Unmet Medical Needs and the Role of Pharmaceutical Companies

Rising health care costs have been prioritized in the budget planning of all Western countries. Rising R&D costs of up to $800 million per marketed new pharmaceutical have dramatically reduced the approval of new chemical entities (NCEs). Globalization of diseases like AIDS and SARS has had a definite impact on the economic situation not only in the Western world, but also in developing countries, especially for AIDS in Africa and SARS in Asia. The World Health Organization (WHO) is calling for free anti-tuberculosis (TB) drugs to be made available to people living with human immunodeficiency virus (HIV). The spread between unmet medical need in large indications (e.g. Alzheimer's disease) and in niche indications (e.g. Huntington disease) and the economic burden to create a blockbuster ($1 billion sales within one year after launch) has created a marketing-driven clinical development of new chemical entities. A paradigm shift has occurred by which developing a new innovative drug by documenting shortterm efficacy, quality and safety rather than long-term efficacy and emphasizing pharma-covilliglance including considerations of health economy within the medical environment a shift that has fundamentally changed and challenged the pharmaceutical industry.