Genetic Information Nondiscrimination Act of 2007

Floor Speech

GENETIC INFORMATION NONDISCRIMINATION ACT OF 2007 -- (Senate - April 24, 2008)

BREAK IN TRANSCRIPT

Mr. KENNEDY. Mr. President, today, the Senate is considering the first major new civil rights bill of the new century. Five years ago this week, we celebrated a milestone that once seemed unimaginable: the completion of the Human Genome Project, which sequenced and mapped all the genes in the human body. This Friday is DNA Day, when we pay tribute to this amazing accomplishment, which was the dawn of a new era in the life sciences.

Mapping the human genome has provided extraordinary insights for modern medicine, and it has opened the door to immense new opportunities to prevent, diagnosis, treat, and cure disease. Its discovery may well affect the 21st century as profoundly as the invention of the computer or the splitting of the atom affected the 20th century.

But with this invaluable new information comes a tremendous responsibility. A person's unique genetic code contains the most personal aspects of their identity. As we begin to decipher this information, Americans have legitimate fears about how this deeply private information will be used. Surveys show that people are already declining to take medically valuable tests out of fear that they will face discrimination or invasion of their personal privacy. These fears are not unwarranted. As Francis Collins, the leader of the NIH project to sequence the human genome, has said:

Genetic information and genetic technology can be used in ways that are fundamentally unjust. Already, people have lost their jobs, lost their health insurance, and lost their economic well-being because of the misuse of genetic information.

The remarkable medical advances of the genetic age will be valuable only if people are not afraid to take advantage of them. The promise of this new science will be in jeopardy if our laws fail to contain adequate protections against abuse and misuse of genetic information.

The bipartisan bill now before the Senate takes a substantial step to preserve the value of new genetic technology and to protect the basic rights
of every American. The Genetic Information Nondiscrimination Act recognizes that discrimination based on a person's genetic identity is just as unacceptable as discrimination on the basis of race or religion. No American should be denied health insurance or be fired from a job because of genetic testing.

The bill before us provides comprehensive protections. It prohibits health insurers from using a patient's genetic information to deny health insurance coverage or raise premiums. It bars employers from using genetic information to make employment-related decisions. It prohibits insurers and employers from seeking genetic information or requiring individuals to take genetic tests. It bars disclosure of genetic information by insurers or employers, and it contains effective remedies so that anyone who has suffered genetic discrimination can obtain relief. By granting these protections, the bill gives the American people the opportunity to reap the rewards of improved health care through genetics without fear of unjust use of their personal genetic makeup.

This bill has been the product of a decade of dedicated effort by Members on both sides of the aisle. My sincere thanks go to Senator Snowe and Senator Enzi for helping to lead this bipartisan effort with me, and to Senator Reid, our majority leader, and the Senate leadership, for their commitment to moving this bill forward. Thanks to Senator Gregg and Senator Dodd and Senator Harkin, who also made important contributions through their leadership and expertise. I commend our House colleagues--Speaker Pelosi, Representative Slaughter, Representative Biggert, Chairman Miller, Chairman Rangel, and Chairman Dingell--for their strong support, and also our former colleague, Senator Daschle, who was a leader in his term here in the Senate. It is a remarkable achievement to get this bill to the President's desk. The administration cooperated with us throughout the process, and we are grateful for its support on this important legislation.

We stand today on the threshold of a major new breakthrough in medical technology. With personalized medicine that genetic science makes possible, patients can receive therapy precisely tailored to their own genetic makeup with reduced side effects and greater potency. But the effectiveness of these new technologies is undercut by people's legitimate fears and the lack of strong protections.

Just this week, doctors announced important findings on the genetic factors that may contribute to Parkinson's disease. There are new discoveries in genetic variations that may confer a reduced risk of heart failure and new insights into the genetic switches that may one day control cancer. But one great barrier stands in the way of these extraordinary advances that are possible in this new field of discovery: the reluctance of patients to receive the benefit of this new science and the fear that is already keeping patients from volunteering for this research.

