What's Behind the Rise in Food Allergies?

The incidence of food allergies in children is rising. Wheat, milk, egg, fish, peanut, walnut, shellfish and soy allergies have led to recalls of pork, turkey, cream of wheat mushroom soup, roast beef, ice cream and corn pasta in recent months. What's behind the increase in allergies?

There are at least two good hypotheses for which there's sound evidence. First, despite what our pediatrician told us, it's probably a good idea to introduce babies to e.g. cow milk sooner rather than later (see "Early Exposure to Cow's Milk Protein is Protective Against IgE-Mediated Cow's Milk Protein Allergy") and make sure they get a large enough dose to produce tolerance as it's apparently the low doses of say peanuts that lead to sensitization and allergy (see e.g. "Peanut Sensitization and Allergy: Influence of Early Life Exposure to Peanuts").

The second emerging hypothesis, another of the increasingly common "Grandma was right" sort of ideas, is that lack of sunshine is also responsible for the rise in food allergies in children. It turns out that vitamin D is crucial to a properly functioning immune system and without it you wind up with a gut full of the wrong sorts of bacteria behaving badly. (See "Potential Mechanisms for the Hypothesized Link Between Sunshine, Vitamin D, and Food Allergy in Children" and "The Role of the Gut Mucosal Immunity in the Development of Tolerance Versus Development of Allergy to Food").

And while we're on the topic of the consequences of this needless epidemic of vitamin D deficiency in the U.S. due to four decades of anti-sun/anti-reason activism you should also read: "North-South Differences in U.S. Emergency Department Visits for Acute Allergic Reactions", "Are Active Sun Exposure Habits Related to Lowering Risk of Type 2 Diabetes Mellitus in Women, a Prospective Cohort Study?" and "Vitamin D and Risk of Cognitive Decline in Elderly Persons" along with "Vitamin D: A Place in the Sun?" and "Vitamin D in Asthma: Panacea or True Promise?"

The takeaway here is that by overreacting to rare and likely uncontrollable risks we've been stampeded right into far more common and otherwise avoidable risks. So who should be liable to all of the eggshell plaintiffs manufactured out of junk science? Should it be the companies whose products would not have caused harm but for the activists or should the activists be called to account for what they have done?

"The Story of Cosmetics" - Sophistry At Its Finest

Though riddled with clever falsehoods and logical fallacies, "The Story of Cosmetics" is brilliant rhetoric - which is to say it's extremely persuasive. The narrator comes across as everywoman - down to earth, smart, earnest, caring and fair yet resolute about protecting families; and, her conclusions follow obviously from her premises.The graphics are especially well done - they enhance what the narrator is saying and add humor and wit. Finally, and importantly, it's short. Before my first trial my Dad told me to "say what you need to say or ask what you need to ask and then sit down and shut up; too many lawyers babble on trying to prove how smart they think they are and accomplish nothing besides annoying the jury and obscuring whatever point they're trying to make." Two decades on I can confirm all aspects of that advice.

Deconstructing this work of rhetorical art needs to be done piecemeal (if only because I have a present ion to complete and thereafter a plane to catch) so let's start at the beginning (well, not the beginning beginning - that's just the anti-consumerism ideological waypoint - I mean the "are these products toxic" beginning). Anyway, the narrator says she loves her shampoo and one day got to wondering what was in it. The first thing she noticed upon reading the label was that it had chemicals in it; specifically sodium laureth sulfate, tetrasodium EDTA and methylisothiazolinone. So she took the list to some unidentified "scientists" who advised that her shampoo "contains a chemical linked to cancer!" Let's look at this claim.

As luck would have it the International Journal of Toxicology just published "Final Report of the Amended Safety Assessment of Sodium Laureth Sulfate and Related Salts of Sulfated Ethoxylated Alcohols". Not surprisingly it's a soap that may irritate your eyes but if properly formulated won't even do that. It's certainly not a carcinogen which is what the American Cancer Society, OSHA and EPA have been saying for years to anyone willing to ask.

And what about tetrasodium EDTA? Before I answer that one I'd bet it's probably not a coincidence that the first two chemicals mentioned have sodium in the name since sodium, as in sodium chloride, has become a politically incorrect element just as California's state rock has become a politically incorrect mineral. In any event there's no evidence that EDTA is a carcinogen. On the other hand, when your dentist uses it to inhibit biofilm formation in your mouth it's actually an anti-carcinogen. Then there's the fact that EDTA is used to remove toxic metals from the body. Hmmm.

Finally, there's methylisothiazolinone, a biocide that keeps fungi and bacteria from growing in your shampoo. A quick trip through the ether to the U.S. National Library of Medicine leads to the brand new "Final Report of the Safety Assessment of Methylisothiazolinone". Reaffirming previous findings the report concludes that in the doses used in personal care products methylisothiazolinone is safe. But there's something very important here that you'll miss if you're not paying attention to the big picture; and that something is the weight given in vivo versus in vitro data.

How should chemicals be tested for toxicity? Typically it's been done on animals but because of political opposition to animal testing and a 20th century belief in genetic determinism a big yet largely unnoticed push has been underway to have EPA, NTP, etc shift to doing toxicity testing on human cell lines in vitro. So far such cell line in vitro testing has repeatedly managed to find signs of cellular damage from a host of substances never before associated with toxicity. Methylisothiazolinone is one such example.

Despite the fact that neurotoxicity has never been associated with methylisothiazolinone in humans, rats, mice, etc in vitro testing found that it produced damage to a line of human neural cells. What gives?

What gives, of course, is that just as a bacterium responds to its environment differently depending on whether it's alone or in a biofilm so it's hardly a surprise that a single cell would respond to stimuli differently than would the entire organism of which it is but a vanishingly small part. Thus the decision that methylisothiazolinone is safe thanks to the weight of the in vivo data. Therefore, as we shift away from the tried and true methods of toxicity testing and towards a new model which, in light of recent discoveries regarding epigenetics and the microbiota which run a good portion of our lives, be prepared for many many more baseless health scares; and the worst part about it is that without the ability to test the hypotheses generated on actual animal models refuting even the most absurd claims will only get harder.

"You Got Your Science In My Activism!" "You Got Your Activism In My Science!"

Yuck! Tastes like CBPR.

CBPR? I hadn't heard of it either; not until this week anyway. It's "community-based participatory research" and the idea is to get activists and scientists together to do research into things like the cause of higher than average breast cancer rates in some high net worth communities. The activists want the scientists to prove that pesticides are causing breast cancer in their communities; and so the scientists promptly set out to falsify the activists' claims. Why wouldn't it turn out well?

The answer can be found in "A Review of Advocate/Scientist Collaboration in Federal Environmental Breast Cancer Research". It turns out that "effective" CBPR requires a different sort of "inquiry paradigm." You see "[t]he positivist paradigm remains dominant in much scientific research, emphasizing objective knowledge that is separate from the knower and can only be uncovered through a scientific method of inquiry that is neutral and bias-free." "CBPR challenges this paradigm by contextualizing scientific research within particular communities, including and legitimizing advocates' knowledge, understandings, and priorities regarding issues by which they are personally affected." (Ibid at pg 17).

So researchers, schooled in the long history of how biases, prejudices and failures to challenge closely held beliefs have thwarted science and medicine in the past, are to drop everything they hold dear? Or is it that advocates are to drop their beliefs, acquiesce to all the money they lobbied for being spent on an effort to falsify those beliefs; and, after seeing them falsified, to say "Nevermind", take the hit to their reputations and set about constructing a new narrative for their lives? The former rejects the scientific method; the latter, human nature. 

Twenty Suspected Carcinogens

The American Cancer Society is calling for new research to settle the issue of whether or not twenty different agents do indeed cause the types of cancer in which they've been implicated. The twenty are:

(1) Lead and lead compounds; (2) indium phosphide (used in many flat screen TVs); (3) cobalt with tungsten carbide; titanium dioxide; (4) welding fumes; (5) refractory ceramic fibers; (6) diesel exhaust; (7) carbon black; (8) styrene oxide and styrene; (9) propylene oxide; (10) formaldehyde (does it cause leukemia?); (11) acetaldehyde; (12) formaldehyde; (13) methylene chloride; (14) trichloroethylene; (15) tetrachloroethylene; (16) chloroform; (17) PCBs; (18) DEHP (a phthalate); (19) atrazine (a herbicide and the subject of a coordinated attack by various activists groups resulting in a new EPA review); and, (20) shift work (the presumed exposure being "light at night" leading to a disruption of circadian rhythms and the most commonly associated malignancy being breast cancer).

You can find the press release here: Report Outlines Knowledge Gaps for 20 Suspected Carcinogens; and you can find the IARC report summarizing past rationale for assigning these suspected carcinogens to groups 2A - 3, the new evidence forming the basis for the recommendation that the status be updated and the sorts of epidemiological and mechanistic studies necessary to answer the question of whether they ought to be added to the list of 107 Group 1 agents known to be carcinogenic to humans, here: Identification of Research Needs to Resolve the Carcinogenicity of High-Priority IARC Carcinogens.

FDA Panel Votes to Keep Avandia Available for Type II Diabetes Patients

Despite a steady drip drip drip of out-of-context memos, disconnected snippets of depositions and dire predictions that rose to a torrent last night, the FDA's panel of experts today voted 20 - 13 to keep Avandia on the market, though, most suggested, with more warnings. More significantly, despite vicious ad hominem attacks on respected academics and physicians, the panel also voted to complete the TIDE study - one of those "gold standard" studies that should in 2015 produce at last some definitive data on the questions of whether Avandia poses an unacceptable risk for diabetics and whether it produces a better outcome than a competitor.

Of all the objectives of those who lead such attacks their effort to declare science settled and to outlaw further experiments that might falsify their claims is the most frightening. On the other hand, when you consider what happened with the breast implant litigation you have to understand that by waiting for the truth those who fed The New York Times stray documents and quotes from discovery would only put their businesses at risk. Fama, malum qua non aliud velocius alium.

 

The Doctor Doth Protest Too Much, Methinks

Today The New York Times, which dutifully fanned the flames of the 2007 "prescription drug crisis" started by those pushing for greater FDA powers and fewer new drugs, published "Caustic Government Report Deals Blow to Diabetes Drug". In essence it reports Dr. Thomas Marciniak's criticism of the RECORD study which in 2007 led the FDA, despite congressional histrionics, to vote 22 - 1 to keep Avandia on the market. What the NYTimes is talking about is this.

What sets off the alarms, to a mass tort lawyer anyway, is slide 22. Why, asks the good doctor, should you believe his numbers? After all he declares that he has "nothing to hide" and that "[n]either my job nor (for me) $100,000,000's are riding on the results." The other slides evidence an effort to dig, but not too much, into the data and upon finding seeming errors to imply, without saying so, that the manufacturer somehow managed to beguile honest researchers from around the world into signing off on bad science. It's the kind of drama you'd expect to see from a certain sort of expert witness testifying at the courthouse in Jefferson County; but hardly the sort of presentation typical of scientific gatherings. Then again the FDA has been hyper-politicized so maybe this is the new normal.

Anyway, the implication that this is the "Government Report" is highly misleading. It is in fact but one of many government reports (if by that we agree to mean presentations generated by government employees/contractors). Indeed, another "Government Report" addresses Dr. Marciniak's claims. You'll find it here.

Dr. Marciniak did the easy thing. Post hoc he rummaged around for evidence of errors that would undermine the RECORD study. When examining the outcomes of thousands of people based on many times that number of documents he found a few seeming inconsistencies. Anyone who does mass tort litigation knows that if a bad data point or two were enough to refute any study then we wouldn't have much to talk about down at the courthouse.

