9
Working the Refs
how do we know if a substance causes cancer? With some difficulty. Rarely does one single study yield a result so conclusive that there is no debate. In most cases, the task of proving a substance’s danger requires interpretation of lots of studies.
Two institutions lead the difficult work of evaluating the scientific literature to identify carcinogens: the International Agency for Research on Cancer (IARC) and the U.S. National Toxicology Program (NTP). Both have rigorous processes to review and evaluate the literature and make the required judgment calls. And it necessarily follows that both have been the target of highly sophisticated doubt and uncertainty attacks from the product defense industry and its corporate sponsors.
IARC is a branch of the World Health Organization and is based in Lyon, France. With a full-time staff of hundreds, it coordinates and conducts research that focuses on identifying the causes of cancer and improving its diagnosis, treatment, and prevention. As part of this work, it regularly convenes groups of expert scientists to review published studies and evaluate whether the weight of the evidence warrants labeling a given substance (or mix of substances, or environmental exposure, or even lifestyle) as a carcinogen. Since 1971, IARC panels have evaluated more than 1,000 agents and labeled more than 400 with one of three designations: carcinogenic, probably carcinogenic, or possibly carcinogenic to humans.
The National Toxicology Program (NTP) is a comparable U.S. program that is housed within the National Institute of Environmental Health Sciences (NIEHS). NTP is unusual in that its executive committee is composed of heads of other federal agencies that rely on NTP’s assessments. This means that NTP’s board is made up of the heads of the Department of Defense, the Environmental Protection Agency, the Food and Drug Administration (FDA), the National Cancer Institute, the Consumer Product Safety Commission, and the Occupational Safety and Health Administration. (I served as chair of the NTP executive committee for more than five years while I ran OSHA.)
In 1978, while Jimmy Carter was president, Congress passed legislation requiring the NTP to publish the Report on Carcinogens, an annual update on substances either “known to be human carcinogens” or “may reasonably be anticipated to be human carcinogens,” and to which a significant number of U.S. residents are exposed. Listing in the Report on Carcinogens (today issued biennially) is the culmination of a rigorous process with multiple internal and public reviews of the agents nominated for inclusion.
Having government agencies label carcinogens is significant for two reasons. First, it is a vital component of cancer prevention, for the straightforward reason that many consumers will avoid purchasing products that are labeled as causing cancer (which is good). Two, manufacturers of consumer products will respond to the market dictated by consumers and will try to find substitutes for these suspect agents—which may impact their profits.
Corporations do not want their products labeled as cancer-causing, for obvious reasons. Accordingly, the scientific and regulatory process leading to a cancer-causing designation can quickly become contested terrain. The first instinct of many corporate executives is to deny the problem by denying the science; to do so, they engage product defense scientists and PR experts for help. Corporations, especially ones that make or market chemicals, have learned the hard way that a designation from IARC or the NTP is very bad news, so they will make great efforts to prevent it from happening.
Think of this strategy as “working the refs.” In basketball, coaches storm up and down the sideline, complaining about the referee’s last call with the hope of affecting the next one. The same is true in industry. Working the refs is a necessary and sometimes elaborate component of any corporate campaign to manufacture doubt and uncertainty. And it can be harassing, even suffocating, for the targeted agency.
Talc is a clay mineral that, in powder form, absorbs moisture and reduces friction. It has widespread industrial applications in the manufacture of products including rubber, paints, plastics, paper, ceramics, and construction materials. Talc is also present in about 2,000 cosmetic products, including antiperspirants, lipstick, and concealing makeup. And of course, baby powder.1
Talc also has some issues. The presence of asbestos fibers in talc deposits has long been a public health concern. So are the fibers that are not asbestos but have similar structure to asbestos, often called asbestiform fibers. These are also commonly found in talc deposits, and they are also worrisome.
Talc made front-page headlines in 2018 after a jury in St. Louis awarded $4.7 billion (yes, billion) to 22 women who claimed that use of Johnson’s Baby Powder contributed to their ovarian cancers. The baby powder, an iconic American product present in many American homes, is produced by Johnson & Johnson, headquartered in New Brunswick, New Jersey. In the case that resulted in the large award, the primary focus of the case was not the talc itself, but the asbestos contamination. To many people who use Johnson’s Baby Powder and other products that contain talc, the decision, as well as the revelation of asbestos in talc, likely came as a surprise. There had been a few previous lawsuits from women with ovarian cancer, some finding for the women, some for the manufacturer, but baby powder and other talcum powder products have contained no warning that these products may contain asbestos and could cause cancer.
