The Toxic Edge
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|David Heath||December 28th 2013|
Center for Public Integrity
At a memorial service held in November in her favorite classroom, Patricia Buffler was hailed as a champion of children.
While dean of the School of Public Health at the University of California, Berkeley, Buffler started the nation’s largest program researching the causes of childhood leukemia. She expanded her study of this rare disease after stepping down as dean in 1998, continuing the work until she died unexpectedly in late September at the age of 75.
Buffler’s research, backed by more than $35 million in federal grants, could save lives. Her team concluded that sending your child to daycare might reduce the risk of getting leukemia, perhaps by bolstering the immune system. It found strong evidence suggesting that preschoolers should stay away from wet paint. One of her graduate students at the memorial was struck by something Buffler once said: “Children are fragile, so it is our role to protect them.”
Yet now some of her peers are torn to learn that, in the past three years, Buffler was paid more than $360,000 to work as an expert witness on behalf of companies that used to sell lead-based paint. Ten California communities, including the county where Buffler lived, this week won a $1.1 billion judgment against the companies. The money will be used to remove lead paint from older homes. Even minute amounts of lead in a child's blood can cause permanent brain damage.
According to a court filing, Buffler concluded -- to the astonishment of other experts -- that lead-based paint in older homes poses little risk to children. The judge rejected that argument in his written decision.
“She may be an expert in some areas but lead poisoning in children is definitely not one of them,” said Dr. Bruce Lanphear, a professor at Simon Fraser University in Canada and lead author of widely cited studies on the effects of lead poisoning on children. Lanphear, who testified against the paint companies, considered Buffler’s views so indefensible that, days before she died, he talked to fellow directors of the International Society for Children’s Health and the Environment about removing her from the group, of which she was a founding member.
Buffler was one of the nation’s most revered and influential public health scientists. But researchers familiar with her chemical industry consulting question whether she bent to the wishes of her corporate sponsors -- a criticism she denied when questioned in lawsuits.
Her dual career arc -- as public health researcher and consultant for private industry -- opens a window into the deeply entrenched influence of the chemical industry on academics. College campuses have embraced collaborating with industry for research as a way to produce innovative products and cure disease. But in public health, influential academics are often sought instead to defend potentially toxic chemicals.
While the Food and Drug Administration treats new drugs as unsafe until clinical trials prove otherwise, the Environmental Protection Agency does just the opposite with chemicals: By law, it presumes a chemical is safe unless scientific evidence shows otherwise. The burden of determining whether a chemical is harmful or deadly falls largely on academic scientists such as Buffler.
Working for industry can be lucrative for researchers, but can also pose conflicts. Even as Buffler led research into whether pesticides and herbicides may cause leukemia, she served for 17 years on the board of directors of a $3 billion pesticide and herbicide company, FMC Corp. In 2010, FMC paid Buffler nearly $200,000 in cash and stock. Securities and Exchange Commission records show that when she sold the stock the company gave her, mostly in 2010, Buffler made more than $2 million.
A review of public records shows that in publishing her results in scientific journals or in applying for government funding from the National Institutes of Health, Buffler did not disclose that she owned stock in FMC or served as one of its directors.
UC Berkeley officials knew that Buffler served on FMC's board, said Graham Fleming, the school's vice chancellor for research. But he said that until federal rules changed recently, it was up to researchers to decide whether their financial ties posed a conflict. The university limited its own review to potential conflicts the researchers disclosed before forwarding the grant application to the NIH.
Fleming wasn't willing to say whether Buffler serving on the board of FMC posed a conflict. “We have no way to know,” he said. “She herself must have determined that there was none. And given her record of integrity throughout her career, I would say that the default would be to accept that as the appropriate judgment.”
Since 1995, the NIH has approved more than $28 million for Buffler's research, money that went directly to UC Berkeley. The NIH wouldn't comment on whether Buffler violated its rules.
Yet Hugh Tilson, the executive editor of NIH's Environmental Health Perspectives, which published some of Buffler's pesticide research, said the journal is now reviewing whether she violated its disclosure rules.
