The C8 Science Panel was chosen to determine whether a probable link exists between C8 and any human disease as part of a class action settlement of a lawsuit involving releases of a chemical known as C8 from DuPont’s Washington Works in Wood County, West Virginia. The Science Panel is made up of three scientists from universities in London, Atlanta and New York. The three panelists were agreed upon by both DuPont and the plaintiffs. They are Dr. Tony Fletcher, Dr. Kyle Steenland, and Dr. David Savitz.

January 2012 Newsletter Contents:
1. Science Panel studies update
2. Science Panel submits Probable Link and Status Reports to the Court
3. Science Panel progress report
4. First series of Probable Link Reports
5. New Status Reports

1. Science Panel studies update

Nearly 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 the large amount of data assembled.

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 has started and the first reports on Probable Links are summarised in this newsletter. The Science Panel is on schedule to complete the remaining Probable Link determinations by July 2012.

2. Science Panel submits Probable Link and Status Reports to the Court

The C8 Science Panel issued its first series of Probable Link assessments on December 5, 2011. This first series addresses several reproductive health outcomes. The next series of Probable Link assessments is scheduled for spring, while the remainder will be issued by the end of July 2012. The Science Panel submitted these reports to the Settling Parties and passed them on to the Court. These reports considered whether there was evidence to support a probable link between C8 (PFOA) exposure in the community and pregnancy loss (miscarriage, stillbirth), pregnancy-induced hypertension (including preeclampsia), preterm birth, low birth weight, or birth defects.

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 primary series of Probable Link assessments is that there was not sufficient evidence to support a Probable Link with pregnancy loss, preterm birth, low birth weight, or birth defects, but that there was sufficient evidence to support a Probable Link with pregnancy-induced hypertension and preeclampsia.

For the last health outcome, there were several analyses, each with different strengths and limitations, that generated evidence supporting an association, judged more likely to reflect a link to PFOA than to be a result of random error or methodologic problems in these studies. As noted in the conclusions of the report on pregnancy-induced hypertension, although none of the individual studies showed a strong association with a dose-response gradient, an association was found in multiple studies and was present in pregnancies that followed enrolment in the C8 Health Project when the exposure assessment may be most accurate.

At the time of the submission of the Probable Link documents to the Court on December 5, 2011, 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. There was strong representation of the local media and extensive coverage that followed. The C8 Science Panel is planning to issue another series of Probable Link assessments in the spring followed by the completion of these by the end of July 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.

Science Panel Members (from left to right) Kyle Steenland, Tony Fletcher, and David Savitz at a press conference in Parkersburg to deliver first series of Probable Link Reports and new Status Reports on December 5, 2011.

3. Science Panel progress report

In 2011, the Science Panel has been busy with numerous studies. In addition, we held two public meetings, where two commonly asked questions have come up. The first is about which specific diseases are being investigated. For most major diseases, apart from some rare conditions, a deliberation will be made whether there is a probable link with C8 and that disease. The second is about why the Science Panel work takes so much time. We feel strongly that it takes time to conduct the studies properly. The original estimate was that it would take about 3 years after getting the complete C8 Health Project data set, which was received in 2008, so we are approximately on track to complete our work within the estimated timeframe.

Up to now, we have interviewed about 32,000 people twice, obtained medical histories when relevant, and matched data with death, birth, and cancer registries. We have completed a number of studies: one of 200 people to determine the time needed for C8 to exit the body; one of about 400 children regarding neurological development; one of nearly 800 people brought back 4 years after they participated in the C8 Health Project, including tests to see how their blood cholesterol, immune markers, liver function and kidney function have changed during a time when C8 blood levels have greatly decreased; and an extensive study to reconstruct estimated C8 blood levels over time, essential to determine how much C8 was in the blood prior to onset of disease. All of these studies have taken time, but they have been necessary to answer the questions about possible links between C8 and disease.

To date the Science Panel has made probable link judgments only on reproductive outcomes. Still to come are a number of serious chronic diseases, such as heart disease, cancer, and diabetes. As the relevant studies are completed, we will evaluate the evidence and collectively decide on whether there exists a probable link with C8. The next series of reports are scheduled for release in the spring, with the final reports by the end of July 2012. Following the last probable link report, we will have 90 days to deliver the supporting information including de-identified data sets to the Settling Parties. Then, having fulfilled its obligation under the settlement, the Science Panel will be dissolved. If possible, we hope to obtain new funds from other sources to follow this population. Valuable information has been collected and it only makes sense to continue follow-up of Mid-Ohio Valley residents.

The Science Panel acknowledges the initial work of Brookmar, the C8 Health Project, and the help of the citizens of the Mid-Ohio Valley who have cooperated in interviews and participated in studies. They would like to thank them again for this cooperation.

4. First series of Probable Link Reports

On December 5, 2011 the Science Panel submitted four Probable Link Reports to the Wood County Court. The Science Panel has concluded that there is a Probable Link between C8 (PFOA) and pregnancy-induced hypertension and preeclampsia; and that there is not a Probable Link between C8 and birth defects, preterm births, low birth weight, or pregnancy loss. All other probable link outcomes will be issued by the end of July 2012. The research they conducted on reproductive health was completed and enabled them to make a determination. Four types of health concerns related to pregnancy were addressed. These reports are summarized below.

