Friday, November 14, 2014

The Scary New Evidence on BPA-Free Plastics And the Big Tobacco-style campaign to bury it. By Mariah Blake | Mother Jones

YOU MIGHT WANT TO READ AND FATHOM THE DATA, ESPECIALLY IF YOU HAVE CHILDREN. This lengthy but worthwhile read gives a chilling inside look at safety testing and regulation of plastics which are used in our food supply containers (Everything from your water bottle, to the tin can your soup came in, to the large bulk bin plastics at the health food store, and more.), motivated by one man's concern for his daughter. Safety testing data of plastics can and has been manipulated by industry "experts", who discourage independent research while instigating legal battles that in effect confuse juries and pre-emptively deflate and squelch the revelation of hard evidence, in favor of skewed results. Take a look at WHO is fighting to keep the status quo (former Tobacco industry insiders who fought to prove 2nd hand smoke was "safe". Do you trust them?). Always follow the money and connections, don't just trust that your government and our legal system is flawless.

Money may seem like a powerful tool, but ultimately, Knowledge is power, and the truth will come out. The researchers had what they called an "oh shit!" moment based on test results that demonstrate plastics now in use (that replaced BPA) affect our endocrine system and can permanently alter cells, not only threatening our own health, but making future generations vulnerable to disease due to genetic mutations. Without the pressure of public concern, plastics manufacturers will feel no need to modify the materials that impact you and your descendants. The story is lengthy, but the details are revealing. Please bookmark it to read later if you can't read it now. ~PB


The Scary New Evidence on BPA-Free Plastics
And the Big Tobacco-style campaign to bury it.


Photographs by Evan Kafka
Photographs by Evan Kafka

Update (3/3/14): After this story went to press, the US Food and Drug Administration published a paper finding that BPA was safe in low doses. However, due to laboratory contamination, all of the animals—including the control group—were exposed to this chemical. Academic scientists say this raises serious questions about the study's credibility. Stay tuned for more in-depth reporting on the FDA's most recent study.
Each night at dinnertime, a familiar ritual played out in Michael Green's home: He'd slide a stainless steel sippy cup across the table to his two-year-old daughter, Juliette, and she'd howl for the pink plastic one. Often, Green gave in. But he had a nagging feeling. As an environmental-health advocate, he had fought to rid sippy cups and baby bottles of the common plastic additive bisphenol A (BPA), which mimics the hormone estrogen and has been linked to a long list of serious health problems. Juliette's sippy cup was made from a new generation of BPA-free plastics, but Green, who runs the Oakland, California-based Center for Environmental Health, had come across research suggesting some of these contained synthetic estrogens, too.


He pondered these findings as the center prepared for its anniversary celebration in October 2011. That evening, Green, a slight man with scruffy blond hair and pale-blue eyes, took the stage and set Juliette's sippy cups on the podium. He recounted their nightly standoffs. "When she wins…every time I worry about what are the health impacts of the chemicals leaching out of that sippy cup," he said, before listing some of the problems linked to those chemicals—cancer, diabetes, obesity. To help solve the riddle, he said, his organization planned to test BPA-free sippy cups for estrogenlike chemicals.


The center shipped Juliette's plastic cup, along with 17 others purchased from Target, Walmart, and Babies R Us, to CertiChem, a lab in Austin, Texas. More than a quarter—including Juliette's—came back positive for estrogenic activity. These results mirrored the lab's findings in its broader National Institutes of Health-funded research on BPA-free plastics. CertiChem and its founder, George Bittner, who is also a professor of neurobiology at the University of Texas-Austin, had recently coauthored a paper in the NIH journal Environmental Health Perspectives. It reported that "almost all" commercially available plastics that were tested leached synthetic estrogens—even when they weren't exposed to conditions known to unlock potentially harmful chemicals, such as the heat of a microwave, the steam of a dishwasher, or the sun's ultraviolet rays. According to Bittner's research, some BPA-free products actually released synthetic estrogens that were more potent than BPA.


click here

Estrogen plays a key role in everything from bone growth to ovulation to heart function. Too much or too little, particularly in utero or during early childhood, can alter brain and organ development, leading to disease later in life. Elevated estrogen levels generally increase a woman's risk of breast cancer.