What's also interesting is the fact that throwing in the extra assumed heart attack episodes (even the ones for which there were no biomarkers confirming same) the study still only shows a small increase (1.38) that is statistically significant by the barest margin (C.I. 0.99 - 1.93) (i.e. "not") and still it does not support the Nissen hypothesis (to say nothing of the study of 227,000 Medicare patients that rejects it).

But most interesting of all is the data on the only question we really, ultimately, want answered. Do the people taking the medication live longer, or die sooner, than those who don't? By that measure, the protesting doctor's numbers still show that patients on Avandia were 14% less likely to die than those who weren't. By this most critical measure, even considering the data cherry picking of Dr. Marciniak, the results for Avandia are "reassuring" - according to that other government report.

Data Dredging For The Masses

Part of what Congress passed in response to the perceived prescription drug crisis of 2007, Title IX, Section 921 of the Food and Drug Administration Amendments Act 2007 (FDAAA) (121 Stat. 962), includes a directive that the FDA "conduct regular, bi-weekly screening of the Adverse Event Reporting System [AERS] database and post a quarterly report on the Adverse Event Reporting System Web site of any new safety information or potential signal of a serious risk identified by Adverse Event Reporting System within the last quarter."  A single sufficiently serious adverse event may be enough to constitute a "potential signal".  The number of potential signals being detected are increasing rapidly and on the most recent quarterly Potential Signals report thirteen additional drugs have been listed including such widely prescribed medications as Zithromax (the highly effective Z-pack) and Premarin for producing signals of serious risks of liver failure and angioedema respectively.

What will be the impact of releasing what is essentially raw data divorced from any analysis of its meaning or discussion of the plausibility of what it implies?  In other words, what good will come from this sort of transparency?  Other than tempting the unwary to the wrong conclusion thanks to the post hoc ergo proptor hoc logical fallacy it's hard to see any good coming of this; unless of course you're a personal injury lawyer.  Google "Zithromax lawyer" and you'll find that though the new potential signal report is only a few days old there are already numerous "Zithromax attorneys" anxious to represent you in your claim for liver failure.

At the end of the day it may well be that the so called prescription drug crisis that the Congress was responding to in 2007 was in fact merely a prophecy only now being fulfilled thanks to the AERS Potential Signals reporting system.

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Avandia: Burn Her Anyway?

Three years ago Dr. Steven Nissen published "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes" in which he reported that those taking Rosiglitazone (Avandia) had about a 40% increased risk of acute myocardial infarction (heart attack). The study was a meta-analysis of published and unpublished data and drew extensively from the manufacturer's unpublished data.

The media simultaneously reported the findings and propagated the following narrative: The pharmaceutical companies collect vast quantities of data; publish only what supports their products; and are at best willfully ignorant of the risks of their products which risks are right before their eyes if only they would look. Dr. Nissen who "has a statistician’s zeal for drilling deep into clinical data, seeking signs that some widely used drugs pose undisclosed risks to patients" was made the hero of the drama. Congress got involved by beating the drums of safety and transparency and demanding that the FDA pay more attention to ensuring that pharmaceuticals are safe.

The FDA reassessed Avandia and panel members voted 21-3 to keep it on the market.

In February of this year, a Congressional investigation conferred near-martyr status on Dr. Nissen after it was revealed that he had secretly tape recorded a meeting with the representatives of the maker of Avandia. The same month, in European Heart Journal, he published the editorial "The Rise and Fall of Rosiglitazone". Meanwhile everyone was waiting for the results of a huge study of Avandia.

Last week that study, "Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated with Rosiglitazone or Pioglitazone" (interestingly, for several days JAMA made you click through an ad for a competitor's type 2 diabetes product to get to the article) was published. And what was the risk of heart attack among those elderly patients on Avandia? Essentially no different than those on the older medication - a statistically insignificant 1.06 increase - especially so given the fact that almost three quarters of all type 2 diabetics wind up dying of heart disease in any event. So, was Avandia cleared? Nope. In fact, the calls for removing it from the market have grown even louder.

The new study, while rejecting the original claim that Avandia causes heart attacks, raised the hypotheses that Avandia causes congestive heart failure and stroke and increases the rate of mortality overall. Yet even though the numbers of patients involved in the study (their records were simply culled from Medicare databases) was large (227,000) the increases were relatively small and by the time the increases appeared (after six to fifteen months of medication) only a small and rapidly decreasing fraction of the original cohort were actually still on one of the two medications.

At almost the same time Dr. Nissen published an updated meta-analysis ("Rosiglitazone Revisited: An Updated Meta-Analysis of Risk for Myocardial Infarction and Cardiovascular Mortality"  also free and also, though published in the Archives of Internal Medicine, only after an ad for the same competitor's type 2 diabetes product) that purports to show that Avandia increases the risk of heart attack but doesn't increase the risk of mortality. What? Hey, wait a second! How can ... So, siding with those advocating "safety over certainty" the New York Times quickly editorialized in favor of those demanding Avandia be removed from the market.

The LATimes went so far as to publish a piece calling for "an immediate moratorium on sales as soon as a credible study raises questions about safety." In that same piece the journalist was posed the following question by a researcher being interviewed: "Suppose a drug saves five people and kills one person. Do you keep it on the market?" His answer was "I know this: If that one person killed is my loved one - or yours - the answer is readily apparent."

Yikes. Really? If a data dredge shows any risk of a fatal outcome then the drug should be pulled from the market no matter how many people are killed in the process? We'll save for another day the question of how thinking about risk goes so badly astray. For now though consider how likely it is (yes likely - and in fact, if the number of endpoints examined are sufficiently large, how almost certain it is) that a risk will be found where none exists. Start with "Data Dredging, Bias, or Confounding: They Can All Get You Into the BMJ and the Friday Papers" and then for more on the perils of statistical deep drilling read "Your Intuitions Are Not Magic" and the links therein.

At the end of the day the issue isn't safety versus certainty. Claiming that pharmaceutical manufacturers are insisting upon certainty before warnings are issued or products are pulled is just a straw man argument. The usefulness of statistical analyses of medical outcomes has not been added to "death and taxes".The real question is which course is less uncertain - making vital judgments on the basis of large randomized controlled trials like the one due out on Avandia in 2015 or on the basis of data dredges? The answer ought to be obvious.

But It's Peer Reviewed! That Counts for Something, Doesn't It?

The acquisition of science, knowledge, is an accretive process. Thus Isaac Newton saw further only because he stood on the shoulders of giants. So how much of that modern peer reviewed science winds up being stood upon by those able to peer a bit further? Less than half and likely a lot less than half.

If you have any doubt read "We Must Stop the Avalanche of Low-Quality Research" at The Chronicle of Higher Education. Don't stop there though. Be sure to read "All Those Worthless Papers" too. And what about those impact factors; don't they count? Yes, but not towards reaching the goal of truth. See: "Lost in Publication: How Measurement Harms Science".

There are so many peer reviewed journals around nowadays that almost anything can be published and then be claimed to have been peer reviewed. So how do will we deal with the crush of junk science being published in peer reviewed journals? At this point I don't think anyone knows.

 

 

 

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Stay Skeptical

If an article is peer reviewed, published in a decent journal and available for free from the National Institutes of Health you'd think there's a pretty good chance that the headline numbers recounted in it would be fairly accurate, right? Well then if you've read "A Brief Review of Silicosis in the United States", you'd likely believe that 94% of all death certificates in the United States listed silicosis as the underlying or contributing cause. On the other hand, you could stay skeptical and check the data at the U.S. Census Bureau.

It's always enlightening to go from advocacy site to advocacy site and to add up the number of bodies claimed by each and then compare the total to the actual number of recorded deaths. The cumulative total always significantly exceeds the actual number revealing that the activists are simultaneously fighting over corpses and overestimating the number of victims. Even so, the claim in this new silicosis paper that from 1966 to 2002 seventy-four million of a total of seventy-eight million U.S. deaths were due to silicosis has to take the cake.

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California Declares Whooping Cough Epidemic

The California Department of Public Health (CDPH) is warning that the rate of pertussis (whooping cough) infection may be the worst in half a century. Five infants have died so far this year and 910 cases have been reported. The CDPH is urging parents to have their children immunized as soon as possible and reiterates that the vaccine "is safe for children and adults".

ABCNews is further reporting that while immunization rates in California are good overall the number of parents refusing to have their children immunized in some schools rises to 20% or more and in a few schools refusal rates exceed 70%.

Junk science like that peddled by activists who claim the DPT (P is for pertussis) vaccine causes autism isn't just a good way to wring money from companies, it's a killer.

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A Little Perspective on the Macondo Well (Deepwater/BP) Oil Spill

While hanging out at the condo pool with the kids during my recent Destin vacation someone pointed out at the Gulf and said woefully "Look. I think the oil is coming in". It was seaweed. The next day there was a stir down on the beach when what appeared to be a piece of charred wood washed up. Some guy on a 4-wheeler rode up, proclaimed it a piece of charred wood, and tossed it into a nearby trash can. Onlookers seemed more disappointed than relieved.

On the way back to Texas we stopped in Louisiana and talked to, among others, an acquaintance who runs a vacuum truck service. Business is good as his trucks and drivers are under contract 24/7. The only bad thing, he said, is that the work is boring as there's been little to vacuum up; less than a gallon. On the other hand, the media livened things up from time to time by shouting things like "Where are you hiding the oil?" and "Who ordered you not to talk to us?" at his workers.

So where's all the oil? More than 100 million gallons have bubbled up according to the higher estimates. That's a lot, right? It is, of course. But according to an AP report, It wouldn't fill the Superdome. And that's not subtracting the oil that has been burned, dispersed and eaten by microbes.

The point of this post is not to minimize the spill or its impact but rather to explain why oil isn't all over the coast. It's a big Gulf (6,000 trillion gallons of water) and a long coast (over 1,600 miles long - just along the U.S. portion).

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Vitamin D Deficiency and Multiple Sclerosis (MS): Who Pays?

In "The Lancet: Neurology" you'll find "Vitamin D and Multiple Sclerosis"  as well as "Vitamin D: Hope on the Horizon for MS Prevention?" Could it be that  the old mocked wisdom of "a healthy dose of sunshine" wasn't so silly after all? Could it be that the health panic precipitated by activists who demanded everyone stay out of the sun actually caused horrific and needless suffering? Could be.

I just got back from a vacation in Destin, Florida. While there I learned that there are people who cover every exposed surface of their kids with zinc oxide before letting them out in the sun. These parents think they're doing the right thing. Their kids seemed about as happy as I'd have been sent out into the world in a powder blue leisure suit. But while powder blue leisure suits don't cause rickets and MS, vitamin D deficiency does. When disease strikes will there be a viable cause of action against the scaremongers who caused it? It's an interesting question.

To Inform; But of What?

According to The New York Times, San Francisco has just passed a law requiring retailers to post readily visible information about the specific absorption rate (SAR) of the cell phones they're selling. This despite the fact that there's not only no credible evidence that cell phones pose a health risk but also that there's absolutely zero evidence that dose (here SAR) has anything to do with the anxiety-producing phantom menace.

People have been given a meaningless yardstick by which to judge their cellular purchase. Expect the unscrupulous to make $$$ selling overpriced "low SAR" phones to their usual prey - people struggling with decision-making under conditions of uncertainty, buffeted by the hyperbolic claims of activists.

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Uninformed or Misinformed, Misperceptions are Hard to Correct

This (free) article “When Corrections Fail: The Persistence of Political Misperceptions” demonstrates that corrections frequently fail to reduce misperceptions among targeted ideological groups and in some instances corrections actually strengthen misperceptions among the most strongly committed subjects.

