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Monday, April 21, 2014

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Silencing Science: What You May Never Know about Plastic Baby Bottles

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This summer in a federal courtroom in Texas, attorneys for a Tennessee corporation with $9 billion in market capitalization will try to convince a federal judge to suppress the findings of a small, private lab in Austin. The lab, founded by a professor from the University of Texas, determined that resins produced by Eastman Chemical Company, and plastic consumer goods made from those resins, contain “estrogenic-active” chemical compounds that scientific research describes as a health risk, particularly to fetuses, infants, and children.

Eastman is asking a federal judge and jury to silence the professor and the small group of scientists who are co-owners of two Texas labs.

The pre-trial phase of the lawsuit is being conducted under extraordinary suppression of information and documents, at the request of the plaintiff, Eastman Chemical.

The Spectator has reviewed hundreds of pages of documents, vital to the public interest, about products consumed by millions of people every day.

The scientific method is on trial in Texas.

As extraordinary as the secrecy surrounding the trial is the absence of a national debate about plastic products that—if results of the labs in Texas are valid—pose a health risk to hundreds of millions of consumers every day.

It is predictable that the manufacturer of the resin, and commercial interests that use its plastic in bottles and food containers, would prefer to avoid a debate about a product that represents “a substantial risk of causing adverse health effects in humans, particularly in the developing fetus, infants, and children.”

The “health effects” quote by Christopher J. Borgert, an expert witness for Eastman in a report filed with the court, leads directly back to studies that found that plastic made from bisphenol A (BPA) is harmful to humans. The science on BPA is conclusive.

“BPA has been shown to be an estrogen,” said Laura Vandenberg in a deposition. “In my opinion, that’s a fact; that’s not an assumption.”

BPA and other estrogenicactive (EA) substances behave like natural estrogen; when inside the bodies of mammals, they become “endocrine disruptors.”

Vandenberg is an expert witnesses for the two labs sued by Eastman: CertiChem and PlastiPure. She has studied the connection between BPA and breast cancer. As a postdoctoral fellow at Tufts University, she is studying the effects of estrogenic-active chemicals on laboratory rats.

In a deposition, Vandenberg disclosed that her former professor, Dr. Ana Soto, who has developed her own test to detect estrogenicity in chemicals, urged her to participate in the lawsuit. Soto is expert witness in the Eastman lawsuit. The defense has also called on Dr. Carlos Sonnenschein—a Tufts Medical School research M.D. with a background in childhood cancer, who now studies “the proliferation of estrogen-target cells.”

A plastic called Tritan is marketed as being free of BPA. According to tests done by a Texas lab, Tritan affects the human body in the same way that BPA plastic does.

Scientific consensus regarding BPA is predictable, considering its effect on the body, particularly reproductive functions. Before it was used to make polycarbonate plastic, BPA was considered for pharmaceutical use as an artificial estrogen in the 1930s.

When the EPA conducted a “ToxCast” survey of 309 potentially harmful chemicals in 2007, BPA was included in the third highest toxicological priority index. In 2009, the U.S. National Toxicology Program warned that BPA could cause behavioral changes in infants and children.

Products for infants and children (and pregnant mothers) are particularly critical, as the adverse effects of estrogen-mimicking BPA are most acute from the fetal stage through puberty.

In 2009, research published in the American Journal of Public Health linked very-low-dose exposure to BPA to increased rates of breast and prostate cancer, chromosomal abnormalities, brain and behavioral abnormalities, and metabolic disorders.

In 2010, Walmart pulled BPA plastic baby bottles and sippy cups from its shelves. The world’s biggest retail chain was responding to the growing body of research on the health risks associated with BPA. In 2012, the Food and Drug Administration followed Walmart’s lead, banning BPA use in baby bottles and cups for small children—in response to an American Chemical Council petition intended to defuse a national campaign to ban all use of BPA in liquid and food containers.


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An alternative to BPA
Eastman was perfectly positioned for a public health crisis in the plastic business. In 2007, it began marketing its trademarked Tritan plastic resins, advertised not only as BPA-free, but EA-free.

