SPEAKERS CONTENTS INSERTS
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80–226PS
2002
ENVIRONMENTAL CONTRIBUTORS TO BREAST
CANCER: WHAT DOES THE SCIENCE SAY?
FIELD HEARING
BEFORE THE
SUBCOMMITTEE ON ENVIRONMENT, TECHNOLOGY,
AND STANDARDS
COMMITTEE ON SCIENCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
JUNE 22, 2002
Serial No. 107–74
Printed for the use of the Committee on Science
Available via the World Wide Web: http://www.house.gov/science
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COMMITTEE ON SCIENCE
HON. SHERWOOD L. BOEHLERT, New York, Chairman
LAMAR S. SMITH, Texas
CONSTANCE A. MORELLA, Maryland
CHRISTOPHER SHAYS, Connecticut
CURT WELDON, Pennsylvania
DANA ROHRABACHER, California
JOE BARTON, Texas
KEN CALVERT, California
NICK SMITH, Michigan
ROSCOE G. BARTLETT, Maryland
VERNON J. EHLERS, Michigan
DAVE WELDON, Florida
GIL GUTKNECHT, Minnesota
CHRIS CANNON, Utah
GEORGE R. NETHERCUTT, JR., Washington
FRANK D. LUCAS, Oklahoma
GARY G. MILLER, California
JUDY BIGGERT, Illinois
WAYNE T. GILCHREST, Maryland
W. TODD AKIN, Missouri
TIMOTHY V. JOHNSON, Illinois
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MIKE PENCE, Indiana
FELIX J. GRUCCI, JR., New York
MELISSA A. HART, Pennsylvania
JOHN SULLIVAN, Oklahoma
RALPH M. HALL, Texas
BART GORDON, Tennessee
JERRY F. COSTELLO, Illinois
JAMES A. BARCIA, Michigan
EDDIE BERNICE JOHNSON, Texas
LYNN C. WOOLSEY, California
LYNN N. RIVERS, Michigan
ZOE LOFGREN, California
SHEILA JACKSON LEE, Texas
BOB ETHERIDGE, North Carolina
NICK LAMPSON, Texas
JOHN B. LARSON, Connecticut
MARK UDALL, Colorado
DAVID WU, Oregon
ANTHONY D. WEINER, New York
BRIAN BAIRD, Washington
JOSEPH M. HOEFFEL, Pennsylvania
JOE BACA, California
JIM MATHESON, Utah
STEVE ISRAEL, New York
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DENNIS MOORE, Kansas
MICHAEL M. HONDA, California
Subcommittee on Environment, Technology, and Standards
VERNON J. EHLERS, Michigan, Chairman
CONSTANCE A. MORELLA, Maryland
CHRISTOPHER SHAYS, Connecticut
CURT WELDON, Pennsylvania
NICK SMITH, Michigan
GIL GUTKNECHT, Minnesota
CHRIS CANNON, Utah
FELIX J. GRUCCI, JR., New York
MELISSA A. HART, Pennsylvania
WAYNE T. GILCHREST, Maryland
SHERWOOD L. BOEHLERT, New York
JAMES A. BARCIA, Michigan
LYNN N. RIVERS, Michigan
ZOE LOFGREN, California
MARK UDALL, Colorado
ANTHONY D. WEINER, New York
BRIAN BAIRD, Washington
JOSEPH M. HOEFFEL, Pennsylvania
JOE BACA, California
JIM MATHESON, Utah
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RALPH M. HALL, Texas
PETER ROONEY Subcommittee Staff Director
MIKE QUEAR Democratic Professional Staff Member
ERIC WEBSTER Professional Staff Member
CAMERON WILSON Professional Staff Member/Chairman's Designee
MARTY SPITZER Professional Staff Member
MARK ABDY Professional Staff Member
MARY DERR Majority Staff Assistant
MARTY RALSTON Democratic Staff Assistant
C O N T E N T S
June 22, 2002
Witness List
Hearing Charter
Opening Statements
Statement by Representative Felix J. Grucci, Jr., Member, Subcommittee on Environment, Technology, and Standards, Committee on Science, U.S. House of Representatives
Written Statement
Statement by Representative Steve Israel, Member, Committee on Science, U.S. House of Representatives
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Written Statement
Prepared Statement by Representative Carolyn McCarthy, U.S. House of Representatives
Panel I
Dr. John S. Kovach, Director, Long Island Cancer Center, Stony Brook University Hospital, Stony Brook, New York
Oral Statement
Written Statement
Biography
Financial Disclosure
Dr. Roger C. Grimson, Principal Research Scientist and Associate Professor, Department of Preventative Medicine, Long Island Cancer Center, Stony Brook University Hospital, Stony Brook, New York
Oral Statement
Written Statement
Biography
Financial Disclosure
Mr. Peter J. Levine, Co-founder, President and CEO, Correlogic Systems, Inc.
Oral Statement
Written Statement
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Biography
Financial Disclosure
Dr. Nancy Kim, Associate Professor of Risk Assessment; Director, Division of Environmental Health Assessment, New York State Department of Health
Oral Statement
Written Statement
Discussion
Contributing Factors to Breast Cancer Incidence Rates
Mapping Studies: The Role of the Federal Government
Needed Resources: The Role of the Federal Government
Panel II
Ms. Gail Frankel, Field Coordinator and Advocate, National Breast Cancer Coalition
Oral Statement
Written Statement
Biography
Financial Disclosure
Ms. Elsa Ford, President, Brentwood/Bayshore Breast Cancer Coalition
Oral Statement
Written Statement
Biography
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Financial Disclosure
Additional Material Submitted for the Record
Ms. Lorraine Pace, Founder, Breast Cancer Mapping Project
Oral Statement
Written Statement
Biography
Financial Disclosure
Discussion
The Role of the Federal Government in Combating Breast Cancer
Environment Areas of Concern
Public Comments
Appendix: Additional Material for the Record
Statement of Mr. John LaValle, Supervisor, Brookhaven Town
Map of Cancer Incidence Rates, Submitted by Representative Steve Israel
Statement of Ms. Geraldine Barrish, President, 1 in 9: The Long Island Breast Cancer Action Coalition; Executive Director, Hewlett House
ENVIRONMENTAL CONTRIBUTORS TO BREAST CANCER: WHAT DOES THE SCIENCE SAY?
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SATURDAY, JUNE 22, 2002
House of Representatives,
Subcommittee on Environment, Technology,
and Standards,
Committee on Science,
Washington, DC.
The Subcommittee met, pursuant to call, at 10:30 a.m. at Port Jefferson Village Hall, 1221 West Broadway, Port Jefferson, New York, Representative Felix J. Grucci, Jr., presiding.
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HEARING CHARTER
SUBCOMMITTEE ON ENVIRONMENT, TECHNOLOGY, AND STANDARDS
COMMITTEE ON SCIENCE
U.S. HOUSE OF REPRESENTATIVES
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Environmental Contributors to Breast
Cancer: What Does the Science Say?
SATURDAY, JUNE 22, 2002
10:30 A.M.–12:30 P.M.
PORT JEFFERSON VILLAGE HALL
1221 WEST BROADWAY, PORT JEFFERSON, NY 11777
1. Purpose and Overview
On Saturday, June 22, 2002 at 10:30 a.m., the Subcommittee on Environment, Technology, and Standards of the House Committee on Science will hold a hearing on Environmental Contributors to Breast Cancer: What Does the Science Say? The hearing will examine what is known about environmental factors that may cause breast cancer and how these factors may be linked to the unusually high rate of breast cancer observed in Port Jefferson, New York and surrounding communities.
The New York Department of Health has mapped cancer rates across the state and discovered higher than expected rates of breast cancer in seven ZIP codes west of the township of Brookhaven, New York, an area that encompasses Coram, Port Jefferson Station, Setauket, Miller Place, Mount Sinai, Port Jefferson, and Sound Beach. Researchers involved in developing the state cancer map have noted that the population in the affected area does not appear to have unusual genetic characteristics that could account for the high breast cancer rates, suggesting instead that environmental factors may play a significant role. The Department of Health is investigating the feasibility of conducting a full environmental study of the area. In the past, however, state officials, backed by some experts, have resisted in-depth studies of cancer clusters, arguing that they have limited scientific value because relatively little is known about the connection between exposure to environmental toxins and subsequent incidences of cancer.
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In the meantime, the School of Medicine at the State University of New York at Stony Brook has established the Long Island Cancer Center to conduct scientific research into Long Island's high incidence of cancer. The Center is developing a clinical database of breast and prostate cancer patients from the Long Island region that will allow researchers to characterize the nature and possible causes of these cancers.
The Subcommittee will explore several questions including:
1. What do we know about the incidence of breast cancer in Port Jefferson, New York and the surrounding region? How high and how unusual is the rate of breast cancer on Long Island compared with other parts of the Nation?
2. What do we know about the possible causes for the high breast cancer rates observed on Long Island?
3. Does the cancer mapping data warrant a full environmental study of the area?
2. Witnesses
The following witnesses will address the Committee:
Panel One:
Dr. John Kovach, Director, Long Island Cancer Center, Stony Brook University Hospital. Dr. Kovach also served as a Professor of Oncology at the Mayo Clinic in Rochester, Minnesota and Chairman of the Department of Oncology and Director of the Mayo Comprehensive Cancer Center. Dr. Kovach received his M.D. from the College of Physicians and Surgeons at the University of Columbia.
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Dr. Roger Grimson, Associate Professor of Preventative Medicine, Long Island Cancer Center, Stony Brook University Hospital, and President of Clinical Statistics, a medical statistics consultancy. He has done extensive research and published leading papers in the areas of disease patterns and clusters. Dr. Grimson is an investigator and advisor on several community-based breast cancer mapping projects.
Mr. Peter J. Levine, co-founder and CEO of Correlogic Systems, Inc., a bioinformatics company engaged in the development of bioinformatic tools and processes for proteomic and genomic-based clinical diagnostic systems and new drug discovery. Mr. Levine is the co-inventor of the technology and processes utilized in the recent ovarian cancer test study published in the Lancet.
Dr. Nancy Kim, Director, Division of Environmental Health Assessment, New York Department of Health. She is also an Associate Professor of Risk Assessment whose research interests include toxicological evaluations, exposure assessments, risk assessment, and structural activity correlations. Dr. Kim has a Ph.D. in chemistry from Northwestern University.
Panel Two:
Ms. Gail Frankel, Field Coordinator and Advocate, National Breast Cancer Coalition. Ms. Frankel is a breast cancer survivor and has been a breast cancer consumer advocate for the past seven years. She currently volunteers at the Adelphi New York Statewide Breast Cancer Hotline and Support Program.
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Ms. Elsa Ford, President, Brentwood/Bay Shore Breast Cancer Coalition. Ms. Ford has broad experience as a breast cancer activist, particularly focused on the environmental contributors to breast cancer. She represents the Coalition in numerous groups including the Long Island Breast Cancer Network, the East End Pesticide Coalition and the Sustainable Energy Alliance of Long Island.
Ms. Lorraine Pace is a breast cancer educator and Founder of the Breast Cancer Mapping Project. Ms. Pace started this project in her kitchen in 1992; it has since expanded across New York State, and has been used as a model nationally and internationally. She has received numerous awards for this work including a NY Governor's Award. Ms. Pace has a M.A. in Secondary Education.
Mr. GRUCCI. I would like to start this hearing off by asking everyone to rise for the pledge of allegiance.
Would you kindly remain standing for a moment of silent prayer?
I appreciate everyone being with us today. I think that this is a very important issue, as demonstrated by those who have turned out. I think this is going to help us not come away today with answers. We are not going to have answers to the questions on people's minds or even answers to some of the questions that may be raised by the members of the dais or even those that will be presented by the witnesses. Today's message is to be able to bring back to Washington those questions that are being asked in communities like this, where a much higher level of breast cancer is certainly prevalent.
We have two esteemed panels. We will get to them in just a moment. Before I do, I would like to acknowledge some very important people with us today demonstrating the commitment of local government, as well in state government, in participating in trying to find a cure.
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First, let me introduce to you all Senator Ken LaValle. For those of you who know Ken, you know of his deep and abiding commitment to trying to find cures for these types of diseases, to improve the quality of life for people and his staunch and dedicated commitment to this community.
Ken, if you would identify yourself?
Also joining us is town councilwoman Gerry Esposito, a relatively new member to the town board, but certainly not to our community, someone fighting hard to improve our quality of life as well. Gerry, thank you for being here.
I welcome you all here this morning to examine an issue that is not only of utmost importance to all Americans, but especially here on Long Island. This year alone we can expect 203,503 cases of female invasive breast cancer will be diagnosed throughout the country. 39,600 American women will die from this disease.
Nationally, one in nine will be diagnosed with breast cancer in her lifetime, with the incidences of disease even higher here on Long Island. As Long Island continues to lead the state and the nation in new cases of breast cancer, it is now more important than ever to learn as much as we possibly can about this devastating illness.
Results from the New York State breast cancer study showed a cluster of zip codes in northwest Brookhaven Town here in Suffolk County to be the highest on all of Long Island. According to the study, communities of Coram, Port Jefferson Station, Setauket, Miller Place, Mount Sinai, Port Jefferson and Sound Beach report the highest rates of breast cancer anywhere in the State of New York.
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Researchers involved in developing the state cancer map have noted that the populations in the affected area does not appear to have unusual genetic characteristics that could account for the high breast cancer rates, suggesting instead that environmental factors may play a significant role.
Upon learning this, I immediately wrote to the state health commissioner requesting a comprehensive environmental follow-up investigation of these clusters.
In the past, however, some officials, backed by some experts, have resisted in-depth studies of cancer clusters arguing that they have limited scientific value because relatively little is known about the connection between exposure to environmental toxins and subsequent incidences of cancer.
That is exactly why we are here today, to take a look at the possible environmental links to these findings and share this information with not only Congress, but also the general public.
I must reiterate my strong support to this follow-up investigation by New York State and also engage the Federal Government in this important issue.
From my first days in Congress, I have worked diligently to raise awareness and fund research for breast cancer. Along with my Long Island colleagues, I have pushed for legislation to provide for early detection, public education, prescription drug assistance and appropriate medical coverage for treatment and therapies, while the State of New York has taken an active role, the issue of breast cancer is real across America. That is why we are gathered here today, to learn more about what is happening on Long Island and hear from the experts who are looking at this issue from where it is most prevalent.
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We must engage the Federal Government in this new finding and take whatever steps are necessary to find the keys to prevention and an eventual cure. Breast cancer is a disease that not only affects the women affected, but also affects the communities of these strong women.
It is my hope that we can learn more through this hearing, take this information to Washington and work together to end this terrible disease.
I thank our witnesses for being with us here today and I look forward to their insightful testimony.
I now yield to Mr. Israel as much time as he may consume for his opening remarks.
[The prepared statement of Mr. Grucci follows:]
PREPARED STATEMENT OF REPRESENTATIVE FELIX J. GRUCCI, JR.
I welcome you here this morning to examine an issue that is not only of utmost importance to all Americans, but especially here on Long Island. This year alone, we can expect that 203,500 new cases of female invasive breast cancer will be diagnosed throughout the country, and 39,600 American women will die from the disease.
Nationally, one in nine women will be diagnosed with breast cancer in her lifetime, with the incidence of this disease even higher on Long Island. As Long Island continues to lead the state and nation in new cases of breast cancer, it is now more important than ever to learn as much as we possibly can about this devastating illness.
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Results from the New York State breast cancer study showed a cluster of zip codes in Northwest Brookhaven Town, here in Suffolk County, to be the highest on all of Long Island. According to this study, the communities of Coram, Port Jefferson Station, Setauket, Miller Place, Mount Sinai, Port Jefferson, and Sound Beach report the highest rates of breast cancer anywhere in New York State. Researchers involved in developing the state cancer map have noted that the population in the affected area does not appear to have unusual genetic characteristics that could account for the high breast cancer rates, suggesting instead that environmental factors may play a significant role. Upon learning this, I immediately wrote to the State Health Commissioner requesting a comprehensive environmental follow-up investigation of this cluster. In the past, however, state officials, backed by some experts, have resisted in-depth studies of cancer clusters, arguing that they have limited scientific value because relatively little is known about the connection between exposure to environmental toxins and subsequent incidences of cancer. That is exactly why we are here today—to take a look at the possible environmental links to these findings and share this information with not only Congress, but also the general public. I must reiterate my strong support for this follow up investigation by New York State and also engage the Federal Government in this important issue.
From my first day in Congress, I have worked diligently to raise awareness and fund research for breast cancer. Along with my Long Island colleagues, I have pushed for legislation to provide for early detection, public education, prescription drug assistance, and appropriate medical coverage for treatment and therapies.
While the State of New York has taken an active role, the issue of breast cancer is real across America. That is why we have gathered today to learn more about what is happening on Long Island and hear from the experts who are looking at this issue from where it is most prevalent.
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We must engage the Federal Government in this new finding and take whatever steps are necessary to find the keys to prevention and an eventual cure. Breast cancer is a disease that not only effects the woman afflicted, but also the families and communities of these strong women. It is my hope that we can learn more through this hearing, take this information to Washington, and work together to end this terrible disease.
I thank our witnesses for being here today and look forward to their insightful testimony.
I yield to Mr. Israel for his opening statement.
Mr. ISRAEL. Thank you. I have always looked up to him, but this is ridiculous, I must say.
Let me also thank the Committee Chair, Sherry Boehlert and our Ranking Minority Member, Congressman Hall, for allowing us to have this field hearing.
The Science Committee has always been one of the most bipartisan committees in the House of Representatives. It has always been our practice when we do field hearings to insist that there be a Republican and Democrat present at those hearings. If there is any single issue that confronts the United States Congress that demands that we be bipartisan it is breast cancer because breast cancer, as we all know, doesn't affect just Democrats or Republicans. It knows no political boundaries or parties. It affects too many people from too many backgrounds. That is why I am so pleased to be here this morning.
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This hearing will explore why we have unusually high rates of breast cancer on Long Island, possible environmental factors, whether past chemical use, high voltage power lines, unsafe drinking water, and a need for targeted Federal resources research and new technology to help prevent breast cancer and help identify causes of the disease.
Like my colleague, since going to Congress in 2001, the issue of health, specifically women's health really dominated my legislative agenda. As residents of Long Island and Suffolk County, we are painfully aware of high rates of breast cancer in our community. We are motivated by very personal and genuine concerns. Cancer is an epidemic that knows no political boundaries and I suspect everybody in this room today knows someone or is someone who struggles with this disease. This isn't about politics, but about the lives of people we love, the lives of my two daughters, growing up on Long Island.
The fact is, we may be on the cutting edge of new technologies and new opportunities to detect cancer and to eradicate this disease. One of the issues that I have been working on and focusing on is ovarian cancer. You all know, about 75 percent of women with ovarian cancer are diagnosed in the advance stages of the disease when the five-year survival rates are only 20 percent. Early detection brings the five-year survival rates up to 95 percent.
Scientists from the FDA, National Cancer Institute reported in early February that patterns of protein found in blood serum might reflect the presence of the disease. Peter Levine is here today to testify about his prospects for early detection, not only for ovarian, but breast cancer.
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The cover article and lead article for the latest issue of U.S. News & World Report is all about cancer and cracking the code. We have heard a lot over the past weeks about connecting the dots and cracking the code. We have a critical and profound obligation to connect the dots and crack the code when it comes to identifying and early detection and diagnosis of breast cancer, ovarian cancer and all diseases and health conditions.
That is our obligation. To do that we have got to ratchet up what we are doing at the Federal level. We have got to focus on new technologies, on ground-breaking resource, new sciences. We have got to coordinate all of that to ensure that we are doing everything possible to crack the code and to connect the dots.
It means more than just having hearings. I will conclude with this. It means more than simply having field hearings and hearings in Washington, more than just giving speeches. It means acting. It means passing the Breast Cancer Environmental Research Act, which authorizes the director of the National Institute of Environmental Health Science to make grants for the development and operation of research centers studying environmental factors that may be related to breast cancer.
I am a co-sponsor of the Breast Cancer Protection Act. We need to pass it. It means health insurance plans must cover at least 48 hours of hospitalization after mastectomies. I am a co-sponsor of that. We need to pass it. It means making sure that every health insurance plan in America provides coverage for post-mastectomy breast reconstruction surgery.
This is a fight we can win. It is going to take government, going to take policy, going to take hearings. More importantly, it is going to take science and research. That is what we are here to probe today. I want to again thank Chairman Boehlert, Ranking Member Hall, and my distinguished colleague Mr. Grucci.
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[The prepared statement of Mr. Israel follows:]
PREPARED STATEMENT OF REPRESENTATIVE STEVE ISRAEL
I would like to begin by saying Good Morning to all of you who took the time and effort to work this hearing into your weekend schedules. We will be privileged this morning, to hear from a distinguished panel of witnesses who collectively and individually have an impressive array of expertise regarding breast and ovarian cancer, related environmental factors, and the cutting edge research to help us better diagnose and even predict the occurrence of these cancers, before any visible symptoms are present.
Since I came to Congress in January of 2001, the issues of health, and specifically, women's health, have dominated my legislative agenda. As residents of Long Island, and in particular, Suffolk County, we are painfully aware of the extraordinarily high rates of breast cancer here in our community. We are all motivated by very personal and genuine concerns. Cancer is an epidemic that knows no political boundaries. I expect everyone here has a friend or loved one who has struggled with this disease. To me, this is not about politics, it is about life—the life of my constituents; and the life of my own two daughters.
As many of you know, about seventy-five percent of women with ovarian cancer are diagnosed in the advanced stages of the disease, when the five year survival rates are only twenty percent. Early detection brings five year survival up to 95 percent. Scientists from the FDA and the National Cancer Institute reported in early February, that patterns of protein found in blood serum, may reflect the presence of the disease. I invited Peter Levine to testify today about his research on the prospects for achieving early detection, not only of ovarian cancer, but potentially of breast cancer as well.
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We are clearly living in an historic time for medical research. The cover and lead article for the latest issue of U.S. News & World Report is all about cancer and cracking the code to early detection, prevention and about developing more exact, and effective treatments with fewer harsh side effects. Scientists are beginning to categorize tumors not by their location in the body, but by the kinds of molecular defects they have in common. Recent advances in molecular biology and computer science are combining to accelerate cancer research, through a new field of research called ''molecular profiling.'' An amazing new tool called ''the gene chip'' is now allowing researchers to sort through thousands of genes at a time, accomplishing work that once took years, in a matter of just a few days. I look forward to hearing more about these promising new research techniques from the experts that we have invited here today. While we are rightfully encouraged by all of these new findings, there is still serious work to be done. It is our charge as elected officials to accept this challenge and to put the appropriate level of commitment and resources to work, to conquer this frightening disease that has caused so much devastation and pain for so many families.
As a reflection of my personal commitment to our collective mission of conquering cancer, I have cosponsored the Breast Cancer and Environmental Research Act, which authorizes the Director of the National Institute of Environmental Health Science to make grants for the development and operation of research centers studying environmental factors that may be related to breast cancer. In addition, I have co-sponsored legislation called the Breast Cancer Protection Act, to require health insurance plans to cover at least 48 hours of hospitalization after mastectomies. I am also fighting to require health insurance plans to provide coverage for post-mastectomy breast reconstruction surgery.
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This is a fight that we can win. We are at a promising moment in history where we can finally see so many pieces to the puzzle that previously we could only imagine. I pledge to you that I will do everything I can to make sure that dedicated medical research professionals like the ones before us today, have the support the necessary support to help them put the pieces together. Once again, it is my pleasure to be here with all of you today, I look forward to the testimony we will hear, and I want to thank my colleague from the Science Committee, Rep. (Felix) Grucci (Jr.), for choosing this important topic and arranging for this hearing.
Mr. GRUCCI. Thank you, Congressman.
Mr. ISRAEL. Mr. Chairman, I failed to note, unfortunately, I have obligations in my district at noon, so I will need to leave at 11:30. I state that for the record and apologize in advance.
Mr. GRUCCI. We appreciate you being here. All of our colleagues on Long Island wish they could be here. They were all extended an invitation to join us, but we are in session now five days a week in Washington, so time back in our districts is at a premium. Congresswoman Carolyn McCarthy sent a letter she asked to have read into the record on her behalf.
I would ask Diedre to do that now.
Ms. WALSH. ''Dear Congressman Grucci: Thank for bringing this important hearing to Long Island. Unfortunately, I am unable to attend due to a scheduling conflict. However, I wanted to express my dedication to solving the breast cancer crisis on Long Island.
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''I have been working on this important issue since I came to Congress and it is great to have the support of one of Long Island's newest members on this bipartisan issue.
''Three years ago, as I was researching the high cost of prescription drugs for seniors, I began wondering if price discrimination was limited to our seniors. Since Long Island women suffer from breast cancer at rates almost the highest in the nation, 20 percent higher than the national average, I decided to investigate breast cancer and the high cost of prescription drugs for these patients. This year alone there will be more than 14,700 new cases of breast cancer in New York State.
''In 1998, 18 percent of all New York women aged 18 to 64 were uninsured. In 2001, the Congressional Research Service estimated 2,200 New York women diagnosed with breast cancer would be uninsured. The results of this ground-breaking study, the first of its kind in the country, indicate a living nightmare for the thousands of women affected.
''Women on Long Island with breast cancer, who pay for their own drugs, pay an average of 116 percent more for the five breast cancer drugs than the drug companies' most favored customers. As a nurse, I know the most frequently prescribed medication for breast cancer is Nolvadex. This drug is essential to breast cancer patients and a Long Island woman must pay 83 percent more for the drug because they don't have prescription drug coverage. That means a women with coverage gets her drugs for $58 a month and a woman without coverage must pay $105.
''We all know the problem. We have a solution. That is why I am proud to have worked with you on our breast cancer prescription drug bill H.R. 758. As you know, our bill gives those on Medicare buying power to buy their drugs at the same low price that HMOs and our veterans enjoy. For the 40 percent of these women with breast cancer under the age of 65, our bill provides an opportunity to buy into these prescription drug benefit plans so they, too, can benefit from lower drug prices.
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''Finally, our bill asks for the Centers for Disease Control to begin studying the disparity in data for women who have breast cancer, but do not have prescription drug coverage. I am very hopeful that in this Congress we are going to make prescription drugs affordable for those with breast cancer. Let's give every woman the fighting chance to beat this disease until we can cure breast cancer.
''Again, I commend you for bringing this hearing to Long Island and look forward to continuing our work on behalf of all Long Islanders.''
Mr. GRUCCI. I ask that Carolyn's letter be made part of the record.
[The prepared statement of Carolyn McCarthy follows:]
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Mr. GRUCCI. We have a letter from Supervisor John LaValle, Supervisor Town of Brookhaven and I ask that be incorporated into the record. In sum and substance, John is pointing out his deep concern over the cancer clusters or the hot spots in the town he is now supervisor of and has pledged his support to work with us and continues to ask us to continue to find the funding necessary to find the cure for this. I will ask that supervisor John LaValle's letter be made part of the Congressional record as well.(see footnote 1)
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Mr. GRUCCI. Now let's hear from the experts in the field.
The first panel is comprised of Dr. John Kovach, Dr. Richard Grimson, Mr. Peter Levine and Dr. Nancy Kim.
The first speaker will be Dr. John Kovach, director of the Long Island Cancer Center, State University of New York at Stony Brook. Dr. Kovach also served as president of oncology at the Mayo Clinic in Rochester, Minnesota, and chairman of the Department of Oncology and director of the Mayo Comprehensive Cancer Center.
Dr. Kovach received his M.D. from the College of Physicians and Surgeons at Columbia University. I have had the pleasure of the working with the good doctor on a couple of other issues. I can attest to his commitment, dedication and integrity in trying to help find a cure for this dreaded disease. Doctor, thank you for being here.
Dr. KOVACH. Thank you very much.
Mr. GRUCCI. What we will try to do is keep your statements to around five minutes—I am not going to hold anybody to a specific time—so we can get into the questions.