All the individuals in your pool of jurors will have beliefs they hold dear to them when they enter the courtroom. Since it appears many people are unwilling to revise their beliefs in the face of corrective information, and attempts to correct those mistaken beliefs may only make matters worse, your job is to uncover those hidden beliefs and determine the best way to present your case facts to correct any misperceptions.

How, and Why, Do Some Bacteria Facilitate Cancer Metastasis?

When you ask a physician or researcher how bacteria cause and/or promote cancer usually the only answer you get is "inflammation" and some hand waiving. It sort of makes sense. Lots of new and different stuff is going on, lots of new and different cells are running all around and lots of old cells are busily dividing and multiplying - surely a recipe for an accident.

But what if the bacteria are actively promoting the metastasis? That's the finding in "Bacteria Peptidoglycan Promoted Breast Cancer Cell Invasiveness and Adhesiveness by Targeting Toll-Like Receptor 2 in the Cancer Cells". Why, in the "what's in it for them" sense, would bacteria promote something that kills their host? Something to ponder over the weekend.

An Unusual Benzene/MDS Opinion

In Quillen v. Safety-Kleen Systems, Inc., 2010 WL 2044508 (E.D.Ky.) the court determined that plaintiff's expert, Dr. George Rogers, could properly attribute a case of myelodysplastic syndrome (MDS) to benzene by doing a differential diagnosis. That some courts have taken to using differential diagnosis to identify the root cause of say splenomegaly rather than to distinguish histoplasmosis induced splenomegaly from Hodgkin's disease induced splenomegaly would likely set many physicians' eyes rolling.  Yet, that's apparently what the 6th Circuit said in Hardyman v. Norfolk & Western Railway Co., 243 F.3d255 (6th Cir. 2001) and thus the thinking by the Quillen court.

The point of doing a differential diagnosis, of course, is to rule out possible causes until just one is left - it's a process of elimination. But just because every other cause of splenomegaly has been ruled out in the case of a male patient that doesn't mean that it makes sense to conclude that the cause must be the remaining possibility - a metastatic ovarian cancer. To be considered for elimination in the first place the putative cause has to be one that makes sense. In Quillen though there was no effort to demonstrate that plaintiff's experience with benzene was the sort that would make benzene a reasonably plausible cause of his MDS.

Finally, please ponder the following. In response to the defendant's objection that plaintiff's expert had not ruled out ionizing radiation  the court wrote: "Defendant points to nothing in the record demonstrating that Quillen was ever exposed to a statistically significant amount of such radiation." Somewhere an epidemiologist just fell out of her chair.

Something to Consider When Considering a State of the Art Defense

When putative cause and effect are perceived to be closer, in time, the degree of belief in the alleged causal nexus increases. That's one way to look at the results of a new study on how people perceive causal relationships in time being reported at MindHacks. But how does that explain the ease with which many juries find a link between a decades old exposure and a modern case of mesothelioma? Perhaps because too often defendants fail to adequately explain the long and difficult path from surmise and suspicion to confirmation of the link; and, because they often fail to demonstrate (sometimes due to judges who prevent it) in a detailed time line all of the intervening and nowadays usually superseding causes.

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The Strange Case of the Report of the President's Cancer Panel

By now you've surely heard or read about "Reducing Environmental Cancer Risk: What We Can Do Now", which is the title of the recently released annual report of the President's Cancer Panel. You've also likely read that the American Cancer Society, no laggard when it comes to stirring up anxiety about cancer, has criticized the report's unfounded claims of wanton devastation from heretofore largely unknown, and still yet to be identified, man-made and occasionally natural carcinogens. But have you read the report itself? You should; it's quite an eye opener.

First, there's the advocacy. There are calls for massive new regulatory schemes based on what the authors think the "precautionary principle" means - i.e. that everything with a CAS number is suspect and can't be trusted until it has been studied not just alone but in every conceivable combination and concentration with the other 80,000 chemicals in use today. There are calls for "environmental justice". There are calls for expensive home water filtering, the end of plastic food and beverage containers, the consumption of "organic" food, lots more "black box" epidemiology and, most importantly for the plaintiffs' bar, "an environmental health paradigm for long-latency diseases .. to enable regulatory action based on compelling animal and in vitro evidence before cause and effect in humans is established". That last bit is all about the emerging "low dose" theory, the newest attack on "the dose makes the poison", explained in the introduction of the report as "harmful effects that may occur only at very low doses".

Then there's the science, or rather, the argumentum ad ignorantiam. The document is largely free of objective data. The authors admit at the outset that cancer incidence and mortality is falling, that not much is known about the causes of cancer and that the evidence concerning the consequences of "cumulative lifetime exposure" to most environmental contaminants is unknown and unstudied. Yet because so much is unknown, because environmental cancers are "grossly under-recognized" and because they are "shattering" and "devastating" the lives of so many Americans, congress must act. And what sorts of things are imperiling our well being? Electricity, clean water, cell phones and juice bottles to name a few. When data does make an appearance it is often put to embarrassingly bad purposes. For example, one section implies the following: ionizing radiation causes cancer; electromagnetic fields are a form of radiation; therefore, electric wires, cell phones and Wi-Fi routers need to be avoided and regulated as carcinogens. 

Early on the authors set out their premise: "Most environmental hazards with the potential to raise cancer risk are the product of human activity ..." The claim is never supported (which is not surprising as it conflicts with what is known about the causes of cancer today) but it's the one consistent theme that runs throughout the paper and it thoroughly accounts for its conclusions. At the end there's a laundry list of chemicals and things to worry about; it's long enough to keep toxic tort lawyers and their experts (some of whom were interviewed by the panel) busy for decades. So it goes.

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Frontline Looks at the Vaccine War

I hope you caught tonight's Frontline episode: "The Vaccine War". For "vaccine" you could substitute "Bendectin" or "silicone" or any number of products made the target of baseless health scares over the years and get pretty much the same story; only this time Frontline sticks to the science and lays bare the empty claims and deadly fruits of the opponents of childhood vaccination.

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No Fracking in the Catskills

There won't be any drilling for natural gas in the Catskills watershed according to the NYTimes. Of interest to some will be how opposition to drilling was shaped and propagated. Who wouldn't be opposed to flaming kitchen faucets?

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Beware of Graphical Representations of Risk Ratios, Odds Ratios and the Like

Would you be surprised to learn that the graphical representations of association (RR, HR, OR) are seriously flawed not just in some but in most of the peer-reviewed articles published in JAMA, The Lancet and NEJM in 2008? I certainly was. Read about it in The Lancet at "Graphical Presentation of Relative Measures of Association". Apparently, rather than improving communication an awful lot of graphics are actually "distorting what the data have to say".

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Lies, Damned Lies, and P-Values

In "Odds Are, It's Wrong", Tom Siegfried lays out the argument for the proposition that much of what you read in the scientific literature is wrong because many of the claims being made rely on statistical significance. You see, an impressive sounding statement like "the association between exposure and disease was highly significant (P<0.05)" does NOT mean (a) that there's a 95% chance that the association is causal; (b) that the absence of an association can almost certainly be ruled out; nor does it necessarily mean that (c) the finding is momentous, compelling or even important. It doesn't even say that if the test were to be repeated that its results would likely hold. A P-value, the arbitrary judge of "statistical significance", won't, and can't, have anything to say about the likelihood that a given hypothesis is or is not true.

The fact of the matter is that if you have a bunch of data and can't find at least one statistically significant association it in only proves one thing - that you're not trying hard enough. The magical P-value level of 0.05 is nothing but a trade-off; a balancing act between finding associations that don't exist (false positives) and missing true associations that do (false negatives). As a result, false associations are not only possible, they're guaranteed when you have enough data and slice it enough ways.

Now, lawyers are getting into the act. And while it's bad enough that "[a] lot of scientists don't understand statistics" (Steven Goodman quote from the "Odds Are, It's Wrong" article) it gets awful when lawyers try to deploy statistics to support or rebut claims. Law review articles are littered with claims resting on nothing more than small P-values. Some purport to show that certain appellate courts are biased against accident victims; others that tort reform is good for your health. And hardly a week goes by that I don't see a brief or a pleading asserting that Texas "jurisprudence" requires an epidemiological study with a risk ratio greater than 2 and a P<0.05 before a plaintiff can recover on a toxic tort claim. 

Apparently many lawyers, especially on the defense side, either forgot or never learned that it's easy to gin up false associations that meet the greater than 2 and less than 0.05 test. In fact, that's how most categories of toxic tort claims got started. Enshrining such a test in the law would turn out to be The Full Employment Act for toxic tort lawyers.

Causal inference from epidemiological statistical analysis is a crude method that nevertheless worked well for finding big effects like that of smoking on lung cancer risk and amphibole exposure on mesothelioma risk. On more subtle effects though, at the population level or molecular level, reliance on 20th century methods has produced so much bad science of late (bad only because statistics are routinely misused and abused and not because statistics aren't powerfully effective tools when properly used) that new methods of causal analysis are beginning to replace them. And these tools can answer the question of "how likely is it that drug A caused injury B?"

To see what the future of causal proof in toxic torts will look like read: "An Introduction to Causal Inference" by Judea Pearl.

Complex Writing Makes You Look Stupid

That's the conclusion of just one of eight studies demonstrating the power of simplicity as summarized by Psyblog. ht Mindhacks

 

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No Association Between Paint Fumes in the Home and Fetal Growth

See "Non-Occupational Exposure to Paint Fumes During Pregnancy and Fetal Growth in a General Population"

Though about half of the mothers surveyed said they'd been exposed to paint fumes in the home while they were pregnant the data suggested that the more fumes to which they'd remembered being exposed the lower the risk that their baby would be underweight. What? This study probably has more to say about the use of interview data as a proxy for exposure than it does about the relationship being examined.

Long Term Smoking Significantly Reduces the Risk of Parkinson's Disease

A greater than 40% decrease in Parkinson's if you smoke more than 30 years? So it seems from this huge NIEHS study of 305,468 Americans. "Smoking Duration, Intensity, and Risk of Parkinson Disease".

Obviously the risk of getting lung cancer, emphysema, etc from smoking is much higher. Still, if you knew you had the genes that protects you from lung disease (whatever they are) but not the ones that protect you from Parkinson's (whatever they are) would you smoke?

 

It Doesn't Seem Logical But It Does Seem To Be So

If people with Type 2 diabetes are at a greatly increased risk of heart disease wouldn't it make sense to get their blood pressure and triglycerides down and their "good" cholesterol up? Quitting smoking and lowering "bad" cholesterol reduces the risk from very, very high to just very high so attacking these other presumed risk factors should help, right? Besides, pushing systolic blood pressure down closer to normal would obviously yield some benefits. And there's no way it could hurt. Right?

It turns out that these interventions, implemented on the basis of reasoning and not rigorous studies, either do no good, do no good and cause side effects, or do no good and increase the risk of heart attack by 50%. Be sure to read about the just published data and the reaction to it in an excellent write up by Gina Kolata in The New York Times.

How could this be? Well, what if the things everyone thinks are causes of heart disease in diabetics are really just other effects of the real cause? Or, and this is where it really gets scary, what if what everyone thinks is a cause in need of eradication is in fact part of the body's defense mechanism against the real cause? For a discussion about how obesity may be just such a protective mechanism see "One of the Scourges of Modern Life May Have Been Profoundly Misunderstood" in The Economist's Science and Technology section.

