Sustained Outrage

Science Panel updates pregnancy outcome report

The C8 Science Panel must be getting the message … because their latest Status Report — just filed in Wood Circuit Court this afternoon — actually contains some data to back up their conclusions.

This Status Report is an update of the panel’s previous report on pregnancy outcomes, which was released in July. This is a broader look than the previous report, using a linkage between C8 Health Project data and state birth records to, among other things, follow women from one residence to another and estimate their C8 intake from local water supplies.

The Science Panel’s summary says of this new analysis, looking at stillbirths, pregnancy-induced hypertension, preterm birth, and several indicators of the infant’s size, including low birth weight and average birth weight:

Overall, these results provide little or no support for an association between PFOA exposure and any adverse effects on pregnancy.

But it also includes these interesting tidbits:

… But there was some indication that male infants with the highest exposure to PFOA weighed slightly less at birth.

… There was some indication that female infants with the highest exposure to PFOA weighed slightly less at birth.

The panel said of these findings:

These small differences in birth weight with conflicting patterns across the two analyses, one limited to male births and the other [to] female births, are of uncertain significance.

On Monday and Tuesday evenings, the three-person C8 Science Panel will for the first time in its more than five years of activity hold public meetings to talk with the people of the Mid-Ohio Valley about its work.

Meetings are scheduled for Monday at Blennerhassett Middle School Auditorium in Parkersburg and Tuesday night at Meigs Local Middle School Auditorium in Pomeroy, Ohio. Both meetings start at 6 p.m.

We’ve written before here about how the C8 Science Panel’s periodic “Status Reports” are pretty bare bones, and don’t contain any data that would really allow anyone to critique the judgments being made by the panel.

And now, a series of new presentations — delivered by Science Panel members at an International Society for Environmental Epidemiology meeting last week in Barcelona, Spain — provides some interesting examples of how the panel’s Status Reports to the community differ from the data they report to other scientists in journals and at academic conferences. Here’s what I mean:

Back in July, the Science Panel issued a Status report called Serum PFOA and liver function markers in the blood of adults in the Mid-Ohio Valley that found an association between higher C8 levels and higher levels of one liver function marker, ALT. The panel also reported that neither of the other two markers examined, GGT or bilirubin, showed a clear relationship with C8, but provided no data to support that conclusion.

In a later interview with me, Science Panel member Tony Fletcher kind of hedged, though, when pressed about these findings … and now we know why.

As part of a presentation in Barcelona, Dr. Fletcher released some data results from this particular Science Panel study. I’ve posted a copy of this presentation here. This is what the new presentation — for the first time — says:

— There is some suggestion of an association between PFOA and GGT in linear regression models; however, these were not replicated in logistic regressions.

The relationship between PFOA and direct bilirubin is suggestive of an increase in bilirubin [with] increasing PFOA concentations up to 40 ng/ML, followed by a decrease in bilirubin after this peak.

— Negative associations observed in some occupational studies might be due [to] inclusion of subjects in the higher range of exposure missing the first part of the inverse U-shaped curve.

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C8 Science Panel schedules public meetings

DuPont Co.’s Washington Works plant near Parkersburg.

For the first time since they announced their initial study plans five years ago, the C8 Science Panel is actually going to meet with and hear from residents of the Mid-Ohio Valley.

The three-member panel just issued this news release, saying:

The C8 Science Panel is organizing two public forums for those interested in hearing more about the status of its work. The public will have a chance to ask the C8 Science Panelists questions, and hear their explanation of the scientific process that goes into making the determination of whether there is a probable link between C8 exposure and human disease.

The C8 Science Panel (Dr. Tony Fletcher, Dr. Kyle Steenland, and Dr. David Savitz) will be present with a complete update on the progress they’ve made so far, and the steps they are taking toward the end result. If you have an interest in the C8 investigation process, we invite you to attend one of these meetings. There are two public meetings each starting at 6pm and planned to last an hour and a half

The meeting schedule:

Monday, September 26, 6pm
Blennerhassett Middle School Auditorium
444 Jewel Road
Parkersburg, WV 26101

Tuesday, September 27, 6 pm
Meigs Local Middle School Auditorium
42353 Charles Chancey Drive
Pomeroy, OH 45769

It’s not clear from the press release how much of the 90-minute meetings the Science Panel plans to take up with their own presentations — and how much time they plan to allow for members of the public to ask questions or make statements. It’s also not clear if the Science Panel is going to make some sort of record — a video recording or a transcript — of the meeting, or create a public archive of any materials provided to them by citizens who appear at the meetings.

