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posted by martyb on Monday October 31 2016, @02:52PM   Printer-friendly
from the can-we-talc? dept.

A jury recently awarded $70 million to a California woman who used Johnson & Johnson's talc-based baby powder and claimed that it caused her ovarian cancer. Two lawsuits from earlier this year awarded a combined $127 million, and thousands of other women have filed suits against Johnson & Johnson. Meanwhile, two other lawsuits in New Jersey were thrown out by a judge who said the scientific evidence wasn't reliable enough to establish a clear cancer link. All these cases follow on an original 2013 jury finding for physician's assistant Deane Berg, which paradoxically found that baby powder could have been a factor in her cancer yet awarded her zero damages.

While these real-world juries have been forced to make decisions on whether a substance causes cancer, the metaphorical scientific "jury is still out." The American Cancer Society's review of the evidence notes:

Findings have been mixed, with some studies reporting a slightly increased risk and some reporting no increase. Many case-control studies have found a small increase in risk. But these types of studies can be biased because they often rely on a person's memory of talc use many years earlier. Two prospective cohort studies, which would not have the same type of potential bias, have not found an increased risk.

The ACS concludes that "if there is an increased risk, the overall increase is likely to be very small." Most other cancer researchers seem to take a similarly measured approach in characterizing the current state of the evidence, such as these guidelines from the Dana-Farber Cancer Institute:

"All of these studies suffer from incomplete data on patients' family history of ovarian or breast cancer, as well as the duration and frequency of powder use, says Panos Konstantinopoulos, MD, PhD, of the Gynecologic Oncology Program in the Susan F. Smith Center for Women's Cancers at Dana-Farber. "In general, population-based studies have shown a statistically significant association with ovarian cancer risk, while hospital-based studies showed that this association is not statistically significant," he says. In addition, none of the studies found that risk rose with increased exposure to the powder, and there is no evidence that talcum powder use on other parts of the body affects ovarian cancer risk.

[Continues...]

On the other side of this argument is Daniel Cramer, an epidemiologist at Brigham and Women's Hospital, also with appointments at Dana-Farber and the Harvard Cancer Center, who was the first to publish research connecting talc to ovarian cancer in the 1980s and who has devoted significant time to further studies on the issue. (He is also a paid consultant for plaintiff's lawyers in many of these cases.) Cramer thoroughly believes the data is incontrovertible, and he has mentioned particular strategies for convincing juries of this: "Juries are very persuaded by the forensic evidence. [...] If you put up a picture of a lymphatic channel with a talc particle in it, that's pretty convincing."

But legal experts don't always think the science is even relevant. A Bloomberg feature story earlier this year quoted University of Michigan law professor Erik Gordon: "You don't win with jurors on science. They don't understand science, statistics, the design of studies. [...] They do understand there was some evidence of a connection between talc and cancer, and J&J didn't tell customers about it."

This final claim -- that J&J "didn't tell customers about it" -- is the rationale behind the inflated punitive awards in the verdicts so far. Rather than merely claiming Johnson & Johnson was negligent, plaintiffs have alleged that the company's actions were knowing and deliberate, thereby justifying hundreds of millions of dollars in punitive damages. Most of these claims seem based on two internal memos (archived by Bloomberg here and here). The first, a 1992 marketing memo, notes various obstacles to successful marketing, including "negative publicity from the health community on talc." While the memo primarily appears to be recognizing that there was a publicity problem with health claims, rather than admitting an actual health problem, plaintiffs have used this as evidence that J&J was aware of the issue decades ago and tried to downplay it. But the plaintiffs have also gone far beyond this in claiming a racial bias, since one of the marketing "opportunities" in the memo is to "investigate ethnic (African American, Hispanic) opportunities to grow the franchise," groups that now appear to have higher rates of ovarian cancer.

Like the tobacco trials a couple decades ago, the plaintiffs have thus alleged that J&J not only knew about risks, but specifically targeted people with what they knew was a dangerous product. Ironically, the second memo was essentially a warning that this could happen if J&J wasn't careful. This 1997 memo from a toxicologist consultant has been widely quoted in media reports:

At [the time of a previous scientific review panel] there had been about 9 studies (more by now) published in the open literature that did show a statistically significant association between hygienic talc use and ovarian cancer. Anybody who denies this risks that the talc industry will be perceived by the public like it perceives the cigarette industry: denying the obvious in the face of all evidence to the contrary.

