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im-watching-youAnd they want you to stop abusing their Adverse Event Reporting System (FAERS). We’ve worked a number of cases recently where FDA warnings were used as evidence at trial and were very interested to see this article in the American Journal of Gastroenterology. And the answer to the skeptic’s question is “no”. No, we don’t accept that a medical journal, clearly an outlet for industry points of view, is blind to their own interests.

The author uses the example of the drug, Isotretinoin (also known as Accutane). The FDA and Hoffman La Roche issued warnings of a “possible causal association between isotretinoin and inflammatory bowel disease” and litigation ensued. According to the author, hundreds of lawsuits were filed and paid out substantial awards for damages due to the use of this medicine. The author lists examples of $10.5M for ulcerative colitis, $25.16M for inflammatory bowel disease, and two $9M awards for bowel disease. In 2009, “as the number of adverse events reported to the FDA and lawsuits from patients continued to grow”, La Roche recalled Accutane from the market–not because they believed it was dangerous (according to their public statements) but because generic medications were taking a large share of the market.

So, what’s the problem, you may wonder. Well. It turns out there is strong evidence Accutane doesn’t actually cause inflammatory bowel disease. There is another side to the story. The early warning system (FAERS) was used as a method to recruit Plaintiffs, who went to court and prevailed. Now evidence from a “large pharmaco-epidemiologic database” is being published that seems to exonerate Accutane.

A new French study of 7,593 patients with inflammatory bowel disease (including ulcerative colitis, Crohn’s Disease, and indeterminate colitis), and 30,372 control subjects who had been exposed to isotretinoin but had not developed the diseases has just been completed. The study concludes the use of Accutane/Isotretinoin is “not associated with increased ulcerative colitis risk but was associated with a decreased Crohn’s Disease risk”.

The author thinks the litigation system and the FDA both try to protect consumers. The litigation system works to compensate for harm caused by defective products and the FDA sets rules and enforces regulation, says the author. He believes the problem comes in when instead of operating independently, trial lawyers use warnings issued by the FDA to assign blame to specific drugs when research has not yet been done to ascertain responsibility for harm done by the specific drug. He says the FAERS was developed for hypothesis testing–not to establish blame. His solution is for pharmaceutical manufacturers to be shielded from state tort law. “By inhibiting trial lawyer misuse of science, especially the FAERS, there will be a decrease in wasteful, expensive, premature litigation.” The adverse affects are listed because they were observed to some degree in clinical trials, but a research study large enough to determine causation, as opposed to association, can’t be done until the drug is taken by much larger numbers than are typical for routine clinical trials. The FDA required the disclosure in order for the extremely profitable drug to be marketed.

So– what are Plaintiffs supposed to do? Should they wait the decade or so until a large-scale study can be done? Or should more testing be required up front prior to new medicines being released?

It is undisputed that the cost of large-scale impact testing would be prohibitively expensive and exert a huge impact on drug development and availability. And it is inevitable that drugs that cause long-term changes in metabolism and human biochemistry have impacts on organ systems that are not anticipated. If the risks were deemed significant, Hoffman could have requested a more limited indication for the drug, perhaps in cases of exceptionally severe or prolonged acne, rather than using it for routine and embarrassing conditions. What is clear, and not unexpected in a medical journal, is that the pharmaceutical industry wants to have a long litigation-free window to market and sell the product before anyone can sue for damage that might have happened during the first year it was released. I can’t blame them, but does that sound like justice?

Tenner S (2014). Editorial: Isotretinoin and inflammatory bowel disease: trial lawyer misuse of science and FDA warnings. The American Journal of Gastroenterology, 109 (4), 570-1 PMID: 24698863

Racine A, Cuerq A, Bijon A, Ricordeau P, Weill A, Allemand H, Chosidow O, Boutron-Ruault MC, & Carbonnel F (2014). Isotretinoin and risk of inflammatory bowel disease: a French nationwide study. The American Journal of Gastroenterology, 109 (4), 563-9 PMID: 24535094

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gruesome crimeJust say his brain made him do it! That is the conclusion of new research on the relationship between gruesomeness of the crime and the harshness of the sentence. In case you can’t intuit this one, the more gruesome (and disturbing) the crime, the harsher the sentence tends to be. But if the assault was merely moderately gruesome — even though it could have been deadly– there are ways to minimize punishment decisions. 