Panel I
STATEMENT OF JOHN S. KOVACH, DIRECTOR, LONG ISLAND CANCER CENTER, STONY BROOK UNIVERSITY HOSPITAL, STONY BROOK, NEW YORK
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Dr. KOVACH. Thank you, Congressman Grucci, Congressman Israel, members of the panel.
I have long-standing research interest in the origins of breast cancer. Insight into the causes of cancer and indeed all chronic diseases can be achieved only by linking basic knowledge in biology, chemistry and genetics to the clinical and molecular details of specific diseases. As a bench scientist and, subsequently, director of two National Cancer Institute designated cancer centers, I was initially skeptical of efforts of advocates to target specific diseases for increased support. Well, I was wrong.
The tireless efforts of predominantly women have cast a spotlight on the multifaceted problem of cancer, bringing issues of causation, early detection, least damaging, most effective treatments and psychological and financial cost to the patient, family and society to national scrutiny and debate. We are fortunate the advocates knew in which direction to go. There is no doubt that the best chance we have to address cancer causation and develop strategies for prevention and early diagnosis will depend on the public's willingness to participate in large-scale studies.
Before I expand upon this point, I want to respond to the three questions each panelist has been asked to address. ''How significant is the incidence of breast cancer in the Port Jefferson area?'' ''What do we know about possible causes and high breast cancer rates?'' And ''do cancer mapping data warrant a full environmental study?''
The strength of the statistical analysis which led to identification of the hot spot will be addressed by other panelists with expertise in disease cluster analysis. However, regardless of whether or not the incidence of breast cancer on the north shore here is significantly greater than other areas of Long Island, the fact remains that breast cancer on Long Island, in New York State and throughout the United States is a major public health problem matched only in several northern European countries.
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The second question is, ''what do we know about possible causes for high breast cancer rates on Long Island?'' My short answer is nothing.
The third question is, ''should a full environmental study of the area be done?'' My short answer here is yes. However, I believe an environmental study limited to the Port Jefferson area may be too narrow to make the associations between specific environmental factors and to connect concentration of those factors in blood, tissue and other markers, such as patterns of genetic damage in the cancers themselves.
The key endemiological finding to me is that when women from nations with low breast cancer incidence, such as China and Japan, emigrate to the United States, within 10 years of residence there is an increase in the incidence of breast cancer. And by the second generation the rate of breast cancer increases two to three hundred percent or more to the very high rate of U.S. women.
There is no dispute that the marked increase in breast cancer rates in Asian women which occurs simply by living in the United States is caused by change in environment and lifestyle.
This is the clue that we should be paying attention to if we are going to make progress in discovering what causes the majority of breast cancers. Yes, just as the advocates have known instinctively all along, ''It's the environment, stupid.''
We know it is an enormous problem in the U.S. We know Suffolk County is at the top of the list. I recommend we focus on Suffolk or, if resources permit, Long Island, to develop a database that can be shared with scientists wherever they are.
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On Long Island we have the three components needed to develop this kind of database. One, an unequivocally high rate of breast cancer with one or more hot spots superimposed on this overall high rate; an active, concerned and well-informed public which, I believe, would be willing to participate in large long-term research projects requiring their time, blood and tissue and some risk of loss of confidentiality, which under current law could compromise insurability, though I think this is not a major problem.
Thirdly, the technical resources to conduct the environmental, molecular, pathological studies needed to relate environmental insult to the rate of disease.
I am confident the County and State Departments of Health of New York, Stony Brook University and Cold Spring Harbor Laboratory could design, implement and maintain an environmental, clinical, genetic database for investigation of the causes of breast cancer.
The New York State Health Department is a leader in environmental toxicology. Cold Spring Harbor is a world leader in basic cancer biology. Bruce Stillman told me recently they established a genomic analysis center directed specifically at studying genetic abnormalities in breast cancer. Stony Brook University has exceptional talent in epidemiology, imaging, ecology, and biologic research and presently has proposals at the National Institute of Environmental Health Sciences, that Congressman Israel referred to a moment ago, and at the National Cancer Institute to establish an NIEHS center and NCI-designated comprehensive cancer center here in Suffolk County.
A single large database in which the same patients could be studied by multiple investigators would be a powerful approach to generating the data needed to understand the relationships between in-born and acquired genetic variants and environmental factors which predispose to breast cancer. Once established, such a project could become a national resource for the study of this disease and other life-threatening chronic diseases.
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Given the drive of our citizens, there is every reason to believe that the political, scientific and administrative effort and financial resources needed to tackle the problem of breast cancer on Long Island in a scientifically rigorous manner can be achieved.
Thank you very much.
Mr. GRUCCI. Thank you, Doctor.
[The prepared statement of Dr. Kovach follows:]
PREPARED STATEMENT OF JOHN S. KOVACH
Congressman Grucci, distinguished members of the panels, and concerned citizens, my name is John S. Kovach. I am a physician with a long-standing interest in the origins of breast cancer. I came to Stony Brook University in September 2000 to develop the Long Island Cancer Center into an NCI-designated Comprehensive Cancer Center. I was especially excited about coming to Long Island because of my conviction that cancer prevention research requires a partnership among the community, scientists and politicians.
Insight as to the causes of cancer, and indeed all chronic diseases, can be achieved only by linking basic knowledge in biology, chemistry and genetics to the clinical and molecular details of specific diseases in humans. The people who have best understood this are known as ''the advocates.'' Many of the most vocal and most effective advocates for more intensive study of the problem of cancer, particularly breast cancer, are in this room today. The challenge for the ''scientific'' experts is to inform and educate the public and the politicians about scientific opportunities in as unbiased a manner as possible so that our valuable but limited public resources are used to maximum benefit for public health.
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As a bench scientist and subsequently as director of two National Cancer Institute-Designated Cancer Centers; one, at the Mayo Clinic in Rochester Minnesota; and the other, at City of Hope National Medical Center, Los Angeles, California, I was at first skeptical of the efforts of advocates to ''target'' specific diseases for increased public and political attention and funding. Well, I was wrong. The tireless efforts of, predominantly, women have cast a spotlight on the multifaceted problem of cancer, bringing issues of causation, early detection, least damaging most effective treatment, and psychological and financial costs to the patient, family and society to national scrutiny and debate.
We are fortunate that the advocates knew in which direction to go. There is no doubt that the best chance we have to address cancer causation and to develop strategies for prevention and early diagnosis will depend on the public's willingness to participate in large scale studies. I will say more about what must be done if we are to build on the base of public interest and energy for progress in cancer prevention.
First, I want to respond to the three questions each panelist has been asked to address. The questions are:
1) How significant is the incidence of breast cancer in Port Jefferson, New York compared to Long Island, New York State and the U.S.?
2) What do we know about possible causes of high breast cancer rates on Long Island?
3) Do cancer-mapping data warrant a full environmental study?
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I am sure the strength of the statistical analysis which led to the identification of a potential ''hot spot'' of breast cancer in this area will be addressed by our other panelists with expertise in this area, Dr. Nancy Kim, in the environmental branch of the New York State Department of Health and Dr. Roger Grimson, Stony Brook University, a biostatistician with expertise in disease cluster analysis.
However, regardless of whether or not the incidence of breast cancer in several zip code areas on the North Shore of Long Island is significantly greater than other areas of Long Island, the fact remains that breast cancer on Long Island, in New York State, and throughout the United States is a major public health problem, matched only in several northern European countries. The key epidemiological finding to me is that when women from nations with low breast cancer incidence, such as China and Japan, emigrate to the U.S., within 10 years of residence there is an increase in the incidence of breast cancer and by the second generation, the rate of breast cancer increases two to three hundred percent or more, to the very high rate of U.S. women.
There is no dispute that the marked increase in breast cancer rates in Asian women, which occurs by simply living in the U.S. is caused by a change in the environment and ''life style.'' This is the clue that we should be paying attention to if we are to make progress in discovering what causes the majority of breast cancers. And, yes, just as the advocates have known instinctively all along, ''It's the environment, stupid.''
I use that phrase easily, having spent 40 years in cancer research. Only recently have many scientists realized that if we are to discover which factors are the culprits in causing human disease, we must develop large databases of affected and unaffected individuals along with properly obtained and stored tissue samples. A single large database in which the same individuals can be studied by multiple investigators with different expertise would allow us to gather and share the data needed to understand the relationships between inborn and acquired genetic variants and environmental factors in chronic diseases.
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My colleague Steve Sommer, a clinical and molecular geneticist now at the City of Hope, and I analyzed a gene that is frequently altered in breast and other cancers. We showed that in breast cancers from different sites around the world, unlike several other common cancers, the pattern of genetic damage varied markedly depending on place of residence. We interpreted the data to mean that a diverse group of environmental toxins probably play a role in breast cancer causation (Lancet 1996; 348:683–84 and Trends in Genetics 1997; 13:27–33).
The main point is that, at least, some environmental toxins leave a ''fingerprint'' at the site where they cause genetic damage, making it possible to get some idea of the nature of the environmental culprit from detailed genetic analysis of the cancer. I am optimistic that in the near future, provided we create large accurate databases, the developing field of molecular epidemiology using both genetic and proteomic data will lead to the identification of high risk individuals, facilitate early diagnosis, and reveal which environmental toxins are truly hazardous to our health.
Before I make specific recommendations about what should be done to address the cause of breast and other cancers, let me give my opinion about the other two questions.
What do we know about possible causes for high breast cancer rates on Long Island? My short answer is NOTHING—and
Should a full environmental study of the area be done? My short answer is YES. However, I believe an environmental study limited to the Port Jefferson area would be too narrow to be able to make associations between specific environmental factors and the concentration of those factors in blood and tissue of women with and without breast cancer and with patterns of genetic damage in breast cancer.
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We know there is a breast cancer problem in the U.S. We know that certain regions of the U.S., such as Suffolk County, are at the top of the list. I recommend that we focus on Suffolk County or, if resources permit, Long Island, to develop a database of information, that can be shared with qualified scientists wherever they are. On Long Island, we have the three components needed to develop this kind of database.
1) An unequivocally high rate of breast cancer with one or more ''hot spots'' superimposed on the overall high rate.
2) An active, concerned and well informed public which, I believe, would be willing to participate in a large long-term research project requiring their time, blood and tissue, and some risk of loss confidentiality which, under current law, could compromise insurability and perhaps, even, employability.
3) The technical resources to conduct the environmental, molecular, biochemical, genetic and pathologic studies needed to relate environmental insult to the occurrence of specific diseases.
I am confident that the County and State Departments of Health, Stony Brook University and Cold Spring Harbor Laboratory could design, implement and maintain an environmental, clinical and genetic database for the investigation of the causes of breast cancer.
The New York State Health Department is a national leader among such departments in epidemiology and environmental toxicology. Cold Spring Harbor Laboratory is a world leader in basic cancer biology and has recently established a genomic analysis center directed specifically at discovering genetic abnormalities in breast cancer by examining the entire genome of the tumor. There is already an ongoing collaboration between the Long Island Cancer Center and the cancer genome center at Cold Spring Harbor on the genetics of ovarian cancer. Stony Brook University has exceptional talent in epidemiology, imaging, oncology, and biologic research and presently has proposals at the National Institute for Environmental Health Sciences (NIEHS) and at the National Cancer Institute (NCI) to establish the only NIEHS Center and NCI-designated Comprehensive Cancer Center on Long Island.
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Once established, this project could lead to the creation a national resource for the study of breast cancer and other life-threatening chronic diseases. Given the drive of our citizens, there is every reason to believe that the political and scientific effort and financial resources needed to tackle the problem of breast cancer on Long Island in a scientifically rigorous manner will be successful.
BIOGRAPHY FOR JOHN STEPHEN KOVACH
Address: Director, Long Island Cancer Center, Stony Brook University, SUNY–7547, Stony Brook, New York 11794–-7547; john.kovach@stonybrook.edu
Date of Birth: October 1, 1936
Place of Birth: Cleveland, Ohio
Marital Status: Married; two children: Alexandra (05/13/81), Elizabeth (10/29/82)
Citizenship: U.S.A.
Education:
1954–1958 Princeton University—B.A. (cum laude), 1958
1958–1962 College of Physicians & Surgeons, Columbia University—M.D., 1962
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Honors:
Alpha Omega Alpha, 1962; Sigma XI, 1958
Training:
1962–1963 Medical Intern, Presbyterian Hospital, New York City
1963–1964 Assistant Resident in Medicine, Presbyterian Hospital, New York City
1964–1965 Senior Assistant Resident in Medicine, Presbyterian Hospital, New York City
1965–1966 Trainee in Hematology, U.S.P.H.S. Fellowship, Laboratory of Dr. Paul A. Marks, College of Physicians & Surgeons, Columbia University
1966–1968 Surgeon, U.S.P.H.S., Section of Biosynthesis and Control, Laboratory of Chemical Biology, NIAMD, NIH—Dr. Robert F. Goldberger
Professional Experience:
1968–1972 Medical Officer, Laboratory of Chemical Biology, NIAMD, NIH
1972–1973 Visiting Resident, Division of Medical Oncology, Mayo Clinic
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1973–1976 Associate Professor of Medicine, College of Physicians and Surgeons, Columbia University; Deputy Director, Clinical Oncology, Cancer Research Center, Columbia University; Attending Physician, Columbia-Presbyterian Medical Center, New York, New York
1976–1981 Associate Professor of Oncology, Mayo Medical School, Mayo Clinic
1976–1994 Consultant in Medical Oncology, Mayo Clinic
1976–1986 Chairman, Division of Developmental Oncology Research; Department of Oncology, Mayo Clinic
1981–1994 Professor of Oncology, Mayo Medical School, Mayo Clinic
1986–1994 Chairman, Department of Oncology, Director, Mayo; NCI—Designated Comprehensive Cancer Center
1994–9/2000 Executive Vice President, Medical and Scientific Affairs, City of Hope National Medical Center and Beckman Research Institute; Director, City of Hope NCI-Designated Comprehensive Cancer Center; Director, Beckman Research Institute
9/2000–Present Founding Director, Cancer Institute of Long Island, Stony Brook University
Certification:
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Diplomate, Board of Internal Medicine—1973
Professional Societies:
American Association for Cancer Research
American Society for Clinical Oncology
American Society for Clinical Pharmacology and Therapeutics
American Society for Microbiology
American Association for the Advancement of Science
American College of Physicians
American Society of Human Genetics
Medical Licensure:
California, C050113
New York 092066–1
Committee Appointments:
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Intramural
Member, Scientific Advisory Committee, Cancer Research Center, Columbia University, 1973–1976
Member, Institutional Committee on Human Investigation, Columbia University, 1973–1976
Member, Curriculum Committee, College of Physicians and Surgeons of Columbia University, 1973–1976
Member, Mayo Institutional Research Committee, 1978–1980
Member, Academic Appointments and Promotions Committee, Mayo Clinic, July 1984–July 1986
Chairman, Cancer Research Committee, Mayo Clinic, 1978
Chairman, Department of Oncology Research Committee, Mayo Clinic, 1986
Member, Education Policy Committee, Mayo Clinic, 1991
Member, Internal Medicine Administrative Committee, Mayo Clinic, 1987
Member, President's Executive Board, City of Hope National Medical Center and Beckman Research Institute, 1996–09/2000
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Chair, Research Council, Beckman Research Institute, 1996–09/2000
Extramural
Member, Biochemical Modifier Advisory Group, National Cancer Institute—Subcommittee of the Phase I Contractors, 1984–1989
Member, Cancer Therapeutics Program Project Review Committee, Grants Review Branch, Division of Extramural Activities, National Cancer Institute, 1984–1986
Member, Cancer Center Support Review Committee, National Cancer Institute, 1988–1992
Chairman, Cancer Center Support Review Committee, National Cancer Institute, 1991–1992
Member, Editorial Advisory Board of the Journal of the National Cancer Institute, 1987
Member, Program Committee, American Association for Cancer Research, 1985, 1988, and 1991
Member, Program Committee of American Society of Clinical Oncology, 1987
Member, Association of American Cancer Institutes, 1986
Board of Directors, Association of American Cancer Institutes, 1987–1989
Member, Scientific Review Committee for the Melbourne Branch of the Ludwig Institute, 1984–1986
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Member, Program Committee, Third Annual Conference on the Interaction of Radiation Therapy and Systemic Therapy, American College of Radiology, 1988–1990
Member, External Advisory Committee for the Drug Development Program at the Meyer L. Prentis Cancer Center of Metropolitan Detroit, Wayne State University, 1986
Member, Peer Review Committee of the Minnesota Cancer Surveillance System, Minnesota Department of Health, 1989
Member, External Advisory Committee, Cleveland Clinic Cancer Center, 1988–1990
Chairman, Scientific Review Committee, Share Foundation, Grandview, Missouri, 1991
Member, External Advisory Committee, Walther Cancer Institute, Consultant, 1990–1992
Member, External Advisory Committee, University of Virginia Cancer Center, Consultant, 1992
Member, External Advisory Committee, Sylvester Comprehensive Cancer Center, University of Miami, Consultant, 1992–1998
Member, External Advisory Committee, Purdue Cancer Center, Purdue University, 1994–1999
Member, National Comprehensive Cancer Network Board of Directors (NCCN), 1994–2000
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Member, NCCN Guidelines Steering Committee, 1996–2000
Member, Grants Advisory Council of the Arnold and Mabel Beckman Foundation, 1997–2000
Invited Speaker:
Third NCI-EORTC (European Organization for Research on Treatment of Cancer) Symposium on New Drugs in Cancer Therapy, October 15–17, 1981, Brussels, Belgium—''Screening for New Anticancer Drugs.''
Tenth International Symposium on the Biological Characterization of Human Tumors, October 24–28, 1983, Brighton, England—''In Vitro Studies of the Anti-tumor Activity of ASTA Z 7557, a New Analogue of Cyclophosphamide.''
Fourth NCI–EORTC (European Organization for Research on Treatment of Cancer) Meeting, December 14–17, 1983, Brussels, Belgium—''Phase I Trial of Tricyclic Nucleoside 5'Phosphate: Bisantrene by Continuous Infusion for 72 Hours;'' ''Pharmacokinetic Studies of Anticancer Drugs During Phase I Trials'' (special lecture series in memoriam of Frank M. Schabel, Jr., M.D.).
Oncology Update meeting, October 10–11, 1984, The Cleveland Clinic Foundation, Cleveland, Ohio—''Current Status of Phase I and Phase II Clinical Trials of Anticancer Agents in the United States.''
Seminar on Biochemical Modulation of Chemotherapy and Immunotherapy, U.S.—Japan Cooperative Research Program—Treatment Area, November 19–20, 1984, Tokyo, Japan—''Tiazofurin, an Investigational Compound with Potential Value in Modifying Guanine Nucleotide Pools in Man'' and ''Enhancement of the Cytotoxicity of Anticancer Drugs by Human Interferons.''
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Hematology Society, November 29, 1984, Mayo Clinic and Mayo Foundation, Rochester, Minnesota—''Re-examination of the Use of Thioguanine as an Anticancer Agent in Man.''
Workshop on Disease-Oriented Anti-tumor Drug Discovery and Development, January 9–10, 1985, National Cancer Institute, Division of Cancer Treatment, Bethesda, Maryland—''Strategies for Clinical Trials of Agents with Potential Disease Specificity.''
Saddlebrook Conference on Regional Chemotherapy, February 14–16, 1985, Tampa, Florida—''Directed Intravascular Precipitation, A New Approach to Regional Chemotherapy of Advanced Cancers.''
The Cancer Center, University of California, San Francisco, April 18, 1985, ''New Insights into the Metabolism of Thiopurines in Patients with Advanced Cancer.''
Gordon Research Conferences, July 21–26, 1985, Colby, New Hampshire—''Role of Animal Pharmacology of Antineoplastic Agents.''
Current Status of Recombinant Interferon in Cancer Therapy—Symposium, May 3, 1986, Los Angeles, California—''Clinical Trials of Recombinant Interferon Alpha Yield Therapeutic Responses and Biologic Insights.''
Second Nagoya International Symposium on Cancer Treatment: Challenges for the Future, October 16–18, 1986, Nagoya, Japan—''Cisplatinum: New Clinical Application.''
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Mayo Alumni Association: 54th International Meeting, March 25–28, 1987, Orlando, Florida—''Biological Growth Modifiers: Fundamental Concepts and Mechanisms.''
20th Annual Detroit Cancer Symposium—Experimental/Clinical Perspectives of Fluorinated Pyrimidines, April 3–4, 1987, Detroit, Michigan—''Human Pharmacology of Fluorinated Pyrimidines.''
Cancer Seminar Series—Invited Lecturer, April 22, 1987, Iowa City, Iowa—''Cellular Pharmacology of Fluorinated Pyrimidines: In Vivo Studies in Man.''
Brookhaven National Laboratory—April 27, 1988, Upton, Long Island, New York—''The Modulation of Incorporation of Iododeoxyuridine into Human Brain Tumors.''
''Advances in Cancer'' Symposium (Moderator)—May 20, 1988, New Orleans, Louisiana.
Symposium, ''Feron (natural human interferon-beta)—What the future holds in clinical and basic research,'' November 15, 1988, Kyoto, Japan—''A Strategy for the Clinical Application of Interferons as Cancer Chemotherapy.''
Visiting Professor—Perelman Lecture—Akron General Medical Center—November 8, 1989, Akron, Ohio—''Modulation of 5–Fluorouracil Results in Therapeutic Advances.''
NCI ''Workshop on Levamisole: Mechanisms of Anti-Tumor Action''—Invited Lecturer, June 11–12, 1990, Gaithersburg, Maryland.
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Cancer Reviews: Invited Lecturer, October 4–6, 1990, Scottsdale, Arizona—''Radioimmunotherapy: Possibilities and Problems.''
Hematology/Oncology Reviews—March 1–2, 1991, Mayo Clinic Jacksonville—''Molecular Aspects of Oncology.''
National Comprehensive Cancer Network, Board of Directors Meeting, March 4, 1996, Fort Lauderdale, Florida, ''Cancer Care and Costs.''
Association of American Cancer Institutes, Annual Meeting, April 19, 1996, Rockville, Maryland, ''Impact of Managed Care Penetrance on Specific Cancer Centers and Their Responses to Impact.''
American Association for Cancer Research, Eighty-Seventh Annual Meeting, April 21, 1996, Washington, DC, ''Molecular Epidemiology of Breast Cancers are Associated with Adverse Prognosis.''
The Banbury Center, Cold Spring Harbor Laboratory, March 6, 1997, ''Null and Missense p53 Mutations in Primary Breast Cancers are Associated with Adverse Prognosis.''
Hirosaki University School of Medicine, June 5, 1997, ''Patterns of Mutations of the p53 Gene in Breast Cancers.''
Guest of Australian Cancer Society, Centre for Behavioral Research in Cancer, Anti-Cancer Council of Victoria, July 11 to 17, 1997. Delivered several lectures including:
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Walter and Eliza Hall Institute of Medical Research, Royal Melbourne Hospital, ''Molecular Techniques to Determine Environmental Factors Important in Carcinogenesis.''
University of Melbourne, Department of Public Health and Community Medicine, ''International Colloraboration in Breast Cancer Research Using Molecular Epidemiology to Explore Geographical and Ethnic Factors.''
New South Wales Cancer Council, ''Smoking, Genetic Changes and Lung Cancer.''
Zhejiang Medical University Cancer Institute, Hangzhou, China, April 28, 1998, and Beijing North Tai Ping Road Hospital, Beijing, China, April 30, 1998, ''Patterns of p53 Gene Mutation as an Epidemiologic Tool: Differences in Patterns Among Ethnic Groups.''
80226d.eps
Mr. Grucci. Our next speaker is Dr. Roger Grimson, principal research scientist, Department of Preventive Medicine, State University of New York at Stony Brook, and president of the clinical statistics and medical statistics consultancy. He has done extensive research and published needed papers in the area of disease patterns and clusters. Dr. Grimson is an investigator and advisor on several community based breast cancer mapping projects.
Thank you for being with us.
STATEMENT OF ROGER C. GRIMSON, PRINCIPAL RESEARCH SCIENTIST AND ASSOCIATE PROFESSOR, DEPARTMENT OF PREVENTATIVE MEDICINE, LONG ISLAND CANCER CENTER, STONY BROOK UNIVERSITY HOSPITAL, STONY BROOK, NEW YORK
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Dr. GRIMSON. Thank you for giving me the opportunity to be a part of these hearings.
Following the guidelines, I will briefly address the issues at hand: the incident of breast cancer in the Port Jefferson region; two, possible causes of high breast cancer rates on Long Island; and three, the implications of cancer mapping in the region.
First, the region identified as Coram, Mount Sinai, Port Jefferson region is comprised of seven contiguous zip code regions in the north shore of Suffolk County. This region is the only one in the state with a female breast cancer rate exceeding 50 percent of expected rate. Furthermore, Nassau and Suffolk Counties are among the few counties that have the highest annual breast cancer rates in the state.
Based upon state cancer registry data, the most recent annual incidence rates for breast cancer are 118 cases and 116 cases per 100,000 women for Suffolk and Nassau Counties, respectively, compared with the state rate of 104 cases per 100,000.
Quick calculation suggests the annual rate in the Coram, Mount Sinai, Port Jefferson region exceeds 150 cases for 100,000 women and statistical analysis indicates that this is not just a random occurrence.
New York State experiences the 13th highest female breast cancer incidence rates in the United States based on figures reported by the American Cancer Society. Furthermore, New York State has the fourth highest breast cancer mortality rate in the United States.
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Data from the National Cancer Institute has shown that the northeast region of the United States has mortality rates 60 percent higher.
[Clock chime]
Mr. GRUCCI. That is not your time running out though by the sound of that, it sounds like all our time is running out.
Dr. GRIMSON. The data from the National Cancer Institute have shown that the northeast region of the United States has mortality rates one percent higher than the rest of the United States. A sub-cluster of this northeast region that contains the very highest mortality rates includes Long Island.
The second part of my testimony addresses the often asked questions, what are the possible causes of the breast cancer rates on Long Island? I will agree, nothing is known. Aside from the attenuating effects of the known risk factors such as age, genetic characteristics, reproductive history, environmental causes are just not known. Very little is known about that. But let's be clear about what we mean by the environment.
The environment includes everything around us. It includes everything that we eat, drink and breathe, everything we are exposed to on a daily basis, including pollution, ionizing radiation, magnetic fields, light, weather, infections and pathogens, pesticides, occupational stress and the medicines we take.
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The list is endless.
Perhaps some of these factors or others interact in complex ways to eventually cause breast cancer and such dynamics will vary among women. Moreover, population dynamics such as residential histories, reproductive histories and genetic factors must be figured into the equation.
In particular, it is necessary to study the gene environment interaction using modern tools of molecular epidemiology, a field of interest to our department and our cancer center.
This conclusion leads me to the last part of my testimony. The final issue I would like to address is a question of whether the Coram, Mount Sinai, Port Jefferson mapping data warrants a full environmental study of the area. Currently, the Department of Health is in the third of a five-step process investigating unusual disease patterns. This step involves the ascertainment of unusual types or levels of environmental pollutions. This could lead into a full epidemiological environmental study of the region. However, ascertainment of the causes of breast cancer will require extraordinary detailed and rigorous long-term prospective epidemiologic studies. These would involve the collection of detailed genetic, lifestyle and environmental information for large groups of women.
The Long Island region, which includes the Coram, Mount Sinai, Port Jefferson regions is ideally suited as a basis of such a process due to its unique potential for yielding positive results as indicated by the high incidence and mortality rates and its large population base.
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Given the community's awareness and the importance of cancer on Long Island, we applaud today's hearing.
Thank you.
Mr. GRUCCI. Thank you, Doctor.
[The prepared statement of Dr. Grimson follows:]
PREPARED STATEMENT OF ROGER C. GRIMSON
My name is Dr. Roger Grimson. I am a Biostatistician and Associate Professor in the Department of Preventive Medicine at the School of Medicine, Stony Brook University. One of my areas of expertise is disease clustering. I have been especially interested in and have studied the patterns of breast cancer clustering for many years. I would like to thank you for giving us the opportunity to be a part of these hearings.
