Commercialization of Human Biological Materials and Ethical Considerations

Key Insight

The commercialization of human biological materials became possible after the 1980 Supreme Court ruling in the *Ananda Mohan Chakrabarty* case. This decision allowed the patenting of genetically engineered living organisms, including human cell lines not naturally occurring outside the body, based on the principle of 'human ingenuity' transforming them into inventions. This set a precedent where researchers could patent cell lines without necessarily informing or obtaining property rights consent from the 'cell donors.' John Moore's cells were exceptionally valuable, producing rare proteins useful for treating infections and cancer, and carrying the HTLV virus, which researchers hoped could lead to an AIDS vaccine, thus attracting enormous financial interest from drug companies.

A contrasting example involved Ted Slavin in the early 1970s, a hemophiliac whose body produced extremely high concentrations of hepatitis B antibodies due to repeated exposures to the virus. Unlike Moore, Slavin's doctor informed him of the commercial value of his blood. Slavin capitalized on this, selling his serum for up to $10 per milliliter, with orders reaching 500 milliliters. Critically, Slavin also partnered with Nobel Prize-winning virologist Baruch Blumberg, offering unlimited free use of his blood for research, which led to the discovery of the link between hepatitis B and liver cancer and the creation of the first hepatitis B vaccine, saving millions of lives. Slavin even founded a company, Essential Biologicals, to help other patients with valuable blood.

The Moore case brought widespread public awareness to the lucrative potential of human cell lines and sparked a national debate among scientists, lawyers, ethicists, and policymakers regarding ownership rights and ethical responsibilities. Some advocated for legislation to mandate patient consent and disclosure of potential profits for commercializing tissues, while others warned that such regulations would create 'logistical nightmares' and impede medical progress. Despite the California Supreme Court denying Moore property rights, it acknowledged the lack of informed consent and breach of fiduciary duty, pointing to a broader absence of regulation and patient protections in tissue research and urging legislative action to remedy the situation.