Both in acetaminophen litigation and in performative political assertion, the Prada Review has loomed large. As noted in an earlier post, one of the authors of the Prada Review was Andrea Baccarelli, who was also a key witness for plaintiffs in the acetaminophen MDL. FDA Commissioner Makary quoted a causal conclusion from Baccarelli’s litigation report at Trump’s September 2025 news conference as though it were a trusted source. Baccarelli tweeted, the same day as the news conference, that his paper, the Prada Review, had reached only a conclusion with respect to an association, not causation, and that his recommendations were based upon the Precautionary Principle.
The Supposed NIH Funding
Baccarelli’s tweet, on the day of the Trump news conference, described his paper, the Prada Review, as funded by the NIH. The paper itself makes a funding disclosure, with the authors stating that their “study was supported by NIH (R35ES031688; U54CA267776).” This disclosure and Baccarelli’s claim to NIH funding, however, are misleading.
The research grant referenced, R35ES031688, is a National Institute of Environmental Health Sciences (NIEHS) research grant. The NIEHS is, of course, one of the National Institutes, but not the Institute that is involved in funding research on a pharmacoepidemiologic issues. Indeed, this grant has nothing to do with children’s neurological status in relation to their mother’s ingestion of acetaminophen.
The NIEHS awarded grant R35ES031688 to Andrea Baccarelli, while he was at Columbia University, for his project “Extracellular Vesicles in Environmental Epidemiology Studies of Aging.” The research focuses on extracellular vesicles (EVs) and their role in environmental health, particularly as it relates to aging. Under the NIEHS grant contract, Baccarelli promised to study the effects of air pollution on accelerated brain aging, and disease states such as dementia. Baccarelli noted that his focus would be on intra-cellular communication enabled by extracellular vesicles, in reaction to air pollution. The described research would understandably be viewed as potentially relevant to the NIEHS mission statement, but it has nothing to do with autism among children of women who ingested acetaminophen during pregnancy. The phrases “extracellular vesicles” and “air pollution” do not appear in the Prada review. NIEHS grant R35ES031688 is irrelevant to research on acetaminophen.
The second grant claimed as supporting the Prada review was U54CA267776. The U54 designation marks this as a career award, not specific to a specific topic or this published work. Ironically, given the Trump administrations embrace of the Prada review, this U54 grant is a diversity, equity, and inclusion grant to the Mount Sinai Icahn School of Medicine, in Manhattan. The Icahn School has long had one of the most ethically, racially, culturally diverse faculties of any medical school, and hardly needs financial incentives to hire minority physicians and scientists.
The NIH awarded grant U54CA267776 for “Cohort Cluster Hiring Initiative at Icahn School of Medicine at Mount Sinai.” The NIH describes the grant as aiming to reduce “[t]he barriers to research and career success for underrepresented groups in academic medicine.” The text of the U54 grant is written largely in bureaucratic jargon, which would require a degree in DEI to understand fully. What is abundantly clear is that nothing in this U54 grant, or in its stated criteria for evaluation, has anything to do with studying the teratologic potential of acetaminophen. The only author affiliated with the Icahn School is Diddier Prada.
Dr. Baccarelli did not have NIH or NIEHS support for conducting a review of acetaminophen and autism. The support, a best, was for DEI purposes, or perhaps general “walking-around” money for research on environmental pollution and brain aging, which has nothing to do with the medical issue driving the Prada review. There is no evidence that Baccarelli or the other authors of the Prada review ever prepared a study proposal or protocol related to acetaminophen for evaluation by a funding committee at NIH. The NIH provided no peer review or guidance for the authors’ acetaminophen review. In short, there is nothing that marks the Prada review as an NIH work product other than the over-claiming of the authors with respect to funding sources.
By claiming that his research was “NIH funded,” Baccarelli was attempting to boost the prestige of the research even though his acetaminophen review was done for litigation, not for the federal government. Apparently the NIEHS acquiesces in this charade because it suggests to the uninitiated that its research grants result in more published papers, even though the topics of those papers are unrelated to the funded research proposal, and the unrelated topics never receiving committee peer review.