Even the crown jewel of our Federal research enterprise, the National Institutes of Health, has been affected by this fear. The threat of genetic discrimination is so real that it is even listed on the informed consent document that the NIH provides to patients considering enrolling in the clinical trials of the new genetic medicines. This is what the chart says:

We will not release any information about you or your family to your insurance company or employer without your permission. However, instances are known in which genetic information has been obtained through legal means by third parties. This may affect you or your family's ability to get health insurance and/or a job.

Can you imagine individuals going out to the NIH and saying: I will volunteer in order to be a part of a research program, only to find out that their genetic information could be leaked? What happens if it is leaked? The insurance companies will say: Look, this individual has a better chance of getting breast cancer, diabetes, bipolar disorder, or a whole series of different types of cancer, so why are we going to go ahead and insure that individual? Or if we are going to insure him, we are going to charge a good deal more.

Some of this genetic information is valuable to know for medical history. For example, if mothers have certain types of genetic markers, the daughters might want to find out whether they have the same kind of proclivity. Yet if they go out and have the test so that they know whether to start thinking about treating that particular health challenge, they know they will be discriminated against. They won't be able to get a job because an employer will say: Why should I hire that person when they may very well develop breast cancer, and why should I hire that person because if they develop breast cancer, then it will cost my company a good deal more to pay for that individual's health insurance. That is the reality today. That is happening today.

There has been an explosion of progress in terms of genetic research. New opportunities for personalized medicine are opening, which is really going to be the pathway in the future. With personalized medicine, patients will no longer have to receive treatments that work for the average person--but may not work for them. Instead, they will receive therapies precisely tailored to their own genetic makeup, with reduced side effects and far greater potency.

Individualized medicine is the way of the future. With that, there is going to be a great deal more information about an individual's health, but also the attendant challenge and problem that this information could be used to adversely impact that individual. That is what we want to avoid, and that is what we want to protect against.

We know there are numerous barriers to new discoveries that Congress can do little about: the complexities of disease, the uncertainties of science, and the rarity of true inspiration. But this is one major problem which is entirely within our power to solve. We can make a difference, and we can do it today. With effective protections against the misuse of genetic information, this amazing new technology can realize its potential and bring better health care to all people throughout our world. I hope all of our colleagues will join in advancing the potential of genetic research by supporting the Genetic Information Nondiscrimination Act.

I want to show on the chart all of the different groups that are supporting this legislation. It gives us a very clear idea of the overwhelming support of the medical profession. Family physicians, pediatricians, the American Cancer Society, the American Diabetes Association, the American Heart Association--virtually the whole health community strongly supports this bill. The National Partnership For Women and Families and other women's groups and civil rights groups are supportive, as are the many specialized medical groups that know about genetic diseases.

Genetic discrimination issues are often tied to national origin. We have the Tay-Sachs disease that affects many members of the Jewish community; sickle cell anemia, which affects many African Americans; Cooley's disease, which affects many of those who come from Mediterranean countries, and a host of others. These are genetic diseases. That is why a number of the different groups are so concerned about this, because they have seen the discrimination.

I will just give ease to our colleagues. This chart shows when we have considered the legislation at other times. We considered it in 2003--the Senate did--and in 2005, and look at the overwhelming votes, Republicans and Democrats, even in the House in 2007. But we haven't been able to get the House and Senate together at the same time. So this has been going on since 2003, and we are in 2008. We have the opportunity with this legislation to get the job done, and the President has indicated he is going to sign it so we can achieve this extremely important undertaking.

Let me just review some of the other statements about why this is so important. We remarked here just a few moments ago about the dangers that are out there in terms of people being concerned about the violation of their privacy based on genetic information. Is this really a problem? This is a chart which shows that 72 percent of Americans think laws are needed to protect genetic privacy. The American people are really way ahead of us in the Congress on this issue. They understand that their genetic privacy is enormously important. They have an inner sense, which is well-founded, that their genetic privacy can be abused. We have 72 percent of Americans who think we need laws.