Estrogenic chemicals found in many common products have been linked to a litany of problems in humans and animals. According to one study, the pesticide atrazine can turn male frogs female. DES, which was once prescribed to prevent miscarriages, caused obesity, rare vaginal tumors, infertility, and testicular growths among those exposed in utero. Scientists have tied BPA to ailments including asthma, cancer, infertility, low sperm count, genital deformity, heart disease, liver problems, and ADHD. "Pick a disease, literally pick a disease," says Frederick vom Saal, a biology professor at the University of Missouri-Columbia who studies BPA.




BPA exploded into the headlines in 2008, when stories about "toxic baby bottles" and "poison" packaging became ubiquitous. Good Morning America issued a "consumer alert." The New York Times urged Congress to ban BPA in baby products. Sen. Dianne Feinstein (D-Calif.) warned in the Huffington Post that "millions of infants are exposed to dangerous chemicals hiding in plain view." Concerned parents purged their pantries of plastic containers, and retailers such as Walmart and Babies R Us started pulling bottles and sippy cups from shelves. Bills banning BPA in infant care items began to crop up in states around the country.


Today many plastic products, from sippy cups and blenders to Tupperware containers, are marketed as BPA-free. But Bittner's findings—some of which have been confirmed by other scientists—suggest that many of these alternatives share the qualities that make BPA so potentially harmful.
Those startling results set off a bitter fight with the $375-billion-a-year plastics industry. The American Chemistry Council, which lobbies for plastics makers and has sought to refute the science linking BPA to health problems, has teamed up with Tennessee-based Eastman Chemical—the maker of Tritan, a widely used plastic marketed as being free of estrogenic activity—in a campaign to discredit Bittner and his research. The company has gone so far as to tell corporate customers that the Environmental Protection Agency (EPA) rejected Bittner's testing methods. (It hasn't.) Eastman also sued CertiChem and its sister company, PlastiPure, to prevent them from publicizing their findings that Tritan is estrogenic, convincing a jury that its product displayed no estrogenic activity. And it launched a PR blitz touting Tritan's safety, targeting the group most vulnerable to synthetic estrogens: families with young children. "It can be difficult for consumers to tell what is really safe," the vice president of Eastman's specialty plastics division, Lucian Boldea, said in one web video, before an image of a pregnant woman flickered across the screen. With Tritan, he added, "consumers can feel confident that the material used in their products is free of estrogenic activity."


"A poison kills you," says biology professor Frederick vom Saal. "A chemical like BPA reprograms your cells and ends up causing a disease in your grandchild that kills him."

Eastman's offensive is just the latest in a wide-ranging industry campaign to cast doubt on the potential dangers of plastics in food containers, packaging, and toys—a campaign that closely resembles the methods Big Tobacco used to stifle scientific evidence about the dangers of smoking. Indeed, in many cases, the plastics and chemical industries have relied on the same scientists and consultants who defended Big Tobacco. These efforts, detailed in internal industry documents revealed during Bittner's legal battle with Eastman, have sown public confusion and stymied US regulation, even as BPA bans have sprung up elsewhere in the world. They have also squelched debate about the safety of plastics more generally. All the while, evidence is mounting that the products so prevalent in our daily lives may be leaching toxic chemicals into our bodies, with consequences affecting not just us, but many generations to come.
 

The fight over the safety of plastics traces back to 1987, when Theo Colborn, a 60-year-old grandmother with a recent Ph.D. in zoology, was hired to investigate mysterious health problems in wildlife around the Great Lakes. Working for the Washington, DC-based Conservation Foundation (now part of the World Wildlife Fund), she began collecting research papers. Before long, her tiny office was stacked floor to ceiling with cardboard boxes of studies detailing a bewildering array of maladies—cancer, shrunken sexual organs, plummeting fertility, immune suppression, birds born with crossed beaks and missing eyes. Some species also suffered from a bizarre syndrome that caused seemingly healthy chicks to waste away and die.


While the afflictions and species varied widely, Colborn eventually realized they had two factors in common: The young were hardest hit, and, in one way or another, all of the animals' symptoms were linked to the endocrine system, the network of glands that controls growth, metabolism, and brain function, with hormones as its chemical messengers. The system also plays a key role in fetal development. Colborn suspected that synthetic hormones in pesticides, plastics, and other products acted as "hand-me-down poisons," with parents' exposure causing affliction in their offspring. Initially, her colleagues were skeptical. But Colborn collected data and tissue samples from far-flung wildlife populations and unearthed previously overlooked studies that supported her theory. By 1996, when Colborn copublished her landmark book Our Stolen Future, she had won over many skeptics. Based partly on her research, Congress passed a law that year requiring the EPA to screen some 80,000 chemicals—most of which had never undergone any type of safety testing—for endocrine-disrupting effects and report back by 2000.


