Expert Panel Meeting Feb. 17 - 18, 2005 Meeting Transcript Day One

Transcript of the
Camp Lejeune Expert Panel
Convened on February 17-18, 2005

DAY ONE - FEBRUARY 17, 2005

Dr. Henry Falk: [Welcome to the Camp Lejeune Expert Panel meeting.] We are all here to provide expert science guidance. Maybe, I'll take a moment or two just to tell you a little bit about ATSDR. You'll understand why this is important to us.

ATSDR, as you know is a health agency that was authorized by the Superfund program to work alongside EPA, Department of Defense and others to evaluate health effects at Superfund sites. We've worked at thousands of such sites over the years. The relationships of EPA and Department of Defense and others are very important. It's a very critical part of our work. I view the work of ATSDR as essentially being that of a service agency. We are called upon at these various sites to evaluate people's exposure to chemicals and hazardous substances and think about the health effects are to people like that. So, we try to deliver that service to identify what are the potential exposures; what are the potential health effects.

The difficulties for us, of course, is that this is sometimes not an easy task. I think of some other service agencies, say like the Post Office. It's easy to understand that a letter has to be delivered, goes to that address. The actual service that's delivered is very easy to define. For us, sometimes exposure is difficult to measure; health effects are sometimes difficult to ascertain. We often deal with sites with many different chemicals with exposures that occurred decades ago, with chemicals that are not so well understood. So, we don't always know what those chemicals do. It's a very important task, but it sometimes requires a lot of good scientific thinking.

So, it's our hope that in this situation, Camp Lejeune, that the panel members can actually look at this situation, where we currently are, and provide really good guidance for us, input on what they see are the potential roads ahead for us. I should say also that it's very important for all of us that the guidance be as good as possible. We really look forward to that. Also, please recognize that we want to make sure that the guidance is not just theoretical, but actually is feasible and practical. Don't come up just with good ideas, but which are difficult to carry out and raise expectations. We want as much as possible to get the very best input and input that we can carry forward.

We count on your wisdom and good advice and deliberations. We very much appreciate the time that you all have put into this and your willingness to be here. Want to thank the members of the public and others who are here today. You traveled from some distance to be part of this and to assist in the public comment period, provide the panel members with their thoughts and we appreciate that. Again, we very much look forward to the recommendations that will come out of these deliberations. We hope that this will really truly assist us going forward at this site. So, thank you very much to the panel members. Thank you very much to the members of the audience.

I'll next introduce Tom Sinks. Tom is the Acting Deputy Director for ATSDR and NCEH at CDC. Tom will also, starting in two weeks, be the Acting Director for the ATSDR/NCEH programs. I'd like Tom to come up next. Thank you.

Dr. Tom Sinks: Thanks Henry. Now that I'm getting older if somebody hands me something to read I actually have to take off these glasses and kind of do this or something. Very awkward for somebody's who's had 20/20 vision all their lives.

Welcome all of you. Just so everybody in the room knows who is here, I thought I'd put some context into this. I believe we have members from the Department of Defense, from the public. There're some congressional staffers out here. We also understand there are a couple of people, at least, who represent the media who have signed up. Everything is going to be on the record. We should keep that in mind. This is a public meeting.

Secondly, just to reemphasize something Henry said. The credibility of the work we do has a lot to do with our integrity. Our willingness to be open to listen to both compliments and criticisms. I think why we're here today is somewhat reflective of that. We have gotten a lot of public comments to us about why are we doing a certain study. Why have we limited that study? Are there opportunities to maybe do more? Rather than us just continuing to respond with a particular, 'this is why we're doing it,' we thought we'd open up this question to a panel and put this to the panel. That's really the purpose of this today. I also want to emphasize that we will take seriously the recommendations of the panel and consider them in any next steps.

I want to introduce Chris Stallard. He has an important job, he's our facilitator. He's going to be our referee. I hope you have a whistle, 'cause you don't have a striped shirt. Okay, he has a clock. So, he's our facilitator, primarily for the public comment period. We have a number of members from our Office of Science, who have put this together, Drue Barrett. Stand up, Drue, in the . . . you get that from Vietnam? In the silk suit. Drue is the Acting Associate Director of Science for NCEH/ATSDR. Athena Gemella, who did the work along with Drue. Athena's back there. Marie Murray. Marie, you can stand up. Marie is going to be our note keeper. She does a lot of these meetings for us. She does an excellent job. David Williamson, your key player. David is our Division Director, with the Division of Health Studies. I wanted to introduce him. That's the Division where this epidemiology is taking place. I'm going to introduce Ken Cantor and pass it over to Ken. Ken is, . . . I'm trying to see your title.

Dr. Kenneth Cantor: Senior investigator.

Dr. Sinks: Senior Investigator. Perfect. He's our Senior Investigator at the Division of Cancer Epidemiology and Genetics at the National Cancer Institute. Ken is a well known expert in epidemiology. He and I have interacted over a number of issues over the years. I'm going to let you introduce the panel, and I'm going to turn it over to you.

Dr. Cantor: I'll introduce myself very briefly. Give you a very brief rundown of my background. Then turn it over to each of the panel members who will do likewise. Again, my name is Ken Cantor. I'm the Senior Epidemiologist in the Occupational and Environmental Epidemiology branch within the National Cancer Institute, basically in Bethesda, Maryland. I've been active in Environmental Epidemiology for all of my career, in fact, for thirty years or so. I've done a lot of work with drinking water contaminants. My particular expertise happens to be disinfection by products and arsenic, though I have done some work in these other areas. I'll turn it over to Paul Visintainer, who will introduce himself.

Dr. Paul Visintainer: I'm Paul Visintainer. I'm the Director of Health Quantitative Sciences at the School of Public Health at New York Medical College. My specialty is epidemiologic methods, biostatistics, data analysis, perinatal epidemiology, and behavioral epidemiology.

Dr. Cantor: Dr. Lynch

Dr. Courtney Lynch: My name is Courtney Lynch. I'm a Reproductive Epidemiologist in the Epidemiology branch of the National Institute of Child Health and Human Development, also in Bethesda, Maryland with the NIH. I've done a lot of work looking at reproductive issues; birth outcomes; recently have started working more with effects of environmental exposures, but also have a lot of expertise in epidemiologic methods and how to study these types of things.

Dr. Wanzer Drane: I'm Wanzer Drane. In addition to a Ph.D. in biostatistics, I have formal training in mathematics, mechanical and nuclear engineering. Currently my activities include modeling space/time phenomenon, which includes environmental modeling and other areas of statistical research.

Dr. Cantor: Dr. Selmin

Dr. Ornella Selmin: My name is Ornella Selmin. I'm an Assistant Professor at the University of Arizona. I've been working for almost ten years on the effects of trichloroethylene on cardiac developments and heart defects using animals and in vitro systems.

Dr. Cantor: Dr. Maas.

Dr. Richard Maas: I'm Richard Maas, Professor of Environmental Science at the University of North Carolina, Asheville, also Director of Environmental Quality Institute [EQI] at UNCH [University of North Carolina at Chapel Hill]. Most of my professional career has been in the drinking water field. The EQI is a drinking water research center. We investigate the toxicology of drinking water contaminants.

Dr. Cantor: Dr. Ozonoff.

Dr. David Ozonoff: My name is Dave Ozonoff. I'm a physician. The last 30, 40 years I've been working with community groups on various environmental epidemiology studies, including a fair number on PCE and TCE. I'm also the director of the Superfund basic research program, which looks at Superfund sites and was the former Director of the Boston Environmental Hazard Center for the VA, which looked at Gulf War issues, and I have done some Agent Orange work as well.

