Greater support for IBS and SIBO patients with indications for Zaxine (Rifaxmin).

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Health Canada, please provide greater support to IBS and SIBO patients in terms of indications for medicines like Zaxine (Rifaxmin).

Good health should not be a privilege, it is the fundamental necessity in which all life can continue to thrive - the key to good health being a healthy digestive system.  

This petition is addressed to Health Canada, specifically those deciding indications for drugs that can be applied to IBS (irritable bowel syndrome), SIBO (small intestinal bacterial overgrowth) and other digestive disorders where beneficial medications can be used. It is being asked that health Canada to further recognize the severity of IBS and SIBO and their many subsidiary health issues as modern health conditions of major concern and consequence that lack affordable treatment and standardized support emphasizing a void in compassion and understanding of these conditions. Broadening indications of medications like Zaxine (Rifaxamin) would be providing the opportunity for greater coverage and affordability to patients whose cases could benefit from such treatment.  

Canada has one of the highest rates of IBS in the world.

5 million Canadians suffer from IBS with 120,000 Canadians developing IBS each year

Each year, the economic and health care burden of IBS is in excess of $6.5 billion. This does not include monies spent on either over-the-counter drugs or prescriptions.

A patient with IBS misses an average of 13 work days a year. At $72.60, this indirect cost represents $8 billion of lost productivity each year.

About 40% of IBS sufferers seek medical attention. Those with milder symptoms typically end up self-treating through life style changes, food avoidance, and non-prescription remedies.

Patients with IBS represent the majority of referrals to gastroenterologist's.

IBS affects more women than men.

Maritime provinces have the highest rates of IBS in Canada with Newfoundland coming in first place.

Acute care inpatient costs for IBS are ranked as the 4th most expensive digestive disease in Canada. [1]

Zaxine (Rifaxmin)[2], [3], is a medication that acts like an antibiotic. Zaxine’s strength is that it targets bacterial infections and imbalances by inhibiting bacterial growth. This can be extremely useful in treating harder to reach areas of the bowel where typical antibiotics aren’t effective or even counter productive. This mechanism of Zaxine allows for much needed relief to a body taxed by bacterial overgrowth as well as helping the immune system and help to restore balance to the guts biome making Zaxine a viable option for those with bacterial related cases of IBS and SIBO. [4], [5], [6], [7]  Zaxine currently has only one approved indication in Canada[8]  for Hepatic encephalopathy. An ‘indication’ means a specific medical condition is recognized by Health Canada to be effectively and safely treated by a medication. For an indication to be given to a medical condition, evidence of the drugs efficacy must be reviewed. Once a medical condition is approved for the indication that correlates with the medication it potentially allows patients greater coverage for the medication through public or private drug plans. For Ontario-specific products: CED (committee to evaluate drugs) reviews the evidence and provides a recommendation to the Executive Officer regarding whether to reimburse through Ontario’s publicly-funded drug program.[9] Furthermore, once an indication is given to a drug it still does not mean it’s covered provincially so we are asking Health Canada to review a new indication for Zaxine compassionately.

What it means to have your digestive health compromised can easily be the difference between existing and living your life.

People can suffer for many years as they’re bounced around the medical community with an IBS or SIBO diagnosis. 12 years ago, I was laughed out of gastroenterologist’s offices just for asking if bacteria could be connected to my problem. This lead to many years of self-treatment while new science on the subject began revealing bacteria’s role in IBS [10] and the existence of SIBO. Unfortunately, and unknowingly, over the next ten years my bones decreased in mass, my digestion got worse, my immune system weakened, my body ached from inflammation, recurring psoriasis kept acting up and my mood suffered as my life was significantly derailed. Not to mention those who suffered around me as I functioned less and less. My good years were usurped by illness that seemed to defy logic with no treatment prescribed. “If it’s not Crohns or Colitis then you’re fine” a doctor once stated. Now we know more. Now we have greater insight into gut related illness. The medical community is catching up and providing for some of us, via medication, a way to break the cycle.