There was a reason for this missing warning: when talc had been under consideration for the NTP’s Report on Carcinogens, the agency’s effort was stopped by a sophisticated product defense campaign financed by the talc industry, including both the companies that mine and produce the mineral and the businesses that use it in their products. The internal documents revealed in that lawsuit provide a comprehensive road map to how their strategy worked.
I had not been closely following the talc/ovarian cancer epidemiology when I received a call in early 2018 from an attorney in Houston whom I had never met, Mark Lanier, who asked if I would testify as an expert witness in an upcoming trial in St. Louis involving exposure to talc. I explained that I was not up to date on the epidemiologic studies and turned him down. Lanier then explained that it wasn’t the epidemiology he wanted me to address; he wanted me to speak as an expert witness to the issue of manufactured uncertainty in general. On this subject I am up to date, but I turned him down again. Lanier persisted, asking then if I would object to being subpoenaed as a fact witness. (Expert witnesses can offer opinions; fact witnesses cannot, and must base their testimony only on personal knowledge.) Nor would I be compelled to go to St. Louis for the actual trial. Subpoenaed witnesses can’t be compelled to travel, so my testimony could be filmed in Washington, DC, where I work.
Having never been a fact witness at a trial, I was intrigued, so I agreed. I had no idea what to expect. And I certainly wasn’t expecting a call a few days before my testimony from Johnson & Johnson’s attorney, asking what I planned to talk about. I explained what little I knew: Lanier planned to ask me questions about the product defense industry and how corporations use it to manufacture scientific uncertainty.
Arriving at the downtown Washington hotel room, I was greeted by Lanier, a team of attorneys for the defendants (Johnson & Johnson and a company that mines talc), a court reporter, a videographer, and, to my surprise, a judge from St. Louis who would preside over the testimony. After just a few minutes, I understood exactly why Lanier asked me to testify. Several of the leading product defense experts had been brought in to help defend talc, and the documents unearthed during discovery had revealed exactly how they did it. I realized that Lanier intended my testimony to demonstrate how their excellent map for the talc uncertainty campaign carefully followed the template instituted by Big Tobacco and perfected over the years by many industries—all things I had written about previously. Over the course of a few hours, I was shown many documents, including the ones I discuss below, and asked to comment on them. I was told that some of the documents were considered confidential, and I could not discuss them with anyone unless they were later used in court, at which point they would become public.
In the end, my videotaped testimony was never used. Lanier later told me he was saving it for rebuttal, when he would have the opportunity to refute the material presented by the other side. Evidently, he felt his case was strong enough, and the defense’s case sufficiently weak, that he didn’t need a rebuttal. He was clearly correct: the jurors awarded the plaintiffs $550 million, or $25 million to each of the women or the families of six women who had died, plus $4.14 billion in punitive damages. One juror explained the message they were trying to send to Johnson & Johnson, the only remaining defendant at that point in the trial: “We were just trying to find something they would feel.” Johnson & Johnson is, of course, appealing the award.2
In that hotel room in Washington, I had been shown only a small fraction of the documents that entered the public record. After the trial, I asked Lanier if I could review the entire corpus that had been admitted into evidence, which he generously shared with me. Examining them was an eye-opening revelation, especially as many of the documents involved the National Toxicology Program. As noted, while running OSHA I served as the chair of the NTP’s Executive Committee. After returning to academia, I was appointed by President Trump’s Health and Human Services Secretary Alex Azar to NTP Board of Scientific Counselors (BSC), which provides scientific advice to the director and evaluates NTP programs (including the Report on Carcinogens). But, needless to say, I had never seen the secret details of a campaign like this.
