“Evidence-based medical treatment guidelines” sounds like such a good idea. Who would want medical treatment that wasn’t based on evidence?
The problem is in the details. Way back in 1996, when “evidence-based medicine” was coming to the fore, the originators of the concept went out of their way to say “evidence-based medicine is not cookbook medicine,” and that it can “never replace individual clinical expertise and it is this expertise that decides whether the external evidence applies to the individual patient at all, and if so, how it should be integrated in a clinical decision.”
Fast-forward twenty years, and now the Pennsylvania General Assembly is considering whether to use evidence-based medicine as the sort of “cookbook medicine” it was never meant to be. Continue reading
Over at The Green Bag, Judge Richard Posner published “What Is Obviously Wrong With the Federal Judiciary, Yet Eminently Curable, Part I.” The article is quintessential Posner: concise, expansive, forceful, and packed with good and bad ideas with minimal supporting citations.
As a parent, this is another story that is impossible to comprehend: A 7-year-old girl is now dead after the bouncy castle she was playing on blew away at an Easter fair in Essex, England.
It is believed the castle was swept away by a gust of wind. The girl, Summer Grant, was taken to a local hospital and died of multiple injuries several hours later. A 24-year-old woman and a 27-year-old man have been arrested on suspicion of manslaughter by gross negligence, according to the Essex police on its Facebook page.
It’s of course tragic, but it’s not “impossible to comprehend.” Back in 2012, the medical journal Pediatrics published a study, “Pediatric Inflatable Bouncer–Related Injuries in the United States, 1990–2010,” which concluded:
From 1995 to 2010, there was a statistically significant 15-fold increase in the number and rate of these injuries, with an average annual rate of 5.28 injuries per 100 000 US children (95% CI: 2.62–7.95). The increase was more rapid during recent years, with the annual injury number and rate more than doubling between 2008 and 2010. In 2010, a total of 31 children per day were treated in US EDs for an inflatable bouncer–related injury, which equals a child every 46 minutes nationally.
It’s not incomprehensible when an inflatable amusement floats away in a gust of wind. It’s preventable.
And that’s the essence of my job: figuring out–after the fact–if an accident was preventable. You can imagine how risk averse I am as a result.
However, just because I’m a trial lawyer doesn’t mean that my kids can’t have fun. It just means that I strive to be reasonable, but sometimes “reason” has to almost hit me on the head. Continue reading
Back in July 2014, I wrote a post about the misuse of “statistical significance” by defendants and courts trying to apply the Daubert standard to scientific evidence. As I wrote,
It’s true that researchers typically use statistical formulas to calculate a “95% confidence interval” — or, as they say in the jargon of statistics, “p < 0.05” — but this isn’t really a scientifically-derived standard. There’s no natural law or empirical evidence which tells us that “95%” is the right number to pick to call something “statistically significant.” The number “1 in 20” was pulled out of thin air decades ago by the statistician and biologist Ronald Fisher as part of his “combined probability test.” Fisher was a brilliant scientist, but he was also a eugenicist and an inveterate pipe-smoker who refused to believe that smoking causes cancer. Never underestimate the human factor in the practice of statistics and epidemiology.
(Links omitted; they’re still in the original post.) As expected, defense lawyers criticized my post.
Last week, the American Statistical Association published its very first “policy statement” on “a specific matter of statistical practice,” making clear that tossing around the term “statistical significance” is a “considerable distortion of the scientific process:”
Practices that reduce data analysis or scientific inference to mechanical “bright-line” rules (such as “p < 0.05”) for justifying scientific claims or conclusions can lead to erroneous beliefs and poor decision-making. A conclusion does not immediately become “true” on one side of the divide and “false” on the other. Researchers should bring many contextual factors into play to derive scientific inferences, including the design of a study, the quality of the measurements, the external evidence for the phenomenon under study, and the validity of assumptions that underlie the data analysis. Pragmatic considerations often require binary, “yes-no” decisions, but this does not mean that p-values alone can ensure that a decision is correct or incorrect. The widespread use of “statistical significance” (generally interpreted as “p ≤ 0.05”) as a license for making a claim of a scientific finding (or implied truth) leads to considerable distortion of the scientific process.
