By 1973, Tom Shelley, director of J&J’s Central Research Laboratories in New Jersey, was looking into acquiring patents on a process that a British mineralogist and J&J consultant was developing to separate talc from tremolite.
“It is quite possible that eventually tremolite will be prohibited in all talc,” Shelley wrote on Feb. 20, 1973, to a British colleague. Therefore, he added, the “process may well be valuable property to us.”
At the end of March, Shelley recognized the sensitivity of the plan in a memo sent to a J&J lawyer in New Jersey: “We will want to carefully consider the … patents re asbestos in talc. It’s quite possible that we may wish to keep the whole thing confidential rather than allow it to be published in patent form and thus let the whole world know.”
J&J did not obtain the patents.
While Shelley was looking into the patents, J&J research director DeWitt Petterson visited the company’s Vermont mining operation. “Occasionally, sub-trace quantities of tremolite or actinolite are identifiable,” he wrote in an April 1973 report on the visit. “And these might be classified as asbestos fiber.”
J&J should “protect our powder franchise” by eliminating as many tiny fibers that can be inhaled in airborn talc dust as possible, Petterson wrote. He warned, however, that “no final product will ever be made which will be totally free from respirable particles.” Introducing a cornstarch version of Baby Powder, he noted, “is obviously another answer.”
Bicks told Reuters that J&J believes that the tremolite and actinolite Petterson cited were not asbestos.
Cornstarch came up again in a March 5, 1974, report in which Ashton, the J&J talc supply chief, recommended that the company research that alternative “for defensive reasons” because “the thrust against talc has centered primarily on biological problems alleged to result from the inhalation of talc and related mineral particles.”
“We may have problems”
A few months after Petterson’s recognition that talc purity was a pipe dream, the FDA proposed a rule that talc used in drugs contain no more than 0.1 percent asbestos. While the agency’s cosmetics division was considering similar action on talcum powders, it asked companies to suggest testing methods.
At the time, J&J’s Baby Powder franchise was consuming 20,000 tons of Vermont talc a year. J&J pressed the FDA to approve an X-ray scanning technique that a company scientist said in an April 1973 memo allowed for “an automatic 1% tolerance for asbestos.” That would mean talc with up to 10 times the FDA’s proposed limit for asbestos in drugs could pass muster.
The same scientist confided in an Oct. 23, 1973, note to a colleague that, depending on what test the FDA adopted for detecting asbestos in cosmetic talc, “we may have problems.”
The best way to detect asbestos in talc was to concentrate the sample and then examine it through microscopes, the Colorado School of Mines Research Institute told J&J in a Dec. 27, 1973, report. In a memo, a J&J lab supervisor said the concentration technique, which the company’s own researchers had earlier used to identify a “tremolite-type” asbestos in Vermont talc, had one limitation: “It may be too sensitive.”
In his email to Reuters, J&J’s lawyer said the lab supervisor’s concern was that the test would result in “false positives,” showing asbestos where there was none.
J&J also launched reserach to find out how much powder a baby was exposed to during a diapering and how much asbestos could be in that powder and remain within OSHA’s new workplace exposure limits. Its researchers had strapped an air sampling device to a doll to take measurements while it was powdered, according to J&J memos and the minutes of a Feb. 19, 1974, meeting of the Cosmetic Toiletry and Fragrance Association (CTFA), an industry group.
“It was calculated that even if talc were pure asbestos the levels of exposure of a baby during a normal powdering are far below the accepted tolerance limits,” the minutes state.
In a Sept. 6, 1974, letter, J&J told the FDA that since “a substantial safety factor can be expected” with talc that contains 1 percent asbestos, “methods capable of determining less than 1% asbestos in talc are not necessary to assure the safety of cosmetic talc.”
Not everyone at the FDA thought that basing a detection method on such a calculation was a good idea. One official called it “foolish,” adding, according to a J&J account of a February 1975 meeting: “No mother was going to powder her baby with 1% of a known carcinogen irregardless of the large safety factor.”
“Misrepresentation by omission”
Having failed to persuade the FDA that up to 1 percent asbestos contamination was tolerable, J&J began promoting self-policing as an alternative to regulation. The centerpiece of this approach was a March 15, 1976, package of letters from J&J and other manufacturers that the CTFA gave to the agency to show that they had succeeded at eliminating asbestos from cosmetic talc.
“The attached letters demonstrate responsibility of industry in monitoring its talcs,” the cover letter said. “We are certain that the summary will give you assurance as to the freedom from contamination by asbestos for materials of cosmetic talc products.”
In its letter, J&J said samples of talc produced between December 1972 and October 1973 were tested for asbestos, and none was detected “in any sample.”
