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Project

Description

The C8 Health Project has been executed in accordance with the terms of the above cited settlement, and supervised by Judge Hill, Jr. To ensure objectivity, the court created and appointed an independent company, Brookmar Inc., to administer the project in the agreed-upon manner. A private company wholly owned by Dr. A. Paul Brooks, Jr., a retired Parkersburg-area physician and hospital administrator, and Mr. Arthur A. Maher, a retired Parkersburg area hospital administrator, Brookmar Inc. was created solely to execute the C8 Health Project, and was charged with coordinating the collection of and assembling data from the Class so that an independent panel of scientists and epidemiologists could investigate the potential links between C8 and human disease in the Class.

Enrollment

Criteria for inclusion in the C8 Health Project was "having consumed drinking water for at least one year before December 3, 2004 supplied by (1) Little Hocking Water Association of Ohio, (2) City of Belpre, Ohio, (3) Tuppers Plains Chester Water District of Ohio, (4) Village of Pomeroy, Ohio, (5) Lubeck Public Service District of West Virginia, (6) Mason County Public Service District of West Virginia, or (7) private water sources within these areas that have been contaminated with C8.

The link below contains the detailed enrollment criteria and documentation requirements used throughout the C8 Health Project.  This document was developed by Brookmar, Inc. in accordance with terms and conditions set forth by the Court.

C8 Health Project Eligibility Criteria

Data Collection

Health Questionnaire

Data collection tools and methods included a “Proof of Claim and Health Questionnaire” and voluntary submission of a blood sample, in the manner and format agreed upon by parties to the settlement and supervised by Judge Hill, Jr. Data and information supplied by members of the Class participating in the C8 Health Project have been stored in a secured SQL-based database.

Here is a copy of the Health Questionnaire completed by all participants in the C8 Health Project. Please note that this document is copyrighted to Brookmar, Inc. with all rights reserved.

Validated Medical Diagnoses

As part of the data collection process, Brookmar, Inc. used medical records to validate the following list of diagnoses if they were reported by participants:

Addison’s Disease
Amyotrophic Lateral Sclerosis
Anemia
Birth Defects
Cancer
Cerebrovascular Accident
Cushing’s Syndrome
Diabetes
Heart Disease
Liver Disease
Lupus/SLE
Multiple Sclerosis
Pregnancy Complications
Raynaud’s Syndrome
Rheumatoid Arthritis
Scleroderma
Sjogren’s Syndrome
Thyroid Disease

Perfluorochemicals

Blood samples, when provided in sufficient quantity, were analyzed for the following perfluorochemicals:

C5 (Perfluoropentanoic Acid)
C6 (Perfluorohexanoic Acid)
C6 Sulfonate (Perfluorohexane Sulfonate)
C7 (Perfluoroheptanoic Acid)
C8 Sulfonate (Perfluorooctane Sulfonate)
C8 (Perfluorooctanoic Acid)
C10 (Perfluorodecanoic Acid)
C11 (Perfluoroundecanoic Acid)
C12 (Perfluorododecanoic Acid)

Clinical Laboratory Tests

In addition to PFCs, the following clinical laboratory tests were performed on blood samples (where serum quantities allowed):

Alpha-Fetoprotein Tumor Marker (Serum)
Albumin (Serum)
Alkaline Phosphatase (Serum)
Alanine Transaminase (ALT or SGPT)
Antinuclear Antibodies (Direct)
Aspartate Aminotransferase (AST or SGOT)
Basophils (Absolute)
Basophils
Bilirubin, Direct
Bilirubin, Total
Blood Urea Nitrogen (BUN)
Calcium (Serum)
Cancer Antigen (CA-125)
Carcinoembryonic Antigen (CEA)
Chloride (Serum)
Cholesterol, Total
Cortisol
C-Reactive Protein (CRP)
Creatinine (Serum)
Eosinophil
Eosinophil (Absolute)
Estradiol
Folates (Folic Acid; Serum)
Free Testosterone (Direct)
Free Thyroxine Index
Gamma-glutamyl Transpeptidase (GGT)
Globulin, Total
Glucose (Serum)
High Density Lipoprotein (HDL) Cholesterol
Hematocrit
Hemoglobin
Immunoglobulin A (IgA; Serum)
Immunoglobulin G (IgG; Serum)
Immunoglobulin M (IgM; Serum)
Insulin
Insulin-Like Growth Factor 1 (IGF-1)
Iron (Serum)
Lactate Dehydrogenase (LDH)
Low Density Lipoprotein (LDL) Cholesterol (Calculated Value)
Lymphocytes
Lymphocytes (Absolute)
Magnesium (Serum)
Mean Corpuscular Hemoglobin (MCH)
Mean Corpuscular Hemoglobin Concentration (MCHC)
Mean Corpuscular Volume (MCV)
Monocytes
Monocytes (Absolute)
Neutrophils
Neutrophils (Absolute)
Phosphorus (Serum)
Platelets
Potassium (Serum)
Prolactin
Prostate-Specific Antigen (PSA; Serum)
Total Protein (Serum)
Red Cell Distribution Width (RDW)
Red Blood Cell Count (RBC)
Sodium (Serum)
T3 Uptake
Testosterone (Serum)
Thyroxine (T4)
Triglycerides
Thyroid Stimulating Hormone (TSH)
Uric Acid (Serum)
Vitamin B12
Very Low Density Lipoprotein (VLDL) Cholesterol (Calculated Value)
White Blood Cell Count (WBC)