Hallelujah! Continue reading
At the invitation of the George Mason University’s Law & Economics Center, I recently went to Washington D.C. to debate Ana Reyes of Williams & Connolly on the subject of preemption in drug injury lawsuits. The video is available here.
I stated many facts during the discussion, and below are my sources for them. Continue reading
The science media has blown up recently over Sci-Hub, dubbed “the Pirate Bay of the science world.” Here’s a BigThink article, a ScienceAlert article, and an Atlantic article. Sci-Hub is, to put it mildly, the greatest open repository of scientific papers in the history of the world. There’s just a small problem: those papers are almost all copyrighted, and the whole purpose of Sci-Hub is to circumvent paying the copyright holder.
Unsurprisingly, Elsevier, the juggernaut scientific journal publisher, has sued the proprietor of Sci-Hub, neuroscientist Alexandra Elbakyan, for running the database. Elsevier says in their complaint that they host “almost one-quarter of the world’s peer-reviewed, full-text scientific, technical and medical content,” amounting to “over 10 million copyrighted publications.” As they brag, “[m]ore than 15 million researchers, health care professionals, teachers, students, and information professionals around the globe rely on ScienceDirect as a trusted source of nearly 2,500 journals and more than 26,000 book titles” — all of whom have to pay for access, typically $35 per article.
In case you’re wondering: the actual authors of the articles don’t receive a dime of that income. Elsevier owns the copyright to those articles. Elsevier thus doesn’t create anything, they’re just the middleman between those 15 million “researchers, health care professionals, teachers, students, and information professionals” and the accumulated knowledge they need to do their jobs. Even Harvard found it difficult to stomach the huge fees charged by Elsevier. Perhaps even more frustrating, many of those papers sitting behind a paywall were funded by U.S. taxpayers through National Institutes of Health grants, but the NIH’s public access policy doesn’t require public access until “no later than 12 months after the official date of publication.” That’s fine for the casual reader, but for researchers in the field, it means they’re paywalled off from the latest scientific information. Continue reading
This morning, MedPage Today — which should know better — began their “Morning Break” with this description and link:
An analysis of closed claim data from The Doctors Company suggests that physicians spend about 10% of their professional life dealing with malpractice claims, but most of those claims are closed with no money paid to the plaintiff.
Goodness! That sounds incredible. Turns out, it is incredible. In fact, it’s false.
The linked post by “The Doctors Company” at The Doctor Weighs In says:
The average physician spends over 10 percent of his or her career consumed in defense of an open malpractice claim. For the average neurosurgeon, that number is 25%—that’s a quarter of a career dealing with the intense emotional stress of defending your reputation and livelihood.
And the majority of those claims close with no payment to the plaintiff. That means the average U.S. physician in every specialty spends a significant portion of his or her career in court defending malpractice claims, but the overwhelming majority of those claims are found to be at best fruitless, and at worst frivolous.
These numbers come from a RAND Corporation objective analysis of the claims database of The Doctors Company, the nation’s largest physician-owned medical malpractice insurer. According to Richard E. Anderson, MD, FACP, chairman and CEO of The Doctors Company, these numbers show that our medical malpractice litigation system is broken—and must be fixed.
The only support given for any of these assertions is this YouTube video, where Dr. Anderson makes the same claims.
But there’s a problem: the RAND Corporation’s “objective analysis” never said anything like that. Continue reading
[Update: The Hamilton County Democratic Party executive committee wisely voted against censuring Ben Lindy. Apparently Lindy was asked, “Why did the story end up in the Washington Post?” That’s easy: the best way to ‘go viral’ is to do something really stupid.]
Ben Lindy is the kind of person we all hope goes into politics: he grew up in Cincinnati, went straight from Cincinnati public school to Yale, then taught through Teach for America, then worked in the DC Public Schools system, then went to Yale Law, and then returned to Ohio to establish Teach for America’s office in Cincinnati. Now he’s running for state representative back in his hometown.
I met Ben Lindy during our first week at Yale. He’s the nicest and most trustworthy person I know. If you meet him, he’ll be the nicest and most trustworthy person you know. It doesn’t surprise me that, though an “upstart” candidate who wasn’t backed by the party, he’s now surging into the lead for the 31st District of Ohio. He’s a great guy who has committed himself to education, which I shouldn’t have to tell you is the first step in building a better world for our children. If our state capitols were filled with people like Ben, we’d have balanced budgets, flying cars, and kindergartners doing calculus (or as close to these things as we can get).
