How industry scientists stalled action on carcinogen

Introduction

HINKLEY, Calif. – Ten days before Christmas 1965, Pacific Gas & Electric Co. station chief Richard Jacobs walked a half-block on a dusty road lined with scraggly creosote shrubs to check out a neighbor’s toilet.

Jacobs carried with him a secret, something he referred to as the “chromate problem.”

Starting in 1952, the power company began mixing a toxic form of chromium with water to prevent rust at a new pipeline pumping station in Hinkley, a remote desert community united by a single school and a general store. PG&E dumped the chromium-laced water into a pond.

Lately there had been reports of problems with the neighbors’ wells. PG&E had just drawn greenish water from one well and discovered high levels of chromium. Now, retired farmer John Speth was complaining of greenish deposits in his toilet bowl.

Jacobs took a look in the bowl but assured Speth that PG&E had nothing to do with it. “When I left Mr. Speth,” Jacobs later wrote in longhand, “he was satisfied but still concerned about his water.” Speth died of stomach cancer in 1974.

It wasn’t until Dec. 7, 1987 — 22 years after that visit to Speth’s house — that PG&E finally told the local water board that it had contaminated the underground water. The company claimed it had discovered the problem just one week earlier.

From here, the story is familiar to anyone who saw the hit film Erin Brockovich. The corporate polluter was taken to court. The victims got millions of dollars. Problem solved.

But in reality, the “chromate problem” has not gone away. Today, tens of millions of Americans drink chromium-tainted tap water. Yet the controversy over whether people like Speth are dying of cancer from it is still being hotly debated.

Some of the most powerful voices in the debate are companies with a stake in the outcome. They’ve hired scientists to convince regulators that the chemical compound is safe. The lawsuit that Brockovich championed was merely the beginning of an intriguing tale about corporate manipulation of science.

In 2008, the National Toxicology Program, part of the National Institutes of Health, published groundbreaking research detailing how mice and rats that drank heavy doses of a toxic form of chromium called chromium (VI) developed cancerous tumors. The findings prompted the Environmental Protection Agency to act.

EPA scientists evaluated hundreds of studies and concluded that chromium (VI) likely causes cancer in people who drink it. The agency in 2011 was on the verge of making its scientists’ findings official — a first step toward forming more stringent clean-water rules. But last year it bowed to pressure and announced it was going to wait for new studies being paid for by the chemical industry.

To lead those studies, the American Chemistry Council, the industry’s main trade group and lobbyist, hired ToxStrategies Inc., a Texas-based firm with scientists experienced in poking holes in research that links chromium to cancer. The company describes its business this way on its website: “We often interact and collaborate with regulatory, academic and industrial professionals to ensure that the most appropriate science is incorporated into each assessment.”

Mark Harris and Deborah Proctor, two principal scientists at ToxStrategies, have a history of attempting to delay regulatory action on chromium. Starting in 1996, they were both leaders in the chrome industry’s efforts to dissuade the Occupational Safety and Health Administration from setting stricter rules for airborne chromium in the workplace. OSHA pushed back action for years despite decades of research showing that workers exposed to chromium were dying at higher-than-expected rates of lung cancer. The agency finally adopted a stricter standard in 2006 under pressure from a court order.

Proctor also worked on revising a 1987 study that concluded that Chinese villagers who drank water polluted with chromium (VI) had higher than normal rates of stomach cancer. With funding from PG&E, Proctor’s employer, ChemRisk, paid the Chinese author to help publish a new analysis of the data. In contrast to the earlier article, the new one concluded that chromium wasn’t the likely culprit.The revised study — which did not reveal the involvement of PG&E or its scientists — helped persuade California health officials to delay new drinking water standards for chromium.

Finally, with industry funding, Proctor worked to try to influence the makeup and findings of a scientific panel deciding whether California needed stricter drinking water standards for chromium. The panel concluded — to the surprise of many — that there was no scientific basis for believing that drinking chromium causes cancer. One-third of Californians have chromium in their water.

Proctor and Harris declined to respond to requests for interviews.

The use of science to delay regulation is part of a familiar pattern in the field of environmental science. Industry pays for research to address “data gaps.” Even when animals or people are believed to be getting cancer from exposure, industry scientists argue that the chemical in question is dangerous only at extremely high doses. Finally, they argue that you can’t determine a safe dose of a chemical unless you understand precisely how it causes cancer. Until all the questions are answered, they say, it’s not fair to ask industry to bear the cost of stricter rules.

“So now what is happening is the industry is trying to get scientists to slow down the EPA,” said Gary Praglin, one of the lawyers who sued PG&E on behalf of Speth and hundreds of others who had lived near the Hinkley pumping station.

