Wrangling over economic and national security issues has left health and genetic discussions on the backburner in the presidential race. However, the three leading candidates have been active on these issues during and prior to their time in the Senate. Barack Obama has encouraged personalized medicine research and genetic test regulation; John McCain has concentrated on stem cell research; and Hillary Clinton has been active in all of these areas as well as newborn screening and genetic and environment interactions.
Genomic Research and Personalized Medicine
Clinton’s and Obama’s past initiatives demonstrate their strong support for and encouragement of the growth and application of genetics-based medicine. From 1998 to 2000, as First Lady, Clinton held nine events called Millennium Evenings at the White House. Each focused on a different subject, and included a session titled “Informatics Meets Genomics” that stressed the development and importance of genetic research.
Obama has sponsored a genetics-related bill twice in his approximately three years in the Senate; both times the legislation stalled in Senate committees. He stated that the goal of the Genomics and Personalized Medicine Act was “to secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research and initiatives to improve the accuracy of disease diagnosis, increase the safety of drugs, and identify novel treatments.”
The bill would have required formal studies of genetic technology in order to advance the field. It also sought to move this field forward through a national biobanking research initiative, and the 2006 version included support for local biobanking initiatives. Additionally, it encouraged the movement of genetic technology from the research laboratory to the clinic through increased training of healthcare professionals and the creation of genetic screening tools, diagnostics, and treatments from genomic information gathered from research initiatives.
Obama attended the 2006 Genetics and Public Policy Center’s National Genetic Policy Summit. At this event, he highlighted “the unparalleled promise genomics holds” of tailoring treatments to people’s individual genetics. However, he pointed out that few genetics-based tests had reached the market. This is what prompted him to introduce the Genomics and Personalized Medicine Act of 2006, he told the audience. Through the bill, he said he hoped to spur increased support for genomics, modernization of the Food and Drug Administration’s process of evaluating genetics tests, and the creation of a database of information from the proposed national biobank.
Genetic Privacy
Clinton cosponsored the Genetic Nondiscrimination in Health Insurance and Employment Act (2001) and the Equal Rights and Equal Dignity for Americans Act of 2003, which sought to outlaw genetic discrimination by employers and health insurance companies. Neither bill reached the Senate floor for a vote, but a similar comprehensive anti- genetic discrimination bill, the Genetic Information Nondiscrimination Acts (GINA) of 2003 and 2005, has passed twice in the Senate. In both years, the bill passed unanimously but then stalled in the House.
In 2003 Clinton and McCain voted in favor of the bill – Obama was not yet elected to office. In her statement on this bill, Clinton said, “Americans have already shown that they will not fully participate in genetic research or take advantage of genetic technologies until they believe that they are protected against genetic discrimination in health insurance and employment.” She added, “Discrimination based on genetic information would be a step backward for civil rights and human dignity.” In 2005 Clinton was one of 25 cosponsors of the bill, and both McCain and Obama voted in favor of it. In 2007 Clinton and Obama cosponsored the current version of GINA with 36 other Senators, but the Senate has not yet voted on it.
Clinton also has addressed genetic discrimination in other ways than GINA. In her introduction to the “Informatics Meets Genomics” Millennium Evening, Clinton asked, “How will we make sure that knowledge about our genes is used to heal us, not deny us health insurance or jobs?” Additionally, in 2001 Senate floor statements, she emphasized the need for Congress to address genetic discrimination.
Regulation of Genetic Tests
Obama called for increased genetic test regulation at the Center’s National Genetic Policy Summit and in the Genomics and Personalized Medicine Act. Among its provisions, the Genomics bill includes “[improving] access to and appropriate utilization of valid, reliable and accurate molecular genetic tests.” Obama stressed that that this would require “greater attention to the quality of genetic tests, direct-to-consumer advertising, and use of personal genomic information.” He said he wanted the bill to increase the “safety, efficacy, and availability of information about genetic tests.” The bill would initiate a study regarding Federal oversight of genetic tests, create a framework for genetic test review, promote transparency by requiring information from federally funded biobanking initiatives to be publicly available, and evaluate direct-to-consumer marketing.
