TORTINI

For your delectation and delight, desultory dicta on the law of delicts.

April Fool – Zambelli-Weiner Must Disclose

April 2nd, 2020

Back in the summer of 2019, Judge Saylor, the MDL judge presiding over the Zofran birth defect cases, ordered epidemiologist, Dr. Zambelli-Weiner to produce documents relating to an epidemiologic study of Zofran,[1] as well as her claimed confidential consulting relationship with plaintiffs’ counsel.[2]

This previous round of motion practice and discovery established that Zambelli-Weiner was a paid consultant in advance of litigation, that her Zofran study was funded by plaintiffs’ counsel, and that she presented at a Las Vegas conference, for plaintiffs’ counsel only, on [sic] how to make mass torts perfect. Furthermore, she had made false statements to the court about her activities.[3]

Zambelli-Weiner ultimately responded to the discovery requests but she and plaintiffs’ counsel withheld several documents as confidential, pursuant to the MDL’s procedure for protective orders. Yesterday, April 1, 2020, Judge Saylor entered granted GlaxoSmithKline’s motion to de-designate four documents that plaintiffs claimed to be confidential.[4]

Zambelli-Weiner sought to resist GSK’s motion to compel disclosure of the documents on a claim that GSK was seeking the documents to advance its own litigation strategy. Judge Saylor acknowledged that Zambelli-Weiner’s psycho-analysis might be correct, but that GSK’s motive was not the critical issue. According to Judge Saylor, the proper inquiry was whether the claim of confidentiality was proper in the first place, and whether removing the cloak of secrecy was appropriate under the facts and circumstances of the case. Indeed, the court found “persuasive public-interest reasons” to support disclosure, including providing the FDA and the EMA a complete, unvarnished view of Zambelli-Weiner’s research.[5] Of course, the plaintiffs’ counsel, in close concert with Zambelli-Weiner, had created GSK’s need for the documents.

This discovery battle has no doubt been fought because plaintiffs and their testifying expert witnesses rely heavily upon the Zambelli-Weiner study to support their claim that Zofran causes birth defects. The present issue is whether four of the documents produced by Dr. Zambelli-Weiner pursuant to subpoena should continue to enjoy confidential status under the court’s protective order. GSK argued that the documents were never properly designated as confidential, and alternatively, the court should de-designate the documents because, among other things, the documents would disclose information important to medical researchers and regulators.

Judge Saylor’s Order considered GSK’s objections to plaintiffs’ and Zambelli-Weiner’s withholding four documents:

(1) Zambelli-Weiner’s Zofran study protocol;

(2) Undisclosed, hidden analyses that compared birth defects rates for children born to mothers who used Zofran with the rates seen with the use of other anti-emetic medications;

(3) An earlier draft Zambelli-Weiner’s Zofran study, which she had prepared to submit to the New England Journal of Medicine; and

(4) Zambelli-Weiner’s advocacy document, a “Causation Briefing Document,” which she prepared for plaintiffs’ lawyers.

Judge Saylor noted that none of the withheld documents would typically be viewed as confidential. None contained “sensitive personal, financial, or medical information.”[6]  The court dismissed Zambelli-Weiner’s contention that the documents all contained “business and proprietary information,” as conclusory and meritless. Neither she nor plaintiffs’ counsel explained how the requested documents implicated proprietary information when Zambelli-Weiner’s only business at issue is to assist in making lawsuits. The court observed that she is not “engaged in the business of conducting research to develop a pharmaceutical drug or other proprietary medical product or device,” and is related solely to her paid consultancy to plaintiffs’ lawyers. Neither she nor the plaintiffs’ lawyers showed how public disclosure would hurt her proprietary or business interests. Of course, if Zambelli-Weiner had been dishonest in carrying out the Zofran study, as reflected in study deviations from its protocol, her professional credibility and her business of conducting such studies might well suffer. Zambelli-Weiner, however, was not prepared to affirm the antecedent of that hypothetical. In any event, the court found that whatever right Zambelli-Weiner might have enjoyed to avoid discovery evaporated with her previous dishonest representations to the MDL court.[7]

