Roger L. Berger
School Director & Professor
School of Mathematical & Natural Science
Arizona State University
Comment on S. Senn’s post: “Blood Simple? The complicated and controversial world of bioequivalence”(*)
First, I do agree with Senn’s statement that “the FDA requires conventional placebo-controlled trials of a new treatment to be tested at the 5% level two-sided but since they would never accept a treatment that was worse than placebo the regulator’s risk is 2.5% not 5%.” The FDA procedure essentially defines a one-sided test with Type I error probability (size) of .025. Why it is not just called this, I do not know. And if the regulators believe .025 is the appropriate Type I error probability, then perhaps it should be used in other situations, e.g., bioequivalence testing, as well.
Senn refers to a paper by Hsu and me (Berger and Hsu (1996)), and then attempts to characterize what we said. Unfortunately, I believe he has mischaracterized. Continue reading
Head, Methodology and Statistics Group
Competence Center for Methodology and Statistics (CCMS)
Responder despondency: myths of personalized medicine
The road to drug development destruction is paved with good intentions. The 2013 FDA report, Paving the Way for Personalized Medicine has an encouraging and enthusiastic foreword from Commissioner Hamburg and plenty of extremely interesting examples stretching back decades. Given what the report shows can be achieved on occasion, given the enthusiasm of the FDA and its commissioner, given the amazing progress in genetics emerging from the labs, a golden future of personalized medicine surely awaits us. It would be churlish to spoil the party by sounding a note of caution but I have never shirked being churlish and that is exactly what I am going to do. Continue reading
Since the comments to my previous post are getting too long, I’m reblogging it here to make more room. I say that the issue raised by J. Berger and Sellke (1987) and Casella and R. Berger (1987) concerns evaluating the evidence in relation to a given hypothesis (using error probabilities). Given the information that this hypothesis H* was randomly selected from an urn with 99% true hypothesis, we wouldn’t say this gives a great deal of evidence for the truth of H*, nor suppose that H* had thereby been well-tested. (H* might concern the existence of a standard model-like Higgs.) I think the issues about “science-wise error rates” and long-run performance in dichotomous, diagnostic screening should be taken up separately, but commentators can continue on this, if they wish (perhaps see this related post). Continue reading
0. July 20, 2014: Some of the comments to this post reveal that using the word “fallacy” in my original title might have encouraged running together the current issue with the fallacy of transposing the conditional. Please see a newly added Section 7.
1. What you should ask…
Discussions of P-values in the Higgs discovery invariably recapitulate many of the familiar criticisms of P-values (some “howlers”, some not). When you hear the familiar refrain, “We all know that P-values overstate the evidence against the null hypothesis”, denying the P-value aptly measures evidence, what you should ask is:
“What do you mean by overstating the evidence against a hypothesis?”
I’m reblogging a few of the Higgs posts, with some updated remarks, on this two-year anniversary of the discovery. (The first was in my last post.) The following, was originally “Higgs Analysis and Statistical Flukes: part 2″ (from March, 2013).
Some people say to me: “This kind of reasoning is fine for a ‘sexy science’ like high energy physics (HEP)”–as if their statistical inferences are radically different. But I maintain that this is the mode by which data are used in “uncertain” reasoning across the entire landscape of science and day-to-day learning (at least, when we’re trying to find things out) Even with high level theories, the particular problems of learning from data are tackled piecemeal, in local inferences that afford error control. Granted, this statistical philosophy differs importantly from those that view the task as assigning comparative (or absolute) degrees-of-support/belief/plausibility to propositions, models, or theories. Continue reading
July 4, 2014 was the two year anniversary of the Higgs boson discovery. As the world was celebrating the “5 sigma!” announcement, and we were reading about the statistical aspects of this major accomplishment, I was aghast to be emailed a letter, purportedly instigated by Bayesian Dennis Lindley, through Tony O’Hagan (to the ISBA). Lindley, according to this letter, wanted to know:
“Are the particle physics community completely wedded to frequentist analysis? If so, has anyone tried to explain what bad science that is?”