David Michaels, an epidemiologist who now heads OSHA, has written extensively about this brand of science.

“Their business model is straightforward,” Michaels wrote in his book, “Doubt Is Their Product.” “They profit by helping corporations minimize public health and environmental protection and fight claims of injury and illness. In field after field, year after year, this same handful of individuals come up again and again.”

Overwhelming evidence of lung cancer

Suspicions that chromium might cause cancer emerged in the late 19th century. In the 1950s, studies of factory workers exposed to airborne chromium showed much higher rates of lung cancer than expected. Thomas Mancuso, a pioneer in occupational medicine, continued to follow the workers at a chromate plant in Painesville, Ohio, for decades. In his final account in 1997, he reported that 23 percent of them had died of lung cancer. Other studies elsewhere confirmed Mancuso’s findings.

Given the overwhelming evidence that chromium particles in the air were killing people, PG&E’s challenge in the Hinkley case was to persuade judges on an arbitration panel that chromium traces in water were different. The company hired academic scientists, such as Steven Patierno at George Washington University, who testified that saliva and stomach acid render toxic chromium harmless, at least at levels that any human would drink.

Still, a few troubling studies at the time suggested that humans and animals may have developed cancer from drinking chromium. To address those studies, PG&E hired ChemRisk, a scientific firm that helped companies with legal or regulatory issues. The chief executive officer of ChemRisk was Dennis Paustenbach, a San Francisco scientist who has become the undisputed star of product defense.

Paustenbach declined interview requests. In a 2009 profile written by two University of Virginia professors, Paustenbach explains that he’s been driven since his modest upbringing to be financially successful, putting in 65-hour work weeks.

His work as a scientist has included advocacy from the start. Each week as a young toxicologist at a chemical company in Connecticut, he flew to the nation’s capital to lobby regulatory agencies such as the EPA. His relationship with the agency evolved and he later sat on numerous EPA advisory panels. For the past four years, he’s served on a panel overseeing EPA research.

A rare inside look at what Paustenbach does can be found in the minutes of a 1996 meeting in Pittsburgh of the Chrome Coalition, then the industry’s trade group. At the time, OSHA was proposing a big reduction in the amount of chromium dust allowed in the workplace. Paustenbach outlined a plan to prevent that from happening.

“Dr. Paustenbach suggested that … the Coalition may wish to approach the regulators with a program designed to fill a ‘data gap’ … to forestall the rulemaking,” the minutes read.

There was a discussion of ChemRisk possibly providing “confidential” and “pro bono” assistance to researchers at Johns Hopkins University to finish analyzing data for an EPA study of a Baltimore chromate plant. The EPA study was designed to answer questions left from Mancuso’s earlier work. At the same time, Paustenbach proposed writing an “anti-Mancuso manuscript” and critiquing all relevant workplace studies in an “effort of convincing OSHA not to go forward with what they presently have.”

Also attending the meeting were Proctor, who worked for Paustenbach at ChemRisk, and Harris, a former ChemRisk employee who at the time worked for Chemical Land Holdings, a company involved in a costly chromium cleanup. Both Proctor and Harris now work for ToxStrategies.

Paustenbach said in a recent statement to CPI and PBS NewsHour, “There is no evidence supporting any unethical conduct by ChemRisk scientist in regards to past work for the Chrome Coalition. The focus of ChemRisk scientists was solely on expanding the body of knowledge on which OSHA and other scientists could evaluate Chromium 6.”

In the end, the EPA study confirmed Mancuso’s findings that workers exposed to chromium were at a substantially higher risk of dying from lung cancer. Still, OSHA would wait more than a decade to tighten workplace standards for chromium under pressure from federal appeals court decision.

For the PG&E lawsuit, Paustenbach decided to conduct original research. Environmental science often lacks good human studies. Few people would volunteer to drink something potentially toxic to see if it would make them sick. Yet, that is precisely what Paustenbach did.

He and other scientists at ChemRisk sat for hours in Jacuzzis filled with chromium-laced water. They also drank chromium-contaminated water by the jug and then ran tests on their blood and urine.

ChemRisk scientist Brent Finley appeared on ABC News in 1996 to drink some of the yellow water, prompting correspondent Cynthia McFadden to say, “There are those who would say you drinking a gallon of this chromium-laced water doesn’t prove anything except that you — in some people’s minds — may be foolish.”

Paustenbach explained in his business school profile that he’s motivated in his work by what he sees as greedy lawyers using bad science to take advantage of corporations.

