Unsealed Emails Show How J&J Shaped Report on Talc's Links to Cancer
The U.S. Food and Drug Administration said it relied in part on the report in its decision to forgo a warning for the product.
(Bloomberg) -- Unsealed emails reveal the role baby-powder maker Johnson & Johnson played in a report that an industry group submitted to U.S. regulators deciding whether to keep warnings off talc-based products linked to cancer.
The emails -- unsealed in the state of Mississippi’s lawsuit against J&J over its refusal to add a safety warning -- show J&J and its talc supplier chose the scientists hired by their trade association, the Personal Care Products Council, to write the 2009 report assessing talc-based powders’ health risks. They also show the researchers changed the final version of their report at the companies’ behest.
The U.S. Food and Drug Administration said it relied in part on the report in its decision to forgo a warning for the product.
The emails among executives of J&J and Rio Tinto Minerals, its supplier at the time, provide a behind-the-scenes glimpse of dealings between companies and their industry group that successfully fended off a cancer warning on talc-based powders for nearly 40 years. Now, almost 39,000 users and their families are suing J&J, most claiming their ovarian cancers and those of loved ones were linked to asbestos, the potent carcinogen in the products pulled from U.S. and Canadian shelves in May 2020.
J&J’s shares fell 0.8% at 11 a.m. in New York. They had risen 3.8% this year through Friday.
Dependence on industry data creates a situation that’s ripe for lobbyists to exert pressure on the FDA. The unsealed emails pull back the curtain on how such efforts get launched, who pays for them, and who has a hand in delivering the final product to regulators.
‘Ghost-Written Materials’
While the practice of companies having a say in industry group submissions to the FDA isn’t new or illegal, the emails reveal just how involved J&J got in a report meant to assess product safety -- down to selecting individual scientists to produce it and having them write an executive summary.
“This is just another example of industry not being transparent about where the science is coming from,” said Peter Doshi, a University of Maryland professor who specializes in the drug-approval process. “Consumers rely on the FDA to make independent decisions on the benefits and harms of products they use every day. Submitting ghost-written materials subverts that process.”
J&J denied any wrongdoing in its decision not to acknowledge its input to the report that the PCPC lobbying group sent to the FDA.
The company “acted in an appropriate and transparent manner,” in its interactions with the products council and the FDA, Allison Brown, a lawyer for Skadden Arps Slate Meagher & Flom who represents J&J in talc suits, said in an email.
“Many different members of the PCPC were involved in reviewing the report and many different members contributed to the cost of the research, which is why the report was submitted on behalf of PCPC,” she said.
Mushrooming Litigation
Lisa Powers, a spokeswoman for the cosmetic-industry’s PCPC lobbying group, said it maintained the “highest standards of professional conduct and transparency” in connection with the response to the warning-label requests.
“The agency is perfectly aware of our role as a trade association and knows that we only act with input from our member companies,” Powers said in an email.
FDA officials acknowledged they weighed the PCPC’s response to the citizens’ petitions demanding a warning for talc-based powders before finding there was “inconclusive evidence” the mineral caused ovarian and other forms of cancer.
“The FDA reviewed and considered all of the information submitted to us in the two petitions, the comments received in response to the petitions, and additional scientific information,” said Tara Rabin, a spokeswoman.
Plaintiffs’ attorneys introduced some of the emails as evidence in a trial of three womens’ claims that J&J’s baby powder caused their ovarian cancers, according to court filings. The women’s lawyers said the emails showed that the talc-maker surreptitiously influenced the FDA’s decision on a health warning. A jury in that case backed J&J’s contention the powder didn’t cause the women’s illnesses.
The company has seen talc lawsuits against it jump nearly 1,500% since 2016, the first year it reported details about the litigation, according to an analysis of filings. Over the last year alone, suits related to asbestos and ovarian cancer targeting the talc-based powders increased 43%.
The litigation has mushroomed to the point where J&J officials said they were forced to put a newly created unit into bankruptcy in hopes of corralling current and future cases. J&J is putting $2 billion into a trust in hopes of forcing a resolution.
Policing Capacity
The emails also highlight the FDA’s limited capacity to police ubiquitous consumer goods that millions of Americans assume are safe. Recently, a private laboratory found carcinogens in a number of sunscreens made by J&J and other big manufacturers that went unnoticed by the agency. J&J has said it’s investigating how the cancer-causing chemical ended up in the products. The same laboratory asked for recalls of deodorants and antiperspirants that have been found to contain the cancer-causing chemical, benzene.
Currently led by Acting Commissioner Janet Woodcock, the FDA has long been more focused on oversight of the $1.3 trillion U.S. drug industry and $6.2 trillion food sector than cosmetics, worth about $49 billion annually. The agency’s cosmetics-monitoring budget is just $14 million.
The agency doesn’t review personal-care products for safety before they go on sale, as it does with drugs. Even when surveillance systems pinpoint concerns, its recourse is limited.