J&J didn’t tell the FDA about a 1974 test by a professor at Dartmouth College in New Hampshire that turned up asbestos in talc from J&J – “fiberform” actinolite, as he put it. Nor did the company tell the FDA about a 1975 report from its longtime lab that found particles identified as “asbestos fibers” in five of 17 samples of talc from the chief source mine for Baby Powder. “Some of them seem rather high,” the private lab wrote in its cover letter.
Bicks, the J&J lawyer, said the contract lab’s results were irrelevant because the talc was intended for industrial use. He said the company now believes that the actinolite the Dartmouth professor found “was not asbestiform,” based on its interpretation of a photo in the original lab report.
Just two months after the Dartmouth professor reported his findings, Windsor Minerals Research and Development Manager Vernon Zeitz wrote that chrysotile, “fibrous anthophyllite” and other types of asbestos had been “found in association with the Hammondsville ore body” – the Vermont deposit that supplied Baby Powder talc for more than two decades.
Zeitz’s May 1974 report on efforts to minimize asbestos in Vermont talc “strongly urged” the adoption of ways to protect “against what are currently considered to be materials presenting a severe health hazard and are potentially present in all talc ores in use at this time.”
Bicks said that Zeitz was not reporting on actual test results.
The following year, Zeitz reported that based on weekly tests of talc samples over six months, “it can be stated with a greater than 99.9% certainty that the ores and materials produced from the ores at all Windsor Mineral locations are free from asbestos or asbestiform minerals.”
J&J’s selective use of test results figured in a New Jersey judge’s decision this year to affirm the first verdict against the company in a case claiming asbestos in J&J products caused cancer. “Providing the FDA favorable results showing no asbestos and withholding or failing to provide unfavorable results, which show asbestos, is a form of a misrepresentation by omission,” Middlesex County Superior Court Judge Ana Viscomi said in her June ruling.
“J&J respectfully disagrees with the Judge’s comments,” Bicks said. “J&J did not withhold any relevant testing from FDA.”
The FDA declined to comment on the ruling.
Lacking consensus on testing methods, the FDA postponed action to limit asbestos in talc. Years later, it did set limits on asbestos in talc used in drugs. It has never limited asbestos in cosmetic talc or established a preferred method for detecting it.
Instead, in 1976, a CTFA committee chaired by a J&J executive drafted voluntary guidelines, establishing a form of X-ray scanning with a 0.5 percent detection limit as the primary test, the method J&J preferred. The method is not designed to detect the most commonly used type of asbestos, chrysotile, at all. The group said the more sensitive electron microscopy was impractical.
The CTFA, which now does business as the Personal Care Products Council, declined to comment.
X-ray scanning is the primary method J&J has used for decades. The company also periodically requires the more sensitive checks with electron microscopes. J&J’s lawyer said the company’s tests exceed the trade association standard, and they do. He also said that today, J&J’s X-ray scans can detect suspect minerals at levels as low as 0.1 percent of a sample.
But the company never adopted the Colorado lab’s 1973 recommendation that samples be concentrated before examination under a microscope. And the talc samples that were subjected to the most sensitive electron microscopy test were a tiny fraction of what was sold. For those and other reasons, J&J couldn’t guarantee its Baby Powder was asbestos-free when plaintiffs used it, according to experts, including some who testified for plaintiffs.
As early as 1976, Ashton, J&J’s longtime talc overseer, recognized as much in a memo to colleagues. He wrote that talc in general, if subjected to the most sensitive testing method, using concentrated samples, “will be hard pressed in supporting purity claims.” He described this sort of testing as both “sophisticated” and “disturbing.”
Actress Blair Brown touts Baby Powder in this 1970s-era TV commercial
By 1977, J&J appeared to have tamped down concerns about the safety of talc. An internal August report on J&J’s “Defense of Talc Safety” campaign noted that independent authorities had deemed cosmetic talc products to be “free of hazard.” It attributed “this growing opinion” to the dissemination to scientific and medical communities in the United States and Britain of “favorable data from the various J&J sponsored studies.”
In 1984, FDA cosmetics chief and former J&J employee Heinz Eiermann reiterated that view. He told the New York Times that the agency’s investigation a decade earlier had prompted the industry to ensure that talc was asbestos-free. “So in subsequent analyses,” he told the paper, “we really could not identify asbestos or only on very rare occasions.”
Two years later, the FDA rejected a citizen request that cosmetic talc carry an asbestos warning label, saying that even if there were trace contamination, the use of talc powder during two years of normal diapering would not increase the risk of cancer.
In 1980, J&J began offering a cornstarch version of Baby Powder – to expand its customer base to people who prefer cornstarch, the company says.