Around this time, the University of Missouri's vom Saal, a garrulous biologist who previously worked as a bush pilot in Kenya, began studying the effects of synthetic estrogens on fetal mouse development. The first substance he tested was BPA, a chemical used in clear, hard plastics, particularly the variety known as polycarbonate, to make them more flexible and durable. (It's also found in everyday items, from dental sealants and hospital blood bags to cash register receipts and the lining of tin cans.) Naturally occurring estrogens bind with proteins in the blood, limiting the amount that reaches estrogen receptors. But vom Saal found this wasn't true of BPA, which bypassed the body's natural barrier system and burrowed deep into the cells of laboratory mice.


Vom Saal suspected this would make BPA "a hell of a lot more potent" in small doses. Working with colleagues Susan Nagel and Wade Welshons, a professor of veterinary biology, he began testing the effects of BPA at amounts 25 times lower than the EPA's safety threshold. In the late 1990s, they published two studies finding that male mice whose mothers were exposed to these low doses during pregnancy had enlarged prostates and low sperm counts. Even in microscopic quantities, it seemed, BPA could cause the kinds of dire health problems Colborn had found in wildlife. Before long, other scientists began turning up ailments among animals exposed to minute doses of BPA.


These findings posed a direct threat to plastics and chemical makers, which fought back using tactics the tobacco makers had refined to an art form. By the late 1990s, when tobacco companies agreed to drop deceptive marketing practices under a settlement agreement with 46 states, many of the scientists and consultants on the industry's payroll transitioned seamlessly into defending BPA.
Plastics and chemical interests worked closely with the Weinberg Group, which had run Big Tobacco's White Coat Project—an effort to recruit scientists to create doubt about the health effects of secondhand smoke. Soon Weinberg, which bills itself as a "product defense" firm, was churning out white papers and lobbying regulators. It also underwrote a trade group with its own scientific journal, Regulatory Toxicology and Pharmacology, which published studies finding BPA was safe.
The industry also worked hand in glove with the Harvard Center for Risk Analysis, a think tank affiliated with the university's school of public health that has a history of accepting donations from corporations and then publishing research favorable to their products. In the early 1990s, its founder, John D. Graham—who was later tapped as George W. Bush's regulatory czar—lobbied to quash an EPA finding that secondhand smoke caused lung cancer, while soliciting large contributions from Philip Morris.




In 2001, as studies on BPA stacked up, the American Chemistry Council enlisted the center to convene a panel of scientists to investigate low-dose BPA. The center paid panelists $12,000 to attend three meetings, according to Fast Company. Their final report, released in 2004, drew on just a few industry-favored studies and concluded that the evidence that low-dose BPA exposure harmed human health was "very weak." By this point, roughly 100 studies on low-dose BPA were in circulation. Not a single industry-funded study found it harmful, but 90 percent of those by government-funded scientists discovered dramatic effects, ranging from an increased breast cancer risk to hyperactivity. Four of the 12 panelists later insisted the center scrub their names from the report because of questions about its accuracy.


Chemical interests, meanwhile, forged deep inroads with the Bush administration, allowing them to covertly steer the regulatory process. For decades, the Food and Drug Administration has assured lawmakers and the public that BPA is safe in low doses. But a 2008 investigation by the Milwaukee Journal Sentinel revealed that the agency had relied on industry lobbyists to track and evaluate BPA research, and had based its safety assessment largely on two industry-funded studies—one of which had never been published or peer reviewed.


The panel the EPA appointed to develop guidelines for its congressionally mandated endocrine disruptor screening was also stocked with industry-backed scientists. It included Chris Borgert, a toxicology consultant who had worked closely with Philip Morris to discredit EPA research on secondhand smoke. He later served as the president of the International Society of Regulatory Toxicology and Pharmacology, the Weinberg Group-sponsored outfit, which met in the offices of a plastics lobbyist.