Dr. Cantor: Thank you. I'm going to turn it over to Christopher Stallard now

Mr. Christopher Stallard: Good morning, everyone. I'm Christopher. As Tom said, I'm your facilitator for the day. He said, 'referee.' One of the things about being a referee is that you cannot be effective unless everybody understands the same parameters on which we operate. So, I'm going to ask your concurrence on some basic guiding principles to govern our interactions over the next two days together. Number one is we will start on time and end on time. [voices overlapping speaker] We're going to ask that you put your cell phones on silent; that we do not interrupt the deliberations. Sidebars, if you have something to discuss, we would prefer that you take it outside the room; that we do not interrupt the deliberations. One speaker at a time. As Tom said, this is being recorded. Ten minutes for the public comment period. The speakers will have ten minutes. I have a clock here and we're going to be very firm on speaking times. We're going to stick to that ten minutes. I'll probably try to indicate that you have a two minute warning, so that you know to bring your presentation to conclusion. Interruptions and questions. We ask that you please do not interrupt the panel while they're discussing. Save your questions. There will be a question and answer period. The role of the facilitator, as I said, we cannot do this without your concurrence. Is there anything else that you would like to add to this? Or anything? Can we agree that this is how we'll guide our interactions over the next few days? Is that all right? Okay.

The next most important thing restrooms. Restrooms are . . . go back out the door to the security desk, just past the elevators and turn left through the door and you'll find the rest rooms. Now we're going to have be a little flexible, I understand, we may not have all our presenters here during the time that they are scheduled. We will work within the agenda as it is and be flexible. Any questions? Any questions of the panel? Anything to add to the operating guidelines? Very good. Then, Ms. Gemella, are we prepared for our first speaker at 9:30, which will now be early. Again, if you have public comments to make, we ask that you be here, I would say, a half an hour prior to your presentation.

Ms. Athena Gemella: Mr. James Brown is unfortunately not here, but the other individuals are.

Mr. Stallard: Is Ms. Hilda Rose here and prepared? Good Morning.

Ms. Hilda Rose: My name is Hilda Rose. I'm a parent. We arrived at Camp Lejeune, North Carolina in January of 1984. We could not get into base housing at Tarawa Terrace until a few months later. My son Daniel was born on December 8, 1984. Six weeks before my due date I went into labor. The hospital was not equipped to handle these complications. That's when the medical doctor's at Camp Lejeune decided to transfer me to Camp Smith, Virginia by ambulance to the Naval Hospital. Daniel was born with a heart valve defect. He had to be on Digoxin, an antiarrhythmic medication to prevent his heart from skipping a beat for a whole year. He later on in his life started complaining from pain in his stomach. However, in March of 1985, I became pregnant again. Two months before Nathan was due my husband Jeff got orders to go to Camp Pendleton. So, we left Tarawa Terrace and headed to Camp Pendleton, California. Nathan was born two weeks premature. He had so many problems. I took Nathan to the doctor for his six week check-up, and that's when they discovered that Nathan did not gain weight, but was losing it. He was admitted to the hospital for a high fever and ear infection. That's when they discovered that Nathan had two holes in his kidneys that caused urine to build up and cause an infection. They wanted to operate on him, but because of his age they kept him on antibiotics for a whole year until he was able to handle the complicated surgery. At eleven months, Nathan was admitted to the hospital to fix the urinary reflux on both sides of his kidneys. Even though the surgery closed the holes, Nathan had to stay under the care of a renal doctor up till today. I live in Virginia. Nathan is nineteen years old. I just took him to a urologist and he told me Nathan needs a kidney transplant.

All these problems I experienced as a parent, I never knew what was the cause of these problems that my kids were having. Every time I questioned the doctors for answers at the naval base they would tell me, "Oh, it's probably hereditary." I would look back and none of my family or my husband's family had problems with their kidneys or we had any problems with our hearts skipping a beat. So, that was very confusing for me. When I was stationed in Germany, I was contacted by the ATSDR research group, and they wanted to speak with me because both my kids were conceived on the based, and I was part of the research. I'm so glad they've done this. It gave me answers to the problems my kids had, they're still having and they will have for the rest of their lives. Thank you.

Mr. Stallard: Ms. Lita Hyland

Ms. Lita Hyland: Good morning, everybody. Thank you for listening to us. The concerned parents of these children unfortunately be born with kidney holes and all the disadvantage that are usually located in a third world country, like the one that I come from. I immigrated to this country looking for the best of the world for my children. Unfortunately, they have the knowledge being respectful to the life of our baby. My daughter was born. My pregnancy was at Lejeune. I moved a couple of weeks before she was born to my mother's house because I was very sick. I could not take care of myself. My husband was constantly on the fields. He decide to bring me back to my mom. My family was in Washington, D.C. She was born and I have very little things to show people what happened to her. This paper, as I explained to the doctors, my daughter was having convulsions. My English was very limited. She was having high fevers. She grew up to have a lot a problems-high blood pressure. She was fourteen years old when she was um. . . tell by the doctors. The doctors told me that she needs a breast reduction. She had extremely big breast for fourteen years old. I wait until she was nineteen to do this. She was having problems with the sleeping, her knees and bleeding noses. That's my oldest daughter. Then, I have my other daugther who was this little baby right here with a red face [shows a photo to the panel]. She was born again at the Naval Hospital. I was not at Lejeune anymore. I was at Fisher Island. As soon as she was born I realized that something was wrong, because I saw her turning blue. Her tongue was swelling and she didn't stop crying from the moment she was born. So I called the nurses and asked the nurses to please bring me a doctor. But she said [the nurse], "You know they just saw your daughter. She was born just a few minutes ago. She's fine. Don't be nervous." I said, "I am nervous." I don't know why my heart was indicating that something was very wrong with my daughter. So I said, "You bring me the doctor. Wake up the Director of the Hospital, if the doctor, you know, is at church right now, or doesn't want to wake up. Just get the Director, because if something happens to my daughter I will blame you straight." She brought the doctor, and that's when they had to run and do the transfusion on my daughter, because something was wrong with her blood.

Now she was two and a half years old, when she had a little tumor on her breast. About three year's ago she developed a disease . . I will say for a very long time, my kids did complain about their stomachs, but I thought they were copying my symptoms, because I did have problems with my stomach. They saw me vomiting and my stomach problems. So I thought, "These kids are picking up my signals." When I took the kids to the doctors, they said that they were fine, but my youngest daugther developed ulcerations out of her body and severe diarrhea and she has Crohn's disease today. I have been . . . I have a letter from the hospital and I am going to read it. I am sorry about my bad English, but I'm very nervous, too. This is a big thing for my family and I want to be my best -okay.

[She reads a letter] ... has been seen in the Gastroenterology Clinic at the National Naval Hospital Center and Walter Reed Medical Center by multiple gastroenterologists, physicians since January 2003. Her condition remains poorly characterized but she has been demonstrated to have varying degrees of intestinal inflammation over the previous twelve months period. They're doing two colonoscopy procedures and multiple radiological examinations. Currently her diagnosis can be described as Indeterminate Colitis. Indeterminate Inflammatory Bowel disease. Ms. Hyland has had multiple medical therapies without significant appreciable benefit in her somatic complaints, and including chronic abdominal pain, chronic diarrhea, oral ulcerations, multifocal joint pain, fatigue and depression. She continues to require close follow up. An attempt to determine her exact diagnosis presents a unique learning opportunity for the military physicians and might help in the treatment of similar patients in the future.

This was signed by Dr. Cash, by most of the doctors at the Naval hospital, except for one person who was the Director of the hospital. The Admiral denied her the continuation of the Navy designee. My . . . my thing is gonna stop right there. I have a letter right now that says that its Crohn's Disease and is severe. She had two blood transfusions lately. She barely can do things. The only thing that she does is that she wakes up everyday to see Oprah Winfrey. I am very thankful for it. It makes her happy to see her everyday. Everything have (inaudible). Today the General Surgeon of the Navy denied her because he was the Director of the Hospital before and denied her. He denied her again for the continuation of medicine. The Social Security have denied her, and Dr. Cash has been making a special letter for her, so that they can pay attention to her. She's only twenty-three. She sleep most of the time. She barely can keep any food. My son have a learning disability. He barely can write. He have ADD. He have everything. How is this happen our kids, I don't know, but I know one thing, this is America the greatest country on earth. I came here. I changed my citizenship because I want to help my husband in everything that he does. I support the Marines, but I never sign for my kids to be drafted when they were in my womb, never. I think they have to have all kind of considerations for our children. They did their duty before they was even born. My kids are my heroes, next to my husband. He didn't do anything wrong but serve his country with all the love. Before I got married he told me my duty and my love is for the Marine Corps and my country and you are the third one. Then, probably that, he never ever have a doubt, and we had also the second place of his life, but it was two things that was important to serve this country. And I hope that someone there is going to serve us with what we deserve. We don't have to have kid's sick.