The takeaway from all this can be found in the first article. While these treatments seemed logical (and as noted in the article, at every meeting "some academic" would always be going on about how elevated blood sugar after a meal was dangerous and had to be lowered until eventually doctors had put thousands of people on these treatments) it turned out they were instead dangerous and ineffective. That'll always be the danger when we attempt to deduce solutions based on just the known variables of a complex and only partially understood system.

Popular Beliefs About Bisphenol A Have Been Repeatedly Falsified, Yet the Controversy Continues. Why?

Claims that bisphenol A causes hormone disruption have been refuted again and again by large, independent studies the results of which have been published in peer reviewed papers. Yet, based on nothing more than an uninspired theory (that estrogen-like molecules ought to do what estrogen does) and a few, small, poorly controlled studies the results of which can't be reliably reproduced elsewhere, the effort to ban a product that prevents bacteria from infecting much of the food you consume continues to accelerate. How could this be?

You can find Richard M. Sharpe's answer in "Is It Time to End Concerns over the Estrogenic Effects of Bisphenol A?" published in the journal Toxicological Sciences (free access!).

Like the autism/vaccine, limb reduction/Bendectin controversies the bisphenol A panic has spread like a virus. And if those past controversies are any guide it'll be several more years before civilization's immune response, empiricism, is able to bring us collectively back to our senses. In the meantime expect opportunistic infections to take advantage of the situation.

Hiding in Plain Sight

There are more than 18 million articles in PubMed and more are added in a day than you could hope to analyze in a month. Surely if someone had the time to digest it all new associations and patterns would emerge suggesting new hypotheses and generating new knowledge. But how?

Here's an article available free at PLoS One setting out one possible solution : "A PubMed-Wide Associational Study of Infectious Diseases" In the paper, a sort of proof-of-concept effort, the authors demonstrate that by running focused text mining software (not just key word searches or tabulating rankings of key words) over more than half a million infectious disease articles they could not only uncover cumulative knowledge already confirmed but also generate new hypotheses from this "hidden public knowledge".

Be sure to have a look at the associational network maps in the article. Then imagine what hidden relationships you might find if you could run similar software over the two million documents just produced in your case and the great demonstratives you could generate to prove them.

 

Will Your Jurors Decide the Case on Conduct or the Consequences of that Conduct?

Apparently it depends on where they fall along the powerful/powerless spectrum.

"In determining whether an act is right or wrong, the powerful focus on whether rules and principles are violated, whereas the powerless focus on the consequences." - from "How Power Influences Moral Thinking" published in the Journal of Personality and Social Psychology. Hat Tip: Barking Up the Wrong Tree.

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You Know Those Mass Screenings for Prostate Cancer? Nevermind.

According to the Houston Chronicle the American Cancer Society has finally come to grips with mounting evidence that indiscriminate screening for prostate cancer causes more harm than good thanks to (a) the inevitable morbidity resulting from needless biopsies and surgeries due to false positive tests; (b) the realization that an awful lot of people who consider themselves "cancer survivors" would never have known they had cancer but for the screening test as their cancers would have gone away on their own or would have grown so slowly that they'd have died of something else before the prostate cancer became threatening; and, (c) the unfortunate fact that early detection, despite what everybody has been led to believe, does not mean that aggressive cancers can be cured - it just means that we get to be treated for them, and worry about them, longer.

Here's a link to the new screening recommendations: "Revised Prostate Cancer Screening Guidelines: What Has -- and Hasn't -- Changed"

Also of interest may be the readers' comments over at the Chronicle and elsewhere. Predictably there are two dominant camps. One sees this change as a nefarious plot by Big Pharma and Big Medicine to prevent early detection so they can make more money by making people wait until they need more expensive medicines and surgeries. The other one sees the new guidelines as a nefarious plot by Big Government to save money by preventing early detection so it can save money on treatment and hasten the deaths of Americans thereby saving money on Social Security payments as the cherry on top. I've run across veniremen able to hold both views simultaneously. But that's a discussion for another day.

What, Exactly, is an "Untainted Juror"?

In "Finding Untainted Jurors in the Age of the Internet" The New York Times examines one of the issues raised by former Enron CEO Jeffrey Skilling in his appeal to the U.S. Supreme Court - whether someone, anyone, can get a fair trial in an age when jurors can download a torrent of information once they get back home from a long day of tedious and vexatious "trial". The article presents no solution but that is, I suspect, because there isn't one.

No one comes to jury duty untainted by life; there are no blank slates to be found among your venire. If they find something relevant online it's just going to be something that confirms what they already believed. Your job then, as always, is to uncover their worldview in voir dire and to thereafter present a narrative that accommodates both their perspective and your facts.

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JAMA Names 2009 Peer Reviewers

Inquiring defense lawyers will be wondering what article(s) plaintiffs' expert Phil Landrigan refereed for JAMA.

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Peer Review: A Good Way to Detect Flaws in Methodology or a Good Way to Silence Heresy?

Back in the day, when the war against junk science was being fought in earnest, the U.S. Supreme Court wrote the following about peer review: "submission to the scrutiny of the scientific community is a component of 'good science,' in part because it increases the likelihood that substantive flaws in methodology will be detected". Today of course we know that most research reported as scientific knowledge in the journals is false. Worse yet, it is becoming increasingly apparent that the peer review process has been hijacked and turned instead to the purpose of safeguarding the prevailing dogma so that "truly original findings may be delayed or rejected" while "[p]apers that are scientifically flawed or comprise only modest technical increments often attract undue profile". These recent observations confirm what I've suspected in the two years since deposing a notorious expert witness who once was regularly excluded as a peddler of junk but who is now a referee for a prominent journal: somehow, some way, the barbarians have become the gatekeepers.

The end may be approaching for peer review, however. Of peer review it has recently been written: "Peer review eludes the immune system of science since it has now been accepted by other bureaucracies as intrinsically valid, such that any residual individual decision-making (no matter how effective in real-world terms) is regarded as intrinsically unreliable (self-interested and corrupt). Thus the endemic failures of peer review merely trigger demands for ever more elaborate and widespread peer review." In the blogosphere you"ll find that the frustration of those whose papers have been delayed or sabotaged by referees more intent on preserving the paradigm that supports them than getting closer to the truth is resonating. Good examples of those concerns and a call to end the ability of reviewers to hide behind their anonymity can be found at Marginal Revolution and Seth's Blog.

I for one support the move to disclose the identity of reviewers as well as the content of their reviews. As we noted in an earlier post, experts facing the prospect of having their opinions critically reviewed by their own peers tend to stay much closer to the truth.

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How Can Something So Green Be So Bad for You?

Under current federal incentives for “green” energy sources, developers have been rushing to place wind turbines in many rural areas. Indeed, even before the Obama administration’s current emphasis on renewable energy, wind farm development has grown rather dramatically in the last decade, as shown by this time elapsed map of installed wind capacity.

In a recent ABA Journal article, the author notes that many neighbors of proposed wind farms have been challenging the placement of the giant turbines near their homes. Most such challenges have occurred before local land use authorities or state public utility boards, but some have been filed in court.

Most interesting from the mass tort perspective is this: at least some challenges to wind turbine developments have been based upon the purported human health effects of the turbines. Nearby homeowners claim that the low level sound, vibration and shadow flicker from the spinning turbines cause a host of non-specific complaints, such as sleep disruption, headaches, nausea and fatigue.

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Numb(er)struck

Pretend you're not a tort lawyer but instead a criminal lawyer. The judge is going to decide whether your client should be committed or set free. Her decision will turn on the likelihood of your client committing an act of violence in the future. You and the prosecutor reach an agreement on the factors to be weighed and a risk assessment is thereafter produced. It shows that your client has a 26% chance of future violent behavior.

Question: How should you frame your case

(a)   there's only a 26% chance that he'll ever commit an act of violence;

(b)   there's a 74% chance that he'll never commit an act of violence; or

(c)   it doesn't make any difference?

If you answered either (a) or (c) you might want to read "The Effect of Framing Actuarial Risk Probabilities on Involuntary Civil Commitment Decisions" just published in the journal Law and Human Behavior.

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Will Your Jurors Find Your Expert to be Knowledgeable and Trustworthy?

It's likely to depend on whether his or her opinion supports, ultimately, the values of each juror. And if the scientific consensus supports the expert's opinion it's likely to have less persuasive effect than you imagine. It's not a matter of your juror rejecting that consensus. Rather, it's a consequence of your juror assuming, perhaps because instances of agreement come readily to mind, that most experts actually support whatever conclusion about the issue would be deduced from that juror's values. That's my take anyway from the new paper (hat tip: The Situationist) "Cultural Cognition of Scientific Consensus" by Dan M. Kahan, Hank Jenkins-Smith and Donald Braman (part of the Cultural Cognition Project.)

At the conclusion of the paper the authors make a recommendation to those tasked with communicating risk that should be heeded equally by trial lawyers. "It is not enough to assure that scientifically sound information - including evidence of what scientists themselves believe - is widely disseminated: cultural cognition strongly motivates individuals - of all worldviews - to recognize such information as sound in a selective pattern that reinforces their cultural predispositions. To overcome this effect, risk communicators must attend to the cultural meaning as well as the scientific content of information". Swap "trial lawyers" for "risk communicators" and you'll get my point.

One last thing. I wonder what role reputation, and by that I mean the reputation of the subject and not that of the expert, plays in such matters. Here's why I ask. I know people who you'd predict from the authors' "hierarchical individualist" vs "egalitarian communitarian" distinction to fall into the "vaccines don't cause autism" camp instead being fervent anti-vaccination zealots. And I've found the reverse to be true as well. What actually seems most determinative is a like-minded group of friends. From my wholly unscientific observations some views about risk seem to spread among a group of friends or social acquaintances more like a virus. A new concern begins to be discussed, is seen as quirky, slowly spreads, then one day comes a tipping point and almost everyone in that group is announcing they won't be having their kids vaccinated (in the other group calls for the water-boarding of Jenny McCarthy are surprisingly typical) and the rest are feeling like Donald Sutherland in "Invasion of the Body Snatchers" (before the end anyway), and trying to change the subject.

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Do Expert Witnesses Help Unsophisticated Jurors? Not So Much

Not so much, that is, unless the experts are at risk of being either penalized or outed for saying something scientifically indefensible. Those are some of the findings from "Competition in the Courtroom: When Does Expert Testimony Improve Jurors' Decisions?" just published in the Journal of Empirical Legal Studies.

Essentially what the authors did was to pick a decision that could objectively be determined as correct or incorrect; and in this case it was a mathematical problem. Then they used SAT scores on math as a proxy for deciding who was and who wasn't sophisticated. Then they exposed the test subjects to competing experts who opined as to the real answer to the math problem. They even mixed things up by having some subjects pose as the experts; leaving some to their own rhetorical devices while others were threatened either with "verification" or a monetary fine.

Among the conclusions: "... our experimental results demonstrate that competition between experts, by itself, does not help unsophisticated subjects to make decisions that are comparable to those of sophisticated subjects..." "Indeed, we find that unsophisticated subjects who are exposed to competing experts make significantly worse decisions than do sophisticated subjects." However, "once competition between experts is coupled with [penalties or threat of exposure] unsophisticated subjects achieve such large improvements in their decisions that the gap between their decisions and those of sophisticated subjects closes."

My takeaway is: add an impartial consulting expert to the gatekeeper's arsenal of expert control measures and jury decision-making is likely to improve dramatically.

