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In Defence of the Realm
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.'

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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!

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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.

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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?

This 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.

Click here to contact Alan Jones

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