This chart shows that Americans want their genetic information kept private. Ninety-two percent of Americans think their employer should not have access to their genetic information for the reasons I have outlined. If you don't have these protections and employers are able to find out that certain individuals they are employing have a greater proclivity to develop disease, there is a very good chance they will discriminate against those individuals. That has been the case.

Eighty percent of Americans think their health insurer should not have access to their genetic information. The reason for that is a very sound reason, which is they believe if the insurer has that kind of information, the cost for the health insurance, which is extraordinarily high today, will go up even further.

So the American people are way ahead of the Congress in getting this. With this, Mr. President, we will be meeting their particular needs.

I want to show this chart. Francis Collins, for many of us in this body--and I think for the health community--is one of the great giants in health research. He is the person who has been at the heart and soul of the research on the Human Genome Project and in understanding the power of genes. He has made an absolutely extraordinary contribution in terms of science and public policy. He is a tireless advocate and a wonderful asset for all of us here in the Senate, on both sides of the aisle, in strong support for this legislation.

As he points out:

Discrimination in health insurance, and the fear of potential discrimination, threaten both society's ability to use new genetic technologies to improve human health and the ability to conduct the very research we need to understand, treat, and prevent genetic disease.

That says it all. It talks about the danger, in terms of discrimination, and also about the ability to do the research. You could be discriminated against in terms of your job or in terms of the increased costs in your health insurance, or if you were involved in research, volunteering for research--the dangers that this kind of information would be out there and could be used against you.

Mr. President, I remember--and it wasn't that long ago--when we listened to Dr. Collins. He was talking about the progress made in genetic research. They were talking about markers at that time. I think some of the earliest progress was made in terms of developing information about breast cancer and who had the proclivity to develop breast cancer. That was truly remarkable. Since that time--and it has only been a few years--we have seen that expand to prostate cancer, diabetes, bipolar, Alzheimer's, schizophrenia, and Parkinson's. Think of that. That list is growing virtually every day. We are eventually going to be getting health care systems that will say: If you have these kinds of diseases, we have the particular targeted kind of personalized medicine to help you either recover or to protect you in terms of the future. That is going to happen, Mr. President. It is going to happen sooner rather than later.

This gives you an idea of how rapidly this kind of research is moving along and how this kind of research, in the hands of top-rated physicians and researchers who know how to treat these illnesses and sicknesses, will make a difference in terms of improving the quality of health care on the one hand. It is so dramatic, as is the danger of abuse by unscrupulous employers or health insurance companies on the other hand. That is what this legislation is really all about. That is why this is so important and why it has strong bipartisan support.

In many respects, this is going to be one of the most important pieces of health legislation we pass in this Congress. We have other very important health proposals, but this will make an enormous difference in terms of the march for progress for good health care. We look forward to a strong vote.

I yield the floor.

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Mr. KENNEDY. Will the Chair let me know when I have 30 seconds left? I yield myself the remaining time.

Mr. President, I thank Senator Brownback for reminding us about our bill dealing with Down's syndrome. It is a very worthwhile effort and one that is enormously compelling. I give him the assurance we want to work very closely with him. We are trying to get a counterpart in the House of Representatives and trying to get this done during this session. We thank him for his strong leadership in that area. He has been working on it for a long time.

Mr. President, we are in a new era of the life sciences, and the truth of that statement can be seen in fields from medical imaging, to new biologic drugs and even to the use of DNA technology to improve our environment and reduce greenhouse gasses. But in no area of research is the promise greater than in the field of personalized medicine.

With personalized medicine, patients will no longer have to receive treatments that work for the average person--but may not work for them. Instead, they will receive therapies precisely tailored to their own genetic makeup, with reduced side effects and far greater potency.

