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
If you live near the Philadelphia area, and you’re into fitness or running, come out to the 5th Annual Runny Nose 5k Run and 1 Mile Walk on the morning of Sunday, June 26th, 2016, at Lorimer Park in Abington. All proceeds go to fund fitness, sign language, and music programs at a local preschool. Walk-ups are more than welcome, you can just show up after 7:30am and we’ll have forms. The race starts 8:30am. This blog is a sponsor of the race.
It’s a beautiful cross-country race through a scenic park, designed by a track coach (and recovering lawyer) who regularly races, and professionally timed by Pretzel City Sports. If you’re familiar with Lorimer Park, or you want to do a practice run, here’s what the course looks like on GPS.
This is a review from someone who ran it before:
I’d highly recommend this race as it was small, beautiful, and quite a lot of fun. I didn’t know until I got there this morning that it was a trail race. I’ve only ever done road races up until today, and I was a bit nervous. There were some pretty major hills and dips, but it all evened out. And it was such a beautiful course!
Exactly! I’ve run the course myself (and shockingly, I actually received an award in my age group!). Serious runners say it’s more interesting than most runs. Casual runners say it’s just the right kind of a challenge, and the “I work out sometimes” folks are thrilled to complete it. The event draws enough participants that nobody feels like there’s attention on them specifically, but not so many that the course feels crowded. It starts with a flat stretch that allows the runners to spread out before they hit the cross-country part.
Runners get a shirt (while supplies last) and a goody bag with the sorts of stuff that typically comes in runners’ bags. The forecast right now (with less than 24 hours to go) is 72 degrees and sunny with no chance of rain, so it should be perfect for a run.
It’s probably closer than you think; here’s Lorimer Park on Google Maps, in Southern Montgomery County, near both Northeast Philadelphia and Lower Bucks County. 30 minutes even from Center City Philadelphia or from Conshohocken. Easy.
Registration starts at 7:30 am, the 5K starts promptly at 8:30 am, and the awards and will happen around 9:30 am.
Below are two pictures from a prior year, unretouched. The race was then run in March, so the trees have leaves now.
He had a whole battery of tests just a couple months ago. He couldn’t eat well and his legs ached. He had nearly every doctor at Emory look at him. They ended up prescribing him Vitamin A and Vitamin D. After all that. He got the full work over and really just needed vitamins. If a 28 year old heart is going to go out, shouldn’t they have found that? Maybe, but they didn’t.
Indeed. It’s a tragic death that raises many questions.
Most of time, when grieving families contact me, they’re not looking to file a lawsuit, they’re looking for answers. Doctors and hospitals rarely tell family members much about the circumstances, or about what could have been done differently, and so those family members start looking for answers. I made it my policy long ago that, even if I didn’t believe a lawsuit was warranted or would be successful, I would try to explain to everyone who contacts me about a medical malpractice case what actually happened and if something could have been done differently.
From the information Jeremy’s family has provided publicly, we can start to figure out what might have gone wrong. The coroner hasn’t determined the cause of death yet, and apparently is not going to conduct an autopsy, but the circumstances strongly suggest a heart attack.
Jeremy was only 28-years-old. Coronary heart disease is rare in individuals younger than 40, but it’s not unheard of. In the famous Framingham Study, acute myocardial infarction occurred in men 30 to 34 years old at a rate of 12.9 per 1,000. One of the few studies to look at risk factors for coronary heart disease in men under 40 found that the risk factors were roughly the same as for older men, i.e., “age, serum cholesterol level, systolic blood pressure, and cigarette smoking.” Continue reading
Big Pharma is trying to ram two sweeping overhauls through Congress, the “21st Century Cures Act” and the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act.” (The latter is so obnoxiously named that it is typically referred to as the Cruz-Lee proposal.) Both of these bills include good provisions, like increasing funding for the National Institutes of Health and allowing the Food and Drug Administration more flexibility to review drug approvals in other countries. However, the bills also include truly terrible provisions, like instructing the FDA to abandon the use of clinical trials and giving Congress the power to approve drugs on its own.
In favor of the bills, there’s economist Alex Tabarrok, who argues there’s an “invisible graveyard” of patients whose lives could have been saved by drugs that were not yet approved. In opposition, there’s medical school professor Dr. Aaron Kesselheim, who argues there’s no evidence the FDA has blocked innovation that actually helps patients.
Tabarrok calls that “laughable” and “magical thinking,” apparently unlike his “invisible graveyard.” He lays down a challenge: “We live in a world of tradeoffs. Let’s debate the tradeoffs.”
Let’s start with some basic facts: Continue reading