PCT — partnerships

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Shifting the balance of power

The major changes emanating from Shifting the balance of power created huge uncertainty within the NHS and the pharma industry. The document stresses the need to develop wider networks of partnerships and the Labour government does appear keen to develop better links with the pharma industry, with a particular focus on the national service frameworks (NSFs) in providing the interface for joint working.

Pharmaceutical Industry Competitiveness Task Force’s first report
Ministers have been particularly keen to involve the industry in the implementation of the NSFs. The first report from the Pharmaceutical Industry Competitiveness Task Force (PICTF) was explicit on such partnerships and the government’s view seems to be that great progress has been made so far. The Association of the British Pharmaceutical Industry is also actively working with the DH on NSFs.

Industry and national service frameworks
As far as PCTs are concerned however, evidence suggests that industry involvement of NSF implementation is not taken seriously by many PCT managers. The talk at national level feels more like rhetoric as far as local industry staff are concerned. Despite the clear ministerial endorsement, the messages appear not to have been consistently filtered down to NHS grass roots.

As many chief executives seem unaware of PICTF, the collaboration message does need to be picked up and rolled out by NHS influencers. Further direction to the health service by ministers and the DH is probably required, enforcing the message that as long as you have transparent relationships, you must look at the pharma industry as a partner.

Building productive relationships between the pharma industry and the NHS would be a vital ingredient to the achievement of the NHS Plan objectives. Indeed, one element of the NHS Plan seems to be about helping the industry to navigate the complexities of the NHS. But at local NHS level, there still appears to be a fundamental need for a real change in thinking if we are to work towards strategic alliances based on added value and services.

Industry and the NHS
The NHS Plan did place an obligation on PCTs to work together and in collaboration with other agencies, to improve the health of the population they serve. Partnerships with the industry could have a number of benefits in the context of this obligation. If partnerships and collaboration are really the new mantra of the new NHS, then why is the local NHS somewhat resistant to buddying with the pharmaceutical industry? Baggage and a clash of value sets have to be part of the problem.

The NHS does not seem to understand how private companies work. For instance, there is clearly little understanding by the NHS on how medicines come to market. Perhaps companies would be wise to educate their NHS audience in this respect? There may be an offering here on which NHS influencers could work with their head office support function.

But an interesting ad in the HSJ for a pharmaceutical communications development manager at Durham Dales PCT is worth noting:

‘...you will work within the PCT pharmacy team to work in collaboration with PCT liaison representatives from pharmaceutical companies to improve patient care… This post is unique… your role will involve facilitation between PCT liaison representatives and appropriate PCT staff, raising awareness of chronic disease states across the PCT and oversee implementation of projects approved by the prescribing sub committee.’

On the partnership front A common understanding: guidance on joint working between NHS Scotland and the pharmaceutical industry came out in 2003 from the Scottish Executive. Note that a Welsh version is also being prepared.

The Modernisation Agency in England has published a similar but briefer document. While this is mostly around the area of critical care Forming productive partnerships with industry does make the point that the 'learning' should be shared with the wider NHS. Case studies are given, including both pharmaceuticals and devices, but a clear differentiation is made between sponsorships and partnerships.

The ABPI has also published a document on NHS/industry partnership. Produced in association with the NHS Alliance and with introductions by David Colin-Thome (primary care tsar) and Trevor Jones, the document has a bit of blurb about partnership and then examples from MSD, Janssen-Cilag, Leo, Shire, Abbott, Pfizer, Lilly and Wyeth.

The framework document received wide publicity with the BMJ carrying a news report quoting the ABPI as saying that the NHS needs to overcome reservations to work in greater partnership with drug companies.

A framework for joint working between the pharmaceutical industry and the NHS aims to provide a framework for future joint working initiatives between drug companies and primary care organisations. Several hundred senior staff at primary care organisations across the UK were interviewed, and the findings show a complex picture of the current state of relations between the industry and the NHS'.

Kevin James, Wyeth MD, is reported as saying:

'Some PCOs are very sceptical about the role and motives of the pharmaceutical industry… Through talking to staff we have been able to understand their reservations and concerns more deeply and to spread examples of best practice.'

Older people NSF champions toolkit
The ABPI and the DH have collaborated on an older people NSF champions toolkit and NHS influencers will find this is a useful document — background, maps, etc. In part 1, section 5 of the document you will find a list of companies, contacts, disease areas and the standards where they might be of assistance to the local NHS.

NHS Confederation
NHS influencers should be aware that the NHS Confederation, the UK-wide organisation representing all NHS organisations, continues to develop partnerships with various companies.