The Zofran Study Protocol

GSK sought production of the Zofran study protocol, which in theory contained the research plan for the Zofran study and the analyses the researchers intended to conduct. Zambelli-Weiner attempted to resist production on the specious theory that she had not published the protocol, but the court found this “non-publication” irrelevant to the claim of confidentiality. Most professional organizations, such as the International Society of Pharmacoepidemiology (“ISPE”), which ultimately published Zambelli-Weiner’s study, encourage the publication and sharing of study protocols.[8] Disclosure of protocols helps ensure the integrity of studies by allowing readers to assess whether the researchers have adhered to their study plan, or have engaged in ad hoc data dredging in search for a desired result.[9]

The Secret, Undisclosed Analyses

Perhaps even more egregious than withholding the study protocol was the refusal to disclose unpublished analyses comparing the rate of birth defects among children born to mothers who used Zofran with the birth defect rates of children with in utero exposure to other anti-emetic medications.  In ruling that Zambelli-Weiner must produce the unpublished analyses, the court expressed its skepticism over whether these analyses could ever have been confidential. Under ISPE guidelines, researchers must report findings that significantly affect public health, and the relative safety of Zofran is essential to its evaluation by regulators and prescribing physicians.

Not only was Zambelli-Weiner’s failure to include these analyses in her published article ethically problematic, but she apparently hid these analyses from the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency, which specifically inquired of Zambelli-Weiner whether she had performed such analyses. As a result, the PRAC recommended a label change based upon Zambelli-Weiner’s failure to disclosure material information. Furthermore, the plaintiffs’ counsel represented they intended to oppose GSK’s citizen petition to the FDA, based upon the Zambelli-Weiner study. The apparently fraudulent non-disclosure of relevant analyses could not have been more fraught for public health significance. The MDL court found that the public health need trumped any (doubtful) claim to confidentiality.[10] Against the obvious public interest, Zambelli-Weiner offered no “compelling countervailing interest” in keeping her secret analyses confidential.

There were other aspects to the data-dredging rationale not discussed in the court’s order. Without seeing the secret analyses of other anti-emetics, readers were deprive of an important opportunity to assess actual and potential confounding in her study. Perhaps even more important, the statistical tools that Zambelli-Weiner used, including any measurements of p-values and confidence intervals, and any declarations of “statistical significance,” were rendered meaningless by her secret, undisclosed, multiple testing. As noted by the American Statistical Association (ASA) in its 2016 position statement, “4. Proper inference requires full reporting and transparency.”

The ASA explains that the proper inference from a p-value can be completely undermined by “multiple analyses” of study data, with selective reporting of sample statistics that have attractively low p-values, or cherry picking of suggestive study findings. The ASA points out that common practices of selective reporting compromises valid interpretation. Hence the correlative recommendation:

“Researchers should disclose the number of hypotheses explored during the study, all data collection decisions, all statistical analyses conducted and all p-values computed. Valid scientific conclusions based on p-values and related statistics cannot be drawn without at least knowing how many and which analyses were conducted, and how those analyses (including p-values) were selected for reporting.”[11]

The Draft Manuscript for the New England Journal of Medicine

The MDL court wasted little time and ink in dispatching Zambelli-Weiner’s claim of confidentiality for her draft New England Journal of Medicine manuscript. The court found that she failed to explain how any differences in content between this manuscript and the published version constituted “proprietary business information,” or how disclosure would cause her any actual prejudice.

Zambelli-Weiner’s Litigation Road Map

In a world where social justice warriors complain about organizations such as Exponent, for its litigation support of defense efforts, the revelation that Zambelli-Weiner was helping to quarterback the plaintiffs’ offense deserves greater recognition. Zambelli-Weiner’s litigation road map was clearly created to help Grant & Eisenhofer, P.A., the plaintiffs’ lawyers,, create a causation strategy (to which she would add her Zofran study). Such a document from a consulting expert witness is typically the sort of document that enjoys confidentiality and protection from litigation discovery. The MDL court, however, looked beyond Zambelli-Weiner’s role as a “consulting witness” to her involvement in designing and conducting research. The broader extent of her involvement in producing studies and communicating with regulators made her litigation “strategery” “almost certainly relevant to scientists and regulatory authorities” charged with evaluating her study.”[12]

Despite Zambelli-Weiner’s protestations that she had made a disclosure of conflict of interest, the MDL court found her disclosure anemic and the public interest in knowing the full extent of her involvement in advising plaintiffs’ counsel, long before the study was conducted, great.[13]

The legal media has been uncommonly quiet about the rulings on April Zambelli-Weiner, in the Zofran litigation. From the Union of Concerned Scientists, and other industry scolds such as David Egilman, David Michaels, and Carl Cranor – crickets. Meanwhile, while the appeal over the admissibility of her testimony is pending before the Pennsylvania Supreme Court,[14] Zambelli-Weiner continues to create an unenviable record in Zofran, Accutane,[15] Mirena,[16] and other litigations.