In the early 1970s—before the NTP was created in 1978—asbestos had become a national concern. Much of the research on the health effects of asbestos was centered in the laboratory of Irving Selikoff at New York’s Mt. Sinai Medical Center. Following Selikoff ’s advice, New York City’s Environmental Protection Administration banned spraying asbestos to insulate buildings in 1971, part way through the construction of the World Trade Center. Around the same time, the administrator of that agency reported that Mt. Sinai had tested two brands of commercial talcum powder and found asbestos, naming Johnson’s Baby Powder as one of them.3 One of the mineralogists in Selikoff’s laboratory wrote to J&J that he had found a “relatively small” amount of asbestos in its product, although he subsequently told reporters that he detected asbestos in several samples of commercial talcum powder, but not in Johnson’s Baby Powder.4 The public furor around these reports created pressure on the U.S. Food and Drug Administration, which, in addition to foods and drugs, is charged with ensuring that cosmetic products are safe. Johnson & Johnson assured the federal agency that no asbestos was “detected in any sample” of talc tested in the company’s laboratories. However, this assurance neglected to mention that at least three tests conducted between 1972 and 1975 by three outside laboratories did find asbestos in talc samples from Johnson & Johnson—including one in which the lab reported the level as “rather high.” In addition, Johnson & Johnson’s own testing methods were not up to the task of monitoring for asbestos, as they routinely allowed trace contaminants to go undetected. Moreover, the firm tested only a tiny fraction of the talc it used in production. Eventually, the FDA decided not to issue any regulation limiting asbestos in cosmetic talc, essentially deferring the Cosmetic, Toiletry & Fragrance Association’s voluntary guidelines that encouraged use of the industry’s testing protocols.5
In 1979, OSHA’s sister agency NIOSH (a research institute situated under the Department of Health and Human Services, like NTP) first nominated talc for review by the newly created NTP. Studies leading up to the NIOSH recommendation had found increased risk of lung cancer and mesothelioma—a cancer caused by asbestos—among talc miners. This was followed in 1982 by a new and very major concern: a study finding increased risk of ovarian cancer among women exposed to talc through perineal applications, or use on sanitary napkins or diaphragms.6
This new threat presented a significant foundational problem for Johnson & Johnson. Its Johnson’s Baby Powder shapes the public’s image of the firm, and it connotes a reassuring image of purity, reminding people of an earlier, less complicated time. (Few people think of Johnson & Johnson as a firm that also manufacturers drugs, including opioids, and medical devices.) The company has long contended that its baby powder is free of asbestos, and the cosmetics and personal care products industry adopted a voluntary asbestos-free standard in 1976. However, special reports published by the New York Times, Reuters, and Bloomberg Businessweek have revealed a very different story. Investigative reporters examined thousands of documents obtained through Freedom of Information Act requests or civil litigation and spoke with individuals involved in testing talc over several decades. These reports all concluded that Johnson & Johnson recognized as early as 1971 that there had been many indications that the baby powder was in fact contaminated with asbestiform particles (again, not technically asbestos, but with a similar structure). Johnson & Johnson pressured scientists conducting testing programs to report no fibers, while, in the words of the New York Times report, “discredit[ing] research suggesting the powder could be contaminated with asbestos.”5
In 1987, IARC, the international agency, classified talc with asbestiform fibers as carcinogenic to humans. It did not make a designation for pure talc containing no asbestiform, saying there was not adequate evidence to make a determination.7 (This may be moot given that asbestiform talc seemingly makes its way to market without consumer knowledge.)
That background brings us to the NTP story. In October 2000, the NTP released publicly its initial document titled the “Draft Background Document for Talc Asbestiform and Non-Asbestiform,” which reviewed the evidence related to talc and cancer. Its recommendation: designate asbestiform talc as a human carcinogen and non-asbestiform talc as “reasonably anticipated to be a human carcinogen.” (Talc with asbestos is of course a carcinogen. This is undisputed.)
How did the NTP scientists reach these conclusions? In most of the numerous studies that found increased risk of lung cancer among talc miners, the talc they were mining included asbestiform fibers. So it wasn’t possible to say definitively that talc alone contributed to the excess risk. And while there were a few studies of miners working in settings with no reported asbestos that also found increased lung cancer risk, those same settings also exposed the miners to silica, radon, or other carcinogens—so it wasn’t possible to attribute the cancer risk to talc alone. (There was animal evidence as well, but it wasn’t as powerful. The draft concluded that there were no adequate experimental animal studies involving talc with asbestiform fibers, and there was only one adequate study of rats exposed to non-asbestiform talc. That one study, however, did find increased risk of cancer in the talc-exposed rats.8)
And then there was the newer evidence of ovarian cancer. By the time of the NTP draft in 2000, more than a dozen studies found women who used talc for perineal dusting and on sanitary napkins and diaphragms were at increased risk of ovarian cancer. On the other hand, one large prospective cohort study was negative on this issue.
Companies involved in talc production and sales interpreted the NTP’s draft document as a dangerous shot across the bow. The fear it generated is captured in a presentation made by Steve Jarvis, head of environmental health and safety at Luzenac America, a branch of a French firm that was (and remains) the world’s largest miner of talc and a producer of many talc products for industrial and cosmetic use.
A listing of talc in the [Report on Carcinogens] would have devastating consequences for the talc market worldwide.
First of all … we would see a virtual immediate loss of our sales to the personal care market—around $10 million in sales in the first year.
Secondly … because of the carcinogenic labeling requirements, we would likely suffer a deterioration of sales in all markets … perhaps anywhere from 20% to 50% of all remaining sales by year three.
Additionally, a listing in the U.S. by NTP would likely trigger a carcinogenic status for talc in Europe and the Far East.