Quality Assurance

Validation of Eligibility to Participate

In order to be eligible to participate in the C8 Health Project and receive payment, all members of The Class had to provide Brookmar, Inc. with the required documentation supporting both identity and use of drinking water for at least a 1 year period (between 1950 and December 3, 2004) in one of the six affected water districts (see the Eligibility section of this website).  Brookmar, Inc. retained a copy of all supporting documentation supplied by participants, and the validity and accuracy of all documents were independently verified by a member of the Brookmar, Inc. staff.  Where validity of documents could not be confirmed, or exposure to the specified drinking water for at least one year could not be verified, participants were excluded from the C8 Health Project, and payment was withheld.  

Verification of Responses to Health Questionnaire

As part of the data collection process, participants were required to complete the Health Questionnaire (see the Data Collection section of this website).  It was requested that participants complete this questionnaire before making an appointment (at which time documentation (above) was collected and blood was drawn).  At the time of this appointment, a member of the Brookmar, Inc. staff verified all Health Questionnaire responses with the participant.  It is important to note that while all responses were verified (i.e., each response was confirmed to be that which the participant intended), each response was not independently validated.

Integrated Information Technology Quality Assurance

The information systems used by Brookmar, Inc. to manage and house the data collected as part of the C8 Health Project incorporated multiple layers designed to improve and enhance data quality.  Extensive programming was used to require that Health Questionnaire responses were both within the expected range and logically consistent.  Further, a direct programming interface was developed in order to electronically transfer results from clinical laboratory testing from the LabCorp, Inc. information system.  

"Data Cleaning" Activities

In addition to the integrated information technology processes (described above), additional data cleaning activities were performed by the WVU team.  The dataset was examined for extreme or unexpected values, or responses that were logically inconsistent.  

Validation of Medical Diagnoses

As part of the Health Questionnaire, participants provided information about their own medical conditions (see the Data Collection part of this website).  A series of medical diagnoses were selected to be independently validated (see the Data Collection part of this website for a list of these diagnoses).  For any participant self-reporting one of these diagnoses, Brookmar, Inc. requested that participants sign a release permitting Brookmar, Inc. personnel to contact hospitals and / or private physicians to retrieve medical records to validate these diagnoses.  Brookmar, Inc. personnel requested only the minimum portion of participants' medical records that addressed the diagnosis as self-reported by the participant.  As needed, Brookmar, Inc. staff reviewed records maintained by physicians, hospitals, diagnostic services, and / or physicians' offices where participants had received the care that validated the self-reported diagnosis.  Resources were provided to caregivers in order to assist Brookmar, Inc. in obtaining the requested minimum medical records.

Perfluorochemicals

All of values of the perfluorochemicals (C5-12, including C8 and several salts) were determined by the Exygen Corporation.  Brookmar, Inc. sent a substantial number of "split" serum samples for a second, independent determination to another laboratory, Axys.  After testing was done, all of the remaining serum samples were sent to West Virginia University's tissue bank for storage.

Brookmar, Inc. put an extensive quality-assurance mechanism into place for PFC serum concentrations and for certain important survey data of concern, such as cancer outcomes.  When the PFC data are complete, WVU intends to submit a peer-review report concerning quality-assurance methods and findings.