Thank you Senator Mack and Senator Feinstein for holding this important hearing and inviting me to testify. As you know, the National Breast Cancer Coalition (NBCC) is dedicated to the eradication of the breast cancer epidemic through action and advocacy, and we seek to increase the influence of beast cancer survivors and other activists over research, clinical trials, and public policy. Therefore, we appreciate your willingness to listen to our perspective on the complex privacy, employment and insurance discrimination questions we face regarding the discovery of the first breast cancer gene, BRCA1.
I co-chair National Action Plan on Breast Cancer of which the Breast Cancer Susceptibility Gene Coordinating Group is an integral part. The Coordinating Group's goal is to implement a comprehensive plan to address the needs of individuals carrying breast cancer susceptibility genes and recommend educational interventions for consumers, health care providers and at-risk patient groups. There has been an incredibly cooperative effort with Dr. Collins and the Human Genome Project,the Working Group on Ethical Legal and Social Implications (ELSI), nd Dr. Klausner and the National Cancer Institute in order to address the full breadth of questions that are raised by this scientific advance. Yet we still have no ensured privacy and discrimination protections to people with heritable disease risk.
As you know, in September of 1994, the breast-ovarian cancer susceptibility gene on the chromosome 17q21 was discovered, and clearly breast cancer is what brings NBCC to the table on these genetic issues. Nevertheless, a few weeks ago, I read an article in the Sunday Times Magazine which focused on genetic heart disease. It is very clear that the issue of genetic testing does not only apply to BRCA1, or the AT gene, but rather to all of us. As science continues to make stunning progress in identifying and isolating genes, we will lean about the role genetics play in countless diseases, and gene testing will come to have an impact on all of our lives.
Just yesterday, Nature Genetics published an article about a specific alteration in BRCA1 among 1% of Ashkenazi Jewish women. What this mans about whether they will develop breast cancer is still unknown, but NBCC has been working closing with both the Human Genome Project and the Nation Cancer Institute to prepare for the announcement of the finding and to respond to the discovery and all of its associated questions.
Clearly science is speeding along, making genetic discoveries. We now face the reality of a presymptomatic test for heritable breast cancer risk. The availability of a test which can determine the degree of familial risk for breast cancer raises extremely difficult issues. First however, we must put such a test into perspective. The test will help identify only those women who are at increased risk of breast cancer because of family history, yet these women are only 5-10% of women who get breast cancer. Women who test negative for the gene must still know that they fact a 1 in 8 lifetime risk of getting breast cancer and should follow appropriate guidelines for screening. The test will not prevent women who carry the gene from getting the disease, nor will it cure existing disease.
For women who test positive for the gene, the effects of those results must be carefully considered. The test will tell them they have as much as an 85% chance of getting a disease for which there is no known cure, and which they can not prevent. Despite our need to carefully monitor this woman for signs of cancer development, no methods of detection have been accurately studied to establish their effectiveness or even possible increased risk for women. For example, it has been shown that mammography is less informative in young women with a family history of breast cancer, than it is for women with no family history. I addition, it is possible that mammography may put women who carry the BRCA1 gene at increased risk of developing the disease.
Breast cancer patients and their families not only want the test available, but they want a valid and reliable test with a full explanation about its ramifications and limitations. It is NBCC's position that because nothing is know yet about the sensitivity, specificity, or reliability of the genetic test, and little is know about the effectiveness of genetic or psychosocial counseling in this context, genetic screening should only be available to individuals who agree to join peer-reviewed approved research protocols. It is imperative that such studies should be widely available, easy to access in both urban and rural areas, and prepared to handle the magnitude of requests for testing. Until the reproducibility, sensitivity, specificity, and predictive values of the test are known, the FDA should not approve the test.
In addition, complex questions about insurance coverage and discrimination are raised by the availability of a genetic test for breast cancer. In August, the national Action Plan and the Human Genome Project held a two day Genetic Discrimination and Health Insurance Workshop at which women with the breast cancer gene would only agree to tell their stories under the strictest confidentiality agreement. Quite simply, they were afraid of the discrimination they would face with their employers and insurance companies if anyone knew they had this gene.
At present, there is no federal legislation that prevents insurance companies from denying coverage based on genetic status. While a few States have enacted laws, all of those provisions contain loopholes which, to varying degrees, undermine the intent of the legislation. Therefore, it is our position that any health care or insurance reform must include protections against discrimination in the provision of coverage based on genetic information, or predisposition to disease.
The National Action Plan and the ELSI Working Group have cooperatively developed a list of recommendations to ensure protection from discrimination which is attached to your copy of my testimony. Allow me to summarized these recommendations:
Genetic information includes information about genes, gene products, or inherited characteristics--including family history.
Insurance provider should be prohibited from using genetic information to:
Limit or deny coverage establish differential rates or premium payments
Insurance providers should be prohibited from requesting or requiring genetic information, and should also be prohibited from releasing genetic information without written authorization for the individual.
While we do not presume to assert that these guidelines address all of the issues, they do begin to establish guidelines and a framework for discussion. Right here, in the U.S. Senate, we are working with Senators Kassebaum and Kennedy in order to ensure that these issues are addressed in their insurance reform bill. And NBCC will continue to work with the National Action Plan, with the Human Genome Project, wit Dr. Klausner, and at every level to ensure that coordination and cooperation among research, health care providers, industry, insurers, government and the affected public. We believe that a national coordinating committee that is composed of various interest, including consumers, should define the research questions, establish the research protocols, prioritize spending and maintain continuous oversight over the process. Decision making at all levels of the process must include consumers.
Thank you, Senators, for inviting the National breast Cancer Coalition to address these difficult issues. We look forward to working with you and your colleagues to forge effective and solid policies that address these pressing genetic policy issues.