And finally … because of our consumer product exposure, civil litigation would likely skyrocket.9
The NTP’s draft was released in October 2000. Only two months later, in December, the NTP’s Board of Scientific Counselors would meet to determine whether talc should be listed for the first time in the annual Report on Carcinogens. So time was short—desperately so—for the industry. The Cosmetic, Toiletry & Fragrance Association (CTFA), the leading national trade association, convened a conference call in red-alert fashion to discuss how to proceed. Much of the campaign to stop the NTP designation would be coordinated through this trade association and the talc mining industry. (Of note: CTFA’s longtime president, including during the years of interest here, was E. Edward Kavanaugh, father of Supreme Court Justice Brett Kavanaugh. In 2007, two years after Kavanaugh’s retirement, the group changed its name to the Personal Care Products Council.)
CTFA had an existing relationship with the Weinberg Group, the product defense firm that did extensive work for the tobacco industry and other industries under duress.10 By the time of the conference call about the talc emergency, the Weinberg Group had already submitted to CTFA a proposal to manage one component of the campaign: reviewing the epidemiologic literature to date and finding experts who could testify against the designation at the upcoming NTP hearing.11
Of course, Johnson & Johnson had been defending talc, and therefore preparing for this fight, for years. Almost a decade earlier, it had hired Alfred P. Wehner, a toxicologist with experience overseeing animal studies related to talc, to counter the first studies suggesting the link with ovarian cancer.12 Wehner was a veteran of the regulatory battles concerning second-hand smoke, and had done good work sowing doubt on behalf of American cigarette makers.13 In 1994, six years prior to the NTP draft, he had dutifully undertaken a literature review focused especially on early talc studies and concluded that the literature “does not provide any convincing evidence that pure cosmetic talc, when used as intended, presents a health risk to the human consumer.”14
In 2000, Wehner reprised his work for talc interests, trashing the NTP draft on talc as “a seriously flawed, biased document.”15 Any notion that Wehner’s critique was a judgment produced independently or without consideration of its sponsors is soundly disproved by the subsequent internal discussions of how it would be used.
Evidence suggests that the industry people didn’t like the tone of the rebuke. One quote indicates that “Wehner’s critique needs to be toned down.” A Luzenac staff person did just that, rewriting and toning down parts of it, then circulated this accompanying email:
Attached is my first go at the Introduction to the submission. It is intended to be colaborative [sic], to hint at the legal and credibility issues for NTP and to suggest a fall guy, i.e. the consultants… I expessed [sic] some concern about the strident, some might say arrogant, tone of his original essay. That document failed to convince (although we do not know if the style contributed to that) so this time I strongly recommend we turn it round into a collaborative style that puts the consultants who prepared the draft in the firing line, not the NTP and its venerable Counsellors. The aim should be to create a reasonable doubt in their minds that they may not be acting on the best of advice from their consultants.16[emphasis added]
Short on time, CTFA realized it needed more effective arguments than Wehner or the Weinberg Group could supply. Smartly, it hired one of the deans of product defense, Jim Tozzi, head of an organization called the Center for Regulatory Effectiveness, or CRE. CRE’s name belies its actual mission, which is to limit regulation on its corporate clients. Tozzi, a former high-level official in the Office of Management and Budget under President Ronald Reagan, had a hand in designing several pieces of legislation that enable business interests to slow regulatory efforts. When he left the government, he established a suite of consulting firms, including CRE, that worked actively with the tobacco industry to oppose the EPA’s efforts to limit smoking in public places. Tozzi was instrumental in advancing one of Big Tobacco’s signature efforts to tie the EPA’s hands, the Data Quality Act, which permits corporations to challenge and re-analyze the data used as the basis for formulating regulations. In the battle around talc, Tozzi brought a wealth of skills and resources to CTFA and the industry’s other defenders. Beyond helping them shape their technical argument, he was well connected to the George W. Bush administration, which would take over in January 2001—the month following the meeting of the NFP committee. He knew how to wield the Data Quality Act to pressure agencies to change findings to avoid a fight with the new White House.