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More Insight Into the Power of Metaphor

That metaphors help us communicate new ideas by casting them in the terms of something similar yet familiar is well known. But did you know that your body not only tends to act out metaphors (e.g. leaning into the future) but also to impose them on the brain (shifting one's judgment about the personality of someone based on whether the perceiver's hands are cold or warm)? Well, it's true, and I was writing up a summary of the recent work when I came across an excellent article by Natalie Angier in The New York Times that does it better than I could. You can find it here: Abstract Thoughts? The Body Takes Them Literally

There's a mind/body debate in there that can wait for another day but in the meantime be conscious of the unconscious impact of metaphors.

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Lancet Fully Retracts Paper Linking Autism to MMR Vaccine

Today The Lancet announced: "it has become clear that several elements of the 1998 paper by Wakefield et al are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were "consecutively referred" and that investigations were "approved" by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record."

Though this final, and finally complete, retraction is based on a determination of ethical lapses on the part of the author the fact remains that the results reported in the article have never been replicated. Nevertheless, contrary to what most lay people might assume published scientific papers aren't retracted just because the "science" within them turns out to be wrong.

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On to a Fifth Age? How About We Finish the Second?

In a 1971 paper that profoundly influenced how scientists and policy makers approached public health issues Abdel Omran set out his theory of "The Epidemiologic Transition". He hypothesized that societies went through three different ages, or phases, that defined their experience with regard to mortality and life expectancy. In the first, the "age of pestilence and famine", life expectancy is low and episodes of widespread death are common. In the second, the "age of receding pandemics", infectious diseases are overcome and life expectancy increases dramatically. Finally, in the third, the "age of degenerative and man-made diseases", diseases of aging and self-inflicted suffering becomes the predominant determinant of mortality. Eventually others, noting the dramatic increase in life expectancy due to the rapid decline in deaths due to heart attack and stroke, posited a fourth age; essentially the same as the original third age but with cardiovascular disease removed from the "degenerative disease" category.

Now in an editorial in this month's JAMA  Dr. Michael Gaziano asserts that we may be entering a fifth phase, or age, of the epidemiologic transition. We are now, he writes, entering the "age of obesity and inactivity" in which ailments due to gluttony and sloth predominate on death certificates. The editorial references two new articles in the same issue purporting to show Americans are fat and getting fatter; especially the children.

But wait a minute. The age of man-made diseases barely materialized. Certainly there have been many many cases of people suffering terribly as a result of some man-made health hazard. Look no further than the cases of mesothelioma among the men who served aboard amosite laden Navy ships. And smoking continues to exact its terrible toll. Yet if you throw all the deaths due to occupational diseases and every last lung cancer/COPD death into the same category you can't get to 10% using worst case estimates. More sober estimates put the percentage of deaths due to man-made diseases at considerably less than one. Nevertheless, this powerful meme - that most of our woes are self-inflicted and due to some failure to live in a natural way - still propels not only mass tort litigation but also much scientific and political thinking.

However, there's more than just AIDS to demonstrate that we never really saw the "disappearance" of infectious diseases. Go to www.pubmed.gov/ and do some searches on helicobacter pylori and humanpapilloma virus and you'll see just how many cancers are now being attributed to just these two organisms. Investigate mollicutes and you'll find that all sorts of microbes are suddenly being found associated with disease and they're only now being found because the technology to identify them is only now being refined.

Finally, remember to read the fascinating journey of Barry Marshall and Robin Warren from authors of an abstract rejected as one of the year's worst to winners of the Nobel Prize in Medicine for the very same work. In the end, the view, supported by the work of one of the world's preeminent public health researchers, that peptic ulcers were caused by that most modern of man-made insults, stress, only gave way to the understanding that the cause was in fact a bacteria when the evidence was irrefutable.

Facts Don't Have Much Impact on Values

By now you've likely heard that Andrew Wakefield, the British doctor whose 1998 paper published in The Lancet linked autism to the measles, mumps and rubella vaccine, has been found by that country's medical supervisory board to be guilty of "unethical" research, dishonesty, financial impropriety and "serious professional misconduct". And if you've been following the story you know that the paper has been partially retracted by The Lancet, disowned by most of Wakefield's co-authors and its findings have been refuted by subsequent and far more rigorous research. You might even know that the vaccine scare precipitated a sharp drop in vaccinations leading to a 20 fold increase in measles cases and at least 11 unnecessary deaths.

But what you might not know is that for an awful lot of people, none of it matters.

Despite the needless deaths, despite the revelation that Wakefield received $100,000 to conduct his test from lawyers hoping to sue vaccine makers and despite studies of millions of children who received the vaccine (as opposed to the 12 studied by Wakefield) showing no link to autism, as the verdict against Wakefield was read by the board's chairman he was "repeatedly heckled by distraught parents who support Wakefield..." And if you read the comments about the verdict at The Times you'll see that there are an awful lot of people who think that Wakefield is a victim of an elaborate plot to silence him orchestrated by the drug companies (out to make money) and the government (out to save money).

So what gives? One explanation is that our perception of risk is shaped largely our values. In a recent post at The Situationist you'll find a link to a video from the National Science Foundation in which Dan Kahan discusses the "cultural cognition thesis" - the idea that people perceive risk through the lens of their beliefs about what is and isn't good for society. By way of example he discusses the HPV vaccine Gardasil and the aversion to its administration by people who typically support vaccination. Apparently, for some at least, the perceived risk of green lighting sexual activity in young women outweighs the known risk of cervical and head and neck cancers.

What values then compel so many people to cling to the scientifically unsupported belief that  vaccines cause autism? That profiting from preventing disease is morally wrong? That mandating vaccination of children is a violation of rights? Something else? Whatever the answer just remember that you won't ever change a juror's values; not in time for the verdict anyway. Instead, find a way to present the facts so that they fit, or at least do not conflict, with those values and if that's not possible then frame the issue so that some other, shared value decides the question.

 

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Simplify, Simplify, Simplify Simplify

The hardest thing a trial lawyer does is also the most important thing a trial lawyer does. It is to distill her case down to its essence so that it can be clearly and easily communicated. Yet simplifying doesn't just ensure that your jurors understand your position; simplifying makes it much more likely that your jurors will believe your account to be true.

In a discussion of their recently published findings about how ease of understanding affects judgments about the information being conveyed authors Song and Schwarz report that something as seemingly minor as the font in which a statement is printed can have a profound effect on people's judgments about whether that statement is correct. Judgments about risk are affected by ease of communication as well. For example, a food additive with an easy to pronounce name was repeatedly perceived to be less risky than one with a difficult to pronounce name, despite the fact that the rest of the information, much more substantive information, about the two additives was identical.

Lastly, from this and other research, the authors conclude that easily communicated information will benefit in one other aspect. Specifically, from our tendency not to scrutinize those things which we "get". So if you want your narrative nitpicked be sure to use big words and complicated demonstratives. On the other hand, if you want your jurors instead to be digging through the testimony for facts that confirm your account be sure to communicate simply and clearly in every avenue of communication.

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Is That "Science"?

Imagine: Someone makes a claim about how things work and assigns to that clam a 90% or greater probability of it being true. The sole evidence for the assertion is a copy of a nine year old popular science magazine in which a telephone interview of someone making the claim was reported. No data. No calculations. No experiments. Nothing.

Would you think that was "science"? Most people wouldn't.

But what if you didn't know the facts. What if all you knew was that the scientists making the claim all had fine educational pedigrees and had won prestigious awards and that their report was supported by the U.S. government, the UN and most of the rest of the world? Well in that case, figuring that someone else had already done his or her job of fact checking, you'd assume the science was sound and you'd get back to doing your own job after updating your understanding of the world with this new knowledge.

The New York Times is reporting today that the scientific claim that Himalayan glaciers will disappear within 25 years leaving hundreds of millions of people without water is based on just that sort of "science". 

The revelation that one claim in the 1000+ page IPCC 2007 report is without foundation does not of course mean that the rest of the report is faulty. Nevertheless, the fact that such a profoundly important claim made its way into the final report, based on nothing more than one person's nine year old hunch, will undoubtedly make many people wonder whether the scientists who wrote it were doing the sort of critical thinking that unshackles minds or rather were, as most people, merely seeking confirmation of their beliefs - blinded to whatever flaws or errors that come with it.

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The Malleability of Memory

Neuronarrative has a write up on a study that goes a long way towards confirming what is often suspected about plaintiffs' exposure testimony in latent disease cases - that showing people pictures of the activity being considered causes them to subsequently remember things that never happened. But how else would you explain the testimony of a witness who swears he used Acme Asbestos Widgets in 1955 on the XYZ jobsite but can't recall for the same year where he lived, his phone number, the brand of toothpaste he used or, in one case, the name of his then wife?

ht The Situationist

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The Power of Negative Thinking

Let's say that a telecom tower was built in your neighborhood to broadcast microwaves at a new frequency. Then, after it was up and running, neighbors began claiming all sorts of ailments including rashes, headaches, nausea, tinnitus, sleep disruption especially among children and gastrointestinal upsets. Finally, following protests from "a residential community filled with children exposed to uninvited microwaves", the company shut off the tower. Thereafter your neighbors reported that their symptoms had improved dramatically or had disappeared altogether. What conclusions would you draw about the new microwave tower and the risks it poses?

Now let's say that the company announced, and proved, that the tower hadn't been "ON" in the first place. Would that change your conclusions? Well, that's exactly what happened here.

We used to have all sorts of fun like this back in the days of multiple chemical sensitivity and similar litigation. The plaintiffs' lawyers though learned to discover everything there was to discover about a defendant's operations first and only then present their witnesses, prepared for all such revelations and ready with new and unfalsifiable claims, for deposition. Alas.

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More Evidence That Vitamin D Prevents Cancer

For a number of years my great grandmother's admonition to get out of the house and get some "healthy sunshine" as soon as winter eased its grip has been at odds with the consensus in the medical community. Sunlight is officially expected to be a human carcinogen. And there's no safe level for carcinogens, right? So stay out of the sun and slather up any uncovered skin with sun block whenever you're forced to venture into the perilous outdoors. That's what the science said anyway.

The problem is that science, which is to say the business of generating knowledge, is as addicted to fads as Madison Avenue. So often when a hot new idea comes along, especially one that confirms part of a dominant narrative, most scientists and physicians seem to immediately buy into it. Thereafter, rather than investigate further whether sunshine is indeed an insidious carcinogen to be avoided at all costs, they investigate ways to stop it, or discover where it is brightest (and so riskiest), or find medicines that might ameliorate its dire effect.

At the same time though a vast and uncontrolled experiment gets carried out on the people who buy into the fad. In this case they're depriving their bodies of the Vitamin D manufactured in their skin when sunshine falls on it. Is that something they should worry about?

Well, it's beginning to look as though the good health of Mediterraneans has a lot more to do with getting plenty of sunshine than it does with getting plenty of dolmades and wine. The number of papers demonstrating vitamin D deficiencies in Americans and the relationship between vitamin D deficiency and increased risk of cancer is astounding. The newest I've found, "Plasma 25-hydroxyvitamin D Levels and the Risk of Colorectal Cancer: the Multiethnic Cohort Study" demonstrates a 37% to 46% decrease in colorectal cancer among Hawaiians of Japanese, Latino, African-American, White and Native ancestries with the highest levels of 25-hydroxyvitamin D in their blood.

And vitamin D deficiency isn't just associated with cancer. In another new paper it's associated with infections leading to more illness, costly treatments and long hospital stays. The authors conclude: "Vitamin D deficiency is intimately linked to adverse health outcomes and costs in Veterans with staphylococcal and c. difficile infections in North East Tennessee".

My great grandmother worked in her garden almost to the end of her days. She made it to 101 without a walker or even a cane then died in her sleep after a fall. Simply an anecdote proving nothing about sunlight, I know. Nevertheless, we might do well to consider tradition and the thoughts of the wise before jumping aboard every bandwagon that rolls by.

