European Journal of Clinical Pharmacology © by Springer-Verlag 1979

Europ. J. clin. Pharmacol. 15, 211-214 (1979)

The Evolving Role of the Doctor in the Pharmaceutical Industry* A. J. Salter The WellcomeResearch Laboratories LangleyCourt, Beckenham, Kent U.K.

In order to survive, and survival depends on profitability and investment in a free economy, internationally-based companies within the pharmaceutical industry will continue to rely upon their own initiatives in research and development. During the late 1950's and the 1960's, rapid advances in technology and methodology were responsible for a pharmaceutical boom, during which a large number of new medicinal products became available. Most of these represented improvements in patient welfare, although with the thalidomide tragedy public confidence in those responsible for producing this plethora of antibiotics, tranquillisers, diuretics and anti-hypertensives, etc. was severely shaken. Prior to this period, the few doctors employed in the larger part of the industry provided advice on what were essentially promotional matters, but in the 1960's the industry set about recruiting rather large numbers of relatively young, generally well-qualified doctors who developed their own expertise in clinical research methods [1]. Although the outside image of employment in the industry was slow to change, those who joined the larger research-based companies found the work interesting and challenging. Much of this was concerned with clinical pharmacology, including tests of efficacy and safety of new compounds, and this work was academically satisfying. During the decade, however, public opinion, and subsequently political pressure, hardened in favour of Government regulation of the issue of new drugs, and many countries set up their own agencies for this purpose. At first, these were mainly concerned with reasonable safety aspects but partly because bureau* Abridged version originally presented at the 3rd International Meeting of Pharmaceutical Physicians, Brussels, 1978

cracy is self-generating, partly because these agencies were not entirely effective in preventing risks to the public at large, and partly for scientific reasons, their demands have become more and more stringent [2]. At first, because new products could be seen on the horizon, the effect on the industry was relatively slight, but nowadays the effect is much stronger and the gloomy predictions of some [3] who spoke out in the 1960's are being borne out. It is now more and more difficult and expensive to produce entirely novel products, and the benefitrisk equation has become so unbalanced that public opinion demands not the production of new effective medicines but that risks must be prevented at all costs; a sentiment which is arguably not in the interests of overall health care. Possibly as a result of these pressures, pharmaceutical research is concentrating now on areas where there are greater chances of financial reward. It is in these areas, of course, that competition is highest and where medical advance is likely to be smallest. It is sometimes argued that the industry only gives scant attention to the major unresolved problems of world health [4]. Those suffering from such diseases, or the governments concerned, are unable to pay sufficient for drugs to allow manufacturers to recoup the investment required for discovery of agents for their own particular ailments. For example, coronary heart disease is too complex, cancers are too diverse, and underdeveloped countries cannot afford to buy drugs, even for simple parasitic diseases. Currently, the industry is still riding upon the wave of discoveries in the 1960's but it is reasonable to ask for how long this will continue? There is a slowing down of innovational success coupled with an increase in R & D costs [5], at a time when a large number of patents are expiring. If this trend con0031-6970/79/0015/0211/$01.00

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tinues, and there is little reason to think it will not, there will be a profound detrimental effect on the future of the industry and those who work within it. Already there are signs of anxiety in the industry, evidenced by the fact that a number of larger research-based companies are experimenting with the introduction of "me-too" products [6]. How will these pressures affect the role of doctors within the industry in the future and furthermore, how will the presence of such doctors affect the industry itself?

Pressures on Industry Let us examine the demands and pressures on the industry. These may come from the prescribing medical profession, research workers, academia, Government bodies, consumer associations including patients, the press and other agencies. Some of these pressures are in line with the objectives of the pharmaceutical industry and some are not. Firstly, the medical profession's interests are concerned with improvements in health care. They are interested in real, not apparent, medical advances, and they require truthful information about drugs. The profession clearly holds differences of opinion about the industry. There is grudging acknowledgement that new drugs have to be produced by industry but this is flavoured by a general dislike of promotional tactics. The medical profession also feels that the industry's research is not always concentrated in areas which will be of most use to patients, and that money should be available to finance expensive drugs for rare diseases [7]. Research workers in hospitals and universities are not generally out of harmony with those in the industry. Their objectives are a stimulus towards discovery, novelty, image-building and profitability. As those in research frequently receive funds from industry this relationship is "symbiotic". Academic units, such as university departments, may have a favourable or unfavourable influence on the industry's aims, depending on the interests of particular institutions and the workers within them. Unfavourable pressures can arise when punic opinion, the press or Government becomes involved. The pharmaceutical industry has existed successfully over the past decades in spite of and partly because of the pressures mentioned above. However, there have been two forces which have grown steadily and which are producing a strong impact. The first of these is Government. The requirements of regulatory bodies have become more and more stringent for proof of safety and efficacy of new potential products. This trend erodes the resources of