Tozzi was a veteran of pressuring the NTP, having campaigned on behalf of the tobacco industry to block the agency from listing second-hand tobacco smoke as a carcinogen. Between that campaign and this one for talc, Tozzi was also tapped by clients who objected to the designation of the infamous chemical dioxin as a known human carcinogen. As part of that job, Tozzi and his organization CRE sued the NTP over its decision-making procedures—a subterfuge for hiding the litigation’s actual sponsorship, the ever-unpopular cigarette manufacturers. The lawsuit was mostly unsuccessful (both dioxin and second-hand tobacco smoke were listed as known human carcinogens), but Tozzi did succeed in exposing a vulnerability of NTP’s: lawsuits and judicial review, which under-resourced, under-lawyered agencies of its kind generally try to avoid.17
At $12,000 per month, Tozzi and his CRE team didn’t come cheaply for the talc companies.18 Some payments went to another of Tozzi’s consultancy groups, Multinational Legal Services, rather than CRE, “in order to have the benefit of an attorney/client relationship” that would protect the work product from discovery in civil litigation.19
Tozzi and his various firms delivered for Johnson & Johnson, the talc producers, and the trade association CTFA. The consultants first formulated what was later referred to as the “fatal flaw” in the reasoning of the NTP report: In the studies that found increased risk of cancer among humans exposed to talc—either miners or talcum powder users—many of the exposures occurred long enough in the past that it was not possible to state unequivocally that the talc was free of asbestos. At the time, there were no studies that could adequately evaluate cancer risk in people whose exposure to talc only occurred after the industry started policing the presence of asbestiform fibers although there are now positive studies that include women with more recent exposures.20 However, given the absence of this evidence in 2000, Tozzi’s argument was that the NTP could not meet the burden of proof to show that non-asbestiform talc caused cancer. Of course, this argument could only be successful if accompanied by the belief that newer cosmetic-grade talc was asbestos-free. The CTFA stressed that it was, and in doing so they had the reputational high ground. After all, the industry had imposed that voluntary asbestos-free standard in 1976. And any evidence cosmetic talc after that date was contaminated, or that the testing was inadequate, had never been made public.
Tozzi’s CRE team formulated the argument and then directly communicated it in a strongly worded letter sent to the NTP before the December vote.21 Under normal circumstances, a trade association might send a letter and argument like this one under its own letterhead. By having CRE send it, the talc trade group conveyed an additional message: we have political muscle here. NTP administrators would recognize they were essentially dealing with a street fighter who had already sued NTP once (in a mostly losing cause, yes, but one nonetheless burdensome for the agency).
Prior to the vote to list talc containing asbestiform fibers as carcinogenic in the Report on Carcinogens, that evidence had been reviewed by two federal scientific review groups: the NIEHS Review Committee for the Report on Carcinogens and the NTP Executive Committee Interagency Working Group for the Report on Carcinogens. The seven members of the first group had voted to designate the tainted talc as a known human carcinogen. The second group, composed of scientists from other agencies, disagreed and voted to designate talc containing asbestiform fibers as “reasonably anticipated” to be a human carcinogen. On the question of talc that does not contain asbestiform fibers, both groups had voted to designate it as reasonably anticipated to be a human carcinogen.
At the meeting in December 2000, representatives of the talc producers and product manufacturers focused on talc without asbestiform fibers and raised what they claimed was the “fatal flaw”: In the human studies to date, it wasn’t possible to know which type of talc was present. An NTP staff scientist reported that before 1976, some samples of talcum powder were found to contain up to 30 percent [asbestiform] fibrous materials. The talc produced after 1976, when the voluntary guidelines were put in place, should not contain fibers—but most studies would not have been able to actually determine that.22 The single animal study came under attack as well: in a study done by the International Life Sciences Institute (which appears in Chapter 14) that suggested that forcing rats to inhale high doses of poorly soluble particles overloads their lungs, and the overload-induced inflammation leads to cancer—cancer they wouldn’t have gotten if their lungs were not overloaded. This study has been widely used to dismiss the results of studies that find increased risk of cancer in rats exposed to these sorts of particles, and this was invoked as well.
The presentations left the members of NTP’s Board of Scientific Counselors confused and overwhelmed, which was exactly the aim of the product defense strategy. The committee members could not judge which studies involved exposure to talc with asbestiform fibers and which did not. Accordingly, they voted to defer the Report on Carcinogens listing until the issues around exposures could be clarified. As Luzenac America executive Rich Zazenski summarized the meeting: “We (the talc industry) dodged a bullet in December based entirely on the confusion over the definition issue.”23 He gave credit where credit was due: “CRE was instrumental in helping divert an almost guaranteed listing for talc into a deferral.”24