“Without a doubt, a large percentage of environmental and occupational claims are simply bogus,” he said, “intended only to extract money from those who society believes can afford to ‘share the wealth.’ “

Secrets of the ‘Blue-Ribbon Panel’

Before the film Erin Brockovich even came out, the state of California was already taking steps to strengthen drinking-water standards for chromium. In 1999, scientists at the California Office of Environmental Health Hazard Assessment concluded that it was safe to assume that drinking chromium may cause cancer. They reasoned that breathing chromium was just another way the metal got into the body and caused damage. Plus, a 1968 study showed that 11 out of 66 female mice developed tumors after drinking chromium-laced water.

OEHHA’s next task was to figure out how much chromium a person could drink each day without exceeding a one-in-a-million chance of getting cancer from it. The agency computed a number that was 40 times lower than the existing U.S. drinking-water limit.

One industry consultant warned that if this standard became law, it would cost $11 billion to clean up California’s water, plus another $1.7 billion every year to keep chromium out of the water.

Before a new drinking-water standard could take effect, the state asked the University of California to set up a “blue-ribbon panel” of scientists to review the science. In August 2001, the panel issued a report that said there was “no basis” for concluding that chromium-contaminated water could cause cancer.

The panel dismissed the rodent study because an unrelated virus had killed many of the mice. It barely addressed the mounds of research on lung cancer.

The state agency concluded that it had little choice but to retract its chromium “public health goal” and wait. The state had asked the National Toxicology Program to do multimillion-dollar rodent studies on chromium. But the results wouldn’t be published for another seven years.

Questions soon arose about whether the blue-ribbon panel was biased. When the group held its only public hearing in July 2001, a lawyer for Hinkley residents, Brian Depew, attended. Depew said an environmental activist approached him afterward and later sent him a binder of documents that touched off months of investigation by Depew’s law firm.

The lawyers soon documented that Paustenbach initially served on the panel even though PG&E had paid ChemRisk at least $1.5 million during the lawsuits. Paustenbach said he didn’t appear at the public hearing and his name is not on the report.

The lawyers also learned from invoices and testimony that Exponent, the company where Paustenbach served as vice president and its most senior scientist, was being paid by an industry group focusing attention on the blue-ribbon panel. The Alliance for Responsible Water Policy was bankrolled by General Electric Co. and Lockheed Martin Corp., two companies entangled in chromium cleanups.

A strategic action plan for the Alliance dated April 6, 2001, and later disclosed in court records, listed as its strategy to “participate in state panel’s review of chromium 6, influence selection of panelists [and] provide input and information to panel.”

Proctor acknowledged in a deposition that she drew up a wish list of panelists and gave it to a lobbyist, Eric Newman. One of her colleagues, Brent Finley, also asked how he could get on the panel. Newman, who declined to comment for this story, responded to Finley in a March 31, 2001, email: “We will be lobbying hard for balanced representation. … It is critical that we get you, Deborah Proctor and/or other folks on the non-alarmist side of things.”

According to Proctor’s testimony, one of the names on her list was Joshua Hamilton, a Dartmouth professor working as an expert witness for PG&E. In 2011, Hamilton would be named to an EPA peer review panel for chromium (VI) and urge the agency to wait for new industry-funded studies led by Proctor. Hamilton, in a statement, has denied that he had any conflicts of interest while he served on the EPA panel.

When Paustenbach was named to the panel, Finley sent an email to Newman saying, “So, it looks like we got ‘one of our own’ on the panel.”

When asked whether Exponent was being paid by an industry-funded group for work related to the blue-ribbon panel, Paustenbach told CPI through a public-relations firm, “I have heard that this is true, but I do not know specific details because I did not participate in any work for the Alliance.”

Proctor, Paustenbach and other Exponent scientists quickly penned a review article that could serve as a blueprint for the panel, and Paustenbach shared it with the group. The article was paid for by Merck, another company involved in a chromium cleanup. The panel chairman, Jerold Last, sent an email to the group on June 14, 2001, saying, “I copied the third chapter pretty much verbatim from a review Dennis and his colleagues have in press, so we will want to do some revisions to eliminate the verbatim aspect.”

Paustenbach denied that the blue-ribbon panel’s report was merely copied from Proctor’s article. He told a California Senate committee investigating the panel that only “4 percent — exactly 4 percent — of the report was, in part, borrowed from a published paper by my colleague,” Proctor. Last, who did not respond to requests for comment, told the committee that what “started out as cutting and pasting … ended up being material that one or all of us reviewed thoroughly before we put it into the report.”

The major conclusions reached in the ChemRisk article and the state report were the same.