Fairly sure it was a joke, I posted it on my “Rejected Posts” blog for a bit until it checked out . (See O’Hagan’s “Digest and Discussion”) Continue reading
There are some ironic twists in the way social psychology is dealing with its “replication crisis”, and they may well threaten even the most sincere efforts to put the field on firmer scientific footing–precisely in those areas that evoked the call for a “daisy chain” of replications. Two articles, one from the Guardian (June 14), and a second from The Chronicle of Higher Education (June 23) lay out the sources of what some are calling “Repligate”. The Guardian article is “Physics Envy: Do ‘hard’ sciences hold the solution to the replication crisis in psychology?”
The article in the Chronicle of Higher Education also gets credit for its title: “Replication Crisis in Psychology Research Turns Ugly and Odd”. I’ll likely write this in installments…(2nd, 3rd , 4th)
The Guardian article answers yes to the question “Do ‘hard’ sciences hold the solution…“:
Psychology is evolving faster than ever. For decades now, many areas in psychology have relied on what academics call “questionable research practices” – a comfortable euphemism for types of malpractice that distort science but which fall short of the blackest of frauds, fabricating data.
Sir David Hendry, Professor of Economics at the University of Oxford , was given the Celebrating Impact Lifetime Achievement Award on June 8, 2014. Professor Hendry presented his automatic model selection program (Autometrics) at our conference, Statistical Science and Philosophy of Science (June, 2010) (Site is here.) I’m posting an interesting video and related links. I invite comments on the paper Hendry published, “Empirical Economic Model Discovery and Theory Evaluation,” in our special volume of Rationality, Markets, and Morals (abstract below). 
One of the world’s leading economists, INET Oxford’s Prof. Sir David Hendry received a unique award from the Economic and Social Research Council (ESRC)…
“Wonderful examples, but let’s not close our eyes,” is David J. Hand’s apt title for his discussion of the recent special issue (Feb 2014) of Statistical Science called “Big Bayes Stories” (edited by Sharon McGrayne, Kerrie Mengersen and Christian Robert.) For your Saturday night/ weekend reading, here are excerpts from Hand, another discussant (Welsh), scattered remarks of mine, along with links to papers and background. I begin with David Hand:
[The papers in this collection] give examples of problems which are well-suited to being tackled using such methods, but one must not lose sight of the merits of having multiple different strategies and tools in one’s inferential armory.(Hand )_
…. But I have to ask, is the emphasis on ‘Bayesian’ necessary? That is, do we need further demonstrations aimed at promoting the merits of Bayesian methods? … The examples in this special issue were selected, firstly by the authors, who decided what to write about, and then, secondly, by the editors, in deciding the extent to which the articles conformed to their desiderata of being Bayesian success stories: that they ‘present actual data processing stories where a non-Bayesian solution would have failed or produced sub-optimal results.’ In a way I think this is unfortunate. I am certainly convinced of the power of Bayesian inference for tackling many problems, but the generality and power of the method is not really demonstrated by a collection specifically selected on the grounds that this approach works and others fail. To take just one example, choosing problems which would be difficult to attack using the Neyman-Pearson hypothesis testing strategy would not be a convincing demonstration of a weakness of that approach if those problems lay outside the class that that approach was designed to attack.
Hand goes on to make a philosophical assumption that might well be questioned by Bayesians: Continue reading
score years ago (!) we held the conference “Statistical Science and Philosophy of Science: Where Do (Should) They meet?” at the London School of Economics, Center for the Philosophy of Natural and Social Science, CPNSS, where I’m visiting professor  Many of the discussions on this blog grew out of contributions from the conference, and conversations initiated soon after. The conference site is here; my paper on the general question is here.
My main contribution was “Statistical Science Meets Philosophy of Science Part 2: Shallow versus Deep Explorations” SS & POS 2. It begins like this:
1. Comedy Hour at the Bayesian Retreat
Overheard at the comedy hour at the Bayesian retreat: Did you hear the one about the frequentist… Continue reading
Wilson E. Schmidt Professor of Economics
Department of Economics, Virginia Tech
Recurring controversies about P values and conﬁdence intervals revisited*
Ecological Society of America (ESA) ECOLOGY
Forum—P Values and Model Selection (pp. 609-654)
Volume 95, Issue 3 (March 2014): pp. 645-651
The use, abuse, interpretations and reinterpretations of the notion of a P value has been a hot topic of controversy since the 1950s in statistics and several applied ﬁelds, including psychology, sociology, ecology, medicine, and economics.
