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CGRP Blockade for Migraine: Some Day We Will Look Back and Laugh (or Cry)

 

  • Science will be rewritten to promote pharmaceutical profits: Now that CGRP-blocking drugs are on the market, the pathophysiology of migraine has to be re-written in order to change the clinical paradigm to accommodate pharmaceutical profiting and the "need" for more medical services surrounding the prescription and laboratory monitoring for these drugs. For the few patients who both 1) can afford these drugs, and 2) benefit from these drugs, I truly wish them well and hope they experience no adverse effects. Unfortunately, these drugs do not address the underlying problems that cause migraine, but certainly acute pain relief has value independent from the delivery of optimal healthcare.

  • Pharmaceutical cheerleaders gain high-profit headline-making employ: I will resist the temptation to embarrass individual people, many with high-profile professorships in esteemed (ie, corporate-friendly) institutions, by showcasing via cited quotations their lack of restraint in their paid and overzealous endorsements of these new drugs. "Breakthrough" is the term most commonly employed as they describe this "new horizon" now visible as these new drugs "shake the ground beneath our feet" and herald "a new age in migraine treatment."

  • High cost: With annual cost-per-patient of US$7,000 - US$8,500, popular use of the new CGRP drugs will bankrupt most patients and most healthcare systems. Borrowing three sentences from Joshua Cohen's "Migraine Breakthrough: Not So Fast" published in Forbes (2018 Jun 6) [1]:

"Suppose all eligible patients were to receive Aimovig or one of its competitors for one year. This would amount to a pharmacy budget impact of $27.6 billion. One sixth of that figure - $4.6 billion - would be money worth spending on the new product, but $23 billion would effectively be wasted. And, $23 billion is approximately the entire federal budget allocated to healthcare services and treatment for people living with HIV in the U.S."

  • Low Efficacy: In the real world, benefit of these new drugs is seen in one-per-six or up to one-per-ten migraine patients, ie, NNT=6 or NNT=10, which means that 83-90% of patients do not benefit. This is worse than the notably low response rate with triptan drugs, and is abysmally less efficient than nutritional treatments' NNT of <2.

  • CGRP is the most powerful vasodilating mediator known. Blocking CGRP is quite likely if not assured to promote cardiovascular, renal, and gastrointestinal complications, among other problems such as delayed wound healing and alterations in gastrointestinal function. Blocking an endogenous vasodilator is effectively the same as inducing iatrogenic vasoconstriction, exactly as occurred with rofecoxib/Vioxx, which was also lauded as a “breakthrough” anti-inflammatory drug because it was considered “specific” for painful inflammation; a “specific” “breakthrough” that killed tens-hundreds of thousands of people before being withdrawn 5 years after it hit the market [2].

  • Beneficial properties of CGRP: Here, I will make a quick list of the benefits of CGRP so that everyone can appreciate what it does and what blocking it is likely to induce (for the latter, just reverse each of the following):

  1. Vasodilation

  2. Blood pressure reduction

  3. Cardioprotection

  4. Promotion of wound-healing

  5. Modulation (biphasic) of gastrointestinal motility

  6. Enhancement of mitochondrial function (likewise with calcitonin)

  • The violence of organized and systematic forgetting: In medicine and biomedical science, we commonly collectively forget major legitimate advances in our understanding of disease causation and cure, especially when our forgetting is convenient for gain of personal and professional power, prestige, and profit. What appears to matter most is that we regularly resign our knowledge and consciousness in service of paradigm.

     Personally, I don't care too much if CGRP-blocking drugs work or don't work; if anything, I actually hope that they do work for the patients who have not responded to the otherwise supremely safe and effective treatments I have outlined [3]. So, in summary and repetition, if anything I am in favor of these drugs, assuming (naively) that they might be used appropriately, which they will not be. Doctors are not trained in nutrition and even though they are increasingly trained in "systems biology", they are not trained in integrative and internventional nutrition as a therapeutic approach, despite the supporting science, clinical efficacy and enviable safety.