[1]  April Zambelli‐Weiner, Christina Via, Matt Yuen, Daniel Weiner, and Russell S. Kirby, “First Trimester Pregnancy Exposure to Ondansetron and Risk of Structural Birth Defects,” 83 Reproductive Toxicology 14 (2019).

[2]  See In re Zofran (Ondansetron) Prod. Liab. Litig., 392 F. Supp. 3d 179, 182-84 (D. Mass. 2019) (MDL 2657) [cited as In re Zofran].

[3]  “Litigation Science – In re Zambelli-Weiner” (April 8, 2019); “Mass Torts Made Less Bad – The Zambelli-Weiner Affair in the Zofran MDL” (July 30, 2019). See also Nate Raymond, “GSK accuses Zofran plaintiffs’ law firms of funding academic study,” Reuters (Mar. 5, 2019).

[4]  In re Zofran Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, Order on Defendant’s Motion to De-Designate Certain Documents as Confidential Under the Protective Order (D.Mass. Apr. 1, 2020) [Order].

[5]  Order at n.3

[6]  Order at 3.

[7]  See In re Zofran, 392 F. Supp. 3d at 186.

[8]  Order at 4. See also Xavier Kurz, Susana Perez-Gutthann, the ENCePP Steering Group, “Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP),” 27 Pharmacoepidemiology & Drug Safety 245 (2018).

[9]  Order at note 2 (citing Charles J. Walsh & Marc S. Klein, “From Dog Food to Prescription Drug Advertising: Litigating False Scientific Establishment Claims Under the Lanham Act,” 22 Seton Hall L. Rev. 389, 431 (1992) (noting that adherence to study protocol “is essential to avoid ‘data dredging’—looking through results without a predetermined plan until one finds data to support a claim”).

[10]  Order at 5, citing Anderson v. Cryovac, Inc., 805 F.2d 1, 8 (1st Cir. 1986) (describing public-health concerns as “compelling justification” for requiring disclosing of confidential information).

[11]  Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” 70 The American Statistician 129 (2016)

See alsoThe American Statistical Association’s Statement on and of Significance” (March 17, 2016).“Courts Can and Must Acknowledge Multiple Comparisons in Statistical Analyses (Oct. 14, 2014).

[12]  Order at 6.

[13]  Cf. Elizabeth J. Cabraser, Fabrice Vincent & Alexandra Foote, “Ethics and Admissibility: Failure to Disclose Conflicts of Interest in and/or Funding of Scientific Studies and/or Data May Warrant Evidentiary Exclusions,” Mealey’s Emerging Drugs Reporter (Dec. 2002) (arguing that failure to disclose conflicts of interest and study funding should result in evidentiary exclusions).

[14]  Walsh v. BASF Corp., GD #10-018588 (Oct. 5, 2016, Pa. Ct. C.P. Allegheny Cty., Pa.) (finding that Zambelli-Weiner’s and Nachman Brautbar’s opinions that pesticides generally cause acute myelogenous leukemia, that even the smallest exposure to benzene increases the risk of leukemia offended generally accepted scientific methodology), rev’d, 2018 Pa. Super. 174, 191 A.3d 838, 842-43 (Pa. Super. 2018), appeal granted, 203 A.3d 976 (Pa. 2019).

[15]  In re Accutane Litig., No. A-4952-16T1, (Jan. 17, 2020 N.J. App. Div.) (affirming exclusion of Zambelli-Weiner as an expert witness).

[16]  In re Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396 (S.D.N.Y. 2016) (excluding Zambelli-Weiner in part).

Practical Solutions for the Irreproducibility Crisis

March 3rd, 2020

I have previously praised the efforts of the National Association of Scholars (NAS) for its efforts to sponsor a conference on “Fixing Science: Practical Solutions for the Irreproducibility Crisis.” The conference was a remarkable event, with a good deal of diverse view points, civil discussion and debate, and collegiality.