Sheldon Krimsky, a Tufts University professor and an expert in conflicts of interest in scientific research, said after reviewing Buffler's case, “This is the worst case of conflict of interest I’ve seen in years.”
Sen. Charles Grassley, R-Iowa, pushed for recent changes at NIH, requiring more financial disclosure and lowering the standard for a conflict of interest. But after recently reviewing documents on Buffler, he said more changes are needed. “It appears NIH doesn’t have a means of auditing or enforcing the rules,” Grassley said. “Research institutions that look the other way on conflicts of interest appear free to do so knowing NIH will take them at their word.”
The recent changes in the NIH rules stemmed from concerns about the integrity of taxpayer-funded science. Studies show, for example, that researchers making money from drug companies publish scientific articles more favorable to those companies than do independent researchers. In 2007, more than half of life sciences faculty at the top 50 research universities reported financial connections to industry.
Yet scant data exist on the influence of industry money on public health.
“There are lots of people who are working as academics who are making lots of money from industry,” said Jennifer Sass, a senior scientist at the Natural Resources Defense Council, an environmental group. “A lot of the research that the industry funds is made to muddy the waters. It’s designed specifically to create uncertainties.”
Stanford University historian Robert Proctor draws parallels between chemical manufacturers today and the tobacco industry in years past, which he says quietly paid thousands of academics to influence the science.
“There’s a long history of academic corruption, of people becoming very heavily involved with industry: testifying, writing expert reports and becoming directors and not disclosing this. Their colleagues don’t know about it, and they are able to zoom under the radar,” Proctor said. “It's not just a conflict of interest. It's worse than that.”
An activist at Berkeley
Buffler earned her master's degree in public health at UC Berkeley and became a teaching assistant there during the 1960s, an era when the school became an icon of liberal activism.
Some of that activist spirit may have rubbed off on her. Her son, Martyn Buffler, recalled at her memorial service that when he was a child, his mother fought successfully to stop construction of an oil terminal in their hometown of Galveston, Texas, because it endangered shrimp in the Gulf of Mexico.
In 2004, Buffler published an article with colleague Paul Brennan reporting that nonsmokers can get cancer from secondhand smoke. One night, Brennan recalled, Buffler dragged him to a Berkeley theater to pass out leaflets because it was accepting money from the tobacco industry. Buffler wanted people to know this.
Buffler is remembered by many for criticizing the FDA for delays in requiring warning labels on aspirin bottles. Giving aspirin to children is linked to Reye's syndrome, a disease that can be deadly. In 1992, Buffler coauthored an article calculating that 1,470 children died because, at industry's urging, the FDA delayed the warning-label rule. Drug companies argued that the science linking aspirin to Reye's syndrome was weak. Buffler rejected that argument, telling the New York Times, “The Reagan administration and the Bush administration have been marked by a commitment to deregulation. When it occurs in an area where it has a health impact, the consequences are profound -- profoundly adverse.” Devra Lee Davis, who coauthored the article while working at the National Academy of Sciences, called Buffler's stance “courageous.”
Davis and Buffler were friends as well as colleagues. It wasn't until after Buffler died of a stroke that Davis realized how much work her friend had done for industry. She didn't know that by the time they worked together in 1992, Buffler already had a long history of consulting for companies, including Dow Chemical, DuPont, Union Carbide, Shell Oil, Goodyear and Atlantic Richfield.
Leukemia focus, and industry work, in Woburn, Mass.
Buffler said her interest in leukemia stemmed in part from her work in 1984 in Woburn, Mass., site of a toxic tort case made famous by the best-selling book and hit film, A Civil Action.
Twenty children in this Boston suburb of 37,000 were diagnosed with leukemia between 1964 and 1983 -- twice the normal rate. Six of the children lived within a few blocks of one another, a cancer cluster highly unlikely to be a coincidence. Tests showed that two of the wells supplying water for the town were heavily polluted with several chemicals, including trichloroethylene, commonly known as TCE. Eight families sued, alleging that industry contaminated the wells. In 1986, a jury cleared Beatrice Foods of wrongdoing. W.R. Grace later settled with the families for $8 million. A third company, UniFirst, had settled out of court for slightly over $1 million.