Thank you very much for listening to us.

Mr. Stallard: (inaudible) … you had some things to share with the panel?

Ms. Hyland: This is when my daughter was waking up, look at that [shows a photograph], and they know what happened to our kids. This is a letter from Dr. Cash. (Inaudible) I make a copy (inaudible), and they notified the Admiral. He is the doctor. He had to know what is happening to us and take care of us. This is my daughter's ulcerations.

Mr. Stallard: Thank you Ms. Hyland. Is Mr. Jerome Ensminger here, please?

Mr. Jerome Ensminger: [spoken away from microphone] I have several others I have to present, and I want to give mine after I give those.

Mr. Stallard: Yes, sir. Mr. Ensminger has asked that he be positioned to later in the program. Is Mr. James Brown here? No. Mr. Jeff Byron?

Mr. Jeff Byron: Thank you. Good morning. I want to thank the panel for being here first and taking the time and also ATSDR for putting this panel together and listening to our concerns. Really, I'm kind of going off the cuff here, I'm going to give a statement of my family's story and then how I feel that it interconnects with what's going on here. I understand that we're here to first off look at possibly doing further studies on children and adults, other than the children that are in utero. So that's our concern today.

My name is Jeff Byron, I'm from Hamilton, Ohio. I served in the Marine Corps honorably from June 1981 to June 1985 on active duty status. I'm here to ensure that the panel is informed of the negative impact of the toxic contamination on the lives the residents of base housing at Lejeune.

The wells were discovered to be contaminated in 1980, yet were not shut down until 1985. The report that this panel submits . . . well you won't be submitting it to the commandant, you'll be submitting it to ATSDR, cannot possibly be complete without the history of those individuals so negatively impacted by the decision of base housing officials to keep the wells open. Your report will directly impact the future of my family and others like mine. Your panel has been tasked with determining whether or not to further study children who were not in utero and adults who were present at base housing. We don't believe that five years is a timely manner to shut those wells, first off, with the type of sampling that was going on and the information that was available at that time even.

I have some documents that I'll present later, not at this time. They show that they were well aware of the exposure levels that we were getting. I actually take a little bit of exception to the letter that I received concerning the residents of base housing where it says that they "may have been exposed". There's no may about it. We were exposed and the documentation proves it. This is my family's story which is similar to others.

After boot camp and air traffic control school I was assigned a permanent duty station at Camp Lejeune Naval Air Station, New River. The air station provides support for Marine Corps Base Camp Lejeune. For the first six months, my family and I, which included my wife and my unborn child, lived off base in Jacksonville, because it there were no quarters at that time. Off base housing was more expensive and it was not an economically sound decision for someone at my pay grade. My first born, Andrea was born June 5th, '82 at Onslow Memorial, while we lived in off-base housing. We were sent to the civilian hospital due to the fact that there were not enough resources for the base naval hospital to handle the amount of pregnancies on base. In August of '82 our family lived at 1247 Butler Drive in the Midway Park Base Housing Complex. Midway Park is directly across from the main gate at Camp Lejeune. At that point, Andrea had her first sick visit to the medical center on October 5th '82. She was seen nineteen times from October '82 through July 1983. These were all sick related visits. Prior to moving to base housing, she was seen only for well baby check-ups-height, weight, etc. In August of 1983 renovation of Midway Park forced our family to move again to other base housing. We were assigned quarters at 3114 Boganville Drive in Tarawa Terrace Base Housing Complex.

During our stay in this base housing my daughter, Andrea, was seen by doctor's at the naval hospital on Camp Lejeune thirty-seven more times in the following twenty-two months for such illnesses as rashes, urinary tract infections, yeast infections and unexplained fevers. Most of the time the medical personnel did not have an explanation for the cause, even though blood tests that were done showed that cell counts and other criteria for blood analysis were below normal range. During this time my wife and I conceived our second child, Rachel. She was also born at Onslow Memorial Hospital under the Champus program as well for the same reasons. On her newborn profile the box for no abnormalities was not check marked, even though she had a large raised birth mark on her lower back, large meningioma close to her spine. Hospital personnel told us to take Rachel to the naval hospital at six weeks for her well baby check-up. She was born six weeks prior to my discharge from active duty, which ended June 25, 1985. When Rachel was seen at the base hospital the following statement was written into her medical record:

Her head's up and tracking. She's smiling. Reflexes are off. Female with periodontal dimples. She had slow weight gain and large meningioma on her back. She had brachial dimples that were posterially rotated ears. She had ASD (Atrial Septal Defect). Atrial Septal Defects are a group of rare heart defects that are present at birth, congenital. Appears . . . Periodontal dimples and an umbilical hernia at that time. They did find some other problems later as she was developing.

Upon returning to Ohio, Rachel was seen by a pediatrician and underwent chromosome testing, an EKG and an EEG. She had to be fed in an infant seat because of projectile vomiting. She was labeled a failure to thrive baby. Meanwhile, six months after being discharged from the Corps, Andrea, my first born, was diagnosed with aplastic anemia, a rare bone marrow disorder. She was treated at Children's Hospital Medical Center [CHMC] of Cincinnati Ohio. Cincinnati Children's Medical Hospital at the time was the number two hematology department in the country. The head of the hematology department asked us, if we had been exposed to toxic solvents. They asked us for all the names of the cleaning and hygiene products we were using. All the products were ruled out. We were asked this because chemical solvents, as we were told, were known to cause Aplastic Anemia in men in the manufacturing industry. I'm familiar with these chemicals because I'm general manager of an aerospace manufacturing facility, and these were used at that time in the mid-late eighties. As you may know they upped the price of those chemicals so high because they wanted the industry to get out of it, because of the issues with health. Our answer was no. I was an air traffic controller, so there was no reason for me to be around solvents.

She was in the hospital under quarantine for thirty days. She was given blood, platelet transfusions. She was treated at CHMC until she was twelve years old. As a result of this disease, she was not allowed to participate in normal activities, such as sports and gymnastics and so forth. Toxicological profiles, for PCE, by ATSDR publications indicate that Aplastic Anemia may be a symptom resulting in the exposure to these chemicals. Andrea's aplastic anemia is in remission now, but her doctors have told her there's a fifty percent chance that the disease could return, if she decides to have a family of her own and becomes pregnant, which both of my daughters at this point are expecting children, one in July and one in August. Our largest fear is that we know these chemicals, from your own toxicological profiles to be mutanagenic and also carcinogenic. We live in fear of what's to come, even though we don't express that to our children. We don't know what the outcome of this is. My second daughter has been dramatically affected. She's learning disabled, developmentally disabled. They found an arachnoid cyst on her spine that's congenital. She has spina bifida. She has curvature of the spine. She's nineteen years old and has the back of a woman who's eighty who has been toiling her whole life. It's rolled over. None of this is in my family. There are no birth defects other than crooked teeth, losing hair maybe. That's not a defect, but that is, . . .you know . . . Those are the only things that run in my family that I'm aware of . There's no heart problems. She's just been . . She's had and has now the following medical problems:

She wore leg braces for leg length discrepancy; was hospitalized for urinary tract infections in '87 and '88. She had surgery for ventricle septal defect and submucous cleft palate, because she was born without a pharyngeal flap. She has speech and hearing impairments, requiring therapy from 1987 through 1996, 9 years. Learning disabilities, she's in an individualized learning program. She's developmentally disabled, as I said. She was enrolled in the county school for developmentally disabled/mentally retarded for fine motor skills and speech therapy. She was exempted from passing the Ohio proficiency tests for graduation, even though she did graduate.