The cost of developing new drugs is likely to be significantly reduced. No longer will a potentially promising drug be consigned to a dusty warehouse because it fails to work well on average, if it has the potential to treat patients with a particular genetic condition.

A main barrier in the way of such extraordinary advances is the reluctance of patients to seek the benefits of this new science and the fear volunteering for this research.

Three stories recounted to the advisory committee on genetic issues at the Department of Health and Human Services make the point.

Tonia Phillips has the BRCA-1 mutation. He told the committee that based on her genetic risk for ovarian and breast cancer, she elected to have a hysterectomy and a prophylactic double mastectomy. Ms. Phillips works for a small company of just four people. After her surgery, the health insurance premium for the company increased by $13,000 year. Her employers asked her to switch to her husband's health insurance policy, and even offered to increase her salary if she would switch policies. She refused. The company then adopted a policy requiring employees to pay half their insurance costs. If GINA is passed, changing the terms of employment based on genetic information would be illegal.

Paula Funk, a 33-year-old mother from Arkansas, told the committee that of her 24 female relatives, 13 have developed breast cancer. She decided to pay out-of-pocket and be tested for BRCA-1 anonymously. She tested positive, had a prophylactic double mastectomy, and plans to have her ovaries removed in the near future. Paula and her husband opened their own computer business but were prepared to abandon their plans unless they could get a group health plan for their two-person company, because they knew she wouldn't qualify for individual insurance based on her BRCA-1 status. Her concern now is for protection against discrimination for her two young daughters, Audrey and Anna, who will someday have to make the difficult decision about being tested. If GINA is passed, Audrey and Anna would not have to fear losing their health insurance based on a BRCA-1 test result.

Judith Berman Carlyle, a 48-year-old woman with a family history of ovarian cancer, was afraid that she wouldn't be able to obtain health insurance if she tested positive for the variant of the BRCA-1 gene that is related to breast and ovarian cancer. Instead of being tested, she decided to have prophylactic surgery to remove her ovaries, believing that the surgery would be less likely to cause her to be dropped by her insurer. Later, having obtained health insurance, Judith decided to be tested for BRCA-1 before having a prophylactic double mastectomy. Her test was negative. If she had known this information, she might not have chosen to have her ovaries removed and might have opted for increased screening measures.

Earlier this year, the Pulitzer Prize was awarded for an extraordinary series of articles on the promise and challenge of this new science. One article dealt with the fears of discrimination faced by those who undergo genetic tests, and the measures they take to protect themselves. Those articles included new revelations about the harm caused by the fear of discrimination.

Victoria Grove, of Woodbury, MN, told how she concealed crucial information about her genetic tests from her doctor, for fear it would be used to deny coverage. As a result, she did not receive proper treatment for her lung condition.

Kathy Anderson's parents refused to let her be tested for a genetic condition that affects blood clotting, for fear of discrimination. When Kathy was prescribed a common birth control pill, she developed massive clots--a life threatening illness that could have been avoided if she had had the genetic tests.

For Judith Carlisle, the consequences of not taking a genetic test were tragic. She has a strong family history of breast cancer, but was afraid that a genetic test to detect a particular gene mutation would provide proof to insurance companies and employers that she was a health risk. So she refused to take the test.

Still, she worried about the risks of cancer, so she had a hysterectomy to prevent that risk. Only later, when she took the gene test, did she discover that her fears had been misplaced. The test showed that she had no elevated risk of cancer.

We've also heard other stories in the years of debate on this bill.

Phil Hardt is a grandfather in Arizona with hemophilia B, a bleeding disorder, and Huntington's disease. His human resources manager told him to withhold that information from his employer, or he would never be promoted or trained. In addition, his grandchildren would be denied health insurance because the genes they might have inherited.

Rebecca Fisher is a mother and early onset breast cancer survivor with a family history of the disease. She recounted how her employer, a small, self-insured community hospital, was more concerned that the cost of her bone marrow transplantation and other health care had exceeded the cap for that year, than with her health or productivity as a worker.