Members of the EPA panel say Borgert seemed determined to sandbag the process. "He was always delaying, always trying to confuse the issue," recalls one participant. And the screening approach the EPA settled on came straight from the industry's playbook. Among other things, the chemicals would be tested on a type of rat known as the Charles River Sprague Dawley—which, oddly, doesn't respond to synthetic hormones like BPA.


"Like the tobacco companies, they want to set up a standard of proof that is unreachable," says Stanton Glantz. "If they set the standard of proof, they've won the fight."
How best to test for estrogenic activity would become a key front in the fight over plastic safety. The American Chemistry Council joined forces with an unlikely ally, PETA, to fight large-scale chemical-safety testing on animals. At the same time, Borgert and other industry-funded scientists made the case that the other common method for testing—using cells that respond in the presence of estrogen—did not necessarily tell us how a substance would affect animals or humans. In fact, a massive, ongoing NIH-run study has found that cell-based tests track closely with animal studies, which have accurately predicted the effects of synthetic estrogens, particularly DES and BPA, on humans.


Stanton Glantz, who directs the Center for Tobacco Control Research and Education at the University of California-San Francisco, argues the chemical industry's real aim in challenging specific testing methods is to undermine safety testing altogether. "Like the tobacco companies, they want to set up a standard of proof that is unreachable," he says. "If they set the standard of proof, they've won the fight."
 

During the height of the battle over BPA, vom Saal periodically traveled to Texas and huddled around the dining table with his old friend George Bittner, whose home overlooks a walnut grove on the outskirts of Austin. Bittner, who holds a Ph.D. in neuroscience from Stanford, is quirky and irascible. But he has a brilliant mind for science and an interest in applying it to real-world problems—in his lab at UT-Austin, he had developed a nerve-regeneration technique that had helped crippled rats walk within days. And he had taken a keen interest in vom Saal's research on endocrine disruption. "It struck me as the most important public health issue of our time," Bittner told me when we met at his lab. "These chemicals have been correlated with so many adverse effects in animal studies, and they're so pervasive. The potential implications for human health boggle the mind."
In the late 1990s, Bittner—a squat, ruddy man with thinning red hair and Napoleon Dynamite glasses who had made a tidy sum investing in real estate and commodities—began mulling the idea of launching a private company that worked with manufacturers and public health organizations to test products for endocrine disruptors. He believed this approach could help raise awareness and break the regulatory logjam—while also reaping a profit.


In 2002, armed with a $91,000 grant from the National Institutes of Health, Bittner launched a pair of companies: CertiChem, to test plastics and other products for synthetic estrogens, and PlastiPure, to find or develop nonestrogenic alternatives. Bittner then enlisted Welshons to design a special test using a line of breast cancer cells, which multiply rapidly in the presence of estrogen. It features a robotic arm, which is far more precise than a human hand in handling microscopic material.




But before long Bittner began butting heads with Welshons and vom Saal. Bittner wanted the researchers to sign over the rights to the test Welshons had developed, while they insisted it belonged to the University of Missouri. Eventually, they had a bitter falling out. Welshons and vom Saal filed a complaint with the NIH, alleging that Bittner had misrepresented data from Welshons' lab in a brochure. (Bittner maintains that he merely excluded data from contaminated samples; the institute found no evidence of wrongdoing.) Bittner, meanwhile, enlisted V. Craig Jordan, a pharmacology professor at Georgetown University with an expertise in hormones—he discovered a now-common hormone therapy that blocks the spread of breast cancer—to refine the testing protocol. By 2005, Bittner had opened a commercial lab in a leafy office park in Austin. He managed to attract some big-name clients, including Whole Foods, which hired CertiChem to advise it on endocrine-disrupting chemicals and test some of its products.


At this point, BPA was among the most studied chemicals on the planet. In November 2006, vom Saal and a top official at the National Institute of Environmental Health Sciences convened a group of 38 leading researchers from various disciplines to evaluate the 700-plus existing studies on the subject. The group later issued a "consensus statement" that laid out some chilling conclusions: More than 95 percent of people in developed countries were exposed to levels of BPA that are "within the range" associated with health problems in animals, from cancer and insulin-resistant diabetes to early puberty. The scientists also found that there was "great cause for concern with regard to the potential for similar adverse effects in humans," especially given the steep uptick in these same disorders.
At the same time, a new body of research was finding that BPA altered animals' genes in ways that caused disease. For instance, it could switch off a gene that suppresses tumor growth, allowing cancer to spread. These genetic changes were passed down across generations. "A poison kills you," vom Saal explains. "A chemical like BPA reprograms your cells and ends up causing a disease in your grandchild that kills him."


