The geneticist C.H. Waddington found in A.N. Whitehead's metaphysics the power of generalization that produced the basic principles of process, creativity and choice, all of which provided a theoretical framework and informed the direction of his scientific research on the development and evolution of organisms. In this paper I begin by examining the flaws in a purely mechanistic and materialistic philosophy, show how Whitehead's concept of organism addresses these flaws and finally explore Whitehead's influence on Waddington. Both Whitehead and Waddington's views suggest a revolutionary change of paradigm in theoretical biology.

BACKGROUND: Medical ethics guidelines require of clinical trial investigators and sponsors to inform prospective trial participants of all known and potential risks associated with investigational medical products, and to obtain their free informed consent. These guidelines also require that clinical research be so designed as to minimize harms and maximize benefits. OBJECTIVE: To examine Merck’s scientific rationale for using a reactogenic aluminum-containing “placebo” in Gardasil HPV vaccine pre-licensure clinical trials. METHODS: We examined the informed consent form and the recruitment brochure for the FUTURE II Gardasil vaccine trial conducted in Denmark; and we interviewed several FUTURE II trial participants and their treating physicians. We also reviewed regulatory documentation related to Gardasil vaccine approval process and the guidelines on evaluation of adjuvants used in human vaccines. RESULTS: It was found that the vaccine manufacturer Merck made several inaccurate statements to trial participants that compromised their right to informed consent. First, even though the study protocol listed safety testing as one of the study’s primary objectives, the recruitment brochure emphasized that FUTURE II was not a safety study, and that the vaccine had already been proven safe. Second, the advertising material for the trial and the informed consent forms stated that the placebo was saline or an inactive substance, when, in fact, it contained Merck’s proprietary highly reactogenic aluminum adjuvant which does not appear to have been properly evaluated for safety. Several trial participants experienced chronic disabling symptoms, including some randomized to the adjuvant “placebo” group. CONCLUSION: In our view, the administration of a reactive placebo in Gardasil clinical trials was without any possible benefit, needlessly exposed study subjects to risks, and was therefore a violation of medical ethics. The routine use of aluminum adjuvants as “placebos” in vaccine clinical trials is inappropriate as it hinders the discovery of vaccine-related safety signals.

Evidence based medicine has been corrupted by corporate interests, failed regulation, and commercialisation of academia, argue these authors

Other| May 01 2022 Ode to Heraclitus Leemon McHenry Leemon McHenry Search for other works by this author on: This Site Google Process Studies (2022) 51 (1): 5. https://doi.org/10.5406/21543682.51.1.01 Cite Icon Cite Share Icon Share Twitter Permissions Search Site Citation Leemon McHenry; Ode to Heraclitus. Process Studies 1 January 2022; 51 (1): 5. doi: https://doi.org/10.5406/21543682.51.1.01 Download citation file: Zotero Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search Search Dropdown Menu toolbar search search input Search input auto suggest filter your search All Scholarly Publishing CollectiveUniversity of Illinois PressProcess Studies Search Advanced Search You do not currently have access to this content.

Sulla scorta della distinzione di P. F. Strawson tra metafisica descrittiva e revisionista, in questo saggio esamino questi due differenti approcci rispetto a un’ontologia degli eventi e avanzo l’ipotesi che un approccio revisionista basato sulla fisica moderna sia una base più realizzabile in vista di una teoria ontologica. La metafisica descrittiva, in accordo con Aristotele e Kant, dà priorità al ruolo che gli eventi rivestono nel linguaggio ordinario. Gli eventi si rivelano dipendenti dalle sostanze poiché sono attività di corpi materiali. La metafisica revisionista, in accordo con Whitehead, Russell e Quine, respinge il linguaggio ordinario in qualità di guida dell’ontologia. In questa prospettiva, gli eventi sono le entità primarie e i corpi materiali si rivelano quali schemi relativamente monotoni nelle sequenze degli eventi. Ciò è la conclusione derivante dalla teoria einsteniana della relatività e da varie interpretazioni della meccanica quantistica. La scienza ha superato la teoria sostanzialistica di Aristotele e dei suoi continuatori.