She has taken the Ohio Driver's Test, at this time, it was six times, but it took her nine times to pass the written exam, which she has finally done, which is an accomplishment for her and our family. She had to have surgery to remove the meningioma in 1997. As I said she's been diagnosed with curvature of the spine, an arachnoid cyst on her spine was diagnosed in 2001. All the tests confirm that its congenital from birth. She's being tracked by the Mayfield Clinic of Cincinnati at this time. Dental work is ongoing, Rachel has had to have all of her teeth capped as a child, so that they would hopefully prevent any problems with her adult teeth. Last year, I capped twelve teeth for a nineteen year old.

My twin boys who were born a year later. . . Have they even had a cavity yet? I don't think they've even had a cavity. So something obviously went wrong. I believe that if you take the medical records that I have, which I'll present this afternoon to the panel, for my daughter Andrea, who was born two months prior to me moving on to base housing, within like two months of the time I moved on to base housing she had to be seen . . . how many times? . . . fifty-seven, in two years. Six months after I leave the Corps she comes down with a bone marrow disease. It's related to these chemicals. Dr. Falk may be able to shed more information on that because I notice his name is on these publications. If you take their medical records and put them together something happened. I think you'll find that if these other individuals have medical records for the time frame they were at Camp Lejeune, you'd definitely see a pattern. It doesn't just affect the children that are in utero. My daughter was not in utero, my oldest. But she has bone marrow problems, which hopefully will remain in remission even though she is pregnant at this time, since she's not near the source of exposure. Rachel's life will be totally compromised. . . Thank you . . . from the time she was born to the time she passes away.

We don't know what's in store for the rest of our family, our grandchildren coming up. I don't think that any of these people know. But we appreciate the fact that you're listening to our circumstances and that you're going to consider furthering this study on children and adults. I hope that does mean the adults, too, because it would be unfair, at this point, twenty years later to come back and not take a look at everyone. If the Department of Defense is here . . . . Gentlemen, you should consider your actions. Take the responsibility to at least address the 103 children first, and then if this panel decides that there should be further studies that you should address that to. That's directly to the Commandant of the Marine Corps. Thank you.

Mr. Stallard: Is Mr. James Brown here? Still not. . . This would be your time to speak. [voices away from microphone] Mr. Ensminger will speak on behalf of Ms. Rhodes. Correct?

Mr. Ensminger: Yes. This is the testimony of Ms. Coley Rhodes. She's from Jacksonville, North Carolina.

Because of my job teaching high school chorus and obligations to a music festival made many months prior to this meeting, I could not be here in person. I wanted to make a video of my request, so you could put a face with this testimony, but I did not want to take up any unnecessary time with logistics.

I was employed by the Camp Lejeune Dependent School System, July 1973 until June of 1986. I taught at Delelio Elementary School aboard the air station from January 1973 until July 1980. I then transferred as a music teacher to Tarawa Terrace Elementary School in August of 1980 and worked there until June 1986. In May of 1984 I became pregnant and found out that I was carrying twins. I continued teaching until school was out for the summer in June of 1984 and resumed my classes in August of 1984. I went on maternity leave in January of 1985. In January I went into premature labor and the twins were born on January 25th, 1985. I was hospitalized in Onslow Memorial Hospital in Jacksonville, North Carolina. After their birth, it was discovered that they both had heart defects. Heart defects are not a factor in my family history.

Elizabeth, being my first born, was immediately transferred to Duke Medical Center in Durham. While there, with all their medical knowledge, they could not save her, and she died on February 18, 1985. Rebecca being my second born was able to come home with me for a while. She had special monitors and medicine that had to be administered daily. She required constant supervision. She had several major surgeries at Duke in her short life span. She finally died on April 18, 1985.

Over the years, I have questioned myself for the reason this happened and have had such anguish in my heart by missing my daughters. There is not a day that goes by that I don't think of them and wonder what their lives would have been, had they lived. The hurt never stops. The pain never diminishes. You just learn to live with it on a daily basis. It wasn't until recently that I found out about the contamination on board Camp Lejeune, specifically in their water, which I drank daily unsuspectingly, while employed at Tarawa Terrace Elementary School.

After reading information concerning chemical contamination, I know within my heart of hearts that this was the very reason I will never see my girls graduate from high school, college or have children of their own. That is why I will never hold them in my arms again. It is my firm belief that the chemical contamination killed my two girls. On July 17th, 2003, I read an article in the Jacksonville Daily News, our local newspaper. The front page story was about a survey showing links to defects and cancer caused by contaminated water at Lejeune. As soon as I read the newspaper, I knew somehow this was the reason for the death of my twins. I called ATSDR, their number listed in the newspaper for information.

On July 21st, 2003 at 10 am I talked with Debra Dunlap. I briefly informed her of my situation and questioned her extensively about the survey that was mentioned in the article. I requested a survey and stressed the importance of the matter. She advised me to follow the study that she indicated would take about eighteen months. She also gave me a number to a Website hotline to call and that was the one for the Marine Corps.

At 2 pm July 21st, 2003, I called this number and spoke with Gunnery Sergeant Hanson. I requested a survey from him as well, after relating my situation. Gunnery Sergeant Hanson told me that they (ATSDR) make the decisions on who will get the surveys. I received some information from the United Stated Department of Health and Human Services on July 26th, 2003. The information was a toxicological profile for trichloroethylene and a toxicological profile for tetrachlorethylene; Public Health Assessment and a page entitled Frequently Asked Questions. I have never received a survey or been contacted by anyone concerning this. I left my name, address, phone number and a brief synopsis of my situation with everyone with whom I spoke. I also made a plea to keep me informed and send me any information. I am very upset that I have not received a survey or any other correspondence.

I hope this letter will help you understand my situation to some degree. Losing children is the most horrible thing in life. When it happens to you, it is something you never get over. I want to emphasize with this letter today, which happens to be the twentieth anniversary of the death of one of my twins, which would be tomorrow, Elizabeth, the importance of being included in this study. I worked on the base for many years, teaching music to many children in what I thought was a safe environment. I conceived and gave birth to two healthy daughters in 1997 and again in 1980, while teaching across town at the Marine Corps Air Station. I transferred in 1980 to Tarawa Terrace School just a few feet from the contaminated wells, became pregnant with my twins and lost them due to severe heart defects. The care they received after their birth was from some of the best doctors at Duke Medical Center. Dr. Anderson, who is the Chief of Pediatric Cardiology, performed the surgeries that were required.

My twins were diagnosed with congenital heart defects, major cardiac defects, arterial ventricular canal defects and chromosome damage. These are the very developmental effects of trichloroethylene on the heart, stated in the profile reports. I have never been given the opportunity to fill out a survey and never been given the acknowledgement of inclusion into this study. I am asking for your immediate attention to this situation, an opportunity to fill out the survey and for an acknowledgement of my inclusion into this study. I am asking for your assistance in finding truthful answers to the effect of these toxic substances on my babies due to my drinking this contaminated water. Thank you. Coley Hunt Rhodes.

That is one of the arguments that all of us have been fighting since the beginning of this thing. We found out what the studies did and didn't include. ATSDR said they weren't including any of the in utero children born to anyone that did not live aboard the base. What's the difference? These civilian employees worked there five days a week, exposed to this crap. They need to be included into this. How much does this stuff take? How much of this stuff does it take to a fetus to harm it? There were hundreds, if not thousands of civilian employee women aboard that base. Thank you.

Mr. Stallard: Thank you Mr. Ensminger, for speaking on behalf of Ms. Coley Hunt Rhodes. Mr. Ensminger you are still speaking on behalf of others, is that correct?

Mr. Ensminger: Dr. Michael Gros. This is the statement of Michael L. Gros, M.D. He's from Spring, Texas. February 13th, 2005.

Dear sirs, ladies. This letter is in reply to the panel's request for statements from those affected by Camp Lejeune's water contamination problem.

My family and I lived on base at H-57 M.O.Q. from July 1980 to July of 1983. This housing area, next to the old naval hospital was my family's residence seven days a week for three years. My wife, Janie, and I chose to live there, trusting in the security and safety of base housing. I practice as an obstetrician/gynecologist at the adjacent hospital, until the new hospital was finished shortly before my departure from active duty as a Lieutenant Commander in the Medical Corps of the United States Navy Reserve in 1983.