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Are Michigan Courts Shifting the Burden of Proof to Defendants?

One explanation for Genna v. Jackson (a new opinion out of the Michigan Court of Appeals) and Gass v. Marriott Hotel Services, Inc is that the courts thought about it and decided to shift the burden of proof regarding causation to the defendant any time a plaintiff suffers an injury that is consistent with the possible harm, as set out on a warning label or MSDS, associated with a potentially toxic material. In Genna the court reversed summary judgment in favor of the defendant in part because "[h]ere, like in Gass, defendant has not submitted any scientific evidence that the mold in her condominium could not have cause [sic] plaintiffs' injuries." In Gass the 6th Circuit noted "Defendants have offered no evidence to refute the MSDS's representation of Demand CS as a chemical which could have caused Plaintiffs' symptoms". The court later continued saying "[p]laintiffs are not required to produce expert testimony on causation where Defendants have failed to offer scientific evidence regarding the effects of Demand CS or Suspend SC."

The Genna court concluded, on the issue of causation, "[t]his is not a complicated case: the children were sick, the children were removed from the home, the mold was discovered, and the children recovered." Noting evidence that there was lots of mold and that mold in general had been reported to cause some of "the types of symptoms suffered by the children" the court concluded [i]t does not take an expert to conclude that, under these circumstances, defendant more likely than not is responsible for plaintiffs' injuries." (citing Gass). "Here, there was ample circumstantial evidence that would "facilitate reasonable inferences of causation, not mere speculation."

Under this view of an unannounced burden-shifting approach taken by these two courts it appears that in Michigan if a plaintiff develops ailments consistent with a those listed on a product's label or MSDS the jury is free to infer causation even in the absence of evidence of what dose produces those ailments and what dose plaintiff suffered and even in the absence of an expert to opine that the product in question caused the harm at issue.

Another explanation for these cases is that Michigan does not require toxic tort plaintiffs to show what some call specific causation - a concept common in cases in which causal inferences are derived from epidemiological evidence. The idea is that when dealing with an illness that has been associated with multiple causes, among which is the chemical at issue, the plaintiff must show that the putative cause was more likely than not the cause in fact of his illness.  Evidence for this view can be found in the following passage from Genna: "Defendant urges this Court to adopt the requirement that, in order to prove causation in a toxic tort case, a plaintiff must show both that the alleged toxin is capable of causing injuries like those suffered by the plaintiff in human beings subjected to the same exposure as the plaintiff, and that the toxin was the cause of the plaintiff's injury. They urge this Court to find that direct expert testimony be required to establish the causal link, not inferences. We decline to adopt this requirement. There is no published Michigan case law on the subject."

A final explanation is that more attention to Aristotle's Rhetoric is needed. As Chief Judge Boggs, dissenting in Gass wrote the problem here is the logical fallacy behind post hoc, ergo propter hoc causal inferences such as those suggested by the plaintiffs in Genna and Gass. "It is the fallacy of saying that because effect A happened at some point after alleged cause B, the alleged cause was the actual cause. Such logic has never been enough to survive summary judgment. See, e.g., Abbott v. Federal Forge, ("[P]ost hoc, ergo propter hoc is not a rule of legal causation.") 912 F.2d 867, 875 (6th Cir.1990).

Equally importantly Chief Judge Boggs understands that lay juries are in no position to judge whether there has been a breach of the duty of care without evidence of what levels are harmful and the levels to which plaintiffs were actually exposed. If you don't know the dose you can't know what risk, if any, the defendant imposed on the plaintiff. He wrote: "Thus presented, the question is whether the plaintiffs needed expert testimony in this case to prove how much chemical exposure is too much chemical exposure or to prove whether the amount of exposure actually caused the alleged harmful consequence. In my view, the majority pays too little attention to this issue, rushing from the fact of exposure and odd symptoms to the legal conclusion of fault." He continued: "As I understand it, these cases require expert testimony in complex, professional, or scientific-based negligence cases in order to limit the dangers associated with indulging the post hoc impulse: it is too easy to charge an uncommon harm to the presence of a mysterious substance. Properly credentialed expert testimony operates as a bulwark against such fallacious attribution of guilt. As in the Daubert context, our concern in applying these cases should be to "assure that the powerful engine of tort liability ... points towards the right substances and does not destroy the wrong ones." General Electric v. Joiner, 522 U.S. 136, 148-49, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997) (Breyer, J. concurring).

Whatever the explanation these cases will be a boon for Michigan toxic tort plaintiffs.

Don't Pitch the Water Softener

Have you been worrying that your water softener is significantly increasing your risk of dying from a heart attack? I didn't think so. But just because you haven't been feeling vulnerable around your water softener doesn't mean the WHO hasn't been fretting for you.

Thanks to epidemiological studies going back a decade or more (e.g. "Magnesium and Calcium in Drinking Water and Death from Acute Myocardial Infarction in Women") a worry arose that we were killing ourselves by eliminating the minerals naturally found in most drinking water. Yet subsequent studies have failed to confirm the finding including the just published "Effect of water hardness on cardiovascular mortality: an ecological time series approach". So what gives?

Well, what gives is that most of what gets published in peer reviewed journals is probably false; and when it comes to causal inferences drawn from epidemiological studies "the apparently indiscriminate indentification of particular aspects of daily life as dangerous to health" is, as witty programmers say, a feature, not a bug.

 

Why Read Old Journal Articles?

The New York Times has published another report by Gina Kolata on the Forty Years' War against cancer. In it you'll find part of the answer to the question I've posed.

"Dr. Barnett Kramer, associate director for disease prevention at the National Institutes of Health, recently discovered a paper that startled him. It was published in the medical journal The Lancet in 1962, about a decade before the war on cancer was announced by President Richard M. Nixon. In it, Dr. D. W. Smithers, then at Royal Marsden Hospital in London, argued that cancer was not a disease caused by a rogue cell that divides and multiplies until it destroys its host. Instead, he said, cancer may be a disorder of cellular organization.

'Cancer is no more a disease of cells than a traffic jam is a disease of cars,' Dr. Smithers wrote. 'A lifetime of study of the internal-combustion engine would not help anyone understand our traffic problems.'

Dr. Kramer said: 'I only wish I had read this paper early in my career. Here we are, 46 years later, still struggling with issues this author predicted we’d be struggling with.'"

There may be lots of science going on these days but review any journal and you'll quickly see that there's often not a lot of deep thinking behind it. Most science is derivative and most of it is false.

What people think of as science nowadays is in fact a vast jobs program, the main purpose of which, after the employment of academics, is to maintain and expand the pardigms on which its various parts rest. Accordingly, research outside the prevailing paradigms is typically starved for cash and efforts to falsify dominant theories don't just go unrewarded, often they are punished. I suspect therefore that the prayer of many if not most scientists today is, to paraphrase St. Augustine, "Lord grant me critical thinking and skepticism, but not yet."  

Reading an old journal article is one way to step back from the minutiae of microarrays and data dredging and to consider big ideas from a time when no one had the ability to sequence the genes of a malignant cell or unleash sophisticated software to find never before noticed confirmatory associations among mountains of numbers. A time when ideas were, perhaps, more likely the spark of sudden insight rather than the product of of a self-replicating system.

 

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A Surprising Number of Americans Fear the Flu Shot is Unsafe

Reuters is reporting on the results of a new poll conducted by the Harvard School of Public Health into the attitudes of Americans towards getting their children vaccinated against swine flu. Slightly more than twenty percent of the parents surveyed had decided not to immunize their children and the main reason disclosed was fear about the safety of the vaccine.

The CDC has been monitoring those who have been vaccinated and has a web page up about the safety of the vaccine, the weekly updated Vaccine Adverse Event Reporting System report and just about anything else you'd want to know about vaccines in general or this one in particular. Nevertheless, and in spite of the fact that by all measurements the vaccine appears to be safe and effective, a sizeable number of Americans fear the vaccine more than they fear a virus that has sickened millions and killed over 10,000. Why?

Part of the answer can be found in a 2002 study in which researchers compared their subjects' reactions to scientific evidence from reliable scientists that debunked a health scare versus inaccurate non-scientific emotional appeals from activists that merely raised the possibility of an adverse health effect. "The surprising result is that when we presented both positive and negative information simultaneously, the negative information clearly dominated. This was true even though the source of the negative information was identified as being a consumer advocacy group and the information itself was written in a manner that was non-scientific." The authors concluded that "even though the scientific evidence is favorable, claims by opponents, even if they are inaccurate and only suggest potential risks, will tend to reduce consumer demand". Hat tip TheGoodTheBadTheSpin

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Why Read Old Books?

"Every age has its own outlook. It is specially good at seeing certain truths and specially liable to make certain mistakes. We all, therefore, need the books that will correct the characteristic mistakes of our own period. And that means the old books. ...

We may be sure that the characteristic blindness of the twentieth century—the blindness about which posterity will ask, "But how could they have thought that?"—lies where we have never suspected it, and concerns something about which there is untroubled agreement between Hitler and President Roosevelt... None of us can fully escape this blindness, but we shall certainly increase it, and weaken our guard against it, if we read only modern books. Where they are true they will give us truths which we half knew already. Where they are false they will aggravate the error with which we are already dangerously ill. The only palliative is to keep the clean sea breeze of the centuries blowing through our minds, and this can be done only by reading old books.  Not, of course, that there is any magic about the past. People were no cleverer then than they are now; they made as many mistakes as we. But not the same mistakes. They will not flatter us in the errors we are already committing; and their own errors, being now open and palpable, will not endanger us. Two heads are better than one, not because either is infallible, but because they are unlikely to go wrong in the same direction."

- C.S. Lewis, Introduction to "Athanasius: On the Incarnation"

The question of whether we should read old books is the subject of a spirited debate over at Overcoming Bias.

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Systems. Errors.

If you've dealt with the Chemical Safety Board or the National Transportation Safety Board or any similar organization following an explosion or accident you know about their emphasis on systems and their reluctance to blame individuals for the events being investigated. Obviously, the working assumption that most errors are committed by good people trying to do the right thing has been a sound one and an emphasis on improving systems so those people can in fact do the right thing has yielded some impressive results. But you've likely asked yourself "does there ever come a point when everyone has been trained enough; when safety systems are redundant enough; when an individual needs to be held accountable rather than some unaccountable 'system'"? Apparently, at least in the case of medical errors, there does.

The New York Times is reporting on the growing concern that "a blame-free culture carries its own safety risks." When hand sanitizers are ubiquitous and training about hand sanitation is incessant, yet some doctors and nurses still fail to wash their hands something's wrong. And it's something, according to the researcher interviewed, that can't be fixed by tweaking the system. Someone has to be held accountable.

 

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Is Your Drinking Water Safe? If Not, Why Not?

The New York Times has run an extensive article about the nation's drinking water claiming that our public water is contaminated with thousands of chemicals, hundreds of which are "associated with a risk of cancer". It even has a link to the articles on which the claims are based. Unfortunately, or fortunately depending on your point of view, the evidence cited for the proposition that tap water is putting the citizenry at risk of cancer is pretty thin if that's all there is.

For example, under "Studies Regarding Illnesses and Drinking Water" (of which there are only eight) the only one to make a broad claim of tap water carcinogenesis is a 28 year old study titled "Cancer and Drinking Water in Louisiana: Colon and Rectum" which used the 1970 census to compare 692 rectal cancer deaths from 1969-1975 by where along the Mississippi River they and controls got their drinking water. The authors noted a small increase in risk as the source got closer to the Gulf of Mexico and suggested that the finding may have something to do with an increasing concentration of industries along the river as it approaches the Gulf. More importantly they wondered whether by-products of chlorination might have something to do with the finding.