Next Page: Eastman's senior toxicologist called this an "oh shit moment."
Page 2 of 2


Scientists were also uncovering links between endocrine-disrupting chemicals known as phthalates and health problems, including genital abnormalities and infertility in humans. These chemical additives were commonly found in soft, pliable plastics, such as those used in pacifiers and baby bottle nipples. In 2008, Congress passed a law banning six types of phthalates in children's products. As concerns about BPA hit the mainstream, Congress also launched an investigation into the industry's efforts to manipulate science and regulation, and a number of states proposed BPA bans.
In 2009, the BPA Joint Trade Association—which included the American Chemistry Council, Coca-Cola, and Del Monte, among others—gathered at the Cosmos Club, a members-only retreat in Washington, DC's Dupont Circle. According to meeting minutes leaked to the Milwaukee Journal Sentinel, the group explored messaging strategies, "including using fear tactics (e.g., 'Do you want to have access to baby food anymore?')." The "'holy grail' spokesperson," attendees agreed, was a "pregnant young mother who would be willing to speak around the country about the benefits of BPA."


Even as the industry crafted defensive talking points, some companies began offering BPA-free alternatives. But they often didn't bother testing them for other potentially toxic compounds or synthetic hormones. Nor did they have to: Under US law, chemicals are presumed safe until proven otherwise, and companies are rarely required to collect or disclose chemical-safety data. Michael Green, the Center for Environmental Health director who worried about his daughter's sippy cup, says this results in a "toxic shell game": Corporations that come under pressure to root out toxins often replace them with untested chemicals, which sometimes turn out to be just as hazardous. "It's an unplanned science experiment we're doing on our families," Green told me when I visited him at his Bay Area home, where Juliette, now 5, was padding around in a pink princess costume.


One of the most popular BPA-free options, especially among companies catering to families and health-conscious consumers, was Tritan, a clear, sturdy, heat-resistant plastic that Eastman rolled out in 2007. (Eastman also produces the chemical that sullied the drinking water of 300,000 West Virginians in January.) A company founded by alternative medicine guru Dr. Andrew Weil launched a line of Weil Baby bottles made from Tritan, which it touted as "revolutionary" and "ultra-safe" material. Thermos began churning out Tritan sippy cups, decorated with Barbie and Batman. With more and more consumers demanding BPA-free products, Nalgene, CamelBack, Evenflo, Cuisinart, Tupperware, Rubbermaid, and many other companies also worked Tritan into their production lines.




Eastman, a $7 billion company that was spun off from Eastman Kodak in the 1990s, assured its corporate customers that it had done extensive safety testing on Tritan. But its methods were questionable. According to internal Eastman documents, in 2008 Eastman signed a two-year contract with Sciences International, another product defense firm that had played a key role in the tobacco industry's scientific misinformation campaign. On Sciences' advice, Eastman then commissioned a study that used computer modeling to predict whether a substance contains synthetic estrogens, based on its chemical structure. The model suggested that one of Tritan's ingredients—triphenyl phosphate, or TPP—was more estrogenic than BPA.


Eastman, which never disclosed these findings to its customers, later commissioned another study, this one involving breast cancer cells. Again, the initial results appeared positive for estrogenic activity. In an email to colleagues, Eastman's senior toxicologist, James Deyo, called this an "oh shit moment."

Cell culture tests for estrogenic effects generally involve soaking plastic in alcohol or salt water, then exposing cells to various concentrations of the chemicals that seep out. After Deyo informed the lab that its findings must "be worded very well relative to the lack of" estrogenic activity, it issued a report that only counted data from the lowest concentrations—even though this violated the lab's testing guidelines, and made the results appear negative when they weren't. "The lab ignored its own criteria and misrepresented its findings," says Michael Denison, a professor of toxicology at the University of California-Davis who evaluated the document.


Eastman wasn't the only company testing Tritan. In 2009, Bittner's PlastiPure, which was searching for nonestrogenic alternatives to recommend to clients, began vetting products made with it and found that some had even more estrogenic activity than their BPA-laden counterparts. PlastiPure's CEO, Mike Usey, says CertiChem disclosed this to clients, but many chose Tritan anyway.
"It's an unplanned science experiment we're doing on our families," Michael Green says.

