Fake Placebos and Red Herrings make Anti-Nutrition Headlines and Direct the Course of Healthcare and Medical Education: Critique of Effect of Vitamin D and Omega-3 Fatty Acid Supplementation on Kidney Function in Patients with Type 2 Diabetes published in JAMA 2019

 

PDF version available from ICHNFM.ORG/journal and https://ichnfm.academia.edu/AlexVasquez

 

Context

Major medical journals publish bogus pro-drug and anti-nutrition research in order to 1) groom medical audiences for pharmaceutical purchases, 2) defend and please their pharmaceutical advertisers (who—in addition to spending hundreds of millions of dollars on advertising—commonly purchase article reprints for millions of dollars/$, euros/€, pounds/£[1]), 3) maintain the financial and sociopolitical dominance of the medical profession, 4) deter the general public from seeking and using nonmedical treatments, and 5) misinform politicians and policymakers so that laws, public funds, policies, and research monies will be directed in favor of the medical profession, including medical schools (that produce consecutive generations of pharmaceutically indoctrinated and nutritionally illiterate clones) and drug researchers who use public funds to create privatized drugs that escalate profit of the pharmaceutical industry. While such has always been the inherent bias of the medical publishing industry, some of us noted a new wave of remarkable exacerbations of this bias including overt deceptions and ethical departures published in the biomedical research starting in 2018.[2],[3] The cyclical-reciprocal feeding of misinformation from medical journals and drug companies to medical students, physicians, policymakers, the media (e.g., television, magazines, and newspapers—all of which receive millions of $/€/£ in drug company advertising) creates the pro-pharma “echo chamber” which—when repetition becomes consensus becomes practice becomes sales becomes profit for bribing politicians to write pro-pharma laws forcing the population to receive mandatory drugs[4]—becomes the pro-pharma “power vortex” with each aspect reinforcing the other, ultimately leading to medical profiteering, political dominance, censorship of information, blockade of criticism, and restriction of free speech, including banning of books, blockade of documentary films, censorship of individuals, and aggressive and structured attacks against medical professionals to “destroy, neutralize, discredit” them.[5] Illustration from: Pharma Echo Chamber, Sociopolitical Matrix, and Power Vortex. IJHNFM 2019 academia.edu/38476348 See also2,3

 

Critique en breve

On November 8 of 2019, JAMA—Journal of the American Medical Association published “Effect of Vitamin D and Omega-3 Fatty Acid Supplementation on Kidney Function in Patients With Type 2 Diabetes” (doi:10.1001/jama.2019.17380); this is yet another pathetic “nutrition study” which was so poorly designed and misrepresentative of the practice of clinical nutrition that it was sure to provide the desired “negative” results for JAMA’s medical audience and the resulting headlining news distributed to millions of professionals, policymakers, and patients. As a matter of course, the story was rapidly echoed by pro-pharma Medscape (and numerous other medial magazines) in the expected uniformed and adolescent commentary.[6] My initial critiques of this publication are as follows

1. Authors and Editors failed integrate previous data: In order for science to advance and avoid repeating the same errors and wasting misappropriated effort (i.e., repeatedly recreating the wheel in the age of air and space travel), research authors and journal editors have the responsibility to competently maintain awareness of the current state of the art so that research and publications reflect advancement in the field. Clearly in the case of this publication, neither the authors nor the editors represented the current state of the art in nutritional management the conditions discussed herein.[7] The numerous nutritional interventions previously shown to provide positive benefit for this condition were ignored in this publication to support what appears to have been the predetermined conclusion and goal.

2. Nobody really thinks this would work: This investigation was mostly a wild goose chase, a strawman fallacy. No Naturopathic or Clinical Nutrition student would intervene in such a complex condition as diabetes with pending renal insufficiency by solely using underdosed fish oil and underdosed vitamin D; as such this intervention represents clinical incompetence more so than the competent clinical practice of Nutrition and any of its related variants (e.g., Functional Medicine, Naturopathic Medicine, Functional Inflammology, etc).

3. The investigators used inadequate doses of both nutrients in order to ensure failure of the intervention: The authors used <50% of the proper dose of vitamin D for healthy patients[8],[9], let alone a proper dose for diabetic patients which is more commonly in the range of 10,000 IU per day.[10],[11] The authors used 44% of the proper dose of EPA+DHA; obviously, under-dosing the treatments is expected to lead to lackluster results and much ado about nothing.

4. The investigators intentionally hid the identity of the placebo so that readers would not know what really happened: The authors failed to provide the identity of the "placebo" so that doctors and policymakers would not know that they used olive oil as the placebo in order to undercut the perception of any clinical benefit; olive oil is one of the most potent antiinflammatory and cardioprotective oils known to biomedical science. Using olive oil as a “placebo” is inappropriate in an intervention testing the efficacy of a cardioprotective and renoprotective intervention.