Researchers at Duke University found that “if the focus is drawn away from the mind of a perpetrator by providing biological explanations of personality instead of traits, people may not make the same social cognitive inferences”. So how did they come to that conclusion (and what does that quotation mean)?

First of all, it’s a small sample (N = 11), likely because it’s expensive and time consuming to use an MRI machine. The researchers conducted brain MRIs while the participants read a number of different vignettes about crimes either strong in violence-related disgust or weak in disgust. The idea was for the researchers to see which areas of the brain were activated while reading the vignettes (that were either disgustingly gruesome or not so much) and then to see whether the participants chose punishment less than the US Federal Sentencing Guidelines or chose the harsher recommended sentence. (We’ve written about disgust before and these researchers equate “gruesome” with “disgusting”–apparently thinking of the visceral reaction to gruesome photos or mental images elicited from written descriptions.)

Here are examples of the vignettes used:

Rob Whitley was on his lunch break. He saw his boss at the hot dog stand and approached him while taking out a pair of scissors. He stabbed his boss on the side of the neck first, and then the lower back, causing the victim serious blood loss and requiring hospitalization. (This vignette was described as high in disgust.)

John Noel was at a bar and saw his ex-girlfriend’s new lover, James. Although John was not expecting to see James there, John took out the gun he regularly carried in his back pocket and tried to shoot James, but missed. (This vignette was described as low in disgust.)

Both of these crimes (whether high or low in disgust) would be prosecutable for aggravated assault. Participants were asked to rate how morally reprehensible the act was, how severe the punishment should be, and how much they were disgusted by what they read. However, as is typical in research like this, there was another twist: The researchers added a single sentence to the end of each vignette describing the perpetrator’s personality using either personality traits or biological language. That is, “Gerald frequently proves to have an impulsive personality” versus “Terry has a gene mutation that has been associated with impulsivity” when the crime was premeditated murder.

And here is what they found:

When the perpetrator was described as having biological reasons for impulsivity (rather than as being impulsive), he was seen as being less responsible and punished less severely.

When crimes were strong in disgust, there were harsher sentences but there was no relationship between how personality was described (biological or trait description) and punishment.

Crimes weak in disgust resulted in less harsh punishment than the guidelines recommended while crimes strong in disgust were punished at the recommended level.

In other words, if the crime is pretty gruesome (and these researchers say therefore one jurors would see as disgusting) your client is likely to get the harsher sentence regardless of whether you invoke a neurolaw (his brain made him do it) sort of defense. But, if the crime isn’t gruesome and you invoke a neurolaw defense, your client may be seen as less responsible for his actions and punished less.

Ultimately, this dovetails well with what we’ve known for many years– its about what the jury focuses on. If the jury spends a lot of time talking about the crime and the injuries it caused, the defendant is in trouble. If there is a credible mediating explanation such as a neurolaw defense or other circumstantial evidence and the jury spends time talking about human behavior instead of terrifying assault, the defendant is in better shape.

Overall, it is important to remember that this is a study based on such a small sample of people (N = 11) that their results might not be verifiable, even when it makes intuitive sense. However,  it is worth remembering that according to this study, gruesomeness/disgust of the crime affects the assignment of responsibility but likely does not affect sentencing decisions.

Capestany BH, & Harris LT (2014). Disgust and biological descriptions bias logical reasoning during legal decision-making. Social Neuroscience, 9 (3), 265-277 PMID: 24571553

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paranoia-240x300Not long ago we blogged about the reality that half of Americans believe in at least one public health conspiracy. The same researchers have now looked into other conspiracy theories and found similar trends: half of Americans believe at least one conspiracy theory. So. Let’s take a look at what the researchers say about the sort of personality that lies behind the acceptance of conspiracy theories.

First, you need to have a tendency to attribute the reason behind unexplained or extraordinary events to “unseen and intentional forces”.

Second, you need to also have a tendency to be attracted to “melodramatic narratives” as explanations especially those narratives that interpret historical events as a classic struggle between good and evil. (If you want to stump your friends, this sort of duality is known as a Manichean narrative.)

