Herrmann represents clients too deeply involved in the subject matter of this post for him to speak on these subjects. He thus had nothing to do with today’s post; what you’re getting here is pure, unadulterated Bexis.
Contrary to what you might think, we don’t just read case law and ALI drafts – and no, we’re not just talking about the sports pages here either, although both the Phillies and the Cubs are in the playoffs (will wonders never cease, at least for a week). One of the other things we read is the popular scientific press. We do that because reading the actual scientific stuff is too hard for us to handle unassisted. So we look through the Science News, and once and a while, if we’re feeling ambitious, we’ll tackle Scientific American. Anything tougher than that, and it’s time to hire an expert witness.
Anyway, in our (too many) years of labor in the mass tort vineyards, one pattern that we’ve definitely seen is that mass torts tend to start with a bang and go out with a whimper.
- We’ve seen it with Bendectin, where there were litigation-spawned screaming headlines about birth defects at the outset – but they never had any valid scientific basis. Indeed, this litigation was so scientifically bogus that it gave us Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), in which the Supreme Court first tried to evict “junk science,” at least from the federal courts. The end result: the only FDA-approved drug for treating morning sickness was driven off the market by the economics of litigation, never to return. We call this category of safe, effective, but legally non-viable drugs “litigens.”
- We’ve seen it with Bone Screws, where the FDA got spooked by the prospect of adverse publicity and made some untoward statements about a product that the medical community always believed was far more beneficial rather than harmful to patients. Years later, FDA finally agreed, and downclassified these devices to end the regulatory quirk that stoked the litigation. See 63 Fed. Reg. 40025 (FDA July 27, 1998).
- We’ve seen it with breast implants, where all of the dire medical claims that spawned the litigation were disproven – first by court appointed experts, and ultimately by regular science. Silicone breast implants recently returned to the market, so the net result of that litigation (other than bankrupting several companies that made an acceptably safe product) was a decade of unavailability of this product to the women who needed it. See Goss, et al, “Clearing Away The Junk: Court-Appointed Experts, Scientifically Marginal Evidence, & The Silicone Gel Breast Implant Litigation,” 56 Food & Drug L.J. 227 (2001) (describing the findings of the court-appointed experts). That litigation is one reason why we think of tort reform as a women’s rights issue. All the litigation over contraceptives is, of course, another.
- We’ve seen it with fen-phen, where initially scary results from analysis of small patient groups of patients turned out – years later – to be wildly overstated, as an author of the original study ultimately concluded. See J. Caccitolo, H. Connolly, et al., “Operation for Anorexigen-associated Valvular Heart Disease,” 122 J. Thorac. Cardiovasc. 656, 662 (2001).
In every one of these cases, megalitigation resulted, sometimes large enough to force defendants into bankruptcy, often bad enough to force beneficial products off the market, and always bad enough to force the defendants to spend millions, or even billions, in attorneys’ fees and/or scientifically unsound settlements. In none of these cases was there a scientific basis for anything near the scope of what transpired.From what we’ve been reading, it looks like this sorry pattern is repeating itself once again. Item 1:Thimerosal is an additive that keeps childhood vaccines – which are complex and delicate biological substances – from deteriorating. For that, it works. Because one of the compounds in Thimerosal contains a small amount of mercury, it’s been targeted by litigants claiming various developmental problems (mostly autism) in children.Childhood vaccines tend to attract this sort of claim. The problem is that many types of developmental problems have always manifested themselves at the same age that children are supposed to be vaccinated against childhood diseases (diseases that once killed millions, and some still do in unvaccinated populations). As we write this, the Thimerosal plaintiffs are trying to bankrupt through sheer numbers the federal fund that compensates real victims of vaccine adverse effects.Well, this week’s Science News reports on a new study – the latest, but apparently largest (1047 subjects) of several – that says it ain’t so. That is, the study finds that exposure to vaccines containing Thimerosal doesn’t cause anything. The New England Journal of Medicine abstract of the study itself is here, but we’re not ambitious enough to tackle something like that unless somebody pays us to. The Science News presents the study’s conclusion as “[a] mercury-containing vaccine preservative is not associated with problems