The NAS has now posted a follow up to its conference, with a link to slide presentations, and to a You Tube page with videos of the presentations. The NAS, along with The Independent Institute, should be commended for their organizational efforts, and their transparency in making the conference contents available now to a wider audience.

The conference took place on February 7th and 8th, and I had the privilege of starting the event with my presentation, “Not Just an Academic Dispute: Irreproducible Scientific Evidence Renders Legal Judgments Unsafe”.

Some, but not all, of the interesting presentations that followed:

Tim Edgell, “Stylistic Bias, Selective Reporting, and Climate Science” (Feb. 7, 2020)

Patrick J. Michaels, “Biased Climate Science” (Feb. 7, 2020)

Daniele Fanelli, “Reproducibility Reforms if there is no Irreproducibility Crisis” (Feb. 8, 2020)

On Saturday, I had the additional privilege of moderating a panel on “Group Think” in science, and its potential for skewing research focus and publication:

Lee Jussim, “Intellectual Diversity Limits Groupthink in Scientific Psychology” (Feb. 8, 2020)

Mark Regnerus, “Groupthink in Sociology” (Feb. 8, 2020)

Michael Shermer, “Giving the Devil His Due” (Feb. 8, 2020)

Later on Saturday, the presenters turned to methodological issues, many of which are key to understanding ongoing scientific and legal controversies:

Stanley Young, “Prevention and Management of Acute and Late Toxicities in Radiation Oncology

James E. Enstrom, “Reproducibility is Essential to Combating Environmental Lysenkoism

Deborah Mayo, “P-Value ‘Reforms’: Fixing Science or Threats to Replication and Falsification?” (Feb. 8, 2020)

Ronald L. Wasserstein, “What Professional Organizations Can Do To Fix The Irreproducibility Crisis” (Feb. 8, 2020)

Louis Anthony Cox, Jr., “Causality, Reproducibility, and Scientific Generalization in Public Health” (Feb. 8, 2020)

David Trafimow, “What Journals Can Do To Fix The Irreproducibility Crisis” (Feb. 8, 2020)

David Randall, “Regulatory Science and the Irreproducibility Crisis” (Feb. 8, 2020)

Counter Cancel Culture – The NAS Conference on Irreproducibility

February 9th, 2020

The meaning of the world is the separation of wish and fact.”  Kurt Gödel

Back in October 2019, David Randall, the Director of Research, of the National Association of Scholars, contacted me to ask whether I would be interested in presenting at a conference, to be titled “Fixing Science: Practical Solutions for the Irreproducibility Crisis.” David explained that the conference would be aimed at a high level consideration of whether such a crisis existed, and if so, what salutary reforms might be implemented.

As for the character and commitments of the sponsoring organizations, David was candid and forthcoming. I will quote him, without his permission, and ask his forgiveness later:

The National Association of Scholars is taken to be conservative by many scholars; the Independent Institute is (broadly speaking) in the libertarian camp. The NAS is open to but currently agnostic about the degree of human involvement in climate change. The Independent Institute I take to be institutionally skeptical of consensus climate change theory–e.g., they recently hosted Willie Soon for lecture. A certain number of speakers prefer not to participate in events hosted by institutions with these commitments.”

To me, the ask was for a presentation on how the so-called replication crisis, or the irreproducibility crisis, affected the law. This issue was certainly one I have had much occasion to consider. Although I am aware of the “adjacency” arguments made by some that people should be mindful of whom they align with, I felt that nothing in my participation would compromise my own views or unduly accredit institutional positions of the sponsors.

I was flattered by the invitation, but I did some due diligence on the sponsoring organizations. I vaguely recalled the Independent Institute from my more libertarian days, but the National Association of Scholars (NAS, not to be confused with Nathan A. Schachtman) was relatively unknown to me. A little bit of research showed that the NAS had a legitimate interest in the irreproducibility crisis. David Randall had written a monograph for the organization, which was a nice summary of some of the key problems. The Irreproducibility Crisis of Modern Science: Causes, Consequences,and the Road to Reform (2018).

On other issues, the NAS seemed to live up to its description as “an organization of scholars committed to higher education as the catalyst of American freedom.” I listened to some of the group’s podcasts, Curriculum Vitae, and browsed through its publications. I found myself agreeing with many positions articulated by or through the NAS, and disagreeing with a few positions very strongly.