The persistence of the industry’s view that cosmetic talc is asbestos-free is why no studies have been conducted on the incidence of mesothelioma among users of the products. It’s also partly why regulations that protect people in mines, mills, factories and schools from asbestos-laden talc don’t apply to babies and others exposed to cosmetic talc – even though Baby Powder talc has at times come from the same mines as talc sold for industrial use. J&J says cosmetic talc is more thoroughly processed and thus purer than industrial talc.
Until recently, the American Cancer Society (ACS) accepted the industry’s position, saying on its website: “All talcum products used in homes have been asbestos-free since the 1970s.”
After receiving inquiries from Reuters, the ACS in early December revised its website to remove the assurance that cosmetic talcs are free of asbestos. Now, it says, quoting the industry’s standards, that all cosmetic talc products in the United States “should be free from detectable amounts of asbestos.”
The revised ACS web page also notes that the World Health Organization’s International Agency for Research on Cancer classifies talc that contains asbestos as “carcinogenic to humans.”
Despite the success of J&J’s efforts to promote the safety of its talc, the company’s test lab found asbestos fibers in samples taken from the Vermont operation in 1984, 1985 and 1986. Bicks said: “The samples that we know of during this time period that contained a fiber or two of asbestos were not cosmetic talc samples.”
Then, in 1992, three years after J&J sold its Vermont mines, the new owner, Cyprus Minerals, said in an internal report on “important environmental issues” in its talc reserves that there was “past tremolite” in the Hammondsville deposit. Hammondsville was the primary source of Baby Powder talc from 1966 until its shutdown in 1990.
Bicks rejected the Cyprus report as hearsay, saying there is no original documentation to confirm it. Hammondsville mine records, according to a 1993 J&J memo, “were destroyed by the mine management staff just prior to the J&J divestiture.”
Bicks said the destroyed documents did not include talc testing records.
In 2002 and 2003, Vermont mine operators found chrysotile asbestos fibers on several occasions in talc produced for Baby Powder sold in Canada. In each case, a single fiber was recorded – a finding deemed “BDL” – below detection limit. Bicks described the finding as “background asbestos” that did not come from any talc source.
In 2009, the FDA, responding to growing public concern about talc, commissioned tests on 34 samples, including a bottle of J&J Baby Powder and samples of Imerys talc from China. No asbestos was detected.
FDA Commissioner Scott Gottlieb said the agency continues to receive a lot of questions about talc cosmetics. “I recognize the concern,” he told Reuters. He said the agency’s policing of cosmetics in general – fewer than 30 people regulating a “vast” industry – was “a place where we think we can be doing more.”
Gottlieb said the FDA planned to host a public forum in early 2019 to “look at how we would develop standards for evaluating any potential risk.” An agency spokeswoman said that would include examining “scientific test methods for assessment of asbestos.”
“Fishing expedition”
Before law school, Herschel Hobson worked at a rubber plant. There, his job included ensuring that asbestos in talc the workers were exposed to didn’t exceed OSHA limits.
That’s why he zeroed in on Johnson’s Baby Powder after he took on Darlene Coker as a client in 1997. The lawsuit Coker and her husband, Roy, filed that year against J&J in Jefferson County District Court in Beaumont, Texas, is the earliest Reuters found alleging Baby Powder caused cancer.
Hobson asked J&J for any research it had into the health of its mine workers; talc production records from the mid-1940s through the 1980s; depositions from managers of three labs that tested talc for J&J; and any documents related to testing for fibrous or asbestiform materials.
J&J objected. Hobson’s “fishing expedition” would not turn up any relevant evidence, it asserted in a May 6, 1998, motion. In fact, among the thousands of documents Hobson’s request could have turned up was a letter J&J lawyers had received only weeks earlier from a Rutgers University geologist confirming that she had found asbestos in the company’s Baby Powder, identified in her 1991 published study as tremolite “asbestos” needles.
Hobson agreed to postpone his discovery demands until he got the pathology report on Coker’s lung tissue. Before it came in, J&J asked the judge to dismiss the case, arguing that Coker had “no evidence” Baby Powder caused mesothelioma.
NO SATISFACTION: Lacking the evidence she needed, Darlene Coker, here with one of her doctors, died without ever finding out what caused her mesothelioma. Cady Evans/Handout via REUTERS
Ten days later, the pathology report landed: Coker’s lung tissue contained tens of thousands of “long fibers” of four different types of asbestos. The findings were “consistent with exposure to talc containing chrysotile and tremolite contamination,” the report concluded.
“The asbestos fibers found raise a new issue of fact,” Hobson told the judge in a request for more time to file an opposition to J&J’s dismissal motion. The judge gave him more time but turned down his request to resume discovery.