in speech, intelligence, memory, coordination, attention, or other measures of childhood development.” In the study, there was “no consistent pattern” that the tiny amount of chemically bound mercury in Thimerosal is associated with any type of adverse event.In the study there were twelve statistically significant positive associations (such as more tics) – and seven statistically significant negative associations (such as kids exposed to Thimerosal-doing better in school) among the 378 total statistical calculations that were conducted. None of that probably means anything, and here’s why. The ordinary measure of statistical significance is 95% confidence that the result is not due to chance. That means that, even in statistically significant results, 5% of them are nevertheless due to chance. In a run of 378 statistical calculations, this five percent rate of chance significance would produce 19 results that appear to be statistically significant, but are still due to chance – and that’s exactly the number of statistically significant results in this study.Another interesting bit of information in the Science News article is that there’s apparently an “ongoing CDC study” on Thimerosal that will weigh in on this issue next year.And the last paragraph of the article contains another nugget that concerns us. Apparently “[o]ne of the 14 outside experts that the CDC consulted” in designing the study was the “executive director of [a] parent-advocacy group” against Thimerosal. Now there’s a really unbiased source. Not surprisingly, this person “disagrees with the published conclusions.” Our question is why was the CDC consulting with one of the fanatic so-called “mercuries” at all. Did they consult with a Thimerosal manufacturer? The article doesn’t say.Representing drugmakers, we’re quite familiar with all the issues that have been raised recently about “conflicts of interest” among members of FDA consultative committees. That’s not surprising to us (except for all the breast-beating about it), since the FDA wants the best docs there are as consultants – and so does industry. Given the ruckus, though, we’re sure that our adversaries would be screaming “conflict of interest” to the heavens if somebody strongly affiliated with our side were in the same consulting position.Item 2:The second recent article we’ve recently read is in this month’s Scientific American (we thought we’d be pushing our competency level here, but actually it’s a pretty easy read), and it’s about hormone replacement therapy. You’ll have to pay for this one (the first Science News article is free, at least for a while), but it’s worth the money. Apparently HRT litigation is turning into another overblown, media-hyped train wreck along the lines of fen-phen – that is, there’s way too much smoke for not much fire:
[In] papers published this year, written by researchers who delivered the original warning, show that taking hormones soon after menopause – within about 10 years – is safe for most women. The data even suggest that hormone therapy for less than 10 years may improve some women’s health more than doing nothing.
T. Powledge, “Easing Hormone Anxiety,” 297(4) Scic. Am., 32, 32 (October, 2007) (emphasis added). We’re not holding our breath that the plaintiffs will dismiss their massive HRT litigation – but scientifically they probably should. At this point it looks like they’re hurting the public health more than they ever could have helped it.That’s apparently what the Womens’ Health Initiative (the “researchers” mentioned above) would conclude if they thought about what happened in such terms. Hindsight is 20/20, but they now wish they hadn’t been so “abrupt” in shutting down the original study or so categorical in their original warnings. When they “reanalyzed their original data and combined them with the estrogen numbers,” they “verif[ied a] decreased risk in heart disease.” Id. at 34. That means that HRT actually has collateral benefits.Not only did WHI belatedly find HRT had beneficial effects, but the “response to hormone therapy depends on a woman’s age,” thus the risks that do exist are “less in younger women (those younger than 70).” Because of that, the WHI now thinks that the initial indiscriminately adverse publicity probably hurt women:
In looking back at the fallout from the [original] report. . .[the] head [of] the WHI trials, acknowledges that women younger than 60 who would have been appropriate candidates . . . fled from hormones along with older women. “My surmise is that women just got scared of hormone therapy across the board, irrespective of what they were using it for,” he says. “With hindsight you could say, well, maybe we should have emphasized reasonable use even more.” The study’s abrupt termination may have also stoked fears. “Maybe we didn’t need to do it that way,” remarks [a] WHI investigator. . . . “It wasn’t an emergency – it wasn’t like people were, you know, under serious threat of adverse outcomes.”
Id. at 34 (emphasis added). Not an “emergency”? We remember that publicity. Could’ve fooled us.