Years later, Buffler reminisced about her work in Woburn, saying that there was never proof that the chemicals caused the cancers. “The people of Woburn won eventually; yet, we could not answer their questions,” she said. Her remarks intrigued Harvard statistician Marvin Zelen, who had conducted a study, with two colleagues, showing a statistical association between the polluted water and leukemia. Buffler never participated in the Woburn study. Instead, she and three other academics were hired by the chemical industry to critique the findings of Harvard researchers Zelen, Barbara Wessen, and Stephen Lagakos.
Buffler's work was sponsored by the American Industrial Health Council, whose board was composed of chemical company executives, including a senior executive of W.R. Grace. Her committee concluded that while the Harvard study was “sophisticated,” its results couldn't be trusted because the people who volunteered to help collect information for a telephone survey were biased.
About half of the 235 unpaid volunteers lived in Woburn, where there had been ample news coverage of the lawsuit. The volunteers called Woburn residents to collect medical information about fetal deaths, birth defects and childhood diseases. Ultimately, they got information from nearly 60 percent of the town's homes.
Figuring out how much polluted water each household drank became a complicated task for the researchers. Water from the polluted wells was blended with other well water and piped into houses throughout Woburn, but not in equal amounts. The Harvard researchers were able to calculate the amount each household consumed and compare it to the medical data. The numbers were striking. They showed significantly higher rates of some types of birth defects as well as deaths of fetuses and newborns. There was also a statistical link between children with leukemia and the polluted water.
The industry panel led by Buffler, then a professor at the University of Texas Health Science Center at Houston, cast doubt on the medical data collected, given that Woburn residents might be tempted to blame their diseases on industrial pollution. The “potential for reporting biases is alarmingly high,” the review committee said.
Zelen didn't know about Buffler's report until a year later, with an interviewer from a PBS show shared it with him. Zelen said it was full of factual errors. For example, the review speculated that the volunteers might know who they were calling. But Zelen said they were assigned random phone numbers and trained not to ask for names. The review also speculated that the volunteers could guess where people lived from the telephone number. Zelen said that was impossible. The data collected on birth defects was verified with doctors’ records, Zelen said. What's more, the data showed that once the two wells were shut down, the higher rates of birth defects disappeared.
The Harvard researchers sent a letter to Buffler and other panelists, but said they never got a response. They did hear back from the journalist at PBS. He said that after Buffler received their letter, she changed her mind about being interviewed for the program.
Since then, similar studies in Toms River, N.J., and Camp Lejeune, N.C., have found links between water polluted with TCE and leukemia.
From Clinton Superfund panel to pesticide company board
A few years later, Buffler left Houston to become dean at the UC Berkeley School of Public Health, one of the most prominent jobs in her field. Within her first two years, she was elected president of two professional associations as well as a member of the National Academy of Sciences and the Institute of Medicine.
She was also selected to serve on a panel during the Clinton administration to recommend reforms to the Superfund law. The law was intended to require businesses to clean up old industrial waste sites, but big businesses complained it went after deep pockets unfairly, and environmentalists complained it was too ponderous.
It was on this panel, in December 1992, that Buffler met Robert Burt, the chairman and chief executive officer of FMC. Burt and Buffler represented opposing interests on the panel. Burt was also a director of the Chemical Manufacturers Association, the chemical industry’s chief lobby group. He asked Buffler to serve on his company’s board.
“Mr. Burt convinced me that the company really was committed to doing the very best -- doing the right thing in terms of the environment and occupational health and safety and needed that kind of independent voice on their board of directors,” Buffler explained in a court deposition in 2007. “I was very outspoken during the deliberations of the Superfund commission, and apparently that did not alarm him as a CEO of a specialty chemical company. … After quite a prolonged due diligence, I became very comfortable with the -- what was being requested,” Buffler said.
In 1994, Buffler joined a board with several political heavyweights, including former Gov. James Thompson of Illinois, Clayton Yeutter, former chairman of the Republican National Committee, and Jean A. Francois-Poncet, former Minister of Foreign Affairs in France. All four were appointed to a committee to review FMC’s dealings with government as well as its environmental efforts. Buffler would eventually chair that committee.