Sulla scorta della distinzione di P. F. Strawson tra metafisica descrittiva e revisionista, in questo saggio esamino questi due differenti approcci rispetto a un’ontologia degli eventi e avanzo l’ipotesi che un approccio revisionista basato sulla fisica moderna sia una base piu realizzabile in vista di una teoria ontologica. La metafisica descrittiva, in accordo con Aristotele e Kant, da priorita al ruolo che gli eventi rivestono nel linguaggio ordinario. Gli eventi si rivelano dipendenti dalle sostanze poiche sono attivita di corpi materiali. La metafisica revisionista, in accordo con Whitehead, Russell e Quine, respinge il linguaggio ordinario in qualita di guida dell’ontologia. In questa prospettiva, gli eventi sono le entita primarie e i corpi materiali si rivelano quali schemi relativamente monotoni nelle sequenze degli eventi. Cio e la conclusione derivante dalla teoria einsteniana della relativita e da varie interpretazioni della meccanica quantistica. La scienza ha superato la teoria sostanzialistica di Aristotele e dei suoi continuatori.

The Journal of American CultureVolume 43, Issue 2 p. 157-159 Book Review American Values: Lessons I Learned From My Family. Robert F. Kennedy. HarperCollins, 2018. Leemon B. McHenry, Leemon B. McHenry California State University, NorthridgeSearch for more papers by this author Leemon B. McHenry, Leemon B. McHenry California State University, NorthridgeSearch for more papers by this author First published: 30 June 2020 https://doi.org/10.1111/jacc.13164Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume43, Issue2June 2020Pages 157-159 RelatedInformation

For most patients, doctors are gods and goddesses who perform medical miracles with magic bullet drugs and precision surgeries. In a society that views medicine as a highly valued commodity, faith in intervention is high and the more of it, the better we are for health and longevity. But according to Stegenga’s somewhat counter-intuitive thesis: ‘[i]f we attend more critically and broadly to our evidence, malleable methods, and background theories, and reason with our best inductive framework, then our confidence in the effectiveness of medical interventions ought to be low’ (2). He asks why so much confidence is placed in medical interventions when: methods that are employed to test medical interventions are ‘malleable’: the design, execution, analysis, interpretation, publication, and marketing of medical studies involve numerous fine-grained choices, and such choices are open to being made in a variety of ways, and these decisions influence what is taken to be the pertinent evidence regarding a medical intervention under investigation. Another line of explanation, which is equally compelling and compliments my focus on the methods of medical research, appeals to the fantastic financial incentives in place for selling medical interventions that seem effective. Such incentives entail that when evidence can be bent in one direction or another because of the malleability of methods, such bending is very often toward favoring medical interventions, and away from truth (2).

Editorial independence is a bedrock principle of academic publishing. The growing domination of academic publishing by large, for-profit corporations threatens this independence. There is alarming evidence that large companies too often serve their own business interests and those of powerful clients rather than serving the scientific community and the general public. This evidence includes the publication of infelicitous commercial science and concealing scientific misconduct. We present two case studies in which the UK-based publisher Taylor & Francis interfered in the editorial process by blocking publication of legitimate criticism that had been reviewed and approved for publication by its specialized editors. The integrity of science depends in part on the transparency and intellectual honesty of all stakeholders. The widely-acknowledged inadequacies of English libel law are reviewed as context for some of Taylor & Francis’s fearful decisions.

Medical ghostwriting is the practice in which pharmaceutical companies engage an outside writer to draft a manuscript submitted for publication in the names of “honorary authors,” typically academic key opinion leaders. Using newly-posted documents from paroxetine litigation, we show how the use of ghostwriters and key opinion leaders contributed tothe publication of a medical journal article containing manipulated outcome data to favor the proprietary medication.The article was ghostwritten and managed by SmithKline Beecham, now GlaxoSmithKline (GSK) and Scientific Therapeutics Information, Inc. without acknowledging their contribution in the published article. The named authors with financial ties to GSK had little or no direct involvement in the paroxetine 352 bipolar trial results and most had not reviewed any of the manuscript drafts. The manuscript was originally rejected by peer review; however, its ultimate acceptance to the American Journal of Psychiatrywas facilitated by the journal editor who also had financial ties to GSK. Thus, GSK was able to take an under-powered and non-informative trial with negative results and present it as a positive marketing vehicle for off-label promotion of paroxetine for bipolar depression. In addition to the commercial spin of paroxetine efficacy, important protocol-designated safety data were unreported that may have shown paroxetine to produce potentially harmful adverse events.