The Department of Preventive Medicine within the School of Medicine has a long-standing relationship with the community to investigate concerns about possible disease clusters on Long Island. In addition, we have a strong interest and involvement with breast cancer research on Long Island, having worked with the State and Local Departments of Health, the State of New York, and the Federal Government in studying the cancer problem on Long Island. This includes mapping potential toxic sites throughout the Island, the study of ''hot spots'' of breast cancer on Long Island, being a part of the federally funded Long Island Breast Cancer Project, leading the Electromagnetic Fields and Breast Cancer on Long Island Study, and other cancer studies funded by the National Institutes of Health; and being involved with cancer education in the schools, communities at large and community physicians.
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Following your guidelines, I will briefly address the three issues at hand: (1) the incidence of breast cancer in the Port Jefferson, New York, region, (2) possible causes of the high breast cancer rates on Long Island, and, (3) the implications of cancer mapping data in the region.
1) First, the region identified as the Coram, Mount Sinai, Port Jefferson region is comprised of seven contiguous zip code regions on the north shore of Suffolk County, New York. This region is the only one in New York State with a female breast cancer incidence exceeding 50 percent of its ''expected'' rate. Furthermore, Nassau and Suffolk Counties are among the few counties that have the highest annual breast cancer incidence rates within New York State, and this high rate has been consistently observed. Based upon New York State Cancer Registry data, the most recent annual incidence rates for breast cancer are 118 cases and 116 cases per 100,000 women for Suffolk and Nassau Counties, respectively, compared with the State incidence rate of 104 cases per 100,000. A quick calculation suggests that the annual rate in the Coram, Mount Sinai, Port Jefferson region exceeds 150 cases per 100,000 women, and statistical analysis indicates that this is not just a random occurrence. Therefore, the data suggest that the incidence rates in the area are indeed higher than expected.
New York State experiences the 13th highest female breast cancer incidence rate in the United States, based upon figures reported by the American Cancer Society for the period 1994–1998. Furthermore, New York State has the 4th highest breast cancer mortality rate in the United States for the same time period. Data from the National Cancer Institute have shown that the north east region of the United States has mortality rates 15.6 percent higher than the rest of the United States, based on 1988–1992 mortality data. A subcluster of this northeast region that contains the highest rates (by 7.4 percent) includes Long Island.
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The identification of the Coram, Mount Sinai, Port Jefferson cluster is a result of the New York State Department of Health (DOH) Cancer Surveillance Improvement Initiative, which is unique among the states in that it involves creating and evaluating cancer maps on small geographic scales (zip code regions). Generally, state disease maps are based on the county scale. I must applaud the State for undertaking this project and look forward to their further developing this resource as an investigational tool.
2) The second part of my testimony addresses the often-asked question: ''What are the possible causes of the high breast cancer rates on Long Island?'' Understandably, public interest is focused on environmental factors. Aside from the attenuating effects of known risk factors like age, genetic characteristics and reproductive history, environmental cause(s) of breast cancer are not clearly understood. To date, only between 25 percent to 30 percent of the breast cancer cases could be explained by established risk factors. An additional 5 percent to 10 percent of women diagnosed with breast cancer have a genetic predisposition, leaving the causes for about 65 percent of breast cancer cases as unexplained. But let us be clear about what we mean about the ''environment.'' The environment includes everything around us. It includes everything we eat, drink, and breath; everything we are exposed to on a daily basis including pollution, ionizing radiation and magnetic fields, light, weather, infections and pathogens, pesticides; who we are and what we do, the choices we make in terms of diet, occupation, and stress, the medications we take. The list is endless.
Perhaps some of these or other factors not listed work in combination with or sequentially to eventually cause breast cancer, and such dynamics will vary among women. We still do not have the answers. Moreover, population dynamics such as residential histories, reproductive histories, and genetic factors must be figured into the equation. We also need to investigate further exposures at critical points in a woman's lifetime as they relate to disease. In sum, the causes remain unknown and we definitely need more research into this subject. In particular, it is necessary to study gene-environment interactions, using the modern tools of molecular epidemiology, a field of interest to our department and our Cancer Center. This conclusion leads me to the last part of my testimony.
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3) The final issue I would like to address is the question of whether the Coram, Mount Sinai, Port Jefferson mapping data warrants a full environmental study of the area. The New York State Department of Health has developed a five step sequential process to follow in the investigation of unusual disease patterns. The first two steps involved defining the cluster and a review of pertinent available demographic and environmental data. Currently the Department of Health is in the third step, which involves the ascertainment of unusual types or levels of environmental pollutants. Earlier this month the State Department of Health was on Long Island on a fact finding mission to speak with local residents to glean data for this third phase. During this phase individual residents or breast cancer patients are not the unit of study; the units of study observation are geographic as opposed to person specific and there are still certain biases and limitations inherent to this approach. Depending on the findings from step three, a feasibility study may be conducted (step 4) which in turn could lead into a full epidemiologic/environmental study of the region. The latter, would collect person specific information to determine potential risk factors for this population.
To better understand breast cancer risk, ascertainment of the cause(s) of breast cancer will require extraordinary detailed and rigorous long-term epidemiologic studies. Prospective population based studies that follow women for long periods of time, though costly are one of the best tools we have to determine risk. In my opinion, the discovery of causes of breast cancer in the region or in general will require a tremendous effort and extensive resources to collect detailed genetic, lifestyle, and environmental information over time for large groups of women. The Long Island region, which includes Coram, Mount Sinai, Port Jefferson is ideally suited as the basis of such a process due to its unique potential for yielding positive results, as indicated by its high incidence and mortality rates and its large population base.
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Given the community's awareness and the importance of cancer on Long Island, we applaud today's hearing. As scientists studying the link between breast cancer and the environment, we at Stony Brook recognizes the need for a special effort and initiative in this area. We are prepared to lend our efforts to meet the challenge to improve the health of the population in the region.
BIOGRAPHY FOR ROGER C. GRIMSON
DATE AND PLACE OF BIRTH: December 2, 1941, Chicago, Illinois
OFFICE ADDRESSES:
Clinical Statistics, Inc., 3 Birdseye Circle, Stony Brook, NY 11790; Department of Preventive Medicine, School of Medicine, Health Sciences Center, L 3, State University of New York at Stony Brook, Stony Brook, New York 11794–8036
TELEPHONE: home: (516) 751–8986; office: (516) 444–2190
EDUCATION:
B.S., Mathematics, University of North Carolina, Chapel Hill, 1964.
Ph.D., Mathematics, Duke University, 1969.
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Postdoctoral Fellowship, Biostatistics, University of North Carolina, Chapel Hill, 9/74–9/76.
APPOINTMENTS:
Assistant Professor, Mathematics, Elon College, N.C., 9/68–9/71.
Associate Professor, Mathematics, Elon College, N.C., 9/71–9/74.
Research Fellow, Biostatistics, School of Public Health, University of North Carolina, Chapel Hill, N.C., 9/74–9/76.
Research Associate Professor, Biostatistics, U.N.C., Chapel Hill, N.C., 9/76–12/81.
Associate Professor, Biostatistics, U.N.C., Chapel Hill, N.C., 1/82–4/83.
Associate Professor, Preventive Medicine, S.U.N.Y., Stony Brook, N.Y., 5/83–12/00.
Principal Senior Scientist, Preventive Medicine, S.U.N.Y., Stony Brook, N.Y., 1/01-
President, Clinical Statistics, 1/01–
HONORS:
Pi Mu Epsilon, 1963.
Duke University Summer Scholarship, 1968.
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NIH Research Assistant, 1965–1967.
Summer Sabbatical Award. The Fund for the Advancement of Education, 1969.
Research Grant, Piedmont University Center, 1971–1972.
NSF Visiting Research Professor, Louisiana State University, Summer, 1972.
NIH Postdoctoral Research Fellow, Occupational Health Studies Group, UNC, 1974–1976.
1980–82, UNC Research Award.
Delta Omega (Honorary Public Health Society), Elected in 1981.
Sigma Xi (Honorary Scientific Research Society), Elected in 1987.
A 1988 invitation to the International Who's Who of Intellectuals.
Certificate of Appreciation from Suffolk County Executive and Legislature, 1998.
Certificate of Appreciation from Breast Cancer Help, Inc. 1999.
Certificate of Appreciation from The Board of Directors, Huntington Breast Cancer Action Coalition 2001.
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PROFESSIONAL SOCIETIES:
American Statistical Association
Mathematical Association of America
OVERVIEW OF RESEARCH AND CONSULTING EXPERIENCE:
Research in the mathematical sciences (as represented in refereed journals): biostatistics, probability, combinatorics, risk assessment, inference, epidemiologic methods, mathematical physics, number theory, order statistics, nonparametric statistics, mathematical modeling, space-time pattern analysis.
Principal biostatistician or team member on large scale multidisciplinary projects (mostly trials, surveys, case-control studies) in the following areas: cancer epidemiology, health services evaluation, radiation exposure assessment, cardiovascular disease epidemiology, ophthalmology, maternal and child health, pediatrics (mostly teratology), public health statistics, aging, sarcoidosis, occupational risks, several infectious diseases, psychology, AIDS, Lyme disease.
Miscellaneous consulting for private industry and federal agencies: Defense Nuclear Agency, Federal Trade Commission, Centers for Disease Control, National Institutes for Health, several corporations and law firms.
TEACHING/EDUCATION:
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Taught courses in basic biostatistics, applied probability, topics in epidemiology and medical geography, statistical topics in occupational medicine, combinatorics, calculus linear algebra, symbolic logic, discrete mathematics.
Directed Ph.D. dissertations and masters papers, served on over 25 Ph.D. committees.
Short courses: ''Clustering of Disease,'' Rocky Mountain Center for Occupational and Environmental Health, Salt Lake City, UT, June 11–12, 1990 and Buffalo, NY, June 10–11, 1991.
Short course: ''Guidelines and Procedures for Investigating Disease Clusters,'' University of Vancouver, British Columbia, July, 1994.
Annually teaches graduate school course (AMS 506) in the Department of Applied Mathematics and Statistics at SUNY Stony Brook. Course name is Finite Structures and is about applied combinatorial statistics and features applications in the health sciences.
Annually participates in teaching the Department of Preventive Medicine course, ''Preventive Medicine'' to medical students.
Annually teaches a biostatistics tutorial to Department of Preventive Medicine residents. Basic statistics with medical and public health applications.
Annual CME and non CME presentations to residents, fellows, faculty in medical school departments.
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Good teaching evaluations.
SERVICE AND COMMUNITY APPOINTMENTS:
Chairman of the Academic Council (faculty senate), Elon College, 1973–74;
Chairman of the faculty committee to assist the Board of Trustees of Elon College in selecting a president of the college, 1973
Reviewer for Mathematical Reviews—1975–present
Referee for papers submitted for publication
Member of site visit teams for the National Institutes of Health
Treasurer, Statistics and Epidemiology Selection of the North Carolina Public Health Association, 1980–82
Vice Chairman, Statistics and Epidemiology Section of the North Carolina Public Health Association, 1982–83
Director of the Statistics program for the Occupational Safety and Health Educational Resource Center, 1980–1982
Consultant (one day per week) to the Division of Health Services of the North Carolina Department of Human Resources, 1976–83
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Research collaborator, Medical Department, Brookhaven National Laboratory, Upton, NY, 1983–1985
Occasional consultant to Suffolk and Nassau County Health Departments, Long Island, NY
Faculty appointment with Department of Applied Mathematics and Statistics, College of Engineering and Applied Sciences, SUNY at Stony Brook, NY, 1983–present
Director of the Preventive Medicine and Public Health Conferences of the continuing Medical Education Program, Dept. of Preventive Medicine School Medicine, SUNY, NY, 1983–1993
Scientific advisor or board member of several community-based breast cancer coalitions in the United States, mostly on Long Island
Biostatistical and Epidemiologic Consultation Services, Dept. of Preventive Medicine, 1992–present
Member of Task Force for investigating environmental and health issues in schools of the South Country Central School District, 1997 (Recognition by the Superintendent of Schools)
Chairman of Suffolk County Task Force to investigate possible effects that Brookhaven National Laboratory may have on the health and environment of county residents, 1996–1998. (Recognition by County Executive and Legislature)
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Member of team comprised of SUNY Stony Brook, NY State and Suffolk County officials to investigate a cluster of Hodgkin's Disease occurring among young people in East Hampton, NY, 1998–2000
Appointed by the NY State Department of Health to serve on the Advisory Committee for the New York State Department of Health's Cancer Surveillance Improvement Initiative, 1998–
Board of Advisors, Breast Cancer Help, Inc. 1999–
Member of Suffolk County Task Force to examine safety on Plum Island Biologics Facility
CERTIFICATION:
Certified by examination through the US Dept. of Health and Human Services to participate in research involving human subjects (code of Federal Regulations, Title 45, Part 6), 2000
GRANTS:
Principal Investigator, ''Life Styles in Health Promotion for Adolescents'', funded by Kellogg Foundation through the Bard College Center through subcontract for epidemiology and analysis, 1985–1988. Consulted on and wrote sections of grants for applicants in most departments of the Medical School. Salary offset biostatistician or co-principal investigator on many of these grants. Currently, co-principal investigator or senior biostatistician on breast cancer, diabetes and Lyme disease projects (NIH) in the Department of Preventive Medicine.
INVENTIONS:
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A device for calculating the probability of paternity, based on the paternity index and a prior probability. 1988. Used by Genetic Design Inc.
FILM/OTHER MEDIA:
Interviewed in educational documentary: Suffolk County Neonatal Home Health Aid. 1991.
''The Joel Martin Show.'' Filmed Fall 1993. Aired on Cablevision.
''Inside the Legislature.'' Filmed Dec. 9, 1993. Aired on Cablevision.
''Talk About.'' Filmed, Mar. 1998. Aired on Television.
Appeared nationwide on WABC, 7:30 P.M., Oct. 3, 1998 regarding a breast cancer special.
''Brookhaven.'' Filmed Summer 1999. Aired on Cablevision.
''Health Connections.'' A SUNY Television Program. Filmed Sept. 21, 1999. Aired on Cablevision and elsewhere.
''Capitol Commentary.'' Filmed May 2000, aired on Cablevision, C–SPAN II.
Other appearances and interviews in newspapers, magazines, radio and television. Name mentioned and popular publications including Scientific American, New York Times, TIME Magazine, Newsday, and other newspapers.
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CONTRIBUTIONS TO AVAILABLE SOFTWARE:
''Grimson's method,'' referring to a disease cluster detection method, has appeared in the following three commercially available software products:
Cluster: Software System for Epidemiologic Analysis, Agency for Toxic Substances and Disease Registry, U.S. Department of Health and Human Services, Atlanta, GA.
Stat!, BioMedware, Ann Harbor, MI.
CAST (Cluster Analysis in Space and Time), Applied Biomathematics, Setauket, NY.
DOCTORAL DISSERTATIONS DIRECTED:
Dat, NV; Tests for Time-Space Clustering of Disease, Chapel Hill, NC 1982, 96 pages.
Knuckles, BN; Strategies for Investigating Health Outcome Patterns and an Extension of Mantel's Generalized Regression Approach: Application to Homicide and Suicide Data, Chapel Hill, NC 1983, 201 pages.
Ingram, DD; A Test for Concordant Nonrandom Patterns among series with Epidemiologic Application, Chapel Hill, NC 1983, 120 pages.
Hwang, K; Exact Distributions of Extreme Value Statistics for Urn Models with Epidemiologic Applications, Stony Brook, NY 1996, 112 pages.
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Mancuso, J.; Exact Null Distributions of Runs Statistics in Occupancy Models, with Applications to Disease Clustering, Stony Brook, NY 1998, 72 pages.
SELECTED LECTURES/SEMINARS:
''Combinatorics and Physics: Polymer Configurations and Lattice Covering Problems,'' Dept of Mathematics, Wake Forest University, Winston Salem, NC, October 1973.
''Polymer Configurations,'' Depts of Mathematics and Physics, Virginia Polytechnic Institutes and State University, Blacksberg, VA, April 1974.
''Combinatorial Problems arising in the Health Sciences,'' Department of Biostatistics, School of Public Health, University of North Carolina, Chapel Hill, NC, March, 1976.
''Combinatorial Problem Arising in the Health Sciences,'' American Mathematical Society, Toronto, Canada, August 1976.
''Flow Rate Patterns for Personal Sampling Pumps'' (Presented at an Environmental Society Meeting in 1975).
''Models for Discrete Epidemiologic Processes with a View Toward Unification,'' Eastern North American Region of the Biometric Society, University of North Carolina at Chapel Hill, NC April 1977.
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''A Cluster Model and a New Characteristic of the Distribution of Infectious Hepatitis,'' ENAR and WNAR of the Biometric Society. San Diego, CA. August 1978.
(With B Hulka) ''Alternative Controls in an Endometrial Cancer/Estrogen Study'' (plenary paper), Society for Epidemiologic Research, New Haven, Connecticut, June 1979.
''The Epidemiology of Sarcoidosis,'' First UNC Symposium on Sarcoidosis: The Great Imitator, Chapel Hill, NC, September 20, 1980.
''Understanding Statistics: Minimal Requirements for Effective Reading of Research Papers and Journal Articles,'' North Carolina State Center for Health Statistics. October 1980.
''Review and Critique of the Hanford Radiation Study,'' Radiation Group, Dept. of Epidemiology, School of Public Health, University of North Carolina, Chapel Hill, NC. 1981.
(With Symons, MJ) ''Clustering of Rare Events,'' Eastern North American Region of the Biometric Society, Richmond, VA, March 1981. Abstract: Biometrics 37 (1981), p. 619.
''Analysis of Case-Control Study Data,'' National Cancer Institute, Bethesda, MD. 1981.
''Adjustment of Rates,'' North Carolina State Center for Health Statistics, 1982.
''Analysis of the Network of Contact among AIDS Patients,'' Continuing Medical Education Seminar. Dept. of Community and Preventive Medicine, School of Medicine, SUNY at Stony Brook, NY. December 1983.
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''Analysis of Disease Patterns,'' Division of Field Services, Centers for Disease Control, Atlanta, GA, March 1983.
''Experiences Using Probability as 'Evidence' in Public Health,'' Continuing Medical Education Seminar, Dept. of Community and Preventive Medicine, School of Medicine, SUNY at Stony Brook NY, September 1985.
''Combinatorial Expectation Methods,'' Meetings of the American Mathematical Society, Honolulu, Hawaii, March 1987.
''Early history of the AIDS Epidemic and AIDS Research'' (Presented to attorneys and pharmaceutical representatives for their information in their preparation for litigation.) San Francisco, Calif., July 1987.
''Combinatorial Moment Methods,'' SUNY at Stony Brook, Dept. of Applied Mathematics and Statistics, February 1988.
''Combinatorial Methods for Epidemic Patterns,'' Biostatistics and Operations Research, Cornell University, March 1988.
''Cancer Clustering,'' American Cancer Society at Brookhaven Memorial Medical Center, Dec. 1988.
Methods for Evaluating Cancer Clusters,'' Disease Clusters Symposium, Chapel Hill, NC, April 1989.
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''Patterns in Space-Time,'' Symposium on Applied Mathematics in Biology, SUNY at Stony Brook, May 1989.
''Assessment of Risk Trends and Patterns,'' National Center for Health Statistics, July 1989.
Three or more presentations per year since 1989.
SELECTED UNPUBLISHED REPORTS:
Grimson, RC; Association of Influenza with Congenital Tracheoesophageal Fistula and Oesophageal Atresia: An Analysis of Clusters, PHSB Studies (number 14), Public Health Statistics Branch, North Carolina Department of Human Resources, March 1979. 5 pages.
Morgenstern, H; Grimson, RC; Winn, DW; Sample Size Determination for CaseControl Studies; Institute of Statistics Mimeo Series No. 1290, June 1980, 14 pages.
Grimson, RC; DelCorso, D; Kennedy, DH; Rhodes, V; A Computer Program for the Analysis of Case-Control Studies (CASCNTRL); Institute of Statistics Mimeo Series No. 1315, November 1980, 43 pages.
Leininger, C; Wallenstein, S; Kiely, J; Paneth, N; Grimson, RC; Condition at Birth and Survival in a Population of Low Birthweight Infants. Prepared for the New York City Public Health Department and the Research Triangle Institute, NC. RTI Report, 1981.
Grimson, RC and DeNapoli, R; Maternal and Child Health, 1976–80, Vol. 1 and Vol. 2, Department of Human Resources, Raleigh, NC, March 1981.
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Grimson, RC; Recommendation and Procedures for the NTPR Radiation Dose Assignment Project. Prepared for JAYCOR for the Defense Nuclear Agency, January 1982, 27 pages.
Grimson, RC; Notes on the Plan of Apportionment of Risk for Lung Cancer Claimants Occupationally Exposed to Asbestos: The Section of the Report on Apportioning. Prepared for John-Manville Corporation, November 1984, 5 pages.
Bogdan, BF; Rand, P; Grimson, R; Wood, RB; Cates, R; Gallagher, K; Barker, ND; Spruce Budworm Spraying and Congenital Heart Defects, Maine, 1973–1982. Prepared for the State of Maine, 1985, 15 pages.
Grimson, RC and Wu, Suh-Yuh; Review and Analysis of Three Studies on the efficacies of Listerine Antiseptic. Prepared for the Bureau of Consumer Protection, Federal Trade Commission, June 1985, 29 pages.
Grimson, RC and Wu, Suh-Yuh; Analysis of the 50% Claims of Listerine Antiseptic. Prepared for the Bureau of Consumer Protection, Federal Trade Commission, October 1985, 46 pages.
With Beasley J, et al; Four annual progress reports and a final report for the W.K. Kellogg Foundation, Battle Creek, Michigan. Life Style in Health Promotion for Adolescents, 1984, 1985, 1986, 1987.
Grimson, RC; Epidemiologic Assessment of an Hypothesized Cancer Cluster Among Former Residents of the Irving O'Neill Residence Hall Complex. Prepared for SUNY at Stony Brook, NY, 1993, 37 pages.
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Grimson, RC; Disease Clusters in Structured Environments, 1994, 125 pages. Prepared for a short course held at the University of Vancouver, British Columbia.
Grimson, RC and Triche D; Evaluation of allegations of contamination and risk associated with the operation of Brookhaven National Laboratory, Part I: Epidemiology; a report to the Suffolk County Legislature, Jan. 26, 1998, 56 pages.
Mendelsohn, SL; Grimson, RC; Report of Findings of East Hampton School District Cancer Investigation, 1999.
Grimson, RC and O'Leary ES; Breast Cancer Results from the Survey of the South Fork Breast Health Coalition, April, 2000, 35 pages.
Several expert reports pertaining to litigation.
DISSERTATION:
Grimson, RC, Enumeration of Rectangular Arrays, Ph.D. Dissertation, Duke University, 1969.
PUBLICATIONS IN JOURNALS:
Grimson, RC, ''Some results on the enumeration of symmetric arrays,'' Duke Math Journal, 38 (1971), 711–715.
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Grimson, RC, ''The evaluation of certain arithmetic sums,'' The Fibonacci Quarterly, 12 (1974), 373–380.
Grimson, RC, ''The evaluation of a sum of Jacobsthal,'' Norske Videnskabers Selskabs Skrifter, 33 (1974), 373–380.
Grimson, RC, ''Enumeration of symmetric arrays with different row sums,'' Rendiconti Seminario Matematico dell Universite di Padova, 48 (1972), 105–112.
Grimson, RC, ''Formulas involving the greatest integer function and some applications,'' Delta, 3 (1973), 18–32.
Grimson, RC, ''Reciprocity theorem for Dedekind sums,'' American Mathematical Monthly, 81 (1974), 747–749.
Grimson, RC, Periodically alternating exponential series and related arithmetic generating functions, Simon Stevin, 47 (1974) 115–123.
Grimson, RC, ''The generating function for (min(n,. . .,nK) )M,'' Elemente Der Mathematik, 29 (1974).
Grimson, RC, ''Some partition generating functions,'' Proceedings of the Fourth Southeastern Conference on Combinatorics, Graph Theory and Computing, 1973, 299–308.
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Grimson, RC, ''Exact formulas for 2 × n arrays of dumb-bells,'' Journal of Mathematical Physics, 15 (1974), 214–216.
Grimson, RC, ''Enumeration of dimer (domino) configurations,'' Discrete Mathematics, 18 (1977), 167–177.
Grimson, RC, ''An exponential series and roots of unity,'' Simon Stevin, 47 (1976), 49–51.
Grimson, RC, ''A summation formula and some properties of Eulerian functions,'' Proceedings of the American Mathematical Society, 53 (1975), 290–292.
Grimson, RC, ''Some formulas that enumerate certain partitions and graphs,'' Capsopis Pest. Mat., 101 (1976), 321–326.
Grimson, RC, ''Combinatorial problems arising in the health sciences,'' Abstract, AMS Notices, Aug. 1976, p. A512.
Grimson, RC, ''Multiple series manipulation and generating functions,'' Canada Math. J., 20 (1977), 103–106.
Grimson, RC, ''The pig house problem or the detection and measurement of pairwise infectious processes,'' SIAM Review, 19 (1977), 727–731.
Grimson, RC, ''The clustering of disease,'' Mathematical Biosciences, 46 (1979), 257–278.
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Peiffer, RL; Gum, GG; Grimson, RC; Gelatt, KN; ''agueous humor outflow in beagles with inherited glaucoma: Constant Pressure Perfusion,'' American Journal of Veterinary Research, 41 (1980), 1808–1813.
Hulka, BS; Fowler, WC; Kaufman, DG; Grimson, RC; Greenberg, BG; Hogue, CRJ; Berger, GS; Pulliam, CC; ''Estrogen and endometrial Cancer: cases and two control groups from North Carolina,'' American Journal of Obstetrics and Gynecology, 112 (3), (1980), 376–387.
Hulka, BS; Grimson, RC; Kaufman, WC; Greenberg, BG; Hogue, CJR; ''Alternative controls in a case-control study of endometrial cancer and exo-genous estrogen.'' Presented before a meeting of the Society of Epidemiologic Research, New Haven, June, 1979, American Journal of Epidemiology, 112 (3), (1980), 376–387.
Hulka, BS; Kaufman, DG; Fowler, WC; Grimson, RC; Greenberg, BG; ''Pre-dominance of early endometrial cancers after long term estrogen use,'' Journal of the American Medical Association, 244 (21) (1980), 2419–2422.
Grimson, RC; Wang KC and Johnson, PWC; ''Searching for hierarchical clusters of diseases: spatial patterns of sudden infant death syndrome,'' Social Sciences and Medicine, 15 (1981), 287–293.
Grimson, RC and DalCorso, D; ''CASCNTRL—A PL/1 program for the analysis of case-control studies,'' The American Statistician, 35 (1981), 163–164.
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Grimson, RC and Chavigny, KH; ''A statistical test for classification with application to the characterization of pathogens according to antibiotic susceptibility patterns,'' Biometrics, 37 (1981), 753–761.
Ozimek, CD; Grimson, RC and Aylsworth, AS; ''A epidemiologic study of tracheoesophageal fistula and esophageal atresia in North Carolina,'' Teratology, 25 (1982), 53–59.
Grimson, RC; ''Standardized ratio for measuring the suddenness of events with applications to the four leading causes of violent deaths and to certain birth defects,'' Social Biology, 27 (1982), 286–293.
Symons, MJ; Grimson, RC, and Yuan, YC; ''Clustering of rare events,'' Biometrics, 37 (1983), 193–205.
Merritt, JC; Whitaker, R; Page, CJ; Peace, JH; Grimson, RC; Olsen, JL; Peiffer, RL; DeVanzo, R; ''Topical 8 tetrahydrocannabinol as a potential glaucoma agent,'' Glaucoma, 4 (1982), 253–255.
Schoenbach, VJ; Kaplan, BH; Wagner, EH; Grimson, RC; Miller, FT; ''Prevalence of self-reported depressive symptoms in young adolescents,'' American Journal of Public Health, 73 (1983), 1281–1287.