That is, a resin that is not only not BPA, but is free from the estrogenic health-risks associated with BPA. Consumers using bottles or food containers made from Eastman Tritan resin would not be ingesting a leachate of chemicals that bind to estrogen receptors in the body.

Producers of plastic containers shifted from BPA to the resins that Eastman advertised as the solution to health risks biologists and toxicologists found in polycarbonate products made from BPA.

Nalgene (water bottles), Thermos Foggo (sippy cups), Sonoma (wine glasses), to name a few brands, turned to EA-free Tritan as an alternative to plastics that leach EA chemicals.

Bisphenol A mimics estrogen, a hormone that can have adverse health effects in the developing fetus, infants, and children.

But what if plastic made from Eastman resin is not EA-free? In 2008, Dr. George Bittner, a University of Texas neurobiology professor and CEO of CertiChem, set out to answer that question.

Bittner’s answer is the issue of contention in the lawsuit that Eastman filed against the two small commercial labs that he and several colleagues established in Austin, Texas, 12 years ago.

CertiChem tested three Tritan resins and 102 bottles and other containers made from Tritan and found they are estrogenic active, according to court documents. Bottles and other finished products were “stressed” before testing to simulate normal usage such as exposure to sunlight and washing in detergents.

If what CertiChem found is correct, when ingested, the estrogenic-active chemical compounds in Tritan will attach to estrogen receptors and can slightly change the way the body functions.

EA chemicals are also androgenic, attaching to androgen receptors in males and potentially altering men’s reproductive function, including prostate and sperm count. Very-low-doses of estrogenic-active chemicals—measured in parts per billion— can effect the biological functions of the body.

Bittner didn’t use the phrase “adverse health risk,” as Eastman witness Christopher J. Borgert did. However, when one of Eastman’s attorneys asked if he considers Tritan safe for human consumption, Bittner said he is “agnostic at best.”

“My bet would be that it probably has a high probability of having adverse health effects … [when] consumed by a particularly vulnerable population, which would be the fetus, the infant, or the juvenile.”

The trial, scheduled for July of this year, will pivot on the assay that Bittner and CertiChem used to test the Tritan resins (or monomers) that CertiChem obtained.

Tritan is made by Eastman Chemical. Court documents reveal that Eastman, in addition to Tristan, also uses a plasticizer with BPA-like properties.

Tests and legal tests
CertiChem’s “cell-proliferation” assay uses a line of cloned breast cancer cells that are responsive to estrogen. (Professors at other universities use different processes with different lines of cloned breastcancer or ovarian-cancer cells.)

In Bittner’s “in vitro” assay (“in vivo” tests use live animals), chemical media that includes Eastman monomers used to produce plastic were introduced into the carcinogenic cell culture. (Monomers are the chemical compounds from which polymer plastics are made.) If the carcinogenic cells, which are sensitive to estrogen, proliferate, it indicates the monomer is estrogenic active. To ascertain that the cell proliferation was caused by the monomer being tested, an anti-estrogenic chemical is added to the culture. If the anti-estrogenic agent stops the cell proliferation, it is further proof that the tested substance is estrogenic active.

There are control tests, using natural estrogen, and a neutral chemical medium, and additional steps and procedures, but the above paragraph describes the basic process of CertiChem’s assay.

When CertiChem CEO (and research Ph.D.- M.D.) Cathy Yang published the test results in 2011 in the National Institutes of Health’s Environmental Health Perspectives, Eastman decided CertiChem had gone too far.

From Eastman’s perspective, there were several transgressions, which are listed in the complaint filed against the Texas labs.

A representative of PlastiPure contacted a client referred to Eastman in court pleadings as the “the Korean company” and described Tritan as estrogenic active. In a brochure prepared for distribution at the 2010 ABC Kids Expo in Las Vegas — billed as “the premier juvenile products show in the world!”—PlastiPure described Tritan monomers and products made from them as estrogenic active.