Reviewed by: Ghost-Managed Medicine: Big Pharma’s Invisible Hands by Sergio Sismondo Leemon B. McHenry Sergio Sismondo, Ghost-Managed Medicine: Big Pharma’s Invisible Hands, Mattering Press, 2018 Sergio Sismondo coined the term “ghost-management” to characterize the broad behind-the-scenes activities of the pharmaceutical industry after he successfully infiltrated publication planning conferences and seminars from 2007 to 2017 as sort of academic spy. His academic espionage mission provided valuable intelligence. In addition to revelations from lawsuits against the pharmaceutical industry and accounts from former ghostwriters turned whistleblowers, Sismondo’s information from within has been crucial to understanding the corruption in the conduct and reporting of industry-sponsored medical research. Ghost-Managed Medicine exposes the conspiracy to conceal the players in the marketing of drugs, including ghostwriters, key opinion leaders, patient advocacy organizations, contract research organizations, publication planners, and even medical journal editors and publishers. The credibility of the claims conveyed by the industry depends on the invisibility of these players. Publication planning of ghostwritten articles is the bedrock of this scheme. It is conducted by pharmaceutical companies working in conjunction with medical communication firms to plant marketing messages in medical journal articles. Medical communication firms also produce continuing medical education programs, medical conference [End Page E-12] presentations, and lunch and dinner drug talks from the same content that produced the journal articles, all delivered by physicians who have the greatest influence on prescribers, namely, the key opinion leaders or thought leaders. Sismondo’s main example of the harm done to patients is the case of OxyContin (oxycodone), now infamous for its part in the opioid epidemic in North America which has taken over 200,000 lives (30–31). Sismondo begins his book describing a common scenario in which a patient takes a drug as prescribed by his physician. For prescribing strategies, the physician relies upon an article she read in a medical journal and a presentation at a medical conference. From this point Sismondo describes how the patient and physician’s trust that they are operating rationally is largely misguided because of a system designed to conceal all of the invisible forces of marketing which influenced the information available. But now let us suppose that the patient suffers a serious adverse event or even death as a result of the drug’s side effects. It turns out, as is so common in these situations, that the drug company concealed the adverse event in the articles published in the medical journals and was able to do so because the critical data from the clinical trials is the intellectual property of the company. Neither the ghostwriters nor the nominal “authors” on the articles ever see that data. In the case of OxyContin, one of the influential ghostmanaged medical journal articles was reprinted 10,000 times for distribution to prescribing physicians (34). One of the most alarming revelations of this book is Sismondo’s discussion of the role of medical journal editors as co-conspirators in the corruption of medicine. Sismondo, who attended meetings of the International Society of Medical Planning Professionals and the International Publication Planning Association, reports that in addition to ghostwriters and medical communication executives, publishers and medical journal editors attended these meetings and gave lectures as stakeholders in the business of publishing the results of industry-sponsored clinical trials. Some medical journal editors gave sales pitches at these meetings, essentially soliciting publication planners to submit ghosted articles to their high-impact journals (91–94). Medical journals in this respect continue to be part of the problem rather than the solution to the problem. Instead of demanding rigorous peer review of submissions and an independent analysis of the data, most editors are eager to publish favorable articles of industry-sponsored trials and rarely publish critical deconstructions of ghostwritten clinical trials. This is due to the simple [End Page E-13] fact that medical journals and their owners have become dependent upon pharmaceutical revenue that comes in the form of advertising, reprint sales and, more recently, fees for open access. Commenting on the role of ghostwriters in the process, Sismondo writes: Articles are produced by teams, perhaps no one member of which meets requirements for authorship. In...