I had extensive exposure to the ground water. I showered at least twice daily, drank extra water to avoid recurrent kidney stones, swam at the indoor pool down the road from my quarters and scrubbed for many surgeries and deliveries. Needless to say my young family did much of the same. Their baby formula and Kool-Aid were mixed with the same contaminated water from the Hadnot Point Water System for three entire years. Our water was later estimated to contain 1400 ppb TCE, along with other volatile organic compounds. This level of TCE is approximately four times the level which poisoned the water in Woburn, Massachusetts. This is the incident made famous by the movie 'A Civil Action.'

Ironically while living there, we regarded Camp Lejeune as an idyllic place to rear our two young sons. My younger son, Tom was conceived while we lived there and was delivered at the old hospital. If not for his birth there, we would have never found out about this entire disaster.

After leaving Camp Lejeune in 1983, I settled and practiced as a civilian solo OB/GYN in Houston, Texas. In 1994, my blood tests started to show subtle abnormalities. In the summer of 1997, my family was thrown into complete turmoil when I was formally diagnosed with non-Hodgkin's lymphoma (Mycosis fungoides). It ruined my older son Andy's high school graduation time and sent us scrambling for second opinions for some sort of a prognosis.

I was the sole bread winner of the family, sole owner and revenue producer in my medical practice and was faced with sending two sons to college, in addition to providing for all of my own living expenses. My cancer was incurable except through a bone marrow transplant. We attempted several ineffective temporizing treatments recommended by our doctors at M.D. Anderson Cancer Center in an effort to forestall the inevitable.

Out of the blue, between seeing patients in November of 1999, I was asked to take a phone call from Dr. Marie Sochia who was doing a look back study on children born at Camp Lejeune. It was only then that I learned that our ground water had been contaminated. I was happy to report that my son Tom seemed to be well, but I was shocked to find that aside from expressing sympathy about my cancer no plans were in the works to study the health outcomes of the adults like me who lived at Camp Lejeune. This disregard for adults exposed continues to trouble me to this day.

In May of 2002, my disease had inexorably progressed to the point where it had displaced 50% of my bone marrow, making me dangerously immune deficient and unable to see sick patients. I had no choice but to suspend my practice and go into reverse isolation at M.D. Anderson for twenty-six days to receive a bone marrow transplant from my son Tom. I had to fund this expensive procedure with my own resources since the Veteran's Administration refused my request to fund my transplant. I was not aware at that time that I would never be able to practice my profession again, due to the subsequent unpredictable and unwelcome side effects of the transplant itself.

While I was thankfully in remission from my original disease, I now had a new chronic disease called graft-vs.-host disease. This arises from the inherent mismatch of DNA between me and my son. In short, my new bone marrow had cleared the cancer cells and now set about destroying my body, the host.

The past two years have been spent in an intensive outpatient treatment costing approximately $50,000 per month. I soon will exceed the lifetime limit on my private health insurance policy. I continue to suffer damage to my connective tissue, my liver, skin, eyes, nervous tissue, and the cumulative joint damage brought about by several courses of high dose steroids. I go for treatment two days out of the week. I am chronically weak, anemic, and am subject to infections as a result of the medications needed to control the graft-vs. host problems. I was forced to sell my practice at a huge financial loss.

During all this time, my loving family has suffered great emotional trauma. They continue to fear for their future health and the potential genetic damage to their offspring. We have learned to enjoy each day in a special way, but we certainly cannot plan for much of the future. We live in fear of bankruptcy and death on a daily basis.

In summary, I present my case as an example of how this water contamination can affect people's lives. I feel like my family and many others were unwitting subjects in some sort of cruel experiment where no attempt is being made to find out the horrible effects which have occurred to the people like me. There are probably hundreds of other stories similar to mine which remain to be told, if only the people involved knew what happened at Camp Lejeune.

Since reading the preamble for the ATSDR health assessment of 1997, I take strong exception to the way in which the plight of adults, such as myself, were summarily ignored in one or two paragraphs without any identifiable peer review or documentation. At the same time, the very limited study undertaken of the in utero exposures was flawed by reliance on inaccurate water supply information provided by the Marine Corps, and fails to account for a large number of infants born on Champus, which is the military's private medical insurance, at Oslow County Hospital.

I do not purport to be an epidemiologist, but I do have some basic medical and scientific training. My informal discussions of this matter with various experts in epidemiology and toxicology reveal their similar skepticism about the assumption that adults were not affected by the levels of TCE and other toxic compounds found in the water supply at Camp Lejeune before 1985.

I think a formal independent review of the data, assumptions and methodology employed in the original studies by ATSDR is long overdue. Hopefully, after twenty years of shameful delays, we can finally get on track and do the right thing for our volunteer service personnel and their families.

All individuals exposed for significant time periods need to be studied in a retrospective fashion for possible adverse effects. I am convinced that our government has the resources and the access to the data to make this possible. Sincerely, Michael L. Gros, M.D.

Mr. Stallard: Thank you Mr. Ensminger on behalf of Dr. Michael Gros. Mr. Ensminger, I see that you are also here to speak on behalf of Mr. Thomas Townsend. Is that correct?

Mr. Ensminger: Yeah. Can I have a break?

Mr. Stallard: I think that would be perfect.

[laughter]

Mr. Stallard: I have approximately 10:10 right now. We will back in fifteen minutes. We will take a break if that's all right. Right now. So be back please at 10:25.

[Whereupon, the meeting adjourned for a break]

Mr. Stallard: Ladies and Gentlemen we'll be resuming in just a few moments.

Dr. David Williamson: Well, good morning. We're going to go ahead and resume with the next part of our expert panel meeting today. I'd like to join Dr. Falk and Dr. Sinks in welcoming each of you here to Atlanta and to our expert panel meeting on the Camp Lejeune study and other activities. The purpose of this session is for us in the Division of Health Studies at ATSDR to give a presentation to the expert panel to update them on some of our most recent activities dealing with the epidemiologic health study that's currently ongoing. But, I would like to take just a second to make a comment. I have worked at the Centers for Disease Control and Prevention for about fifteen years before I joined ATSDR about three and a half years ago. I had heard an awful lot about ATSDR and the commitment that ATSDR has to communities. When I worked at CDC, I worked a lot with state and local partners. I worked also with communities, but mainly with the public health officials of communities. That changes at ATSDR. One of the things that I'm very proud to say is that there is a very strong commitment of ATSDR for the scientists who are at ATSDR and for everybody at ATSDR to work with the communities to actually go out into the communities, put names and faces together and really try to gain the trust of the communities. To let them know that our job is to help the communities as best we can. One of the things that I think is unique to ATSDR is that we do have specific. . not that we have specific authorities and responsibilities, because all agencies have those, but I think one of the things that makes ATSDR unique is the commitment of its' individuals. Our scientists, who you are going to meet in a few minutes, are very, very committed to you, to the communities of Camp Lejeune and the other communities that we work with and are so committed that even, if there are things that we can do that are outside our responsibilities and authorities, we will do everything we can to try to help you and the communities. That's a commitment that you have from ATSDR, and you certainly have that from our division, the Division of Health Studies.

Now let me introduce Perri Ruckart. Perri is an epidemiologist in the Division of Health Studies and she is the Principal Investigator for this epidemiologic study that the panel and you are going to hear a little bit about, right now. I think Perry's going to introduce the rest of the team. Or at least significant members of the team, because we have a lot of people working on the Camp Lejeune activities and on this health study. Some of the significants ones are here. It's my understanding that they will be here throughout the next couple of days in order to be resources for the panel, should you have questions, technical questions. Then we'll be happy to be here and try to answer . . . .answer those and be available as a resource. So Perri with that, I'm going to turn it over to you and again thank everybody for being here. If there's anything that we can do in the Division of Health Studies doesn't hesitate to ask us.