“They do not do independent research themselves,” said Susan Wood, an associate professor of health policy at the George Washington University School of Public Health and Health Services who served as FDA’s associate commissioner for women’s health from 2000 to 2005. “The vast majority of the data that comes into the FDA is funded by the companies.”
As far back as 1983, public-health advocates and consumers pushed the FDA to mandate cancer warnings on talc-based powders. In 1994 and again in 2008, Samuel Epstein, a University of Illinois environmental-health professor and head of the Cancer Prevention Coalition, filed citizen petitions demanding such a warning. The second asked the FDA to require J&J and other companies that sold them to alert consumers that “frequent application of talcum powder in the female genital area substantially increases the risk of ovarian cancer.”
In 2014, Mississippi’s attorney general accused J&J of violating the state’s consumer-protection laws by refusing to add the warning. The state is seeking tens of millions of dollars in damages and penalties. Emails unsealed in that case show Epstein’s warning request prompted officials at Rio Tinto, the predecessor to Paris-based talc mining firm Imerys SA, to swing into action.
In a series of 2008 emails, Craig Bernard, then a Rio Tinto regulatory affairs manager, said he’d talked with his counterpart at J&J about teaming up to respond to Epstein’s warning request. J&J’s Kathleen Wille had proposed spending $50,000 to fund “external experts to provide scientific arguments against the petition with the recommendation of rejecting it,” Bernard said in his emails.
J&J suggested hiring Joshua Muscat, a Penn State University cancer researcher, and Michael Huncharek, a Greenville, South Carolina-based internist who did cancer research earlier in his career, to respond to Epstein’s petition. The two had earlier found “no relationship between talc user and cancer,” according to Bernard’s emails.
‘Behind the Scenes’
The emails show the PCPC officially hired Muscat and Huncharek. Neither scientist responded to requests for comment on the company’s editing of the review.
It was Wille who suggested the companies submit the scientists’ final report through the lobbying group rather than in their own names, the emails show. While the companies would provide “much of the work behind the scenes,” using the lobbying group would allow them to “indirectly provide comments to the FDA” about Epstein’s requests, she said in the emails.
Read More: J&J Cleared of Responsibility in Woman’s Talc-Cancer Case
In another 2008 email, Bernard said Wille recounted a meeting with an unnamed FDA manager who oversaw cosmetic products. That official said the agency was inclined to nix Epstein’s warning request, but wanted “scientific support from industry to help justify their position,” Bernard wrote. Muscat and Huncharek’s report could serve that purpose, he added. The FDA’s Rabin said the agency “was not aware of such an encounter.”
J&J and Wille, now retired, also deny such a meeting ever took place. Brown, the J&J company lawyer, says Bernard confused it with a different meeting between Wille and John Bailey, the former head of the industry’s lobbying arm. Neither Bailey nor Bernard responded to emails seeking comment on the alleged miscommunication.
Wille acknowledged in an affidavit she “reviewed and provided comments” about the scientific analysis prepared by the experts retained by the trade association’s experts, but denied altering “the analysis, opinions or any scientific finding contained in the experts’ report.”
J&J convened a November 2008 meeting “to make any needed modifications or suggestions” before the industry group sent the report to the FDA, Bernard said in an email. In an email Huncharek sent Wille later that month about the scientists’ final report, he noted “an executive summary was added and editorial changes made per our meeting.”
J&J officials refused to comment on what specific changes were made to the report’s final version. The summary requested by the company says in part that “we conclude that the weak statistical associations cited in the petition do not support a causal relationship.”
‘Difficult to Dismiss’
It wasn’t until April 1, 2014 that FDA officials formally denied Epstein’s warning-label requests in a decision that relied on Muscat’s and Huncharek’s report. “While the growing body of evidence to support a possible association between genital talc exposure and serous ovarian cancer is difficult to dismiss,” according to the decision, “the evidence is insufficient for FDA to require as definitive a warning as you are seeking.”
That decision held up even after J&J pulled the talc products in the U.S. and Canada last year. In the meantime, the company has lost about a dozen court cases to women blaming baby powder for their tumors, including one for $2.1 billion that the U.S. Supreme Court left intact on appeal. Many of those cases are on hold while a bankruptcy judge weighs the J&J unit’s Chapter 11 filing.
Since 2017, J&J has won more than a dozen talc trials, according to data compiled by Bloomberg. In a filing earlier, J&J noted it “has obtained a number of defense verdicts,” but didn’t provide a specific number. Officials also said in the filing some plaintiffs’ verdicts over its iconic baby powder have been reversed on appeal.
Still, the company faces as much as $7.5 billion in potential settlement losses from the suits, according to Bloomberg Intelligence analyst Holly Froum.
The State of Mississippi v. Johnson & Johnson, Civil Action No. 25CH1:14-cv-001207; In the Chancery Court for the First Judicial District of Hinds County, Mississippi
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