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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.
(Score: 1, Interesting) by Anonymous Coward on Monday October 31 2016, @04:14PM
Cell division causes cancer, nothing else. Tobacco etc damages tissue which causes a need for cell division to maintain it. But also the smokers in the original studies had much lower mortality rates than the population at large and the non smokers were uber healhy (these were studies of veterans and doctors), so who knows how big a deal that even is for a typical person? You haven't heard that because medical research is so messed up, and has been for a long time. They always miss the interesting stuff in the data to focus on spinning towards whatever preconceived notions they had.
The crazy tying is I will sound like a crackpot to you when this is the position of people like Bruce Ames, Ronald Fisher, etc. Meanwhile you will get advice from a bunch of people who use stats without knowing wtf a p value is.
(Score: 0) by Anonymous Coward on Monday October 31 2016, @04:17PM
Erroneous and thing.
(Score: 1, Insightful) by Anonymous Coward on Monday October 31 2016, @05:09PM
Cell division is what cancer is. Cancer is not CAUSED by cell division. Something damages the DNA or otherwise causes cells to divide out of control. Medical research doesn't hide or ignore these facts, so what are you smoking?
(Score: 2) by ledow on Monday October 31 2016, @05:19PM
"Original studies" is your error.
The follow-up studies confirmed, without bias or excuses.
It's a medical, and scientific, fact that smoking increases your risk of cancer. It doesn't matter who you are.
It is NOT a medical, or scientific, fact that talc does. Nobody has established that beyond the usual margins of error. And it's had 1/100th the testing of things like tobacco, which took decades to establish the science behind.
So to make a legal judgement on talc is - at this point - nonsense.
But to say you should stop smoking, to ban things likely to lead to passive smoking (e.g. public-places smoking bans, etc.), and so on - that's NOT nonsense. It is, indeed, sense. Even if there are a few crackpots studying the field and doing bad science.
The carrying out of bad science does not negate the findings of proper science in the same areas.
(Score: 2) by curunir_wolf on Monday October 31 2016, @06:39PM
On the other hand, the tobacco control community is now spreading the misinformation that vaping is just as dangerous as smoking, to such a degree that three times as many people believe that than did several years ago. Complete misinformation campaign. And new FDA deeming regulations that classify all kinds of completely non-tobacco projects (batteries, glass tubes, atomizers, etc.) as actual "tobacco products", even though over 30% of users of those products don't use nicotine in them at all.
These regulations are so onerous and the misinformation campaign at such a fevered pitch that vaping products are going to get a lot more expensive or disappear altogether. Completely irresponsible behavior on the part of the CDC and the FDA that's encouraging more people to smoke combustibles and not try vapes, protecting the profits of big tobacco and possibly even costing A Billion Lives [abillionlives.com].
I am a crackpot
(Score: 0) by Anonymous Coward on Tuesday November 01 2016, @01:38AM
A local vape shop had to jack prices recently and reduce their service because of this nonsense. So I bought a pipe and I'm back to burning tobacco for my nicotine fix. :(
(Have tried to quit nicotine several times now, but there's too much drama horseshit at the day job to do without it.)
(Score: 0) by Anonymous Coward on Monday October 31 2016, @05:47PM
Cell division causes cancer, nothing else.
That is incorrect. Viral DNA insertions can cause cancer. Uncontrolled cell proliferation is a property of cancer and every time a cell divides there is an increased chance for mutation, but this is not a strict cause of cancer.
There is plenty of evidence about how smoking tobacco increases the risk for particular types of cancer. This has been found despite preconceived notions that it wasn't a problem and a large amount of industry pressure to find no link.
If you have some other evidence or know of another correlative factor that fits the increases and decreases of lung cancer as well as tobacco smoking does, then feel free to stack it up against the current evidence and see if it does better.
(Score: 0) by Anonymous Coward on Monday October 31 2016, @06:30PM
"Viral DNA insertions can cause cancer."
Source? Perhaps the insertions make the cells divide more often.
(Score: 0) by Anonymous Coward on Tuesday November 01 2016, @12:53AM
HTLV is the first virus that comes to mind. IIRC EBV and HPV have also been found to be integrated upstream oncogenes, but they also use viral proteins to force cell proliferation.
Perhaps the insertions make the cells divide more often.
Yes, cancer demonstrates the property of uncontrolled cell proliferation.
https://en.wikipedia.org/wiki/Human_T-lymphotropic_virus [wikipedia.org]
(Score: 0) by Anonymous Coward on Tuesday November 01 2016, @05:37AM
Which reference do you say includes what you say and vouch for from that summary?
(Score: 0) by Anonymous Coward on Tuesday November 01 2016, @01:26PM
I'm not sure if you're disingenuous, so how about a trade?
Provide a primary reference for your claim:
Cell division causes cancer, nothing else.
and I'll provide a primary reference for mine.
(Score: 0) by Anonymous Coward on Wednesday November 02 2016, @05:19AM
Great to see we are operating at the same level.