Eastman argues that the two labs are doing what might be described as a Texas two-step, one lab declaring Tritan monomers unsafe, the other lab selling a process to make them safe. CertiChem tests products for EA toxicity. PlastiPure designs and markets processes that companies can use to retool and create plastics that are EA-free.

Eastman concluded that both companies are a threat to its business, if not a competitor. (CertiChem and PlastiPure rent space in a commercial strip mall in north Austin. Eastman is traded on the NYSE and has $9.4 billion in market capitalization.)

Eastman has exposed itself to public scrutiny that corporations work very hard to avoid.

But there is a larger issue on trial in the courtroom of Judge Sam Sparks, a George H.W. Bush appointee with a reputation for an iron fist and fair-handedness.

The scientific method is on trial in Texas.

Laura Vandenberg has studied in the Tufts University lab of Ana Soto, one of a half dozen stars in the small universe of biologists studying estrogen active chemical agents and endocrine disruptors. Vandenberg described what Soto had told her regarding the Eastman lawsuit:

“She told me that there was a dispute between two companies about what is the nature of an estrogen and that this is a scientific dispute that has moved into a legal venue, and that she felt an obligation as a scientist to get involved because the definition of an estrogen in a legal venue could potentially affect a huge body of already published scientific work as well as work going forward.”

Scientists resolve disputes through peerreviewed research, Vandenberg wrote. To disprove CertiChem’s findings, Eastman could contract with a university lab, or an another independent testing facility, and replicate the experiment. Scientific findings, she argued, cannot be proved out in a courtroom.

Silencing the messenger
Eastman’s attorneys have asked the court to enjoin PlastiPure and CertiChem from ever saying that Tritan “exhibits any measurable level of EA,” and from representing that the MCF-7 test CertiChem used to measure the estrogenicity of Eastman’s Tritan resin “is sufficient, standing alone, to establish that any tested chemical or substance has EA.”

Nowhere in Eastman’s pleadings are the results of those tests refuted.

Asking Bittner and CertiChem to refrain from claiming that their test can detect EA in a chemical or substance would put the company out of business. It could also pose a threat to other labs arriving at similar conclusions.

For 30 years, in-vitro testing for estrogenic activity has provided useful data on chemicals. Soto wrote about the process in Environmental Health Perspectives in 1995, describing in-vitro assays as a valid and efficient means of evaluating the safety of chemicals: “Rodent bioassays are not suited for the large-scale screening of chemicals before their release in to the environment, because of their cost, complexity, and ethical concerns.” Like the tests run by CertiChem, Soto’s E-Screen assay uses cloned MCF-7 cells, although from a different line of cells.

Eastman hired a researcher to publish a peer-reviewed report finding its Tritan is not like BPA plastic. Turns out the report is bunk.

And the results of Bittner’s tests were confirmed after Eastman filed suit. Michael Denison is a professor of environmental toxicology at the University of California, Davis. Brought in as an expert witness by attorneys representing the defendants, Denison supervised tests of Tritan resins in his own lab.

He used a different assay, a BG1-Luc test which uses firefly luciferace to determine if cancerous ovarian cells respond to estrogenic chemicals. Denison found that Tritan “contains compounds with EA,” according to results he filed in court.

The assay that Denison uses has been validated by the U.S. Health Department’s Interagency Coordinating Committee on the Validation of Alternative Methods (an evaluation process that can take as long as 10 years after a test is nominated; Bittner’s MCF-7 assay has been in ICCVAM’s evaluation process for six years).

Blowback from a lawsuit
Denison’s test results, of course, are not the end of the story. The legal and scientific dispute is now left for judge and jury to decide, and Eastman certainly could prevail in court in July.

Yet because the discovery process works two ways, Eastman has exposed itself to public scrutiny that corporations work very hard to avoid.

Not only did tests done in an independent lab reveal that Eastman’s monomers have EA properties, while Eastman was fighting over the estrogenicity of its product, it was revealed in court documents that Eastman monomers include a plasticizer that also possesses EA properties.