5. This study does not represent the modern practice of Clinical Nutrition: Half-baked ideas presented as reasonable intervention are still half-baked ideas; this study is inappropriate in its design, implementation, and reporting. This study does nothing to inform the practice of Medicine, and—in fact by misrepresenting a flawed study as a legitimate study—this publication simply misleads healthcare professionals, policymakers, and the general public.

6. As expected, this low-quality research was repeated throughout the pro-pharma echo chamber: The inaccurate summary of this meaningless publication resounded via various pro-medical and pro-drug websites internationally. The commentary published by Medscape concluded, “This was a high quality [sic] trial that tells us that we don't need to focus our energies here [on using vitamin D and fish oil]. Only a novice or ignoramus would consider this “a high quality [sic] trial” and describing it as such does more than mislead the reader about this particular topic but also by extension about the very nature of clinical research, ethics, and investigational study design.

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"A red herring is something that misleads or distracts from a relevant or important question. It may be either a logical fallacy or a literary device that leads readers or audiences toward a false conclusion." from Wikipedia

 

Conclusion

This publication "Effect of Vitamin D and Omega-3 Fatty Acid Supplementation on Kidney Function in Patients with Type 2 Diabetes" published in JAMA 2019 is a disservice to physicians, policymakers, and patients and should be retracted from the biomedical record. This investigation intentionally underdosed both interventions, withheld the identity of the placebo, and attempted to apply these interventions in an inappropriate manner that was unlikely to benefit patients and was nearly ensured to produce negative results which would then be inappropriately generalized in news and other media outlets; as such this publication is a red herring—a piece of information which is or is intended to be misleading or distracting. Journal editors and trial authors should consult with legitimate nutrition experts prior to the design and publication of research outside their scope of training, knowledge, and experience. 

           

PDF version available from ICHNFM.ORG/journal and https://ichnfm.academia.edu/AlexVasquez

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About the author and presenter: Alex Kennerly Vasquez DO ND DC (USA), Fellow of the American College of Nutrition (FACN), Overseas Fellow of the Royal Society of Medicine: An award-winning clinician-scholar and founding Program Director of the world's first fully-accredited university-based graduate program in Human Nutrition and Functional Medicine, Dr Alex Vasquez is recognized internationally for his high intellectual and academic standards and for his expertise spanning and interconnecting many topics in medicine and nutrition. Dr Vasquez holds three doctoral degrees as a graduate of University of Western States (Doctor of Chiropractic, 1996), Bastyr University (Doctor of Naturopathic Medicine, 1999), and University of North Texas Health Science Center, Texas College of Osteopathic Medicine (Doctor of Osteopathic Medicine, 2010). Dr Vasquez has completed hundreds of hours of post-graduate and continuing education in subjects including Obstetrics, Pediatrics, Basic and Advanced Disaster Life Support, Nutrition and Functional Medicine; while in the final year of medical school, Dr Vasquez completed a Pre-Doctoral Research Fellowship in Complementary and Alternative Medicine Research hosted by the US National Institutes of Health (NIH). Dr Vasquez is the author of many textbooks, including Integrative Orthopedics (2004, 2007 2012), Functional Medicine Rheumatology (Third Edition, 2014), Musculoskeletal Pain: Expanded Clinical Strategies (commissioned and published by Institute for Functional Medicine, 2008), Chiropractic and Naturopathic Mastery of Common Clinical Disorders (2009), Integrative Medicine and Functional Medicine for Chronic Hypertension (2011), Brain Inflammation in Migraine and Fibromyalgia (2016), Mitochondrial Nutrition and Endoplasmic Reticulum Stress in Primary Care, 2nd Edition (2014), Antiviral Strategies and Immune Nutrition (2014), Mastering mTOR (2015), Autism, Dysbiosis, and the Gut-Brain Axis (2017) and the 1200-page Inflammation Mastery 4th Edition (2016) also published as a two-volume set titled Textbook of Clinical Nutrition and Functional Medicine. "DrV" has also written approximately 100 letters and articles for professional magazines and medical journals such as TheLancet.com, British Medical Journal (BMJ), Annals of Pharmacotherapy, Nutritional Perspectives, Journal of Manipulative and Physiological Therapeutics (JMPT), Journal of the American Medical Association (JAMA), Original Internist, Integrative Medicine, Holistic Primary Care, Alternative Therapies in Health and Medicine, Journal of the American Osteopathic Association (JAOA), Dynamic Chiropractic, Journal of Clinical Endocrinology and Metabolism, Current Asthma and Allergy Reports, Complementary Therapies in Clinical Practice, Nature Reviews Rheumatology, Annals of the New York Academy of Sciences, and Arthritis & Rheumatism, the Official Journal of the American College of Rheumatology. Dr Vasquez lectures internationally to healthcare professionals and has a consulting practice and service for doctors and patients. DrV has served as a consultant, product designer, writer and lecturer for Biotics Research Corporation since 2004. Having served on the Review Boards for Journal of Pain Research, Autoimmune Diseases, PLOS One, Alternative Therapies in Health and Medicine, Neuropeptides, International Journal of Clinical Medicine, Journal of Inflammation Research, BMC Complementary and Alternative Medicine (all PubMed/Medline indexed), Integrated Blood Pressure Control, Journal of Biological Physics and Chemistry, and Journal of Naturopathic Medicine and as the founding Editor of Naturopathy Digest, Dr Vasquez is currently the Editor (2013-) of International Journal of Human Nutrition and Functional Medicine and Editor (2018-present) of Journal of Orthomolecular Medicine, published for more than 50 consecutive years by the International Society for Orthomolecular Medicine.