[B]etween 2002 and 2004, declarations made in press releases or interviews were much more negative than the conclusions in published scientific papers.
Id.We have to say that, all of this pretty much confirms what we’ve always thought. The screaming headlines of supposedly new drug risks, accompanied inevitably by stark “Have You Been Injured” advertisements by lawyers trolling for clients, are often misleading. Scientific data is manipulated to create what looks like a large (“29 percent increase”) risk, when in fact the statistical increase is minimal (“rose by just 0.07 percent”) in absolute terms. Id. This kind of publicity – while great for generating lawsuits – is not so great for the public health. It deters everyone, not just people actually at a significant risk, from taking whatever product is being targeted this week.While it’s nice to read that somebody at WHI confess that, “I wish we had figured out a way to change prescribing practices but have fewer people distressed about it,” id., such remorse doesn’t do either society or litigants a great deal of good several years after the fact. By now plaintiffs’ counsel are heavily invested in the HRT litigation and they’ve signed of lots of clients who, under the actual science, turn out to be proper candidates for this therapy. Think they’ll dismiss voluntarily? HRT manufacturers are still going to have to spend millions of dollars that they could otherwise have used to improve their products to fight the resultant mass tort. Maybe a proper penance would be testimony as defense witnesses in this litigation.Again, we’re not holding our breath.Item 3:Finally, and what’s probably the saddest of all, last week’s Science News reports (unless you’re a subscriber you’ll have to pay for this article too) that the suicidality scare over so-called SSRIs (selective serotonin reuptake inhibitors) is actually killing people. SSRIs are used to treat depression. One of the biggest risks of depression is suicide – that sounds logical, doesn’t it?Well, plaintiffs can’t sue God, let alone their deceased family members, so they prefer to claim that SSRIs, not depression, is what caused suicide. As a result of adverse, largely litigation-driven publicity, there was pressure (Public Citizen filed citizen’s petitions) on the FDA and other regulatory bodies to issue warnings over what is a controversial and scientifically questionable risk. That happened, especially as to SSRIs prescribed to children.The Science News article reports on the predictable result: doctors cut back on their prescription of SSRIs, especially to children. The article reveals that this reduction is SSRI use is now associated with large increases in suicide rates in all populations studied:
As of 2005, SSRI prescriptions for kids and teens had decreased by about 22 percent in both countries after regulators issued warnings, Gibbons and his coworkers report in the September American Journal of Psychiatry. In the Netherlands, the youth-suicide rate increased by 49 percent between 2003 and 2005. The U.S. youth-suicide rate rose 14 percent between 2003 and 2004, the largest 1-year change in suicides for this population since federal researchers began collecting such data in 1979.
Emphasis added. Here are the links to the two scientific papers referenced in the article. Read ‘em and weep.We’ve often speculated, including on this blog, that litigation generates publicity that actually harms people who are deterred from taking medicine. Now there seems to be hard scientific proof that, at least in this instance, that scaring people away from taking these medications has not just harmful – but fatal – effects.What do these statistics mean? They translate into hundreds, if not thousands, of medically preventable suicides. From our perspective, that’s terrible. For those on the other side, we wonder if they see all these dead kids as merely collateral damage. Worse, it may be another method of increasing the potential client base. We hope not, and we’d really like to hear from someone who can justify continuing any litigation in the face of this type of statistical data showing that not taking the product at issue greatly increases precisely the risk being sued over.Anyway, we call articles like these “the scientific underground.” The press, sad to say, is much more interested in scaring people – whether about the risks of prescription drugs and medical devices, or about terrorism, or about practically anything else. The “if it bleeds, it leads” philosophy sells papers and gets eyeballs on screens, and has for hundreds of years. Articles like we’ve discussed here, which in each case refute previous press hype, end up solely in the scientific press. They won’t get anything near the front-page attention from the traditional media that the initial scares did. Nor have we ever seen a plaintiff’s firm, after hyping a supposed risk, ever print an equally prominent ad that retracts what turns out to be a scientifically unjustified misrepresentation.We don’t buy ink by the barrel. All we do is run this little blog. So this is all we can do to try to level the playing field a bit.