The journal that published the Prada Review is a member of the Committee on Publication Ethics (COPE), and claims to be committed to the “highest level of integrity in the content published.”[1] COPE’s guidance on declaring funding sources prescribes that authors identify “the activities supported by the grant should be included in funding statements.”[2] Baccarelli’s declaration of NIH funding sources failed to specify the activities actually supported by the grants. Completely absent from Baccarelli’s funding disclosure was any mention that he developed the navigation guide review while working for the lawsuit industry to advance litigation claims in court.
The Journal Chosen for the Prada Review
Peer Review
Ever since the Supreme Court identified peer review as a hallmark of “reliable” science, lawyers and judges have mechanically and hopefully pointed to the presence or absence of peer review to avoid the hard work of assessing the validity and studies and causal inference from a body of evidence. The Daubert case did indeed, in dicta, suggest that courts could rely upon peer review to help determine the admissibility of expert witness opinion testimony.[3] Nothing in Daubert, in later decisions, or in Rule 702 itself, however, supports admitting expert witness testimony just because the witness relied upon peer-reviewed studies, especially when the studies relied upon are invalid or are based upon questionable research practices. The Daubert Court was careful to point out that peer-reviewed publication was “not a sine qua non of admissibility; it does not necessarily correlate with reliability, … ”[4]
Well-ground opinions, or the facts and data on which they are based, may not have been published. The fact of peer-reviewed publication may be relevant but certainly not dispositive in assisting in the key inquiry, which concerns “the scientific validity of a particular technique or methodology on which an opinion is premised.”[5] At best, peer review is a crude proxy for study validity. If the Supreme Court were writing today, it might well have written that peer review is often a feature of bad science, advanced by scientists who know that peer-reviewed publication is the price of admission to the advocacy arena. The wild proliferation of journals, including predatory, “pay-to-play,” and ideologically driven journals, accelerates the decline in the value o peer review.
The chapter, “How Science Works,” in the third edition of the Reference Manual on Scientific Evidence, by the late Professor David Goodstein, provides a helpful discussion of peer review. Goodstein’s chapter emphasizes that peer review “works very poorly in catching cheating or fraud.”[6] Goodstein invokes his own experience as a peer reviewer to note that “peer review referees and editors limit their assessment of submitted articles to such matters as style, plausibility, and defensibility; they do not duplicate experiments from scratch or plow through reams of computer-generated data in order to guarantee accuracy or veracity or certainty.”[7] Indeed, Goodstein’s chapter characterizes the ability of peer review to warrant study validity as a “myth”:
“Myth: The institution of peer review assures that all published papers are sound and dependable.
Fact: Peer review generally will catch something that is completely out of step with majority thinking at the time, but it is practically useless for catching outright fraud, and it is not very good at dealing with truly novel ideas. …
It certainly does not ensure that the work has been fully vetted in terms of the data analysis and the proper application of research methods.”[8]
Baccarelli’s Choice of Journal
Medical and scientific journals have proliferated, with the field populated by many predatory and pay-to-play journals. Another dubious category of journals are those that exist in an ideological silo. Baccarelli, the corresponding author of the Prada, placed the review in a journal that was started and carried forward by members of a pro-lawsuit industry advocacy group.
The journal Environmental Health was established in 2002 as a peer-reviewed journal, to be an outlet for research in the field of “environmental health.”[9] The current webpage for the journal describes its aims and scope a bit more broadly as publishing “on important aspects of environmental and occupational health.”[10] The Prada review involved an issue of pharmacoepidemiology and medicinal safety, not environmental or occupational health.