Buffler’s objectivity is beyond question, FMC said in a statement. “Dr. Buffler was nominated to the FMC Board of Directors due to her expertise in health and environmental issues,” the company said. “She served as chairperson of our board’s Public Policy Committee and supported the eventual evolution of that committee to a new Sustainability Committee that focuses primarily on sustainability and health, safety and environmental matters.”
In 1996, Buffler was appointed to an EPA panel to advise the agency of scientific matters related to pesticides.
FMC at the time was facing scrutiny from the EPA and the Justice Department. In 1993, the EPA inspected FMC’s phosphorus plant in Pocatello, Idaho, and found the company was illegally dumping phosphorus residue into an open pond.
When exposed to air, phosphorus spontaneously ignites. The plant had a history of fires along the banks of its pond. Phosphine gas is also poisonous, which authorities reported may have caused the deaths of migratory birds attracted to the pond. In 1998, the Justice Department reached a settlement with FMC to cap the pond and fined FMC almost $11.9 million, which at the time was the largest penalty ever imposed under the Resource Conservation and Recovery Act. Since then, FMC has been named as potentially liable for 28 other Superfund sites.
A year after joining the board, Buffler launched her leukemia research program at Berkeley, a collaboration with five institutions focused on leukemia cases in the Bay Area. “These projects cover a wide range of Superfund related areas and chemicals,” the grant application begins. In 1999, she expanded to other parts of California and strengthened the focus on children’s exposure to household chemicals and pesticides.
In 2002, Buffler co-authored an article in Environmental Health Perspectives showing a link between household pesticides and leukemia. The article explicitly reported no link to agricultural pesticides or herbicides, the products sold by FMC. At the time, Buffler was on the editorial board of the journal.
The lead author of that study, Xiaomei Ma, now an associate professor at Yale University, said she doesn't believe Buffler's ties to FMC had an impact on the study's findings. Ma said she had high regard for Buffler's integrity and was offended anyone would question it.
A later study, published by Buffler and her team in 2009, showed a possible link between some pesticides used on farms and childhood leukemia, including a class of pesticides known as organophosphates. FMC's Web site shows that two of its 15 brands of pesticides fall into this class. The article said, however, that children exposed to the highest levels of organophosphates did not show higher rates of leukemia.
A year earlier, Buffler had co-authored a review funded by Dow AgroSciences that was favorable to organophosphates. Several studies, including some done by Buffler's colleagues at the UC Berkeley School of Public Health, had already linked exposure of organophosphates in fetuses to problems with mental development. But in her review, Buffler challenged those findings.
FMC said organophosphates account for “a very minor part of our crop protection portfolio. … These two premix products, while important to help farmers combat crop destroying insects, account for less than 1 percent of our Agricultural Solutions sales in the United States.”
During her career, Buffler co-authored 15 articles in scientific journals paid for by companies or industry groups that asked her to evaluate chemical and other risks. In one article, her findings were unfavorable to her sponsor. In 1990, she and others found an unusually high number of colon cancers among workers at General Motors who made early vehicle prototypes. In three articles, the results were mixed. And in 11 articles, her findings were favorable to her sponsors, an analysis found.
Buffler also served as an expert witness in toxic tort lawsuits. When asked in depositions, she could not recall ever testifying against industry.
Buffler was criticized in a 2004 law review article for views the article equated with giving chemicals the same presumption as criminal defendants: nontoxic unless proven toxic beyond a reasonable doubt. “The expert’s assertions represent a view of the scientific method which came under strenuous attack long ago, and a view of statistical testing that was rejected even earlier,” wrote Sander Greenland, a former professor at UCLA, and co-author of a textbook on epidemiology.
For her legal work, Buffler charged $600 an hour. She and her husband split time between homes in Berkeley and a house they built in the mountains of Santa Fe, N.M. Property records show they also owned a house in Austin, Texas, where a relative lived, and four timeshares. She routinely used a limousine service to get around, according to her deposition testimony in the lead-paint lawsuit.
She was also one of UC Berkeley’s largest donors, giving the school $245,000.