Thousands of other patients who refuse to receive the benefits of this new technology have similar stories. The time for delay is over--and I urge my colleagues to pass this needed legislation.

I again acknowledge the great work and effort of my colleague and friend, Senator Enzi, the work he and his strong staff have provided. We know we would not be here without his strong commitment to this legislation.

This legislation was stuck for a time in the legislative cauldron of good works, but it was never lost. Through his efforts we had the good opportunity to work out some of the final differences and we have the opportunity to get it passed today. I am very grateful to him.

Senator Snowe has been a long-time leader in this. Her leadership has been referred to and all of us who have been interested in this thank her for her long-time dedication and commitment to it.

I want to mention some of the other people and say a final word. Dr. Collins, who has been the leader of the Human Genome Project, has been such a strong voice in passing this legislation; Sharon Terry, the Director of the Genetic Alliance; Kathy Hudson, who works at NIH and gave us excellent technical assistance; Representative Louise Slaughter, who has a long-time commitment to this program--I thank her and Michelle Adams, who has worked with her; Representative Judy Biggert and her staffer Brian Peterson; Shana Christrup, Keith Flanagan, and Ilyse Schuman--all have worked with Senator Enzi, and I thank them personally for their strong help working with me and with our staff; Kim Monk and David Thompson with Senator Gregg, who was a strong supporter of this bill when he chaired the HELP Committee--I thank him; Pete Goodloe from Congressman Dingell, Michelle Varnhagan from Congressman Miller; Cybele Bjorklund, who worked with Charlie Rangel and previously worked with us on our staff when we were fortunate to have her efforts here in the Senate; Kate Leone and Jennifer Duck had worked for Senator Daschle--they are not now here, but we acknowledge their work at an important time in this bill's history; Stephanie Carlton for Senator Coburn staff, her efforts are appreciated as well.

On my staff I thank Portia Wu, Lauren McFerran, Holly Fechner, Michael Myers, Laura Kwinn, and especially David Bowen. All have been invaluable.

This bill opens a new frontier in medicine, in which can read the genetic makeup of patients to stop diseases before they ever happen. This legislation opens the door to modern medical progress for millions and millions of Americans. It means that people whose genetic profiles put them at risk of cancer and other serious conditions can get tested and seek treatment without fear of losing their privacy, their jobs, or their health insurance.

It is the first civil rights bill of the new century of the life sciences. This is the era of life science, with extraordinary possibility over these next years.

With the passage of this legislation we take a quantum leap forward in preserving the values of new genetic technology and protecting the basic rights of every American. We will ensure that our laws reflect the advances we are making each and every day in medical science. The promise of new science will be in jeopardy if our laws fail to maintain adequate protections against abuse and misuse of private genetic information.

It was a hard-fought battle to get here. This bill has been the product of a decade of dedicated efforts by Members of both sides of the aisle. I am honored to work with many of my colleagues, particularly Senator Enzi, Senator Snowe, and Congresswoman Slaughter on this bill. I hope it will get overwhelming support.

AMENDMENT NO. 4573
(Purpose: In the nature of a substitute)

Mr. President, I call up the Snowe-Kennedy-Enzi substitute, which is at the desk.

The PRESIDING OFFICER. The clerk will report.

The legislative clerk read as follows:

The Senator from Massachusetts (Mr. Kennedy), for Ms. Snowe, for herself, Mr. Kennedy, and Mr. Enzi, proposes an amendment numbered 4573.

(The amendment is printed in the Record of Wednesday, April 23, 2008, under ``Text of Amendments.'')

Mr. KENNEDY. Mr. President, I ask for the yeas and nays.

The PRESIDING OFFICER. Is there a sufficient second? There is a sufficient second.

The yeas and nays were ordered.

Mr. KENNEDY. I yield any time that remains.

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