The founding editor of Environmental Health was David Ozonoff; its current editors in chief are Ruth A. Etzel and Philippe Grandjean.[11] All three lead editors are fellows of an advocacy organization known as the Collegium Ramazzini,[12] which is committed to the precautionary principle.[13] The principle, as its name suggests, seeks to shift the burden of proof, out of caution, to those who would resist a claim of harm.[14] From its inception, the Collegium has been closely aligned with the lawsuit industry in the United States. The organization was founded in 1982, by an American physician, Dr. Irving Selikoff, who distinguished himself for his ability to influence legislation and regulations on occupational health issues, on behalf of labor unions. Selikoff’s zealous advocacy sometimes crossed the line, as when he and his Collegium Ramazzini sponsored and funded a conference, for scientific presentations on asbestos hazards. The Collegium paid for judges’ expenses to attend what was nothing more than a one-sided ex parte meeting for judges and plaintiffs’ litigation and consulting expert witnesses. The Collegium’s shenanigans led to the disqualification of one attending judge, who had a large asbestos class action pending before him.[15] The Collegium, however, escaped any consequences for its efforts to pervert the course of justice.
Anemic Conflicts of Interest Disclosures
The authors of the Prada review chose to publish in a journal founded and controlled by members of the Collegium Ramazzini. Two of the authors, Andrea Baccarelli and Beate Ritz, are both members of the Collegium, with its ideological commitment to the precautionary principle. Both the editors and the authors of this review had ideological conflicts of interest, not disclosed in the text of the published article.
The disclosure of conflicts of interest has become a ritual in scientific publication. Disclosures by scientists with ties to manufacturing industry face demanding scrutiny and criticism. Disclosures by scientists with ties to the lawsuit industry often pass without comment. In the case of the Prada review, the senior and final author, Andrea A. Baccarelli, had been an expert witness for plaintiffs’ counsel in lawsuits against the manufacturers and sellers of acetaminophen. Baccarelli was the only author to include a conflict disclosure in the published Prada review:
“Dr. Baccarelli served as an expert witness for the plaintiff’s legal team on matters of general causation involving acetaminophen use during pregnancy and its potential links to neurodevelopmental disorders. This involvement may be perceived as a conflict of interest regarding the information presented in this paper on acetaminophen and neurodevelopmental outcomes. Dr. Baccarelli has made every effort to ensure that this current work—like his past work as an expert witness on this matter—was conducted with the highest standards of scientific integrity and objectivity.”
The convoluted statement is revealing. Using the passive voice, Baccarelli states that this work might be perceived as a conflict of interest, which suggests that the problem lies with those persons who might think so. In his sworn testimony, Baccarelli acknowledged that he reported his involvement in the acetaminophen litigation to his university employer as a potential conflict of interest, so he knew very well there were persons would did, in fact, see his activities as a potential conflict of interest.[16] If industry scientists working on the relevant issue had published, members of the Collegium Ramazzini would have been the forefront of those accusing the authors of having had conflicts. Baccarelli’s published disclosure was seriously incomplete in failing to mention whether Dr. Baccarelli was compensated for his playing on the “plaintiff’s legal team,” and if so, then how much. Plaintiffs’ counsel paid him $700 an hour, for an amount at least $150,000,[17] for his work that included producing a “guide” review of the evidence that maternal use of acetaminophen had a relationship with children’s autism. The very article for which Baccarelli was giving a disclosure substantially included work done for and paid by plaintiffs’ counsel in the acetaminophen litigation. Baccarelli failed to disclose that he had been paid for much of the actual content of the published paper.