In recounting the factors that led to their success, Steve Jarvis, head of environmental health and safety at Luzenac America (and the same person who warned of “devastating consequences” after reading the draft NTP report), called CRE the industry’s “secret weapon.” The industry had “decided to be aggressive. This was a fight we simply could not lose. As such, we retained expert legal counsel to ensure we would have a solid foundation for a legal challenge if necessary … it was the same firm which assisted CRE in their court battle with NTP … and we also became very aggressive in our communication with NTP and other federal agencies. When [sic] didn’t let the windows of ‘formal comment periods’ become restrictive. We sent e-mails, faxes, overnight letters, and even telephones calls to key players in this battle right up until hours before the final Executive Committee meeting.” [ellipses in original]25
The NTP’s deferral of its consideration of talc as a carcinogen was not a final decision. Zazenski recognized that the doubt his consultants had generated might not last. He wrote that “given the issue at hand, the Draft report can be amended to remove the ‘fatal flaw assumptions’ by accounting for the ambiguities surrounding the content of body powders prior to 1976 in a different context. Essentially, if the report were to be rewritten to state that the possibility of asbestos contamination of cosmetic talc prior to 1976 should simply be accounted for as an additional ‘confounding’ factor in the epidemiology studies, a re-vote for ‘talc not containing asbestos fibers’ would likely go the other way.”26
Jim Tozzi agreed. According to Zazenski’s account of an in-house meeting held soon after the big NTP meeting, the CRE product defense wizard warned that the talc industry advocates should “not get too confident just yet.” He then laid out a set of very specific actions meant to ensure that talc would not return to NTP’s agenda. He explained that “for the most part, these agency heads do not attend the meeting themselves, but send alternates in their place. Therefore, some lower ranking agency person (who knows nothing about the substances being reviewed) is voting on the recommendation” … “Tozzi recommended that over the coming months, we target specific individuals at each of the agencies on the Executive Committee who might likely be the attendees for the talc review. Then we select an issue which we want that particular individual to become familiar with before the committee meeting. For example, we target individuals within the FDA and the CPSC to focus on the weaknesses of the epidemiological studies. Then perhaps we target individuals at OSHA and NIOSH for pointing out the irrelevance of the NTP animal study.” Tozzi also said it was time to bring political pressure, recommending the talc industry “enlist the support of senate and congressional representatives from Vermont and Montana [where talc is mined] to lobby the committee members to ‘uphold the findings of the BSC Subcommittee and not allow talc to be listed.’”
In a separate and remarkable document, Eric Turner of Luzenac America explained why it was worthwhile to have Tozzi’s group play an active role—rather than behind-the-scenes one—in the talc campaign. Some of the highlights:27
I have no doubt that agencies like NIEHS and NTP recognize CRE for what it really is—an industry sponsored “advocate” group whose purpose is to pursue the interests of its clients. CRE is not unlike CTFA in this manner… While CRE is actively promoting the interests of talc and challenging the NTP review process, NTP does not know for sure who is sponsoring the effort… CRE can afford to be aggressive and visible in their efforts without risking credibility… Tolerance of such tactics is usually only extended to ‘insiders’ or ‘powerful lobby groups.’ It is how business is conducted in Washington… CRE has been successful because Tozzi and his network of advisors are fairly well “connected.” This networking capability does not go un-noticed by political appointees’ and ambitious staffers… I would strongly recommend that we continue our association with CRE in some capacity in the event NTP finds cause to list talc as a carcinogen… I believe we want NTP to be ‘looking over their shoulder’ and seeing CRE is right there watching their every move until this issue is properly resolved.
Over the next few years, Tozzi and CRE kept up the pressure on the NTP, regularly conveying a message that they could inflict pain, and that the pain would disappear if the NTP dropped talc from consideration. Tozzi wrote to NIEHS Director Ken Olden, invoking the Data Quality Act and calling on the director to notify the public that “further review of the evidence has indicated that the listing is not warranted.”28 CRE also wrote to higher-ups in the Department of Health and Human Services, requesting increased scrutiny on the NTP budget: “The scientific community and [Report on Carcinogens] stakeholders, including government agencies with related programs, have raised serious and legitimate issues regarding the usefulness of the [Report on Carcinogens] program and the manner in which it is administered.”29 Bringing out the biggest guns, the Data Quality Act challenges raised by Tozzi and CRE prompted John Graham, the head of the White House Office of Information and Regulatory Affairs (this was now the early years of the George W. Bush administration, remember), in early 2005 to send a sternly worded letter to the secretary of the Department of Health and Human Services, predictably raising concerns about NTP’s Report on Carcinogen deliberations.30
At the same time, the industry paid for production and publication of more mercenary studies aimed directly at the NTP’s process. In November 2001, toxicologist-for-hire Alfred Wehner submitted yet another article reviewing the talc literature to Regulatory Toxicology and Pharmacology, one of the peer-reviewed journals I cited in Chapter 2 as one that provides a venue for publishing some of the product defense industry’s most mercenary studies. This version toned down Wehner’s over-the-top earlier effort, but covered much of the same material. His title could not make its message more clear: “Cosmetic Talc Should Not Be Listed as a Carcinogen: Comments on NTP’s Deliberations to List Talc as a Carcinogen.” The paper makes no mention of the CTFA, which sponsored the original report, or any other organization which may have paid for the work. It was published early the following year.31