Buffler volunteered to help industry groups challenging scientists who published studies unfavorable to the chemical industry or who testified against chemical companies. She served as an advisor to the industry-funded American Council on Science and Health. And she put her name on legal briefs generated by the Atlantic Legal Foundation.
Some of Buffler’s pro-industry testimony came in cases in which plaintiffs said toxins were sickening or killing them.
An asbestos case in Maryland
Struggling to catch her breath, Joan Dixon drove 35 miles to a Morgantown, W.Va., emergency room. There, in March 2008, she learned that her left lung was soaked in fluid. The doctor revealed that she had a rare form of lung cancer, one Dixon had never heard of: mesothelioma. There is no cure. The doctor said there was only one known cause -- exposure to asbestos.
Starting in the late 1960s, Dixon’s husband Bernard spent three or four nights a week in a friend’s garage fixing brakes for neighbors. The Dixons lived in Friendsville, Md., a speck of a town of 142 families a few miles from the borders of Pennsylvania and West Virginia. Dixon charged $10 or $20 for his brake jobs. Sometimes he accepted a six-pack of beer instead.
The job was dirty. Dixon would spray the exposed brake with an air gun, sending clouds of dust particles into the air and onto his clothes. The dust was full of asbestos. Sometimes Joan would help. Other times she was the one who threw her husband’s dirty clothes into the wash.
Joan was adamant about suing Ford Motor Co. for warning employees and dealers -- but not others -- about the dangers of asbestos in its brakes. She died in February 2009, before her case went to trial. Her husband said he was against taking action at first, thinking it futile and mostly for the benefit of attorneys. But he promised his wife he would carry out her wish.
At the end of a trial in April 2010, a Baltimore jury sided with the Dixons with a $15 million verdict. The court reduced it to $6 million.
Buffler became involved on appeal. She and 12 other scientists, including two Nobel laureates, signed a “friend of the court” brief. It was filed by the Atlantic Legal Foundation, a nonprofit whose board includes current and former executives of companies grappling with their own asbestos lawsuits.
The foundation said in one report that it has a “deep commitment to redressing the bias against business which manifests itself in favor of narrow consumer or environmental concerns.” When asked during the 2007 deposition if she agreed with that goal, Buffler said, “My understanding in the role that I play is -- trying to find the right way to express it. Best way I can express it in terms of my understanding and the role that I play is advancing the role of science in litigation.”
Buffler said she would receive briefs from the Atlantic Legal Foundation, review them, edit them and, if she agreed, sign them. She did this in several asbestos cases as well as others, but said she didn’t get paid. FMC, on whose board she served, has over the years faced nearly 100,000 asbestos claims, the company reports in recent financial statements.
In the Dixon case, the "friend of the court" brief signed by Buffler argued that the testimony of the family’s scientific expert, Dr. Laura Welch, shouldn’t have been allowed because it was “unacceptable” science. Welch is the medical director of the Center to Protect Workers’ Rights in Silver Spring, Md. There are no studies proving that people get mesothelioma from doing brake work, let alone that wives of brake mechanics are at risk, the brief said. It added that Welch “ignored the overwhelming evidence that chrysotile asbestos, the type used in automobile brakes and that Mr. Dixon and Mrs. Dixon were exposed to, has far less, and maybe nil, potential to cause mesothelioma than other types of asbestos.”
In June 2012, the Maryland Court of Special Appeals threw out the jury’s verdict. Citing the brief’s argument that Welch never quantified how much asbestos Dixon was exposed to, the court said Welch couldn’t know if it was enough to cause the cancer.
In an earlier lawsuit, Welch filed her own “friend of the court” brief responding to Buffler’s arguments, signed by 51 scientists. She quoted a U.S. Public Health Service report citing “general agreement among scientists and health agencies” that chrysotile asbestos can cause mesothelioma. In addition, “there is sufficient evidence in humans for the carcinogenicity of all forms of asbestos,” says the latest report of the World Health Organization’s International Agency for Research on Cancer.
In July, Maryland’s highest court reversed the appeals court ruling, saying it has been established in previous cases that chrysotile asbestos can cause cancer. The court also ruled that Welch had quantified Dixon’s exposure. Bernard Dixon said he never understood why Buffler got involved in the case.