The initial controversy between Fisher’s signiﬁcance testing and the Neyman and Pearson (N-P; 1933) hypothesis testing concerned the extent to which the pre-data Type I error probability α can address the arbitrariness and potential abuse of Fisher’s post-data threshold for the P value. Continue reading
“The medical press must become irrelevant to publication of clinical trials.” So said Stephen Senn at a recent meeting of the Medical Journalists’ Association with the title: “Is the current system of publishing clinical trials fit for purpose?” Senn has thrown a few stones in the direction of medical journals in guest posts on this blog, and in this paper, but it’s the first I heard him go this far. He wasn’t the only one answering the conference question “No!” much to the surprise of medical journalist Jane Feinmann, whose article I am excerpting:
So what happened? Medical journals, the main vehicles for publishing clinical trials today, are after all the ‘gatekeepers of medical evidence’—as they are described in Bad Pharma, Ben Goldacre’s 2012 bestseller. …
… The Alltrials campaign, launched two years ago on the back of Goldacre’s book, has attracted an extraordinary level of support. … Continue reading
The complicated and controversial world of bioequivalence
by Stephen Senn*
Those not familiar with drug development might suppose that showing that a new pharmaceutical formulation (say a generic drug) is equivalent to a formulation that has a licence (say a brand name drug) ought to be simple. However, it can often turn out to be bafflingly difficult. Continue reading
Over 100 patients signed up for the chance to participate in the clinical trials at Duke (2007-10) that promised a custom-tailored cancer treatment spewed out by a cutting-edge prediction model developed by Anil Potti, Joseph Nevins and their team at Duke. Their model purported to predict your probable response to one or another chemotherapy based on microarray analyses of various tumors. While they are now described as “false pioneers” of personalized cancer treatments, it’s not clear what has been learned from the fireworks surrounding the Potti episode overall. Most of the popular focus has been on glaring typographical and data processing errors—at least that’s what I mainly heard about until recently. Although they were quite crucial to the science in this case,(surely more so than Potti’s CV padding) what interests me now are the general methodological and logical concerns that rarely make it into the popular press. Continue reading
27 May 1923- 1 July 1976
Today is Allan Birnbaum’s Birthday. Birnbaum’s (1962) classic “On the Foundations of Statistical Inference” is in Breakthroughs in Statistics (volume I 1993). I’ve a hunch that Birnbaum would have liked my rejoinder to discussants of my forthcoming paper (Statistical Science): Bjornstad, Dawid, Evans, Fraser, Hannig, and Martin and Liu. I hadn’t realized until recently that all of this is up under “future papers” here . You can find the rejoinder: STS1404-004RA0-2. That takes away some of the surprise of having it all come out at once (and in final form). For those unfamiliar with the argument, at the end of this entry are slides from a recent, entirely informal, talk that I never posted, as well as some links from this blog. Happy Birthday Birnbaum! Continue reading
BLOG Contents: March and April 2014
Compiled by Jean Miller and Nicole Jinn
(3/1) Cosma Shalizi gets tenure (at last!) (metastat announcement)
(3/2) Significance tests and frequentist principles of evidence: Phil6334 Day #6
(3/3) Capitalizing on Chance (ii)
(3/4) Power, power everywhere–(it) may not be what you think! [illustration]
(3/8) Msc kvetch: You are fully dressed (even under you clothes)? Continue reading
Here are the slides from my presentation (May 17) at the Scientism workshop in NYC. (They’re sketchy since we were trying for 25-30 minutes.) Below them are some mini notes on some of the talks.
Now for my informal notes. Here’s a link to the Speaker abstracts;the presentations may now be found at the conference site here. Comments, questions, and corrections are welcome. Continue reading
At the start of our seminar, I said that “on weekends this spring (in connection with Phil 6334, but not limited to seminar participants) I will post some of my ‘deconstructions‘ of articles”. I began with Andrew Gelman‘s note “Ethics and the statistical use of prior information”[i], but never posted my deconstruction of it. So since it’s Saturday night, and the seminar is just ending, here it is, along with related links to Stat and ESP research (including me, Jack Good, Persi Diaconis and Pat Suppes). Please share comments especially in relation to current day ESP research. Continue reading