A separate statement that was emailed to the media does say:

The format for both meetings will be exactly the same, so interested attendees are asked to choose one meeting most convenient for them in order to maximize participation.

The forums will consist of a short introduction by the Panelists including updates of where the research is now, what they’ve done to get to this point, and when final results can be expected. Questions will then be taken from the public.

That statement also says:

No new results or conclusions will be announced at the meeting. This is rather an opportunity, while the work is still ongoing, for dialogue between the local community and the Science Panel. The Science Panel hopes to have the opportunity to learn more of community concerns and explain more of the process of the science, the results and their careful consideration in this landmark case.

These meetings were scheduled only after Wood Circuit Judge J.D. Beane blasted Science Panel members Tony Fletcher, Kyle Steenland and David Savitz at a court hearing in May for not moving fast enough and not doing enough to update the community on their work.

Latest WVU study ties C8 to chronic kidney disease

There’s another significant new study out from the folks at West Virginia University’s C8 Health Project, who are churning out tons of important research about the potential toxic effects of the DuPont chemical C8.

This one is called Perfluoroalkyl Chemicals and Chronic Kidney Disease in U.S. Adults (subscription required) and was published last week in the American Journal of Epidemiology.

The study examined data for more than 4,500 adults from the National Health and Nutritional Examination Survey, or NHANES, and found associations between higher levels of C8 and PFOS exposure and chronic kidney disease, or CKD.

These associations were independent of possible other factors, such as age, sex, race/ethnicity, body mass index, diabetes, hypertension and cholesterol levels.  One caution is that the NHANES data, because it measures C8 levels in blood and CKD at the same time, it cannot tell us which came first — the chemical exposure or the kidney disease.

Still, author Anoop Shankar and colleagues report:

Our results contribute to the emerging data on the health effects of PFCs, suggesting for the first time that PFOA and PFOS are potentially related to CKD.

… Our findings are of public health importance because serum PFCs appear to be positively related to kidney disease even at relatively low background exposure levels in the U.S. general population.

They continued:

… If our findings are replicated in future prospective studies, the population attributable risk of CKD by PFC exposure would be high. This is unlike findings form certain other specific populations that were exposed to very high serum PFC levels through local environmental contamination. Also, because PFCs are manmade, it may be possible to remove this excess exposure risk.

This new WVU study comes on the heels of the C8 Science Panel’s report outlining associations between chemical exposure and kidney cancer deaths in DuPont workers (see here and here).  So far, though, I don’t believe that we have seen any results from the Science Panel on chronic kidney disease among the non-worker population in the Mid-Ohio Valley.

Two weeks ago, we reported on the findings of a West Virginia University study that raised serious concerns about the relationship between exposure to C8 and the function of the thyroid gland.

And today, the C8 Science Panel has made public a summary of its latest report on the matter — raising more questions about how exposure to C8 and similar chemicals affects thyroid function and thyroid disease in kids.

The most significant new piece of information?

Science Panel members found a 50 percent higher risk of thyroid disease among kids exposed to higher levels of C8.

In a three-page status report, the Science Panel concludes its latest results:

… Suggest that exposure during childhood to two perfluoroalkyl acids, PFOS and PFNA, may be capable of disturbing thyroid hormone levels. Reported thyroid disease in children was found to be associated with PFOA but not PFOS or PFNA,

The panel cautioned that “the results are not sufficient to prove that PFOA is leading to increased thyroid disease” but also concluded:

Taken together, these new findings suggest that normal thyroid function may be affected by exposure to one or more of the family of pefluoroalkyl acids.

The Science Panel explains the importance of any connection between C8 exposure levels and the thyroid this way:

Disturbances to the thyroid system, particularly in children, may have a number of negative effects, as thyroid hormones play important roles in regulating metabolism, growth and development, especially in normal brain maturation and development.

