Pharmaceutical medicineBMJ 1996; 313 doi: https://doi.org/10.1136/bmj.313.7056.2 (Published 31 August 1996) Cite this as: BMJ 1996;313:S2-7056
In the first of a series of occasional articles devoted to careers in specialties not represented on the undergraduate syllabus, Darrell L Higson discusses working for the drug industry.
Pharmaceutical medicine is the discipline concerned with the medical aspects of research, development, evaluation, registration, monitoring, and marketing of medicines in the interests of patients. It is one of the fastest growing medical specialties in Britain: in 1974 there were some 260 doctors in the specialty; by 1989 numbers had doubled to 500, and today more than 700 doctors are employed within the British pharmaceutical industry and the contract research industry that serves it.
The expansion has been driven by the increased regulatory activity that followed the thalidomide tragedy in the ‘sixties. Both the Medicines Act of 1968 and the formation of the Committee on Safety of Medicines increased the need for physicians within the pharmaceutical industry and the regulatory authorities.
The British Association of Pharmaceutical Physicians (BrAPP) plays a major part in raising awareness of the specialty, introducing the Diploma in Pharmaceutical Medicine in 1975, and establishing the Faculty of Pharmaceutical Medicine as part of the three Royal Colleges of Physicians in Britain, in 1989.
Aims of industry
The pharmaceutical industry strives to develop and manufacture high quality new medicines with excellent efficacy and safety profiles. To continue to do this companies need to be profitable within a commercial environment, while recognising the special nature of medicines as distinct from general commodities, which is embodied in the ethical and legal codes of practice by which the industry operates.
Companies must seek approval from national regulatory authorities, such as the Medicines Control Agency in Britain before a medicine in development can be evaluated in patients or made available on the market.
Only one out of 5000 or so compounds discovered and investigated is likely to reach the prescription market. The development process from patent filing to product launch takes an average of 12 years at a total cost of some £200 million.
No two pharmaceutical physicians in the industry have exactly the same combination of roles but most physicians work within one of three main areas - clinical pharmacology, clinical research, or medical affairs which correspond to the well defined phases through which a drug passes in its clinical evaluation. The ratio of the number of physicians in each area is approximately 1:5:10. The skills and personal attributes required by physicians working in each of these areas are rather different although some doctors, especially in smaller companies, may find their responsibilities extend across more than one area. A proportion of doctors work in drug surveillance/pharmacovigilance, pharmacoeconomics, regulatory affairs, medical writing, and marketing, though these are not usually entry level positions. There is some movement of doctors between the industry and regulatory authorities and such broad experience can be a valuable asset. Nowadays some doctors choose to enter managerial roles directly from a background in administration rather than clinical medicine.
The clinical pharmacologist works closely with basic research scientists including chemists, biochemists, pharmacologists, and toxicologists involved in the initial drug development process. A new chemical entity undergoes extensive laboratory screening and only those with acceptable safety profiles are given to humans. The clinical research physician is involved in the design and monitoring of studies of the effects of new chemical or biological entities when they are first used in patients (phase II, and when they go on to be studied in large multicentre trials, phase III) looking at safety and efficacy. These studies form the key part of the clinical submission for international product registration.
Clinical research physicians work with clinical research associates, who are usually non-medical graduates, on trial, design, and monitoring. They work with statisticians and pharmacoeconomic experts during the planning and reporting stages, are responsible for ensuring an ethical and objective approach to the conduct of trials, and will be involved in writing the final report for publications. The medical adviser works alongside marketing and sales colleagues in the commercial part of a company. Although mostly working with licensed products, activity in phase III/IV clinical trials can be part of the mix.
The medical adviser provides a medical viewpoint on marketing strategy and ensures that product literature and promotional material are factually accurate and legitimate. Lecturing on company training programmes and to external audiences can be a significant part of the work, as can a variety of activities broadly categorised as public or professional relations.
Most companies encourage pharmaceutical physicians to maintain an occasional clinical appointment, which are usually honorary and flexible to allow company business to take priority.