This was part of a broader pattern of indifference. According to Usey, hundreds of manufacturers—including most of the big baby bottle makers—contacted CertiChem to inquire about testing their BPA-free products for estrogenic chemicals, but few actually followed through. "Their position was: Until consumers are demanding nonestrogenic products, there's no reason to be an early adopter," Usey explains. "They want to delay as long as they can, because they know any transition will cost them." In some cases, manufacturers paid for testing, then never collected the findings. "They didn't want to know the results because there's liability in knowing," Usey says. "They're right in the sense that you don't want to know if you're not going to fix the problem."


Despite its "oh shit" findings, by 2010 Eastman began to produce marketing materials claiming that Tritan was free of all synthetic estrogens. One section of its website featured the tagline "Safety is our key ingredient" along with photos of smiling children eating and drinking out of plastic containers. The site claimed "third-party research" had shown Tritan to be free of estrogenic activity, but when corporate customers tried to verify this information, Eastman grew cagey. In early 2010, Philips Avent, a top producer of baby bottles and sippy cups, inquired about having an outside lab run testing on Tritan. Eastman's senior chemist Emmett O'Brien fired off an email to colleagues, saying, "We need to [do] everything possible to convince the customer NOT to do EA [estrogenic activity] testing." Philips was persuaded. But, according to testimony from Eastman executives, that same year Nestlé vetted Tritan, and found it leached synthetic estrogen. (Frédérique Henry, a spokeswoman for Nestlé, acknowledges the company tested Tritan but denies the results were positive.) Nestlé has nevertheless continued using Tritan in some of its water bottles.


Bittner and Usey, meanwhile, decided to go public. "As long as the consumer demand wasn't there, product manufacturers felt we were selling them a problem rather than a solution," Usey explains. "We saw this as the only way forward." Bittner's companies, which have received more than $8 million in NIH funding, began working with Jordan, the Georgetown professor, on a paper for publication. In the fall of 2010, Usey attended the ABC Kids Expo, a children's product extravaganza in Las Vegas, and handed out flyers with a graph showing how various products that were marketed as nonestrogenic stacked up in CertiChem's tests. The most estrogenic among them, Weil Baby bottles, were made from Tritan. (The company referred Mother Jones to a press release on its website stating that it "remains confident that Tritan is safe.")


Soon Eastman's customers began inquiring about CertiChem's findings. For the most part, Eastman convinced them to disregard Bittner's claims. At one point, O'Brien met with Whole Foods executives. They were considering replacing their polycarbonate bulk food bins with ones made from Tritan, even though Bittner had previously informed them that the product was estrogenic. According to a memo O'Brien later wrote, when the subject came up, he responded by attacking Bittner, whom he called "shady," and his test results, which he alleged were "very questionable." The Whole Foods executives later pressed O'Brien about the other tests carried out on Tritan.



The chemist claimed, falsely, that they were performed by independent scientists with no funding from Eastman and hadn't turned up any evidence that Tritan leached synthetic estrogens. Whole Foods—which declined to comment for this story—plowed ahead and installed Tritan bins in many of its 270 US stores.

Eastman refused to answer questions for this story, but it released a written statement saying that it had "paid the labs for their time and expertise and not for a particular conclusion," and remained "confident in the testing and safety of Tritan."


In March 2011, the Environmental Health Perspectives paper by Jordan and researchers from CertiChem and PlastiPure appeared online. They'd tested 455 store-bought food containers and storage products, including several made from Tritan. The results? Seventy-two percent leached synthetic estrogens. And every type of plastic commonly used in food packaging (polypropylene and polystyrene, for example) tested positive in some cases, which suggested there was no surefire way to avoid exposure.


Other scientists have also found evidence of estrogen-mimicking chemicals in BPA-free plastics. In 2009, two German environmental toxicologists tested PET, a plastic commonly used in water bottles, on a strain of mud snails that produce more embryos when exposed to synthetic estrogen. Snails reared in PET bottles produced twice as many as those reared in a glass culture dish.


These studies don't identify which estrogenic chemicals are leaching from BPA-free plastics, but many of these products are known to contain phthalates or bisphenol S (BPS), a chemical cousin of BPA that plastic makers frequently use in its place. Cell-culture tests suggest that BPA and BPS have similar effects.