  • We've been here before: Rofecoxib/Vioxx was shown to increase cardiovascular deaths several years before the drug was withdrawn [4]; the most aggressive advertising campaigns hitherto seen in medicine overran what medicine always says is its precautionary principle. So, here again I believe, we are overriding science in favor of another high-profit flash-in-the-pan. Only time will tell, and like I said, I hope I'm wrong, but I'm not: the mere fact of spending ~US$8,000 per patient-year at 17% effectiveness before metabolically corrective treatment has been used is already a losing game, even if zero cardiovascular risks are demonstrated. A few years from now, we will either look back and laugh at this ridiculous overexpenditure, or we'll be (de)crying in witness of yet another pharmacocentric profiteering scheme that hoodwinked patients and doctors into yet another round of iatrogenic injuries and deaths. 

"But down there- there speaks everything, there is everything misheard. If one announce one's wisdom with bells, the shopmen in the market-place will out-jingle it with pennies! Everything among them talks; no one knows any longer how to understand. Everything falls into the water; nothing falls any longer into deep wells. Everything among them talks, nothing succeeds any longer and accomplishes itself."

Nietzsche in "Thus Spoke Zarathustra"

 

Citations: [1] Cohen J. Migraine Breakthrough: Not So Fast. Forbes 2018 Jun 6 forbes.com/sites/joshuacohen/2018/06/06/migraine-breakthrough-not-so-fast [2] Cockburn A. When half a million Americans died and nobody noticed. The Week 2012 Apr theweek.co.uk/us/46535/when-half-million-americans-died-and-nobody-noticed. Topol EJ. Failing the public health--rofecoxib, Merck, and the FDA. N Engl J Med. 2004 Oct 21;351(17):1707-9 https://www.nejm.org/doi/full/10.1056/NEJMp048286 [3] Pain Revolution https://www.amazon.com/dp/B01AR3NX0S/ or in slightly cheaper grayscale as Brain Inflammation https://www.amazon.com/dp/B01EQ9KMH6 [4] Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA. 2001 Aug 22-29;286(8):954-9

Originally posted 25 Sep 2018: https://www.linkedin.com/pulse/cgrp-blockade-migraine-some-day-we-look-back-laugh-alex/?published=t

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The migraine protocol excerpted from Inflammation Mastery (PDF cover, PDF contents) has been developed and published since Dr Vasquez was professor of Orthopedics and Rheumatology at Bastyr University nearly 20 years ago. Since then, the protocol has been repeatedly verified and updated, including a commissioned continuing medical education (CME) monograph published by Institute for Functional Medicine in 2008. Dr Vasquez has presented this information to international audiences of healthcare providers and has published related information in journals such as Nature Reviews Rheumatology and Journal of the American Osteopathic Association.

The exact same migraine protocol is available in different formats, contexts, and under different titles, depending on whether you want 1) the entire protocol or just a smaller section, 2) migraine with fibromyalgia or just migraine alone, and 3) paper book or digital ebook:

  1. Inflammation Mastery 4th Edition: This is the complete protocol and context at 1,200 pages; also published separately as two volumes titled Textbook of Clinical Nutrition and Functional Medicine with Chapter 5 published as volume 2

  2. Pain Revolution in full-color, includes the protocols for migraine and fibromyalgia, since these conditions commonly occur together; available as paper book and digital ebook

  3. Brain Inflammation printed in discounted grayscale, ie, black and white; available as paper book and digital ebook

  4. Migraine and Headache Revolution: Digital ebook exclusively focused on migraine

 

Recommendations: ​

  • Paper book version: The general consensus is that people learn information at a deeper level when they read paper books because they interact with the material physically, can take notes directly on the page, and can easily flip pages to see other related information.

  • Digital ebook version: The digital ebook version for example via Amazon's Kindle platform allows the owner to read the book on phone, iPad and computer and to make highlights and notes that are synchronized across all devices. The Kindle app is free; download a *free* sample of Inflammation Mastery to your phone and/or computer here via the *free* Kindle software from Amazon.

  

News and updates: ​

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Inflammation Mastery 4th Edition (PDF cover, PDF contents) is the "master textbook" that details the functional inflammology protocol, described below. The full-color paper book is available for international shipping from ICHNFM.ORG while paper and digital versions are available from major bookstores such as Amazon.com (also amazon.co.uk in the UK and amazon.de in Germany...) and BarnesandNoble.com. Because the information in this book has already been time-proven via previous publications and extensive peer-review and thousands of citations to authoritative sources, it will not change nor be replaced in the foreseeable future. Any necessary updates will be provided by articles, videos, live webinars, and an extending separate "volume 3" described below.