The chance to be at the forefront of medical progress
The intellectual interest of researching and developing new medicines and working to clear objectives
The sense of purpose and the striving for worthwhile medical goals
The ability to have a wider influence on the medical treatment of patients than can be achieved through individual patient contact
The possibility of studying particular problems in depth and becoming an expert within the company and possibly internationally
The stimulus of working cooperatively in a multidisciplinary team
The international scope of the work and the possibility of travel
The facilities and technical support provided by companies in order to keep up to date
The opportunities for personal and career development, which are mainly limited only by an individual's ambitions and ability
and potential drawbacks…
Very limited or no clinical contact with patients unless in clinical pharmacology
Adjusting to corporate life in a commercially driven environment
Ability to operate under pressure and work to tight deadlines and agreed objectives
Willingness to accept flexible working patterns which can mean long working days with some nights and weekends away from home
Constraints of being “a small fish in a large corporate pond.”
Companies would expect a physician to start specific training once in post. Recruitment is therefore based on an assessment of personality as well as qualifications. The table on this page indicates the relative importance of ten characteristics sought by the industry when appointing physicians to the different types of post. In general, companies prefer to recruit within the age range 28-35 and usually with at least two years' clinical training. The hospital/academic background is the most common route into the pharmaceutical industry and outstrips appointments from general practice by about 8 to 1. A general practitioner's chances of being selected may be enhanced by the possession of an MRCP or MRCGP, although other personal qualities may be just as important.
Higher qualifications are not essential but as competition for places increases year by year, so does the proportion of physicians entering the industry with postgraduate diplomas and degrees such as the MRCP, an MD, or a PhD. Some companies insist on an MRCP-level qualification especially in the clinical pharmacology or clinical research areas.
Pharmaceutical companies in Britain generally encourage and fund relevant training in pharmaceutical medicine. A two year part time course for the Diploma in Pharmaceutical Medicine (DPM) is offered by the University of Wales, Cardiff, in collaboration with the BrAPP which acts as a qualifying examination for associate membership of the Faculty of Pharmaceutical Medicine. Membership (MFPM) is acquired following the successful presentation of a dissertation on an aspect of pharmaceutical medicine. Election to Fellowship (FFPM) is by merit.
The University of Surrey offers a modular MSc in pharmaceutical medicine, the compulsory modules of which also cover the syllabus in pharmaceutical medicine and prepare doctors for the diploma in pharmaceutical medicine.
In addition a variety of specialist courses are run within the pharmaceutical industry to aid further personal development. The Faculty of Pharmaceutical Medicine has applied for specialist recognition and when this has been obtained a continuing medical education scheme will be introduced, to be overseen by the Joint Committee on Higher Medical Training.
There are no nationally agreed salary scales for medically qualified staff in the industry. They may vary widely and are related to levels of seniority and size of company. Larger companies devise their salary scales from surveys across the industry in order to remain competitive.
In very general terms, a doctor joining the industry would expect to receive a salary of about 80-95% of the NHS junior consultant scale, a senior research physician/senior medical adviser 83-100% of the NHS consultant scale, and head of clinical research 90-115% of the maximum NHS consultant scale
A medical director of a large research-based international company would expect a salary in the region of an NHS consultant with a “B” merit award, although the most senior appointments in the industry can command salary packages well in excess of this. In addition, most companies offer a variety of taxable benefits. A booklet entitled The Pharmaceutical Physician will be published by the BMA Pharmaceutical Physicians Group later this year.
BMA Pharmaceutical Physicians Group, BMA House, Tavistock Square, London WC1H 9JP.
British Association of Pharmaceutical Physicians, 1 Wimpole Street, London WIM 8AE.
Faculty of Pharmaceutical Medicine, 1 St Andrew's Place, London NWI 4LB.
Talentmark Recruitment, King House, 11 Westbourne Grove, London W2 4UA (tel 0171 229 2266).
Roger Stephens & Associates, Chequers House, 1-3 Park Street Old Hatfield, Hertfordshire AL9 5AT (tel 01707 275361).