Stem Cell Research and Cloning
Clinton, Obama, and McCain have supported federal funding of embryonic stem cell research. All three candidates voted in favor of the Stem Cell Research Enhancement Act of 2007, which would have authorized human embryonic stem cell research with the condition that the stem cells were from excess embryos donated from in vitro fertilization clinics. In Senate floor statements, McCain remarked that the bill “promote[d] the benefits of stem cell research while maintaining clearly our ethical and moral values and obligations” and that “[s]tem cell research has the potential to give us a better understanding of deadly diseases and spinal cord injuries affecting millions of Americans.” This bill passed the Senate and the House, but was vetoed by the President.
All three candidates have opposed human cloning. The Human Cloning Ban Act of 2005 was cosponsored by Clinton and Obama, and the Human Cloning Prohibition Act of 2007 was cosponsored by McCain. Both bills are still in Senate committees. Clinton again demonstrated her opposition to cloning by cosponsoring the Human Cloning Ban and Stem Cell Research Protection Act of 2005, which also never left the Senate committee to which it was referred. The bill was designed to build an ethical framework for stem cell research by banning human cloning, prohibiting research on embryos after they are 14 days old (excluding any time they are stored at subzero temperatures), requiring informed consent of egg donors, mandating that eggs be donated and not sold or purchased, and requiring egg collection sites to be separate from research laboratories.
McCain cosponsored the Human-Animal Hybrid Prohibition Act of 2007, which is still in committee. Due to a shortage of donated embryos from IVF treatments, some researchers want to remove the nuclei of animal eggs and replace them with human DNA. After the embryos develop for up to two weeks, the stem cells would be removed and the embryos destroyed. Scientists would then grow the stem cells, study their development and the causes of diseases, and test treatments on the cells. The act would prohibit this practice, as well as the creation of human-animal embryos for any other purpose, on ethical grounds.
Newborn Screening
Clinton has cosponsored two bills related to newborn screening, including introducing the Screening for Health of Infants and Newborns Act (SHINE) in 2006 and 2007. In her introductory remarks, she highlighted that “[e]arly detection by newborn screening can lessen side effects or completely prevent progression of many … disorders if medical intervention is started early enough” and that “[e]very child should have access to tests that may prevent them from a life-threatening disease.” The bill aimed to help states strengthen their screening programs; to establish procedures for newborn screening tests, reporting, and data standards for states; and to create a database of “current educational and family support and services information, materials, resources, research, and data on newborn screening.”
The SHINE Act failed to progress past a Senate committee, but its provision to create a database was incorporated into The Newborn Screening Saves Lives Act of 2007, which Clinton cosponsored. This bill also would create a screening program at the National Institutes of Health, and it passed the Senate by unanimous consent and is awaiting committee consideration in the House.
Genetics and Environmental Health
Clinton introduced the Coordinated Environmental Health Network Act in 2004 and 2005 and in 2007 as the Coordinated Environmental Public Health Network Act. This bill sought to build a network to track diseases and identify and address risks, particularly environmental risks, as well as “encourage coordination between researchers and Federal, State, and local entities, including the National Institutes of Health, for genetic studies on diseases associated with environmental factors with an emphasis on finding genetic risk factors and mutations associated with such diseases.” In her introductory remarks for the bill in 2007, Clinton emphasized the importance of researching how genetic factors interact with the environment to cause disease, and she highlighted “initiatives like the Human Genome Project” that have made “incredible strides in our understanding of the science of genetics, so that we can better prevent and treat diseases.” The bill currently sits with the Senate Committee on Health, Education, Labor, and Pensions.
McCain’s, Obama’s, and Clinton’s initiatives have promoted the growth and potential of genetics as well as encouraged increased federal regulation in several areas of the field. All three candidates would bring to the office of the President the potential for much-needed movement on genetics-related issues.
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