Dr. Baccarelli’s disclosure self-servingly, and with epistemic arrogance, claims that he “made every effort to ensure that this current work—like his past work as an expert witness on this matter—was conducted with the highest standards of scientific integrity and objectivity.” Baccarelli neglected to omit any mention that his work failed critical scrutiny in the multi-district litigation. In an extensive, closely reasoned opinion, federal district court judge Denise Cote ruled that Dr. Baccarelli’s proffered opinions failed to meet the relevance and reliability standards of federal law.[18]
Only Dr. Baccarelli attempted to disclose conflicts of interest, but there are serious questions concerning two of the three remaining authors. Anne Z. Bauer was the lead author of the 2021 article that falsely claimed a consensus for precautionary action to restrict pregnant women’s use of acetaminophen.[19] Bauer’s prior advocacy positions were a potential conflict of interest, which should have been declared. Furthermore, Bauer may well have been a consulting expert witness for the “plaintiffs’ team.” Parties usually do not have to disclose their consulting expert witnesses, but when those witnesses publish, they are under the ethical constraints of their profession to declare their conflicts. In a regulatory filing by Kenvue Brands LLC, the manufacturer of Tylenol (acetaminophen) identified Bauer as an expert or a consultant to the plaintiffs’ litigation team.[20]
Although author Beate Ritz does not appear to have served as an expert witness in acetaminophen litigation to date, she is a frequent expert witness for other lawsuit industry endeavors. Ritz has played a large role in the lawsuit industry’s campaign against glyphosate.[21] Ritz has testified, for claimants, in cases involving claims of heavy metals in baby food.[22] And she has been involved on behalf of the lawsuit industry in claims that paraquat exposure causes Parkinson’s disease.[23] Ritz’s litigation work in glyphosate and baby food cases has been on behalf of the Wisner Baum firm, which employs a son of Secretary Robert Kennedy, Jr.,[24] and which is a source of the Secretary’s personal income.[25] In the Prada review, Ritz did not disclose any of her activities that constitute actual or potential conflicts of interest.
The Navigation Guide Methodology
The Navigation Guide “methodology” is a relatively arcane approach to reviewing studies. It was created with precautionary principle assessments in mind by staff scientists at the Environmental Protection Agency. Relatively few published papers have actually used this so-called navigation guide. Before the Prada review, no scientists appear to have used this approach to assess a body of pharmacoepidemiologic evidence. The Prada paper and its deployment of a “navigation guide” systematic review thus cry out for critical scrutiny.
History of the Navigation Guide
The history and purposes of the so-called navigation guide method are obscure. The earliest citation to navigation guide review methodology appeared in a 2009 conference paper, which discussed the methodology as a proposal.[26] The authors of the conference paper described themselves as the Navigating the Scientific Evidence to Improve Prevention Workshop Organizing Committee. None was particularly well known in the field of research synthesis.
The Organizing Committee never identified a clear rationale for a new, different approach to systematic review. By the time of the 2009 conference paper, there were well over three decades of experience with systematic reviews,[27] with well-regarded full-length textbook treatment by experts in the field.[28] The Organizing Committee 2009 paper does not explain the rationale for their new approach, other than their own felt need to emphasize the precautionary principle in derogation of causal analysis.
Aside from the authors’ inexperience in field of evidence synthesis and the preemption of their topic by treatises and dozens of articles on systematic reviews, there are at least three other questions raised by the 2009 conference paper relevant to Baccarelli’s invocation of navigation guide methodology. First, the Organizing Committee emphasized the alleged need for a review methodology for environmental exposures. The Committee did not attempt to justify its focus on environmental exposures with a showing that well-described methodologies already in use were in any way inadequate or inappropriate for environmental exposures. Baccarelli’s Prada review did not address an environmental exposure, which makes this consideration irrelevant as a rationale.
Second, the Organizing Committee urged the need for precautionary assessments, which might make their method potentially appropriate when evidence syntheses for precautionary pronouncements are called for. In the United States, regulatory assessments vary depending up the governing statutes that create the regulatory mandate. Some regulatory assessments call for precautionary assessment; determining causation in litigation does not. Indeed, in personal injury litigation, the precautionary principle is nothing less than an end run around the burden of proof on the party claiming harm and suing in tort. The designated subject matter of environmental exposures for the proposed systematic review technique offers an insight into why these authors believed that they had to propose a new-fangled systematic review methodology. Previously described methods interfered with authors’ ability to elevate “iffy” associations into conclusions of causality in the name of the precautionary principle.