Paustenbach said that he disclosed his involvement in the PG&E lawsuit to Last but that neither he nor Last considered the PG&E work to be a conflict of interest. Still, because of concerns raised by an advocacy group, Paustenbach said he stepped down from the panel before the panel held its public hearing.

When the blue-ribbon panel report came out, Paustenbach attached it to an email to a colleague at Exponent saying, “Buy a good bottle of wine, pull up a chair, and then read this. Then say to yourself, ‘Yep, I really finally did something good for society…’ The world is now a better place to live.”

When a lawyer read the email aloud during a deposition, another scientist who served on the panel called it “sad.”

“This [is] about winning. It’s not about truth,” John Froines, a toxicologist at the University of California, Los Angeles, testified. “The world isn’t a better place to live. The world is actually a poorer place to live because of this. It makes people cynical about trusting in the science, and I think that’s really too bad.”

Froines quit the panel before it finished its report, saying he was concerned about panelists with ties to industry. But also, Froines simply didn’t believe the panel’s findings.

Chinese study revisited

Meanwhile, the California Environmental Protection Agency also had suspicions about the blue-ribbon panel.

Two studies highlighted in the panel report came from China’s Liaoning province, northeast of Beijing, where a smelter began contaminating the water with chromium (VI) in 1965. A doctor in the area cared for the sick for years and eventually counted the deaths from cancer. He published an article in 1987 in a Chinese journal, concluding that villagers who drank the tainted water suffered higher rates of stomach cancer.

A decade later, the same doctor published a new article in an American journal concluding that chromium most likely wasn’t the culprit.

The head of California EPA’s Office of Environmental Health Hazard Assessment, George Alexeeff, asked a new epidemiologist on staff, Jay Beaumont, to look into the studies. In recent interviews, Beaumont said he quickly found things that didn’t seem to add up.

For example, the revised article said stomach-cancer rates for the province weren’t available. But Beaumont had a colleague quickly track down the data at the University of California, Berkeley, library. Beaumont said the numbers came from the same source the Chinese doctor used for other comparisons.

Within a few days, Beaumont ran his own analysis and found that villagers who drank chromium-laced water were 85 percent more likely to have stomach cancers than were those who lived in the surrounding province.

Beaumont tried to reach the Chinese author, Dr. Zhang JianDong, but he had died in 1999. However, there was still a website promoting a book Zhang had written. Something caught Beaumont’s attention. The site revealed that Zhang was a consultant to McLaren/Hart Environmental Engineering Corp., the company that at the time owned ChemRisk.

Putting the pieces together, Beaumont wrote an email to his boss, saying that “the money to pay Dr. Zhang likely came from the industrial clients of McLaren/Hart who have a strong financial interest in the health effects evidence for Cr6. I don’t know what Dr. Zhang was paid to do by McLaren/Hart, but republishing his study with different conclusions seems a possibility.”

PG&E now acknowledges it paid for the revised analysis, though records show only about $2,000 went to Zhang.

Two ChemRisk documents describe Zhang’s role as “research assistance” and “document review and consultation.” Meanwhile, a ChemRisk scientist named project coordinator was budgeted to be paid $13,500 to “interpret data” and “write reports” that were then to be edited by Paustenbach and Finley. The ChemRisk proposal linked the research to the PG&E lawsuit by saying that the new article “can be used as the foundation of a number of trial exhibits that summarize the absence of the association between cancer and groundwater exposure to Cr6.”

Proctor, the same scientist who recently conducted studies for the American Chemistry Council, billed for her time on the Chinese article as well, according to a deposition.

“What was important to PG&E at the time is that the science was accurate,” said Sheryl Bilbrey, now in charge of the cleanup in Hinkley for PG&E. “So we did fund that work, and I think it’s unfortunate that when it was republished they didn’t acknowledge PG&E’s involvement, because it really took away from the focus of the science and had more to do with the disclosure issue.

“PG&E’s intention on any project is to make sure that we have the best science,” Bilbrey said. “These projects are incredibly important to us, and we want to get it right. So we looked to Dr. Paustenbach and his experts to make sure that the science was accurate.”

Paustenbach, through a public-relations firm, released a 9-page statement acknowledging that ChemRisk approached Zhang and another author to point out that “there were shortcomings in how these physicians interpreted their data.” The statement said that Zhang was surprised by the new ChemRisk analysis but agreed with it. The firm also released hundreds of pages of documents that included one signed by Zhang saying he agreed to the “editing and expanding of the original manuscript.”