The talc industry’s multi-front assault on regulation succeeded. While the memos show the industry recognized many weaknesses in the arguments of its various product defense advocates, the pressure they applied did confuse the NTP’s Board of Scientific Counselors, first inducing them to defer their decision, and then convincing the agency to drop the matter altogether. An NTP staffer commented that his colleagues “wished the problem would just go away.”32 In 2005, it did. Talc was withdrawn from the list of substances being considered by the NTP for inclusion in the upcoming Report on Carcinogens. Johnson & Johnson credited the success to its collaborative work with Luzenac America and CTFA.33
Of course, the problem facing the industry has not disappeared. Epidemiologists around the world have focused on talc and ovarian cancer, with positive and negative studies now appearing with some regularity. The industry has continued to sponsor papers that question the relationship. The most recent meta-analyses performed by independent researchers have concluded that perineal talc use was associated with a 30 to 40 percent increased risk of ovarian cancer—small in epidemiologic terms but of huge public health significance.34
Much trouble would have been avoided, and perhaps thousands of cases of ovarian cancer prevented, if the firms that mined talc or used it in their products had shifted to a safer substitute after the first studies showing increased risk of ovarian cancer appeared. Simply put, this was not the finest hour of either the industry or the federal regulators. In reviewing the documents uncovered by Mark Lanier’s lawsuit, it is clear that Johnson & Johnson, its trade association, and the mining companies successfully framed what should have been a scientific inquiry as if it were a criminal trial, essentially demanding proof beyond a shadow of a doubt that talc was a carcinogen. That isn’t how the NTP process is supposed to work, but that was the industry’s stated strategy: “Time to come up with more confusion.”35 They brought in expert strategists to shape the message and conflicted scientists to seed the literature and promote a very one-sided interpretation of the evidence. Their attorneys used attorney-client privilege to protect actions and relationships. They had no qualms about bullying the NTP staff. The regulatory process they disrupted is important to the prevention of cancer. After all, it’s the only one we have. But throughout the process, the objective of these firms was not learning the truth—far from it. They wanted to defend their ability to sell a product, and no matter if it increased cancer risk.
In the spirit of equal time, I should note here that many industries try to influence NTP carcinogen designations. Virtually every NTP Report on Carcinogens nomination prompts affected companies and their trade associations to hire product defense experts to send in comments and come to public meetings to plead the industry’s case. At the same meeting of NTP’s Board of Scientific Counselors that considered talc, two trade associations representing tanning salons showed up to assert that ultraviolet radiation is not associated with increased skin cancer risk. This is a ludicrous position that no one takes seriously. And there is a long list of attempts to make similar, questionable claims to NTP. Talc is different and important because we have access to the inside story—how one well-organized industry and its product defense hires were able to bring NTP to its knees.
Recall that NTP isn’t the only health agency to receive industry heat for calling out carcinogens. IARC reviews agents for their cancer risk, then publishes findings in a prestigious set of books called the IARC Monographs. The IARC labels carry all the same heft—and all the same contentiousness—as their U.S. equivalents from NTP.
Perhaps in response to ongoing pressure from the private sector, IARC has taken promising steps to insulate itself from outside influence. Previously, IARC panels included scientists who worked for the companies whose products were under review; these scientists, clearly with conflicts, had an equal vote on these issues. In 2005, responding to questions about the integrity of its work, IARC announced that scientists with “‘real or apparent conflicts of interests’” would no longer serve on the panels that produce its famous monographs on the causes of cancer. These scientists, now dubbed “invited specialists,” would be welcome to share their critical knowledge and experience but would not draft text or vote on the monograph’s conclusions.
Progress, definitely, but still not a panacea. The corporations, even stripped of their inside men on the committee, still launch grenades at IARC, often with success.
A prominent example is glyphosate, one of the largest-selling herbicides in the world, marketed by Monsanto as Roundup and by other brand names in parts of the world. Glyphosate works by killing the grasses and leafy plants it comes in contact with—except those that have been genetically modified to be resistant to glyphosate. When sprayed on genetically modified crops, this chemical should kill only the weeds. Monsanto, DuPont, and a few other agribusiness firms have developed and now market those glyphosate-resistant seeds, labeled “Roundup Ready” and including soybeans, corn, and cotton. The USDA reports that more than 90 percent of these crops grown in the United States are now of herbicide-resistant variety, with the value of glyphosate sales worldwide estimated to be almost $10 billion in 2020.36 As a result of this ubiquity, all of us—consumers and especially agricultural workers—have some glyphosate exposure. Clearly, determining the human toxicity of glyphosate is a most pressing question.