Grimson, RC; Soukup, J; Kammerman, LA; ''Statistical procedures for assignments of radiation doses to an unbadged individual in a group for which some individuals are badged,'' Health Physics, 45 (1983), 723–729.
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Broadhead, EW; Kaplan BH; James, SA; Wager, EH; Schoenbach, VJ; Grimson, RC; Heyden, S; Tibblin, G; Gehlbach, SH; ''The epidemiologic evidence for a relationship between social support and health,'' American Journal of Epidemiology, 73 (1983), 521–537.
Chavigny, KH; Grimson, RC; (4-page reviewed letter) comments on catalytic models in hospital epidemiology, Infection Control, 4 (1983), 431–434.
Merritt, JC; Whitaker, R; Grimson, RC; Olsen, JL; ''Vehicle effects after Topical Cannabinoids.'' Trans Asia-Pacific Acad Ophthalmol, 9 (1984), 207–212.
Grimson, RC and Quade, D; ''A simple test for equally likely random responses in a sequence of Bernoulli trials,'' Communication in Statistics, 13 (1984), 1063–1071.
Wagner, EH; James, JA; Beresford, SAA; Strogath, DS; Grimson, RG; Kleinbaum, DG; Williams, CA; Cutchin, LM; Ibrahim, MA; ''The Edgecombe County high blood pressure control program: 1. Correlates of uncontrolled hypertension at baseline,'' American Journal of Public Health, 74 (1984), 237–242.
Clark, LC; Graham, GF; Crounse, RG; Grimson, RC; Hulka, B; Shy, CM; ''plasma selenium and skin neoplasms: A case-control study,'' Nutrition and Cancer, 6 (1984), 13–21.
Adams, WH; Harper, JA; Rittmaster, RS; Grimson, RC; ''Pituitary tumors following fallout radiation exposure,'' Journal of the American Medical Association, 252 (1984), 664–666.
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Peoples, MD; Grimson, RC; Daughtry, GL; ''Evaluation of the effects of the North Carolina Improved Pregnancy Outcome Project: Implications for state-level decision-making,'' The American Journal of Public Health, 74 (1984), 549–554.
Sterman, AB; Coyle, PK; Panasci, DJ; Grimson, RC; ''Disseminated Abnormalities of Cardiovascular Autonomic Functions in Multiple Sclerosis,'' Neurology, 35 (1985), 1665–1668.
Hurewitz, AN; Sidhu, U; Bergofsky, EH; Leff, B; Averbuch, I; Grimson, R; Chanana, AD; ''Cardiovascular and respiratory consequences of tension pneumothorax,'' Bull. Eur. Physiopathol. Respir., 22 (1986), 545–549.
Grimson, RC; Groshen S; ''A statistical test for contact among individuals in an epidemic and a pattern among cases of acquired immune deficiency syndrome,'' Statistics in Medicine, 5 (1986), 271–279.
Merritt, JC; Ballard, DJ; Checkoway, H; Mower, P; Grimson, RC; ''Ocular sarcoidosis: A case-control study among black patients,'' Annals of the New York Academy of Sciences, 465 (1986), 619–624.
Lundy, J; Grimson, R; Mishriki, Y; Chao, S; Oravez, S; Fromowitz, F; Viola, MV; ''Elevated ras oncogene expression correlates with lymph node metastases in breast cancer patients,'' Journal of Clinical Oncology, 14 (1986), 1321–1325.
Cutaia, M; Friedrich, P; Grimson, R; Porcelli, RJ; ''Pregnancy- and gender-related changes in pulmonary vascular reactivity,'' Experimental Lung Research, 13 (1987), 343–357.
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Grimson, RC., ''Apportionment of risk among environmental exposures; application to asbestos exposure and cigarette smoking,'' Journal of Occupational Medicine, 29 (1987). No. 3, 253–255.
Weiser, B; Burger, H; Steimer, K; Lifson, J; Engleman, E; Grimson, R; Robinson, WS; ''Antibody to human immunodeficiency virus correlates with decreased T helper lymphocytes in asymptomatic individuals,'' Journal of Medical Virology, 22 (1987), 237–244.
Deysine, M; Grimson, R; Soroff, HS; ''Herniorrhaphy in the elderly,'' The American Journal of Surgery, 153 (1987), 387–391.
Fromowitz, FB; Viola, MV; Chav, S; Oravez, S; Mishriki, Y; Finkel, G; Grimson, RC; Lundy, J; ''ras p21 expression in the progression of breast cancer.'' Human Pathology, 18 (1987), 1268–1275.
Lozowski, MS; Mishriki, Y; Chao, S; Grimson, R; Pai, P; Harris, MA; Lundy, J; ''Estrogen receptor determination in fine needle aspirates of the breast. Correlation with histologic grade and comparison with biochemical analysis,'' Acta Cytologica, 31 (1987), 557–562.
Chylack, LT; Leske, MC; Sperduto, R; Khu, P; McCarthy, D; and the Lens Opacities Case-Control Study Group (Grimson, RC is a member); ''Lens opacities classification system,'' Arch Ophthalmol, 106 (1988), 330–334.
Leske, MC; Chylack, LT; Sperduto, R; Khu, P; Wu, S; McCarthy, D; and the Lens Opacities Case-Control Study Group (Grimson, RC is a member); ''Evaluation of a lens opacities classification system,'' Arch Ophthalmol, 106 (1988), 327–329.
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Burger, H; Paul, D; Siegal, FP; Wendel, I; Neff, S; Eilbott, D; Gehan, K; Grimson, R; Weiser, B; ''Comparison of antigen immunoassay and reverse transcriptase assay for monitoring human immunodeficiency virus infection in an antiviral trial,'' Journal of Clinical Microbiology, 26 (1988), 1890–1892.
Pullman, AL; Beveridge, I; Phillips, PH; Martin, RR; Barelds, A; Grimson, R; ''The effects on merino lambs of chronic infection with Trichostrongylus ragatus,'' Veterinary Parasitology, 32 (1989), 213–228.
Beveridge, I; Pullman, AL; Phillips, PH; Martin, RR; Barelds, A; Grimson, R; ''Comparison of the effects of infection with Trichostrongylus colubriformis, T. vitrinus and T. rugatus in merino lambs,'' Veterinary Parasitology, 32 (1989), 229–245.
Grimson, RC; ''Assessment of risk trends and pattern,'' Proceeding of the 1989 Public Health Conference on Records and Statistics, National Center for Health Statistics, Jan. 1990, 327–333.
Grimson, RC; A Book Review: The Architecture of Chance. An Introduction to the Logic and of Arithmetic Probability. The Quarterly Review of Biology, 65 (1990), 349.
Burger, H; Belman, A; Grimson, R; ''HIV-positive but not symptomatic,'' Nursing Times, 86 (1990).
Grimson, RC; ''Uncertainty,'' Year One, 2 (1990), Spring, 70–78.
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Burger, H; Belman, A; Grimson, RC; Kaill, A; Flaherty, K; Gulla, J; Weiser, B; ''Long HIV–1 incubation periods and dynamics of transmission within a family,'' The Lancet, 1990, 134–136.
Beasley, JD; Grimson, RC; Bicker, AA; Closson, WJ; Heusel, CA; Faust, FI; ''Follow-Up of a cohort of alcoholic patients through 12 months of comprehensive biobehavioral treatment,'' Journal of Substance Abuse and Treatment, 8 (1991), 133–141.
Grimson, RC; Rose, R; ''A versatile test for clustering and an analysis of sensory projection patterns,'' Methods of Information in Medicine, 30 (1991), 299–303.
Deysine, M; Grimson, RC; Soroff, HS; ''Inguinal herniorrhaphy,'' Archives of Surgery, 126 (1991), 628–630.
Bilfinger, TV; Moeller, JT; Kurusz, M; Grimson, RC; ''Anagnostopoulos CE. Pediatric myocardial protection in the United States: a survey of current clinical practice.'' Thoracic & Cardiovascular Surgeon, 40 (4) (1992), 214–8.
Grimson, RC; Aldrich, TE; Drane, JW; ''Clustering in sparse data and an analysis of rhabdomyosarcoma incidence,'' Statistics in Medicine, 11 (1992), 761–768.
Vlay, SC; Burger, L; Vlay, LC; Yen, O; Novotny, H; Grimson, RC; ''Prediction of sudden cardiac arrest: risk stratification by anomatic substrate,'' American Heart Journal, 126, (1993), 807–815.
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Grimson, RC; ''Disease clusters, exact distributions of maxima, and p-values,'' Statistics in Medicine, 12 (1993), 1773–1794.
Etzi, S; Lane, DS; Grimson, RC; ''The use of mammography vans by low-income women: the accuracy of self-reports,'' American Journal of Public Health, 84 (1994), 107–109.
Mead, DM; Hyman, L; Grimson, RC; Schein, OD; ''Primary graft failure: a case control analysis of a purported cluster,'' Cornea, 13 (1994), 310–316.
Weiser B; Nachman, S; Tropper, P; Kelly, KV; Grimson, R; Baxter, G; Guowei, F; Reyet, C; Hutcheon, N; Burger, H; ''Quantification of human immunodeficiency virus type 1 during pregnancy: relationship of viral titer to mother-to-child transmission and stability of viral load.'' Proceedings of the National Academy of Sciences, Medical Sciences, 91 (1994), 8037–8041.
Grimson, RC; ''Disease cluster test based on the maximum cell frequency,'' 1994 Proceedings of the Section on Epidemiology, American Statistical Association, (1995), 64–69.
Burgman, MA; Grimson, RC; Ferson, S; ''Inferring threat from scientific collections,'' Conservation Biology, 9 (1995), 923–928.
DeLisi, LE; Tew, W; Xie, S; Hoff, AL; Sakuma, M; Kushner, M; Lee, G; Shedlack, K; Smith, AM; Grimson, R; ''A prospective follow-up study of brain morphology and cognition in 1st episode schizophrenic patients: preliminary findings,'' Biological Psychiatry, 38 (1995), 349–360.
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Guowei, F; Weiser, B; Tropper, P; Nachman, S; Hawkins Viscosi, K; Moore, R; Grimson, R; Baxter, G; Sporysz, N; Melendez, M; Reyelt, C; Hutcheon, N; Baker, D; and Burger, H; ''Maternal HIV–1 Plasma RNA level determined by RT QC–PCR: A major determinant of mother-to-child HIV–1 transmission,'' Vaccines, 95 (1995), 189–194.
Caplan, LS; Lane, DS; Grimson, R; ''The use of cohort vs repeated cross-sectional sample survey data in monitoring changing breast cancer screening practices,'' Preventive Medicine, 24 (1995), 553–556.
Fang, G; Burger, H; Grimson, R; Tropper, P; Nachman, S; Mayers, D; Weislow, O; Moore, R; Reyelt, C; Hutcheon, N; Baker, D; Weiser, B; ''Maternal plasma human immunodeficiency virus type 1 RNA level: A determinant and projected threshold for mother-to-child transmission,'' Proceedings of the National Academy of Sciences, 92 (1995), 12100–12104.
Krupp, LB; Coyle, PK; Doscher, C; Miller, A; Cross, AH; Jandorf, L; Halper, J; Johnson, B; Morgante, L; Grimson, R; ''Fatigue therapy in multiple sclerosis: results of a double-blind, randomized parallel trial of amantadine, pemoline and placebo,'' Neurology, 45 (1995), 1956–1961.
Zucker, S; Lysik, RM; Dimassimo, Bl; Zarrabi, HM; Moll, UM; Grimson, R; Tickle, SP; Docherty, AJ; ''Plasma assay of Gelatinase B—tissue inhibitor of metalloproteinase complexes in cancer,'' Cancer, 76(4) (1995), 700–708.
Leske, MC; Connell, AMS; Wu, SY; Hyman, LG; Schachat, AP; Grimson, R; McManmon, EP; Cheung, H; Squicciarini, V; Babb, Y; Bradshaw, A; Bird, J; Griffith, V; Nurse H; Hall, JD; Selleck, C; Alexander, JA; Javornik, NB; et al ''Risk factors for open-angie glaucoma—the Barbados Eye Study,'' Archives of Ophthalmology, 113(7) (1995), 918–924.
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Lake-Bakaar, G and Grimson, R; ''Alcohol abuse and stage of HIV disease in intravenous drug abusers,'' Journal of the Royal Society of Medicine, 89 (1996), 389–392.
Grimson, RC and Oden, N; ''Disease clusters in structured environments,'' Statistics in Medicine, 15 (1996), 851–871.
Jacquez, GM; Waller, LA; Grimson, RC; Wartenberg, D; ''The analysis of disease clustering, Part I: State of the art,'' Infection Control and Hospital Epidemiology, 17 (1996), 319–327.
Jacquez, GM; Grimson, RC; Waller, LA; Wartenberg, D; ''The analysis of disease clustering, Part II: Introduction to techniques,'' Infection Control and Hospital Epidemiology, 27 (1996), 85–9.
Oden, N; Jacquez, G; Grimson, R; ''Realistic power simulations compare point- and area-based disease cluster tests,'' Statistics in Medicine, 15 (1996), 783–806.
Lane, DS; Caplan, LS; Grimson, R; ''Trends in mammography use and their relation to physician and other factors,'' Cancer Detection & Prevention, 20 (1996), 332–41.
Burger, H; Kovacs, A; Weiser, B; Grimson, R; Nachman, S; Tropper, P; van Bennekum, AM; Elie, MC; and Blaner, WS; ''Maternal serum vitamin A levels are not associated with mother-to-child transmission of HIV–1 in the United States,'' Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, 14 (1997), 321–326.
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Fang, G; Siegal, FP; Weiser, B; Grimson, R; Anastos, K; Back, S; Burger, H; ''Measurement of human immunodeficiency virus (HIV) type 1 RNA load distinguishes progressive infection from nonprogressive HIV–1 infection in men and women,'' Clinical Infectious Diseases, 25 (1997), 332–3.
Froom, J; Trilling, S; Yeb,SS; Gomolin, IH; Filkin, AM; and Grimson, R; ''Withdrawal of antihypertensive medications,'' JABFP, 10 (1997), 249–258.
DeLisi, LE; Sakuma, M; Tew, W; Kushner, M; Hoff, AL; and Grimson, R; ''Schizophrenia as a chronic active brain process: a study of progressive brain structural change subsequent to the onset of schizophrenia,'' Psychiatry Research, 74 (1997), 129–140.
Slanetz, CA and Grimson, R; ''Effect of high and intermediate ligation on survival and recurrence rates following curative resection of colorectal cancer,'' Diseases of the Colon and Rectum, 40 (1997), 1205–1219.
Diot, P; Palmer,. LB; Smaldone, A; DeCelie-German, J; Grimson, R; and Smaldone, GC; ''RhDNase 1 aerosol deposition and related factors in cystic fibrosis,'' Am J Respir Crit Care Med, 156 (1997), 1662–1668.
Belman, AL; Reynolds, L; Preston, T; Postels, D; Grimson, R; and Coyle, PK; ''Cerebrospinal fluid findings in children with Lyme disease-associated facial nerve palsy,'' Arch Pediatr Adolesc Med, 151 (1997), 1227–1228.
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Wu, Suh-Yuh; Leske, MC; ''Associations with intraocular pressure in the Barbados Eye Study,'' Arch Ophthalmol, 115 (1997), 1572–1576.
Leske, MC; Wu, Suh-Yuh; Connell, AMS; Hyman, L; Schachat, A.P; ''Lens opacities, demographic factors and nutritional supplements in the Barbardos Eye Study,'' International Journal of Epidemiology, 26 (1997), 1314–1322.
Trilling, JS; Froom, J; Gomolin, IH; Yeh, S-S; Grimson, RC; and Nevin, S; ''Hypertension in nursing home patients,'' Journal of Human Hypertension, 12 (1998), 117–121.
Bond, P; Grimson R; ''A note on the 1997 Santa Susana (Rocketdyne) Report,'' HPS Newsletter, 26 No. 10 (1998), 19–21.
Philpott, S; Burger, H; Charbonneau, T; Grimson, R; Vermund, SH; Visosky, A; Nachman, S; Kovacs, A; Tropper, P; Frey, H; and Weiser, B; ''CCR–5 genotype and resistance to vertical transmission of HIV–1,'' Journal of Acquired Immune Deficiency Syndromes, 21 (1999), 189–193.
Schoenfeld ER, Henderson K, O'Leary E, Grimson R, Kaune W, Leske MC; ''Magnetic field exposure assessment—a comparison of various methods,'' Bioelectromagnetics, 20 (1999), 487–496.
Grimson, RC and DeLisi, LE; ''Quantitative assessments of change over time: application to brain MRI studies,'' submitted.
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Zucker, S; Mian, N; Drews, M; Conner, C; Davidson, A; Miller, F; Birembaut, P; Nawrocki, B; Docherty, AJP; Greenwald, RA; Grimson, R; and Barland, P; ''Increased serum stromelysin-1 levels in systemic lupus erythematosus: lack of correlation with disease activity,'' submitted.
Grimson, RC; Mendelsohn, S; ''A method for detecting current temporal clusters of toxic events through data monitoring by poison control centers,'' Journal of Toxicology-Clinical Toxicology, 38 (2000), 759–763.
Messina, CR; Lane, DS; Grimson, R; ''Effectiveness of education and counseling interventions to improve breast cancer screening utilization among women who underuse mammography,'' submitted.
Grimson, RC; O'Leary, ES; Kaune, W; ''Geometric statistics for left censored magnetic field exposure data: adjustments and limitations,'' submitted.
Lane, DS; Messina, CR; Grimson, R; ''An educational approach to improving physician breast cancer screening practices and counseling skills,'' Patient Education and Counseling, 1432 (2000), 1–13.
Krupp, L; Hyman, L; Grimson, R, Coyle, P, Melville, P, Ahnn, S, Dattwyler, R, Chandler, B, and the STOP–LD Study Group, ''Study and treatment of fatigue and post Lyme Disease (STOP–LD): a randomized double masked clinical trial,'' submitted.
Lau, R; Grimson, R; Sansome, C; Tornos, C; and Moll, UM; ''Low levels of cell cycle inhibitor p27kip1 combined with high levels of Ki-67 predict shortened disease-free survival in T1 and T2 invasive breast carcinomas,'' International Journal of Oncology, to appear.
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Anderson, J; Hubbard, P; Alpern, Z; Grimson, R; Ells, PF; Messina, C; Brand, D; ''Wine: Protective against colorectal neoplasia or surrogate of healthy lifestyle?'' submitted.
Grimson, RC; Mancuso, JP; Kornheiser, L; Hyman, LG; Krupp, LB; ''An exact scan-type test for temporal clustering of rare adverse events in clinical trials,'' submitted.
Grimson, RC; Mancuso, JP; Mendelsohn, S; ''A scan-type test for rare events: application in an epidemiologic investigation of Hodgkin's disease,'' submitted.
Wu, CC; Grimson, RC; ''Exact moments of maxima for occupancy models,'' submitted.
Kalish, R; Wood, J; Golde, W; Dattwyler, R; Bernard, R; Davis, L; Grimson, RC; Coyle, P; Luft, B; ''Human T–Cell response to Borrelia Burgdorferi infection: No correlation between Human LFA–1 Peptide response and disease,'' submitted.
PUBLICATIONS IN BOOKS:
Grimson, RC; Darrow, WW; ''Association between acquired immune deficiency syndrome and sexual contact: An analysis of the incidence pattern,'' in Chapter 13 of Infectious Complications of Neoplastic Disease (eds. Brown, AE and Armstrong, D). Yorke Medical Books, New York, NY 1985: 221–227.
Grimson, RC; Discussion on the analysis of the AIDS epidemic in Chapter 13 of Infectious Complications of Neoplastic Disease (eds. Brown, AE and Armstrong, D). Yorke Medical Books. New York, NY 1985: 262–265.
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EDITORSHIPS:
Guest Co-Editor. Vol 12, number 19/20. Statistics in Medicine (Oct. 1993) Wiley. (Workshop on statistics and computing in disease clustering.)
Guest Co-Editor. Vol 15, number 7/8/9. Statistics in Medicine (May 1996) Wiley. (Workshop on statistics and computing in disease clustering.)
LETTERS:
Hulka, BS; Grimson, RG; Greenberg, BG; ''Endometrial Cancer and Detection Bias,'' The Lancet, Oct. 10, 1981, P. 187.
Grimson, RC; ''The 'Poppers' hypothesis,'' American Journal of Epidemiology, 1990, 198–199.
Guowei, F; Siegel, FP; Weiser, B; Grimson, RC; Anastos, K; Back, S; and Burger, H; ''Measurements of human immunodeficiency Virus (HIV) Type 1 RNA load distinguishes progressive infection from nonprogressive HIV–1 infection in men and women,'' Clinical Infectious Diseases, 25 (1997), 332–333.
Hulton, MB; Grimson, R; ''Factor V leiden, prothrombin 20210 gene variant, and risk of myocardial infarction,'' Circulation, 99 (1999), 457–458.
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Grimson, R; ''Cancer rates accessed,'' TIME magazine, Feb. 8, 1999, Page 11.
ABSTRACTS:
''Combinatorial Problem Arising in the Health Sciences,'' Notices of the American Mathematical Society, 23 (1976) p. A–512.
Grimson, RC; ''Models for Discrete Epidemiologic Processes with a View Toward Unification,'' Biometrics, 33 (1977) p.579.
Grimson, RC; ''A Cluster Model and a New Characteristic of the Distribution of Infectious Hepatitis,'' Biometrics, 34 (1978), p. 725.
(With B Hulka) ''Alternative Controls in an Endometrial Cancer/Estrogen Study,'' (plenary paper), American Journal of Epidemiology, 110 (1979), p. 373.
(With Symons, MJ) ''Clustering of Rare Events,'' Biometrics, 37 (1981), p. 619.
DeLisi, LE; Grimson, R; Kushner, M; Lee, G; Sakuma, M; Gao, T; and Kantawala, K; ''Is there progressive brain change following a first hospitalization for schizophrenia? A 4-year follow-up study,'' 11 (1994), 135–136. (Journal unknown).
Trilling, JS; Froom, J; Gomalin, IH; Yeh, SS; Filkin, AM; Grimson, RC; and Nevin, S; ''Hypertension in nursing home patients,'' American Journal of Hypertension, 10 (1997), 207A.
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80226e.eps
Mr. GRUCCI. For purposes of the next introduction, I will yield to my colleague and friend, Steve Israel.
Mr. ISRAEL. Thank you, chairman. Several months ago a distinguished scientific journal accelerated publication of an article about, as I said before, patterns of protein and blood serum reflecting the early presence of ovarian cancer. I brought Mr. Levine to Washington to push for passage of a bill I introduced called Save America's Women From Ovarian Cancer Act, and asked, if we could use that technology to find early diagnosis of ovarian cancer, can we use it to potentially find early diagnosis of breast cancer.
He is here to answer that question. He is co-founder and CEO of Correlogic Systems, Incorporated, a bioinformatics company engaged in the development of bioinformatic tools and processes for proteomic and genomic based clinical diagnostic systems and new drug discovery. Mr. Levine is co-inventor of the technology and processes utilized in the recent ovarian cancer test study published in The Lancet, of which he was co-author.
I am proud Mr. Levine has been able to join us on Long Island today. Mr. Levine?
STATEMENT OF PETER J. LEVINE, CO-FOUNDER, PRESIDENT AND CEO OF CORRELOGIC SYSTEMS, INCORPORATED
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Mr. LEVINE. Thank you very much, Congressman Grucci and Congressman Israel, and thank you for the kind words.
I am pleased to be here this morning and I thank the Subcommittee for holding this hearing and keeping attention focused on the special concerns of cancer on Long Island. Again, I want to thank Congressman Israel for his support of new cancer technologies and working to ensure they are available to the public.
On a personal note, I grew up in Huntington a few short miles from here and I had first-hand knowledge of this disease and its effect on families and on the Island overall. It is a special honor this morning to be testifying and to contribute in any small way I can to the work of the subcommittee.
I would like to explain to the committee the new technologies the Congressman was referring to that we believe can assist in the fight against breast cancer. I will keep my comments brief. My written testimony provides a fuller explanation of the technology and possible applications.
With that as a brief introduction, let me turn to a Power Point presentation which I will also keep limited.
Congressman Israel referred to a Lancet study published in February 2002. In collaboration with the FDI and NCI, Correlogic Systems conducted a study on ovarian cancer using our technology. What we found in the study was really quite startling. Of course, it resulted in a lot of publicity and a lot of interest in what we do.
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Fundamentally, what we are doing is looking at what we call invisible patterns in complex data streams that characterize biological states. Put another way, the proteins that flow through all our bodies—there are tens and tens of thousands—it makes the human genome look like a rather simple configuration. Our approach was to look at these patterns of proteins within blood and see whether or not there were subtle patterns that could distinguish between cancer and non-cancer.
We found that we could. What we have done is to begin with two groups of patients, one where we knew they had cancer, and one where we knew that they didn't. By analyzing the sera—the liquid from the blood—through a mass spectrometer, we were able to come up with 15,200 data points per patient, an indirect measure of some of the proteins in the blood.
Then, through a rather complicated process, we created what we call ''computational models.'' These are not 3–D models, though what you are seeing on the screen in position 3 are three-dimensional depictions of what we found. Essentially what we are looking at are actually five-dimensional models, which are not possible to reveal on a two-dimensional surface like this.
What we are looking at is whether or not there are features within these 15,200 data points which can distinguish those individuals with cancer from those without.
What we discovered was that we could. In step 3, what we found for ovarian cancer was that there was one model that could distinguish all the ovarian cancer patients. There were four different models that all the normals or unaffected patients fell into. Biologically that made sense. What you had for breakfast in the morning, coffee or orange juice, will affect the proteins in your body. But there is something about in this case ovarian cancer, which was so distinct, a very subtle pattern was created.
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What we did for the Lancet study was look at 116 women who were blinded to us. We had no idea of what the medical condition was. We went through the same process. The individual at the bottom of the screen—first patient goes through, small sample is taken, it goes onto a protein chip, it is analyzed. Out comes from the 15,200 data points. It is analyzed again and then the model is compared to the original model, we are able to diagnose the patients.
What turned out was that when we did this—let me back up. This gives you some idea of the complexity. If you are looking for five features, in the case of ovarian cancer what we had was five features out of the 15,200 that distinguish what actually created the model. Mathematically that is 15,200 to the fifth power, which gives you a rather large number. I am not sure whether that is a gazillion or what the number is. 28 zeros following 2.113.
That is the number of possible combinations you would have from 15,200 data points if you are looking for five features that will distinguish them. If you took all the computing power on earth, it would still be a million year task.
Our technology essentially addressed that issue to come up with the bottom part of the analysis. What we found, what was reported in The Lancet was that looking at the 116 blinded samples, we detected 100 percent of all the cancers. Of course, that included 100 percent of all the stage one cancers.
What is so significant about that, and I think has application to breast cancer is, this is at a stage where the cancer is organ confined. So, clearly what this is indicating is that there are changes happening systemically through the system, through the patient's system that can be detected very early. As Congressman Israel indicated, if you can detect it in stage one, survival rates are 95 percent.
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We were very pleased with these results. The NCI and FDA, our partners in doing the work, are very, very pleased. We are now beginning to move into what will be the pre-clinical trials and eventually clinical trials sometime this fall to further validate that this approach to cancer detection can work over a large number of patients.
This has importance for Long Island and importance for breast cancer. We are initiating similar work on breast cancer and while results are very, very preliminary, in fact only been done through nipple aspirants, we are seeing a similar pattern. That is to say, we can detect in an early stage that there are biological changes.
In closing, I would like to note that we believe the same technology, which is to look at very, very subtle patterns in protein expression, can also be applied to the very specific issue of what is going on on Long Island. Through the assistance of Congressman Israel, we have been introduced to a number of the researchers and institutions on Long Island that are doing this work and we believe we can begin to do some work with them to advance the causes of the concerns the committee is addressing this morning.
With that brief overview, let me end on that point and take questions when we are done with the other presentations.
