"...a good introduction to the development of new products and their worldwide marketing." (Pharmaceutical Research, Vol. 20, No. 9, September 2003)
Principles and Practice of Pharmaceutical Medicineby Andrew J. Fletcher, Lionel D. Edwards, Anthony W. Fox, Peter D. Stonier, Anthony Fox
Principles and Practice of Pharmaceutical Medicine begins with a detailed overview of its origins, and goes on to examine current career opportunities, education and training. Encompassing the entire spectrum of pharmaceutical medicine, it also discusses international drug development and registration, including animal toxicology and human volunteers,
Principles and Practice of Pharmaceutical Medicine begins with a detailed overview of its origins, and goes on to examine current career opportunities, education and training. Encompassing the entire spectrum of pharmaceutical medicine, it also discusses international drug development and registration, including animal toxicology and human volunteers, pharmacoeconomics and statistics, medical services, legal and ethical issues and business aspects. It is the most up-to-date guide to drug development and marketing, and the only book with an international outlook.
• The authors are all experts in their field and include an assessment of the current status of their specialities
• This book provides an insight into how things may develop in the future
• It is designed to be a guide for those who are actually practicing pharmaceutical medicine
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- Older Edition
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Principles and Practice of Pharmaceutical Medicine
John Wiley & SonsCopyright © 2002 John Wiley & Sons Ltd.
All right reserved.
Chapter OnePharmaceutical Medicine as a Medical Specialty
Michael D. Young Celltech Chiroscience PLC, Slough, UK
Medicine is an art that has been practiced since time immemorial. The use of herbs and natural medicaments to relieve pain or to aid the sick in coping with their afflictions has been a part of all societies. In the Western world, medicine has developed at least since the time of the Greeks and Romans-the Hippocratic oath reminds us of this nearly 2500 year history. However, the progress of medicine has been very different from that of many other arts within society. It has come of age after an incredibly long maturation period. As a function capable of offering a successful treatment for an human ailment, medicine is very much a development of the last 100-150 years. Indeed, the major advances have come in the last 50-75 years.
The role of physicians in society has changed over the centuries. It may have reached its nadir during the early renaissance, when the general attitude was, as Shakespeare said, 'Trust not the physician; his antidotes are poison'. From the nineteenth century onward, as their diagnostic understanding has grown and as their therapeutic agents have become increasingly effective, physicians have come to be increasingly valued. Today, much of the practice of medicine in all of its subspecialties is based on a physician's diagnosis and treatment with drugs, devices, or surgery. This radical change to an era of focused treatments, after aeons of using homespun remedies and then watching hopefully for the crisis or the fever to pass, has accompanied the recent revolutions in the understanding of biological processes and in technical and bio-technical capabilities. These developments have allowed us to produce pure therapeutic agents and to establish how to use them safely and effectively.
The exponential growth in scientific knowledge, particularly over the last 100 years, has brought about a paradigm shift in our approach to pharmaceuticals. Until the twentieth century, the sale and use of medicines and medical devices was almost entirely unregulated by governments. It was a case of caveat emptor, with only the drug-taker's common sense to protect against the dangers of the so-called patent medicines and 'snake oils'. The obvious abuses in these situations led eventually to government intervention, to professional regulation, and to requirements that drugs be pure and unadulterated. With advances in science and in the ability to define and establish drug efficacy came a requirement to demonstrate that drugs were also safe. Finally, as late as the second half of the twentieth century came the legel requirement to establish that pharmaceuticals were effective before they were marketed. These legal requirements reflected changes in social attitudes and expectations grounded in the questions that the development of biological and basic sciences had made it possible to ask and to answer. The response to these changes has led to the development of the specialty of pharmaceutical medicine.