In 2014, IARC announced that it planned to convene a panel of experts to review the published evidence to date on the carcinogenicity of a group of pesticides, including glyphosate. That triggered a secret initiative by Monsanto, outlined in a memo titled “IARC Carcinogen Rating of Glyphosate Preparedness and Engagement Plan.” This plan included the familiar trappings of product defense: first the rapid production of three new papers on glyphosate “focused on epidemiology and toxicology,” supplemented with a strategic communications effort to “amplify existing studies and new papers.” Compared to the defiant tone of the internal communications around talc, the tenor of Monsanto’s memo is noticeably more practical, even defeatist: there is hope to affect IARC’s decision in favor of glyphosate’s safety, but only faint. The plan is largely centered on what the company will do after IARC labels glyphosate a human carcinogen, including outlining how Monsanto will “Orchestrate Outcry with IARC Decision.” It anticipated the need to “provide cover for regulatory agencies to continue making re-registration decisions based on science.” It would use sympathetic scientists, front groups, and trade associations to shape public opinion and pressure regulators to “remain focused on the science, not the politically charged decision by IARC.” Monsanto focused on devaluing the decision and portraying it as political, not scientific.37
Early in 2015, as Monsanto expected, the IARC panel did classify glyphosate as a “probable” human carcinogen, based on “limited” human evidence but “sufficient” evidence from studies of laboratory animals.38 Monsanto’s plan for response was implemented immediately. It has been the subject of in-depth reporting by, among others, Carey Gillam in the United States39 and Stéphane Horel and Stéphane Foucart in France.40
The Monsanto response was also the subject of a 2018 report issued by the minority committee staff (that is, the Democrats) of the U.S. House of Representatives Committee on Science, Space, and Technology. Much of this reporting is based on the thousands of pages of documents disclosed in a series of lawsuits raised by herbicide-exposed people, including agricultural workers, who believe that glyphosate contributed to their cancers.41
The House minority report was triggered by an effort from Republican leadership to pressure IARC to revise its designation. Before they were voted out of power in the 2018 midterm elections, Republican leadership wrote several threatening letters to the newly installed IARC director, Elisabete Weiderpass, demanding the agency send a representative to answer questions about the glyphosate decision and the monograph process. These letters raised the possibility of cutting U.S. government funding for the agency and were followed by a legislative effort to actually do so.42
These U.S. efforts to pressure IARC backfired in the face of the remarkable findings of the House minority report. It describes the secret efforts by Monsanto and the American Chemistry Council, the industry’s trade association, to villify IARC, including ghostwriting scientific papers and articles in business publications, hiring journalists to discredit the agency, establishing front groups that appear to be independent, and aggressively attempting to silence scientists who were involved in the IARC process or who have publicly agreed with the IARC conclusions.
Monsanto’s campaign amounted to a full-employment program for product defense scientists, with work going to Ramboll Environ,43 Exponent,44 and a host of private consultants. In one instance, Monsanto brought together 16 sympathetic experts, working in four groups, to review the evidence on glyphosate’s carcinogenicity. They all concluded, not surprisingly, that “the data do not support IARCs conclusion” and that “glyphosate is unlikely to pose a carcinogenic risk to humans.” The paper, titled “An Independent Review of the Carcinogenic Potential of Glyphosate,” was published as part of a special group of five studies (31 authors altogether), all of them minimizing risks associated with glyphosate exposure. The journal: Critical Reviews in Toxicology, a known haven for science produced by corporate consultants. Many of the authors had done extensive work for Monsanto, but these conflicts of interest were not disclosed. Monsanto paid the authors through a consulting firm, and when this conduit was later acknowledged, the authors claimed “Neither any Monsanto company employees nor any attorneys reviewed any of the Expert Panel[’]s manuscripts prior to submission to the journal.”45
In fact, documents from the litigation later revealed a singular lack of independence. Monsanto scientists were deeply involved in organizing, reviewing, and editing drafts.46 These revelations were evidently embarrassing even for that journal, which then insisted on an extensive correction which noted the many, many ways in which the authors of the various papers are anything but independent from Monsanto.47
As of 2019, the data remain equivocal and the IARC designation has not changed, but we will no doubt hear more about Monsanto’s never-ending uncertainty campaign. Nor will the lawsuits end anytime soon. In the first of these lawsuits to go to trial, a San Francisco jury awarded $289 million, including $250 million in punitive damages, to a school groundskeeper with non-Hodgkin’s lymphoma. This was followed by a case in which the jury awarded $80 million, and then a third in which a glyphosate-exposed married couple were awarded $2 billion. In each of these cases, the judge reduced the punitive component of the award, but the total for the three still approached $200 million. The German chemical giant Bayer, which purchased Monsanto in 2018, now faces thousands of additional suits by people who believe they were sickened by glyphosate. And of course science never sleeps. The jury is still out but the studies keep coming. And while it’s unclear where it will end, this is a perfect example of a fundamental principle in public health: the need to make decisions based on the best evidence available, interpreted by truly independent scientists.