In other cases, little may be known about the specific health effects of the chemicals involved, but a 2012 literature review by 12 prominent scientists found there is "substantial evidence" that endocrine-disrupting chemicals generally harm human health. "We know that there's a cost when we mess with the levels of these hormones in our bodies, regardless of how we do it," says the study's lead author, Laura Vandenberg, a professor of environmental health sciences at the University of Massachusetts-Amherst. "Even small changes early in life can alter brain and organ development and set us up for disease later on."


Every type of plastic commonly used in food packaging tested positive in some cases, which suggested there was no surefire way to avoid exposure.

The month after Bittner's study appeared, the American Chemistry Council contacted Chris Borgert, the former tobacco industry scientist who stymied the EPA's Endocrine Disruptor Screening Program. According to internal emails, the council and the Society of the Plastics Industry offered to pay him $15,000 to write a brief letter to the journal's editor refuting CertiChem's study, and to enlist another scientist to sign on. Their letter argued that CertiChem's findings were "unconvincing"; just because a substance behaved like estrogen in a culture dish didn't mean it would do so in animals or humans.
At the same time, Eastman laid plans to sue CertiChem and PlastiPure for false advertising.


Expecting that Bittner would lash out after being served papers, the company launched a preemptive PR blitz. "By proactively promoting Tritan safety," an internal memo noted, "it will put PlastiPure in a position to have to prove Eastman wrong." The company also paid a scientist named Thomas Osimitz $10,000 to author a research paper on Tritan. While Osimitz was ostensibly working independently, Deyo, the Eastman toxicologist, micromanaged the process, from designing the study to writing the introduction. Deyo's study design virtually guaranteed estrogenic activity wouldn't be found. For example, he opted to use the hormone-insensitive Charles River Sprague Dawley lab rat. Rather than testing Tritan itself, he instructed Osimitz to test only some Tritan ingredients—TPP, the one that had raised red flags in the computer-modeling study, was not included. (The European Union has since classified the compound as a suspected endocrine disruptor.)


In June 2012, Osimitz's paper—finding that Tritan was not estrogenic—appeared in Food and Chemical Toxicology, an industry-friendly journal. Its editor, A. Wallace Hayes, was previously vice president of biochemical and biobehavioral research at R.J. Reynolds, which led the attack against science linking secondhand smoke to human health problems.


Scientific journals generally require authors to disclose any conflicts of interest. But the Food and Chemical Toxicology article made no mention of Eastman's role in the study. According to internal Eastman emails, the company was also aiming to hire Osimitz to author a second paper, again with "no…mention of Eastman." As Deyo noted, "credibility is somewhat enhanced if it is not 'Eastman' authors."




Once its own data had been published, Eastman set out to bury Bittner's findings. In August 2012, the company sued CertiChem and PlastiPure, which it claimed were spreading false information about Tritan to generate demand for their own services. Eastman's lawyers asked the judge to bar both firms from ever claiming Tritan was estrogenic—or saying that cell-based tests could detect estrogenic activity, even though scientists routinely use them for this purpose. For decades, scientists have relied on the same breast cancer cell line Bittner's lab uses, MCF-7, to screen for estrogenic activity.
According to UMass' Vandenberg, these cells have proven "remarkably good at telling us if compounds found in plastics and personal care products mimic estrogen" and their "failure rates are minuscule."

On July 15, 2013, Bittner squared off against Eastman at a federal courthouse in Austin. The company's attorneys went in hard. Specifically, they claimed running a company that tested products for estrogenic activity, as well as one that helped companies find nonestrogenic alternatives, created a conflict of interest. (Bittner counters that he's no more conflicted than a doctor who both diagnoses and treats patients.) But they didn't directly challenge the validity of Bittner's findings. Instead, they leaned on the questionable industry claim that tests based on human cells aren't sufficient to establish estrogenic activity.


Eastman's star witness, Chris Borgert, made the case that animal studies—which the industry had also fought to undermine—were a more telling indicator. But even they were not "in and of themselves" definitive. For the result to be relevant, the effects had to be demonstrated "in an animal, at least, and then on to humans." There was no mention of the ethical and legal barriers to testing on humans. And the judge barred Bittner's lawyers from mentioning Borgert's tobacco industry ties, which Eastman argued were "prejudicial." This left the jury ill-equipped to gauge his credibility.