Triphenyl phosphate (TPP), which is found in Eastman resins, is a known estrogenic-active chemical compound. Test results that mention TPP were not included in a paper that Eastman paid a toxicologist to write for a peer-reviewed journal, according to court records.

That the paper has become an issue of contention in the trial presents another problem for Eastman. Thomas Osimitz is a Ph.D. toxicologist and the “founder and Principal of Science Strategies, LLC a consulting firm that helps companies of all sizes navigate the turbulent intersection of science, policy, and product development.”

According to court documents, Eastman paid Osimitz $10,000 to serve as lead author of a paper published in Food and Chemical Toxicology entitled: “Lack of androgenicity and estrogenicity of the three monomers used in Eastman’s Tritan™ copolyesters.”

scale“There would be no Eastman author, nor mention of Eastman,” an Eastman consultant wrote in an e-mail described in Osimitz’s deposition.

Although Eastman solicited and paid for the academic paper, and the co-authors recruited by Osimitz provided him disclosure forms indicating they were paid by Eastman, the disclosure that is de rigueur in scientific publishing and required by the journal never appeared in print or online—even after the journal’s editor was made aware of the conflict of interest.

Osimitz’s deposition also revealed the extent of Eastman’s influence in shaping the paper. And his central position in the legal proceeding now brings into focus the flaws in testing commissioned by Eastman, according to expert witnesses for the defense.

Test data involving TPP appears to have been intentionally excluded from the paper. And the rodent testing results that Osimitz published to refute CertiChem’s findings were so flawed they have no predictive value, according to court reports. “The uterotrophic assay presented in the Osimitz paper (2012) is an example of how not to run an in vivo assay correctly,” Denision wrote in submitted testimony.

Vandenberg is more specific. She writes that the rodent study that Eastman commissioned was performed in a way that “does not allow for any conclusion regarding the presence—or absence— of estrogenic properties in the monomer mixture.”

The tests exposed lab rats to dosages she could find nowhere in peer-reviewed scientific literature. “[R]elatively high doses (usually ranging from 50-1000 mg/kg/day) are typically required” to detect “known weak estrogens,” according to Vandenberg.

Eastman’s test dosages, Vandenberg wrote in her report to the court, were 10/mg/kg/day—far below what’s required daily to elicit a response. Eastman’s test, she concluded, was incapable of detecting estrogenic activity.

False advertising, tortious interference, and unfair competition are the heart of Eastman's complaint. But the scientific method, a definition of what estrogen is, and the validity of tests that detect invisible chemical compounds that are a proven health risk are a corollary to the complaints in Eastman’s legal pleadings. These corollary issues are also on trial.

Most critically, testing. And who controls testing.

Eastman wants the judge presiding over the trial, which begins in July, to say scientists didn't find out what they say they found out about Tritan.

When Frederick vom Saal of the Endocrine Disruptors Group at the University of Missouri surveyed 115 tests for estrogenicty in BPA conducted between 1997 and 2005, he found that 90 percent of the 104 studies funded by government detected chemicals that would effect “mammary gland development, disruption of chromosomal alignment in developing eggs in females, altered immune function, metabolic abnormalities, and changes in the brain and behavior.”

Not one of the 11 tests funded by industry detected any estrogenicity in BPA.

It could be that industry doesn’t believe that there is a problem.

When one of the defendants’ attorneys asked Eastman’s Chief Toxicologist Jim Deyo if he believed the FDA reacted to “consumer hysteria” when it banned BPA, Deyo didn’t miss a beat.

“Yes,” he said.

And Eastman is fighting to keep its tests beyond the purview of the judge and jury. In mid-April, it filed a motion arguing that its testing should not be considered in the lawsuit, and that only the results of tests done by CertiChem, which Eastman is trying to discredit and suppress, are an issue in the trial.

The Spectator asked Eastman’s lead attorney for a response to issues raised in the lawsuit and was told a company representative would call. At press time, Eastman had not responded.


Lou Dubose is the editor of The Washington Spectator.


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