Scientific Publications
Ethics & Policy
Affymetrix products enable scientists to turn genetic information into specialized detailed knowledge. We believe this enhanced knowledge will transform the quality of our lives, and help us more fully understand ourselves.
For society to benefit from these extraordinary biological advances, Affymetrix believes that informed public discussion, meaningful application of ethical principles, and thoughtful public policy must foster the constructive uses of genetic information. Education of the public and health care providers will help us become genetically literate, and enable us to make informed choices. Below is some current legislation that Affymetrix is working on to improve genetic policies.
Affymetrix Applauds Congress and President for Enacting the Genetic Information Nondiscrimination Act (5/21/2008)
Company Plays Leading Role in Helping to Prevent the Misuse or Abuse of Genetic Information
Affymetrix Inc. applauds the U.S. Congress and President George W. Bush for enacting the Genetic Information Nondiscrimination Act (GINA). GINA establishes a much-needed federal prohibition in the United States against genetic discrimination and enacts a national standard for ensuring the privacy of personal genetic information. For more than seven years, Affymetrix has been recognized as a leading industry voice in helping to support and promote this important civil rights legislation.
Affymetrix products enable scientists to turn genetic information into specialized detailed knowledge. Since its inception, the company has helped to prevent the misuse or abuse of this knowledge through a number of grassroots efforts, educational programs and public policy initiatives. Affymetrix co-founded and has been an active executive committee member of the Coalition for Genetic Fairness, an influential organization established to promote genetic nondiscrimination policy. The company also offers a number of educational resources for teachers and students interested in learning more about genes and ethics.
"Affymetrix would like to thank President Bush and members of Congress for transforming GINA into a U.S. law. We have actively supported this much-needed legislation for more than seven years and we are pleased to see the U.S. government take steps toward addressing the issues around genetic discrimination," said Stephen P.A. Fodor, Ph.D., founder, chairman and CEO of Affymetrix. "Affymetrix is engaged in many efforts to encourage the appropriate use of genetic information and to ensure that people around the world continue to benefit from the latest scientific and technological advances. A better understanding of our genome will lead to improved healthcare and an enhanced quality of life."
Genomics and Personalized Medicine Act (2007)
On August 9, 2006, U.S. Senator Barack Obama (D-Ill.) introduced the Genomics and Personalized Medicine Act to advance personalized medicine by increasing funding for genomics research, eliminating regulatory obstacles, and creating incentives for the development of companion diagnostic tests. Specifically, the proposed legislation would allocate $150 million for genomics research and provide a 100 percent tax credit for private research to develop diagnostic tests that can improve the effectiveness or safety of certain drugs.
To improve the quality of genetic testing, the bill also instructs CMS to develop a genetic testing specialty under the CLIA regulatory program and calls on the FDA to expand their oversight of genetic tests. Affymetrix supports these initiatives and earlier this spring, Dr. Janet Warrington, Vice President for Emerging Markets and Molecular Diagnostics Research and Development, sent a letter to Dr. Mark McClellan, the CMS Administrator, requesting the creation of a genetic testing specialty under CLIA.
In 2004, Affymetrix launched the world's first diagnostic microarray system, through a partnership with Roche Diagnostics. This test was the first microarray based diagnostic to receive FDA approval and since then, has provided clinicians with a validated and regulated pharmacogenetic test to guide their prescribing decisions. Affymetrix has also forged additional partnerships focused on the development of microarray-based diagnostic products. Accelerating the development and use of these diagnostic products will help improve the lives of millions of Americans suffering from chronic diseases and conditions.
Genomics and Personalized Medicine Act - search to find "S.3822.IS"
Genetic Nondiscrimination Act (2003)
On October 14, 2003, by a vote of 95-0, the U.S. Senate approved the Genetic Nondiscrimination Act of 2003 (S.1053). This action is truly historic as it marks the first time one house of Congress has voted to prohibit the use of genetic information in a discriminatory manner with regard to health insurance or employment.
For almost three years, genetic privacy and nondiscrimination has been a signature policy issue for Affymetrix. Steve Fodor, Affymetrix' CEO, has written a public letter (pdf, 73 KB) supporting the Genetic Nondiscrimination Act of 2003 and Affymetrix has lobbied aggressively in both the House and Senate for its passage.
Affymetrix intends to continue to play a leading role supporting the bill as the action now shifts to the House and to the Administration.
Statement of Administration Policy (pdf, 67 KB)
Genetic Nondiscrimination Act of 2003 - search to find "S.1053.ES"
Ethics Resources
To ensure that beneficial uses of genetic information are available, while preventing inadvertent or intentional misuse, it is essential to determine limits on the use of genetics. A portion of the Human Genome Project fund is used to study ethical, legal, and social issues surrounding genetics. In addition, Affymetrix directs works towards promoting an ongoing discussion surrounding appropriate applications of genetics and genetics technologies.
- Your Genes, Your Choices describes the Human Genome Project, the science behind it, and the ethical, legal, and social issues.
- The Nuffield Council on Bioethics examines ethical issues arising from developments in medicine and biology.
