Policy responses and statements

Name of organisation:

Royal College of Physicians of London: RCPLond's Physicians and the Pharmaceutical Industry Working Party

Name of policy document:

Physicians and the Pharmaceutical Industry

Deadline for response:

31 March 2008

Background: For a number of months, the Royal College of Physicians of London has held informal meetings with representatives of the pharmaceutical industry and others to discuss how to enhance and support working relationships between doctors and the pharmaceutical industry in the UK. Barriers are perceived between the industry, the NHS and academic medicine which inhibits a truly dynamic and productive relationship between the key players, which could be detrimental to the best interests of patients.

RCPL identified a need to look into this relationship and to examine in some detail the political, economic, commercial, organisational, professional, and public barriers to creating an ideal relationship. The overwhelming principle is to improve patient care.

As part of its work, a working party has been consulting widely on matters relating to physicians and the pharmaceutical industry by inviting written submissions.

COMMENTS ON
ROYAL COLLEGE OF PHYSICIANS OF LONDON
PHYSICIANS AND THE PHARMACEUTICAL INDUSTRY: A ROYAL COLLEGE OF PHYSICIANS WORKING PARTY

The Royal College of Physicians of Edinburgh is pleased to respond to the Royal College of Physicians of London’s Working Party on its consultation on Physicians and the Pharmaceutical Industry.

Ideal relationship between Pharma, NHS and Academic Medicine

The relationship among these various groups is symbiotic regarding new drugs in development; industry needs academic expertise, and also needs the clinical base on which to pursue clinical trials.  Society needs the clinical advances bought about by industry to be available for the improvement of human well being.  The key elements here must be:

• Clinical relevance
• Scientific rigour
• Integrity of purpose and practice
• Transparency

Many of the key practical advances in medical management over the last 25 years (at least in Westernised health services) have arisen directly from pharma-sponsored clinical trials. (statins, ACEI/ARBs, proton pump inhibitors, tamoxifen, cytokine modulators, chemotherapeutic agents for cancer, to name but a few).  Most of these have necessitated good working relationships between pharma and academic medicine at the design and analysis phases, and all of these have involved recruitment and monitoring large cohorts of NHS patients.  It is hard not to accept that these relationships have not been mutually beneficial.

In cardiovascular medicine, such relationships have been especially fruitful, with numerous examples of “landmark” trials that could not have been conducted without good tripartite relationships, eg:

SYSTEUR: established benefit of treating isolated systolic hypertension
PROGRESS: established benefit of lowering BP after stroke/TIA
HPS: established role of simvastatin in a broad spectrum of vascular risk
ASCOT: established role of atorvastatin in hypertensive patients

In each and every one of these the protocol design, data analysis and interpretation of results were entirely in the hands of a Steering Committee independent of pharma.  Pharma supported the studies to the tune of many millions of pounds, providing employment to many thousands of medical, nursing, monitoring, support and scientific staff.  This is a very significant industry and the benefits of this activity to the UK economy may not be widely appreciated.  Pharma is very well-skilled at self-promotion and needs little advice on drug-specific marketing skills from academia or from the NHS, but the wider implications of the industry could perhaps be presented in a more sympathetic light.

Barriers to maintaining this relationship

Economic/commercial

One feature of these trials worthy of note is their international dimension.  Pharma is no longer dependent on the USA and the UK.  Indeed, a growing trend – well illustrated in a number of these and in successive studies - is the ability to study very large numbers of patients very quickly and to a very high standard in China.  In a recent three way study of patients post myocardial infarction, the Chinese arm recruited 5,000 patients well before the UL and Scandinavian arms had got into their stride.  We predict that this will be a growing trend and that emerging economies, and China in particular, will be a force to be reckoned with in respect of pharmaceutical drug development.  The sheer size of the populations is an attraction in itself, but let no-one be in any doubt that trials can be done in China to an exceedingly high standard.  UK research centres and the NHS in particular must not be complacent in respect of this and need to be alert to the potential threat posed by competitive recruitment strategies.  UK clinical trials research still has a very high international standing, but the UK will increasingly become marginalised as a significant slice of the international market place for new pharmaceuticals.  It is essential that the UK concentrates on the highest ethical and scientific standards, on a professional approach and remains competitive in respect of cost.