In looking over the list of other invited speakers, I saw great diversity of view points and approaches, One distinguished speaker, Daniele Fanelli, had criticized the very notion that there was a reproducibility crisis. In the world of statistics, there were strong defenders of statistical tests, and vociferous critics. I decided to accept the invitation, not because I was flattered, but because the replication issue was important, and I believed that I could add something to the discussion before an audience of professional scientists, statisticians, and educated lay persons. In writing to David Randall to accept the invitation, I told him that with respect to the climate change issues, I was not at all put off by healthy skepticism in the face all dogmas. Every dogma will have its day.

I did not give any further consideration to the political aspect of the conference until early January, when I received an email from a scientist, Lenny Teytelman, Ph.D., the C.E.O. of a company protocols.io, which addresses reproducibility issues. Dr Teytelman’s interest in improving reproducibility seemed quite genuine, but he wrote to express his deep concern about the conference and the organizations that were sponsoring it.

Perhaps a bit pedantically, he cautioned me that the NAS was not the National Academy of Sciences, a confusion that never occurred to me because the National Academies has been known as the National Academies of Science, Engineering and Medicine for several years now. Dr. Teytelman’s real concern seemed to be that the NAS is a “‘politically conservative advocacy group’.” (The internal scare quotes were Teytelman’s, but I was not afraid.) According to Dr. Teytelman, the NAS sought to undermine climate science and environmental protection by advancing a call for more reproducible science. He pointed me to what he characterized as an exposé on NAS, in Undark,1 and he cautioned me that the National Association of Scholars’ work is “dangerous.” Finally, Dr. Teytelman urged me to reconsider my decision to participate in the conference.

I did reconsider my decision, but reaffirmed it in an email I sent back to Dr. Teytelman. I realized that I could be wrong, in which case, I would eat my words, confident that they would be most digestible:

Dear Dr Teytelman,

Thank you for your note. I was aware of the piece on Undark’s website, as well as the difference between the NAS and the NASEM. I don’t believe anyone involved in science education would likely to be confused between the two organizations. A couple of years ago, I wrote a teaching module on biomedical causation for the National Academies. This is my first presentation at the request of the NAS, and frankly I am honored by the organization’s request that I present at its conference.

I have read other materials that have been critical of the NAS and its publications on climate change and other issues. I know that there are views of the organization from which I would dissent, but I do not see my disagreement on some issues as a reason not to attend, and present at a conference on an issue of great importance to the legal system.

I am hardly an expert on climate change issues, and that is my failing. Most of my professional work involves health effects regulation and litigation. If the NAS has advanced sophistical arguments against a scientific claim, then the proper antidote will be to demonstrate its fallacious reasoning and misleading marshaling of evidence. I should think, however, as someone interested in improving the reproducibility of scientific research, you will agree that there is much common ground for discussion and reform of scientific practice, on a broader arrange [sic] of issues than climate change.

As for the political ‘conservatism’, of the organization, I am not sure why that is a reason to eschew participation in a conference that should be of great importance to people of all political views. My own politics probably owe much to the influence of Michael Oakeshott, which puts me in perhaps the smallest political tribe of any in the United States. If conservatism means antipathy to post-modernism, identity politics, political orthodoxies, and assaults on Enlightenment values and the Rule of Law, then count me in.

In any event, thanks for your solicitude. I think I can participate and return with my soul intact.

All the best.

Nathan

To his credit, Dr. Teytelman tenaciously continued. He acknowledged that the political leanings of the organizers were not a reason to boycott, but he politely pressed his case. We were now on a first name basis:

Dear Nathan,

I very much applaud all efforts to improve the rigour of our science. The problem here is that this NAS organization has a specific goal – undermining the environmental protection and denying climate change. This is why 7 out of the 21 speakers at the event are climate change deniers. [https://docs.google.com/spreadsheets/d/136FNLtJzACc6_JbbOxjy2urbkDK7GefRZ/edit?usp=sharing] And this isn’t some small fringe effort to be ignored. Efforts of this organization and others like them have now gotten us to the brink of a regulatory change at the United States Environmental Protection Agency which can gut the entire EPA (see a recent editorial against this I co-authored). This conference is not a genuine effort to talk about reproducibility. The reproducibility part is a clever disguise for pushing a climate change denialism agenda.

Best,

Lenny

I looked more carefully at Lenny’s spreadsheet, and considered the issue afresh. We were both pretty stubborn:

Dear Lenny,

Thank you for this information. I will review with interest.