Mr. GRUCCI. Thank you, Mr. Levine.
[The prepared statement of Peter J. Levine follows:]
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PREPARED STATEMENT OF PETER J. LEVINE
Introduction
My name is Peter J. Levine. I am President of Correlogic Systems, Inc., a bioinformatics company that has developed a promising new technology for the early detection of cancer and other diseases.
Before I begin to discuss the work Correlogic is doing, I would like to thank the Chairman, Congressman Grucci and the Subcommittee for the important work they are doing on the critical issue of the high incidence of breast cancer in Port Jefferson, New York and elsewhere in Nassau and Suffolk Counties. I grew up nearby in Huntington, New York, and I know from my own personal experiences how cancer can impact the lives of the people of this area.
I would like to thank Congressman Israel, for his leadership in support of cancer research and his ongoing efforts to ensure Medicare and other insurance coverage of effective technologies. In particular, his bill, H. Con. Res. 385, now with 134 cosponsors, is a dramatic demonstration of congressional support for this research and for the availability and accessibility of diagnostic testing.
Major Developments in the Early Detection of Cancer
Today, I want to tell the Subcommittee about new technologies for the early detection of cancer. While these technologies have not been used to explore possible causes for the high breast cancer rates in this region, these technologies will address, in the very near future, the critical issue of early detection. This technology can be used to help identify the possible causes.
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I am testifying this morning in my capacity as the President of Correlogic Systems, Inc., a bioinformatics company that has developed scientifically validated methodologies for the early detection of various cancers through the use of high throughput bioassays and pattern discovery software. The technologies we have developed have a wide variety of applications for the creation of diagnostic ''models,'' biomarker discovery, disease detection and new drug discovery processes.
In the 1990's new ''protein separation'' technologies—devices that measure the molecular weight and intensity of the proteins in a patient's blood (sera)—became available. Researchers had identified individual proteins from sera for many years. The new technologies provided researchers with unprecedented volumes of data about the proteins in sera. But, standing alone, the new technologies provided limited information. Now, presented with as many as 20,000 individual data points from a single drop of blood, researchers still continued to look for specific, individual proteins that might serve as a biomarker.
A New Approach
Correlogic, in cooperation with the FDA and NCI Clinical Proteomics Program, developed a patent-pending process entitled ''A Process for Discriminating between Biological States Based on Hidden Patterns from Biological Data.'' The central premise of the invention is that subtle patterns of proteins, rather than individual biomarkers, can be analyzed to detect disease at the earliest and most treatable stage. For example, rather than looking for the increased presence of a single protein like PSA for prostate cancer, or CA–125 for ovarian cancer, our technology evaluates thousands of proteins simultaneously to identify subtle changes that reflect the health of the patient.
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A New Technology
However, this concept—looking at the composition of the haystacks rather than looking for the needle in the haystack—required a higher order of analysis than was available when we initiated our research.
In the spring of 2000, Correlogic's Chief Scientist, Dr. Ben Hitt invented an algorithm, ''A Heuristic Method of Classification,'' also known as the Knowledge Discovery EngineTM. With this algorithm, Correlogic built an analytical software system designed to validate the concept that patterns of proteins can be used for the early detection of disease.
Working with Dr. Emanuel Petricoin of the FDA and Dr. Lance Liotta of the NCI, and using sera from prostate cancer patients, we concluded that it was possible to make a diagnostic assessment based upon patterns of proteins. We then extended the concept to research on ovarian and breast cancers as well as other disease states.
The Results
In February 2002, the results of our work with the FDA and the NCI on the early detection of ovarian cancer were ''fast-track'' published in the British medical journal, the Lancet (see Appendix A). I have included a copy of this article for the record. The reported results were remarkable. From a single drop of blood, we were able to detect 100 percent of the patients with cancer—including all Stage 1 cancers, when treatment is most effective.
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While the results were exciting on a number of levels, the fact that 100 percent of all Stage 1 cancers were identified is particularly important because women diagnosed in Stage 1 have a five-year survival rate of 95 percent. The five-year survival rate for late-stage diagnosis is 25 percent. Currently, nearly two-thirds of women diagnosed with ovarian cancer over the age of 50 are detected in that late stage. Clearly, early detection and treatment equal survival.
The Process
How exactly did we obtain the results reported in the Lancet, and can they be applied to other disease states, including breast cancer? The attached diagram (Appendix B) provides an overview of the process.
We started by taking a small blood sample from each patient from two defined groups: Group 1, in yellow on the slide, are patients with clinically diagnosed ovarian cancer; and, Group 2, in blue on the slide, a mixture of patients unaffected by ovarian cancer, some with other gynecological conditions such as ovarian cysts, and others ''normal.''
The blood from each patient is spun to separate the serum from the blood cells. The serum is then placed on a chip that attracts and binds certain categories of proteins. The chip is then placed into a mass spectrometer, and a laser is used to ionize the proteins on the chip. The proteins and/or protein fragments fly down a vacuum tube, and their time of flight is measured, yielding the molecular weight and intensity of the proteins and/or protein fragment. The result of this process is 15,200 data points per patient.
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The next step is to find a pattern within each of the 15,200 data points per patient that will effectively and consistently distinguish the cancer patients from the unaffected patients. This was not a simple task. In fact, it is a nearly impossible task.
For ovarian cancer, we found that five features out of the 15,200 formed a pattern, or ''model'' that would separate the cancer patients from the unaffected. What this means is that we had to explore 15,200=—or approximately 8,113,000,000,000,000,000,000—possible combinations to find a model that worked. If all of the conventional computing power on the Earth were applied to this task, it would take millions of years to sort through. Our program, Proteome QuestTM (Appendix B, Step 2), accomplished this task in a far more manageable time frame, and created two diagnostic models: one of ovarian cancer patients and one of healthy patients.
In Appendix B, Step 3, and in Appendix C, we show a three-dimensional representation of the diagnostic ''models'' as taken from the actual ovarian cancer data. It is important to note that this is simply a representation. The pattern discovery and pattern matching that is at the heart of the process is not a visual matching. Rather, the diagnostic ''model'' is a computational model that exists in ''N'' dimensional space. For ovarian cancer, it is a five-dimensional model.
At this point in the process—the creation the diagnostic model—we had ''trained'' Proteome QuestTM. We then repeated the process on 116 blinded samples. That is, samples from patients whose condition was unknown to us. This was the testing, or validation of the diagnostic model. Each patient's protein patterns were compared to the diagnostic model created during the training process (See Appendix B, Step 4).
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The results, as noted earlier, were that we correctly identified all of the patients with cancer, 50 of 50, including 18 patients in Stage 1, the organ confined stage. We had 3 false positives out of 66, resulting in an overall positive predictive value of 94.3 percent (See Appendix D). The most widely used biomarker for ovarian cancer CA–125, has a positive predictive value of less than 10 percent as a single marker and about 20 percent with the addition of trans-vaginal ultrasound.
We are currently developing standard operating procedures and clinical trial protocols in preparation for clinical trials for the ovarian cancer test. We expect to commence these trials with the FDA and NCI in the coming months.
Beyond Ovarian Cancer
Can this approach to early detection be applied to other cancers? I am pleased to report that the answer is yes.
Our original work was on prostate cancer. We obtained similar results, and these results are pending publication.
We have also begun our exploration of breast cancer. Our preliminary results, which are not yet published, but appear in our patent application, used nipple aspirants. The results are promising, but much work needs to be done.
Under the terms of our Cooperative Research and Development Agreement (CRADA) with the FDA/NCI Clinical Proteomics Program, we will be focusing our attention on the development of early diagnostic tests for ovarian, prostate and breast cancer. We will also examine the application of the technology to pancreatic, colon, lung and other cancers.
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The Connection to Long Island
We are currently talking with a number of Long Island institutions about their participation in the trials and other research efforts, and we are encouraged by their interest in participating.
Approximately 300 Long Island women are diagnosed with ovarian cancer each year. There is a significant connection between the incidence of breast cancer and ovarian cancer. According to the National Breast Cancer Coalition, women who have had breast cancer before the age of 50 are twice as likely to develop ovarian cancer. So our work on ovarian cancer may be of particular interest to Long Island women.
As I described, our work on breast cancer, is underway.
Correlogic's technology has many applications. In addition to early detection, it may also be used to guide researchers seeking the causes of increased cancer incidences on Long Island. Studying women with breast cancer on Long Island, the technology may be used to determine whether there are unique patterns in the protein expressions among these individuals. With that information, we may be able to better determine if the higher rate of cancer has a cause specific to Long Island.
Conclusion
When our study was published in the Lancet in February, Correlogic and our colleagues at the FDA/NCI Clinical Proteomics Program received a great deal of attention from the press, the scientific and business communities. News about the new technology also struck a cord with the general public. Their heart-felt outpourings for more information on this new technology is a reflection of the hunger that people have for good news in the area of cancer research.
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The implications for public health are far reaching—from a single drop of blood, we may be able to determine the entire state of a person's health, reducing the need for unnecessary biopsies and surgery on one hand, and initiating treatment earlier when a disease is present.
I would again like to thank Congressman Israel, for his leadership in support of cancer research and his ongoing efforts to ensure Medicare and other insurance coverage of effective technologies. I also want to thank Congressman Grucci for focusing attention on the critical issue of the cancer ''hot spots'' here on Long Island. As we continue our research in cancer and other disease states, we will make every effort possible—consistent with good science—to see these tests through the clinical trial process quickly. To that end, we appreciate the Congressional support we've received to date to make these technologies available to the public as soon as possible.
Thank you again for the opportunity to present the results of our research to the Subcommittee.
Correlogic Systems, Inc.
Proteome Pattern Blood Test—Development Chronology
An Idea is Born (June 1999)
During a social brunch, Peter J. Levine (now President of Correlogic Systems), Inc., and Dr. Emanuel F. Petricoin of the Food and Drug Administration (FDA), engage in a brainstorming session about Petricoin's search for protein biomarkers for cancer. The discussion leads to the radical idea that will join the seemingly disparate work they are both doing Drawing on his experience in computer-generated data analysis, originally developed in connection with civil rights litigation, Levine suggests the use of pattern discovery technology to detect patterns of proteins rather than individual protein biomarkers. They literally sketch on a napkin the prospect of using powerful algorithms to search within the huge volume of data generated by new protein separation equipment for patterns of proteins in the blood.
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Refining the Idea (July 1999–May 2000)
Dr. Ben Hitt (now the Chief Scientific Officer of Correlogic Systems, Inc.), refines the concept and develops a powerful algorithm to test the theory that ''hidden'' patterns of proteins could be analyzed to detect early stage disease. In May 2000, using blood (sera) from prostate cancer patients, Hitt, Petricoin and Levine conclude that this algorithm makes it possible to make a diagnostic assessment based upon patterns of proteins. Extension of this approach to research on ovarian and breast cancers as well as other disease states is initiated.
Correlogic Systems, Inc. Founded (May 2000)
Levine and Hitt found Correlogic Systems, Inc. to further develop the technologies regarding the identification and use of ''hidden'' protein patterns as a diagnostic tool. The company also enters into a Material Transfer Agreement with the FDA to continue its research.
Patent Applications Filed (June 2000–July 2001)
Correlogic files a provisional patent application on the core algorithm used in the company's research work. Hitt is named as the inventor of the technology, referred to as the Knowledge Discovery EngineTM. In July 2000, Correlogic files the first of several provisional patent applications on a ''Process for Discriminating Between Biological States Based Upon Hidden Patterns From Biological Data'' and names Hitt, Levine and Petricoin as co-inventors. The filing process for the patents is completed in July 2001. Dr. Lance Liotta, Chief of Pathology of the National Cancer Institute is added as a co-inventor of the ''hidden patterns'' patent application.
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The Lancet Fast-Track Publishes Ovarian Cancer Study (February 2002)
The Lancet ''fast track'' publishes results of a groundbreaking study utilizing Correlogic's techniques and technology, which showed that ovarian cancer can be detected from a single drop of blood, even in Stage One when the cancer is organ confined and most curable. The study demonstrates that the test can find 100 percent of the patients with cancer. Co-authors of the study are Hitt, Levine, Liotta, Petricoin and others.
Formal Research Agreement Signed with FDA/NCI (April 2002)
Correlogic and the FDA/NCI Clinical Proteomics Program enter into a Cooperative Research and Development Agreement (CRADA). Work under the CRADA will further validate and expand the joint research that has begun on the early detection of ovarian, prostate, breast, and other cancers and will investigate application of the same technique to drug toxicity, drug metabolism, prion diseases and viral agents.
Exclusive License Agreement (April 2002)
To move the technology from the research lab into the hands of health care providers as soon as possible, Correlogic signs an exclusive, worldwide licensing agreement with NIH (on behalf of the FDA and NCI) for the shared ''hidden patterns'' invention. The license provides for the commercialization of the intellectual property rights associated with the use of patterns of molecular expression as a diagnostic tool. The license also provides for sub-licensing, joint venture and other business arrangements with various organizations and, importantly, will facilitate the rapid commercialization of the technology and development of clinical diagnostic tests.
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Clinical Trials Scheduled (for August 2002)
The FDA/NCI and Correlogic will begin clinical trials of the ovarian cancer detection test in August 2002.
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BIOGRAPHY FOR PETER J. LEVINE
Peter Levine is co-founder and CEO of Correlogic Systems, Inc., a Bethesda, MD-based bioinformatics company engaged in the development of bioinformatic tools and processes for proteomic and genomic-based clinical diagnostic systems and new drug discovery. Levine conceived the idea of looking at patterns of proteins in human blood to detect diseases rather than individual biomarkers as had traditionally been the approach to disease detection. Together with Dr. Ben Hitt, a leader in pattern discovery technologies, he founded Correlogic to pursue this diagnostic approach.
Prior to founding Correlogic in 2000, Levine was an attorney and entrepreneur. A common denominator in his experience is finding patterns in large amounts of data. His past experience also includes work with multinationals on technology transfer issues, the creation of market entry strategies for consumer and capital goods and international business development and licensing of software and pharmaceuticals.
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Levine began his career as a government trial attorney where he created and used some of the first complex computer databases to evaluate data ''patterns'' and present computer-generated evidence in litigation. He worked for the Departments of Justice, and Health Education and Welfare, as well as the Office of the U.S. Attorney in Washington, DC.
In 1978, Levine was appointed General Counsel of the U.S. Senate Subcommittee on Intergovernmental Relations, serving under Senator Jim Sasser until 1981. He then entered private practice, and specialized in intellectual property and computer software-related matters, providing him with a strong background in technology and business development. Clients included several start-up software firms in the Washington, DC area.
Levine left the practice of law to begin TransNational, an international trade and investment consulting company with offices around the world. At TransNational, Levine pursued business opportunities in various foreign markets, including computer software and technology licensing in Japan; the licensing and sale of pharmaceutical and consumer products in Argentina; and the sale of industrial products in Western Europe and Japan. He also advised companies and government agencies such as Mitsubishi, the Japanese Ministry of International Trade and Industry, the Japan External Trade Organization, Pharmavite/Otsuka Pharmaceutical, Laboratorios Bernabo and Finadiet, Ivax Corporation, 3M Corporation, and the U.S. Department of Commerce.
Levine earned his J.D. from the New England School of Law, and a B.A. in political science from Fairleigh Dickinson University, in New Jersey, in 1969. Levine lives in Potomac, Maryland with his wife, Annette Fribourg.
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Mr. GRUCCI. Final panelist is Dr. Nancy Kim. She is Associate Professor of Risk Assessment, whose research interests include toxicology evaluation, exposure assessment, risk assessment and structural activity correlations. Dr. Kim has a Ph.D. In chemistry from Northwestern University.
Welcome, Doctor. Thank you for being here.
STATEMENT OF DR. NANCY KIM, ASSOCIATE PROFESSOR OF RISK ASSESSMENT; DIRECTOR, DIVISION OF ENVIRONMENTAL HEALTH ASSESSMENT, NEW YORK STATE DEPARTMENT OF HEALTH
Dr. KIM. Thank you for having us. The Health Department is pleased to be able to participate in this hearing today.
The Department has thought about the question you raised in your hearing title for many years. One of the ways this concern is being addressed is through the Department's cancer surveillance improvement initiative.
In April 1998, we started this initiative to help answer people's questions about cancer in their community. As part of the project, scientists were asked to relate cancer occurrence in relation to geographic location. Since that time, breast, lung, colorectal and prostate cancer have been mapped.
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The maps are based on cancer incidence observed in zip codes throughout the state. That was then compared to the expected number of cancer cases, a calculation that assumes the people in each zip code would get cancer as people everywhere in the state, taking age into account. When the number of cases are compared to what would be expected, some communities were found to have a higher incidence than what would be due to chance alone. The Coram, Mount Sinai, Port Jefferson region was one of the areas.
You ask questions about breast cancer incidence in this area and also Long Island. The three zip codes that include Port Jefferson Station, Mount Sinai and Coram in Suffolk County were identified as having 50 percent more breast cancer cases than would be expected. Based on patterns in the rest of the state about 146 breast cancers would be expected for an area with this population over a five-year time period from '93 to '97. Instead, 219 were diagnosed, a difference probably not due to chance.
We have determined that the high rate of breast cancer in this area is probably not due to increased cancer detection rates or higher proportion or seasonal or part-time residents in the area. Other areas of the state also have breast cancer rates as high as this area. Because of the small number of cases in these areas, however, the increases may have been due to random year to year fluctuations.
Breast cancer incidence rates on Long Island are ten to fifteen percent higher than New York State and the nation as a whole. Several counties in New York State also have similar breast cancer rates. It does not appear that Long Island is unique in its breast cancer rates.
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What do we know about possible causes for the high rates observed on Long Island? Scientists do not know all the risk factors for breast cancer. The strongest risk factors is increasing age. Breast cancer is also related to female hormones. Women who have their first menstruation at early age or experience menopause at later age have a higher risk. Having a first child at a younger age and having more children decreases the risk.
Many studies found higher rates in areas with higher socio-economic status. This is probably due to the relationship between higher socio-economic status and child birth patterns. Women who go to college and graduate professional school tend to wait longer to have first baby and have fewer children. Since these factors influence the risk, areas with very well-educated and professional women tend to have higher breast cancer rates. While not all women in this area fit the profile, the relatively higher proportion of women with these risk factors in areas such as this may contribute to the higher breast cancer rates.
The fact is, however, less than 50 percent of breast cancers can be explained by known risk factors. Thus, it is clear more research is needed to learn what other factors may be involved in causing breast cancer.
In our cancer surveillance project, when areas of unusual disease patterns emerge, a follow-up investigation is initiated. Investigation follows five steps, though in any one investigation all five steps may not be undertaken.
At this particular point in our process of the investigation we are in step three. At this step in the process we seek information from the community and local government. That is what happened on June 5th at the library in Port Jefferson Station where more than 600 people came, primarily from the seven zip code areas. Some came to learn about the project and what we know so far and many offered ideas about possible historic or exposures concerned. We are now analyzing data to determine if residents could have been exposed to unusual types or levels of environmental factors. We are reviewing the scientific literature on risk factors for breast cancer.
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Once we complete this step, we will determine what further action should be taken, additional environmental or epidemiological study may be needed. We will determine if we have enough information as to exposure and enough people to participate in a study.
Is a full environmental study of the area warranted? At our step in the process we don't know the answer yet and are just beginning to evaluate the information we obtained a few weeks ago. We will be providing a status report in December as to where we are in that process.
As mentioned previously, more research is needed to completely understand why women get breast cancer and how we can prevent the burden of this disease on women. Several projects including Dr. Kovach's, Long Island study of the National Cancer Institute, those funded by New York State will contribute to our knowledge. Projects differ in their design and purpose and together include epidemiological, environmental and mechanistic considerations. No one study can answer every question, but by scientists continuing to cooperate, we should be able to make significant strides in understanding and preventing breast cancer.
I will try to answer any of your questions. Thank you for the opportunity.
Mr. GRUCCI. Thank you, Doctor.
[The prepared statement of Nancy Kim follows:]
PREPARED STATEMENT OF NANCY KIM
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Good morning. My name is Nancy Kim, and I am the Director of the Division of Environmental Health Assessment in the New York State Department of Health. The Department has been engaged for many years in thinking about the very question you raise in your hearing title. One of the ways this concern is being addressed is through the Department's Cancer Surveillance Improvement Initiative. This is a cross-functional activity in the Department, and I am part of a much larger team. Today I will present information about the team's efforts thus far on this very important project.
In April 1998, the New York State Department of Health started the Cancer Surveillance Improvement Initiative to help answer people's questions about cancer in their community. As part of the project, DOH scientists were asked to illustrate cancer occurrence in relation to geographic locations in New York. Since that time, four types of cancer—breast, lung, colorectal and prostate—have been mapped at the ZIP code level of detail. The maps are based on cancer incidence, or the number of newly diagnosed cancer cases ''observed'' in ZIP codes throughout the state. Cancer incidence was then compared to the ''expected'' number of cancer cases, a calculation that assumes the people in each ZIP code would get cancer at the same rate as people everywhere in the state, taking age into account. When researchers studied the number of breast cancer cases and compared them to what would be expected, some communities were found to have a higher incidence than what would be expected due to chance alone. The Coram/Mt. Sinai/Port Jefferson Station region was one of these areas.
What do we know about the incidence of breast cancer in Port Jefferson, New York, and the surrounding region? And, how high or unusual is the rate of breast cancer on Long Island compared with other parts of the Nation?
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The three ZIP code areas that include Port Jefferson Station, Mount Sinai, and Coram in Suffolk County were identified as having 50 percent more breast cancer cases than would be expected.
Based on the breast cancer patterns in the rest of New York State, about 146 breast cancers would be expected for an area with this population over the five-year time period from 1993 to 1997. Instead, 219 breast cancers were diagnosed, a difference that is probably not due to chance.
The New York State Department of Health is examining the breast cancer patterns in this area as well as the surrounding area. In addition to Port Jefferson Station, Mt. Sinai, and Coram, the ZIP code areas included in the investigation are East Setauket, Miller Place, Port Jefferson and Sound Beach.
Epidemiologists at the New York State Department of Health have determined that the higher rate of breast cancer in this area is probably not due to increased cancer detection rates or a higher proportion of seasonal or part-time residents in the area.
Other areas of the state were also observed to have breast cancer rates as high as the Port Jefferson Station, Mount Sinai, and Coram area. Because of the small number of cancers in these other areas, however, the increases may have been due to random, year to year fluctuations.
The breast cancer incidence rates on Long Island are 10 to 15 percent higher than New York State and the Nation as a whole. The breast cancer mortality rates on Long Island are five to eight percent higher than New York State, and 15 to 19 percent higher than the Nation as a whole.
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Several other counties in New York State, including Rockland, Monroe and Richmond Counties, also have breast cancer rates that are 10 to 15 percent higher than the state as a whole.
It does not appear that Long Island is unique in its breast cancer rates. Connecticut, Massachusetts and New Jersey also have higher breast cancer incidence rates than New York. In general, the highest breast cancer death rates are found in the Northeastern U.S. and California. The two states with the highest breast cancer death rates are Delaware and New Jersey. New York is third.
What do we know about the possible causes for the high breast cancer rates observed on Long Island?
Scientists do not know all the risk factors for breast cancer.
The strongest risk factor for breast cancer is increasing age. Almost 50 percent of breast cancers occur among women age 65 years and older. About 2 percent occur among women younger than 35 years of age. This pattern is also true for Long Island.
Breast cancer is related to female hormones. Women who have their first menstruation at an early age or who experience menopause at a later age have a higher risk. Having your first child at a younger age, and having more children, decreases the risk of breast cancer.
Other risk factors for breast cancer are low physical activity, being overweight, increased breast density, alcohol intake and exposure to ionizing radiation.
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Having a mother, sister or daughter who has had breast cancer may indicate that a woman is at higher risk. Also, women who have had a previous breast cancer are at higher risk of developing breast cancer again.
Many studies have found higher breast cancer rates in areas with higher socioeconomic status. This is probably due to the relationship between higher socioeconomic status and childbirth patterns. Women who go to college and graduate or professional school tend to wait longer to have their first baby. They also tend to have fewer children. Since these factors increase the risk of breast cancer, areas with many well-educated and professional women tend to have higher breast cancer rates.
Other factors, such as diet, may contribute to the higher risk among women with higher socioeconomic status.
While obviously not all women in the Port Jefferson Station, Mount Sinai, and Coram area fit this profile, the relatively higher proportion of women with these risk factors in areas such as this may contribute to the higher breast cancer rates.
The fact is, however, less than 50 percent of breast cancers can be explained by the risk factors I've mentioned. More research is needed about why women get breast cancer.
Since these risk factors might explain only a sub-set of breast cancer cases, it is clear that more research is needed to learn what other factors might also be involved in causing breast cancer.
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In this project, when areas of unusual disease patterns emerge from the mapping process, a follow-up investigation is initiated. This investigation involves a five-step process, and helps determine whether follow-up studies may be indicated. In any one investigation, all five steps may not be undertaken. The process is designed so that the information gathered during each step can be used at various decision points to determine the need for further activity. In short, the steps are as follows:
Step 1: We select the areas for investigation and refine the boundaries. This is why the investigation area for Port Jefferson included seven ZIP codes, since we create a contiguous grouping of elevated areas and in doing so, may include some areas that are not as elevated.
Step 2: Then we examine some of the factors that might explain the increase in disease occurrence and I have just presented those findings to you. We also complete an initial environmental inventory of the area's air, water and soil. We did this for the Coram/Mt. Sinai/Port Jefferson Station Area. The inventory included hazardous waste sites, major oil storage facilities, hazardous waste generators, toxic emission sources, air emission sources, wastewater discharges, pesticide use, golf courses, spill incidents, fish consumption advisories and drinking water quality. We also looked at sources of information about chemical concentrations in air and groundwater. DOH concluded that the available information about potential sources of environmental exposure justified proceeding with Step 3 of the process.
Step 3: Although the data for environmental sources are in many ways more comprehensive and accessible than in the past, they are still limited and are least complete for historical sources of exposure. Since the latency period for cancer can be as much as 40 years, it is important to understand what kinds of exposures people faced years ago that may be contributing to the cancer diagnoses of today. Therefore, at this step in the process, DOH seeks information from the community and local government. That is what happened on June 5th, at the Comsewogue Library in Port Jefferson Station, with more than 600 people coming from primarily the seven ZIP code area. Some came to learn about the project and what we knew so far and many offered ideas about possible historical or current exposures of concern. We are now reviewing and analyzing the data on potential exposures, including the information that we obtained that day, to determine if residents could possibly have been exposed to unusual types or levels of environmental factors. We are also reviewing the scientific literature on possible environmental risk factors for breast cancer.
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A decision is made at the end of this step on how to proceed with the investigation, based on environmental exposures and risk factor information. If no relevant environmental risk factors are identified in this geographical area or portions of the area, the area will not proceed to step four; however, the Department will consider other possible risk factors that may be contributing to the breast cancer burden in an area.
Step 4: Once the investigation has proceeded to this point, the Department will determine what further actions should be taken. Additional environmental and epidemiologic studies may be needed. During this step, scientists will see if we have enough information about exposures and enough people available to participate in a study. Then, a determination will be made whether a study is feasible. In answer to the question, ''does the cancer mapping data warrant a full environmental study of the area,'' the answer is we do not know yet, and we are just beginning to evaluate the information we obtained a few weeks ago. We will provide a status report in December.
Step 5: Should this final step be indicated, we will request community participation, develop a study protocol and conduct the study. At the conclusion of the follow-up investigation (and at whatever step the process ends), we would prepare a report of our findings and share it with members of the community.
I hope this explanation of activities and current status of the Cancer Mapping Improvement Initiative has been helpful. A number of materials have been developed about the cancer mapping project and can be found on the State Health Department's website. General information about the project may be accessed at http://www.health.state.ny.us/nysdoh/cancer/csii/nyscsii.htms and specific information about the Coram/Mt. Sinai/Port Jefferson Station investigation may be found under ''Follow-up activities.'' Hard copies of this material may also be obtained by calling our toll-free Environmental Health Infoline at 1–800–458–1158.
