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C8 Science Panel Newsletter

C8 Science Panel Quarterly Newsletter #9

August, 2012

Contents:

1. Science Panel studies update
2. Science Panel submits Probable Link Reports to the Court
3. Third series of Probable Link Reports
4. Status Report: Exposure to PFAAs and markers of kidney function in children and adolescents

1. Science Panel studies update

All the data on health and exposure have been collected and the teams led by the three members of the C8 Science Panel are working on analyzing and interpreting the large amount of data assembled.

Due to the large number of remaining Probable Link assessments, the C8 Science Panel notified the Settling Parties and the Court of the need for an extension on June 25, 2012. This was confirmed at a Status Hearing, at which the Science Panel spoke by telephone link, in Wood County Court on July 16, 2012. The final series of Probable Link assessments by the C8 Science Panel will now be submitted by the end of October 2012.

Study results have contributed to Science Panel Probable Link determinations and will continue to do so until they are complete, by October 2012.

Each quarter the Science Panel teams are making progress in completing analyses and interpretations of the data they have assembled. For each disease we have to wait for sufficient results to be available before we can complete the evaluation and make a decision on whether or not there is sufficient evidence to declare a Probable Link between PFOA exposure and a disease. This evaluation phase is well underway and the third set of reports on Probable Links are summarized in this newsletter. The Science Panel is on schedule to complete the remaining Probable Link determinations by the end of October 2012. The Science Panel will then have completed its work and we will have one final newsletter.

2. Science Panel submits Probable Link Reports to the Court

The C8 Science Panel issued its third series of Probable Link assessments on July 30, 2012. This third series addresses infectious, neurological, stroke, and thyroid disease outcomes. The last series of Probable Link assessments is now scheduled to be issued by the end of October 2012. The Science Panel submitted these reports to the Court via the Settling Parties. These reports considered whether there was evidence to support a Probable Link between C8 (PFOA) exposure in the community and autoimmune disease, infections, neurodevelopment, respiratory disease, stroke, or thyroid disease. The Science Panel also submitted a Status Report on kidney function. They are summarized below.

As mandated in the language of the Settlement creating the C8 Science Panel, a Probable Link means that it is more likely than not that there is a link between exposure and a medically significant health outcome in the members of the settling class. The Science Panel weighed evidence from all sources, including the C8 Health Project, various C8 Science Panel studies, and other scientific research. The conclusion emerging from this third series of Probable Link assessments is that there is a Probable Link between C8 (PFOA) and ulcerative colitis and thyroid disease; but that there is not a Probable Link between C8 and other autoimmune diseases, common infections, neurodevelopmental disorders in children, respiratory disease, or stroke.

At the time of the submission of the Probable Link documents to the Court on July 30, 2012, the C8 Science Panel held a press conference to release these findings and provide an explanation of the reasoning and implications of them to the media, and thus to the public. The C8 Science Panel is planning to complete these by the end of October 2012. These will follow the same procedure, with preparation and submission of a written report to the Settling Parties and a press conference to disseminate the judgments that have been reached.

 The Science Panel members, while visiting Parkersburg for the press conference on Monday, July 30, also visited the local attraction, Blennerhassett Island, with the restored house pictured here.

The Science Panel members, while visiting Parkersburg for the press conference on Monday, July 30, also visited the local attraction, Blennerhassett Island, with the restored house pictured here.

 

 

 

 

 

 

 

 

 

 

 

 

3. Third series of Probable Link Reports

On July 30, 2012 the Science Panel submitted six Probable Link Reports to the Wood County Court. The Science Panel has concluded that there is a Probable Link between C8 (PFOA) and ulcerative colitis and thyroid disease; and that there is not a Probable Link between C8 and other autoimmune diseases, common infections, neurodevelopmental disorders in children, respiratory disease, or stroke. All other remaining Probable Link decisions will be issued by the end of October 2012. These conclusions are summarized below and are available in full on the Science Panel website. For each decision, in reaching an evaluation of a Probable Link between C8 and disease, the Science Panel considered evidence from toxicologic data in animals, epidemiologic studies by others and four epidemiologic studies by the Science Panel.

Probable Link Evaluation of Autoimmune Diseases

Autoimmune diseases are diseases in which one’s body’s immune system attacks oneself. These diseases are generally relatively rare. They are not usually fatal but are incurable diseases which cause serious chronic discomfort and may be disabling. We considered the five most common autoimmune diseases that occur in the Mid-Ohio Valley. It should be noted that some of these diseases, such as inflammatory bowel disease, are likely to involve both auto-immunity and other non-autoimmune processes.