The third remarkable aspect of the 2009 Committee’s proposed approach is its omission of any need or desirability for a pre-specified protocol. Later articles on the proposed navigation guide methodology similarly failed to describe the need for such a protocol.[29] By 2014, however, two of the original committee members published an article describing the proposed methodology in which they added the requirement of a pre-specified protocol to the requirements for a navigation guide systematic reviews.[30] This 2014 publication did not, however, prescribe, as most systematic review approaches do, the public pre-registration of the protocol.
Although systematic reviews are often described the “gold standard” for evidence synthesis, their methodological rigor vary widely. Given standard practice for over two decades, omitting reference to a protocol in describing any type of systematic review is methodologically egregious. Systematic reviews vary widely in quality, methodological rigor, and validity, but one of the key determinants of their validity is whether they were preceded by pre-specified protocols. Reviews that lack a pre-specified protocol are decidedly less rigorous than those reviews that employ a protocol.[31] The absence of a protocol is thus an important tell that a systematic review may be untrustworthy:
“The purposes of the protocol are to discourage ad-hoc changes to methodology during the review process which may introduce bias, to allow any justifiable methodological changes to be tracked, and also to allow peer-review of the work that it is proposed, to help ensure the utility and validity of its objectives and methods.”[32]
A more recent definition and assessment of systematic reviews similarly points to their essence in terms of a protocol:
“Systematic review (SR) is a rigorous, protocol-driven approach designed to minimise error and bias when summarising the body of research evidence relevant to a specific scientific question.”[33]
The Prada Review’s Application of the Navigation Guide
The Prada review, put together by Baccarelli’s team, purports to use the Navigation Guide methodology, but the published paper does not cite to any source for this methodology. The Prada review as published has no protocol, which marks a serious deviation from the scientific standard of care. The absence of methodological rigor in systematic reviews and meta-analyses can readily change the outcome.[34] Several other reviews of the acetaminophen issue were published about the time of the Prada review, but with pre-specified and pre-registered protocols. One such review was an “umbrella” review of systematic reviews, published in 2025, concluded that there was no clear “link” between maternal acetaminophen use during pregnancy and children’s autism or ADHD.[35] In 2026, two additional high-quality systematic reviews, with preregistered protocols, were published. One group, led by Anick Bérard, published a systematic review and meta-analyses, which was conducted with the benefit of a protocol, and which found no increased in risks for neurodevelopmental disorders, including autism, and small associations for ADHD that were not confirmed as causal. The authors noted that the findings suggested cautious interpretation for clinical guidance.[36] In their review of the extant studies and prior reviews Bérard and colleagues noted the methodological inadequacy of the Prada review for causal analysis.[37]
Another systematic review and meta-analysis published in 2026, in a Lancet journal, concluded that the current state of the evidence did not show clinically important increases in ASD or ADHD in children born to women who used acetaminophen.[38]
The Prada review has other features that point to the unreliability of its methodology.[39] The Prada review’s risk of bias assessment was controversial, to say the least. The published article rates study quality, including bias, on a scale of -2 to +2. The paper fails to explain fully how the authors selected the bias scores. Part of the Prada review study score was association size, but this conflates study result with methodological quality, and thus assumes that that exposure is strongly associated or not associated with the outcome. This scoring scheme downplays the contribution of a well-designed null study with a relative risk equal to 1.0. The Prada review authors ignored potential for recall bias and for confounding by genetic and familial factors.
The Navigation Guide approach, as applied by the Prada review, weighs the individual studies being considered, but does not give greater weight to studies that have more robust design and are better suited to support causal inference. The Prada review provides no quantification of the risk of bias. The Prada review also exhibited self-interested personal bias. The review assessed a body of studies including studies written by Beate Ritz, a co-author of the Prada review. Not surprisingly, the studies for which Ritz was a co-author were evaluated as studies with low risk of bias. The sum total of the Prada review’s scoring system and study evaluation created substantial cherry picking or outcome bias.