A baggage explosion
Despite ongoing attempts aimed at better and improved working between the NHS and the pharmaceutical industry, intermittently in the media we see the expression of what one might call ‘baggage’. Such constant criticism of the industry should be relevant to NHS influencers in their dealings with PCT managers and many may recall the special BMJ theme issue on the industry (31 May 31). As the content is important to NHS influencers and still highly relevant, find below a review and analysis. Although the BMJ would not normally be on the reading list of non-medical managers, NHS influencers should be aware that public health physicians and prescribing advisers will have read this issue and brought it to the attention of other PCT managers.

BMJ theme issue
According to the editors of the BMJ, doctors and drug companies are ‘entwined in an embrace of avarice and excess, an embrace that distorts medical information and patient care.’ These comments accompanied 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’s all in there — the use of third parties by companies to spin their messages, the 'abuse' of patient organisations, the claim that industry funding is corrupting medical journals, 'conference tourism,' bribery and corruption, bias in clinical trials, undue pressure on GPs, etc. The BMJ was keen to point out that it is does not intend to be anti-drug company but that doctors and drug companies must work together (for the benefit of patients) to disentangle relationships.

Richard Smith, then BMJ editor, fretted around the relationships between medical journals and pharmacos as ‘uneasy bedfellows’ and suggested that the substantial income from companies regarding advertising, reprints and sponsoring of supplements may be ‘corrupting’ journals. There was also comment on the fact that advertising may often be misleading since companies often overstate effectiveness and minimise risks and their ads are void of any information on cost-effectiveness. Studies have also shown that many references in adverts are untraceable. The danger is that scientific studies may be being manipulated to give results favourable to companies — the use of seeding and switching trials, post-marketing studies and over-use of placebo-controlled trials may all be debasing the randomised trial for marketing reasons.

There is also an increasing use of advertorials as a kind of proxy editorial ‘because companies always prefer editorials if they can get them’ and ‘many other similar tricks can be used to give companies the results they want.’ ‘Something’s wrong, and medical journals are part of what’s wrong,’ suggested Dr Smith. Another article in the same vein suggested that journals should regularly vet advertisements more carefully to avoid these problems otherwise journals will definitely be used as vehicles for drug company ‘propaganda.’

In ‘Unhealthy spin’ a journalist suggested that many of his colleagues are particularly 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.'’ ‘Company spokespersons have low credibility so an apparently independent 'messenger' with a higher credibility rating in the eyes of the target audience is often used to divert the spotlight of media attention.’ The article heavily knocked the use of KOLs (key opinion leaders), the use of medical publications in ‘buttressing sales spiel’ and the use of reprints from ‘low readership/low budget’ journals who appear to want to ‘prostitute’ their editorial standards (‘puff pieces’). Interestingly the references cited include Pharmaceutical Marketing (PM) publications. One piece quoted from PM is about the ‘tricks of the trade’ and the fact that the advisory panel process is one of the most powerful ways of getting close to people and influencing them.

In an article by Andrew Herxheimer (professor of prescribing policy at St George's, London) there was the suggestion that pharmacos and patients’ organisations are unequal partners and that this raises very serious questions. The article had an interesting list of short, medium and long-term wishes by both sides and the conflicts that these present. He suggested that current guidelines are inadequate and closed with the statement, ‘For over 40 years I have tried to help the pharmaceutical industry with notably little success.’

Other studies reported in the BMJ criticised industry-sponsored research — ‘citadels of evidence-based medicine are being undermined by clever companies’ was the strap line. For instance, a systematic review of industry sponsorship and research outcome appeared 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 be biased. This is not because the studies are methodologically worse but because of inappropriate comparators and publication bias. There was mention of new guidelines aimed at increasing transparency and encouraging the responsible and ethical reporting of industry-sponsored clinical trials (ie, that old bogey of publishing all clinical trials of marketed products and not ‘suppressing’ trials with unfavourable findings). There was also comment on stopping multiple presentations of the same trial results to avoid ‘double counting.’

Accusations abound over double standards in the information provision on medicines, with seemingly one scientific standard for peer-reviewed journals and yet another one where ‘the language used by industry is stuffed full of personal opinions when they speak directly to practitioners or policy makers.’ One article cited Diffusion of medicines from the European Federation of Pharmaceutical Industries and Associations (EFPIA), which was a paper on the problems of market access to drugs, in areas such as dementia, asthma and cancer, owing to the strict cost containment methods used by some healthcare systems:

‘The document is worth reading for the way it is written — it overlooks basic principles of synthesis of scientific information… None of the 20 conditions listed is discussed with reference to systematic reviews. In Clinical Evidence and the Cochrane Library one can find five to 15 systematic reviews for each of the conditions discussed… and in, for example, Alzheimer’s Disease none of the available systematic reviews support the views made.