the industry, clearly affecting profits and investment [8]. This is not to say that such requirements were initially against the interests of patients, but as the trend continues, it produces a decrease of new products. Governments are also concerned with drug prices, both within their countries and increasingly in other countries [9], particularly when they are involved in paying all or part of the national drug bill out of taxation. The other growing area which affects the pharmaceutical industry is the increasing public interest in hazards of drugs, a trend which is encouraged by the press. Clearly, the general public is not interested in facts about the effectiveness of medicines, as shown by the enormous daily ingestion of unnecessary vitamins, herbal remedies and health foods. Reports of disaster, earthquakes and violence, and the possibility that large numbers of the population can be gradually poisoned by minute quantities of a toxic metal or food additive, are certainly of more appeal to the press. Conservation is a growth industry and I believe that pharmaceutical companies will be faced with public criticism and enquiry, public liability suits and adverse press for many years to come. With the slowdown of development of new medicines comes the expiry of patents on those discovered during the pharmaceutical boom. Pharmaceutical research is essentially a long-term exercise, the fruits of success are only rarely within reach and then only after 15-20 years of germination and growth. How will the industry respond to these pressures?

Response of Industry As Government regulatory pressures have increased, R & D budgets have tended to swing towards "development" rather than innovation [10] because demands have strengthened in the toxicity, pharmaceutical and clinical areas. This trend, which is unlikely to be reversed, may reduce the chances of innovation, although as basic dlemical and biological research is the life-blood of the industry R & D budgets have had to increase to prevent innovation being deprived of funds. Surely, the industry will do its utmost to maintain R & D expenditure at as high a level as possible, as it will continue to strive for the discovery and development of novel compounds. In personnel terms, the recruitment and retention of high calibre scientists is an obvious step in this effort, but it is also clear that tasks at present being undertaken by highly qualified staff unnecessarily must be delegated to less qualified individuals. Another predictable response by industry is the

A. J. Salter: The Evolving Role of the Doctor in the Pharmaceutical Industry

consideration of policies which are more geared to short-term commercial gain. Success in this field will, to some extent, depend on the country in which parent companies are based and their relationships with their own subsidiaries in other countries. Unfortunately, the activities associated with such shortterm policies are medically unattractive and include heavier promotional activity with a leaning towards unacceptable practices, the development of products with little or no improvement in patient welfare and "me-tooism". Multi-national companies may increase their efforts in areas of the world where there is ready money but little sophistication. Diversification into other areas of para-medical business, and "take-overs" may also tend to increase, although these do provide administrative, personnel and financial problems. Another challenge, and one which will be influenced by public opinion, is the search for new facts on already marketed products. The National Academy of Sciences with the F. D. A., and also the Committee on Review of Medicines in the U.K., have been reviewing these older products, and such activity will doubtless spread to other countries. It will become unacceptable in the future to keep agents on the market which may be dangerous; certainly more facts will be needed about them.

Effects on the Industry's Doctors

The role of doctors in the pharmaceutical industry varies widely, from clinical pharmacologists on one hand to medical advisers in sales departments on the other. This seems to depend on the size of their Companies, whether employment is in parent or subsidiaries, and the country of domicile. The latter is important because of different attitudes, the organisation of the local health services and the salaries of peers and colleagues. The following remarks, therefore, are generalisations which I believe will gradually be instituted throughout the world, although the speed will be variable. First, I would like to consider the doctor's role in clinical research. As fewer novel compounds come through research, in many companies there will be less opportunity for clinical investigational work. This is regrettable, as many doctors now in the industry joined it in the expectation that they would be mostly employed in this field. The swing in clinical research is likely to be towards the less exciting marketed products or "me-too" compounds. It is difficult to know how long this trend will continue, but I think that the amount of time spent by the doctor in