Taken out of context, this quote surely sounds like a "smoking gun" of a scientist sounding the alarm. Unfortunately, media reports (and the plaintiffs in court, presumably) don't quote the memo sentences immediately following, which make the context clear:

This would be a particularly tragic misperception in view of the fact that the [talc] industry does have powerful, valid arguments to support its position. [...] What the workshop panel did conclude was that (1) the results of the studies were ambiguous, inconsistent, contradictory and therefore inconclusive, (2) therefore hygienic use of cosmetic talc does not present a risk to the consumer. So why not use these powerful and irrefutable arguments [...] instead of questionable mush that leaves one vulnerable to counterattack?

In other words, we have a scientist here who was arguing for nuance: He isn't saying there's proven research and the talc industry is "denying the obvious" like Big Tobacco. He's saying if you make sweeping claims that there's no creditable scientific evidence out there, you'll be portrayed like Big Tobacco, i.e., denying reality. Instead, it should be noted that there are studies out there (some of which seem statistically valid), but expert review panels have found them contradictory and inconclusive. In effect, here's a scientist trying to help an industry avoid a future "Big Tobacco-like" lawsuit by presenting a more nuanced scientific perspective, and his words have been taken out of context in that very future lawsuit to make it look like the industry was acting just like Big Tobacco.

Whether or not talc is associated with cancer seems unclear, at least from a science standpoint. But the law professor quoted above may be right -- there really is no room for scientific nuance in the courtroom.


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  • (Score: 2) by JoeMerchant on Tuesday November 01 2016, @12:43PM

    by JoeMerchant (3937) on Tuesday November 01 2016, @12:43PM (#421230)

    Diversity of particle size in the dirt would be rather tremendous as compared to industrial scale produced nanoparticles (though, some of those processes are still quite uncontrolled themselves and not yielding quite the uniformity they are trying for.)

    So, I suppose if you do a study of female mammals that bathe their parts in mud and dirt, you might find some adaptations that deal with tiny particles better than California women do.

    With a population of 7 billion, there's going to be small subsets of people who are vulnerable to all kinds of things - any big uniform process you roll out is at risk of harming some people, the question is: how do you deal with that? Are we satisfied that controlled testing on 1000 "representative" people is sufficient (0.000014% sample size)? The current regulatory thinking includes post-market surveillance, but that's only just been getting going for the last 5-10 years.

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  • (Score: 2) by Reziac on Tuesday November 01 2016, @02:21PM

    by Reziac (2489) on Tuesday November 01 2016, @02:21PM (#421253) Homepage

    Allowing for discussion that she has some genetic predisposition to hypersensitivity to what's okay for everyone else, or perhaps abused the product by packing her nethers solid with it, how is that the product's problem?? Cuz if it's the product's problem, then makers of just about everything that can be ingested deliberately or accidentally are in deep trouble. You can always find someone who reacts badly to just about every possible product, if you look long enough. Given 7 billion subjects, there's likely a chance intersection with someone who has an unrelated but concurrent issue... for any combination of product and issue you care to pick.

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    • (Score: 2) by JoeMerchant on Tuesday November 01 2016, @08:49PM

      by JoeMerchant (3937) on Tuesday November 01 2016, @08:49PM (#421394)

      And this is where post-market surveillance comes in. Reported problems should be investigated, recorded and trended. If the problem really does only show up in 0.01% of the population (350,000 women world-wide) and this is a world-wide marketed product, I would think it only basic human decency to at least inform women of the potential probability of the problem.

      At some threshold (do you have to kill 1,000,000 people at least 10 years early to be a significant problem?) stronger steps need to be taken to keep the product from doing harm - or, at least prove that the product is doing more good than harm (see: anti-microbial hand soaps in the US recently.)

      I don't think that products should be kept off the market until they're "proven 99.999% safe" (which still means potential harm for 70,000 people)... I do think that the effects of products on people need to be tracked, analyzed and trended - preferably by an organization independent of the one that profits from the products' manufacture and sale, and it would only seem fair that the company profiting from the manufacture and sale of the product foot the bill for this activity (yes, evil taxes and wasteful government programs), otherwise you get things like "perfectly harmless cigarettes" in broad commercial distribution, complete with mis-information campaigns backing up their marketing departments, for decades, costing trillions of dollars in extra medical care, lost productivity, etc.

      Whatever system we are moving toward for product regulation, I hope it also protects manufacturers against $70M+ random lawsuits - if that's the best we've got for checks and balances in the marketplace, we need to take a few hundred lawyers, fit them with concrete shoes and make them take a long walk on a short pier.

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