Who's paying for new drugs?

Direct payment by patients for treatment with drugs still in development is the subject of controversy. The matter goes deeper than it might first appear.

KIE: Oldham is the director of the Biological Therapy Institute, which has been criticized for accepting patients' money for laboratory research leading to experimental drug treatments. He raises the question of who pays the bills for the development of new drugs elsewhere in the clinical research system. Oldham argues that many fees and laboratory costs for university hospital- and clinic-based research are billed to patients and their insurance companies. Research grants and contracts to universities from the government and pharmaceutical companies are funded by taxpayers (former, current, and future patients) and by purchasers (patients) of already-approved drugs. Oldham asks why indirect funding of research by patients is acceptable while direct funding is not.

Governmental toxicology regulations: an encumbrance to drug research?

The science of toxicology has become infinitely more complex and sophisticated over the past 20 years, a trend which has been particularly marked within the research-based pharmaceutical industry. Governmental rules and regulations have had a strong impact on the types of toxicity test now performed on drugs both in the course of their development and after their introduction on the market, and have thus contributed to the increased cost--in terms of time and money--of drug development. However, it will never be possible to measure or predict the safety of drugs in man by the application of toxicological techniques alone. Close collaboration between toxicologists and the authorities responsible for drawing up toxicological regulations is called for in order to ensure that the rules applied during the important and fascinating process of discovering and developing new drugs do not become unnecessarily burdensome.