There is also comment about the undue pressure being placed on GPs by representatives. The BMJ has reported on this before and this similar survey of around 1,000 doctors found that those who see medical representatives at least once a week ‘are more likely to express views that will lead to unnecessary prescribing than those who report less frequent contact.’ In addition, these doctors were more likely to prescribe a drug that is not indicated in response to a patient request and are more receptive to drug adverts and promotional literature from pharmaceutical companies. The observations made here would most certainly relate to the conclusions of the Audit Commission report, Prescribing in primary care.

‘Food, flattery and friendship are all powerful tools of persuasion,’ suggested another article. There was description of some attempts by the University of California Medical School to regulate the access of drug company representatives to young doctors and removing representatives from the hospital system entirely. Rep-free zones? ‘But industry won’t give up without a fight,’ the article suggested. Apparently there are campaigns like ‘PharmaFree’ and ‘No Free Lunch’ with its motto ‘Just say no to drug reps’ and even pen amnesties!

‘We are addicts to big pharma’s money and we will have to wean ourselves off such a dependency… We need to clean up our act. You walk through the rooms of some professional meetings and medical conferences and they just stink with pharmaceutical propaganda and paraphernalia… you just have to hold your nose.’

In terms of disentangling this, an article in the BMJ identified some 16 ways in which doctors are ‘entangled’ with the drug industry — see ‘Who pays for the pizza? Redefining the relationships between doctors and drug companies’. The same author in yet another article suggested 13 ways not to tango but to disentangle. These included restrictions or prohibitions on drug representatives visiting doctors; restrictions or prohibitions 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. The author suggested that the industry is just simply refusing to listen to these kinds of ideas, rejecting out of hand all such calls for disentanglement.

The World Medical Association is reviewing doctors’ links with drug companies and is proposing guidelines which suggest that no individual doctors should receive payment from companies to cover travel expenses, room and board at conferences, or compensation for their time. But this is already being criticised by some as unenforceable and that doctors themselves are to blame for accepting company largesse. Even the idea of an ‘independent not-for-profit institutional intermediary’ is being suggested, responsible for all interactions between physicians, scientists and companies as well as a blind trust whereby companies can contribute to a pool of funds that are then distributed to educational providers. Interestingly the very same suggestion was made in the Task and Finish prescribing report, commissioned by the Welsh Assembly. It has also been picked up on by the all-Wales medicines strategy group.

In this entire diatribe one repeatedly sees an almost complete lack of understanding of how the industry operates. In the systematic review paper mentioned above you can read the following, ‘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 becoming synonymous in some quarters with questionable research.

This outpouring of baggage also goes to the heart of industry attempts to get into partnerships with the NHS. Of course there has always been a strong cultural tradition within the NHS that looks upon the private sector with suspicion — this outlook was supported by the government itself as little as three years ago — and this is still indeed the case amongst incoming managers (as part of the NHS general management trainee programmes) as it is amongst the traditionalists. This kind of thinking will definitely not help attempts at developing new ways of working.

NHS people simply do not understand how drugs get to market and this was shown very clearly by one suggestion, that in terms of disentanglement new national bodies should be created to conduct (pharmaceutical) research driven by public interest. Suggestions too that drug discovery and marketing are different pursuits and need differentiating in some way.

Having said all of this, there was one article that did attempt to answer these criticisms. ‘In praise of the devil’ asks why, when the industry has achieved so much, is it so often attacked in this way. It is written by a vice president at Merck & Co and is a ray of sunshine in a rather dark and bleak BMJ landscape.

All sorts of anti-industry baggage continue to be aired by the BMJ. ‘How to make a compelling submission to NICE: tips for sponsoring organisations’ was a piece from Dr Amanda Burls, a senior clinical lecturer at the University of Birmingham. Using her experience of health technology assessment for NICE and closely going through company submissions, Dr Burls jocularly examined some of the more dubious techniques that can be (are?) used by companies to make their products seem more attractive than they really are. She says her advice is based on real examples of submissions to NICE but is basically an anti-industry tirade.

For example, she suggests that companies try to make their technologies look more effective by comparing the intervention with an inactive control or a lower dose comparator; in reporting the evidence, they place most emphasis on the outcome in the trial that produces the most significant results; they minimise the possibility of independent evaluation of the evidence by suppressing unfavourable results; they make the technology seem more cost effective by the use of iffy models; they enhance the chance of success by ensuring media hype and when it all goes pear shaped throw a tantrum and threaten to withdraw companies’ R&D activities from the UK.