"Nondetected": The Politics of Measurement of Asbestos in Talc, 1971–1976

David Rosner, PhD, MPH; Gerald Markowitz, PhD; Merlin Chowkwanyun, PhD, MPH

Disclosures

Am J Public Health. 2019;109(7):969-974. 

In This Article

Origins of the Concern Over Talc

The suspicion that asbestos was a dangerous pollutant in talc can be traced back to the 1930s, when a number of clinical reports appeared indicating that talc workers were suffering from a pneumoconiosis whose symptoms resembled asbestosis, the insidious lung disease that was of major concern at the time. For example, Waldemar Dreessen published a study of workers in two mills in 1933 and concluded that "[t]he silicate dusts of tremolite talc [i.e., talc mixed with tremolite, one of the six major forms of asbestos] and slate induce a fine, diffuse bilateral fibrosis of the lungs which is definitely demonstrable in the X-ray."[6] In 1942, F. W. Porro and his associates presented 15 cases of talc miners and millers with pneumoconiosis. They wrote: "It would appear from a consideration of Dreessen's analysis that the dust responsible for the disabling pneumoconiosis must be the talc itself in the form of tremolite or soapstone or both." They also commented that "common to all cases is moderately frequent presence of asbestos bodies in the lesions… . The presence of asbestos bodies in fibrotic areas implies a degree of similarity between asbestosis and pneumoconiosis due to talc."[7]

In 1956, A. C. Hunt, publishing in Thorax, wrote that "commercial talc is a mixture of the pure mineral talc (hydrated magnesium silicate) with related minerals such as dolomite, serpentine, anthophyllite and tremolite. The amount of pure talc in commercial specimens is very variable."[8] In 1963, the National Safety Council, an historically management-friendly group, founded in 1912 by industry to inform companies about—and help them address—ongoing health and safety problems in their plants, issued a pamphlet that stated: "Talcosis is usually associated with tremolite talc." The council noted that the diseases "[produce] changes in the lungs and symptoms similar to those of asbestosis."[9]

By the mid-1960s, miners of talc had been identified by occupational health researchers as at increased risk for lung cancer. Morris Kleinfeld and his colleagues conducted a study "to ascertain the health hazards associated with exposure to dust in talc mining and milling." They concluded that "the data on carcinoma of the lung and pleura shows an overall mortality from carcinoma of the lung and pleura to be approximately four times that expected."[10] The asbestos manufacturers identified tremolite in some "body talcum powders."[11] In addition, researchers identified tremolite in samples of cosmetic talc products. Louis Cralley and his colleagues analyzed 22 talcum products and found that all of them had "an appreciable fiber content, ranging from 8 to 30%… . The fibrous material was predominantly talc but probably contained minor amounts of tremolite, anthophyllite and chrysotile as these are often present in fibrous talc mineral deposits."[12] Some went even farther, arguing that cosmetic products were a threat to consumers: "It is difficult to conceive of a better way of having fibers inhaled than the use of cosmetic talcum powders."[13]

In light of growing suspicion that asbestos, even at minimal levels, was carcinogenic, the FDA called representatives of a wide range of cosmetics manufacturers and scientists to Washington in August 1971 to "discuss in detail analytical methods for the determination of minor amounts of 'asbestos like' materials in talc with particular reference to cosmetic grade talcs," or, as one member of the CTFA called it, "the asbestos in talc problem." The meeting brought together a number of parties: talc manufacturers, including Johnson & Johnson and Pfizer; government officials from the FDA, the Bureau of Mines, NIOSH, and the US Geological Survey; physicians and scientists such as Irving Selikoff, William Nicholson, and Arthur Langer of Mt. Sinai School of Medicine and Seymour Lewin of New York University; and representatives of Johns Manville and the Consumers Union.[14] At the meeting, as reported by Pfizer researchers, attendees discussed a number of different methods for identifying asbestos in talc, including light microscopy, x-ray diffraction, electron microscopy, and electron diffraction.[15] The meeting laid out the evolving concerns of industry, consumers, researchers, and the FDA regarding how to evaluate the dangers from asbestos contamination in their products in light of the growing evidence that even the smallest exposures to asbestos could prove carcinogenic.

By August 1972, some results had begun to come in from both inside and outside NIOSH indicating that there was a problem. NIOSH had independently been testing "nine commercially available baby powders" by using electron microscopy. Its study indicated "possible asbestos fiber contamination of commercial baby powders."[16] A month later, Seymour Lewin, under contract with the FDA, began reporting his findings of the contamination of talcum powders. Of the 102 samples "of standard, commercial products containing talc" that he tested, x-ray diffraction showed "that 59 of the products [had] no detectable amounts of any asbestiform minerals…";[17] "20 had small but definite percentages of tremolite," and "7 had substantial percentages of one or both of these asbestiform minerals."[18] In a memo, CTFA representatives noted Lewin's conclusion that "over 40 percent of the samples may contain asbestiform minerals such as chrysotile or tremolite."[19]

There was a lot at stake for both the industry and consumers. The Wall Street Journal, in February 1973, gave a detailed summary of Lewin's findings, telling its readers that "10% [of the 200 talcum powders tested] contain 2% to 4% asbestos impurities, with a handful running as high as 10% to 20%." The impact was expected to fall primarily on "manufacturers of dusting powders, baby powders, after shave products and the talc-containing cosmetics." The Journal reported that the FDA would "impose stringent limits" on these products but optimistically predicted that manufacturers would likely support these changes. "Most cosmetic concerns agree that asbestos must be eliminated from their products and some have already moved to do so, partly under FDA pressure."[20]

Apart from economic considerations, the political milieu of the time also gave both the manufacturers and the FDA reason to worry. Skepticism of large institutions was burgeoning, with activist ire aimed at everything from major research universities to the military to large corporations. Advocacy for the interests of the everyday consumer, particularly around health and safety concerns, was exemplified by the attorney Ralph Nader, who became the public face of a revived consumer movement that thrived from the early 1960s into the 1980s. Nader had made his mark with a scorching investigation of automobiles, entitled Unsafe at Any Speed, which had shaken the entire industry and led to sweeping legislative reforms.[21] He subsequently led young investigative teams—dubbed "Nader's Raiders"—that wrote critical and detailed reports on other targets, including government agencies like the Federal Trade Commission and Department of Veterans Affairs.[22]

The FDA was no exception to this muckraking. One Nader-spawned entity, Public Citizen, created a Health Research Group, headed by the physician Sidney Wolfe. It focused on pharmaceutical safety and transparency in the approval process, taking advantage of new laws like the Freedom of Information Act to request previously classified material.[23] Other groups, most notably activists in the women's health movement, set their sights on the safety of synthetic hormones and contraceptives.[24] Corporations and the FDA both faced a new culture of accountability: for corporations, over the safety of their products; for the FDA, over the ability to ensure that safety if corporations themselves could not provide it. It is in this context that the exchanges on methodology between the CTFA and the FDA occurred.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....