I do not see that the conference is primarily or even secondarily about climate change vel non. There are two scientists, Trafimow and Wasserstein with whom I have some disagreements about statistical methodology. Tony Cox and Stan Young, whatever their political commitments or views on climate change may be, are both very capable statisticians, from whom I have learned a great deal. The conference should be a lively conversation about reproducibility, not about climate change. Given your interests and background, you should go.

I believe that your efforts here are really quite illiberal, although they are in line with the ‘cancel culture’, so popular on campuses these days.

Forty three years ago, I entered a Roman Catholic Church to marry the woman I love. There were no lightning bolts or temblors, even though I was then and I am now an atheist. Yes, I am still married to my first wife. Although I share the late Christopher Hitchins’ low view of the Catholic Church, somehow I managed to overcome my antipathy to being married in what some would call a house of ill repute. I even manage to agree with some Papist opinions, although not for the superstitious reasons’ Papists embrace.

If I could tolerate the RC Church’s dogma for a morning, perhaps you could put aside the dichotomous ‘us and them’ view of the world and participate in what promises to be an interesting conference on reproducibility?

All the best.

Nathan

Lenny kindly acknowledged my having considered his issues, and wrote back a nice note, which I will quote again in full without permission, but with the hope that he will forgive me and even acknowledge that I have given his views an airing in this forum.

Hi Nathan,

We’ll have to agree to disagree. I don’t want to give a veneer of legitimacy to an organization whose goal is not improving reproducibility but derailing EPA and climate science.

Warmly,

Lenny

The business of psychoanalyzing motives and disparaging speakers and conference organizers is a dangerous business for several reasons. First motives can be inscrutable. Second, they can be misinterpreted. And third, they can be mixed. When speaking of organizations, there is the further complication of discerning a corporate motive among the constituent members.

The conference was an exciting, intellectually challenging event, which took place in Oakland, California, on February 7 and 8. I can report back to Lenny that his characterizations of and fears about the conference were unwarranted. While there were some assertions of climate change skepticism made with little or no evidence, the evidence-based presentations essentially affirmed climate change and sought to understand its causes and future course in a scientific way. But climate change was not why I went to this conference. On the more general issue of reform of scientific procedures and methods, we had open debates, some agreement on important principles, and robust and reasoned disagreement.

Lenny, you were correct that the NAS should not be ignored, but you should have gone to the meeting and participated in the conversation.


1 Michael Schulson, “A Remedy for Broken Science, Or an Attempt to Undercut It?Undark (April 18, 2018).

American Statistical Association – Consensus versus Personal Opinion

December 13th, 2019

Lawyers and judges pay close attention to standards, guidances, and consenus statements from respected and recognized professional organizations. Deviations from these standards may be presumptive evidence of malpractice or malfeasance in civil and criminal litigation, in regulatory matters, and in other contexts. One important, recurring situation arises when trial judges must act as gatekeepers of the admissibility of expert witness opinion testimony. In making this crucial judicial determination, judges will want to know whether a challenged expert witness has deviated from an accepted professional standard of care or practice.

In 2016, the American Statistical Association (ASA) published a consensus statement on p-values. The ASA statement grew out of a lengthy process that involved assembling experts of diverse viewpoints. In October 2015, the ASA convened a two-day meeting for 20 experts to meet and discuss areas of core agreement. Over the following three months, the participating experts and the ASA Board members continued their discussions, which led to the ASA Executive Committee’s approval of the statement that was published in March 2016.[1]

The ASA 2016 Statement spelled out six relatively uncontroversial principles of basic statistical practice.[2] Far from rejecting statistical significance, the six principles embraced statistical tests as an important but insufficient basis for scientific conclusions:

“3. Scientific conclusions and business or policy decisions should not be based only on whether a p-value passes a specific threshold.”

Despite the fairly clear and careful statement of principles, legal actors did not take long to misrepresent the ASA principles.[3] What had been a prescription about the insufficiency of p-value thresholds was distorted into strident assertions that statistical significance was unnecessary for scientific conclusions.

Three years after the ASA published its p-value consensus document, ASA Executive Director, Ronald Wasserstein, and two other statisticians, published an editorial in a supplemental issue of The American Statistician, in which they called for the abandonment of significance testing.[4] Although the Wasserstein’s editorial was clearly labeled as such, his essay introduced the special journal issue, and it appeared without disclaimer over his name, and his official status as the ASA Executive Director.