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As mentioned previously, more research is needed to completely understand why women get breast cancer and how we can prevent the burden this disease has on women. Several breast cancer projects, including Dr. Kovach's, the Long Island study of the National Cancer Institute, and those funded by New York State through the Health Research Science Board, will be contributing to our knowledge. These projects differ in their design and purpose and together include epidemiologic, environmental and mechanistic considerations. No one study can answer every question; but, by scientists continuing to cooperate and consider advances in all these areas, we should be able to make significant strides in understanding and preventing breast cancer. I will try to answer any question you might have. Thank you.
Discussion
Mr. GRUCCI. At this time, the procedure is that members of the panel will be asked a series of questions and then we will move to our second panel. At the conclusion of our second panel, if anybody with us today has any questions or any statements they would like to make, I would be very interested in hearing that and we will make that part of the record as well.
Contributing Factors to Breast Cancer Incidence Rates
Let me start off by asking Dr. Kovach, Dr. Kim and Dr. Grimson their opinion on this issue.
In your testimony you indicated that we know very little about what causes breast cancer and we know the serious effects of it most assuredly.
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One of the things that I have learned from being on the Science Committee and being in the front of my TV watching the weather reports, if you look at the wind patterns as they blow across our country, they blow from west to east. If you look at the Gulf Stream, it moves from south to north. In fact, it literally swirls around the southern part of Long Island as Long Island sticks out into the ocean.
With what is going on in other parts of the country, other parts of the world, understanding that the Gulf Stream really circulates the globe and ultimately makes its way back to us again, could there be any correlation in what is happening—taken from a winds perspective first—what is happening in the Midwest and in the far west is becoming airborne and migrating across our country, depositing itself in our region and what may be happening to our oceans is finding its way up through the Gulf Stream currents and making its way toward our shores; Long Island acting as a barrier sticking out into the ocean would certainly capture whatever is coming up through the Gulf Stream.
Could that be a contributing factor to what is causing a high level of breast cancer?
The last part of the question is, what can we do as a Federal Government to help you all in the research in trying to find the cure or at least the cause?
Dr. Kovach?
Dr. KOVACH. I can start off. I think it is a very interesting question. I must say I haven't thought about the unique environmental situation of Long Island with respect to the Gulf Stream and the winds. That is something to consider.
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We need to figure out what it is that is driving this process. I am more focused really in thinking about how we are going to get a clue to what it is that may be brought by the wind or the currents or what is in our food supply that might contribute to breast cancer. There are approaches that are now possible if you have the material.
Let me take one minute to amplify. Several years ago, my colleague and Steve Sommers, molecular biology, genetics at Mayo Clinic, sequenced a gene commonly altered in breast cancer from different groups throughout the world. What we published and the conclusion led us to was there was this marked variation, a kind of genetic damage in this particular gene associated with all kinds of cancers depending on where you live.
We know that cancers are diseases of altered genes. By having material, the breast cancers, having the blood sample and doing genetic analysis, you can begin to get a signature of what the offending agent might be from the molecular damage of the gene. In some cases that signature actually suggests what the offending agent is. A way to work backward, rather than try to fish the environment, as Dr. Grimson pointed out, of all the things that could be there.
While I am not trying to avoid the specific question, there are ways to at least get some idea of what agents are damaging our genes by careful analysis. Signature of pollutants can be detected. Some can measure pollutants themselves.
Dr. GRIMSON. It is an interesting question. The weather patterns, Gulf Stream currents and air currents are a part of the environment. As I indicated, the environment is a very complex thing and different components may work together to cause breast cancer. I think that though there are other places in the country that have high rates also, small communities—I know Marin County, California has for a long time had a relatively high rate of breast cancer, too.
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But based on your question, I am going to go back and look to see if, in general, there is a west to east trend. The only thing I can say is that it seems to be to be kind of spotty, not really indicating that there are lower rates in one part of the country that increase to a different part of the country, but rather the pattern bounces around.
Mr. GRUCCI. The reason why I asked that question is, in some of the hearings we have had on the Science Committee where the issue of breast cancer was the subject of the hearing, there were maps indicating a higher concentration of breast cancer was happening in the northeast. I am not suggesting that I found the cure for it, by any means, but when you look at those things it kind of became pretty clear to me that something is happening in the northeast that is not happening elsewhere in the country.
We have already determined that acid rain has been able to be traced back to what was happening out in the Midwest, depositing itself on our forests in the Adirondacks causing them to have some decaying effect. I thought there might be a correlation between what was happening with all that and here.
Dr. GRIMSON. You are right, the mortality rates, which is the number of deaths for 100,000 women, are the highest in the northeast. As I mentioned, they are very high on Long Island as a sub-cluster of the northeast.
The incidence rates, which is the number of new cases per year, that pattern may be less clear. What is interesting or what would be an interesting project is to determine why mortality rates can have one pattern but incidence rates may diverge from that a little bit. The answers aren't clear yet, but that is an interesting observation.
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Mr. GRUCCI. Dr. Kim, would you care to comment?
Dr. KIM. It is a difficult and interesting question. One of the things we will be looking at in the next stage of our investigation is to look at air pollution levels, air contaminant levels so we will have the opportunity to look at what data are available. Many of those data are collected by DEC in conjunction with the environmental protection agency and look at what we know in this area versus other parts of the state. Perhaps we can tie in information about California and other areas in the western part of the country in terms of our comparison. That is something we will be looking at.
Mr. GRUCCI. Thank you. Mr. Levine, do you have any comment on that or thought?
Mr. LEVINE. Actually, I do. The work we have done, as I mentioned, is in the area of proteomics, a little further downstream, but I believe it is probably an application for the technology. We can be comparing, for example, women with breast cancer from this area with women with breast cancer from other regions in the country. We may be able to find there are different proteomic patterns which would then say whether or not what is going on here is different than what is happening elsewhere, as well as using the same technology for looking for more subtle patterns than normally found typically used in large studies.
Mr. GRUCCI. Thank you. I yield now to my colleague, Mr. Israel.
Mapping Studies: The Role of the Federal Government
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Mr. ISRAEL. Thank you, gentlemen. I want to commend to the subcommittee and to our guests this study that was conducted by the Huntington Breast Cancer Action Coalition several years ago. I was a member of the Huntington Town Board when this was conducted and it was conducted with the cooperation of the Town of Huntington and with our tax receiver. It was intended to ascertain breast cancer prevalences and clusters throughout the Town of Huntington. The study was done over many years, but yearly done as a local initiative, supported by a local town with the help of a geographic information system company.
My question to each of the panelists is, what should the Federal Government be doing in order to spearhead and support more of these studies. This should not be confined to the Town of Huntington. I know it has not been. Other towns and geographic areas have engaged in these kind of environmental cluster studies.
First, are these studies useful in mapping the potential environmental correlations with breast cancer? If they are, what should the Federal Government be doing in order to support more frequent and ongoing effective studies?
We will start with Dr. Kovach.
Dr. KOVACH. Again, I am going to emphasize the fact that the United States has rates in some cases four to five times higher than other countries around the world and when women live in New York or Los Angeles their rates go up three or four times. We are looking at something that may be locally increasing our already extremely high rate. Something is wrong in the country overall with the high rate of breast cancer where others come from outside the country, live in this country and rates go up extraordinarily.
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These clues may be very important, the hot spots as Congressman Israel points out. What is needed is to make the link between elements in the environment and disease. It sounds almost trite to say that, but it is possible now with the kinds of things Mr. Levine has mentioned, by doing genetic analysis on the tissue, on the blood, to begin to relate and look for specific agents in these hot spots. Are they different from other areas? They are important clues. We have to go to the next level with expensive, careful studies of getting the information, defining it, letting our best scientists examine it.
They are important, but creating the database, the material for scientists to study is the single-most important and difficult thing to do.
Dr. GRIMSON. This map and other maps that have been created by coalitions going back to the early 1990's—I think Lorraine Pace initiated these maps and they are still continuing. They have served a very good purpose in terms of bringing to attention the importance of breast cancer problems on Long Island.
The maps are based on a brief questionnaire which are derived to identify patterns in time and space, geographic, temporal patterns to see if there are clusters. But the maps are not—and the questionnaires behind getting the maps do not really delve into individual exposures, maybe briefly in some instances, but they are not very person specific as far as exposures go.
What is really needed now, I think, as I mentioned and as Dr. Kovach has mentioned, is a deeper kind of study, a long-range prospective study, studies that involve genetics and environment and demographic patterns of movement. Very, very detailed, much more detailed than community maps can provide.
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I think we are at that stage now where a great effort has to be made. I think breast cancer is a much more complex disease than many other kinds of diseases. Lung cancer and smoking, other kinds of cancer seem to have more—I am a little out of my element here—but seem to have a little more specificity to the causes than breast cancer. Breast cancer seems to be, in my mind, a result of a very complex kind of interaction that requires these detailed databases.
These maps have served a good purpose. If communities want to do studies on their own, I would not discourage it. I would encourage them to receive as much scientific help and assistance as possible and have them make sure that the objectives are well defined and that the ultimate outcomes are well defined.
Dr. KIM. The question of disease clusters is something that is a community concern in many areas throughout the state whether it be breast cancer or other diseases. That was one of the reasons we undertook to see whether or not we could identify clusters rather than waiting for people to try and identify it themselves.
However, it is very difficult to tie exposure, either environmental or occupational, to disease end point. Even with occupational exposures where exposure levels are frequently higher than they are than in environmental, it is very difficult to carry out these studies to be able to find an association between an exposure and a disease end point.
I agree that these studies that have been undertaken by citizen groups have focused attention on issues and in that way have provided some valuable information.
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Mr. LEVINE. When I look at that map, I, of course, see all the dots indicating the cancer, but what I want to see are the normals. One of the biggest problems that we face in the work we are doing is not to find patients who have been diagnosed with a disease, but to get the citizens who do not have the disease to volunteer to give their blood—their sera—to a doctor with permission that it be used in a study. I look at that map and I want to see 2,000 women from that area who do not have breast cancer. I want to be able to compare their sera to those women who do have breast cancer. That, to me, is one of the issues that really needs to be addressed.
I think Dr. Kovach mentioned this earlier. If we can have greater citizen participation in these studies overall, we can build up an enormous data bank with individual personal histories, we can begin to determine where the problems lie.
Mr. ISRAEL. In fact, this map does show frequency of breast cancer. If people have never had it or been diagnosed, it is reflected in this. If there is a way, Mr. Chairman, for us to somehow reduce this and make it part of the Committee record, I am sure it will be helpful.(see footnote 2)
Mr. GRUCCI. We will make sure that gets done.
Mr. ISRAEL. Thank you.
Mr. GRUCCI. We will take a five-minute recess and then get ready for the second panel.
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Needed Resources: The Role of the Federal Government
One of the questions I think we are interested in hearing an answer to—and I suspect that this will be a far easier question than the more difficult question as what is causing this and why we haven't found cures—is, what do you think is going to be needed in the form of resources from the Federal Government to be able to continue to do the research, to be able to continue to do the mapping, to be able to take what has been done in Huntington, Brookhaven and other places and compile that so we can get a real overview of what is happening on Long Island? Dr. Kovach?
Dr. KOVACH. I will start and defer to the epidemiologists. In discussions with them, I am focused on getting blood tissue, tissue sample and samples maintained and stored properly from patients with the disease. We also need control patients. In fact, we turn to epidemiologists and they tell me the best would be to have a population-based database, something that is really random. Say in Suffolk County, say five percent of the entire population, 75,000 people, and on top of that, be able to select disease affected cases.
It sounds like a lot, but, in fact, the cost—maybe $20 million. A big number but it could be a national resource if done carefully and we have the momentum to do that here.
It doesn't take so much money to do it. Suffolk County or Long Island is a perfect spot to do such a thing, where resources can be put together. The people are interested. The political force is here and the scientific expertise is here.
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Mr. GRUCCI. Thank you.
Dr. GRIMSON. I will again mention a type of design that I think is very ambitious. The idea would be to look at the best way that we could solve the breast cancer environmental problem. That would be to, ideally, follow a large group of women from a very early age throughout a lifetime, a large enough group so you would have enough breast cancer cases develop that can be studied.
Along the way, this temporal trend, one would periodically collect information about exposures, very detailed information about their surroundings, their home, yard, their vacation places, their occupation. Many, many details.
Such a process would be very, very expensive. I can't even put a dollar figure on it.
Along with that, genetic information would be obtained and other personal habits of women and all that would be obtained.
Such studies have been done. There is a so-called Framingham study in Massachusetts that has been going on many years that follows a community over a period of time. A study like that has a chance of catching complex environmental interactions that can cause breast cancers. It is a very refined approach.
The question is, what can we do? How can we have a study that is kind of like that maximize, get all the benefits from it? Maybe it doesn't have to be as ambitious, but start from there and work back to a reasonable approach to see what we can do to follow women and find out what the causes of breast cancer are.
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Mr. GRUCCI. Thank you, Doctor.
Dr. KOVACH. I am sorry. I have to jump in. That is exactly what I am talking about, a population database with long-term follow, like the nurse's study, the Framingham study. You have to follow with time. It won't only be breast cancer that can be a focus. As you are studying, people will come with other diseases and give information to that. You are really studying all chronic diseases as they develop.
Mr. GRUCCI. Dr. Kim? A comment?
Dr. KIM. You stated this question might be easier. I am not so sure it was easier than the other questions.
Mr. GRUCCI. Usually when you ask people how much money they want, it is usually a lot easier to get an answer.
Dr. KIM. I think what you have heard from the previous speakers are some good ideas. What you also heard today is that you need people from a variety of disciplines to work on these problems. Not just one approach, I think, alone is going to solve all these problems.
The concepts of having good cancer incidence data, the concept of being able to follow populations over time, the concept of being able to bring in people with expertise in epidemiology and genetics are the kinds of people you have to bring together to be able to solve some of these questions. What you learn now from the ongoing NCI study on Long Island, what you can learn about how the Framingham study has succeeded and failed, those kinds of things should be looked at and used to decide where we should go next.
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Mr. LEVINE. I echo Dr. Kim's comment. From my perspective in the private sector, it is a matter of coordination, a matter of institutions at the Federal, State, and local levels working together.
One of the greatest impediments we face is getting qualified samples. Many institutions, understandably, view their databases of collected sera as being more valuable than gold. So if we can find a way to, in fact, both make use of the existing data that we have to analyze that as well as setting up additional future prospective collection, I think that is very important.
I would say the coordination between the Federal, State and local as well as the private sector. I think what Correlogic has done is a good example of that: This is a three-way relationship between the FDA, NCI, and one small private sector company, that came up with the ovarian cancer test. I think that is an area that needs to be explored further.
Mr. GRUCCI. Thank you. It seems like while money is certainly an issue and will be required, that does not seem to be the driving issue. It seems to me from what I glean from your testimony, that it is more of a sharing of information, gathering everything that is already out there, trying to assimilate the groups and then move forward from there, which at that point you will be able to determine what the costs are going to be. That is an interesting concept.
Just to highlight the daunting challenge that lies in front of people like this esteemed panel, one of the things that I saw, and it really shocked me when I saw it at one of our Science Committee hearings, was, again, that nationwide map that was put out about where high levels of cancer was determined.
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You would think a place like the Nevada desert, where great research was done in nuclear energy and nuclear weaponry: above ground detonations were done, subterranean detonations were done. You would expect to see a higher level of mortality rates and higher level of cancer in those areas.
Our region, the northeast region, per capita had a significantly higher rate of cancer and specifically breast cancer than in those areas where we did, such great research and, perhaps, put a lot of radiation in the air at a time when we didn't understand it completely and the ramifications it had.
So while the challenge that lies in front of these fine folks and others around the country is a very daunting challenge, I think that the answer to finding the cure is probably not a single answer, but a combination of answers. And I don't think it is very far out there in front of us. I think it is just a matter of cutting through the haze so we can get to see more clearly the correlation of all these things. That is why I found your answers to be very interesting about it: It is not necessarily the money, it is the information, that may already exist, that could help us speed up the process.
I thank you all for being here. We are going to take a quick five-minute recess and reconvene.
[Recess.]
Panel II
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Mr. GRUCCI. Before we get underway with our next panel I would like to introduce a couple of other people joining us here today. Dr. Norman Edelman, Vice President of the Health Science Center for the School of Medicine at Stony Brook. Dr. Edelman, thank you for being with us. Thank you for your outstanding work in this field and the research and commitment that Stony Brook is making. I think we have one of the foremost institutions right here in our community doing such ground breaking work in the research field.
Dr. Edelman, would you identify yourself? Thank you.
Mr. GRUCCI. Our second panel, we will hear from people who have been in the field trying to do all that they can to help find a cure for this dreaded disease. Our first speaker, Ms. Gail Frankel is field coordinator and advocate from the National Breast Cancer Coalition. Ms. Frankel, is a breast cancer survivor and has been a breast cancer consumer advocate for the past seven years. She currently volunteers at the Adelphi NY Statewide Breast Cancer Hotline and Support Program. Thank you for being with us. We look forward to your testimony.
STATEMENT OF GAIL FRANKEL, FIELD COORDINATOR AND ADVOCATE FROM THE NATIONAL BREAST CANCER COALITION
Ms. FRANKEL. Good morning. My name is Gail Frankel and I am a resident of Brookhaven Township on Long Island nearly 40 years. I was diagnosed with breast cancer in 1993 and have been a survivor advocate volunteer since 1995.
I would like to thank this committee for holding this hearing and I would especially like to thank you, my representative, Congressman Grucci, for supporting breast cancer initiatives in Congress as well as on Long Island. Thank you to all the Committee Members for inviting me here today to testify.
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In two weeks I mark my ninth year as a survivor. I certainly don't celebrate because who celebrates a nightmare? However, after two years I got my head together and for the past seven years, after being thoroughly trained for the work, I have been a telephone hotline volunteer with the Adelphi New York State Hotline Breast Cancer Support Program.
Thanks to Project Lead, an incentive science program offered by NBCC, I have a rudimentary understanding of molecular biology and epidemiology. In no way, however, am I a biologist or epidemiologist. My forthcoming testimony will be that of a survivor/advocate.
Having spoken to thousands of women on the hotline in the past seven years, I would like to tell you what concerns most women in New York State. Women and men call the Adelphi hotline when newly diagnosed, wanting to know about their disease, treatment options and support. People call asking about where they can get low cost mammography. They call with concerns about buying homes next to high tension wires. They call wondering if they should buy bottled water. In essence, after questions of a personal nature, questions most asked concern the cause of breast cancer and the safety of the environment.
I can tell you that a disproportionate number of our calls coming from women newly diagnosed as well as seasoned survivors with recurrences or metastatic disease come from Long Island. This despite the fact the Adelphi hotline is a New York Statewide agency, well publicized by our assemblymen and senators in the state and despite the fact we have a 1-800 telephone number. I believe this speaks to the fact that the incidence of breast cancer is higher on Long Island than in other parts of New York State.
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My experience with the National Breast Cancer Coalition, of which I am but one of 70,000 individual members nationwide tells me that breast cancer is a concern not limited to Long Island.
Women across the Nation, those living with breast cancer, those not yet diagnosed and those who will never be diagnosed want to know why. What caused this epidemic? What can they do to survive? There is no conclusive evidence about what causes the disease, but it is generally believed that the environment has some link.
Much of what has been learned from the human genome project is very useful, but more investigation is needed into how and what in our environment causes genes to turn on and off and ultimately cause cells to malfunction. We are anticipating an announcement of the results of the Long Island Breast Cancer Study Project this summer. Previous results could not match any specific carcinogen in the environment with breast cancer. Perhaps the new release will. But so far no smoking gun has been found. Many of us feel that the environment is to blame, but which part or what combination? We don't know.
In the 1930's, there was a potato blight on Long Island. Potatoes were our most important crop on the majority of farms here. In response, DDT was sprayed and sprayed and sprayed. Through the 1950's DDT was sprayed. The chemical didn't dissipate. It settled on the soil, it seeped into the water table, it was breathed in by our mothers, eaten in the potatoes they ate when we baby boomers were in utero. We ask, could this be the problem? Is it more? Is it a combination? What combination?
The high incidence of breast cancer on Long Island is the tip of the iceberg. The Long Island Breast Cancer Study Project was the first step toward finding an answer. But now it is time to focus our attention and public resources on developing an overall strategy to look at all aspects of environmental impact on the development of breast cancer, an all-encompassing strategy somewhat like the president's Department of Homeland Defense proposal.
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The Bipartisan Breast Cancer and Environmental Research Act mentioned by Congressman Israel outlines such a plan. The legislation recommends $30 million a year for five years to be authorized to allow the National Institutes for Environmental Health Sciences to create grants to develop and operate research centers to study environmental factors that may be related to the development of breast cancer.
Under a peer review grant-making process, the NIEHS director could award grants to up to eight centers across the nation for the purpose of conducting research on the links between breast cancer and the environment.
The legislation would require each center to be a collaborative effort of various institutions and personnel. As I understand it, an example of such a consortium might be research scientists working with clinical oncologists working with companies and men like Peter Levine, as well as patient advocates all from the same community and geographic areas where the research is being conducted.
They would be looking at the strategy from different perspectives and pooling their resources.
I am aware that this is a unique approach, but a complex problem calls for out-of-the-box thinking. I appreciate that Congressman Grucci and Congressman Israel and other members of the committee had the courage and vision to support this innovative approach. Thank you again for giving me the opportunity to testify today and I would be happy to respond to any questions.
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Mr. GRUCCI. Thank you, Ms. Frankel.
[The prepared statement of Gail Frankel follows:]
PREPARED STATEMENT OF GAIL FRANKEL
Good morning. My name is Gail Frankel and I've been a resident of Brookhaven Township on Long Island for nearly forty years. I was diagnosed with breast cancer in 1993 and have been a survivor/advocate volunteer since 1995.
I would like to thank this committee for holding this hearing and I would like to thank my Representative, Congressman Grucci for supporting breast cancer initiatives in Congress and on Long Island. Thank you to all the committee members for inviting me here to testify today.
I am a nine year survivor of breast cancer and for the past seven years, after being thoroughly trained for the work, I have been a telephone hotline volunteer with the Adelphi NY Statewide Breast Cancer Hotline and Support Program. I am also the Long Island Field Coordinator for the National Breast Cancer Coalition. Thanks to Project LEAD, an intensive science program offered by the National Breast Cancer Coalition, I have a rudimentary understanding of molecular biology and epidemiology. (In no way, however, am I a biologist or an epidemiologist.) My forthcoming testimony will be that of a survivor/advocate.
Having spoken to thousands of women on the hotline over the past seven years, I would like to share the breast cancer concerns most women in New York State have. Women and men, call the Adelphi Hotline when they are newly diagnosed wanting to know more about their disease, treatment options and support programs. People call asking about where to get a low cost mammography, with concerns about buying homes close to high tension wires, wondering if they should buy bottled water. In essence after questions of a personal nature, the questions most asked concern the cause of breast cancer and the safety of the environment. I can tell you that a disproportionate number of our calls from women newly diagnosed, as well as seasoned survivors with recurrences and/or metastatic disease come from Long Island. This, despite the fact that Adelphi Hotline is a New York Statewide agency , well publicized by our State Assemblymen and Senators, and despite the fact that we have an 800 telephone number. I believe this speaks to the fact that the incidence of breast cancer is higher on LI than other parts of New York State. My experience with the National Breast Cancer Coalition, of which I am but one of 70,000 individual members nationwide, tells me that breast cancer is a concern, not limited to Long Island.
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Women across the Nation, those living with breast cancer and those not yet diagnosed want to know why, what causes this epidemic and what they can do to survive. There is no conclusive evidence about what causes this disease but it is generally believed that the environment plays some role in the development of breast cancer. Much has been learned from the Human Genome Project but more investigation is needed into how and what in our environment causes genes to turn on and off and ultimately cause cells to malfunction.
We are anticipating an announcement of the results of the Long Island Breast Cancer Study Project this summer. Previous results could not match any specific carcinogen in the environment with breast cancer. Perhaps the new release will, but so far no smoking gun has been found. Many of us feel that the environment is to blame but which part or what combination, we do not yet know. In the 1930's there was a potato blight on Long Island. Potatoes were a most important crop on the majority of farms here. In response to the blight, DDT was sprayed. Through the 1950's DDT was sprayed. The chemical didn't dissipate, it settled on the soil, it seeped into the water table it was breathed in by our mothers when we (baby boomers) were in uteri. We ask, could this be the problem? Or is it more, is it a combination? What combination? The high incidence of Breast Cancer on Long Island is the tip of the iceberg. The Long Island Breast Cancer Study Project was the first step toward finding an answer.
It is time to focus our attention and public resources on developing an overall strategy to look at all aspects of environmental impact on the development of breast cancer—an all encompassing strategy somewhat like the President's Department of Homeland Defense Proposal. The bi-partisan Breast Cancer and Environmental Research Act outlines such a plan. The legislation recommends $30 million per year for five years be authorized to allow the National Institutes of Environmental Health Sciences to create grants to develop and operate research centers to study environmental factors that may be related to the development of breast cancer. Under a peer reviewed grant making process, the NIEHS director could award grants to up to eight centers for the purpose of conducting research on the links between the breast cancer and the environment.
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The legislation would require each center to be a collaborative effort of various institutions and personnel. As I understand it, an example of such a consortium might be breast cancer research scientists, oncologists from breast centers, industrial toxicologists and patient advocates from community organizations in the geographic areas where the research is being conducted pooling resources. The enactment of such legislation would bring together a diverse group of individuals, institutions and disciplines which would be able to take a broad look at the issue and develop a strategy based on differing perspectives.
I am aware that this is a unique approach to looking at the environment and breast cancer. But a complex problem calls for a coordinated, responsible, innovative plan: which is exactly what this bill offers. I appreciate that Congressman Grucci and the other members of the Committee have the courage and the vision to support this innovative approach.
Thank you again for giving me the opportunity to testify today. I would be happy to respond to your questions.
BIOGRAPHY FOR GAIL FRANKEL
90 Lolly Lane, Centereach, NY 11720; 631–588–0068; frankelg@optonline.net
Personal Information: Married, three daughters, three granddaughters, one grandson; Breast Cancer Survivor: diagnosed 1993
Education:
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BS Ed SUNY College at New Paltz
Accounting Certificate SCCC
Work Experience:
Teacher
Bookkeeper
Purchasing Agent
Retired: 2000
Survivor/Advocate Experience:
Trained as a telephone hotline volunteer by Adelphi NY Statewide Breast Cancer Hotline & Support Program: 1995
Adelphi NY Statewide Breast Cancer Hotline & Support Program Volunteer 1995–present
Invited Speaker at Adelphi Celebration of Survivorship 1997
Hotline Outreach Coordinator & Speaker 1996–2001
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National Breast Cancer Coalition Member 1996–present
Attend NBCC training sessions on legislative issues pertaining to breast cancer 1998–present
NBCC Team Leader 1998–2000
NBCC Long Island Field Coordinator 2001–present
Guest on Fox 5 Cable Talk Show as a Survivor: 1998
Interviewed by Channel 12 News concerning results of Tamoxifen Trial: 2000
Completed Project LEAD—Science Program Training—sponsored by NBCC: 2000
Testified before the U.S. Senate Committee on Environment and Public Works: 2001
New York State Health Research Science Board Review Panel, member: 2001
Scholarship from the Alamo Breast Cancer Foundation to attend the San Antonio Breast Cancer Symposium as a Survivor/Advocate, author of a published a ''Hot Topic Report'': 2001
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Mr. GRUCCI. Next we have Ms. Elsa Ford, president, Brentwood/Bay Shore Breast Cancer Coalition. Ms. Ford has broad experience as a breast cancer activist, particularly focused on environmental contributors to breast cancer. She represents the coalition in numerous groups, including the Long Island Breast Cancer Network, East End Pesticide Coalition and Sustainable Energy Alliance of Long Island.
We welcome Ms. Ford.