OBJECTIVE:Examination of de-classified Monsanto documents from litigation in order to expose the impact of the company's efforts to influence the reporting of scientific studies related to the safety of the herbicide, glyphosate.METHODS:A set of 141 recently de-classified documents, made public during the course of pending toxic tort litigation, In Re Roundup Products Liability Litigation were examined.RESULTS:The documents reveal Monsanto-sponsored ghostwriting of articles published in toxicology journals and the lay media, interference in the peer review process, behind-the-scenes influence on retraction and the creation of a so-called academic website as a front for the defense of Monsanto products.CONCLUSION:The use of third-party academics in the corporate defense of glyhphosate reveals that this practice extends beyond the corruption of medicine and persists in spite of efforts to enforce transparency in industry manipulation.

Reviewed by: The Philosophy of Evidence-Based Medicine by Jeremy Howick Leemon McHenry Jeremy Howick, The Philosophy of Evidence-Based Medicine, Wiley-Blackwell, 2011 The idea that prescribing physicians should be guided by the most reliable scientific evidence seems obvious, but the actual methodology of evidence-based medicine was only introduced in the early 1990s by an international group of clinicians and researchers led by Gordon Guyatt. Since then it has provided a new paradigm for the scientific foundation of medicine and has influenced other disciplines outside of medicine, for example, evidence-based psychotherapy, science and government. The novel concept of evidence-based medicine is based on hierarchies of evidence from opinions of respected authorities, mechanistic reasoning (pathophysiologic rationale), and reports of expert committees at the bottom to various levels of observational studies and finally to randomized clinical trials (RCTs) at the apex of the pyramid. Since RCTs provide the most rigorous testing of therapies, they are the gold standard. When treatments long believed to be safe and effective are subjected to RCTs, many turn out to be as useless as the quackery of snake oil or as harmful as mercury. So, attention to RCTs as the evidence informing clinical judgment and practice is perhaps analogous to results of rigorous experiments in physics which turn out to be very different from our intuitions. Everyone, it seems, is on the bandwagon, from medical societies and pharmaceutical companies to general practitioners and surgeons, in the quest for an evidence-based practice. Since evidence-based medicine was conceived with the practical aim of improving the efficacy of medicine, it does not appear that there is much of philosophical interest in the concept until one raises the epistemological question, as Jeremy Howick does in this book: What is the evidence for evidence-based medicine philosophy of evidence (9)? In other words, what is the evidence that evidence-based medicine is any better in improving patient outcomes than medical practice before the new paradigm? So, evidence-based medicine requires evidence and this is what Howick attempts to achieve in this splendid treatment of the subject. With an eye on the philosophical, Howick is also concerned with various paradoxes that [End Page E-1] arise concerning the hierarchies of evidence-based medicine; for example, many treatments in whose effectiveness we have the most confidence have never been subjected to RCTs, including simple procedures such as the Heimlich maneuver and tracheotomy. Howick’s thesis is that the evidence-based medicine hierarchies are sustainable provided that we take into account certain modifications, for one that “strict hierarchies should be replaced by the requirement that all evidence of sufficiently high quality should be admitted as evidential support” (xiv, 187). This being the case, we need not subject treatments we know to be effective to RCTs, for this would be as redundant as the need to test parachute effectiveness against parachute placebo. In order to qualify as good evidence for an evidence-based medicine, outcomes must be clinically effective (clinically significant, rather than merely statistically significant) according to which: (i) patient-relevant benefits outweigh any harms, (ii) the treatment is applicable to the patient being treated, and (iii) it is the best available option (24). The evidence must demonstrate that the patient will live longer or better. Good evidence also rules out plausible rival hypotheses (33). So, RCTs generally maintain their position in the hierarchies because when well-designed and well-conducted (double-masked and randomized), RCTs minimize confounding factors such as the expectation of patients to recover by knowing they are given the experimental treatment. Observational studies cannot meet this standard because they involve observations in routine practice that cannot rule out the confounding factors. Certain observational studies will claim a treatment to be effective and safe but, when subjected to rigorous RCTs, show the very opposite. The same relationship holds between conclusions drawn on the basis of mechanistic reasoning and well-conducted clinical studies. Faced with contradictory conclusions from results in the hierarchies, Howick says it is rational to bet on the results form RCTs since RCTs are less likely to suffer from bias (53). However, Howick introduces his rule of evidence: comparative clinical studies (or observational studies...