Sample PDF downloads: ​

 

Contents: Preamble/Contextualization, Chapters/subsections

  1. Patient Assessments, Laboratory Interpretation, Clinical Concepts, Patient Management, Practice Management and Risk Reduction: This chapter introduces/reviews/updates patient assessments, laboratory interpretation, musculoskeletal emergencies, healthcare paradigms; the common and important conditions hemochromatosis and hypothyroidism are also included in this chapter since these need to be considered on a frequent basis in clinical practice 

  2. Wellness Promotion & Re-Establishing the Foundation for Health: Reviewed here are diet, lifestyle, psychosocial health, and—given the pervasiveness of persistent organic pollutants and their increasingly recognized clinical importance—an introduction to environmental medicine

  3. Basic Concepts and Therapeutics in (Nondrug) Musculoskeletal Care and Integrative Pain Management: Nonpharmacologic management of musculoskeletal problems is preferred over pharmacologic (e.g., NSAID, Coxib, steroid, opioid) management because of the collateral benefits, safety, and cost-effectiveness associated with manual, dietary, botanical, and nutritional treatments. A brief discussion of the current crisis in musculoskeletal medicine is provided for contextualization and emphasis of the importance of expanding clinicians' knowledge of effective nondrug treatments

  4. The Major Modifiable Factors in Sustained Inflammation: Major components of the “Functional Inflammology Protocol” are reviewed here, from concepts and molecular biology to an emphasis on practical clinical applications: A few sections have been printed separately and are thus linked

    1. Food & Basic Nutrition  307

    2. Infections: Dysbiosis / Viral Infections  396 / 540

    3. Nutritional Immunomodulation  609

    4. Dysmetabolism, Mitochondrial Dysfunction/ERS/UPR, and mTOR  622

    5. Special Considerations: Sleep, Sociopsychology, Stress, Surgery  674

    6. Endocrine Imbalances  688

    7. Xenobiotic Immunotoxicity  699

  5. Clinical Applications 

    1. Hypertension  727

    2. Diabetes Mellitus  819

    3. Migraine & Headaches  863 (also published separately)

    4. Fibromyalgia  901 (also published separately)

    5. Allergic Inflammation  984

    6. Rheumatoid Arthritis  1019

    7. Psoriasis and Psoriatic Arthritis  1038

    8. Systemic Lupus Erythematosus  1053

    9. Scleroderma & Systemic Sclerosis  1074

    10. Vasculitic Diseases  1094

    11. Spondyloarthropathies & Reactive Arthritis  1108

    12. Sjögren Syndrome/Disease  1119

    13. Raynaud's Syndrome/Phenomenon/Disorder  1127

    14. Clinical Notes on Additional Conditions: Behçet's Disease, Sarcoidosis, Dermatomyositis and Polymyositis  1131

  6. Index & Appendix (PDF)

Available in one large volume or 2 smaller volumes, in paper or digital ebook for phones, iPads, computers: ​

  • Same content either all together or in 2 volumes: Because Inflammation Mastery 4th Edition is large at nearly 1,200 pages and because the previous version of chapters 1-4 had been published as "volume 1" in 2004, the book was also published separately as two volumes titled Textbook of Clinical Nutrition and Functional Medicine; this was done at the request of the students who use the book in their classes and clinical work and also to respect those who had purchased the previous version of chapters 1-4 and who simply needed to add chapter 5, which is published as volume 2

  • Paper book version: The general consensus is that people learn information at a deeper level when they read paper books because they interact with the material physically, can take notes directly on the page, and can easily flip pages to see other related information.

  • Digital ebook version: The digital ebook version for example via Amazon's Kindle platform allows the owner to read the book on phone, iPad and computer and to make highlights and notes that are synchronized across all devices. The Kindle app is free; download a *free* sample of Inflammation Mastery 4th Edition here via the *free* Kindle software from Amazon.

  

News and updates: ​

  • Volume 3 which will focus exclusively on dysbiosis and the microbiome and its clinical implications and treatments will be published in 2018 or more likely 2019. The information in this new 3rd volume will be completely new, derived from Dr Vasquez's 30-hour video course Human Microbiome and Dysbiosis in Clinical Disease.

  • See smaller updates and news at Dr Alex Vasquez 's Inflammation Mastery on facebook.com/InflammationMastery

Bulk discounts (orders of 5 or more books shipped to the same address) are available for students, book clubs, and study groups by emailing admin@ichnfm.org.

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