(to be continued)
[1] Environmental Health – Ethics & disclosures, https://link.springer.com/journal/12940/ethics-and-disclosures
[2] Committee on Publication Ethics, Guidance on Declaring funding sources for research – Last reviewed: 29 April 2026, https://publicationethics.org/guidance/discussion-document/declaring-funding-sources-research.
[3] Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 593 (1993).
[4] Id.
[5] Id. at 593-94.
[6] David Goodstein, How Science Works, in National Academies of Sciences, Engineering and Medicine & Federal Judicial Center, REFERENCE MANUAL ON SCIENTIFIC EVIDENCE 37, 44-45 (3rd 2011). Goodstein’s chapter is vastly superior to the parallel chapter in the fourth edition, published in December 2025.
[7] Id. at 44-45 n. 11.
[8] Id. at 48 (emphasis added).
[9] Philippe Grandjean & David Ozonoff, Environmental Health: the first five years, 6 ENVT’L HEALTH 27, 27 (2007). See Environmental Health, available at https://link.springer.com/journal/12940.
[10] Environmental Health: Aims and scope, available at https://link.springer.com/journal/12940/aims-and-scope.
[11] Environmental Health: editorial board, available at https://link.springer.com/journal/12940/editorial-board,
[12] Collegium Ramazzini Membership, available at https://perma.cc/9B25-WXB9.
[13] See Council of Fellows, Seventh Collegium Ramazzini Statement – The Precautionary Principle: Implications for Research and Policy Making, (Oct. 25, 2003), 45 AM. J. INDUS. MED. 380 (2004); Collegium Ramazzini, The
Precautionary Principle: Implications for Research and Policy Making, 11 HUM. & ECOL. RISK ASSESS. 3 (2005).
[14] See Wingspread Conference on the Precautionary Principle (Jan. 26, 1998), https://perma.cc/R6N7-9PLR (among those in attendance was David Ozonoff, founding editor of Environmental Health and member of the Collegium Ramazzini).
[15] In re School Asbestos Litig., 977 F.2d 764 (3d Cir. 1992). See Cathleen M. Devlin, Disqualification of Federal Judges – Third Circuit Orders District Judge James McGirr Kelly to Disqualify Himself So as to Preserve ‘The Appearance of Justice’ Under 28 U.S.C. § 455 – In re School Asbestos Litigation (1992), 38 VILL. L. REV. 1219 (1993); Bruce A. Green, May Judges Attend Privately Funded Educational Programs? Should Judicial Education Be Privatized?:
Questions of Judicial Ethics and Policy, 29 FORDHAM URB. L. J. 941, 996-98 (2002).
[16] Notes of Testimony from Deposition of Andrea Baccarelli, In re Acetaminophen ASD-ADHD Prods. Liab. Litig., Case No. 1:22-md-03043-DLC, at 55-56 (Aug. 14, 2023).
[17] Rebecca Robbins & Azeen Ghorayshi, Harvard Dean Was Paid $150,000 as an Expert Witness in Tylenol Lawsuits, N.Y. TIMES (Sept. 23, 2025), available at https://www.nytimes.com/2025/09/23/health/harvard-dean-autism-tylenol-lawsuits-payment.html.
[18] In re Acetaminophen ASD-ADHD Prods. Liab. Litig., 707 F. Supp. 3d 309 (S.D.N.Y. 2023) (Cote, J.).
[19] Ann Z. Bauer, Shanna H. Swan, David Kriebel, Zeyan Liew, Hugh S. Taylor, Carl- Gustaf Bornehag, Anderson M. Andrade, Jørn Olsen, Rigmor H. Jensen, Rod T. Mitchell, Niels E. Skakkebaek, Bernard Jégou & David M. Kristensen, Paracetamol use during pregnancy — a call for precautionary action, 17 NATURE REV. ENDOCRINOL. 757 (2021). [Call for Precautionary Action]
[20] Kenvue Brands LLC, Comment to Docket No. FDA-2025-P-4153, Response to the citizen petition filed by the Informed Consent Action Network (“Petitioner”)
on September 22, 2025 (Oct. 17, 2025) (identifying Baccarelli and Bauer as experts / consultants in the acetaminophen litigation), available at https://www.kenvue.com/kenvue-brands-citizen-petition-response.
