Study links talc to ovarian cancer, with implications for J&J

New research published this week lends credence to the more than 50,000 lawsuits against Johnson and Johnson who allege that their talc-based baby powder caused ovarian cancer.

The analysis, published Wednesday in the Journal of Clinical Oncology, found that applying talcum powder to the genitals was associated with ovarian cancer, and that the association was stronger for people who used the powder frequently or for long periods. periods of time.

The researchers are from the National Institutes of Health and their findings were based on data from the Sister Study, which enrolled more than 50,000 women in the US between 2003 and 2009. The participants joined when they were between 35 and 74 years old , and each had a sister who had been diagnosed with breast cancer, which could put them at higher risk for breast or ovarian cancer.

Lawsuits involving J&J's talc-based baby powder date back to 1999, when a woman alleged that using it throughout her life caused mesothelioma, a rare cancer usually caused by exposure to asbestos, a known carcinogen. In 2009, another woman sued the company, alleging that its talc-based products caused her ovarian cancer. Since then, thousands more people have filed lawsuits over cases of ovarian cancer or mesothelioma that they say were caused by asbestos in J&J's baby powder.

J&J has defended the safety of its talc products and denies they ever contained asbestos. The company has also argued that studies have not shown a convincing link between ovarian cancer and talc-based products.

The new research could undermine that line of reasoning as legal battles continue. Most of the lawsuits against J&J have been consolidated into a single federal case in New Jersey, which is scheduled for trial in December.

“This study is quite timely. We believe it fully affirms and confirms the position taken by plaintiffs' experts,” said Leigh O'Dell, principal at Beasley Allen Law Firm. O'Dell is the co-lead attorney of the plaintiffs' steering committee, a group of attorneys appointed to act on behalf of the many people with cases pending against J&J.

However, Erik Haas, J&J's global vice president of litigation, said the new analysis does not establish causality or implicate a specific cancer-inducing agent.

“This study does not change the overwhelming evidence that talc does not cause ovarian cancer,” he said.

Earlier this month, J&J proposed a payment of about $6.48 billion to resolve the lawsuits, but the deal would involve moving the cases to bankruptcy court and would require 75% of plaintiffs to vote in favor.

J&J has twice tried, unsuccessfully, to resolve talc lawsuits in bankruptcy court. The company created a subsidiary in 2021 that could take responsibility for legal claims related to talc, a legal maneuver known as Texas two-step. But so far, courts have dismissed bankruptcy filings on the basis that the subsidiary is not in financial difficulty.

O'Dell said her team “would like to see these women be offered a reasonable and fair solution outside of bankruptcy.”

“We believe that any attempt to file for bankruptcy again is just another abuse of the bankruptcy system,” he said.

The new study asked women how often they used talcum powder on their genitals between ages 10 and 13 and during the year before enrolling in the study. NIH researchers followed up with surveys from 2017 to 2019 that asked women about their lifetime talcum powder use.

Based on the responses, the researchers estimated that up to 56% of women used talcum powder on their genitals at some point. These women were more likely to be black, less educated, and live in the South compared to people who did not use talcum powder.

The analysis cannot prove that talc causes ovarian cancer, nor does it identify a brand or chemical driving the association. Dale Sandler, one of the study's authors and chief of the epidemiology branch at the National Institute of Environmental Health Sciences, said there probably isn't a way to prove causality in human studies.

“You can't do a clinical trial and randomly assign people to 'powder' and 'no dust'. So we're going to need to look at other types of research,” he said.

At the very least, the findings should prompt women to reconsider using talc products, said Katie O'Brien, lead author of the analysis and an epidemiologist at the National Institute of Environmental Health Sciences.

“We don't know of any medically necessary reason why someone would need to use talcum powder,” he said.

Current formulations of J&J baby powder use cornstarch, not talc. The company removed talc-based versions from the North American market in 2020, citing declining demand and “misinformation about product safety,” and discontinued the product internationally last year.

Talc and asbestos are found in close proximity in nature, so some raw talc collected through mining may be contaminated with asbestos, according to the Food and Drug Administration.

A 2018 Reuters investigation suggested that J&J knew that some of its baby powder was contaminated with small amounts of asbestos as early as the 1970s. But J&J denies that asbestos was ever present in its products.

O'Brien said asbestos may not be the only reason for an association between talc and cancer. Some talcum powder products may also contain phthalates, chemicals that disrupt the body's hormones and have been linked to ovarian cancer. Additionally, talcum powder itself can be abrasive, he added, so it can cause inflammation in the areas where it is applied. Inflammation is independently associated with the development of cancer.

Debates over research linking talc and ovarian cancer will almost certainly be the focus of upcoming litigation in the J&J case.

The federal court in New Jersey ruled in March that the company can challenge findings linking ovarian cancer to talc.

To support its position, J&J has pointed to research that O'Brien and Sandler published in 2020, which found no statistically significant association between ovarian cancer and talc use.

But O'Brien said an earlier study may not have been designed to detect small changes in risk because it didn't ask women about their lifetime use or take into account the possibility that people misremembered. their past habits. Sandler said the new study takes those two variables into account.

“This most recent analysis tips the balance by taking into account all of these possible ways that reporting could have been incomplete in the earlier literature,” he said.

J&J began selling talc-based baby powder in 1894.

Although many women have used it to keep their genitals dry, it is not necessary to use powder to remove moisture in that area, said Alexandra Scranton, director of science and research at Women's Voices for the Earth, a nonprofit organization whose objective to eliminate chemicals. that negatively affect women's health.

“Moisture in this part of the body is a very healthy thing,” Scranton said. “This part of the body is covered in mucous membranes. It's supposed to be moist.”

According to O'Brien's research, some women in the 2000s, often in their 20s and 30s, also used talcum powder on their genitals to feel clean and reduce odor. Health experts do not recommend this application either, since the vagina cleans itself and the good bacteria inside naturally produce a slight odor.

Companies like J&J were “basically creating and promoting this myth that this part of your body (your genitals, your vagina) is inherently dirty and that it's inherently smelly and therefore inherently embarrassing,” Scranton said.

J&J said it disagrees with that characterization.

Some women continue to use baby powder on their genitals or have adopted new products such as vaginal washes or scented body deodorants.

“It's so ingrained and part of the way they take care of their bodies that they can't imagine not doing it,” Scranton said. “They have their mother's voice in their head: 'This is what you have to do to be a respectable woman.'”