Over the past two years, scientists working on human embryonic stem cells (hESCs) have been waiting for a court decision that would decide the fate of their research. In the case Sherley v. Sebelius, two stem cell researchers — James Sherley, M.D., Ph.D. and Theresa Deisher, Ph.D. — filed a case against the U.S. government and U.S. Secretary of Health and Human Services Kathleen Sebelius. The U.S. Court of Appeals for the District of Columbia reviewed whether federal law prohibits the funding of hESC research or just funding the creation of the cells. This is not the first time science and research was decided in the courts — and unfortunately, it probably will not be the last.
Scientific issues, especially those related to patenting rights of biological products, have been reviewed in courts for decades. In 1980, the seminal U.S. Supreme Court Diamond v. Chakrabarty determined the patentability of living organisms. In their decision, the justices determined that “anything under the sun made by man” was eligible to be patented. More recently, the case AMP v. U.S. Patent and Trademark Office is reviewing if “anything under the sun” includes genes that are isolated. What all three cases have in common is that justices with little to no science background or access to scientific experts, instead of scientists or our elected officials in Washington, are responsible for determining science policy.
Scientists should be included in discussions that result in the creation of laws or legal precedents that directly impact scientific research. Regulations are traditionally reviewed by a group of scientific experts, and most congressmen consult with scientists when drafting legislation. But in the judicial process, scientists are extremely limited in how they can advise judges. Only researchers called by one of the parties are able to give their direct testimony in court. As a result, the judicial branch plays a role in developing science policy with little input from scientists. This is problematic because the courts are forced to rule on scientific issues particularly when Congress is unwilling to address them, which seems to be the case with Sherley v. Sebelius. Because of the ethical controversy surrounding hESC creation, which involves the destruction of a human embryo, Congress avoided passing legislation that would clarify and finalize the government’s position on such research and thus left an opening for legal challenges.
The Baker Institute Science and Technology Policy Program examined the progression of the case in the recently released policy report “Stem Cell Research in the Courts: Sherley v. Sebelius.” In the end, the appeals court sided with the U.S. government. The court ruling defined research as limited to the set of experiments or a specific project, and not the totality of the work. The judgment allows scientists to use hESCs for an NIH research project, but not to create hESCs. While some scientists are now breathing a sigh of relief for being allowed to carry on their research, others are wondering when the next court case will challenge science policy, as well as which judges will be making scientific decisions that have far-reaching implications.
Kirstin Matthews is a fellow in science and technology policy at the Baker Institute. Her research focuses on the intersection between traditional biomedical research and public policy. Matthews’ current projects include the Baker Institute International Stem Cell Policy Program, the Civic Scientist Lecture Series and policy studies in research and development funding, genomics and climate change.