STATEMENT OF ELSA FORD, PRESIDENT, BRENTWOOD/BAY SHORE BREAST CANCER COALITION
Ms. FORD. Thank you, Congressman Grucci and thank you for convening this hearing.
I am president of the Brentwood/Bay Shore Breast Cancer Coalition, a grassroots not-for-profit group. Like other coalitions, when we didn't get answers to our questions about breast cancer and our environment, we organized, spoke with scientists and developed our own survey and mapping program. But there was no testing. So we joined together with other groups and got the federally funded Long Island breast cancer study with some testing, a case controlled study. But it was too limited.
What do we know about the incidence of breast cancer in the Coram/Port Jeff area? We know in the Long Island area New York State Department of Health found a cluster of five zip codes where the breast cancer incidence rate is 50 percent higher than expected. Of that group Mount Sinai, Coram and Sound Beach have the highest rates.
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With the breast cancer rates rising steadily in the United States and other industrialized countries since the 1940's, less than 50 percent of the causes of breast cancer are associated with previously known risk factors. Ionizing radiation is a proven environmental cause of breast cancer and many studies confirm other environmental triggers. What we do not have is a good site community collaborative research intervention study. We need the science to plot the actual plume paths of toxic releases on a map and for testing of residents' body burdens of toxins. Then we have residents tell us about their potential for exposure, including lifestyle practices.
We want to apply science to the real world in which we live, to understand environmental connections to disease in their multiplicity and in their potential for prevention. What we lack is understanding of various effects in a useful way upon which we can then make personal and societal decisions to lower the risk of breast cancer.
We have learned that it is important that the first step must be to bring the people of the community and the scientists together to design the study and to follow it through to dissemination of results. Since one size risk doesn't fit all, representatives from the specially vulnerable groups, such as elderly and breast cancer activists are included in a working group. They develop a campaign to raise awareness of toxic effects and ways to avoid them, then gather volunteers that will take a finger stick blood test, monitor their changes and practices in a survey and take a second blood test after a year. Test soil, air and water as well.
Specific identified contamination problems can be addressed and accounted for in the same period of time.
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This might sound like a lot to do, but it has been done in the case of high lead levels in the blood of children under five who are most severely affected because their brains are still developing. In New York State, all preschool children's blood is tested. When a child has a high level reading, house paint and water are tested and corrected.
In addition, as a society, we have removed lead from gasoline. Now children's blood levels have plummeted, preventing many cases of brain damage. But the testing of many toxins to which we are exposed has been too complicated and expensive until now.
With the recent use of sophisticated artificial intelligence computer programs developed by Correlogic, science can now, from a finger stick sample of blood, distinguish genes, proteins and chemicals, and pick out a handful of those of concern from thousands in just 30 minutes. Mass spectroscopy sorts out the molecules based on their differing weights and electrical charge.
Based on the initial testing, individuals can take definitive steps to reduce toxic exposure and rid the body of toxins. In the case of lead, chelation is used. Other ways are sweating from exercise and diet. In a resent study of exercise and low fat diet, they were found to lower the PSA level in men and the greater the lifestyle change, the greater was the lowering of the PSA level.
In our community, with other coalitions we have this great success with legislation for studies, pesticide notification and municipal phase-out of pesticides. We created programs such as ''I Am Fed Naturally'' lawn care and ''Long Island Organic Horticultural Association'' and ''Prevention is the Cure'' campaign. All these programs are based on the precautionary principle.
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Now we have gained the ear and heart of the people in the community. We have primed the pump and we are ready for this study. Our mission is to further prevention as the first principle of public and personal health.
I have a short statement from Scott Carlin, director of the Institute for Sustainable Development at Long Island University.
''While it is important to study the causes of breast cancer, it is also important to give these communities information on how to reduce their risk of breast cancer, in particular it is important to promote non-toxic products to reduce public exposure.''
I have this document, State of the Evidence, from the Breast Cancer Fund and Breast Cancer Action Fund and it outlines the specifics of breast cancer, what is known at the moment, strong indicators and other indicators of triggers to breast cancer. They have a five-point plan to reduce cancer causing chemicals in our bodies and environment.
First, phase out toxic chemicals. Enact sunshine laws and enforce existing environmental protection laws to reduce the use of toxins. Practice healthy purchasing with local, State and Federal Government leading the way in purchasing environmentally friendly products. Offer corporate incentives that encourage companies to eliminate the use of harmful chemicals and monitor breast milk. It is so easy, and don't we want to know what are the body burdens going into the newborn babies?
I have all this information available in the record. There is also here the Victoria declaration. Delegates attending a plenary session on primary prevention at the World Conference on Breast Cancer call for governments of the world to comply with and implement the precautionary principle, and there is a statement on that, too.(see footnote 3)
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Mr. GRUCCI. Thank you, Ms. Ford. I will make all those documents you refer to in your testimony as part of the record.
Ms. FORD. Thank you very much, Congressman Grucci.
[The prepared statement of Elsa Ford follows:]
PREPARED STATEMENT OF ELSA FORD
I'm Elsa Ford, President of the Brentwood/Bay Shore Breast Cancer coalition. We are a grass roots, not-for-profit group. Like other such coalitions, when we didn't get answers to our questions about breast cancer and our environment, we organized, spoke with scientists and developed our own survey and mapping program.
But there was no testing. So we joined together with other groups and got the federally funded Long Island Breast Cancer Study with some testing, a case controlled study. But it was too limited.
What do we know about the incidence of breast cancer in the Coram/Port Jefferson area? We know that in the Long Island high incidence area, the New York State Department of Health has found a cluster of five zip codes where the breast cancer incidence rate is 50 percent higher than expected. Of that group, Mount Sinai, Coram, and Sound Beach, have the highest rates. With breast cancer rates rising steadily in the United States and other industrialized countries since the 1940's, less than 50 percent of the causes of breast cancer are associated with previously known risk factors. Ionizing radiation is a proven environmental cause of breast cancer, and many studies confirm other environmental triggers. What we do not have is a good site community collaborative research intervention study. We need the science to plot the actual plume paths of toxic releases on a map, and for testing of residents' body burdens of toxins. Then have residents tell us about their potential for exposure including life style practices.
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We want to apply science to the real world in which we live, to understand environmental connections to disease in their multiplicity and the potential for prevention. What we lack is understanding of various effects in a useful way upon which we can then make personal and societal decisions to lower the risk of breast cancer.
We have learned that it is important that the 1st step must be to bring the people of the community and the scientists together to design the study and follow it through to dissemination of results. Since one size risk doesn't fit all, representatives from especially vulnerable groups such as the elderly, and breast cancer activists are included in a working group. They develop a campaign to raise awareness of toxic effects and ways to avoid them. Then, gather volunteers who will take a finger stick blood test, monitor their changes in practices in a survey, and take a second blood test after a year. Test soil, air and water as well. Specific identified contamination problems can be addressed and accounted for in the same period of time.
This has been done in the case of high lead levels in the blood of children under five, who are most severely affected because their brains are still developing. In New York State, all pre-school children's blood is tested. When a child has a high lead reading, house paint and water are tested and corrected. In addition, as a society, we have removed lead from gasoline. Now, children's blood lead levels have plummeted, preventing many cases of brain damage.
But the testing of the many toxins to which we are exposed has been too complicated and expensive until now. With the recent use of a sophisticated artificial intelligence computer program developed by Correlogic, scientists can now, from a finger stick sample of blood, distinguish genes, proteins, and chemicals, and pick out a handful of those of concern from thousands in just 30 minutes. Mass spectroscopy sorts out the molecules based on their differing weights and electrical charge.
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Based upon the initial testing, individuals can take definitive steps to reduce toxic exposure and to rid the body of toxins. In the case of lead, chelation is used. Other ways are sweating (exercise) and diet. In a recent study of exercise and low fat diet, they were found to lower the PSA level in men. The greater the lifestyle change, the greater was the lowering of the PSA level.
In our community, with other coalitions, we have had great success with legislation for studies, pesticide notification, and municipal phase out of pesticides. We created programs such as ''I am Fed Naturally'' lawn care, the ''Long Island Organic Horticulture Association,'' and the ''Prevention Is The Cure'' campaign. Please note that all these programs are based on the Precautionary Principle.
Now we have gained the ear and heart of the people of the community. We have primed the pump and we are ready for this study. Our mission is to further Prevention As The First Principle of public and personal health.
Elsa Ford, 18 Stockton St., Brentwood, NY 11717; Tel: 631–273–4074.
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Mr. GRUCCI. Our final speaker, Ms. Lorraine Pace—certainly we save the best for last. In the business I used to be in, we always waited for the finale.
Ms. Lorraine Pace is a breast cancer educator and founder of the breast cancer mapping project. Ms. Pace started this project in her kitchen in 1992. It has since expanded across New York State and has been used as a model nationally and internationally. She has received numerous awards for her work, including a New York Governor's award. Ms. Pace has an MA in secondary education.
It is a great pleasure for me to welcome my good friend Lorraine Pace.
STATEMENT OF LORRAINE PACE, BREAST CANCER EDUCATOR AND FOUNDER OF THE BREAST CANCER MAPPING PROJECT
Ms. PACE. Thank you for inviting me and having this hearing. I am a breast cancer survivor, activist and founder of the breast cancer mapping project. I have resided in the same zip code of West Islip 47 years.
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I would like to start by answering the questions that were sent to me about this hearing. ''What do we know about the incidence of breast cancer in Port Jefferson, New York and surrounding regions?''
Before I was diagnosed with breast cancer, I was on an airplane and started to talk to a person next to me. He happened to be a mortician from Suffolk County. During our conversation he informed me of all the young women on the east end of Long Island who were brought into his funeral home who had died of breast cancer. This conversation prompted me to make an appointment with my surgeon to get a breast biopsy. This awareness saved my life.
When diagnosed in 1992, I found out 20 other women in my community were also diagnosed with breast cancer. I was determined to find out if I was living in a high incidence area so I contacted the Suffolk County Department of Health. After repeated calls to the Health Department, they informed me that at the time Port Jefferson was a higher risk area than West Islip. However, at the time cancer information reported from New York Hospitals and submitted to the Department of Health by postcard sat in boxes for approximately five years.
It was for this reason that we began the West Islip breast cancer mapping project in 1992 that pinpointed breast cancer clusters. This original mapping project which spearheaded the breast cancer environmental movement now spread to other parts of New York, the U.S., and abroad. These mapping projects have also helped prompt the Long Island Breast Cancer Study Project, a five-year study, which was supposed to begin in 1993, but was delayed. Years later the results of the study have not been reported, but promised for July or August of this year. I urge you to ensure these results are reported as promised so we can take some steps in the right direction toward finding some answers.
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Next question. ''Can you give us a sense of how high or how unusual the rate of breast cancer is on Long Island compared to other parts of the Nation?'' There are other parts of the Nation that have high incidences of breast cancer. For example, during the time volunteers and myself were conducting the first breast cancer mapping project, I was interviewed by national television programs about the mapping. Chris Mason, from Marin County, California contacted me and asked if I could help her begin a similar mapping project in this community, which also, through anecdotal evidence, experienced high incidence of breast cancer believed to be the highest in the country.
I flew to California with Dr. Grimson, a biostatistician from SUNY, Stony Brook, to help and later formed what is now the Marin County Breast Health Watch. A mapping project is also currently in progress.
What do we know about the possible causes for high breast cancer rates observed on Long Island? We still do not know the cause of breast cancer. However, many years ago in the Great South Bay, there was an abundance of clammers. In fact, there were so many that you could jump from one boat to the other. Presently there are hardly any clam boats left.
There was industry in the area that dumped heavy metals, such as cadmium, chromium and cyanide into the ground which then crept into the lake, creek and eventually the Great South Bay. Could there possibly be a link between the high rate of breast cancer and decline in shellfish since we know certain metals kill shellfish?
We need to know why there are breast cancer clusters such as those found on the north shore communities of Brookhaven, now the subject of the state Department of Health study. Statistically, these high rates are not coincidences. I believe that some of the answers can be found in the environment.
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I want to caution you that some breast cancer coalitions are saying prevention is the cure, but how can you prevent something if you don't know the cause? We need to find out the cause. But I agree with Elsa, who says the precautionary principle. If you know that there are certain carcinogens, they should not be used.
''Does the current mapping data warrant a full environmental study of the area?'' Yes. The cancer mapping does warrant a full environmental study. However, we need to have a better tracking system nationwide. One of the most important things that needs to be done is to have a unified national cancer registry that includes residential and occupational history. This will give the scientists a better way to track cancer for a possible link between the environment and breast cancer.
Residential history is essential because if a woman who is a lifelong residence of Long Island moves to Florida and is shortly after diagnosed with breast cancer, she is on the Florida registry as having been diagnosed in Florida. This is misleading; in reality they developed the tumor on Long Island.
Occupational history should be included in the registry. A person exposed to chemicals near a workplace and then diagnosed with cancer—could the diagnosis be work related? When a person is diagnosed with cancer, the hospital should ask their residential and occupational history. This information should then be included in the information sent to the Department of Health in Albany.
The first fifty years of my life were filled with family, a career in real estate and return to college where I earned a Bachelor's and Master's degree. I am a mother of three and proud grandmother of three girls, but nothing in those years prepared me for my 50th year in 1992, the year I discovered the lump I had been feeling in my breast for many years was what I had many years feared was cancer and it spread to my lymph nodes. That is when I, Lorraine Pace, a typical suburban woman became an activist.
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I never smoked and as far as drinking, I am an occasional social drinker. I was not on hormone replacement therapy and birth control pills except two months. I had all my children before 30. I was in excellent health, good eating habits and exercised. Neither my grandmothers nor my mother had breast cancer. I did everything I was supposed to do for early detection, including regular mammograms since my early 30's. I knew there had to be another reason why I developed breast cancer.
Mammography screening is the best tool we have presently for early detection, but it is not always effective for young women or women who have dense breasts. Recently Breast Cancer Help, Inc., obtained and makes monthly lease payments for a digital mammography unit housed at Stony Brook University Hospital.
It is a more precise and accurate method for screening women. However, we still could use better screening methods to detect breast cancer. We have the technology to put a man on the moon. Surely we can find a better way to diagnose breast cancer. As it is now, by the time a tumor is found in the breast, it has been there approximately eight to 10 years, maybe more. After all, we have a blood test for prostate cancer.
Why can't we have one for breast cancer?
I was pleased to hear Mr. Levine give us that good news about ovarian cancer. Possibly the next thing will be a blood test for breast cancer.
A while after I was diagnosed with breast cancer, it struck me 20 other women had this. Our community has lovely fresh air, water views. The only thing odd about this environment was that occasionally my tap water was rusty. I began to wonder if possibly the metals that made the rusty water could have anything to do with the breast cancer rate in my neighborhood and the rest of Long Island. I read the Center for Disease Control was to come to Long Island. I testified before them and showed them my rusty water and asked if there was any connection between my breast cancer and rusty water.
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Newsday took a picture that appeared on the front page in the spring of 1992 titled ''Asking for Answers.'' Joan Wirsky of the New York Times wrote several articles after this. During the time I was undergoing chemotherapy and radiation, NJ Burkett of Channel 7 did a series on breast cancer mapping, and was awarded the FOLIO award, along with Suffolk Life. They also put the survey on the cover of their newspaper for free for West Islip zip code residents.
Once I suspected the culprit might be the water, I looked at other communities, at other environmental factors that could be involved. I found out New York City has a much lower rate of breast cancer than Long Island, yet they are so close to us, just a few miles. Is that because they get their water from upstate reservoirs or that they don't have lawns that they obsessively fertilize, dumping every kind of killer chemical into the underground aquifer that is our sole source of water or is it because their wires are buried underground instead of overhead like in parts of the suburbs? This is not only the chemicals put on our lawns that are poisoning our water, but the chemicals on our golf courses as well. Older industries are also to blame that have dumped hazardous chemicals into the ground for years.
When there appeared to be no answers to the questions, I asked my oncologist to help me prove a theory I had about dead-end water mains. My concern was that if you lived on a dead-end street, the water did not circulate as well as if you lived in the middle of the block, and you were exposed to more contaminants. He offered his help to see if this theory could be proved.
On his days off, we met with former Suffolk County Health Commissioner Dr. Mary Hibberd and head of Suffolk Water Authority to do a survey. After the initial meetings, my friend Pat and I approached our congressman. He sent us to a printer for a quote on printing the survey. She sent us to Good Samaritan Hospital and then we got a call from the editor of Suffolk Life Newspaper. Lou Grasso and Dave Wilmott, publisher, contacted me and they in turn printed the survey. Liz Tonis kept Suffolk Life and the community apprised of the results.
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At the time I was undergoing radiation and chemotherapy, and my doctor encouraged me to pursue the mapping project. With the help of people like Maria Diorio and Jenny and other people from the neighborhood and other volunteers, we were able to get responses from the survey on the map. This was done from my dining room table for 18 months. The map shows clusters of breast cancer with definite patterns of concentration in certain areas. The data was then analyzed by Dr. Roger Grimson, a biostatistician from Stony Brook. Without the help of the volunteers, this could not have been accomplished.
After the mapping was completed, we received a 69 percent response rate from the community and that was due partially to efforts by people in the community, such as a priest, Father Tom Arnao, formerly of Our Lady of Lourdes. He was the first priest to get involved in the breast cancer movement. He and others in the community helped from the pulpit, asking people to complete the surveys.
When I was diagnosed, another risk factor was being rich and Jewish and we needed a Catholic face on the breast cancer movement. Out of the 20 friends I had, 19 of them were Catholic, only one happened to be Jewish. So we needed that.
In 1992, I started the West Islip Breast Cancer Coalition. My husband John formed the corporation 501(c)3 pro bono and did the same for Breast Cancer Help, Incorporated and Breast Cancer Research Fund. Meanwhile, the idea of mapping has caught on across Long Island, New York State and nationwide.
I received calls from women in Huntington—who is here now, Karen Miller—Great Neck, Babylon, Southampton, Brentwood, Elsa Ford, Islip and Brookhaven and asked for assistance on how to do mapping in their towns. New York State Senators Owen Johnson and Caesar Trunzo gave us a grant to study the maps. Dr. Grimson did the scientific analysis.
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The state legislature should be applauded now for passing legislation requiring cancer mapping for all New York State. In fact, New York State Department of Health was awarded the Gold Certification from the North American Association of Central Cancer Registries, work that would not have been possible without the $4 million from Governor George Pataki.
After leaving the West Islip Breast Cancer Coalition in 1993, I started Breast Cancer Help, Incorporated in 1994 with Father Tom Arnao, co-president.
Our members and I are proud of the many accomplishments which we have, but, in conclusion, we need to have all the hazardous waste sites cleaned up and the people of Long Island should avoid using pesticides and herbicides that harm the environment. A population-based study should be done that studies bio-markers present in the blood and tissue to determine what the possible environmental causes of breast cancer are.
We also need the most advanced technologies in our hospitals for treatment and diagnosis of cancer patients on Long Island and New York. State-of-the-art equipment should be included in network centers using digital mammography, MRI, PET scan.
We need to find out why so many young women are being diagnosed with breast cancer on the east end of Long Island where there is a high incidence of this disease. We owe it to the future generations to find the cause or causes and the cure of breast cancer.
In conclusion, we need to find out why clusters of breast cancer are occurring in Port Jefferson, Coram, Mount Sinai and Setauket area. I am sure it didn't happen by chance. There has to be an environmental reason. We need to find out what is in the environment that is causing cancer. Once the culprit is known, it should be discontinued or banned.
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I would also like to see more studies done on heavy metals—cadmium, chromium, mercury and lead—and how they relate to cancer since heavy medals take many years to break down. Students nationwide should be required to learn about the environment and how to protect it. We had legislation from Senator LaValle to get cancer education into the high schools.
We, on Long Island, depend on our underground aquifers, which is our sole source of water. We need to protect our drinking water, our most valuable resource. If a cure is found, it would not only help the women on Long Island, but all over the world as well.
Mr. GRUCCI. Thank you, Lorraine, for that complete presentation. You have always been a good friend and strong advocate for this issue and I appreciate you being here and taking the time to thoroughly put that presentation in front of us.
It is important because once it goes back to Washington, as will all of the testimony presented here today, Members of the Science Committee who were unable to make this hearing today will have an opportunity to read and understand the blight we have here certainly in New York, but more pointedly here on Long Island.
[The prepared statement of Lorraine Pace follows:]
PREPARED STATEMENT OF LORRAINE PACE
My name is Lorraine Pace. I am a breast cancer survivor, activist and founder of the breast cancer mapping project. I have resided in the same zip code of West Islip for 47 years.
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What do we know about the incidence of breast cancer in Port Jefferson, New York and the surrounding regions?
Before I was diagnosed with breast cancer I was on an airplane and started to talk to the person next to me. He happened to be a mortician from Suffolk County. During our conversation he informed me of all the young women on the East End of Long Island who were brought to his funeral home who had died of breast cancer. This conversation prompted me to make an appointment with my surgeon to do a breast biopsy. This awareness saved my life.
When I was diagnosed with breast cancer in 1992 I found out that 20 other women in my community were also diagnosed with breast cancer. I was determined to find out if I was living in a high incidence area so I contacted the Suffolk County Department of Health. After repeated calls to the Health Department, they informed me that at that time Port Jefferson was a higher risk area than West Islip. However, at that time cancer information reported from New York hospitals and submitted to the Department of Health by post cards sat in boxes for approximately five years.
It was for this reason that we began the West Islip Breast Cancer Mapping Project in 1992 that pinpointed breast cancer clusters. This original mapping project, which spearheaded the breast cancer environmental movement, has now spread to other parts of New York, the U.S. and abroad. These mapping projects also helped prompt the Long Island Breast Cancer Study Project, a five-year study which began in ————. ———— years later, the results of the study have not been reported but have been promised for July or August of this year. I urge you to ensure that these results are reported as promised so that we can take some steps in the right direction towards finding some answers.
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Can you give us a sense of how high or how unusual the rate of breast cancer is on Long Island compared with other parts of the Nation?
There are other parts of the Nation that have high incidences of breast cancer. For example, during the time volunteers and myself were conducting the first breast cancer mapping project, I was interviewed by national TV programs about the mapping. Chris Mason, a woman from Marin County, California contacted me and asked if I could help her begin a similar mapping project in this community, which also through anecdotal evidence, experienced high incidences of breast cancer, believed to be the highest in the country. I flew to California with Dr. Grimson, a biostatistician from SUNY, Stony Brook, to help and later form what is now the Marin County Breast Health Watch. They are now in the process of completing a mapping project.
What do we know about the possible causes for the high breast cancer rates observed on Long Island?
We still do not know the cause of breast cancer, however, many years ago in the Great South Bay there was an abundance of clammers. In fact, there were so many that you could jump from one boat to another. Presently there are hardly any clam boats left. There was industry in the area that dumped heavy metals such as cadmium, chromium and cyanide into the ground which then crept into a lake, creek and eventually into the Great South Bay. Could there possibly be a link between the high rate of breast cancer and the decline in shellfish?
We need to know why there are breast cancer clusters such as those found in the north shore communities of Brookhaven now the subject of the State Department of Health Study. Statistically, these high rates are not coincidences. I believe that some of the answers can be found in the environment.
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I want to caution you that some breast cancer coalitions are saying that prevention is the cure. But how can you prevent something if you don't know the cause?
Does the cancer mapping data warrant a full environmental study of the area?
Yes, the cancer mapping does warrant a full environmental study, however, we need to have a better tracking system nationwide. One of the most important things that needs to be done is to have a unified national cancer registry that includes residential and occupational history. This will give the scientists a better way to track cancer for a possible link between the environment and breast cancer. Residential history is essential because if a woman who is a lifelong resident of Long Island moves to Florida and is shortly thereafter diagnosed with breast cancer, she is on the Florida cancer registry as having been diagnosed in Florida. This is misleading; in reality, she developed the tumor on Long Island. Occupational history should also be included in the cancer registry. For instance if a person is exposed to chemicals in their workplace, and is then diagnosed with cancer, could the diagnosis be work related? When a person is diagnosed with cancer the hospital should ask their residential and occupational history. This information should then be included in the information sent to the Health Department in Albany.
I am an active member in the following organizations:
Division for Women's Advisory Council
Charter Member of the Suffolk County Breast Health Partnership
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Cornell Ad Hoc Advisory Board
National Breast Cancer Coalition
Vice President of Promote Long Island
Environmental Committee of the Long Island Association
New York State Breast & Cervical Cancer Advisory Board
Department of Health Cancer Surveillance and Early Detection Board
NYS Breast Cancer Network
NCI's Consumer Advocate in Research and Related Activities
Advisory Board Member of the Marin County Breast Cancer Watch in California
Charter Member of the Walk For Beauty Committee
I was also on the following peer review boards:
Department of Defense
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Health Research Science Board
Breast and Prostate Cancer Detection, Treatment and Research Act funded by the cigarette tax in California
Advocate Guide for the California Breast Cancer Research Program
I appeared on two television documentaries:
Rachels Daughters—1997
Say It, Fight It, Cure It on Lifetime Television for Women—1997
There is a book written by Joan Swirsky, titled Map of Destiny, about the breast cancer mapping project. It is currently being reviewed by 2 publishers.
The first 50 years of my life were filled with family, a career in real estate, and a return to college where I earned a Bachelor and Masters degree. I am a mother of 3, but nothing in those years prepared me for my 50th year in 1992—the year that I discovered that the lump I had been feeling in my left breast for many years was what I had feared along—it was cancer and spread to my lymph nodes. That is when I, Lorraine Pace, until then a typical suburban woman, became an activist. I never smoked in my life, and as far as drinking, I am an occasional social drinker. I was not on hormone replacement therapy and on birth control pills for only 2 months. I had all my children before the age of 30. I was in excellent health, had good eating habits, and exercised regularly. Neither my grandmother nor mother had breast cancer. I did everything that I was supposed to do for early detection, including having regular mammograms since my early 30's. I knew there had to be another reason why I developed breast cancer.
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Mammography screening is the best tool we presently have for the early detection and diagnosis of breast cancer. But it is not always effective for young women or women with dense breasts. Recently Breast Cancer Help, Inc. obtained and makes monthly lease payments for a digital mammography unit which is housed at Stony Brook University Hospital. It is a more precise and accurate method of screening women for breast disease. However, we still could use better screening methods to detect breast cancer. After all, we have the technology to put a man on the moon, surely we can find a better way to diagnose breast cancer. As it is now, by the time a tumor is found in the breast, it has been there for approximately 8–10 years. After all, we have a blood test for prostate cancer, why can't we have one for breast cancer?
A while after I was diagnosed with breast cancer, it struck me that 20 other women I knew had also been diagnosed. After a great deal of thought, the one thing I could see that we had in common was that most of us lived on dead-end streets. I started to think about what this could mean.
Our community has lovely fresh air and water views. The only thing that was odd about this environment was that occasionally my tap water was rusty. I began to wonder if possibly, the metals that made the water rusty could have anything to do with the breast cancer rate in my neighborhood and the rest of Long Island. I read that the Center for Disease Control was to come to Long Island. I testified before them and showed my rusty water and asked them if there was any connection between my breast cancer and my rusty water. Newsday took a picture of me that appeared on the front page in the spring of 1992 titled, ''Asking for Answers.'' Joan Swirsky of the New York Times wrote several articles after this article appeared. During this time I was undergoing chemotherapy and radiation. NJ Burkett of Channel 7 Eyewitness News did a series on breast cancer mapping and was awarded the FOLIO Award for his coverage. Suffolk Life Newspaper also received a FOLIO Award, but for newspaper coverage.
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Once I began to suspect the culprit might be the water, I looked around at other communities and at other environmental factors that could be involved. I found that New York City has a much lower rate of breast cancer than Long Island. Yet they are so close to us—just a few miles. Is that because they get their water from upstate reservoirs? Or that they don't have lawns that they obsessively fertilize—dumping every kind of killer chemicals into the underground aquifer that is our sole source of water? Or is it because their wires are buried underground instead of overhead like they are in parts of the suburbs?