Paustenbach’s recent statement says, “The record makes clear not only that Zhang prepared the report, but also that Zhang, fearful of political pressure from his government, indicated that acknowledgment of American researchers was not appropriate since it was his study.” Paustenbach testified in 2002, “We asked Dr. Zhang, in fact, to be coauthors on that paper for sake of transparency … Dr. Zhang, on his own decision, chose to keep that as a singular authorship.”

None of the documents Paustenbach provided CPI indicate that Zhang explicitly objected to other names being listed as authors.

Despite the question of authorship, scientists at California’s OEHHA said they took the new study at face value. Still, they rejected its findings.

“The ’97 study basically concluded that there was no association between chromium (VI) in the drinking water and cancer cases among the Chinese villagers, in large part because the villages that were more distant from the source of the drinking water contamination had higher cancer rates,” said Allan Hirsch, OEHHA’s deputy director, in a recent interview. “People closest to the facility may not have been drinking the water, because it was yellow and unpalatable.”

In a recent statement, Paustenbach characterized the California EPA’s analysis as “flawed and incorrect.”

The Journal of Occupational and Environmental Medicine retracted the article. Journal editor Paul Brandt-Rauf said in a recent interview with CPI that the article violated its policies by not revealing all of the significant authors or the funding.

Paustenbach said through a spokesman that the rules did not require disclosure because the amount paid Zhang was so small. However, Brandt-Rauf rejected that explanation.

The Environmental Working Group, an advocacy organization, did its own investigation of the Zhang study and was troubled by what it found. “I mean, this really is a story about science for sale,” said Heather White, executive director of the group.“It’s shocking.”

EPA faces industry pressure

In 2008, the National Toxicology Program published the results of its rodent studies. High numbers of the mice and rats developed tumors in their oral cavities and small intestines. The NTP concluded that there was “clear evidence” that drinking chromium (VI) causes cancer. At about the same time, the California EPA took the nearly unprecedented step of publishing its own findings on the Chinese study.

Both the federal and California EPAs began preparing scientific assessments based on the new research. Both would come to the same conclusion. Hexavalent chromium is safe only in miniscule doses.

Yet the American Chemistry Council planned to have a number of new studies ready just before the EPA was scheduled to issue its final assessment. The ACC urged the EPA to wait until the agency could digest the new data. The scientists at ToxStrategies proposed studies to address “data gaps” in the NTP study.

It was a move harkening back to the Chrome Coalition meeting in 1996 that Proctor and Harris attended. When she worked for Paustenbach, Proctor published a series of articles about workers in the same plant that Mancuso studied for decades, but her conclusion was quite different. Her studies concluded that OSHA did not need to tighten its standard to protect workers.

In the end, OSHA adopted a stricter standard, but critics argue that it’s still too high. By OSHA’s own calculations, 10 to 45 workers out of 1,000 are expected to get lung cancer in their lifetimes from the current exposure limit.

The California EPA, which had already delayed a chromium assessment for a decade, refused to wait for ToxStrategies’ studies, saying, “It would be very difficult for OEHHA to justify further delay.”

California’s assessment of chromium went through not one, but two peer-review panels. Some of the independent scientists questioned whether the safe-dose level was actually too high, so OEHHA lowered it. The agency issued its public-health goal on chromium (VI) in July 2011.

At first, the head of the EPA’s chemical-assessment program, Vincent Cogliano, also refused to wait for the ToxStrategies studies. But five of nine peer reviewers selected by a private contractor urged delay. One of the reviewers was Steven Patierno, a former PG&E expert witness who served as a consultant on the ToxStrategies’ studies.

In January, the NTP published new research from its rodent studies that challenges Patierno’s contention that saliva and stomach acids render chromium (VI) completely harmless, undermining the theory that chromium is dangerous only in high doses.

Celeste Monforton, a professorial lecturer at George Washington University’s School of Public Health who has written about industry scientists’ influence on chromium policy, said that, based on her own experience working with agencies, regulators are aware that research done by industry is often an attempt to delay.

“Some people at EPA understand that and know that,” she said. “It takes the political will to stand up to that.”

In the Hinkley lawsuit, judges more 16 years ago considered the scientific arguments and ruled against PG&E. In essence, they concluded that the contaminated water in Speth’s toilet was capable of causing cancer.

Froines, the UCLA scientist who resigned from the blue-ribbon panel, said it’s time for public health agencies to do the same.

“At this point, we shouldn’t be debating the carcinogenicity. … We should be at a place where we’re looking for alternatives to the use of chromium,” said Froines, who has evaluated more than 400 chemicals for a California advisory panel he chairs. “You’re dealing with people’s lives.”

Miles O’Brien, science correspondent for the PBS NewsHour, contributed to this story