Without evidence from J&J and no hope of ever getting any, Hobson advised Coker to drop the suit.
Hobson is still practicing law in Nederland, Texas. When Reuters told him about the evidence that had emerged in recent litigation, he said: “They knew what the problems were, and they hid it.” J&J’s records would have made a “100% difference” in Coker’s case.
Had the information about asbestos in J&J’s talc come out earlier, he said, “maybe there would have been 20 years less exposure” for other people.
Bicks, the J&J lawyer, said Coker dropped her case because “the discovery established that J&J talc had nothing to do with Plaintiff’s disease, and that asbestos exposure from a commercial or occupational setting was the likely cause.”
Coker never learned why she had mesothelioma. She did beat the odds, though. Most patients die within a year of diagnosis. Coker held on long enough to see her two grandchildren. She died in 2009, 12 years after her diagnosis, at age 63.
Coker’s daughter Crystal Deckard was 5 when her sister, Cady, was born in 1971. Deckard remembers seeing the white bottle of Johnson’s Baby Powder on the changing table where her mother diapered her new sister.
“When Mom was given this death sentence, she was the same age as I am right now,” Deckard said. “I have it in the back of my mind all the time. Could it happen to us? Me? My sister?”
A guiding hand on talc safety research
Johnson & Johnson developed a strategy in the 1970s to deal with a growing volume of research showing that talc miners had elevated rates of lung disease and cancer: Promote the positive, challenge the negative.
That approach was summed up by a J&J applied research director in a “strictly confidential” March 3, 1975, memo to managers of the baby products division, which used the talc in J&J’s signature Baby Powder.
“Our current posture with respect to the sponsorship of talc safety studies has been to initiate studies only as dictated by confrontation,” the memo said. “This philosophy, so far, has allowed us to neutralize or hold in check data already generated by investigators who question the safety of talc.”
Also, the memo said, “we minimize the risk of possible self-generation of scientific data which may be politically or scientifically embarrassing.”
J&J’s effort to protect its iconic Baby Powder franchise by shaping research was led by physician and scientist executives. An early 1970s study of 1,992 Italian talc miners shows how it worked: J&J commissioned and paid for the study, told the researchers the results it wanted, and hired a ghostwriter to redraft the article that presented the findings in a journal.
The effort entailed other attempts to influence research, including a U.S. government study of the health of talc workers in Vermont. J&J’s Windsor Minerals Inc subsidiary, one of several mine operators involved in the study, developed a relationship with the U.S. National Institute of Occupational Safety and Health researchers to “even influence the conclusions” through suggestions of “subjective interpretations,” according to a 1973 Windsor Minerals memo.
Peter Bicks, outside counsel for J&J, told Reuters in an email that for the Vermont study, company “representatives acted in an ‘educational and advisory capacity’ to provide the researchers with a realistic study plan.”
A 1979 article in the Journal of Environmental Pathology and Toxicology detailing the findings of the study was not good news for talc. It reported a “significant increase” in “respiratory cancer mortality” among miners. A subsequent analysis of the underlying data published in 1988 determined that at least one of the workers died of mesothelioma, the cancer most closely associated with asbestos.
The proposal to study the health of miners of the Italian talc used in Baby Powder for decades came from William Ashton, J&J’s longtime talc supply chief. Ashton had obtained a summary of miners’ medical records compiled by an Italian physician, who also happened to control the country’s talc exports.
J&J should use those records “for maximum benefit,” Ashton said in a May 8, 1973, letter to Dr Gavin Hildick-Smith, J&J’s director of medical affairs. “It seems to me that the Italian records give us the opportunity to fortify a position on talc safety.”
At the time, the U.S. Food and Drug Administration was considering a limit on asbestos in talcs. In an Oct. 18, 1973, memo, Hildick-Smith advised J&J: “The risk/benefit ratio of conducting an epidemiological study in these mines must be considered.”
By early 1974, the study was a go. Hildick-Smith sent money to the Italian talc exporter-physician to hire a team of researchers. Hildick-Smith told the lead researcher in a June 26, 1974, letter exactly what J&J wanted: data that “would show that the incidence of cancer in these subjects is no different from that of the Italian population or the rural control group.”
That is exactly what J&J got, Hildick-Smith told colleagues a few months later. At a meeting on Sept. 27, 1974, for a “Talc/powder Safety Studies Review,” he reported the Italian study would dispel the “cancer concern associated with exposure to talc.”
The following spring, Hildick-Smith got a draft of the Italian study from the lead researcher. It needed work to meet the “form and style” requirements of the target journal, he told colleagues in a March 31, 1975, memo. He added that he would send it to a scientific ghostwriter “who will hold it in confidence and rewrite it.”