And it's not only the chemicals that are put on our lawns that are poisoning our water, but the chemicals put on our golf courses as well. Older industries are also to blame that have dumped hazardous chemicals into the ground for years.
When there appeared to be no answers to my questions, I asked my oncologist, Dr. Michael Feinstein, to help me prove a theory I had about dead-end water mains. My concern was that if you lived on a dead-end street the water did not circulate as well as if you lived in the middle of the block and you were exposed to more contaminants. He offered his help to see if this theory could be proved. On his days off we met with former Suffolk County Health Commissioner Dr. Mary Hibberd and the head of the Suffolk County Water Authority, Michael LoGrande to develop a survey. After these initial meetings my friend Pat and I approached our Congressman Tom Downey. He in turn sent us to Angie Carpenter for a quote on printing the survey. She in turn sent me to Ted Shiebler who worked in public relations at Good Samaritan Hospital. He then called Lou Grasso, editor of Suffolk Life Newspaper. Lou Grasso and Dave Wilmott, publisher, contacted me and they in turn printed the survey on their front page and this is how the breast cancer mapping originated. Liz Tonis of Suffolk Life kept the community apprised of the results of the surveys with ongoing articles. My radiation oncologist, Dr. Allen G. Meek encouraged me to pursue the mapping project. With the help of Maria Diorio and many other volunteers from the neighborhood we put the responses from the survey on to a map. This was done from my dining room table every day for 18 months. The map showed clusters of breast cancer with definite patterns of concentration in certain areas. This data was then analyzed by Dr. Roger Grimson, a biostatistician from SUNY, Stony Brook. Without the help of the volunteers this couldn't have been accomplished. After the mapping was completed we received a 69 percent response from the community and that was due partially to efforts by people in the community such as Father Tom Arnao formally of Our Lady of Lourdes Church in West Islip. He was the first priest to get involved in the breast cancer movement. He and other priests in the community encouraged their parishioners to complete the surveys.
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In 1992 I started the West Islip Breast Cancer Coalition. My husband, John Pace formed the corporation and 501(c)3 pro bono. He also did the same for Breast Cancer Help, Inc., and for the Carol M. Baldwin Breast Cancer Research Fund. Meanwhile, the idea of mapping has caught on across Long Island, New York State, nationwide and abroad. I received calls from women in Huntington, Great Neck, Babylon, Southampton, Brentwood, Islip and Brookhaven, etc., asking for assistance on how to do mapping in their towns. New York State Senators Owen Johnson and Caesar Trunzo gave a grant to the West Islip Breast Cancer Coalition to study the map, and Dr. Roger Grimson a biostatistician of Stony Brook University, did the scientific analysis. The state legislature should be applauded for passing legislation requiring cancer mapping for all of New York State. In fact the NYS Department of Health was awarded the ''Gold'' Certification from North American Association of Central Cancer Registries, work that would have not been possible without Governor George Pataki pushing for 4 million dollar increase in funding.
After leaving the West Islip Breast Cancer Coalition in 1993, I started Breast Cancer Help, Inc. in 1994 with Father Thomas Arnao, who is now co-president, Dr. Allen G. Meek, Chairman of the Board and Treasurer and John Pace, Secretary and General Counsel. Our members and I are proud of our many accomplishments, some of which are listed below:
Our Vice President spearheaded the national campaign to create the first breast cancer awareness stamp. Our group also supported the creation of the breast cancer research stamp
Originating the breast cancer mapping project and helping other coalitions to do mapping locally, nationally and abroad
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Initiating the move to establish the toll-free Cancer Helpline at Stony Brook Hospital
Leading the effort to organize and establish the annual ''Walk for Beauty'' in Stony Brook
Supported the petition that resulted in President Clinton's commitment to a National Action Plan to fight breast cancer and a $250 million increase in federal funding for breast cancer research.
Initiating the change in federal regulations that provides insurance coverage for stem cell infusion therapy for federal employees and their spouses who have breast cancer
Support the passage of the NYS law that ends the practice of drive-through mastectomies
Initiating the move to update and expand the NYS Breast Cancer Registry
Leading the move to create the check-off for breast cancer research and education on the NYS income tax form and supported the subsequent legislation that authorizes the State to provide dollar-for-dollar match for each contribution made to breast cancer research and education
Helping to launch the Long Island Breast Cancer Study Project
Supporting the establishment of the NYS Pesticide Registry
Testifying at local, state and federal hearings on the environment and the possible link to breast cancer
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Raising breast cancer awareness by generating local, regional and national media coverage as well as contributing to public service programs, educational symposiums and fund-raisers
Supported the Neighborhood Notification Bill
Charter member of the Suffolk Breast Health Partnership
Member of the National Breast Cancer Coalition
Initiated the Carol M. Baldwin Breast Cancer Research Fund at Stony Brook
Keynote speaker at the first breast cancer rally in Suffolk County on the steps of the H. Lee Dennison Building in Hauppauge. Suffolk County Executive Robert Gaffney supported this rally
Supporting passage of the NYS Adoption Bill that allows breast cancer patients to adopt children
We need to have all the hazardous waste sites cleaned up, and the people of Long Island should avoid using pesticides and herbicides that harm the environment. A population-based study should be done that studies bio-markers present in the blood to determine what the possible environmental cause(s) of cancer on Long Island are. We also need the most advanced technology in our hospitals for the treatment and diagnosis of cancer patients on Long Island and NY. State-of-the-art equipment should be included in networked centers utilizing digital mammography and MRI and PET scan facilities at the central treatment centers. We need to find out why so many young women are being diagnosed with breast cancer on the East End of Long Island where there is a high incidence of this disease. We owe it to the future generations to find the cause(s) and the cure of breast cancer.
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In conclusion we need to find out why clusters of breast cancer are occurring in the Port Jefferson, Coram, Mt. Sinai and Setauket area. I am sure it didn't happen by chance. There has to be an environmental reason, and we need to find out what's in the environment that's causing cancer. Once the culprit is known it should be discontinued or banned.
I would also like to see more studies done on heavy metals such as cadmium, chromium, mercury and lead and how they relate to cancer since heavy metals take many years to break down. I would also like students nationwide to be required to learn about the environment and how to protect it.
We on Long Island depend on our underground aquifers which are our sole source of water. We need to protect our drinking water, our most valuable resource.
If a cure is found, it would help women not only on Long Island, but all over the world as well.
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Discussion
The Role of the Federal Government in Combating Breast Cancer
Mr. GRUCCI. Just a couple of questions, if I can. Let me ask you all the same question I asked of the other panel. What role do you see us in the Federal Government playing? How can we be helpful? What is it you would like us to do and when would you like to see us do it? I probably know the answer to the last.
Ms. FRANKEL. I would say that the NIEHS bill is the first thing I would like to see enacted in Congress, providing or authorizing the $30 million a year for five years so the NIEHS can get started on planning a strategy to examine all possible links with the environment and breast cancer.
I know that you signed on to that bill and Congressman Israel did as well. Most of our New York State people did. What you can do for us is talk to those Congressmen—and I don't know if congressmen talk to senators, but if they do—.
Mr. GRUCCI. We are allowed to cross the line and go the other side occasionally and speak to them. Unless they stamp our visa, we are not allowed on the other side.
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Ms. FRANKEL. We would appreciate it if you could lobby for us for this bill.
Mr. GRUCCI. Most assuredly. Consider it done.
Ms. FRANKEL. Thank you.
Mr. GRUCCI. Ms. Ford?
Ms. FORD. I would like to see that the many studies we are talking about be collaborative from people in the community in study design. We are able to work with researchers and provide insights into practices and communities that they may not see, but it can't be done by just inserting it in line 3 or line 4. It has to be done from study design to the dissemination of the material, the results. Dissemination of the results is very important because that is where we have something we can use that does better prevention for the future. I think that is really very important.
I would like to just say a word about Prevention Is The Cure campaign. In friendship—but just to clarify—we don't doubt that carcinogens cause cancer. Because of that, we are saying prevention ahead is better than cure after. That is our understanding of prevention is the cure.
It is very important to include preventative practices as part of the study because now we are seeing, like we did with the PSA and the levels dropping from changes in food, etcetera, that we can make a difference.
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I think this is the hopeful part. I don't think we want to tell people we are living with a terrible problem and you are all going to die. That is not our message. Our message is to say that informed people with adequate information can make decisions about their life, even contradictory information—we can figure that out. We do it from morning until night every day. The kids come home, tell you a story and you figure out what really went on.
So, we are capable of looking at various aspects and I think it is important to empower the citizens to have useful information that they can run their lives on.
Mr. GRUCCI. Thank you.
Ms. FORD. You are welcome.
Ms. PACE. I would like to see a national tracking system with residential history and occupational history, uniform, so when people move from state to state they can be tracked. Like I said before, if you have lived on Long Island all your life and then you move to Florida, you are diagnosed with breast cancer the next day, you are on the cancer map in Florida.
I would like to address the problem in California. When I went to California and I spoke to these women where they claim the rate is almost the highest in the world, I was amazed to find out that a lot of those women came from Long Island. You see, that is extremely, extremely important, to really have a national tracking system so that the scientists can have a lot more at their fingertips to study. It would make it so much easier for the scientists to do their work.
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Environmental Areas of Concern
Mr. GRUCCI. You all mentioned in your testimony a number of contributing factors that may indeed be causing these terrible cancer rates. Dead-end water pipes, accumulation of heavy metals, past use of DDT, current use of other insecticides, use of fertilizers and other lawn care products and the presence of high tension voltage power lines.
Does any of the information that has been gathered so far in any of the studies that you have point in any specific direction? Can we look at the data that has been collected and say, ''Aha! This may very well be a cause more so than any of the other causes''? Have you seen any of that in any of the data you have viewed?
Ms. PACE. Well, when we did the map in West Islip Dr. Grimson found more breast cancers south of Montauk, more toward the water. There seemed to be a higher incidence. When you are south toward the water, you also have more dead-end streets because of the water. Different marinas.
Mr. GRUCCI. You are hooked to public water more often? Is that what you are saying?
Ms. PACE. No. We all have public water, but there are a lot of dead-end streets.
Mr. GRUCCI. As opposed to well water?
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Ms. PACE. On the east end, there are still women there with well water and we know the east end is also very high with breast cancer.
Ms. FORD. This is from the Breast Cancer Fund report, the paper that they developed. It says, ''Powerful evidence indicates that some of the 85,000 synthetic chemicals in use today are responsible for many of the unexplained cases of the disease. The strongest evidence—so we have different levels of evidence, strong and less strong—the strongest are links based on the fact that lifetime exposure to natural estrogens increases the risk of breast cancer and concerns natural and synthetic estrogens found in pesticides, plastics, household cleaning agents and fumes from burning diesel. There are also chemicals for which the evidence indicates a probable but less certain link to breast cancer. These include dioxin, the pesticide DDT, and PCBs used in the manufacture of electrical and other industrial and consumer products.
''Finally, there is evidence of chemicals that affect how the body functions and ways that suggest a possible link between these substances and breast cancer. These chemicals include the insecticide heptchlorthalates. Because of the existing gaps in our knowledge we need to focus our research efforts in areas that are most likely to provide useful information for framing public practices. However, while we pursue this research, we must act now on the evidence [we already have].''
One of the things the scientists are looking at now, it is not just the chemical, but that it is at the stage of life of exposure. So the most serious would be the mother's milk for the newborn baby, or the fetus before that. On a particular day of fetus development exposure to thalidomide causes a particular part of the body not to be developed. On that one day. It is not—it doesn't have to be a lot. It can just be a little bit.
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So these things—that is why we want to have the precautionary principle while we figure the rest of this out. But it is not one size risk fits all. It is really, there are many subtleties. I think our best protection is to try to ensure we live in a healthy environment. Anything that we can do to improve our environment will be of help.
It goes across then to other diseases. What is causing asthma today in a child may be cancer in the future for more exposure. It is just that the child with asthma is sensitive and is telling us today, ''There is something in the air that I can't breathe.'' We should listen to that.
Mr. GRUCCI. Ms. Frankel?
Ms. FRANKEL. Aside from DDT, which has been tried and found guilty and banned, so it is really a moot issue except for research value, we do not know what pesticides cause cancer. There has been no smoking gun, as I mentioned. I think it is very important that we find out which pesticides and which chemicals and which combinations are problems because we cannot eliminate them all without increasing hunger in the world and we can't just say ''Ban everything.''
If we ban everything, we will have more starvation. If we ban things to kill mosquitos, we might get the West Nile virus. There is a balance. We have to find that balance and that is my thought.
Mr. GRUCCI. A very interesting point.
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Along the lines of trying to make sure the environment is as clean as it can possibly be, one of the bills that recently came through one of the committees I serve on, which is financial services, it was a brown fields bill and I am sure you are very familiar with the brown fields legislation, designed to provide funding and incentives to clean up the, quote, ''hot spots of contaminated properties'' from over the years.
The bill did pass the House in its version and I believe it is at the Senate level right now.
Those days that I am able to go across the Senate line, I will ask them to move that bill as well. You can also be very helpful in doing that, in all seriousness. Any opportunity we can to clean up the hot spots that are out there will probably serve all of us to best of our abilities.
I thank you ladies for being here. I think you have given us a great deal of insight as to what it is like to be a breast cancer survivor and the fight you have and what you are doing. I commend you for it, praise you for it and I keep you all in my prayers that you will continue that energy and your efforts until we find that cure. Thank you for being with us.
Ms. PACE. I want to thank all the coalitions for doing a spectacular job for getting the word out, Elsa and Karen and all the groups in Nassau and Suffolk.
Public Comments
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Mr. GRUCCI. What I will ask you to do, if you don't mind, if you could remain seated a few moments. As I said at the beginning of the hearing, if there are people in the audience that have any questions, you might be helpful in responding to some of them.
I don't know if anyone does.
Yes?
Ms. HERMAN. I would like to start by thanking you for having this hearing here. I am very proud to have you representing me in Congress.
My name is Vanessa J. Herman, 33 years old, born and raised here on Long Island, in Centereach. Growing up on Long Island, breast cancer was not something I thought about at all. That changed in 1994 when working for Senator Alphonse D'Amato, I met a group of breast cancer advocates from Long Island. Actually, they stormed our office, Lorraine Pace being one of them. Their goals and commitment is truly amazing to me. I have worked with them for many years, 1994 on, and now currently in my position with Stony Brook University. They continue to earn my respect and admiration daily and they fight a battle not only on my behalf, but on behalf of all women here and across the Nation.
I have been asked by Geri Barish, president of 1 in 9, Long Island Breast Cancer Action Coalition and executive director of Hewlett House to read a letter she wrote. She can't be here due to a previous commitment. She is currently undergoing her third battle with breast cancer. She was diagnosed recently again for the third time. During her treatment with radiation after her surgery, she wrote this letter and asked me to come here today and read it on her behalf.
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''The Dots Don't Connect by Geri Barish.''
''In 1974, my son Michael underwent radiation for cancer. I used to listen to his stories of how he was about to imagine different things in order to make time pass while getting his treatment. In 1986, on August 23rd, Michael died due to complications from all the radiation he had. Today for his stage of cancer, they would have only given eight to ten treatments. Back then they gave 52. The damage to his heart and lungs was so severe, he was rejected for a heart and lung transplant.
''On the day of Michael's funeral, I was to start my own radiation treatments. Knowing how much he loved life and trusted the medical profession, he would have been devastated if I didn't follow the course of treatment my doctor recommended. A week later, I started the same treatments.
''I remembered the stories Michael used to tell about how the dots in the ceiling panels would tell a story. They never seemed to connect. He found two with misshapen bodies and named one Fat and one Skinny. He said Skinny was gaining weight. He was only thirteen and in his mind, he looked at those dots as cancer cells. The game became a maze of who could find his way out first. Before it was too late, Fat had to find his way out of the maze so that he didn't eat up any more of Skinny's cancer cells.
''In 1987, once again I developed breast cancer. This time there was chemotherapy and more surgery. Seven years of Tamoxifen, fighting for more research, fighting to find out why the dots don't connect and finding out why nothing has changed.
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''It is now 16 years later. We have spoken out in the halls of Washington, D.C. and Albany, in the White House, and through the media. We have marched, cried, rallied, done outreach, educational programs, changed public policy and increased research dollars. We created an awareness about breast cancer that almost moved mountains, yet the dots still don't connect.
''Now, every morning, at 7:45 a.m., I sit in a room waiting to be called for radiation in the same room I sat in 16 years ago. I am now fighting this disease for the third time. There are people that wait along with me. Young, elderly, male, female. They are the faces of fear and the unknown. The same questions I asked in 1974 and 1986 are still being asked today.
''You make light conversation before everyone tells his story and then we compare. Your name is called and you go into the dressing room. You put on the gown, hoping that the one you pick from the pile will not be worn through or so washed out that it will give you some privacy. You grab your personal belongings, pass through the waiting room, give a quick smile and share knowing looks with the people you just left and approach the large door that says 'Warning, radiation.'
''The table with a sheet covering it is long and cold. You put your arm in a holder and down comes the gown. Just like so many years ago, no dignity, no privacy, no shame. You lie down and look up to the ceiling as they match up the machine to where the radiation is to enter your body.
''Sure enough, as I knew I would, I found Fat and Skinny. As I had suspected, they had never left. After all these years they are still there. The technician leaves, the lights grow dim and you are alone. You stare at Fat and Skinny and wonder if you will ever get out of the maze in time. Then you hear the sound. A long sound like hearing an apartment bell or a buzzer that lets you enter the building. That's when the radiation is entering your body. The technician comes to change the machine for the next entry into your body. Another buzzer and you know it will soon end, until tomorrow at 7:45 a.m. And you know that Fat and Skinny will be there waiting for you.
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''I write this because, after all these years, nothing has changed. New treatments have been developed, early detection is increasing, all the things we as activists have been preaching. The dots still don't connect. We are still being burned, scarred and cut. And we still suffer the indignities and embarrassments.
''We need to continue to fight even harder for research, research to find out how to turn off that switch. We need to stop it before it develops. We need research. I beg our President, our Senators and our Congressmen and women to put more money in research.
''The Long Island Cancer Center, Cold Spring Harbor Laboratory, these are great research institutions right here on Long Island doing wonders for cancer research. We need everyone's help in fighting this injustice. We must insist our government push for more research in genetics to find out how to stop and prevent this insidious disease. We cannot afford to wait much longer.''
That is all Geri wrote. Again, I would like to thank you and all the activists because hopefully I will never have to experience something like this.
Mr. GRUCCI. Geri's letter is very powerful. Please thank her for taking the time to bring her trials and tribulations to us because I think it will help, again, when it makes it into the record.(see footnote 4)
Mr. GRUCCI. Other questions?
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Ms. MILLER. My name is Karen Miller, President of the Huntington Breast Cancer Action Coalition. I was diagnosed in 1987.
Congressman, you ask where money should go? It should go for the National Institute of Environmental Health Science. We need more research into environmental health science. That should be our government's first priority.
About 15 years ago, we started this movement and, basically, as you have heard, nothing has changed except one thing. I personally, and I think the constituencies here, have become very distrustful of where has all this money gone?
Where have the millions of dollars gone? We have research money that goes into pockets. I still look at the Centers of Excellence and I am going to ask our policymakers and certainly our neighbors to make sure that these Centers of Excellence, once chosen, communicate with each other. We are not going to actually find anything if we don't communicate.
We found that through networks, such as the New York State Breast Cancer Network, of which Huntington Breast Cancer is a founding member, that networking is singularly important.
I ask, first, that more money be put toward the environmental health science. Second, when the centers of excellence are chosen, that they communicate. I agree totally with Elsa Ford from Brentwood/Bay Shore that those of us who have something to add be put at the decision-making table from the very onset.
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Gail Frankel had spoken about what else is out there that we know besides DTD, and that is Dursban. Let's look at that. Dursban is a carcinogen and we found out that this—we have all been told Dursban causes cancer, yet it is going to be on our shelves I think until the year 2003. Why is that? Because we are going to hurt economics by taking Dursban off the shelves?
When things are discovered to be known carcinogens, they should be banned immediately. I don't understand and I would like the policymakers to tell me why it is still on the shelf. The activist with very little money, grassroots activists are trying to get the word out, ''Don't buy Dursban.'' yet when you go there, Dursban is on the shelf. It is Scott that makes Dursban? And they can afford this multimillion dollar advertising so my neighbors are still buying this product, which is a carcinogen.
Radiation. Let's discuss radiation. Radiation is a known carcinogen. We are caught between a rock and a hard place. I would like everybody to know that every time they go for a mammogram or go for their treatments, radiation accumulates in your body. So that is a crap shoot. Should I go for all these diagnostic tests or should there, perhaps, be a calling card or a business card that lets me know, with all my specialists, my specialists about my neck, about my ankles, about my breasts, how much medical radiation I have been exposed to. That is a known carcinogen. We are not doing anything about it. We need to do something about it right now.
Prevention Is The Cure is about preventing cancer before it starts. The public, the homeowner, the policymaker at home can make individual lifestyle changes in what they do in their lifestyle practices to change their risks of getting cancer.
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Under the National Institute of Environmental Health Science, Dr. Kenneth Olden put together a public interest liaison group that is studying diabetes, autism, auto-immune disease, cancer, the American Lung Foundation and others. We sit together and we discuss the common threads, the common environmental threads to our disease.
Again, very strongly, I suggest that all policymakers put most of the money toward the National Institute of Environmental Health Sciences and I thank you.
Mr. GRUCCI. Thank you. I appreciate your questions and your statements.
Anyone else?
Ms. GALDANO. My name is Mimi Galdano, also from the Huntington Breast Cancer Coalition. I am the director of our breast health survey. I brought several maps with me today, one that Congressman Israel held up and I would like to suggest something that could be done right in this area of the seven zip codes in the Port Jefferson/Coram area right now that you could have results of within two months, if not sooner.
The New York State Department of Health has released this information at the zip code level. They could easily look at it at the nine-digit zip code level, keeping people's privacy, and see within that area where the particular clusters are, rather than looking at the whole area, which has to be looked at, but specifically seeing where the breast cancer clusters are within the seven-digit zip codes and then look at environmental factors. I think it would be very helpful.
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Mr. GRUCCI. Thank you. A couple more questions, if anyone has them? Ma'am?
Ms. OSTREICHER. My name is Annette Ostreicher, a medical writer. Listening to all the information presented today, everyone has called for cooperation among all the various constituencies and I just wanted to make another plea for a sharing of this information that we have heard today. We have a prestigious SUNY Stony Brook Medical Center here with great researchers that have been discussing a lot of their work and then this new technology that we heard about and we have a very active group of women and population on Long Island that is very willing to be helpful. SUNY Stony Brook also has access to a lot of that information.
I would like to just put in a plea for the sharing of information among these groups and would hope that the technologies that are now available, in fact, will be made available to the researchers who can evaluate these and other cancers and use them for breast cancer analysis here.
Mr. GRUCCI. Thank you very much.
Let me take this opportunity to introduce the staff of the Science Committee, my legislative assistant, Diedre Walsh. If you ever need anything from me in my office and can't reach me, you can certainly get a hold of Diedre and she will help find answers, if there are indeed answers to be found and to bring your message to me if I can't get to you directly and personally.
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Also, we have with us from our Science Committee, Peter Rooney, taking copious notes of everything that was said, as well as our stenographer, who has captured every word of what was said here today.
Trust me, this is a very important hearing to me, to the Members of the Science Committee and to you all.
I appreciate you being here, I appreciate you taking time out of a beautiful Saturday morning to spend time with us on these very important issues.
Ladies, thank you for your insight and your sharing of your personal stories with us.
Thank you all for being here. God bless you and God bless us all.
[Whereupon, at 1 p.m., the Subcommittee was adjourned.]
Appendix:
Additional Material for the Record
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PREPARED STATEMENT OF GERI BARISH
The Dots Don't Connect
In 1974, my son Michael underwent radiation for cancer. I used to listen to his stories of how he was about to imagine different things in order to make time pass while getting his treatment. In 1986, on August 23, Michael died due to complications from all the radiation he had. Today, for his stage of cancer, they would have only given eight to ten; back then they gave 52. The damage to his heart and lungs was so severe that he was rejected for a heart and lung transplants. On the day of Michael's funeral, I was to start my own radiation treatments. Knowing how much he loved life and trusted the medical profession, he would have been devastated if I didn't follow the course of treatment that my doctor recommended.
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A week later, I started the same treatments. I remembered the stories Michael used to tell about how the dots in the ceiling panels would tell a story; they never seemed to connect. He found two that had misshapen bodies, so he named one Fat and the other Skinny. He said Skinny was gaining weight. He was only thirteen and in his mind, he looked at those dots as cancer cells. The game became a maze, who could find his way out first: Before it was too late, Fat had to find his way out of the maze so that he didn't eat up any more of Skinny's cancer cells.
In 1987, once again I developed breast cancer—this time there was chemotherapy and more surgery. Seven years of Tamoxafin, fighting for more research, fighting to find out why the dots don't connect and finding out why nothing has changed.
It's now sixteen years later. We have spoken out in the halls of Washington, DC and Albany, in the White House and through the media. We've marched, cried, rallied, done outreach, educational programs, changed public policy and increased research dollars. We've raised the consciousness level and created an awareness of information about breast cancer that has almost moved mountains. The dots still don't connect.
Now, every morning, at 7:45 a.m., I sit in a room waiting to be called for radiation in the same room I sat in sixteen years ago. I am now fighting this disease for the third time. There are people that wait along with me—young, elderly, male and female. They are the faces of fear and the unknown. The same questions that I asked in 1974 and 1986 are still being asked today.
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You make light conversation before everyone tells his story and then we compare. Your name is called and you go into the dressing room. You put on your gown, hoping that the one you pick from the pile will not be worn through or so washed out that it will give you some privacy. You grab your personal belongings, pass through the waiting room, give a quick smile and share knowing looks with the people you just left and approach the large door that says ''WARNING: RADIATION.''
The table with a sheet covering it is long and cold. You put your arm in a holder and down comes the gown. Just like so many years ago—no dignity, no privacy and no shame. You lie down and look up to the ceiling as they match up the machine to where the radiation is to enter your body.
Sure enough, and as I knew I would, I found Fat and Skinny. As I had suspected, they had never left. After all these years, they're still here. The technician leaves, the lights go dim and you're alone. You stare at Fat and Skinny and wonder if you'll ever get out of this maze in time. Then you hear the sound. It's a long sound, like ringing an apartment bell and hearing the buzzer that lets you enter the building. That's when the radiation is entering your body. The technician comes to change the machine for the next entry into your body. Another buzzer and you know it will soon end, until tomorrow at 7:45 a.m. And you know that Fat and Skinny will be there waiting for you.
I write this because, after all these years, nothing has changed. New treatments have been developed, early detection is increasing—all the things we, as activists, have been preaching. The dots still don't connect. We are still being burned, scarred and cut. And we still suffer the indignities and embarrassments.
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We need to continue to fight even harder for research. Research to find out how to turn off that switch. We need to stop it before it develops. We need research. I beg our President, our Senators and our Congressmen and women to put more money into research and proven scientists to the work, the way they did with Polio.
The Long Island Cancer Center, Cold Spring Harbor Laboratory, these are great research institutions right here on Long Island, who are doing wonders for cancer research. We need everyone's help in fighting this injustice. We must insist our government push for more research in genetics to find out how to stop and prevent this insidious disease. We cannot afford to wait much longer.
1 in 9; The Long Island Breast Cancer Action Coalition is a grassroots advocacy organization of dedicated volunteers who are working to keep the concerns about the breast cancer epidemic in organization of forefront. We are committed to promoting action towards finding causes and cures, with the eradication of breast cancer as our ultimate mission.
(Footnote 1 return)
Mr. LaValle's statement appears in Appendix: Additional Material for the Record, p. 114.
(Footnote 2 return)
See Appendix: Additional Material for the Record, p. 115.
(Footnote 3 return)
These materials follow the written statement of Ms. Ford.
(Footnote 4 return)
See Ms. Baresh's written statement in Appendix: Additional Material for the Record, p. 123.