Dr. Perri Ruckart: Good Morning. I'm going to be giving a summary of the ATSDR Activities at U.S. Marine Corps (USMC) Base, Camp Lejeune. Can everyone hear me? As David said, I'm Perri Ruckart, Principal Investigator. I wanted to introduce the other members of the Camp Lejeune Team for the current study: Frank Bove, Shannon Rossiter, and Morris Maslia.

Base operations at Camp Lejeune began in the 1940s. Currently, the base is home to a population of 150,000. According to the 1990 census almost two-thirds of active military personnel and their dependents are under age twenty-five. So, it's a relatively young population living on the base. In 1980 the census showed a similar age distribution. Because this is a military base there's been considerable in and out migration from the base. Camp Lejeune Naval Hospital staff estimated that one-third of mothers receiving pre-natal care at the naval hospital during the 1970s and '80s were transferred from the base before delivery. The average duration for on base housing is about two years. Fifteen different base housing areas were available for enlisted personnel, officers and their families. Three distinct water distribution systems served these housing areas. I'm going to show you them on the map. . . . Sorry . . . At the upper central part of the map is Tarawa Terrace. It was constructed in 1954, below that is Holcomb Boulevard. It was constructed in 1972 and below that is Hadnot Point which was constructed in the 1940s.

Among these three water distribution systems during the 1970s and '80s drinking water was extracted from over a hundred wells, treated at eight treatment plants and distributed through a network of distribution pipes. We think that each of these three systems operated independently. Underground storage tanks were installed at Hadnot Point in the 1940s and '50s and were used to store waste degreasing solvents. In 1954, ABC One Hour Cleaners began operations near the base. In 1958, a supply well for Tarawa Terrace was installed near the septic tank system of the dry cleaners. In January 1985, a fuel pump broke at Holcomb Boulevard causing Hadnot Point to temporarily supply water to Holcomb Boulevard, for a twelve day period while repairs were being made. Contamination of Hadnot Point and Tarawa Terrace drinking systems was intermittent because each system had more wells than necessary to supply water on any given day. Wells were rotated in and out of service. Therefore, contamination levels in the drinking water distribution depended on the wells being used at a particular time. It is believed that water from each system, water from all wells in use was mixed before treatment and distribution.

There was no sampling prior to the 1980s. However, VOCs were detected at Hadnot Point and Tarawa Terrace Wells during a sampling program in 1980 into 1985. TCE, PCE, benzene and DCE were found at the levels that I will show on the next slide. Contamination of the wells likely began many years before detection, and could have started as early as the 1950s. The possible sources of contamination include, for Hadnot Point, leaking underground storage tanks, spills and other waste disposal practices. In Tarawa Terrace, the contamination was mainly PCE from the dry cleaners. The contaminated wells were shut down by February 1985.

The base began sampling Hadnot Point in 1980 for Trihalomethanes (THM). The analysis showed VOCs other than THMs. Samples taken in 1981 also noted the presence of VOCs other than THMs. In 1982, the base began using a different lab to analyze the samples. This lab also noted interference with identified VOCs. Reanalysis of the samples collected in 1982 and additional samples collected during 1983 to 1985 found the levels of the chemicals found in the tables. There were no water quality standards for these VOCs in 1982, so no actions were taken. However, all contaminated wells were shut down by February 1985. Camp Lejeune and ABC Cleaners were listed on the EPA national list for Superfund sites in 1989.

ATSDR is required by law to conduct a public health assessment, which we call a PHA, at each Superfund site. The aim of the PHA is to determine whether the population residing around a particular site is exposed to toxic substances and to assess whether any adverse health effects resulted from the exposure. ATSDR published a PHA for Camp Lejeune in final format in 1997. The PHA determined that VOC exposure in drinking water at Camp Lejeune was substantially lower than the levels of concern in animal studies and also lower than the levels seen in workplace studies. Therefore, ATSDR concluded that the cancer and non-cancer health effects were unlikely in adults exposed to VOC contaminated water at Camp Lejeune, based on worst case scenarios.

I wanted to point out something about the column on this table called Exposure Time Frame. We don't have any data to confirm contamination prior to the 1980s. That's why that time period is listed as unknown about exposure; however, the dry cleaners began operations in 1954 and underground storage tanks were installed in 1940s and 1950s.

Because of the limited information in the scientific literature on how these chemicals might affect a fetus or a child, the PHA recommended that an epidemiologic study be conducted to evaluate whether in utero exposure to chlorinated solvents in drinking water at Camp Lejeune was associated with a higher risk of having an adverse birth outcome or childhood cancer. As a first step in following up the PHA recommendation, ATSDR utilized available databases to evaluate whether associations existed between potential maternal exposure to drinking water contaminants on base at Camp Lejeune and pre-term birth, small for gestational age (known as SGA), and mean birth weight deficit. Preterm birth was defined as less than thirty-seven weeks gestational age and SGA was defined as less than a tenth percentile weight by gestational week using the published specific norms for whites in California. We chose 1968 as the starting point for the study, because this is the year birth certificates became electronic in North Carolina. We attained birth certificate information on 12,493 singleton live births at the base, during the period 1968 to 1985. Base housing records provided dates of occupancy, which were used to estimate the dates during pregnancy that the mother resided in a base housing unit.

The study estimated that 6,117 births occurred to moms exposed to PCE from residing at Tarawa Terrace for at least one week. Thirty-one births occurred to mothers exposed to PCE from residing at Hadnot Point for at least one week and fourteen births occurred to mothers exposed to PCE from residing at Holcomb Boulevard when that water system was briefly supplied by Hadnot Point. Half of the births in the study were not served by Tarawa Terrace or Hadnot Point water and were therefore considered unexposed at the time. However, new information shows that some of these births may also have been exposed to contaminated drinking water. The study identified eight-three fetal deaths. This was likely an under-ascertainment and the cause of death was missing for most. Therefore, there is insufficient data available to study fetal death.

The study concluded that there was an elevated risk for SGA among male infants exposed to Hadnot Point water which was primarily contaminated with TCE. It also concluded there was an elevated risk of SGA among infants born to mothers greater than 35 years of age and among mothers with two or more prior fetal losses exposed to Tarawa Terrace water, which was primarily contaminated with PCE. There was no elevated risk found for females.

Because the 1998 study relied on birth certificate information, it could not evaluate birth defects or childhood cancer. The current study will do this using a case control design. This is a multi-step process. The first step consisted of reviewing toxicologic and epidemiologic literature to narrow the focus of the specific birth defects and childhood cancers that might be associated with drinking water contaminants detected at Camp Lejeune. This slide shows the outcome selected for further study based mainly on evidence from PCE studies at VOC contaminated drinking water.

The second step was to conduct a telephone survey to identify the potential cases of the selected adverse childhood outcomes among births occurring to mothers residing on bases at any time during their pregnancy from 1968 to 1985. The objective of the survey was to determine whether an epi study of the selected adverse outcomes was feasible. This slide shows the questions that needed to be addressed by the survey before we could proceed.

The survey began in September 1999 and concluded in January 2002. The survey included births on base and births that occurred after the mothers were transferred off base. It is estimated that 3,500 to 4,500 mothers were transferred off base for delivery. It's estimated that 16,000 to 17,000 births occurred where the mother was pregnant at any time while living on base form 1968 to 1985. We surveyed the parents of 12,598 eligible children. This was a labor intensive effort and we used several means to identify this population, such as Marine databases, the media, and referrals from other people who were part of the survey. The survey was necessary because data from the North Carolina Cancer and Birth Defects Registries were not available prior to 1985. Also, a high number of mothers were transferred off-base before delivery and did not give birth in North Carolina. Sufficient numbers of neural tube defects, oral clefts and childhood leukemias were reported in the survey. A total of ninety-nine cases were reported. Thirty-five neural tube defects, forty-two oral cleft defects and twenty-two childhood leukemias.