[21] See, e.g., In re Roundup Prods. Liab. Litig., 390 F. Supp. 3d 1102 (2018); Barrera v. Monsanto Co., Del. Super. Ct. (May 31, 2019), at https://scholar.google.com/scholar_case?case=1288295772524535914&q=BARRERA+v.+MONSANTO&hl=en&as_sdt=2006; Pilliod v. Monsanto Co., 67 Cal. App. 5th 591, 282 Cal. Rptr. 3d 679 (2021). See also Dan Charles, Taking the stand: For scientists, going to court as an expert witness brings risks and rewards, 383 SCIENCE 942 (Feb. 29, 2024) (quoting Ritz as coyly suggesting that she was reluctant to get involved as an expert witnesses).
[22] In re Baby Food Prods. Liab. Litig., case No. 24-md-03101-JSC (N.D. Calif. Feb. 27, 2026), available at https://scholar.google.com/scholar_case?case=3987170845628579218&q=%22Beate+Ritz%22&hl=en&as_sdt=2006; R. Brent Wisner, Expert Hearing for Heavy Metals in Baby Food Litigation Begins Jan. 31, 2022, WISNER BAUM (Jan. 25, 2022), at https://www.wisnerbaum.com/blog/2022/january/expert-hearing-for-heavy-metals-in-baby-food-lit/.
[23] Mary-Rose Abraham, How are pesticides and Parkinson’s disease linked? One doctor’s research spans 25 years, UCLA HEALTH NEWS (June 12, 2025)
https://www.uclahealth.org/news/article/how-are-pesticides-and-parkinsons-disease-linked-beate-ritz.
[24] Conor Kennedy, at WISNER BAUM (Aug. 1, 2026), at https://www.wisnerbaum.com/attorneys/conor-kennedy/.
[25] John Wilkerson, RFK Jr. is giving his son any fees he earns from Gardasil vaccine litigation, STAT (Jan. 31, 2025) (Robert F. Kennedy, Jr., was a consultant and case referral source for the Wisner Baum law firm), at https://www.statnews.com/2025/01/31/rfk-jr-hhs-gardasil-litigation-fees-divest-son-wisner-baum/.
[26] Patrice Sutton, Heather Sarantis, Julia Quint, Mark Miller, Michele Ondeck, Rivka Gordon & Tracey Woodruff, Navigating the Scientific Evidence to Improve Prevention: A Proposal to Develop A Transparent and Systematic Methodology to Sort the Scientific Evidence Linking Environmental Exposures to Reproductive Health Outcomes (July 29, 2009), available at https://www.healthandenvironment.org/uploads-old/7-29-09%20Complete%20Final%20Discussion%20Document%20Navigating%20the%20Science%20Workshop.pdf.
[27] See Quan Nha Hong & Pierre Pluye, Systematic reviews: A brief historical overview, 34 EDUCATION FOR INFORMATION 261, 261 (2018) (describing the evolution of systematic reviews as made up of a “foundation period 1970-1989,” an “institutionalization period 1990-2000, and a “diversification period” from 2001 forward.)
[28] Matthias Egger, Julian P. T. Higgins & George Davey Smith, SYSTEMATIC REVIEWS IN HEALTH RESEARCH: META-ANALYSIS IN CONTEXT (3rd ed. 2022). The first edition of this text was published in 1995.
[29] Tracey J. Woodruff, Patrice Sutton, and The Navigation Guide Work Group, An Evidence-Based Medicine Methodology To Bridge The Gap Between Clinical And Environmental Health Sciences, 30 HEALTH AFFAIRS 931 (2011); Julia R. Barrett, The Navigation Guide Systematic Review for the Environmental Health Sciences, 122 ENVT’L HEALTH PERSP. A283 (2014).