Sowing further confusion, the editorial made the following pronouncement:[5]

“The [2016] ASA Statement on P-Values and Statistical Significance stopped just short of recommending that declarations of ‘statistical significance’ be abandoned. We take that step here. We conclude, based on our review of the articles in this special issue and the broader literature, that it is time to stop using the term “statistically significant” entirely. Nor should variants such as ‘significantly different’, ‘p < 0.05’, and ‘nonsignificant’ survive, whether expressed in words, by asterisks in a table, or in some other way.”

The ASA is a collective body, and its ASA Statement 2016 was a statement from that body, which spoke after lengthy deliberation and debate. The language, quoted above, moves within one paragraph, from the ASA Statement to the royal “We,” who are taking the step of abandoning the term “statistically significant.” Given the unqualified use of the collective first person pronoun in the same paragraph that refers to the ASA, combined with Ronald Wasserstein’s official capacity, and the complete absence of a disclaimer that this pronouncement was simply a personal opinion, a reasonable reader could hardly avoid concluding that this pronouncement reflected ASA policy.

Your humble blogger, and others, read Wasserstein’s 2019 editorial as an ASA statement.[6] Although it is true that the 2019 paper is labeled “editorial,” and that the editorial does not describe a consensus process, there is no disclaimer such as is customary when someone in an official capacity publishes a personal opinion. Indeed, rather than the usual disclaimer, the Wasserstein editorial thanks the ASA Board of Directors “for generously and enthusiastically supporting the ‘p-values project’ since its inception in 2014.” This acknowledgement strongly suggests that the editorial is itself part of the “p-values project,” which is “enthusiastically” supported by the ASA Board of Directors.

If the editorial were not itself confusing enough, an unsigned email from “ASA <asamail@amstat.org>” was sent out in July 2019, in which the anonymous ASA author(s) takes credit for changing statistical guidelines at the New England Journal of Medicine:[7]

From: ASA <asamail@amstat.org>
Date: Thu, Jul 18, 2019 at 1:38 PM
Subject: Major Medical Journal Updates Statistical Policy in Response to ASA Statement
To: <XXXX>

The email is itself an ambiguous piece of evidence as to what the ASA is claiming. The email says that the New England Journal of Medicine changed its guidelines “in response to the ASA Statement on P-values and Statistical Significance and the subsequent The American Statistician special issue on statistical inference.” Of course, the “special issue” was not just Wasserstein’s editorial, but the 42 other papers. So this claim leaves open to doubt exactly what in the 2019 special issue the NEJM editors were responding to. Given that the 42 articles that followed Wasserstein’s editorial did not all agree with Wasserstein’s “steps taken,” or with each other, the only landmark in the special issue was the editorial over the name of the ASA’s Executive Director.

Moreover, a reading of the NEJM revised guidelines does not suggest that the journal’s editors were unduly influenced by the Wasserstein editorial or the 42 accompanying papers. The journal mostly responded to the ASA 2016 consensus paper by putting some teeth into its Principle 4, which dealt with multiplicity concerns in submitted manuscripts.  The newly adopted (2019) NEJM author guidelines do not take step out with Wasserstein and colleagues; there is no general prohibition on p-values or statements of “statistical significance.”

The confusion propagated by the Wasserstein 2019 editorial has not escaped the attention of other ASA officials. An editorial in the June 2019 issue of AmStat News, by ASA President Karen Kafadar, noted the prevalent confusion and uneasiness over the 2019 The American Statistician special issue, the lack of consensus, and the need for healthy debate.[8]

In this month’s issue of AmStat News, President Kafadar returned to the issue of the confusion over the 2019 ASA special issue of The American Statistician, in her “President’s Corner.” Because Executive Director Wasserstein’s editorial language about “we now take this step” is almost certainly likely to find its way into opportunistic legal briefs, Kafadar’s comments are worth noting in some detail:[9]

“One final challenge, which I hope to address in my final month as ASA president, concerns issues of significance, multiplicity, and reproducibility. In 2016, the ASA published a statement that simply reiterated what p-values are and are not. It did not recommend specific approaches, other than ‘good statistical practice … principles of good study design and conduct, a variety of numerical and graphical summaries of data, understanding of the phenomenon under study, interpretation of results in context, complete reporting and proper logical and quantitative understanding of what data summaries mean’.

