(Date published: 20 January 2004)
By
Alan Jones
of ajc
healthcare
Earlier this year a 'baggage' volcano erupted on a grand
scale. Has the dust yet settled? Alan Jones revisits.
Following shortly
after Channel 4's rather inflammatory documentary Dying for Drugs, the BMJ at
the end of May ran a wholly negative 'theme' issue on the Industry, essentially
saying what 'naughty boys' companies were. According to the BMJ, doctors and
drug companies are 'entwined in an embrace of avarice and excess, which is
distorting medical information and patient care.' These comments were
accompanied by a whole series of articles looking at the 'entangled'
relationships between the Industry and doctors, as well as the way the industry
reports its clinical trial results. It was all there - the use of third parties
by companies to 'spin' their messages, the 'abuse' of patient organisations,
industry funding corrupting medical journals, 'conference tourism,' bribery,
bias in clinical trials, undue pressure on GPs, etc, etc..... The key issue of
course is always what should companies do in response to this kind of
stuff.
Richard Smith, BMJ editor, fretted particularly around the
relationships between medical journals and pharmacos suggesting that the
substantial income from companies re advertising, reprints and sponsoring of
supplements might be 'corrupting' journals. There was also comment that drug
advertising is frequently misleading since companies often overstate
effectiveness and that their ads are void of any information on
cost-effectiveness. Also studies have shown that many references given are
often untraceable. The danger in all of this, he says, is that scientific
studies may be being manipulated to give results favourable to companies. The
use of seeding trials, post marketing studies and over use of placebo
controlled trials may all be debasing the randomised trial for marketing
reasons, Dr. Smith continued. There is as well an increasing use of
'advertorials' as kind of proxy editorials and 'many other similar tricks are
used to give companies the results they want.'
Another article asks if
journals are being used as vehicles for drug company 'propaganda' and a
journalist suggests that many of his colleagues are proving to be vulnerable to
uncritically accepting the 'disguised messages' of the drug industry because of
the activities of public relations companies. These are 'experts at the third
party technique,' a process which 'helps the drug industry separate the message
from what could be seen as a self-interested messenger.'.... The article
heavily knocks the use of KOLs, the use of medical publications in 'buttressing
sales spiel' and the use of reprints from 'low readership/low budget' (pay)
journals who appear to want to 'prostitute' their editorial standards ('puff
pieces')...... Interestingly one reference cited in the article is an Industry
publication. The piece quoted is apparently about the 'tricks of the trade' and
the fact that advisory panels are one of the most powerful ways of getting
close to people and influencing them. Well someone let the cat out of the bag
didn't they!.... In fact this piece created quite a stink at the time. A staff
member at the BMJ had got hold of a copy of the piece and was incensed -
venting his anger over the 'inappropriate' use of influential professionals as
some kind of pawns in the 'game' of marketing and deriding the methods of
'opinion leader development.' He also had a big go at Advisory Boards because
the piece was very explicit here that this is all about 'getting close to
people and influencing them.
Anyway back to the more current BMJ. Other
articles criticised industry-sponsored research. For instance, a systematic
review of industry sponsorship and research outcome seemed to show that
research sponsored by companies was much more likely to produce results
favouring the company's product than that funded by other sources and may thus
be biased. What was required, the article suggested, was more transparency in
the 'ethical' reporting of industry sponsored clinical trials, i.e. that old
bogey of publishing all clinical trials of marketed products and not
'suppressing' trials with unfavourable findings!
There was also some
stuff about 'undue pressure' being placed on GPs by reps. A survey of @ 1,000
doctors apparently had found that those who see medical representatives at
least once a week 'are more likely to prescribe unnecessarily than those who
report less frequent contact.' In addition, these same doctors were more
'receptive' to drug adverts and promotional literature from pharmaceutical
companies. No rocket science here then!
In terms of what to do about all
of this stuff, one article identified some 16 ways in which doctors were
'entangled' with the drug industry (www.bmj.com/cgi/content/full/326/7400/1193) and the same
author in another article suggested some 13 ways to 'disentangle'....