[30] Tracey J. Woodruff & Patrice Sutton, The Navigation Guide Systematic Review Methodology: A Rigorous and Transparent Method for Translating Environmental Health Science into Better Health Outcomes, 122 ENVT’L HEALTH PERSP. 1007 (2014).
[31] Paul Whaley, Crispin Halsall, Marlene Ågerstrand, Elisa Aiassa, Diane Benford, Gary Bilotta, David Coggon, Chris Collins, Ciara Dempsey, Raquel Duarte-Davidson, Rex Fitzgerald, Malyka Galay-Burgos, David Gee, Sebastian Hoffmann, Juleen Lam, Toby Lasserson, Len Levy, Steven Lipworth, Sarah Mackenzie Ross, Olwenn Martin, Catherine Meads, Monika Meyer-Baron, James Miller, Camilla Pease, Andrew Rooney, Alison Sapiets, Gavin Stewart, and David Taylor, Implementing systematic review techniques in chemical risk assessment: Challenges, opportunities and recommendations, 92-93 ENV’T INTERNAT’L 556, 560 (2016).
[32] Id.
[33] Julia Menon, Fréderique Struijs & Paul Whaley, The methodological rigour of systematic reviews in environmental health, 52 CRITICAL REV. TOXICOL. 167 (2022).
[34] David Coghill, Rigorous Methods Matter: Reassessing Acetaminophen Safety in Pregnancy, 65 J. AM. ACAD. CHILD & ADOLESCENT PSYCHIATRY 477 (2026).
[35] Jameela Sheikh, John Allotey, Soha Sobhy, Maria Nieves Plana, Hilario Martinez-Barros, Harshitha Naidu, Fatima Junaid, Reecha Sofat, Ben W Mol, Louise C Kenny, Melissa Gladstone, Helena Teede, Javier Zamora & Shakila Thangarati, Maternal paracetamol (acetaminophen) use during pregnancy and risk of autism spectrum disorder and attention deficit/hyperactivity disorder in offspring: umbrella review of systematic reviews, 391 BRIT. MED. J. e088141 (2025).
[36] Anick Bérard, Judith Cottin, Lisiane F. Leal, Cyndie Picot, Justine Pleau, Jan M. Friedman, MD, Per Damkier, Michel Cucherat, Sura Alwan, Lucie Jurek, Louise M. Winn, Bruce C. Carleton, Andréa D. Bertoldi, Sonia M. Grandi, Reem Masarwa, Philippe Dodin, Michael Ceulemans, Robert W. Platt, Mikail Nourredine, Erika Björkström Gram, Areti Angeliki Veroniki, Jérôme Massardier & Andrea C. Tricco, Systematic Review and Meta-Analysis: Acetaminophen Use During Pregnancy and the Risk of Neurodevelopmental Disorders in Childhood, 65 J. AM. ACAD. CHILD & ADOLESCENT PSYCHIATRY 484 (2026).
[37] Id. at 485.
[38] Francesco D’Antonio, Maria Elena Flacco, Lorenza Della Valle, Smriti Prasad, Lamberto Manzoli, Athina Samara & Asma Khalil, Prenatal paracetamol exposure and child neurodevelopment: a systematic review and meta-analysis, 2 LANCET OBSTET. GYNECOL. WOMEN’S HEALTH e190 (2026).
[39] See Eric Fombonne, The acetaminophen scare: association vs causation, 66 J. AM. ACAD. CHILD & ADOLESCENT PSYCHIATRY 1621, 1623 (2026); Frank Louwen, Eileen Deuster, Fionnuala M. McAuliffe, Bo Jacobsson, Michael Geary, Steven Fleischman & Anne-Beatrice Kihara, Paracetamol (acetaminophen) use during pregnancy and autism risk: Evidence does not support causal association, 171 INTERNAT’L J. GYNECOL. & OBSTET. 915, 916 (2025) (“The Prada et al. 2025 review cited by political figures, while employing the Navigation Guide methodology, suffers from fundamental methodological limitations that significantly compromise its reliability and clinical applicability.”).