Pharmaceutical medicine can be defined as: 'the discipline of medicine that is devoted to the discovery, research, development, and support of ethical promotion and safe use of pharmaceuticals, vaccines, medical devices, and diagnostics'. (By-laws of the American Academy of Pharmaceutical Physicians). Pharmaceutical medicine covers all medically active agents from neutraceuticals, through cosmeceuticals and over-the-counter (OTC) pharmaceuticals, to prescription drugs. Furthermore, the specialty is not confined to those physicians working within what is classically considered the pharmaceutical industry, but includes those involved in the clinical management or regulation of all healthcare products. It is the basic specialty for physicians within the cosmetics and nutrition industry for those in the device industry and for those in 'not-for-profit' companies, such as those responsible for the national blood supplies and/or for specialized blood products. Furthermore, it is the fundamental discipline for physicians who are in government health ministries, insurance companies, National Health Trusts or HMO management, drug regulatory agencies or any other oversight or regulatory function for healthcare.
In the early part of this quarter-century, for a medicine to be adopted and for it to sell, it was sufficient that science could conceive of a new treatment, that technology could deliver that treatment, and that clinical research could prove it effective and safe for the physician to use. This is no longer the case.
Over the past three decades we have seen the emergence of two major influences in decisions about new advances in healthcare. These are the payer-providers and the patient-consumers. Their role in the decision-making process has increased rapidly in the last 25 years, as can be seen in Figure 1.1
With an increasing proportion of society's healthcare budget going on pharmaceuticals, even a growth in the percentage of the gross national product that governments are willing to allocate to healthcare has been unable to meet the demands of unbridled development. This has made the payer/ provider a major determiner of the use of pharmaceuticals. All possible treatments cannot be freely available to all and a cost-to-benefit consideration has had to be introduced. This in turn has ensured that pharmaceutical medicine involves pharmacoeconomics training and even media training to deal with what, for some, may be seen as the rationing and/or the means-testing of access to the totality of healthcare options. These are significant ethical and social issues and physicians within the pharmaceutical industry or the health regulatory agencies will inevitably be required to provide a perspective, both internally and to those outside.
The second new decision maker in the provision of healthcare has arrived even more recently as a crucial component. These are the end-user or patient groups. The rising status of the physician since the nineteenth century encouraged a paternalistic doctor-patient relationship, with the physician clearly in the lead. In recent times the nature of this relationship has come under question. The advent of holistic medical concepts focused on the whole patient, and taking into account the entirety of an individual patient's life has forced changes in the focusing of any therapeutic interaction. The general increase in educational standards within the developed world and the massive increase in available information culminating today with the electronic media and the Internet has inevitably produced a more informed patient. This has empowered the patient and led to the formation of all kinds of public interest and patient groups. Furthermore, the ability in this century to think in terms of the maintenance of good health and even of the abolition of disease (e.g. smallpox and polio) has changed the patient's and society's attitude to what they can and should expect of physicians. Today we are very much moving towards a balance in the therapeutic interaction, if not to a patient-doctor relationship. This change is a seminal one for the delivery of healthcare and for the development of new therapeutic agents.
For prescription drugs, the major factor bringing about the involvement of patient groups was probably the revolution in the new drug evaluation process caused by the AIDS epidemic. This terrible affliction occurred at a time when groups within society were forming to fight for their recognition and/or rights quite independent of the occurrence of a life-threatening disease. Nonetheless, within the Western world, it is clear that these groups rapidly came to form a vanguard for patients rights with respect to AIDS. They challenged the paternalism within medicine and insisted on access and full disclosure of what was going on in pharmaceutical medicine and within academic medical politics. Without this openness such patients had lost confidence in pharmaceutical companies, in academia, and in the medical and regulatory establishment. Having forced a re-evaluation and a greater respect for patients' needs, AIDS Coalition to Unleash Power (ACTUP) and others have brought patient representatives into the drug development process. Such educated and involved patients have, in their turn, come to understand the scientific methodology and the requirement for the adequate testing of new drugs. Indeed, the requirements have consequently become much more acceptable to patients in general. Nevertheless, there is no doubt that these proactive patient representative groups have changed forever the role of the patient in the development of therapeutics and of healthcare within society.
