Stem-cell Research and the Government's Authority to Regulate

Introduction

For more than a decade, Pfizer has been using animal and adult stem cells in its laboratories to help screen new compounds and identify safer and more effective medicines.

Research knowledge about potential use of human stem cells for the development of new medicines and therapies began in the 1960's when scientists discovered certain types of cells could develop into a broad range of tissues. By the 1970's researchers were able to identify stem cells in mice. Almost 20 years later, a team at the University of Wisconsin isolated and created the first human embryonic stem cells (hES cells). “The achievement with human cells was significant because of its implications for improved health. The dual capacity of hES cells for self-renewal and for differentiation into repair cells offers great potential”1 for curing or slowing the progression of disease and for understanding disease mechanisms.

A 2007 book title describes hES cells best - they are the “Cell of Cells.” The hES cell can regenerate into any and all of the body's cells. Because of this power, the “Cell of Cells” is a rich target for research projects around the world. Scientists, patient advocates and members of the public are hopeful hES cell research will assist in the discovery of cures for dreaded diseases such as Parkinson's, Alzheimer's and cancer.

The former head of the National Institutes of Health, Dr. Harold Varmus, described the power of embryonic stem cells: “This research has the potential to revolutionize the practice of medicine and improve the quality and length of life...There is almost no realm of medicine that might not be touched.”2

While stem cells can be derived from a range of sources such as bone marrow and adult tissues, the use of human embryonic stem cells for research is somewhat controversial, because it touches on the fundamental debate over when life begins with regard to the use of cells from human embryos for research. This paper reviews Pfizer's development of a policy on the ethical use of stem cells for medical research at Pfizer.

What are Stem Cells?

Stem cells are “unspecialized” cells derived from several sources including embryos, umbilical cord blood, bone marrow, and many other non-embryonic tissues. All stem cells demonstrate the ability to self-renew. hES cells are primitive, that is, have not yet become a particular type of cell. The cells go through a process called differentiation and then become specialized cells such as those making up blood, brain or muscle cells.

Under the proper conditions, researchers can direct stem cells to form the highly specialized cells that make up our tissues and organs. These traits make stem cells ideal candidates for use in drug development and a potentially valuable source for replacement cells for a variety of diseases, including Alzheimer's, diabetes, Parkinson's, and many others.

What Ethical Issues Arise from Stem Cell Research?

The first hES cells created in Wisconsin were derived from a very early human embryo donated to researchers by a couple who had undergone ...