The three-cornered partnership between the NHS, pharma and academic medicine can only benefit from a more open culture, says Timothy Evans.
Cooperation between medical professionals and the pharmaceutical industry at all stages of medicine development and use would seem mandatory if patients are to benefit from novel, safe and effective new therapeutic interventions. But despite the distinguished history of UK pharma, the paradigm of doctors and industry working in harmony to translate drug discovery into patient benefit has not always been realised.
Despite the genuine capacity of UK universities and the pharmaceutical industry to innovate, the three-cornered partnership of the NHS, academic medicine and the pharmaceutical industry has, at least in recent years, been of questionable strength.
Each community bears some responsibility for the failure. The Royal College of Physicians 2009 report Innovating for Health attributes some problems to failures in what could be termed “NHS basics”, such as safe and effective prescribing. The seeming inability of medical teaching and electronic systems to prevent large numbers of prescription errors in primary and secondary care is particularly concerning. The return of clinical pharmacology as a specialty, and effective education and re-education of students and practitioners could address this issue.
Transparency is vitally important. The reluctance of scientific journals to publish the results of negative clinical trials could be regarded as a failure of academic medicine to lobby effectively. Any purposeful retention of data by companies sponsoring trials has profound implications for patient safety.
The hypothesis, methods and design of each trial should be registered and publicly accessible, and the results made available within 12 months of completion. A lack of transparency over the financial agreements between pharma and medical professionals regarding research sponsorship, publications and educational events is lamentable in the era of freedom of information. Other barriers to effective translation of research into medication are externally imposed.
Sir Michael Rawlins’ inquiry for the Academy of Medical Sciences concluded last year that existing systems for research regulation and governance are fragmented and characterised by multiple layers of bureaucracy, uncertainty and duplication. Most damningly, a culture that fails to fully support the value and benefits of research was identified.
What is the way forward? First, the relationship between medical professionals and industry must be re-established on an equal, open and transparent basis. The newly formed Ethical Standards in Health and Life Sciences Group has set itself the task of doing so, and of grasping the nettle of financial disclosure.
Second, embedding research and development in the ethos of every NHS trust has long been a mantra of the National Institute of Health Research. The introduction of biomedical research centres and units, and dispersal of research funds more equitably and widely from bench to bedside is to be welcomed.
Third, the Rawlins inquiry recommended that a health research agency should be created to rationalise the regulation and governance of all health research. That could be seen as establishing a new quango to deal with the legacy of the old, but if that freed trust research and development departments to focus on local issues pertaining to capacity, performance and conduct, an agency could be a very good idea.
Finally, the potential of the NHS to contribute to economic growth in the health and bioscience industries has recently been recognised, with recommendations extending beyond the laboratory and into organisation and leadership.
While the Health and Social Care Bill’s impact on research and innovation remains to be seen, no one would argue against the need to reduce variation in the NHS and to drive greater compliance with effective systems of clinical practice and relevant standards.
However, the increasing and reasonable demand that care should be delivered by fully trained doctors seven days per week will place a greater strain on research, and is likely to drive further apart the career paths and aspirations of clinical scientists and research-active consultants.
This process is likely to be exacerbated by revalidation requirements, commencing this year. The findings of the Mid Staffordshire foundation Trust public inquiry will probably also result in calls for further changes in clinical practice and attitudes. A Royal College of Physician’s Commission on the “future hospital” aims to address at least some of these demands.
The relationship between medicine – academic and clinical – and the pharma industry is no longer cosy, but challenging. The demand for change is coming from inside and out, and is occurring against a backdrop of new and unparalleled demands upon the clinical workforce and the NHS. Like most relationships, it will need to be adaptive and open to change if it is not to fail.