On the basis of epidemiological and other data available to the C8 Science Panel, we conclude that there is a probable link between exposure to C8 (also known as PFOA) and ulcerative colitis, and find no probable link between PFOA and any of the other autoimmune diseases (rheumatoid arthritis, lupus, type1 diabetes, Crohn’s disease, or multiple sclerosis).

Probable Link Evaluation of Infectious Diseases

Common infections include coughs, colds, flu, and other infections. These infections were classified into different categories according to severity, site, and probable etiology. In terms of severity, infections were defined as minor/seasonal (cold, sinus infection, flu, and sore throat), medium severity (cold sore, bronchitis, ear, tooth, mouth, gastrointestinal, and skin infection), and severe infections (pneumonia, shingles, and meningitis). Respiratory infections included cold, sinus infection, flu, sore throat, bronchitis and pneumonia; gastrointestinal infections included mouth, tooth and gastrointestinal tract infection; “other sites” included cold sore, shingles, meningitis, and ear and skin infections. Infections were also classified as of viral/probable viral aetiology (cold, sore throat, flu, cold sore, bronchitis, shingles, ear and gastrointestinal infections) and of bacterial/probable bacterial etiology (sinus, mouth, tooth, and skin infections).

On the basis of epidemiological and other data available to the C8 Science Panel, we conclude that there is not a probable link between exposure to C8 (also known as PFOA) and common infections, including influenza, in children or adults.

Probable Link Evaluation of Neurodevelopmental Disorders in Children

The Science Panel addressed the possibility that PFOA may affect risk of neurodevelopmental disorders in children, including attention deficit hyperactivity disorder (ADHD) and learning disabilities. We assessed IQ; reading and math skills; language, memory and learning; visual-spatial processing; and attention using standardized instruments for measuring these realms.

On the basis of epidemiologic and other data available to the C8 Science Panel, we conclude that there is a not probable link between exposure to C8 (also known as PFOA) and neurodevelopmental disorders in children, including attention deficit disorders and learning disabilities.

Probable Link Evaluation of Respiratory Diseases

Asthma and COPD (chronic obstructive pulmonary disease or chronic obstructive airways disease) are both inflammatory lung diseases and although acute exacerbations may be triggered by viral or bacterial infections, the etiology of the diseases is thought to be primarily non-infectious. Asthma is an immune-mediated inflammatory disease.

On the basis of epidemiological and other data available to the C8 Science Panel, we conclude that there is not a probable link between exposure to C8 (also known as PFOA) and asthma or chronic obstructive airways disease (COPD).

Probable Link Evaluation of Stroke

This report considers stroke, also referred to as a cerebrovascular accident, which is defined as the sudden death of brain cells resulting from inadequate blood flow. This can result from blockage of an artery supplying blood to the brain or leakage of blood into the brain tissue. Symptoms vary and may include paralysis, loss of speech or memory, and loss of consciousness.

On the basis of epidemiologic and other data available to the C8 Science Panel, we conclude that there is not a probable link between exposure to C8 (also known as PFOA) and stroke.

Probable Link Evaluation of Thyroid Disease

Thyroid hormones play important roles in regulating metabolism, growth, and development. The pituitary gland produces thyroid-stimulating hormone which regulates the production of thyroid hormones, as needed. There are several major disorders of the thyroid gland, but the most common ones are either hypothyroidism or hyperthyroidism. Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone, i.e. the thyroid gland is under-active. In contrast, if the thyroid is too active, it makes more thyroid hormones than the body needs; this disease is known as hyperthyroidism.

On the basis of epidemiological and other data available to the C8 Science Panel, we conclude that there is a probable link between exposure to C8 (also known as PFOA) and thyroid disease.

4. Status Report: Exposure to PFAAs and markers of kidney function in children and adolescents

After delivering the third series of Probable Link findings, the Science Panel submitted a Status Report on kidney function to the Wood County Court on July 30, 2012. This report is summarized here.

This report summarizes findings relating concentrations of PFOA (C8) and other perfluoroalkyl acids (PFAAs) – PFOS, PFNA, and PFHxS – in serum and markers of kidney function among children and adolescents aged 1 to 17 years living in the Mid-Ohio Valley. We analyzed data from the questionnaires and blood tests collected for children in the C8 Health Project in 2005-2006. In addition, we were able to estimate PFOA exposure at time points prior to 2005 for a subset of the children with residential histories. This allowed us to compare estimated PFOA exposure during in utero development and early childhood with kidney function during later childhood and adolescence.

In conclusion, although we observed an association between measured levels of PFOA in serum and reduced kidney function in children and adolescents, our findings highlight the possibility that this association and resulting increased concentrations of PFOA may be a consequence of, rather than a cause of, decreased kidney function.