. We are seen as independent;
we are seen as a source of evidence and yet we ourselves can be
corrupted by this very perverse set of incentives that we are
businesses in our own rights, that we are often owned by publishers
which have to make a profit.
Q534 Mr Jones: To get back to the
point that you have acknowledged that you are maybe sometimes
overly reluctant to use the power that you have been given, do
you want to reconsider whether you want to tell the Committee
the name of the company?
Dr Horton: I would say we do use
our powers a great deal.
Q535 Mr Jones: That is all right;
I was just giving you a second chance.
Dr Horton: Thank you but I will
decline it.
Q536 Mrs Calton: Can we move on to
the influence of the industry and articles covered by the press.
I am directing my questions now to Ms Hope and to Ms Rogers in
particular. Can you give us a general picture of the types of
articles you like to write or chose to write and the types of
articles to do with health stories and reports that your readership
wish to read?
Ms Hope: Health and medicine are
very important to our readership. We know that from feedback in
the surveys, the letters I get and the phone calls I get. We cover
the whole gamut and it can be from new drugs through to hospital
closures through to patient problems. Drugs and the drug industry
form a small part of all of this. We get a tremendous amount of
information coming to the office every day; dozens of potential
story idea presenting and competing for attention and space in
the paper. Priority is given to the stories that are embargoed
for the day because they are the stories that will be going all
around your competitors; they are the ones that have to be screened
and filtered and we have to assess whether or not we think they
are worth running. Certainly they are going to be in our competitors'
papers or considered for publication there. Then you can work
through all the other competing attentions such as exclusive stories
that you may be working up, government announcements on the day,
that kind of thing. New drugs stories are of great interest to
us. The whole point is that they are new; they are news; it is
innovation; it is discovery; it is possibility of optimism and
hope. Something good is coming out of human endeavour. It has
all the ingredients. What is there not to like? The point is that
that is the news value of the story not the fact that I have been
got at by a drug company to run a story about a new drug. It is
the fact that here is a story that will interest our readers.
Along the way it may be that we are writing a story that actually
does not live up to the initial promise of the original announcement
or launch or trial data on which it was based. As we know, science
is littered with false storms and we cannot know that at the beginning.
Q537 Mrs Calton: Would you like to
add anything to that, Ms Rogers?
Ms Rogers: No, because our agenda
is vastly different from that of a daily paper anyway and for
obvious reasons we just approach it from a completely different
point of view. We are not driven by a news agenda, if you like;
we are not driven by embargoed stories, press releases or that
sort of thing. It is a different way of working.
Q538 Mrs Calton: The answers you
have given indicate that you are very much driven by the needs
of the newspaper obviously to sell newspapers and nobody can criticise
you for that. What role do you think the lay media has in telling
the public about new medicines or warning them about problems?
Do you have an educational role besides your need to sell newspapers
with stories which are news?
Ms Hope: And with stories which
readers want to read. That is a critical part of it. We are not
going to sell newspapers unless we actually tap into what readers
want to read about. I think the thing about the public health
element—the educational element—is that it is a subsidiary
element of my work. I am completely conscious of the fact that
people are reading these stories and may be alarmed, overly optimistic
as a result of reading them; they may be my family and friends.
I am a responsible journalist and I am conscious of the impact
of these stories on my readers. We are a conduit for messages
and quite often we get blamed as the messenger for the message.
I am thinking particularly of health scares because when the Government
wants to put out a warning about a drug and a set of side effects
we are the first port of call. We are the first people to say:
"Do not take this drug" or "Go and see your doctor
because new problems have been raised about it". Going back
to the pill scare in 1995—and I know this is ancient history
but it still rankles—newspapers were actually used to put
out this message that you must change your brand of pill instantly.
It caused complete panic; it caused 29,000 abortions in the long
run and even at the time journalists are saying that this is based
on unpublished, unreviewed evidence; we cannot see it and we are
having to go on trust. Within months the European drugs agency
refused to endorse the Government's advice—the Government
of the time—and within four years the Government had changed
the advice.
Q539 Chairman: When you get this
good news story or the bad news story what do you do to check
the other side? Last week we had the predication that we are all
going to die of bird flu next winter or something; the reason
we are going to die of bird flu is because we do not have enough
of this great drug that is going to stop us getting bird flu.
I do not think it was your paper I read. It was a paper I read.
How do you get the balance in there? We all like to read good
news. We are all going to live forever, great, it is really nice
to know that, but how do you balance it out? What do you do to
get the other side of the story, particularly where that other
side may not have been analysed sufficiently to get a balanced
picture?
Ms Hope: That is a very good point.
It is a constant dilemma in journalism about balancing information.
If you have a basic story, a basic working hypothesis based on
research evidence you are going to want to run this, but you need
to ask questions while you are assessing the information and work
out if there is someone you want to contact or some people in
order to check out problems that you see arising from this data
or from the interpretation that the public is going to put upon
it. You just have to use your common sense sometimes about how
this is going to play with the public and try to contact sources
of information you think are going to put some sort of perspective
on the story.
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