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