The link suggests just four other papers that have cited the study and of those only two studied drinking water. Of the two, the first is a Canadian paper from 2000 (the first true Y2K victim I've ever run across - note: "Received 1999 Accepted 1900") which found no association with rectal cancer but a small one for colon cancer among males who drank "chlorinated surface water for 35-40 years".

Following the papers that cited the Canadian paper you quickly find another drinking water paper that finds a small protective effect for all leukemias combined, a large protective effect for chronic lymphocytic leukemia and a small but significant association with chronic myeloid leukemia.

The other papers are similarly all over the place and there appears to be no consensus that U.S. drinking water is a cause for concern about cancer from the perspective of chemical contaminants.

On the other hand, there's a growing body of literature associating drinking water contaminated by microorganisms with cancer. There's a new one discussing the waterborne transmission of helicobacter pylori to be published in next month's Journal of Water and Health and then there's this alarmingly titled paper in the same journal: "Free-living amoebae, Legionella and Mycobacterium in tap water supplied by a municipal drinking water utility in the USA

It's unclear why the NYTimes focused on trace levels of chemicals as a cause for concern when there does appear to be something to be worried about when it comes to bugs in our water.

Fun With Statistics

The new jobless data show that for every educational category of worker (college graduates, those with some college, high school grads and dropouts) the unemployment rate today is higher than it was at the peak of the 1982 recession. The same data show that the overall unemployment rate today is lower than it was in 1982. How can this be?

Try this example of an unnervingly common flaw that can arise when you reason from percentages alone. There are two treatments for kidney stones, Treatment A and Treatment B. Each treatment is tried out on two different types of kidney stones - small stones and large stones. Here are the results:

Treatment A   small stones - 93% effective    large stones - 73% effective

Treatment B   small stones - 87% effective   large stones - 69% effective

Which treatment do you think would be most effective overall among small and large stones? As it turns out:

Treatment B was effective 83% of the time for  either small or large stones

Treatment A was effective 78% of the time for either small or large stones

Huh? Here are the actual numbers:

Treatment A   small stones - 81 out of 87 effective       large stones 192 out of 263 effective

Treatment B   small stones - 234 out of 270 effective   large stones - 55 out of 80 effective

Thus the overall success rate for Treatment A is (81 + 192) / 350 = 78% whereas the overall success rate for Treatment B is (234 = 55) / 350 = 83%

This effect, where the results seem to switch between subcategories and overall rates is known as Simpson's Paradox. I don't think it's as much a paradox as it is a problem that arises out of an all too common problem people, including lots of expert witnesses, have with percentages - specifically, thinking of percentages as something independent of the data from which they were generated. The result of this flawed thinking is often a classic, but sometimes hard to perceive, apples to oranges comparison failure.

Here's a good discussion of the issue as it relates to the unemployment conundrum at The Wall Street Journal. For further discussion, including a take on why comparing unemployment among education categories over time is even dicier than comparing different treatments for different types of kidney stones there's another good write up at Andrew Gelman's Statistical Modeling, Causal Inference, and Social Science blog.

 

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Negotiation: Which Side Should Set The Starting Price?

According to an excellent write up of this Galinsky paper at Mind Hacks the short answer is: The side that wants to get the best deal.

The first number offered acts as an anchor. Individuals then reflexively tend to look for information that is consistent with, and so to them confirms, that the number is indeed legitimate. People tend to take the first number as a working hypothesis and so, as with any hypothesis that does not produce an immediate rejection, this first number too often induces people to recall and magnify supporting data while failing to recall or underestimating contradictory data. Is there a way to protect against this effect?

The author suggests that 1) despite the advice of many books on negotiation that recommend waiting for the other side to go first, several studies demonstrate that the buyer, or defendant, will do better by going first with a low offer; 2) when faced with a high demand the buyer (defendant) should focus on information inconsistent with the first offer; and, 3) the initial focus should be on the buyer's / defendant's ideal price by recapitulating the basis for the buyer's / defendant's valuation.

 

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Are Big Punitive Awards in HRT Cases Justified?

Law.com is reporting that Philadelphia juries have awarded a total of $103 million in punitive damages alone to two women in separate breast cancer product liability trials. The women claimed that hormone replacement therapy (HRT) was responsible for their subsequent development of breast cancer.

In light of the recent controversy over the use of Bayesian decision-making approaches to mammography and Pap testing in which probabilities of outcomes are estimated and benefits are then weighed against costs (including other bad outcomes) I thought it might be of interest to see if such an approach had been applied to HRT. Sure enough, "Bayesian Meta-analysis of Hormone Therapy and Mortality in Younger Postmenopausal Women" was just published in The American Journal of Medicine.

So what does it show? It shows that across a number of randomized controlled trials of HRT in postmenopausal women under 60 those women had a reduced overall mortality compared to those postmenopausal women under 60 who weren't on HRT.

As is often the case in these modern times science does not yield a cure but does allow one to pick one's poison as it were; not to avoid death but to influence the odds of whether you die of stroke instead of breast cancer.

A Fun Lecture About Good Decision-Making

Over at TED.com you'll find an entertaining and enlightening lecture by Dan Gilbert, a professor of psychology at Harvard University.

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And Now, New Guidelines for the Pap Test

The New York Times is reporting early this morning that a panel of the American College of Obstetricians and Gynecologists is recommending: a) that women not be tested until 21; b) that beginning at 30, and assuming three consecutive negative test results, screenings be reduced from every year to every third year; and, c) that testing can end altogether after age 65 with three straight tests without an abnormality in the last ten years.

First the PSA test, then mammograms and now Pap tests. An appreciation of the limitations of these tests, combined with the realization that many of the lesions detected by them never posed a risk, is responsible for this seismic-seeming shift. Changing a decades-long culture of screening early and often to catch cancer "when it's treatable" won't be easy and, as is apparent from the mammography fracas, won't happen without a fight.

 

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Figure the Odds

We ended yesterday's post by promising to show you how to more easily understand the debate over breast cancer screening.  Here's a handy way to calculate odds like the ones being discussed in the breast cancer debate. 

First, let's start with another test. Assume the following:

a) The accuracy rate of mammography is 95%

b) The false positive rate for mammography is only 3%

c) Only 1% of women over 50 have breast cancer

d) A woman over 50 has a positive mammogram
 
Question:  What are the odds that she actually has breast cancer?
 
Before we give you the answer let's talk a little bit about percentages.  First most people think they understand them, second they don't, and third even when they do most people tend to have a very difficult time reaching the right answer to a question like the one above.  On the other hand, people tend to do better when dealing with rates or frequencies.  So before we introduce you to Bayes' theorem (not today) let's try solving the question using rates.

If 1% of women over 50 have breast cancer that means that out of 10,000 women 100 of them will have breast cancer.  If all 10,000 women are screened by mammography and the accuracy rate is 95% then the test will detect 95 of the 100 cases.

However, if all 10,000 women are screened and the false positive rate is 3% then, of the 9,900 who don't have breast cancer, 297 (3% x 9,900) of them will have a mammogram indicating that they do have breast cancer.

The total number of positive mammograms thus equals the 95 who actually have breast cancer and whose cancers were detected plus the 297 who don't have breast cancer but who had a positive mammogram for a total of 392 possible cases of breast cancer.  So, if only 95 of the 392 women with positive mammograms actually have breast cancer what are the odds that your hypothetical patient is one of them?

Well, 95 is only 24% of 392 (95 / 392) - slightly less than a one in four chance that she actually has breast cancer.  So how did you do?

Risk is hard because it's counter-intuitive.  Comparing percentages is inevitably an apples to oranges trap.  Instead of thinking that a 95% accuracy rate is really high and 3% false positive rate is really low, maybe try asking yourself whether you'd rather have 95% of $100 or 3% of $10,000.

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Doctors and Screening Tests: Usually Wrong but Rarely in Doubt

The controversy over new breast cancer screening guidelines continues unabated today. There are already more than one thousand comments and letters to the editor addressing the issue at The New York Times alone.

Especially interesting are the statements from some of the physicians in both the articles and the comments. Many express a degree of confidence in the ability of mammograms to detect cancer well beyond what the literature would justify. How typical then is this discrepancy between medical opinion and what the numbers actually reveal? Quite.

Here's a test given to a group of obstetricians from a study published in 2006 :

There's a blood test available that can detect Down's syndrome in the fetuses of pregnant women. If the baby has Down's syndrome there's a 90% chance the test will catch it. The test has a false positive rate of only 1%. Just 1 in 100 fetuses are likely to have Down's syndrome. A pregnant woman walks into your office; she's had the blood test and it's positive for Down's syndrome. What advice do you give her about whether or not her baby actually has Down's syndrome?

Fifty seven percent of obstetricians got it wrong. Of those who got it wrong most got it spectacularly wrong, putting the odds of the baby having Down's syndrome at anywhere from 80% to 100%. And those who were most wrong were the most confident that their diagnosis was correct.

In fact the odds are (52.4%) that the woman's baby DOESN'T have Down's syndrome. Think about what advice that woman would probably get. That's a very real and chilling example of the inadvertent harm inflicted on women by doctors who put too much faith in even the most accurate diagnostic tests.

Want a handy way to figure out the odds in such cases? More on that tomorrow.

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No Mammogram Until 50? Let's Get Ready to Rumble.

Gina Kolata at The New York Times is reporting on new breast cancer screening recommendations by the United States Preventive Services Task Force. They are: a) routine mammograms for most women shouldn't begin until 50; b) even then they should occur only every two years; c) they shouldn't continue past 74; and, d) self examination is of no benefit and should be discontinued. The recommendations are based on analyses of a series of studies showing the cost (including the physical and emotional harm done to women overtreated due to false positives and unalterable cancers) of mass yearly screenings far outweighs the benefits.

That these recommendations will provoke a fight is obvious. But which side will prevail? In one corner: the probabilities and statistics. In the other: our beliefs, hopes, fears and intuitions. If this were Texas Hold 'Em we'd know which side would win. But this is breast cancer and so one side comes with all the psychological, sociological and political weight that tends to make many people poor judges of fights like this.

Expect a litany of logical fallacies, from supporters on both sides, in the comments section - chief among which, sadly, will be of the ad hominem variety. 

 

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State of the Art: Turning a Shield Into a Sword

Why is our blog subtitled "State of the Art"? For several reasons; chief among which is our fascination with the effect on mass tort litigation of our error-inducing mental shortcut responsible for what is called hindsight bias.

It turns out that mass tort defendants' claims of "I didn't know" or "I couldn't possibly have known" not only tend to fail but tend to backfire. Plaintiffs' counsel have learned how to exploit our tendency to Monday morning quarterback other peoples' decisions and now hindsight bias has become a problem in every mass tort case. Unwary defendants risk having "I couldn't possibly have known" turned into a belief that "they had to have known and thus their failure to act is evidence of gross neglect."

What is the hindsight bias? Here's an excellent introduction.

Continue Reading...
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It's A Proven Fact: Your Body Language Speaks as Loudly as Your Words

When preparing for a jury trial, lawyers are more often focused on what to say rather than how they look when they say it. A recent study on human brain function and its interpretation of the words and gestures, reminds us that the gestures you make before a jury are as equally important as the words you say.

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When Your Opponent Muddies the Water

Here’s some good advice about what to do when your opponent makes numerous arguments for ruling against your client. The short version is of course don’t take the bait because, as Perelman advises, the very act of acknowledging an argument is tantamount to telling your jurors that it’s worthy of their consideration.