Suggestions included prohibitions on drug reps visiting doctors; restrictions
on educational events funded by industry; campaigns to end acceptance of all
gifts, trips and honorariums for speaking at educational conferences and
medical journals reducing their reliance on advertising revenue and sponsored
supplements. And the author suggested that the industry was just simply
refusing to listen to any of these kinds of ideas - rejecting out of hand all
such calls for 'disentanglement.' Even the idea of a 'blind trust' was
suggested whereby companies can contribute to a pool of funds that are then
distributed to educational providers. Funny this as the very same suggestion
was made in the Task & Finish Prescribing report, commissioned by the Welsh
Assembly Government! It has now been picked up on by the All Wales Medicines
Strategy Group.
So what to make of all of this? Something that will just
all blow over perhaps? I actually don't think so. As I write this article in
oppressive heat, I see the BMJ is still publishing letters in this area some
three months later. So the dust has not settled and the issues have not gone
away. I would like to suggest that there are huge implications here for
companies and that 'we' may now be entering some very turbulent (uncharted?)
waters on a number of different fronts so some 'steerage' from somewhere in
these choppy waters may be vital.
Messages from the industry to the NHS
about increased health gain for patients etc seem not to be getting through and
in all this entire diatribe one repeatedly sees an almost complete lack of
understanding of how the industry operates. NHS folk just simply do not
understand how drugs get to market and this was shown very clearly by one
suggestion in the BMJ that a new national body should be created to conduct
(pharmaceutical) research driven by public interest.... and "An increasing
number of clinical trials at all stages in a product's life cycle are funded by
the pharmaceutical industry." But what do these authors expect!!.... 'Industry
sponsored research' is thus becoming synonymous in some quarters with
questionable research. This outpouring of baggage is also of great relevance to
industry attempts to increasingly get into 'partnerships' with the NHS as this
kind of stuff may well hinder attempts at developing new ways of working.
The responses I have seen to all of this from companies and the
industry have been rather tired, limp and defensive with no recognition at all
that actually some of these authors were occasionally making fairly reasonable
points. Having said all of this, there is one article in this BMJ 'special'
which attempts to position the industry more favourably and responds fairly
sensibly to these criticisms. It is written by a VP at Merck & Co and is a
ray of sunshine in a rather dark and bleak BMJ landscape... See
www.bmj.com/cgi/content/full/326/7400/1220. It has always
been my view that since the Industry gets this kind of stuff thrown at it all
the time these things need to be faced and discussed openly and honestly.
Sometimes views are so polarised that they do need to be challenged. Taking the
easy way out by saying nothing could end up with a result of guilt by silence.
But it is the way you do it and what you say!
The Industry continues to
have a problem in that it is not well understood by those outside it as regards
how it works and how medicines get to market. When one gets involved in
explaining how medicines do get to market and the dilemmas that pharmacos now
face in a post-NICE world, the discussions always become more reasonable.
Similarly companies do need to understand the value sets that drive the NHS and
then they too can understand where these kinds of comments are coming from. But
the industry always seems to show some unwillingness to come back on criticism,
legitimate or not.
So are we at some kind of 'tipping point' in terms of
relationships between the industry and its NHS customers? Or is this just a
storm in a tea cup?
The article was first published in the
Pharma Times: December
2003
About the author
Alan Jones
is an independent health policy analyst and adviser. He writes and presents
widely on the New NHS. Alan spent some 20 years in the Pharmaceutical Industry
in a variety of sales, marketing and business development roles including some
10 years at Glaxo Wellcome UK where he was responsible for relationship
building between Glaxo Wellcome and the Department of Health, and in developing
a corporate understanding of current NHS policy initiatives and their likely
implications and impact on the business.
Alan is also managing
consultant at ajc healthcare, which specialises in NHS policy issues for both
the Pharmaceutical Industry and the NHS and aiming to support organisations in
steering the right strategic course through a rapidly changing NHS
environment.
Alan has a Masters in Business Administration and is a
fully qualified teacher - before joining the Pharmaceutical Industry, he spent
a decade teaching and lecturing in colleges, schools and universities in the
UK, the United States and West Africa. He is also a reviewer with the NHS
National Co-ordinating Centre for Health Technology Assessment (NCCHTA) and was
a member of the UK Local Organising Committee for the International Society for
Technology Assessment in Health Care (ISTAHC) held in Edinburgh in June
1999.
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