The third step is verification of the reported cases. To date, medical records have been obtained for sixty percent of ninety-nine reported cases. Twenty reported cases were confirmed as either not having the condition of interest or were ineligible. So that leaves us with seventy-nine remaining cases, who were either confirmed or pending. We use pending to mean that we are still trying to obtain the medical records to confirm that the child has the condition of interest. Out of these seventy-nine we have fifteen neural tube defects confirmed as having that condition and thirteen are still pending. We have twenty cases that are confirmed as having oral clefts and sixteen are still pending for oral clefts. Twelve children confirmed as having childhood leukemia and three are still pending. We randomly selected 818 controls from the original survey population of children who did not have the condition of interest. Controls were over sampled to insure an approximate ten to one ratio of controls to cases. This is not a matched sample.

Mr. Byron: Can you explain that? We are not medical people.

Dr. Ruckart: Are we taking questions from the panel?

Mr. Stallard: Yes, please hold questions.

Dr. Ruckart: Detailed interviews will be administered beginning in March 2005 to parents of the cases and controls to obtain information on maternal water consumption habits, residential history and maternal and paternal risk factors. We will attempt to interview all confirmed and pending cases and controls. Case verification will continue until interviewing is completed. We anticipate a ninety percent participation rate based on previous contact with this population and their interest in this study.

There is a lack of historical contaminant specific data at Camp Lejeune. This requires a modeling approach. To provide a quantitative estimate of exposure, a historical exposure reconstruction approach will be taken consisting of modeling ground water flow and present day water distribution systems at Camp Lejeune and extrapolating backwards in time. This is a similar approach as was taken in the Dover Township, New Jersey childhood cancer study. The water modeling component needs to address the following questions shown on the slide. …The goals of the water modeling component are to determine when contamination arrived at the wells and the spatial and temporal distribution of contaminants by housing location.

I'd like to conclude with a project timeline. We anticipate the study will be completed by the end of 2007. Then, the findings can be disseminated to the public.

Mr. Stallard: Thank you Perri. That concludes our presentation. This is a period of time now for the panel to ask the presenters and the team members any questions pertaining to the presentation.

Dr. Cantor: So we have the full team that's mentioned here is seated? I think it is Dr. Bove, Ms. Rossiter, and Mr. Maslia. Is there a panel member who would like to start the questioning?

Dr. Ozonoff: Well, before we do that, maybe I could just cede my question to Mr. Byron. Maybe he can have his question answered.

Mr. Byron: Thank you. I just didn't understand one page, wanted clarification.

Mr. Stallard: The question was about selecting controls?

Dr. Ozonoff: It was a good question about what does it mean for this not to be a matched sample.

Dr. Ruckart: Not to be a matched sample on how we're selecting controls or . . . .

Dr. Ozonoff: Matched control set. Right.

Dr. Ruckart: For case control study we have identified the cases that have the conditions of interest and then from our surveyed population we also identify children who do not have those conditions. Then we look and see who was exposed. Then we can say, if there is more risk, people are cases or not. So you have to have some children that they're being compared to, those are the controls. They're drawn from the same survey population, but as I mentioned, they do not have the conditions of interest. So, we can see if exposure to the contaminated drinking water is an influence and a factor. We've selected more controls than cases to make sure that we have enough power to actually find something and we're not matching. Meaning, sometimes studies will try to make sure that the keys and controls are somewhat similar to sex or gender, or grades or things like that. We're not doing that in this case. We'll be able to handle anything like that when we analyze it.

Mr. Stallard: Dr. Drane.

Dr. Drane: Yes. I want to know why you left out cancer in children, or did you not leave it out?

Dr. Ruckart: No. The conditions that we are going to be including are neural tube defects, oral clefts and childhood leukemias.

Dr. Drane: Childhood leukemia, but no other cancer?

Dr. Ruckart: We did initially hope to include non-Hodgkin's lymphoma and the survey identified or reported seven cases of non-Hodgkin's lymphoma, but of those seven, three were either ineligible or confirmed as not having non-Hodgkin's lymphoma. That left us with four, of the four non-Hodgkin's lymphoma. Two were confirmed as having non-Hodgkin's lymphoma and the other two were still in the pending category. That only left us with four, which was not enough to further study that outcome. We had to not include that.

Dr. Ozonoff: Could I just follow up on that? I know Courtney has a question, too, but, did you consider just doing blood cancers and that would allow you to include some non-Hodgkin, whatever non-Hodgkin's lymphomas you were able to confirm?

Female voice: You'll have to go to a microphone.

Mr. Stallard: This one would work.

Dr. Bove: It was decided to look at childhood leukemias and non-Hodgkin's lymphomas based on . . . first of all the New Jersey study, which looked at seventy-five towns in northern New Jersey and found associations between TCE and childhood leukemia, also adult, non-Hodgkin's lymphoma for TCE and PCE. So that was sort of the basis for why we decided to even look at non-Hodgkin's lymphoma, even though there are no studies that look at childhood non-Hodgkin's lymphoma for TCE or PCE, as far as I know, as Perri just said. We only found really two confirmed and two possible. So, we decided to abandon that part of the study.

Dr. Ozonoff: Well, I . ... My question is why not throw them in with hematapoietic cancers in children.

Dr. Bove: You mean combine them. Well, we could do that. We could still see, if we can confirm those other two pending cases. We could do that, so that if they are confirmed we'll have four and link them with the other. We would basically just link them, because I don't know how much information we've gotten from medical records to determine cell type, although most of the children …. the all will be B-cell.

Dr. Ozonoff: Yeah, I mean, they're all coming from a common progenitive stem cell. Depending upon where TCE or PCE waxed at, in the development for those cells it could turn out to be a solid tumor or a blood tumor. I worry sometimes that we slice the bologna so thin, that by the time you look at all the cell types you never get any answers.

[Applause]

Dr. Bove: Well, yeah, well, given that we don't have that many childhood leukemias either that are confirmed. We could do that.

Dr. Visintainer: I was wondering about the heart defects. I assume you didn't find sufficient numbers, is that why they're not included?

Dr. Ruckart: Yes, we felt that those were likely to be unascertained. We did not get enough to study that further.

Dr. Bove: Basically, we found about a third of what we expect, based upon the metropolitan Atlanta congenital birth defects registry. The problem here is that a lot of these heart conditions are detected by a surveillance system. Certainly surveillance systems that go off to two years and, uh, confirmed cases as they go. Survey, I would say is one of the worst ways to get at birth defects, but unfortunately that was the only way in this situation. Because there was no population based birth defect registry and birth certificates will miss them as well. Actually, birth certificates do not evaluate to that fine a detail, even a current birth certificate, let alone birth certificates in the past. So we found about a third of what would be expected. We felt that we were obviously under-ascertaining. So it wasn't worth continuing. That's unfortunate because there is a Tucson study that was not very well done. It would be nice to revisit that. I didn't see heart defects in my study in New Jersey associated with TCE or PCE, but Tucson did. At Woburn there were too few birth defects in general to even look at. They didn't find an association there either. It was I think, again, a problem of small numbers. It would be nice to evaluate it, but there'd have to be another study.

Dr. Visintainer: But the heart defect information coming back from the survey was low . . . that's what you're saying was below, was one third of what you expected?

Dr. Bove: Right. The conotruncal heart defects which were listed, the Tucson study . . It's not clear what heart defects are included in that study. They were confirmed by echocardiogram or some other method. So, we figure they're the severe heart defects, but there was never in the article itself a description of what heart defects were included. In my study, I had a longer list than conotruncal heart defects, but there again, they were more severe ones. We didn't include PDAs. We looked at VSDs separately and so on. But in general, we were either going to under-ascertain them. So that's why we're not studying them.

Dr. Cantor: Just to follow up on that, I wonder if it would be possible to go back to the investigators in the Tucson study to get them to differentiate the heart defects they did see. So the ones that were more likely to appear as a self report in your survey could be separately identified there.

Dr. Bove: There are a whole lot of problems with the Tucson study. I'm the only one . . .I'm not the only one, there are a lot of researchers missing because of the problems, trying to understand the study. I actually think you can get something out of it. Again, I looked at severe heart defects in New Jersey and TCE. They didn't have these kinds of levels. I'm not sure what the levels were in Tucson. I can't remember them off the top of my head, but they were higher than in New Jersey, for sure.