In this particular study, the Science Panel compared blood levels of thyroid-stimulating hormone, or TSH, and total thyroxine (TT4) to levels of C8 and similar chemicals in the blood of 10,725 children ages 1 to 18 years. They also compared the hormone levels to the C8 in the blood of mothers at the time of pregnancy.

And, the Science Panel looked at the number of children for whom a diagnosed thyroid disease was reported.

The three-scientist panel found that thyroid disease “was positively associated with” C8 levels in the child “with borderline statistical significance.”  The panel reported a 50 percent higher risk for hypothyroidism for those with higher levels of C8 versus lower levels of the chemical.  Similar associates were found for both C8 levels in the child’s blood and the mother’s blood while pregnant.

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Revisiting the reporting on the latest C8 reports

On Monday, a commentator named Jon Entine, working for a group called the Statistical Assessment Service, or STATS, published a piece called “Toxic Alert: There’s a Killer, C8, Lurking in Your Kitchen, Says the Associated Press — Oops, Maybe Not!”

Mr. Entine alleges that I (and Vicki Smith from the AP) botched coverage of the recent release of status reports from the C8 Science Panel, the three-person committee investigating potential health effects of C8, also known as PFOA. His piece concluded:

Ward appears to embrace a conspiracy theory. He’s resistant to the likelihood that the C8 scientists are actually doing their job, independently, letting the ideological chips fall where they may. He and the AP’s Smith seemed determined to “correct” the public record on the C8 panel’s behalf, presenting a narrative they believe the scientists should have written, not what they actually found. The result was two misleading pieces, including the AP’s C8 Godzilla, unleashed into cyberspace.

I’m writing this post to address and respond to Mr. Entine’s allegations. I encourage you to first click here and read what he wrote, and then come back and read through this post. You can read my initial blog post on this story here and the Gazette print edition here. The AP story is available here.

We’ll take the findings of the C8 Science Panel’s study of liver function markers first. Here’s what Mr. Entine wrote:

The summary report on C8’s impact on the liver functions was highly anticipated because it was designed to address a question posed earlier in the research: what’s the relationship between increased levels of C8 and three markers, bilirubin, ALT and GGT. Analyzing data from 47,000 adults, the panel found no direct link between increased levels of C8 and bilirubin or GGT. Ward and the AP ignored these unexpected but scientifically significant findings.

Rather, they both led with the only sensational finding, an association, described by the panel as “small,” between increased levels of C8 in blood and ALT. The scientists also stressed the study’s structural “limitation,” which it wrote “makes it impossible to know whether PFOA can cause changes in liver markers.”

But the relationship between GGT and bilirubin is not as clear as he makes it sound. The Science Panel did not report that it “found no direct link” between those markers and C8. What they said was that neither of those two markers “showed a clear relationship with C8 exposure.”

Keep in mind: At this point, we haven’t seen the data the C8 Science Panel relied on. All we have is their summary “status report” filed with the Wood Circuit Court and posted on their Website. As we reported in a follow-up story on Sunday

In an email interview, panel member Tony Fletcher of the London School of Hygiene and Tropical Medicine said the detailed data about the other enzymes and C8 would be released once a formal scientific paper is published.

But, Fletcher said, the pattern of comparisons between C8 exposures and the other enzymes was “not completely flat,” but that the “pattern is less convincing” than with ALT.

While Fletcher said his personal conclusion is there is “little or no evidence of an association, he also said the results “are insufficient to prove an association, but also insufficient to conclude there is no association,” Fletcher said.

In addition, even the status report the Science Panel released wasn’t as clear-cut in arguing no impacts from C8 as Mr. Entine would have it sound. While he describes the association between ALT and C8 exposure as “small,” Mr. Entine truncated the quote. Here’s the entire sentence:

In conclusion, a small but clear linear association between PFOA and PFOS serum concentrations and ALT, a marker of liver injury, was observed in this large population.

Mr. Entine didn’t mention this further elaboration by the Science Panel:

This association with ALT is unlikely to be due to chance, as it is highly statistically significant. It is not explained by the other detailed information included in the statistical models — age, physical activity, body mass index (BMI), average household income, educational level, race, alcohol consumption and cigarette smoking.

