The way I see it
Authors: Tanweer Hussain
Publication date: 20 May 2009
Tanweer Hussain says that failure to make radical changes now will mean the specialty is unlikely to survive
I recently attended a meeting at the Medicines and Healthcare Products Regulatory Agency and a clinical pharmacology colloquium with a large number of specialist registrars in clinical pharmacology and therapeutics.
Inspired by the high turnout, the chair at both meetings remarked that perhaps the predictions about the imminent demise of the clinical pharmacologist were premature. This optimistic sentiment conflicts with reality, however—a Royal College of Physicians survey published in 2007 revealed that the NHS did not employ any clinical pharmacologists between 2005 and 2007. In fact, the number of clinical pharmacologists is in decline and there are concerns about the viability of clinical pharmacology as a specialty. Many training vacancies within clinical pharmacology remain unfilled despite junior doctors’ fears about unemployment.
Clinical pharmacologists have a well defined role in teaching centres, with the most academic candidates going on to be heads of department and to take leading roles in national organisations. The current crisis is a result of failure to develop a unique role in the district general setting and to attract candidates who would otherwise be competent clinicians. A policy statement in the British Journal of Clinical Pharmacology more than 30 years ago defined the role of the clinical pharmacologist in the district general hospital. The authors believed there was an urgent need to increase the number of general physicians with a special interest in clinical pharmacology in non-teaching centres. At that time, the authors defined the following special roles for clinical pharmacologists in the district general setting:
Management of complex toxicology
Therapeutic drug monitoring
Drug information service offering pharmacoeconomic advice.
Such roles were subsequently generally and readily taken up by other professionals such as pharmacists, clinical chemists, and emergency physicians. The battle to establish clinical pharmacology in the district general hospital has been lost, and this failure could have far reaching effects. The important issue facing clinical pharmacologists at the moment is how the specialty will survive in the NHS. Some clinical pharmacologists might argue that they should lead local drugs and therapeutics committees and promote rational prescribing at a local level, although there are many other professionals who perform equally well in this role. Clinical pharmacologists are frequently excellent general physicians and perhaps the last of a dying breed. The obvious role for clinical pharmacologists is to take a lead role in developing the academic basis for acute medicine, and in the age of problem based learning ensure that undergraduates have the ability to prescribe rationally. Although acute medicine could help preserve clinical pharmacology in the NHS it might only be a temporary respite. Changes to the acute medicine curriculum could exclude clinical pharmacologists from leading acute medicine teams in the future.
In 2005, Professor Ritter headed a think tank debating the future of clinical pharmacology. His findings were published in the royal college bulletin in 2008. He points out that while the importance of medical education in clinical pharmacology has been recognised, the specialty is not attracting new academic lecturers. In contrast, pharmaceutical medicine, which contains a substantial element of clinical pharmacology, is flourishing. Perhaps forging links with the Faculty of Pharmaceutical Medicine would increase awareness of clinical pharmacology among trainees—although there might be no difficulty in recruiting doctors to the industry there are problems attracting them to clinical pharmacology.
The unfortunate events following the clinical trials of TGN 1412 might present an opportunity for the specialty. Following the adverse reactions experienced by participants in the clinical trial of the drug in 2006, an expert scientific group convened by the secretary of state for health looked at how to improve the safety of drug trials involving products such as monoclonal antibodies.
The recommendations included:
The development of specialist centres to do phase I studies on higher risk agents
Better access to hands on experience in the planning and conduct of clinical trials for relevant staff—Organisations that conduct clinical trials are increasingly separate from a medical environment and from academic or other educational centres, affecting their ability to train the next generation of relevant staff, especially clinical pharmacologists.
The Association of the British Pharmaceutical Industry’s guidelines for phase I clinical trials suggest that those individuals who act as principal investigators should have specific qualifications, including a certificate of completion of clinical training in clinical pharmacology and a minimum of two years’ phase I experience. Except for a handful of doctors in the country, few individuals will have the necessary qualifications. On that note, perhaps a rethink is in order with regard to training clinical pharmacologists in the UK in order to fulfil demands when the current crop of phase I clinical pharmacologists retire.
In my opinion, what is required is active collaboration with parties that have a vested interest in preserving the specialty, which involves a three-fold alliance between industry, the Medicines and Healthcare Products Regulatory Agency, and academic departments of clinical pharmacology. Training programmes should be developed to give individuals the opportunity to pursue a portfolio career between acute medicine and industry (including phase I clinical pharmacology) and the Medicines and Healthcare Products Regulatory Agency. What form this programme will eventually take will require careful thought by the appropriate parties. Failure to take radical changes now will mean it is unlikely the specialty will survive.
A version of this article first appeared in Pharmacology Matters—the newsletter of the British Pharmacological Society.
Tanweer Hussain graduated in medicine from the University of Liverpool in 1994, where inspirational pharmacology lectures by Professor Breckenridge influenced his decision to pursue a career in clinical pharmacology. After a period of general medical training in the East Midlands, he spent two years as a physician in one of the largest independent clinical pharmacology units in the UK, undertaking phase I clinical trials in healthy volunteers on behalf of the international drug industry; from first in man administrations of new chemical entities to complex pharmacokinetic and pharmacodynamic studies. Returning to the NHS, he was appointed specialist registrar in clinical pharmacology and therapeutics in March 2003. Dr Hussain is also an honorary lecturer at Liverpool University where he is currently completing an MD in pharmacogenetics. He completed higher medical training in clinical pharmacology and therapeutics and in general (internal) medicine in December 2008.
Competing interests: None declared.
Tanweer Hussain specialist registrar in clinical pharmacology and therapeutics
Derby City Hospital, Uttoxeter Road, Derby DE22 3NE