Probable Link Evaluation of Birth Defects

Birth defects are structural malformations in the infant that arise during fetal development. The evidence to evaluate the probable link between PFOA exposure and birth defects comes primarily from use of the C8 Health Project data on serum PFOA levels and self-reported birth defects, and historically estimated PFOA levels. Limited evidence for an increased risk of congenital heart defects with increased estimated serum PFOA was observed in one study, but the Science Panel considered this most likely to be due to chance. In the other studies, either no meaningful associations were found or specific types of birth defects could not be examined due to the small population size.

On the basis of epidemiologic studies and other scientific data available to the C8 Science Panel, the conclusion is that there is not a probable link between exposure to PFOA (C8) and birth defects. For more details, follow this link.

Probable Link Evaluation of Pregnancy Induced Hypertension and Preeclampsia

Pregnancy-induced hypertension is defined as significantly elevated blood pressure that begins after the 20th week of pregnancy. Preeclampsia is a specific type of pregnancy-induced hypertension, which is accompanied by leakage of protein into the urine. The evidence to evaluate the probable link between PFOA exposure and pregnancy-induced hypertension comes from various studies using data from the C8 Health Project (such as residential data, measured serum PFOA, and self-reported pregnancy conditions), data from birth certificates, and historically estimated serum PFOA levels.

While one study found no association between C8 and pregnancy-induced hypertension, other studies showed a small association. There was also evidence of an association between estimated serum PFOA and pregnancy-induced hypertension based on the continuous exposure indicator. Measured serum PFOA was weakly and irregularly associated with preeclampsia, an association that was strengthened when the analysis was restricted to more recent pregnancies.

On the basis of epidemiologic and other scientific data available to the C8 Science Panel, the conclusion is that there is a probable link between exposure to PFOA (C8) and pregnancy-induced hypertension. For more details, follow this link.

Probable Link Evaluation of Miscarriage and Stillbirths

Pregnancy loss refers to miscarriage and stillbirth, the former defined as loss of pregnancy before 20 weeks of gestation and the latter at 20 weeks gestation or later. The evidence to evaluate the probable link between PFOA exposure and pregnancy loss comes from various Science Panel studies using C8 Health Project and follow-up data (such as measured serum PFOA and self-reported pregnancy loss), WV Health Dept vital records, and historically estimated serum PFOA. The studies found no association (or essentially none) between pregnancy loss and measured or estimated serum PFOA exposure among these pregnancies.

On the basis of epidemiologic and other scientific data available to the C8 Science Panel, the conclusion is that there is not a probable link between exposure to PFOA (C8) and miscarriage or stillbirth. For more details, follow this link.

Probable Link Evaluation of Preterm Birth and Low Birth Weight

Preterm birth is defined as early delivery of an infant before completing 37 weeks of gestation. The evidence to evaluate the probable link between PFOA exposure and pregnancy loss comes from various studies, most of which were Science Panel studies, but also included studies from other populations. These studies used, but were not restricted to, data from C8 Health Project and follow-up study (such as measured serum PFOA and self-reported preterm birth), birth certificate records, and historically estimated serum PFOA. Most studies found no association between preterm birth and measured or estimated serum PFOA. An association with early preterm birth and estimated PFOA was found in one study, although the sample size was small. The results from the studies of other populations found little or no association between measured serum PFOA and preterm birth.

On the basis of epidemiologic and other scientific data available to the C8 Science Panel, the conclusion is that there is not a probable link between exposure to PFOA (C8) and preterm birth or low birth weight. For more details, follow this link.

5. New Status Reports

At the same time as they issued the first series of Probable Link Reports, the Science Panel also submitted three Status Reports to the Court.

More detailed summaries and links to each status report follow.

Changes in serum PFOA/PFOS and serum lipids between 2005 and 2010 in the Mid-Ohio Valley

The first report described results from the Science Panel’s Short Term Follow Up study. Nearly 800 participants from the C8 Health Project were invited back and provided further blood samples in 2010, a little over 4 years since the first survey. In that time serum levels of C8 for these people has fallen, on average, by about a half. In the first results from that study, the relationship between cholesterol and changes in C8 levels has been considered. Cholesterol did not change much overall but the change was found to be correlated with the change in C8. The greater the fall in C8, the greater the drop in cholesterol, for LDL cholesterol in particular. For LDL a halving of C8 was associated with a 3.6% drop in LDL.

The full status report can be found here.

Prospective study of reproductive health outcomes in the Mid-Ohio Valley

Also submitted was a report describing a Science Panel prospective study, in which approximately 15,000 women from the Mid-Ohio Valley were interviewed in 2009-2010 about their reproductive outcomes since 2005. There were approximately 1,800 births in this group during the 5-year study period. There was little evidence of an association between 2005 C8 blood levels in the mothers and with miscarriage, preterm birth (<37 weeks), or low birth weight (<5.5 lbs). However, there was some evidence that pregnancy-induced hypertension among mothers giving birth in 2005-2010 in Ohio and West Virginia was associated with increasing levels of PFOA in the blood measured in 2005-2006. Results from this study were used by the Panel in making their overall probable link decisions regarding reproductive outcomes.

The full status report can be found here.

PFOA and adult thyroid disease in the Mid-Ohio Valley

The last report described the association of PFOA and adult thyroid disease in the Mid-Ohio Valley. There were about 33,000 people in the study and 3,600 reported cases of thyroid disease. The Science Panel concluded that data shows a positive association between cumulative blood levels of PFOA and thyroid disease occurrence, using all cases or restricting to cases validated from medical records. Positive trends were statistically significant only for women. The risk of disease increased above the lowest exposure categories, but then did not increase after that.

The full status report can be found here.