What’s more, ALT is the most significant marker here, the one that is the most accurate in predicting liver disease and also the least likely to be influenced by other factors, such as alcohol consumption.

And, Mr. Entine left out any mention of this additional finding:

Increases in another similar chemical called PFOS, which was not released from the DuPont plant, were associated with increased levels of the two of the markers: ALT and bilirubin.

Contrary to Entine’s bottom line — that the Science Panel’s findings are good news regarding any potential association between C8 and markers of possible liver disease — the panel actually reported:

These results show a positive association between PFOA and PFOS concentrations and ALT serum levels, a marker of liver cell damage. This observed association between PFOA and PFOS with ALT is consistent both in terms of direction and magnitude with previous findings of occupational studies. Notably, these results are also consistent with data coming from a general population survey where background concentrations of PFOA are much lower compared to those reported here.

Continue reading…

When last we heard from the three scientists on the C8 Science Panel, they were explaining to Wood County Circuit Judge J.D. Beane all their reasons for not yet issuing a finding about whether there is a “probable link” between exposure to the chemical C8 and adverse human health effects.

Well, the Science Panel has very quietly concluded three more of its many studies, and the findings are interesting and important:

— An association between increased levels of C8 in blood and increased alanine aminotransferase, or ALT, an enzyme that can indicate liver damage.  The Science Panel said:

This association with ALT is unlikely to be due to chance, as it is highly statistically significant.

— Significantly increased rates of death among more highly exposed workers from DuPont’s Washington Works plant from kidney cancer and non-malignant kidney disease. The panel reported:

… The increased risk for the more highly exposed in relation to malignant kidney and non-malignant kidney disease could possibly be due to PFOA; the kidney is a site in the body where PFOA is found.

—  Evidence of an association between C8 exposure and pre-eclampsia among pregnant women living in areas where DuPont’s chemical had polluted drinking water supplies.  Unlike some previous studies, the Science Panel did not, however, find associations between C8 exposure and reduced birth weight. The panel said:

There are no other studies to support or challenge our finding of an association for pre-eclampsia. The association with pre-eclampsia is small but clearly present based on a variety of ways of examining exposure.

I haven’t yet seen any indication of the C8 Science Panel‘s plans for distributing the results of these three new studies to the public in the Mid-Ohio Valley. Lawyers for DuPont and the area residents who sued the company were briefed on the studies and have provided summaries of them to Judge Beane.

I’ve posted copies of those publicly available summaries here.

UPDATED:  Very shortly after I posted this item on our blog, a press release showed up in my email inbox from Lisa Collins, on behalf of the C8 Science Panel. I’ve posted its contents below:

The C8 Science Panel submitted three reports to the Wood County Court this week, summarizing findings from three separate studies of information collected and tests performed on participants in the C8 Health Project and a follow-up study of workers at the DuPont plant where Teflon is manufactured.

The first report, investigating liver function markers, related C8 levels in 47,092 adults to three clinical markers of liver function. The three markers measured include bilirubin, ALT (alanine aminotransferase), and GGT (gamma glutamyltransferase). With all three markers, increased levels indicate lowered liver function.

While there was no direct association between increase of PFOA (C8) and bilirubin or GGT, there was an increase in levels of ALT , related to increasing PFOA.

However, the Science Panel advises caution in interpreting this link found between PFOA and a marker of liver injury, because of the cross-sectional design of the C8 Health Project. Both PFOA and the liver markers were measured at the same time and therefore we cannot be sure whether the PFOA exposure came before any changes in markers of liver function. Ongoing work is addressing whether liver disease may be affected by raised exposure to PFOA.

The next report submitted to the court detailed the mortality (death) rate of workers employed at DuPont. The group included 5793 workers employed there between 1948 and 2002. The Science Panel looked at 92 causes of death, and the only one significantly higher than the US population was mesothelioma, a rare cancer caused only by exposure to asbestos and unlikely to be related to PFOA. Significant trends of increased kidney cancer and nonmalignant kidney disease were seen with higher PFOA exposure, based on small numbers. There was no overall excess of kidney disease compared to the US population.