Pharmaceutical medicine is the discipline that specializes within medicine in overseeing the process of developing new therapeutics to improve the standard of health and the quality of life within society. Inevitably, then, it was one of the first medical specialties to feel this change in patients' view of the quality of their care. An integral part of all progress in healthcare is evaluating the needs of patients and society and the gaps in the present provisions for those needs. In order to oversee this progress, pharmaceutical medicine involves the combination of first, the medical sciences to evaluate disease; second, the economic sciences to evaluate the value with respect to costs; and third, the ethical and social sciences to evaluate the utility of any new drug to patients and to society as a whole.
As with all products, truly successful therapeutic agents are those that meet all the customers' needs. In today's and tomorrow's world the concept that all that is needed is for medicines to meet the scientific requirements of being effective and safe is essentially an anachronism. It is not just the scientific factors and customers that must be satisfied. Table 1.1 shows that the two other critical factors or influences outlined in Figure 1.1 produce many more customers to be served.
As members of the public become generally more and more informed, it is inevitable that they will want to take more of a role in deciding on their own health and how any disease they may have is to be treated. It is important to realize that this is likely to change the demand for healthcare. Some of the focus will move to areas not classically considered diseases or to health areas considered today an inevitability of life or a condition for which the patient should 'just take charge'. Typical examples will be, on the one hand, an increased focus on quality of life or on the effects of aging (such as cognitive dysfunction, the menopause, osteoporosis, and waning immunological function, with consequent increasing vulnerability to disease) and, on the other hand, disorders such as obesity, attention deficit, hyperactivity, and even anorexia/ bulimia. As the patients or their representatives respond and 'take charge', we should not be surprised to see a change in what are considered therapeutic modalities and how they are made available. We might expect a demand for products that do not need prescriptions (e.g. minerals, neutraceuticals, and cosmeceuticals) or for patients to be able to self-diagnose and use prescription drugs moved to a 'pharmacy only' or to a full OTC status. Some of these moves may well fit within one or more governments' desire to reduce the national pharmaceutical bill and hence may be something that has both patient and provider endorsement.
Those seeking to develop therapeutic products will need to understand these dynamic interactions and the consequent potential changes in one or more society's approach to its healthcare. Indeed, this is another opportunity for pharmaceutical medicine to broaden. The speciality should cover all pharmacologically active treatments, all disease preventions and all health maintenance modalities. The objective is to maximize patient benefits and extend product lifecycles, as well as company sales. Clearly, pharmaceutical medicine requires an ability to read the direction society is taking and an understanding that, on a global basis, various societies can take different attitudes to how they will regulate and/or classify a therapeutic agent. However they are classified or regulated, new therapeutic agents will continue to be needed, health benefits to deliver now, and to be potentially significant revenue generators for a business, allowing investment in future therapeutics. This is the basic cycle (Figure 1.2) that drives the pharmaceutical industry.
The R&D process is moving forward as biomedical science progresses and disease processes are better understood. The process of developing a therapeutic agent is much more than the better understanding of a disease leading to a new approach to its management. The process includes: first, state-of-the-art technical manufacturing sciences to ensure a drug substance is pure; second, appropriate and innovative pre-clinical science to ensure that a new chemical entity is as safe as possible before being used by humans; third, the most sophisticated clinical evaluation methodology. This methodology must establish the efficacy and safety of a new treatment in humans and include a multidisciplinary approach to the medical, social, and economic issues of quality of life and cost-benefit. Finally, the process includes the business management of the social and political issues inherent in establishing, communicating and assuring the value of the new drug within a global economy.
The amount spent on R&D by the pharmaceutical industry has grown logarithmically over the last few decades and now the industry outspends the National Institutes of Health in the USA (Figures 1.3, 1.4).
Similar growth in R&D investment has been seen outside America, e.g. in the UK. With such a massive R&D effort, the process has inevitably become subdivided into several functional sections, the most obvious being:
Basic chemical or structural research-exploring the genetic basic of a disease or the microstructure of a receptor or enzyme active site, and from that, developing tailored molecules to provide specific interactions and potential therapeutic outcomes.
Preclinical research and development-using biological systems, up to and including animal models, to explore the causes of diseases and the potential safety and efficacy of new therapeutic agents.
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