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research will decrease somewhat, more emphasis being placed on his other duties. This may be partly offset by the requirement for more detailed studies on fewer compounds. Related to research on marketed products will be his attitude towards Company statements about such products. As review bodies carry out their work, such statements will have to be more and more rigorous. Additionally, there is growing publicity about differeing recommendations for the same pharmaceutical product in different countries [11]. The pharmaceutical physician will be intimately concerned with producing reasoned medically-sound statements about his Company's products. Some of these statements may conflict with the commercial interests of his Company, and it is important that the industry's doctors do not become medically "compromised". One of the jobs of parent company boards of management is to try and avoid serious friction between those involved in the medical and marketing sides, as it is in the long-term interests of the industry to maintain an ethical position. The term "ethical pharmaceutical industry" was not coined by accident, and it may be argued that such an industry has a responsibility towards society at large. I raise this point because the changes now taking place in the industry are likely to be friction-producing, as the achievement of short-term commercial objectives wilt be regarded more importantly by boards of management. The latter will not wish to hear unwelcome facts about established and profitable products; likewise, medical personnel will not be enthusiastic about carrying out clinical research on compounds with little medical advantage. It is also clear that outside research workers will share the latter view. There may be pressures on doctors in the industry to aquiesce to promotional activities which do not appeal to them and to approve promotional material which does not tell quite all the facts. All this is understandable when one considers that our commercial colleagues are mainly motivated to increase profitability, whereas the doctor in the Company depends mostly on his professional credibility and administrative expertise. There may well be some who argue that the doctor can be dispensed with if his attitudes become increasingly negative, and I suspect that many companies employ non-medical people to administer what are, in effect, medical departments. Smaller companies may elect to seek the advice of outside consultants who are not in an executive capacity. Another factor is that doctors are expensive when compared with other staff in the industry. Their salaries are generally related to doctors in practice and in many countries such incomes are high. There

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are now definite trends towards the employment of pharmacists and other graduates for much of the support work that has to be carried out in medical departments.

such attitudes that the long-term objectives of the pharmaceutical industry can be protected. These objectives must surely strive to contribute towards improvements in world health.

Conclusions

References

As a result of outside pressures, the pharmaceutical industry will have to adapt itself in a way that will have a profound effect on the role of doctors within it. Due to the decreasing numbers of novel products becoming available and the public interest in the safety of marketed products, there is likely to be a shift in clinical research towards the latter, plus some decrease in innovative research work. However, the doctor will also be involved increasingly in the provision of balanced statements and opinions about his Company's products and for this there will be a continued need for highly qualified and experienced doctors. There will be a shift towards greater responsibility in advice related to Company policy and away from day-to-day activities which can be performed by non-medical, less expensive, personnel. There is likely to be increased potential for friction with marketing colleagues and the avoidance of such friction will require skills of diplomacy. Boards of management in the industry will have to accept that many of the doctors they recruited for clinical research work will have their own medical and ethical standards and these will have a substantial effect on Company policies from within. Provided that pharmaceutical physicians keep the health of the world community in mind in their tasks, they will provide a valuable service to medicine and the industry in the long term. It is by the adoption of

1. Cromie, B. W.: Role of the Medical Adviser. In International Aspects of Drug Evaluation and Usage. A.J. Jouhar and M. F. Grayson (eds.), pp. 171-176. Edinburgh & London: Churchill Livingstone 1973 2. Rationality of Drug Development. P. E. Lucehelli, N. Bergamini and V. Bacchini (eds.), pp. 71-100. Amsterdam-Oxford: Excerpta Medica 1976 3. Modell, W.: Editorial-FDA censorship. Clin. Pharmacol. Ther. 8, 359-361 (1968) 4. Medicinal products for all who need them. WHO Chron. 32, 154-155 (1978) 5. Cromie, B.W.: Innovation in the Pharmaceutical Industry. Letter. Brit. Med. J. 1978/I, 1618 6. Slatter, S. St. P.: Competition and marketing strategies in the pharmaceutical industry, p. 121. London: (2room Helm 1977 7. Medico-Pharmaceutical Forum/Project selection in the pharmaceutical industry 69, 891 (1976) 8. Slatter, S. St. P.: Competition and marketing strategies in the pharmaceutical industry, p. 20. London: Croom Helm 1977 9. Cooper, M.H.: European Pharmaceutical Prices, pp. 1964-1974. London: Croom Helm 1975 10. Dumas, P. A.: The Pharmaceutical Industry Viewpoint on the Future. Presented at 3rd International Meeting of Pharmaceutical Physicians, Brussels, 1978 11. Yudkin, J. S.: Provision of medicines in a developing country. Lancet 1978/I, 810-812

accepted: February 8, 1979

A. J. Salter, M. D. (Lond.). The Wellcome Research Laboratories Langley Court Beckenham, Kent BR3 3B5 England

The evolving role of the doctor in the pharmaceutical industry.

European Journal of Clinical Pharmacology © by Springer-Verlag 1979 Europ. J. clin. Pharmacol. 15, 211-214 (1979) The Evolving Role of the Doctor in...
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