The panel noted that mortality studies are not the best way to study many diseases which may not be fatal. Therefore they have conducted an additional worker study based on disease occurrence rather than deaths, and those results will be available in the first half of 2012.

In the third report, the group analyzed pregnancies of women occurring between 1990 and 2005, and studied the relationship between PFOA exposure around the time of pregnancy and the risk of miscarriage (loss of pregnancy before 20 weeks), stillbirth (loss of pregnancy after 20 weeks), preeclampsia (a condition involving high blood pressure and leakage of protein into the urine during pregnancy), preterm birth (early delivery), term low birth weight (an indication of reduced growth), and birth defects (abnormalities in the infant).

No association was found between PFOA levels and miscarriage, stillbirth, preterm birth, low birth weight or birth defects. There was a small but clear connection between preeclampsia and higher levels of PFOA. There are no other studies to support or challenge this finding. The group will be obtaining additional information on preterm birth and birth weight from ongoing analyses of health department birth records for the study area. These new records will be combined with the current records and other new data before a final assessment about pregnancy outcomes is made.

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 the 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 Providence, Rhode Island. The three panelists were agreed upon by both DuPont and the plaintiffs. They are Dr. Tony Fletcher, Dr. Kyle Steenland, and Dr. David Savitz. More information on the panel and its work can be found here.

C8 exposure linked to osteoarthritis

The folks at West Virginia University’s C8 Health Project just keep churning out important new papers about the potential impacts of the toxic chemical DuPont for years used to make its prized Teflon products.

Just this week, Drs. Kim Innes and Alan Ductman, along with others, had a paper in the respected scientific publication the American Journal of Epidemiology.

The paper reports, apparently for the first time, a significant association between exposure to C8 and the development of osteoarthritis, a degenerative joint disease and the most common form of arthritis.

Interestingly, the relationship between chemical exposure and the disease was significantly stronger among younger people and non-obese adults. Also interesting is the fact that the researchers found a negative association between PFOS exposure and osteoarthritis.

The study is based on the C8 Health Project’s work looking at the data from roughly 70,000 residents of the Mid-Ohio Valley who gave blood samples and medical histories to the project, funded by money from a legal settlement between the residents and DuPont.

Researchers concluded:

… We found a significant, positive, linear association between PFOA and reported diagnosis of osteoarthritis and a signficant negative association between PFOS and osteoarthritis. If replicated in prospective studies, these findings could have substantial public health implications and may inform future studies regarding possible mechanisms underlying the development and progression of this important and common chronic disorder.

This study comes on the heels of another major study of C8/PFOA, published in the journal Environmental Health Perspectives and reported on here by the great Marla Cone:

… Scientists with three federal agencies who studied mice exposed in the womb to a chemical used to make Teflon found delayed breast development and impaired lactation. The effects were found in the mice at the concentrations detected in the water supply of an Ohio town near a DuPont Co. plant that uses the chemical, known as PFOA. Water supplies are not routinely monitored for it.

“If human exposures in distinct populations are approximating those provided in this study, concern over human breast health and lactational competency are justified,” said the authors, led by Suzanne Fenton, a mammary gland expert at the National Toxicology Program.

That study was published as part of a major editorial in which scientists urged federal officials to add new tests for industrial chemicals and pesticides to find out which ones could disrupt breath development. That editorial said:

Given the magnitude of potential public health impacts on breast feeding and breast cancer, it is critical to strengthen testing methods and give more weight to them in policy decisions. Good decisions about pollution limits, pesticide approvals, and chemicals in consumer products and food rely on a full and accurate understanding of risks associated with exposure.

Judge sets hearing with C8 Science Panel

Wood Circuit Judge J.D. Beane has scheduled an unusual hearing for tomorrow afternoon in Parkersburg … the hearing is billed as a “status conference” in the landmark case in which DuPont agreed to fund an in-depth review (subscription requited) of the potential human health impacts of its chemical, C8.

Present will be lawyers for DuPont and for the thousands of residents whose water supply was contaminated with C8 from the company’s Washington Works plant outside Parkersburg. Also present, I understand, will be all three members of the C8 Science Panel, which is charged under the court settlement with determining if there is a link between C8 exposure and adverse health effects.