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Bayesian Trials 77030

John Cook at The Endeavor posted this comment by Mithat Gönen of Memorial Sloan-Kettering Cancer Center about a recent paper concerning Bayesian clinical drug trials of chemotherapeutics.

"While there are certainly some at other centers, the bulk of applied Bayesian clinical trial design in this country is largely confined to a single zip code."

That zip code is 77030 and it’s the zip code for M.D. Anderson Cancer Center. Here’s a great article about M.D. Anderson just published in the New York Times by Gina Kolata.

Bayesian decision-making approaches are proving their worth every day in a wide variety of fields and more than a few courts are starting to grasp and apply probabilistic decision rules. Expect to see more and more Bayes decision theory as courts take an increasingly modern approach to the question of causal inference in mass tort cases.

Snatching Defeat from the Jaws of Victory

When should you poll the jury? Generally speaking, when you lose. But how about when you win? Maybe it's not such a great idea. Juries makes the point today in a post about a Washington state criminal trial in which a defendant’s attorney decided to have the jury polled after it had returned its verdict – a “not guilty” verdict. The very first juror polled by the judge stated that she did not in fact agree with the verdict and so the jury was sent back for further deliberations. Upon further review the jury came back with a unanimous verdict of “guilty” on a charge of vehicular assault. Oops.
 

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Overdiagnosis is Pure, Unadulterated Harm

That's a quote from an article in today's New York Times by Gina Kolata, the finest journalist covering medical issues out there IMHO.

It appears that the American Cancer Society is about to take a stand, at long last, on excessive screening for breast and prostate cancers. It's a practice that results in few, if any, cures of otherwise lethal cancers but which is responsible for a vast amount of unnecessary morbidity. People in whom cancers which would never spread nor even produce symptoms are, thanks to modern techniques, diagnosed with the dread disease thereafter precipitating needless surgeries and treatments, not to mention worry and stress.

This is vindication for a woman I sat next to on a plane back from Washington D.C. several years ago. She was a researcher at one of the best cancer facilities in the country and she'd gone to present evidence to Congress that screening young women for breast cancer did little if anything to arrest the course of aggressive cancers but did lots of serious and needless harm to thousands of women annually. For her troubles she was accused by some breast cancer advocates of being a lackey of the insurance companies as they thought, I presume, that the only reason anyone would oppose mass screenings would be the costs involved. It's nice to see science prevail over emotion.

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The Case of The Missing Title

A recent post on Winning Trial Advocacy Techniques entitled "Does your case have a title?" reminds us of the importance of simplifying our trial narrative and that developing a title can provide a shortcut to framing your entire case.

With a title in an instant you convey a hint of what your case is about while helping to raise an inquiring attitude among your jurors that will help them follow your examinations and arguments and understand how they fit within the framework you’ve developed.

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The Same Facts Seen From Different Perspectives

Deliberations reminds us that facts are rarely just “facts”. How facts are perceived depends very much on the perspective of the person assessing those facts so that the very same fact may drive two different people to draw two different conclusions from that fact.

Always be mindful that your perspective on how a particular fact impacts the narrative of your case may not be shared by your jurors. A billionaire isn’t just someone with a billion dollars; a billionaire is someone who has succeeded wildly or someone who has exploited the system. She’s someone to be admired, or envied or despised. Facts then, even seemingly simple numeric ones, are often laden with emotive potential and peril.

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And Now For Something Completely Different

Yesterday was the 40th anniversary of the first broadcast of Monty Python's Flying Circus. Today the NYTimes gave me a reason to boast about owning all the shows on DVD. In an article titled "How Nonsense Sharpens the Intellect" the author discusses recent research into how people make sense of the world; how they find meaning in the absurd; and, how incomplete and dissonant bits of stories caused their brains to work overtime to find patterns otherwise invisible or nonexistent. One result of the exercise was to tune up their pattern-recognizing abilities so that they thereafter performed better on tests of implicit learning: knowledge gained without awareness.

I'm not sure that this means you should work a dead parrot into your next voir dire but you should probably be aware of the tendency of jurors to fill in holes in your narrative in ways that you might find nonsensical.
 

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The Power of Metaphor

“Metaphor most brings about learning; for when he calls old age “stubble” he creates understanding and knowledge…” – Aristotle, Rhetoric.

Appreciation for the power of metaphor is ancient. Yet today tools newly available to cognitive scientists are revealing metaphors to be the underlying frame on which thought is formed. The Situationist reports on recent research in the field and concludes ”[m]etaphors aren’t just how we talk and write, they’re how we think”. And Situationist contributor John Bargh, professor at Yale, is quoted as saying “The abstract way we think is grounded in the concrete, bodily world much more than we thought.” Aristotle (and George Berkeley) must be smiling somewhere.

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It Takes a Villain

The New York Times is now reporting on the biggest risk to the water supply - nasty little microbes.

"[D]airy owners, some of whom are perceived as among the most wealthy and powerful people in town" are said by some to be behind the contamination.

Post Hoc Ergo Propter Hoc

Many millions of Americans will get sick this year. A couple of million will get very sick. Hundreds of thousands will die. It happens every year. But this year tens of millions will get the swine flu shot. Shortly thereafter some will come down with whatever it was they were going to get anyway. And many of them will blame the swine flu shot. After all, they will have been healthy, then have gotten the shot, and then have gotten sick. Obvious, and obviously wrong.

Wrong and obviously dangerous. If a vaccine health panic erupts people may be frightened into not getting vaccinated and that's the real danger. So public health officials have developed a plan to deal with the expected outbreak of bad causal analysis. You can read more about it here.

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The 411 On An Old Healh Scare Revived by Congress

Senator Tom Harkin (D-IA), the new head of the Senate Committee on Health, Education, Labor and Pensions promised on Monday to probe deeply into any potential links between cell phone use and cancer. This issue has been extensively studied, particularly in Scandinavian countries where cell phone manufacturers such as Nokia and Ericson are headquartered. Each study to date has found no statistically significant association between cell phone use and cancer, including brain cancer.

However, there are still some who attribute brain cancer to cell phones on the theory that radio waves, a form of radiation, damage brain cells. The debate comes on the heels of the 1980's and 1990's controversy regarding the potential adverse health effects of electromagnetic fields EMFs emanating from power lines. While studies cleared EMFs they implicated population mixing likely via some sub-clinical infection as a cause of cancer in children. More on population mixing to come.

How They Know What Isn't So

Today The New York Times has a very interesting article about reasoning.  It includes a discussion of what is called motivated reasoning which is "processing and responding to information defensively, accepting and seeking out confirming information, while ignoring, discrediting the source of, or arguing against the substance of contrary information". 

Here the authors of a paper linked to in The Times' article examined a particular mental shortcut, the situational heuristic, in which cues as to how to judge a contention are drawn from the nature of the actions in question.  Their hypothesis is that because going  to war is an important decision people believed there had to have been important reasons for having done so and went so far as to assume the existence of reasons that didn't exist or weren't suggested.

More evidence that the typical juror is similarly likely to believe, unless disabused of the notion, that lawsuits aren't filed unless there are strong grounds for doing so.

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Sugar Pills More Potent Than Ever

Wired has a new article about the placebo effect and evidence that placebos are becoming more increasingly more potent.

Years ago I was thinking about going to medical school and so hung on every word from a friend's father when he talked about what he did for a living. I remembered being fascinated by his stories about sugar pills and the patients to whom he prescribed them. He said that he'd learned years before that for some patients, the ones without any objective signs of treatable illness, he did his best work by being part priest and part witch doctor.

He'd listen to their stories, affirm their suffering, advise them to live better, forgive them their faults and prescribe powerful new magic - "penta-methyl-tri-something-or-another-cis-this-and-that". And it worked. He and his pharmacist friend had to be creative though as patients would compare pills and often return to demand stronger magic citing a neighbor's far milder symptoms. So they wound up having a number of different sugar pills in varying shapes and sizes. I don't recall him saying much about color other than that one lady, upon discovering that she'd been prescribed a very large red and white pill, returned to the office to say that she wasn't nearly as sick as the doctor apparently thought she was.

So what does this have to do with mass torts? Well, particularly in the realm of adverse effects from the use of psychotropic drugs, there's a huge risk of (or opportunity for) getting the causation arrow pointed in the wrong direction especially when so little is known about the causes of mental and emotional disorders and the mechanisms by which they are alleviated. After all, trial lawyers thrive in conditions of uncertainty.

An Explanation of the Trolley Problem?

At Overcoming Bias there's a post, Moral Rules Are To Check Power, that may shed some light on yesterday's trolley problem. Could it be that we judge more harshly the person who shoves the fat man under the trolley than the one who flips a switch to divert the trolley so that it kills an innocent pedestrian because the former has physical power and directed it at someone over whom he could exert that power whereas the latter, who flipped a switch that anyone can flip merely made a choice that anyone could make? If that's the case, then the context of a defendant's action, including its ability to impose its will on another, may be strictly scrutinized and mere utilitarian arguments will fall flat.

So be cognizant of the power relationships in the narratives you construct for your cases and never assume that the good things your client did will be seen to outweigh the suspicions and biases raised when the outcome at issue resulted from an exercise of that power.

Our morals may exist to contain the powerful.
 

Don't Throw Your Client Under the Trolley

When defending a client's actions it's important to remember that those actions will be judged not solely on the basis of outcome but also on the basis of your client's freedom to have varied from the choice it made, its relative power vis-a-vis the plaintiff, its intentions and, I suspect, whether any benefit accrued as a result of those actions.

Why this is so is explained, perhaps, by findings related to the so called trolley problems.  In the standard trolley problem a runaway trolley is running down the tracks and will crash and kill all five people on the trolley unless something is done.  A bystander has the option to throw a switch which, if thrown, will divert the trolley onto another track where it will run over and kill a pedestrian but save the five people on the trolley.  Various permutations of the problem involve varying the bystander's range of  choices, intentions and physical actions in diverting the trolley.  These permutations elicit, from those judging the bystander's conduct, widely differing views of her culpability though in each iteration, from a strictly utilitarian perspective, five are always saved and one is always lost if she chooses to save the five.

In their new paper "Pushing moral buttons: The interaction between personal force and intention in moral judgment" Joshua Greene, et al. examine the impact on how an action is judged when personal force is applied.  Hat tip: MarginalRevolution which has a nice discussion of the issue.  Perhaps not unsurprisingly though the outcome is the same (net four lives saved) people's judgment of the life-saving action seems to vary with the degree of force applied.
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Choose Your Words Carefully

Do people listen to an argument and then decide what they think of it or are there mechanisms in the brain which, when triggered by the use of value-laden language, prevent further consideration? 

In "Right or Wrong?  The Brain's Fast Response to Morally Objectionable Statements" the authors found that words that are inconsistent with the reader's values almost immediately caused the reader to make a judgment about the statement being made.  In fact, the readers often made sense of, or in other words judged, the statement before the sentence containing the value-laden word(s) was even completed.

The take away is that one misplaced word can destroy the best argument if it triggers a moral objection.

Will Empathize For Food

Men don't read emotions as well as women, right? Maybe not. In a study being discussed at Overcoming Bias it appears that men indeed can read emotions - they just don't - unless there's something in it for them. Hmmmmm. Here's a link to the article.
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An Epidemic of Depression?

Antidepressants are now the most commonly prescribed class of medications in the U.S. The use of antidepressants has doubled in the last decade. And the rate of use by women is double that for men. What's going on here? What's behind the increase?  Who's to blame? Is anyone to blame? Discuss.

Hat tip: http://neuroskeptic.blogspot.com/
 

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