Clinical trials of nanomedicine: ethical and safety issues.

The applications of nanotechnology to medicine (nanomedicine) one day will have a major impact on the diagnosis, treatment, and prevention of disease. Although nenomedicine is likely to generate significant improvements in human health, it is also raises many different ethical questions and concerns. Chief among these are issues related to managing and regulating risks to human beings and the environment, including risks to research subjects. This article examines the ethical issues in clinical trials involving nenomedicine and argues that the research community needs to revamp its system for assessing the risks of new therapies to deal with some of the problems that will occur when nanotechnology is applied to human beings.

Key words: clinical trials, ethics, nanomedicine, nanotechnology

Introduction

In 1959, the late physicist Richard Feynman imagined that one day scientists would be able to manipulate matter at the atomic level, one atom at a time. In 1974, Japanese physicists first coined the term nanotechnology to describe the ability to engineer materials at the scale of one nanometer (one billionth of a meter). (1) Today, nanotechnology has become the hottest new development in science and industry. Across the globe, private companies and governments are investing billions of dollars in nanotechnology research and development, and new nanotech companies are springing up across the Americas, Europe, and Asia. The United States is spending more than $1 billion a year on the National Nanotechnology Initiative (NNI) to help stimulate basic and applied research, and other countries have developed similar initiatives. Nanoscale materials (nanomaterials) have been used to make computer chips, sunscreens and cosmetics, tennis balls and tennis racquets, ink, dental bonding agents, and metal-cutting tools. Nanomaterials have been used as protective coatings for automobile bumpers, sunglasses, and clothing. (2) Nanotechnology is expected to make profound contributions to many different areas including electronics, telecommunications, manufacturing, construction, textiles, and medicine.

Like the genetic revolution, the nanotechnology revolution is likely to have a significant impact on medicine. Private companies and government organizations have begun to experiment with many different applications of nanotechnology to medicine (nanomedicine). FDA has approved several therapeutics and imaging devices that use nanoscale particles (nanoparticles), and other products are in clinical trials or are awaiting clinical trials. (3) Some of the products that FDA has approved are new treatments for cancer. Other nanotechnology-based cancer treatments still are being tested. (4) The National Institutes of Health (NIH) has made a substantial commitment to nanomedicine research. Two NIH institutes, the National Cancer Institute (NCI) and the National Institute for Occupational Safety and Health (NIOSH) will devote some of their resources to nanomedicine. The NCI has set aside $144 million to fund seven cancer nanotechnology centers of excellence. (5) The National Toxicology Program of the National Institute of Environmental Health Sciences has begun a program to study the toxic effects of nanomaterials. (6) Other agencies studying nanomaterials include the Environmental Protection Agency (EPA) and the National Science Foundation (NSF).

According to many experts, in the next five years, nanotechnology will have important applications in drug delivery and diagnostic testing. In 10 years, nanomaterials will help to repair and remodel tissues, and the market for nanotechnology-based pharmaceuticals is expected to be more than $18 billion a year. By the middle of the 21st century, nanoscale machines may be used to deliver drugs, destroy cancer cells, diagnose disease, or repair tissues. (7)

Although nanomedicine is likely to lead to significant improvements in medical practice and human health, it is also raises many different ethical, legal, and social issues. It is important to address these issues while nanotechnology is still in its infancy and to try to anticipate problems that may arise. The NNI already has awarded $39 million to study the social impacts of nanotechnology. (1) Since nanomaterials pose risks to human beings and the environment that are not well understood, many of the questions and concerns surrounding nanotechnology pertain to risk assessment, management, and regulation. (8-11) Other questions relate to the use of …