Importantly, if the Science Panel concludes there is a probable link, then DuPont is on the hook for up to $235 million to fund future medical monitoring for residents who drank the C8-contaminated water.

Already, DuPont expects to have spent $32 million to fund the Science Panel between 2009 and the end of this year, according to the company’s most recent filing with the U.S. Securities and Exchange Commission.

Perhaps the judge is going to ask Science Panel members to explain exactly how far along they are toward making their “probable link” determination.

Regular readers know that the Science Panel has published a number of reports that found associations between C8 exposure and adverse health effects, including high cholesterol, hypertension and other cardiovascular diseases, immune system changes, birth defects and high blood pressure in pregnant womenelevated cholesterol levels in children and teens, early puberty in children, and Attention Deficit/Attention Deficit Hyperactivity Disorder and Learning Disorder among children.

Other recent studies have also found C8 to be associated with, among other things, early menopause in women, and thyroid problems. The law firm of Hill, Peterson, Carper, Bee & Deitzler, which represents residents in the case, has posted a new collection of C8 health studies on its website.  You can search them chronologically or by toxic endpoint.

The  Science Panel’s current timeline calls for it to be continuing its work on other studies of C8’s impacts through sometime next year.

C8 update: About that new WVU study …

The Parkersburg-area media had an interesting take on last week’s new WVU study about the potential impacts of the toxic chemical C8 on the early onset of menopause among women.

The first paragraph of the story summarized the WVU study, but the article didn’t get to any further details about what the scientists studied or reported until much later in the piece. Instead, the next few paragraphs were simply quotes from a prepared statement issued by DuPont:

“This paper does not actually report an association between early menopause and exposure to PFOA. The authors do not present any data in this study that would suggest any associations at all between PFOA and endocrine disrupting effects. The study does not demonstrate a statistical correlation between PFOA exposure and the onset of menopause in women between 18 and 42 years of age. If early onset of menopause were to occur, it would be observed in this age group. The authors neither present data nor make such a claim in the paper,” said Robin Ollis Stemple, external affairs, Washington Works spokesperson for DuPont.

“The authors state that additional caveats include the fact that information about menopause comes from survey data and was not independently confirmed, nor was it possible to establish the exact age of menopause. Further, the authors reported no association between PFOA exposure and levels of estradiol in any age group,” said Janet E. Smith, Global public affairs leader, DuPont Chemicals and Fluoroproducts, DuPont spokesperson.

Huh?

The Gazette was the first media outlet to report the findings of this study, published in the Journal of Clinical Endocrinology & MetabolismIn our story, we explained the findings this way:

Women exposed to higher levels of the toxic chemical C8 were more likely to have experienced menopause, according to a new West Virginia University study that offers some of the strongest evidence to date that such chemicals disrupt the human body’s natural hormone system.

The study found an association between chemicals called perfluorocarbons, or PFCs, in women’s blood and the onset of menopause. It also found that higher levels of the chemicals appeared related to lower levels of estrogen.

A story by ABC News explained it in a similar way:

Chemicals found in everyday products such as non-stick pans, clothing, furniture, carpets and paints have been associated with the early onset of menopause, according to a new study from the West Virginia University School of Medicine.

But that Parkersburg paper’s report got me wondering if maybe I misunderstood something here, especially the part where a DuPont publicist said:

This paper does not actually report an association between early menopause and exposure to PFOA.

So I circled back to Sarah Knox, the WVU researcher who was the study’s lead author, and asked about the DuPont comments … Dr. Knox told me:

The study found that women with higher levels of two PFCs, perfluourooctanoic acid (PFOA) and perflourooctane sulfonate (PFOS) were more likely to have experienced an early menopause.

The conclusion was that the two PFC are associated with this outcome. In addition, one of the PFCs (PFOS) was also associated with lower estradiol (an estrogen level).

Of course, no one study proves something this complicated, and as Dr. Knox pointed out:

These results add to and are consistent with other animal and human studies suggesting endocrine disruption. However we were clear in the published paper and in intereviews that this single study was short of proof that PFOA and PFOS are the cause of the earlier menopause.