- Hastings Center Report, a leading bioethics journal.
- University of Pennsylvania Center for Bioethics provides a thorough overview of current issues in medical ethics.
- The American Journal of Bioethics examines current topics in the field.
- The Secretary's Advisory Committee on Genetics, Health and Society examines the status and future directions of genetic technologies.
Links to external resources are for the reader's convenience and the views expressed do not necessarily reflect the views of Affymetrix.
Ethical Principles
Revolutionary scientific advances are creating valuable and useful genetic information that can enhance our daily lives. Affymetrix believes that three powerful ethical principles apply to all medical information and all personal genetic information: individual autonomy, health information privacy, and non-discrimination. Application of these principles helps ensure that beneficial uses of genetic information are available, while preventing inadvertent or intentional misuse.
Health Information Privacy
People have a right to understand and provide consent for use of all their medical information, including genetic information. All persons have the basic right to make decisions regarding the disposition and use of their medical information, including genetic information; to prevent others from determining or having access to this information; and to ensure that they are not discriminated against based on medical information. To ensure that medical advances continue, clinical trials need to be conducted in an environment of informed consent and privacy protection.
Individual Autonomy
It is imperative to ensure that all medical information, including genetic information, is treated as private and confidential. All individuals have the right to control who has access to their personally identifiable medical information, and how that information is used in exactly the same way that they have the right to stop others from performing physical examinations.
Non-Discrimination
We support the President of the U.S.A.'s Executive Order banning discrimination in the federal workplace based on genetic information. Discrimination based on medical information, including genetic information, should be prohibited in all employment and insurance decisions. People should not be judged on the basis of genetic inheritance or other medical conditions.
Tremendous advances in genetic information availability require policies to ensure that the benefits of these advances can be recognized, while preventing the misuse or abuse of genetic information. Affymetrix supports the development of thoughtful public policy surrounding genetics and genetics technologies.
We invite you to explore various perspectives on the ethical issues associated with genetic information using the following links.
Gene Patenting
- Nuffield Council on Bioethics Discussion Paper: The Ethics of Patenting DNA.
- The Genetic Age: The Era of Personalized Medicine Center for Genetic Medicine, Northwestern University (12/04/2006)
- The Duke Center for Genome Ethics, Law, and Policy: Commercialization of Human Genomics: Consequences for Science.
- The Biotechnology Industry Organization (BIO) provides its testimony on patent guidelines.
- The Forum on Technology & Innovation hosted a discussion entitled "Who Owns the Genome? Human Genetics and Intellectual Property" which examined this complex issue.
Genetic Privacy and Non-Discrimination
- The Health Privacy Project objectives and initiatives for protecting privacy of personal medical information.
- The Nuffield Council on Bioethics examines genetic privacy in the context of genetic screeners.
- The GeneForum examines genetic privacy in the 21st century.
- The Forum on Technology & Innovation hosted a discussion entitled "Gene Chips, Privacy & Nondiscrimination: The Promise & Peril of Genetic Technology" which examined this complex issue.
- The Human Genome Project presents an overview of genetics privacy and legislation through its ethical, legal, and bioethics program.
General Policy Resources
- Use THOMAS to search U.S. legislation information including Committee reports, Bill summary and status, and roll call votes.
- The National Human Genome Research Institute (NHGRI) provides information on public policy topics related to genetic research and provides useful links to other sites.
- The Center for Strategic and International Studies (CSIS) examines a number of issues at the intersection of science and policy.
- The Human Genetics Commission is the UK government's advisory body on how new developments in human genetics will impact people and health care.
Links to external resources are for the reader's convenience and the views expressed do not necessarily reflect the views of Affymetrix.
To fully realize the potential of the coming Genetic Age, we, as a society, must become genetically literate. Significant public and health care provider educational efforts are already underway.
We invite you to explore various perspectives on the ethical issues associated with genetic information using the following links.
Genetic Testing
- Understanding Gene Testing, presented by The National Health Institute and the National Cancer Institute.
- The Human Genetics Consortium's statement on the supply of genetic tests direct to the public.
- Understanding Gene Testing from the US Department of Health and Human Services.
- The Human Genome Project asks, what does gene testing mean for you?
- Genetic testing for breast cancer - facts from the National Cancer Institute (NCI).
- The European Society for Human Genetics present an examination of genetics and genetic testing from a European point of view.
Human Subjects Research
- The National Bioethics Advisory Commission, provides ethical & policy issues in research involving human subjects.
- The Human Genome Organization, an international organization of scientists, presents its position on DNA sampling control and access.
- The Office for Human Research Protections develops guidelines for human subject research.
- The Hastings Center publishes "IRB: Ethics & Human Research" examining this topic.
- The NIH provides resources and guidelines for research involving human subjects.
Genetics & Genetics Support Groups
- Genetics Support Group.
- Additional resources for Genetics.
- Learn more about Affymetrix technology.
- Search the Affymetrix scientific publication database.
Links to external resources are for the reader's convenience and the views expressed do not necessarily reflect the views of Affymetrix.