But now there’s a “controversy” surrounding him. It seems the Hamilton County Democratic Party establishment favors someone else — why would they do that is a good question that needs to be asked — and so they dug deep into Ben’s past to find the absolute worst thing about him they could find, a skeleton in his closet to knock him out of the race. Continue reading
[Update, January 20, 2016: The Montgomery County District Attorney’s Office filed its response, laying out how Cosby’s claimed “non-prosecution agreement” is really a grant of immunity, which is only available by a specific statutory process that was not even arguably followed here. Intriguingly, they also include correspondence between the prior District Attorney (Risa Vetri Ferman) and Bruce Castor, in which Ferman bluntly said she had never heard of this agreement and asked Castor to provide every document he had reflecting the agreement. Castor pointed only to that same press release which says nothing about immunity.]
[Update, January 28, 2016: Billy Penn has a story on the issue. I disagree that Judge Steven O’Neill would be required to find Castor’s testimony incredible in order to find the “agreement” unenforceable. Rather, I think Jeffrey Lindy has it right:
“Every DA is different,” said Jeffrey Lindy, a Philadelphia defense attorney and former prosecutor. “I’ve never heard of oral immunity. What I have heard of is a nod and a wink.” … Lindy said it’s possible Castor didn’t want a record of the deal and Phillips, who was “very old fashioned,” agreed to the oral deal because it might have been the best he was going to get.
Exactly. The best Cosby could get from Castor was “a nod and a wink.” That’s not the same thing as an enforceable immunity agreement.]
Last week, Bill Cosby filed a “petition for writ of habeas corpus” which argued:
The charges violate an express agreement made by the Montgomery County District Attorney in 2005, in which the Commonwealth agreed that Mr. Cosby would never be prosecuted with respect to the allegations of sexual assault made by complainant Andrea Constand This agreement was made for the express purpose of inducing Mr. Cosby to testify fully in Ms. Constand’s civil litigation against him. In reliance on that agreement, Mr. Cosby testified in 2006 without indication of his constitutional rights against self-incrimination.
It would sure be helpful to see a copy of that agreement, but it turns out there is no written agreement at all. Rather, the “agreement” was a conversation between Cosby’s lawyer and the District Attorney, a conversation that neither Cosby’s lawyer nor the District Attorney documented at the time. Cosby’s petition says, “Although Mr. Cosby’s then-counsel is since deceased, then-District Attorney Bruce Castor has confirmed he entered into this agreement on behalf of the Commonwealth. Mr. Cosby is prepared to offer Mr. Castor’s testimony at an evidentiary hearing on this petition.”
As a reminder, last fall Bruce Castor lost his electoral battle against Kevin Steele for the office, after which Steele initiated the prosecution against Cosby. So it seems the fate of the new District Attorney’s biggest case may hinge upon the testimony of his opponent in the election. There are few worse places to take a political feud than to the middle of a criminal trial, but it seems that’s just what will happen here.
Wait, it gets better. Continue reading
I’ve written about transvaginal mesh so many times I feel like a broken record. But it’s still an issue affecting tens of thousands of families and will continue to be an issue as long as that infernal implant keeps being sold and the manufacturers keep refusing to do right by the families that have already been hurt by them.
Yesterday, the FDA announced:
The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
On the surface, this is quite a victory, and it may mean the end for many of these implants.The requirements for a “class III” premarket approval device are far stricter than those for the “class II” medical devices.
As I wrote several years ago, that “class II” status was a big reason why the transvaginal mesh health debacle happened in the first place:
Highly similar surgical meshes have been used by surgeons to repair hernias and other abdominal issues, and so the FDA allowed the use of those meshes for pelvic repairs, including when implanted into the vaginal wall, without first requiring controlled human studies. This loophole — called the “510(k) clearance” — has been sharply criticized by the Institute of Medicine, which has recommended eliminating the “510 (k) clearance” program entirely. Those studies would have likely revealed the problem before the surgical meshes were implanted in over 70,000 pelvic and vaginal wall procedures a year.
With the “class II” status gone, the mesh manufacturers can no longer use that loophole. But the FDA left open a pretty big loophole themselves, as revealed in the FDA’s discussion of the orders in the Federal Register, which includes this: Continue reading