Borgert's testimony may have done less damage than other factors. Bittner's lawyers struggled to explain the science to jurors, and Bittner grew testy on the stand. Welshons, who'd designed CertiChem's tests, testified in a deposition—just as he'd told the NIH—that Bittner had misrepresented some data in a brochure. Bittner's attorneys managed to block his testimony from being introduced. But, Bittner says, his attorneys balked at presenting key evidence, such as figures on CertiChem's NIH funding, because it might have made Welshons' testimony admissible. Bittner also maintains that his rift with vom Saal and Welshons made it difficult to recruit witnesses.


Still, several prominent scientists testified for CertiChem, including UC-Davis' Michael Denison, who coinvented a widely used test for estrogenic activity using human ovarian cells. Denison testified that he'd tested 27 samples of Tritan for estrogenic activity using this method and registered positives across the board.


But the most remarkable data might have come from none other than Wade Welshons. In the run-up to the trial, the University of Missouri scientist, who expected to prove Bittner wrong, began testing Tritan products in his lab. To his surprise, he wound up confirming CertiChem's findings. "It doesn't matter what I think of them personally," Welshons told me. "If they're right, they're right, and many of my objections no longer matter."


Welshons' findings never made it into court, however, and when the jurors returned their verdict in late July, they found against Bittner's companies on counts of false advertising and unfair competition. They also concluded Tritan was not estrogenic. Their rationale, according to postverdict interviews, echoed Eastman's claims that estrogenic activity could not be established solely through cell-based tests. In his final ruling, the judge also noted that the "jury was likely unimpressed with Dr. Bittner's combative demeanor." And he upbraided both sides for failing to explain the science in terms jurors could understand. In the end, he barred Bittner's companies from ever talking about their Tritan findings, at least in a commercial setting. But he refused to stop the companies from asserting that their tests could detect synthetic estrogens.


The long legal battle has depleted CertiChem and PlastiPure's coffers—"We've laid off half of our staff," Usey told me. "It has pretty much crushed us"—and emboldened Eastman. After I began raising questions about Tritan, Rick W. Harrison, an attorney for the chemical giant, inadvertently copied me on an email about Eastman's damage control strategy. "If this somehow gets picked up by mainstream media—Oprah or NY media—Eastman sends Lucian [Boldea, the vice president of Eastman's specialty plastics division] or whoever on the show prepped with the verdict, order and judgment and express surprise and indignation that these issues are still being raised after three years of litigation," he wrote. "The court/jury has spoken and spoken loudly."


The industry, meanwhile, has revived its campaign to downplay the dangers of BPA. A month after the Eastman case concluded, the American Chemistry Council relaunched its pro-BPA website, FactsAboutBPA.org. The section on infant health suggests that BPA isn't harmful, even to premature babies. "They're reverting back to exactly the arguments they were making in 1998," says vom Saal. "It's as if the last 15 years didn't happen."


US regulators also have continued to ignore the mounting evidence linking BPA and similar chemicals to human disease, even as bans have cropped up around the world. Although more than 90 studies examining people with various levels of exposure suggest BPA affects humans much as it does animals, the FDA recently announced that its research "supports the safety of BPA" in food containers and packaging. And the EPA program that was supposed to screen some 80,000 chemicals for endocrine disruption hasn't fully vetted a single substance. In 2010, the agency sought White House approval to add some endocrine-disrupting chemicals that are commonly found in plastic—among them BPA, phthalates, and a class of compounds known as PBDEs—to its "chemicals of concern" list because it found they "may present an unreasonable risk to human health." This would have required chemical makers to share safety-testing data with federal regulators. The proposal languished until last September, when the EPA quietly withdrew it, along with a proposed rule requiring manufacturers to disclose safety data on chemicals in their products.


Still, Bittner isn't giving up the fight. When I visited CertiChem's office in Austin recently, he was sitting barefoot at a conference table surrounded by sippy cups and heaps of lab notebooks. CertiChem and PlastiPure were planning to appeal the Eastman ruling (they've since done so) and were working with Denison on data for new papers, one on estrogenic activity in plastic resins, which are used to make plastic products and contain fewer additives that can skew results. Bittner called up a series of graphs on the overhead projector, showing the results for several new BPA-free plastics that he had tested for estrogenic activity. He raked his laser pointer over a graph displaying the results for Tritan. The line curved up steeply. "Eastman won the battle," he said. "But that doesn't mean it will win the war."


Page 2 of 2 END

No comments:

Post a Comment