Again, I just think that no matter what we do here, we're not going to ascertain the full. The better approach would be to find another population exposed to TCE or PCE where there's a birth defect registry. I think that's really where the better science will occur, with a surveillance system ascertaining the birth defects.

Mr. Stallard: Dr. Lynch.

Dr. Lynch: Actually, I'm curious. I share some of the questions that have been raised about how the various birth defects and outcomes were selected. For instance in the July 2, '03 progress report, there's one list of outcomes of interest and that doesn't seem to agree with the list that Dr. Ruckart presented. Like for instance, anencephaly. I'm assuming you probably didn't find enough. . .

Dr. Bove: No, no. Anencephaly is neural tube defect.

Dr. Lynch: Oh, yeah.

[voices overlap]

Dr. Lynch: Okay. It's considered under NTD. Okay.

Dr. Bove: We also don't point out any choanal atresia, by the way. That was why we're not…

Dr. Lynch: Okay. That's why.

Dr. Bove: Probably we didn't expect any either; it's a small population.

Dr. Lynch: So, my question is basically did you it sounds like you used a combination of . . . You looked at . . . You (up - phonetic) your areas set out to look at things that have been shown previously in the literature to have an effect, and then basically looked at the data to see what was collected to see, if there would be enough power to even look at these things. I would definitely share Dr. Ozonoff's suggestion of going back and looking at that list and trying to do some reasonable groupings, because I think you might be able to get some reasonable answers doing some groupings.

And my other question is related to the birth certificates. So you estimate the 16,000 to 17,000 births occurred during that time. You found . . . was it correct you found 12,598 birth certificates.

Dr. Bove: No. It's twelve thousand. . .

Dr. Ruckart: Well, it depends if you're talking about the 1998 study or our current study. The 1998 study relied only on birth certificates in North Carolina, births occurring on the base. That was 12,493. Our current study was also open to births that occurred after the mothers were transferred from the base. Our estimate is that that total population is 16,000 to17, 000 using the 12,493 that occurred on the base, plus the estimated 3,500 to 4,500 that occurred off base. So that's how we get a total of between 16,000 to 17,000. Of those we, as part of the survey, interviewed 12,598. That's why we say the range 74 to 80 pending.

Dr. Bove: Remember though that that 3,000 to 4,000, we really don't know.

Dr. Lynch: Right.

Dr. Bove: It was based on hearsay at the hospital, how many women had their prenatal care at that hospital and then were transferred off base including delivery. So we don't really know.

Dr. Lynch: I guess what I'm asking about is the participation rate . . .of that 74 to 80 percent participation rate, what portion of the people who were not surveyed could you not find, versus those who refused to participate? We're you able to kind of figure out who you were not able to find, because from public comments this morning it sounds like there were some people who were not contacted.

Dr. Bove: We have the percentage of participation of those we know were born at the base, and that was, what, about eighty percent? I don't remember exactly. Something of that sort. So, it's about eighty percent of those we know were born in Onslow County; that also lived at base housing at the time of delivery, was what the requirement was. There are other births that occurred in Onslow County some to Marine families, but they were living off-base at the time of delivery. So they weren't included in the 1998 study. So this 12,490 some, where the mother delivered in a residence that was on base, housing. Of that I think we were able to interview up to about eighty percent. I don't have the figures right in front of me.

Dr. Cantor: That's because the other group you were not able to find.

Dr. Bove: Then there's thirty-five to forty-five hundred we're not sure, based on what the hospital says the percent the hospital says take their prenatal, get transferred before delivery and then give birth, who knows where. Okay. So that's where this figure varies.

Dr. Cantor: Okay, I see.

Dr. Bove: So what we do know. . . What we did was we looked at all the births in Onslow County. We were able to do that because by '68 they were computerized at the county level. Okay. We then hand searched through that to get the street address that wasn't computerized. We then matched that to the housing records, which was also not computerized, around some 70, 80,000. . . I can't remember how many boxes, and then matched, based on the father's name and the mother's street address. Of those matched, we got 12,493 for that study of small for gestational age. There were a lot of people who were waiting for housing on base during the study period. There was a waiting list to get on base housing. That's our understanding anyway. So that explains some of he discrepancy between the amount of births occurring in the county during that period and the amount in the 1998 study.

Dr. Ruckart: That's because the births that occurred to the people who did not live on base at any time couldn't be included.

Dr. Bove: It's confusing but….

Dr. Cantor: The birth stuff that you do know about do you have reasons for the twenty percent that you were not able to interview?

Dr. Bove: It was an incredible effort to try to locate and then contact these people. We were able to get Social Security numbers on some, from the hospital. We also used the manpower database that the Marines had to get Social Security numbers, but there was a large number that we couldn't get Social Security numbers. Then we would send the Social Security number to the Lexus Nexis. They would give us the contact information, we would contact them. But there were a lot of people we could not get Social Security numbers from and we had to rely on other methods. We looked at the Marine Association. We looked at the Marines themselves to link with their records. We used the media. The Marines sent memos to news sites and so on. We got referrals from the people we interviewed to give it . . . those in particular for people who were born off base. So there were various methods we used. I think part of the problem is not being able to locate them and then there were some refusals.

Dr. Cantor: Obviously, the only major concern scientifically is that, if any of the refusals or the proportion of the refusals were based on the fact that they didn't want to deal with this issue. . that it was too difficult for them to deal with. So, did you have a response to that? Or you don't know at this point?

Dr. Ruckart: Of the ninety-nine cases, there are twenty that were either confirmed did not have any condition of interest or ineligible and that does include a few refusal. . people who refused to provide documentation. Now, we don't know if that would actually turn out to be a confirmed case or not. But there are a very small percentage of those who refusing to provide the records.

Dr. Bove: Keep in mind that a large percentage, we're not sure how many, were unexposed. In the 1998 study, Nancy Sonnenfeld did the study. That study estimated that 5,000 some births were unexposed, okay, based on information we had at the time from the military. Since then we learned that the information was somewhat erroneous, that, in fact, more births probably were exposed. So, we're waiting for the water modeling effort to determine that. It could have been four or five years, for example, where exposures to TCE could have occurred to quite a sizable number of births. In Nancy's study, in the 1998 study, there was probably a good deal of exposure misclassification probably non-differential. There are still quite a number of births that were not exposed to either TCE or PCE. I don't think that the refusal rate is related to that. I don't think it's related . . . I think people were contacted wanted to tell us about other health problems they had. You could say it might be related to that, but it's hard to say. But I don't think it was related to exposure, at least.

Dr. Ruckart: One thing I want to add. We are going through the process now of verifying our pending cases. We haven't closed out anymore of those one way or the other, but anecdotally, it seemed that some of those may also turn out to be confirmed as not having the condition of interest. It's very hard to get confirmation of our cases, of reported cases, difficult.

Dr. Visintainer: Just for my own clarification, I just want to verify that the survey includes mothers who had a residence on base from 1968 to endpoint who gave birth, even though they may never have contacted medical personnel on base. Everything is off-base, right? We've heard some testimony this morning that through Champus, or something, that all medical care may have been taken off-base.

Dr. Bove: If they were born in the county. . .

Dr. Visintainer: If they were born in the county and claimed residence on base they would have been in the survey?

Dr. Ruckart: Yes, because . .

Dr. Visintainer: Regardless of where they got their medical care.

Dr. Ruckart: Yes, because we're including . . . the requirement is that the mother lived on base at any time during her pregnancy between 1968 and 1985, but they could have delivered off-base. That is where we don't have records of the birth, that the referral service could be used. They would call us and then we would get the birth certificate, then we would have confirmation from the housing records they lived on base. They could be included.

Dr. Bove: Of course, there could be data entry errors.

Dr. Ozonoff: This includes civilian employees, too?

Dr. Bove: What?

Dr. Ozonoff: Does this include civilian employees on the base?

Dr. Bove: No. They had to reside in base housing. The mothers had to reside in base housing or their father had to reside in base housing.

Dr. Ozonoff: So the testimony that we heard this morning, of a woman who was not contacted because she taught at the school. She would not be included, is that right?

Dr. Bove: Right. Unless she lived in base housing.