The guest editors of the March 2019 supplement to The American Statistician went further, writing: ‘The ASA Statement on P-Values and Statistical Significance stopped just short of recommending that declarations of “statistical significance” be abandoned. We take that step here. … [I]t is time to stop using the term “statistically significant” entirely’.

Many of you have written of instances in which authors and journal editors – and even some ASA members – have mistakenly assumed this editorial represented ASA policy. The mistake is understandable: The editorial was coauthored by an official of the ASA. In fact, the ASA does not endorse any article, by any author, in any journal – even an article written by a member of its own staff in a journal the ASA publishes.”

Kafadar’s caveat should quash incorrect assertions about the ASA’s position on statistical significance testing. It is a safe bet, however, that such assertions will appear in trial and appellate briefs.

Statistical reasoning is difficult enough for most people, but the hermeneutics of American Statistical Association publications on statistical significance may require a doctorate of divinity degree. In a cleverly titled post, Professor Deborah Mayo argues that there is no other way to interpret the Wasserstein 2019 editorial except as laying down an ASA prescription. Deborah G. Mayo, “Les stats, c’est moi,” Error Philosophy (Dec. 13, 2019). I accept President Kafadar’s correction at face value, and accept that I, like many other readers, misinterpreted the Wasserstein editorial as having the imprimatur of the ASA. Mayo points out, however, that Kafadar’s correction in a newsletter may be insufficient at this point, and that a stronger disclaimer is required. Officers of the ASA are certainly entitled to their opinions and the opportunity to present them, but disclaimers would bring clarity and transparency to published work of these officials.

Wasserstein’s 2019 editorial goes further to make a claim about how his “step” will ameliorate the replication crisis:

“In this world, where studies with ‘p < 0.05’ and studies with ‘p > 0.05 are not automatically in conflict, researchers will see their results more easily replicated – and, even when not, they will better understand why.”

The editorial here seems to be attempting to define replication failure out of existence. This claim, as stated, is problematic. A sophisticated practitioner may think of the situation in which two studies, one with p = .048, and another with p = 0.052 might be said not to be conflict. In real world litigation, however, advocates will take Wasserstein’s statement about studies not in conflict (despite p-values above and below a threshold, say 5%) to the extremes. We can anticipate claims that two similar studies with p-values above and below 5%, say with one p-value at 0.04, and the other at 0.40, will be described as not in conflict, with the second a replication of the first test. It is hard to see how this possible interpretation of Wasserstein’s editorial, although consistent with its language, will advance sound, replicable science.[10]


[1] Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” 70 The Am. Statistician 129 (2016).

[2]The American Statistical Association’s Statement on and of Significance” (Mar. 17, 2016).

[3] See, e.g., “The Education of Judge Rufe – The Zoloft MDL” (April 9, 2016) (Zoloft litigation); “The ASA’s Statement on Statistical Significance – Buzzing from the Huckabees” (Mar. 19, 2016); “The American Statistical Association Statement on Significance Testing Goes to Court – Part I” (Nov. 13, 2018).

[4] Ronald L. Wasserstein, Allen L. Schirm, and Nicole A. Lazar, “Editorial: Moving to a World Beyond ‘p < 0.05’,” 73 Am. Statistician S1, S2 (2019).

[5] Id. at S2.

[6] SeeHas the American Statistical Association Gone Post-Modern?” (Mar. 24, 2019); Deborah G. Mayo, “The 2019 ASA Guide to P-values and Statistical Significance: Don’t Say What You Don’t Mean,” Error Statistics Philosophy (June 17, 2019); B. Haig, “The ASA’s 2019 update on P-values and significance,” Error Statistics Philosophy  (July 12, 2019).

[7] SeeStatistical Significance at the New England Journal of Medicine” (July 19, 2019); See also Deborah G. Mayo, “The NEJM Issues New Guidelines on Statistical Reporting: Is the ASA P-Value Project Backfiring?Error Statistics Philosophy  (July 19, 2019).

[8] See Kafadar, “Statistics & Unintended Consequences,” AmStat News 3,4 (June 2019).

[9] Karen Kafadar, “The Year in Review … And More to Come,” AmStat News 3 (Dec. 2019).

[10]  See also Deborah G. Mayo, “P‐value thresholds: Forfeit at your peril,” 49 Eur. J. Clin. Invest. e13170 (2019).