 

Citations: 

[1] Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med 2005 May;2(5):e138 https://doi.org/10.1371/journal.pmed.0020138

[2] Vasquez A, Pizzorno J. Concerns About the Integrity of The Scientific Research Process-Focus On Recent Negative Publications Regarding Nutrition, Multivitamins, Fish Oil And Cardiovascular Disease. Integr Med (Encinitas). 2019 Feb;18(1):8-15 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6601430/ Archived by author (Vasquez) at https://www.academia.edu/39907759 

[3] Vasquez A. Vitamins Against Viruses: Implausible Pro-Vaccine Publications Contrasted Against Ignored Public Health Campaigns and Double-Blind Placebo-Controlled Clinical Trials. Journal of Orthomolecular Medicine 2019 https://isom.ca/article/vitamins-against-viruses  Archived by author at https://www.academia.edu/39406350

[4] "Critics of Senate Bill 277, which would eliminate the personal belief and religious exemptions for schoolchildren, accuse the measure’s supporters in the Legislature of doing the bidding of donors who make vaccines and other pharmaceuticals. ... Receiving more than $95,000, the top recipient of industry campaign cash is Sen. Richard Pan, a Sacramento Democrat and doctor who is carrying the vaccine bill. In addition, the industry donated more than $500,000 to outside campaign spending groups that helped elect some current members last year. Leading pharmaceutical companies also spent nearly $3 million more during the 2013-2014 legislative session lobbying the Legislature, the governor, the state pharmacists’ board and other agencies, according to state filings." Miller J. Drug companies donated millions to California lawmakers before vaccine debate. Sacramento Bee 2015 Jun https://www.sacbee.com/news/politics-government/capitol-alert/article24913978.html

[5] "Merck made a "hit list" of doctors who criticized Vioxx, according to testimony in a Vioxx class action case in Australia. The list, emailed between Merck employees, contained doctors' names with the labels "neutralise," "neutralised" or "discredit" next to them. According to The Australian, Merck emails from 1999 showed company execs complaining about doctors who disliked using Vioxx. One email said: We may need to seek them out and destroy them where they live..." Edwards J. Merck Created Hit List to "Destroy," "Neutralize" or "Discredit" Dissenting Doctors. 2009 May https://www.cbsnews.com/news/merck-created-hit-list-to-destroy-neutralize-or-discredit-dissenting-doctors

[6] Wilson FP. The Charlie Brown of Supplements Strikes Out Again. medscape.com/viewarticle/920520 2019 November 13

[7] Vasquez A. Textbook of Clinical Nutrition and Functional Medicine (Inflammation Mastery). International College of Human Nutrition and Functional Medicine. Barcelona, 2016 https://www.inflammationmastery.com/book-nutrition-functional-medicine

[8] Vasquez A, Manso G, Cannell J. The clinical importance of vitamin D (cholecalciferol): a paradigm shift with implications for all healthcare providers. Altern Ther Health Med. 2004 Sep-Oct;10(5):28-36 https://www.academia.edu/18078062

[9] Vasquez A, Cannell J. Calcium and vitamin D in preventing fractures: data are not sufficient to show inefficacy. BMJ. 2005 Jul 9;331(7508):108-9 https://www.academia.edu/40429791

[10] Vasquez A. How to Understand, Refute, and Plan Studies Using Vitamin D. Int J Hum Nutr Funct Med 2017 https://www.academia.edu/31412957

[11] Kimball SM, Mirhosseini N, Holick MF. Evaluation of vitamin D3 intakes up to 15,000 international units/day and serum 25-hydroxyvitamin D concentrations up to 300 nmol/L on calcium metabolism in a community setting. Dermatoendocrinol 2017 Apr 13;9(1):e1300213. doi: 10.1080/19381980.2017.1300213