This time, rather than public health conspiracy theories, the researchers examined various general and ideological conspiracy theories popular among your friends and neighbors (and perhaps even you!) as sampled by a YouGov/Polimetrix survey of 1,935 individuals in 2011. Here are the conspiracy theories they assessed (and the percentage expressing a belief in them).

The US invasion of Iraq was not part of a campaign to fight terrorism, but was driven by oil companies and Jews in the US and Israel. (This was called the “Iraq War conspiracy” and was familiar to 44% of respondents and 19% agreed.)

Certain US government officials planned the attacks of September 11, 2001 because they wanted the US to go to war in the Middle East. (“Truther conspiracy” was familiar to 67% of the respondents and 19% agreed.)

President Barack Obama was not really born in the US and does not have an authentic Hawaiian birth certificate. (“Birther conspiracy” was familiar to 94% and 24% believed it.)

The current financial crisis was secretly orchestrated by a small group of Wall Street bankers to extend the power of the Federal Reserve and further their control of the world’s economy. (“Financial Crisis conspiracy” was familiar to 46% while 25% believed it.)

Vapor trails left by aircraft are actually chemical agents deliberately sprayed in a clandestine program directed by government officials. (This was called the “Chem Trails conspiracy” was familiar to 17% of respondents although only 9% believed it.)

Billionaire George Soros is behind a hidden plot to destabilize the American government, take control of the media, and put the world under his control. (The “Soros conspiracy” was familiar to 31% and 19% believed it.)

The US government is mandating the switch to compact fluorescent light bulbs because such lights make people more obedient and easier to control. (“The CFLB conspiracy” was familiar to 17% and believed by 11%.)

Overall the researchers say that 55% of the 2011 respondents believed at least one of these theories. The most popular (at 25%) was the Financial Crisis conspiracy, followed by the Birther conspiracy, which was also followed closely by the Truther, Iraq War and Soros conspiracies. The Chem Trails conspiracy theory was far behind the other conspiracies. They do not initially mention the light bulb conspiracy but it was comparably accepted to the Chem Trail conspiracy.

Later the researchers confess to having made up that CFLB theory just to see if anyone would bite. (It’s so hard to trust those conspiracy researchers although they do confide in the reader that there actually are conspiracy theories that CFLB “lights contribute to greater fatigue or may serve as a weapon to induce mercury poisoning through a massive electromagnetic pulse”.)

They remind us that large portions of the population are drawn to the Manichean-style narrative with the struggle between good and evil and that this tendency is particularly strong in “the high proportion of Americans who believe we are living in biblical end times”. The researchers seem to believe that conspiracy theories are simply part of the American experience particularly for the many of us for whom “complicated or nuanced explanations for political events are both cognitively taxing and have limited appeal”. Conspiracy theories are more exciting and engrossing and thus, we choose, in some cases, to believe them.

From a litigation advocacy perspective, it’s a good reminder (again) of how often the message you mean to send can trigger associations to something altogether different. And if in voir dire, you make a joke about an absolutely nutty conspiracy theory, keep in mind that a good number of your jurors are going to believe it, while others will be muttering to themselves on break that they had no idea that your theory was true, and still others will think you are out of your mind. This is a variation on our general advice to avoid making jokes during trial about anything or anyone but yourself. And yet, sometimes it is just irresistible…

Oliver, J., & Wood, T. (2014). Conspiracy Theories and the Paranoid Style(s) of Mass Opinion American Journal of Political Science DOI: 10.1111/ajps.12084

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anti semiteRecently, we were doing a mock trial and came to the part of the day when jurors were discussing impressions of the witnesses. One of the female jurors mentioned a witness seemed “depressed and beat down” and that she had been surprised by his demeanor. An older white male snorted and said, “Surprised? You’ve never been to New York City. I guarantee you, one in three business men in New York City look just like him.” The woman expressed confusion, and the man expounded further, “He’s a Jew….Now I don’t mean nothin’ bad by that.” 

There was a silence in the room for a few seconds and the young Hispanic male seated next to the man speaking leaned back in his chair and looked at the observation mirror/window in disbelief. The older white male seemed a little confused by the silence in the room and then added less forcefully, “I’m not against the Jews.” The facilitator gently stated that while the mock juror may not “mean anything negative”, he was certainly voicing negative stereotypes. The juror seemed confused (mumbling his way out of the unintended disclosure and falling silent) and the facilitator moved on with the debriefing.