Expert witness in lead-paint lawsuit
Several of Buffler’s friends and acquaintances say they were most surprised by her work as an expert witness in the lead-paint lawsuit.
Ten miles south of the Berkeley campus, Tamara Moore lives with her three children on the second floor of a cramped three-room duplex more than a century old. A single mother, she can barely afford the $1,700-a-month rent. When they moved in, the dull teal paint outside on the windows and stairs was peeling badly, especially in the backyard. It’s a common problem in Alameda County, where 80 percent of homes still have lead paint.
When she applied for public assistance, Moore was required to get blood tests for her children. The results for her two-year-old daughter were disturbing: Erica had lead in her blood, a level so high it nearly required emergency medical treatment. Now eight, Erica struggles with a learning disability and takes special-education classes.
The Centers for Disease Control and Prevention now says there’s no safe level of lead in a child’s blood. But to focus resources on children with the highest exposures, the CDC defines a “level of concern” at five micrograms of lead per deciliter of blood. For a typical two-year-old girl, that’s just 1.4 millionths of an ounce of lead in her whole body.
Friction from opening a window can create lead dust, according to the National Safety Council. The dust sticks to the fingers and can end up in a child’s mouth.
The CDC estimates that during an eight-year period that ended in 2010, there were 535,000 children under the age of six with this much lead or more in their blood.
The Healthy Homes Department in Alameda County is notified whenever a child has a blood test with a level of concern. Erica’s test reading was eight times that level. In her case, the agency was able to remove some of the old lead paint and paint over the rest. That was five years ago. But on a recent visit, some of the paint on the front and back stairs was peeling again, exposing the underlying lead.
Julie Twichell, a spokesperson for the county agency, said there’s little money available to remove lead paint from homes. While driving through Moore’s neighborhood in Alameda, she pointed out house after house with peeling lead paint.
Alameda County is among 10 communities in California that just won a $1.1 billion judgment against the lead-paint companies Buffler defended. Buffler was not called as a witness during the trial, but revealed her opinions on lead in a disclosure form filed in the lawsuit. “There are many indicators that the risk of injury to children living in homes with lead-based paint is low, and that the risk to children from lead-based paint in homes is not probable or imminent,” according to the document.
Yet in his ruling, Superior Court Judge James P. Kleinberg rejected that claim. “Leading experts in the field of lead poisoning are virtually unanimous in concluding that lead paint is the primary cause of lead poisoning in young children,” he wrote.
Buffler said the average likelihood of a child under the age of three being harmed by lead is 1 in 58,400, citing a report from the U.S. Department of Housing and Urban Development. But Warren Friedman, a senior advisor for the HUD division that published the report, said this number is not accurate for the United States. Friedman said the real risk is 1 in 40.
Kim Dietrich, a professor of environmental health at the University of Cincinnati who specializes in lead research, said the statistic is an obvious error that any epidemiologist should have challenged. After reading Buffler’s opinions on lead, Dietrich said, “The doctor reveals a stunning and perhaps deliberate ignorance of the problem, but typical of those the lead industry pays very well to give this kind of testimony.”
Drawing the line on corporate interference
Buffler once spoke candidly about her views on financial ties and attempts by funders to interfere with research. While testifying in the 2007 deposition, Buffler cited cases where she objected to a sponsor’s intrusion on her work. Without offering details, she recalled one situation where a sponsor objected to her analysis. “That’s not appropriate,” Buffler said she told them. Without elaborating, she added, “I mean, there are many instances.”
Buffler said UC Berkeley adopted guidelines to assure the independence of research, and she followed them. “Research involves a great deal of public trust. The research enterprise is such that if we don't have those kinds of [guidelines], then how could the public trust the work that we do? I feel very strongly about that.”
But now, fully understanding her ties to industry, some close friends are torn by questions. “I admired and loved her,” said one, Devra Davis. “I had never dreamed, never imagined that she would have put her expert opinion up for sale .... It sends me into a tailspin of reflection as I try to fathom what the hell she could have been thinking.”