Abstract
Thirty-five years ago we produced a poliovirus vaccine in cultured normal human cells and demonstrated its efficacy and safety in children. This was the first human biological ever produced in a normal human cell population. The major advantages of using a normal human diploid cell strain over the primary monkey kidney cells then used were safety and standardization. A normal human cell strain derived from a single tissue can be cryogenically preserved, extensively tested, and then used as the substrate for the production hundreds of millions of vaccine doses. This cannot be done with a primary cell population. Today, hundreds of millions of people worldwide have benefited from vaccines produced in cultured normal human cells. For example, all of the rubella vaccine used in the Western Hemisphere is produced in my human diploid cell strain WI-38.
Because biological systems could not be patented in 1962, I brought a law suit against the NIH and the United States Department of Health, Education and Welfare who claimed title to WI38. After six years of litigation, a settlement was reached confirming my position that legal title to self-reproducing biological systems should be vested in those whose intellectual property rights provide value to the system.
Because some essential molecules needed to benefit humans will probably only be capable of manufacture in human cells, it is inevitable that human cells or tissues will be used increasingly for the production of human biologicals. The direct use of more human organs and tissues is also inevitable when cultural barriers fall as a result of the realization that the use of human tissue, that would otherwise be discarded, can be defended on the basis that it could be used to save or better another human life.