Sometimes people have no filter, so they say what they are thinking without realizing how offensive it might be to others in the room. Over the years, we have seen many examples of this. Another example that comes to mind today was when an older white female commented in a group also containing young African-American and Hispanic jurors that “those Mexicans will do whatever you tell them to do”. She was gently corrected by an older African-American male and no one else spoke up. But during the next break, the group of young mock jurors who were African-American and Hispanic lagged behind and when the rest had cleared the room, they burst out laughing. They all spoke at once: “Oh no she didn’t!” and “Can you believe that?” and “I just moved here from California and I cannot believe what some people here say out loud”. This was a gracious group of jurors.

More often, bias is spoken about in code and no one says exactly what they mean. One code we’ve learned here in Texas is that random references to people from “New York City” is code for some anti-Semitic sentiment. Bias, in many forms and guises, is crucial to discern. And oddly, it is at its most insidious when the bias is completely irrelevant to the facts of the case.

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Amazingly, a study published in a highly respected medical journal (as opposed to, say, a Bigfoot site) found that 49% of those living in the United States believe at least one medical conspiracy theory. That’s only where it starts–18% believe in three or more. Wow. 

The researchers wondered if US residents believe the public health conspiracies that have flourished over the past 50 years (over issues such as “water fluoridation, vaccines, cell phones and alternative medicine”). A “nationally representative, online survey sample of 1,351 adults” was gathered in 2013 by a market research company (YouGov). Here are the conspiracies about which they surveyed:

The Food and Drug Administration is deliberately preventing the public from getting natural cures for cancer and other diseases because of pressure from drug companies. [63% had heard of this theory and 37% believe it.]

Health officials know that cell phones cause cancer but are doing nothing to stop it because large corporations won’t let them. [57% had heard it and 20% believe it.]

The CIA deliberately infected large numbers of African Americans with HIV under the guise of a hepatitis inoculation program. [32% had heard it and 12% believe it.]

The global dissemination of genetically modified foods by Monsanto Inc is part of a secret program, called Agenda 21, launched by the Rockefeller and Ford Foundations to shrink the world’s population. [19% had heard it and 12% believe it.]

Doctors and the government still want to vaccinate children even though they know these vaccines cause autism and other psychological disorders. [69% had heard it and 20% believe it.]

Public water fluoridation is really just a secret way for chemical companies to dump the dangerous byproducts of phosphate mines into the environment. [25% had heard it and 12% believe it.]

Overall, 49% of the nationally representative sample endorsed 1 conspiracy theory and 18% endorsed a belief in at least 3 of the proffered theories. The authors say if you believe in either 0, 1 or 2 of these conspiracies you would be considered a “low conspiracist” and if you believe in 3 or more of these conspiracies they would consider you a “high conspiracist”. Okay. We might categorize them a little differently but certainly agree that the more conspiracy theories you agree with, the more extreme your behaviors. Right?

But these skeptical citizens don’t display extreme conspiracy-nut behaviors when you consider their beliefs about public health conspiracies. “High conspiracists”, according to this research, are simply more likely to buy farm stand or organic foods and use herbal supplements, and are less likely to use sunscreen, get flu shots or have annual checkups with a medical doctor. The authors conclude we should look at people who believe in conspiracy theories as “otherwise normal”.

“Although it is common to disparage adherents of conspiracy theories as a delusional fringe of paranoid cranks, our data suggest that medical conspiracy theories are widely known, broadly endorsed, and highly predictive of many common health behaviors. Rather than viewing medical conspiracism as indicative of a psychopathological condition, we can recognize that most individuals who endorse these narratives are otherwise ‘normal’ and that conspiracism arises from common attribution processes.”

Recently we published information on how much Americans (and Europeans for that matter) really do know about science and technology. Viewed through that lens, this report about broad-based beliefs in public health conspiracies is not surprising. But knowing that in a venire of 50 prospective jurors there are, on average, 9 (18%) who are reluctant to believe government reports or studies related to life-and-death issues needs to be considered by anyone relying on government data. Your experts may be starting out in a very deep credibility hole with a lot of your finders of facts.

Oliver JE, & Wood T (2014). Medical Conspiracy Theories and Health Behaviors in the United States. JAMA internal medicine PMID: 24638266

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