Both academia and the NHS benefit from clinical research activity sponsored by pharma. Both, however, would benefit from a higher degree of transparency in respect to the fees or “overheads” that they charge.  In an increasingly competitive market these need to be fair, reasonable and explicit.  Too many “overhead” charges are still poorly accounted for and are allocated in a complex and Delphic manner to unspecified “R&D support”.  Similar concerns have been expressed in respect of so-called ACT(R) funding which was subject to somewhat opaque rules of distribution.  NHS trusts should all have well-developed Clinical Trials Support Units to provide the necessary administrative and financial support for clinical research.

Organisational/Professional

A rather negative attitude has emerged in some sections of academia in respect of pharma-led studies.  This, in part, reflects the emphasis placed by the Research Assessment exercises on peer-reviewed grants and on molecular biology rather than in translational research.  It is possible to see signs of that tendency abating a little.  The recent development in Scotland of the Wyeth Initiative is an example of new ways of working across Scotland in a co-operative fashion.  This Initiative is about to enter a critical phase where it needs to demonstrate some tangibly successful outcomes and merits support across disciplines.  The RCP may have a role here in supporting and promoting such initiatives.

In a recent important development a consortium of clinical academics and physicians, working with colleagues in primary care, has attracted funding to Scotland of a major EMEA-commissioned trial to evaluate the relative safety of celecoxib versus traditional NSAIDS. This will capitalise not only on excellent personal relationships, but of the facility within Scotland of record linkage, which may provide a major research resource in the future.  We need to deliver on this to demonstrate an exciting, novel approach to clinical trial design and drug safety evaluation.

Another slightly negative aspect that many clinicians have seen emerging in recent years is poor recognition by NHS managers of the importance of clinical research.  Waiting list and waiting time targets have become the new obsession.  Clinical trials in some disciplines may be even regarded as a threat if they even raise the prospect of resulting in new and expensive drugs.  Researchers and pharma need to work together to demonstrate the benefits to patients, to the NHS and to medical progress of participation in research studies.  There is a case, in some disciplines at least, for regarding recruitment rates into clinical trials as a positive quality indicator, but some work needs to be done to develop this.  The MRC childhood leukaemia trials and many recent advances in oncology are testament to this.

Public/Media

Pharma have been brilliant at marketing new drugs to the medical profession.  That their combined marketing budget still exceeds their research budget is an oft quoted, much derided, but still essentially accurate statistic.  Ethical companies appreciate the importance of good quality research and will go to great lengths to ensure adherence to Good Clinical Practice, to establish Independent Data and Safety Monitoring Committees, Independent Steering Groups and Independent Publication Subcommittees.  Unfortunately, the role of Big Pharma is not necessarily viewed by the general public as a benign, well-intentioned organisation.  The path of pharmaceutical development has been strewn by the corpses of failed drugs where the benefits have been over-exaggerated and risks either unrecognised or concealed.  One thinks of thalidomide, benoxaprofen and, more recently, rofecoxib, to name a few.  In the case of rofecoxib, a persistent concern is that both the manufacturer, Merck and the US FDA may have failed to act timeously to withdraw the drug on the basis of information at their disposal – this saga runs on.  More recently, concern has been raised about the potential suicide risks induced by paroxetene and concerns have been raised that Glaxo Smith Kline may have been less than forthcoming about disclosing information about this.  Whatever the truth of these assertions, the overall perception is one of doubt, concealment and lack of transparency.  John Le Carre’s novel, The Constant Gardener did no favours to pharma, and helps perpetuate the notion of a manipulative, profit-oriented industry.  

Some of the risks run by pharma could be more clearly explained.  Recent examples include mibefridil and cerivastatin, withdrawn shortly after marketing as a result of adverse drug interactions emerging after the drugs had been on widespread release for only a few months. Even more wounding has been the withdrawal from further development of ximelagtran (liver injury) and etorcetrapib (unexplained increase in mortality) shortly before expected licensing after over a decade of development and at a cost of hundreds of millions of pounds and thousands of jobs. 

Bad news and scandals sell newspapers and the NHS, pharma, Royal Colleges and academia have not necessarily covered themselves in distinction when it comes to handling the media and covering stories of drug-related misadventure.  More work can be done to present the successes and the science behind them, and the Colleges can have an impartial role in this provided they are not tied to pharma.

SIGN is one of the very important roles of the Colleges in Scotland.  It is now established as a major source of guidance on many aspects of medical practice, with an international reputation.  However, it is essential that it is kept at arm’s length from any form of pharma influence.  This will be difficult if the Colleges develop major conflicts of interest and all their ties with industry must be explicit and transparent.

Regulation