What we’re up against - what happens in the gut doesn’t stay in the gut. A problem that exists in the gut can affect almost every other function of the body. Bacteria in the gut and throughout the body have the potential to contribute to a long list of physical and even mental disorders. [11], [12]  Our gut biome is not just a fun buzz topic anymore when gut related issues are on the rise and affecting people who may or may not have identifiable digestive disorders but are suffering from the effects of a poorly functioning gut just the same.

Digestive disorders cost $18 billion (2000) annually in health care costs and lost productivity. [13]

Bacteria is where it gets even more complicated because it’s not obvious which bacteria are a threat when we live symbiotically with over 10,000 species in our bodies [14] [15] [16], one third of which is common while the other two thirds are unique to us. Common bacteria we all have like H. pylori, one of the oldest known strains, can move quite freely throughout the body.[17]  H. pylori [18], though not observed as an immediate threat when kept in check, can in fact become opportunistic resulting in serious health issues [19] [20] [21]but thankfully we have affordable antibiotics as a treatment in those cases. A greater concern is if the bacteria become opportunistic somewhere else in body – like the small intestine. This could require a specific antibiotic where the affordability of treatment changes drastically. Zaxine is a one-of-a-kind antibiotic costing roughly $500 a round because it does what others can’t by reaching and affecting bacterial overgrowth in the small intestine. With an approved indication from Health Canada, Zaxine could help patients now and prevent more serious and costly health issues from developing later - prevention is the key we should all be working towards.

More than 20 million Canadians suffer from digestive disorders every year. Those of you who are affected know how devastating this can be on your personal and professional life. However, because few people speak openly about their digestive symptoms, the magnitude of the problem is underestimated by government, employers and the general public.[22] 

When acute problems arise in the gut, general health is compromised. Daily life becomes a nightmare with food behaving like an enemy. Imagine reacting to good, healthy foods of all kinds as if they were toxic? With SIBO, specific carbohydrates and fiber are consumed by bacteria. What’s bad about that? Largely it’s what they produce in terms of chemicals that can be extremely toxic to the body leading to major health issues. [23], [24], [25],[26],[27] The rabbit hole gets deeper in terms of bacteria and its long arm of disruption to our bodies. Now the best part. Bacteria can reside deep within the body settling into areas like the upper or lower bowel - the small intestine - and it’s there where they can thrive creating systemic illness and relentless health trouble.

 

Friendly bacteria are in fact not always our friends - we are more like their hosts. They don’t owe us anything and it’s up to us to enforce an equilibrium. When the balance is off, something as harmless as digesting an apple can mimic the same symptoms of a nasty flu. The list of foods to avoid seems endless and regaining a balance of beneficial bacteria in the gut is an ambitious task as conditions such as IBS (an umbrella for many troubling and life altering physical conditions. [28], [29], [30]) and SIBO contribute to a growing population of struggling patients suffering from digestive or digestive related woes.[31], [32], [33] The commonality in these and some other illnesses that are being observed are gut bacteria[34] and their relationship with many debilitating conditions[35] ranging from autoimmune disorders, malabsorption of nutrients and specifically fructose[36], weight loss, weight gain, skin disorders [37], [38], [39], [40], [41]  mental health and brain function [42],[43], [44], inflammation[45], [46]and the list goes on. [47], [48], [49], [50], As a result, the endless amount of debilitating systemic responses can leave one unable to function like a healthy human being.

Health Canada, you won’t cover a $100-dollar fecal calprotectin test, but you will cover going into a hospital for an endoscopy and colonoscopy which could costs thousands. I learned more from a calprotectin test than from four invasive scopes.

Why not help by making a drug more affordable while leading the way in restoring hope for the many who suffer. [51]

We don’t own these bodies completely, we share them in order to thrive. [52], [53] 

[1] http://www.cdhf.ca/en/statistics
[2] http://www.lupinpharma.ca/zaxine/
[3] https://en.wikipedia.org/wiki/Rifaximin
[4] https://www.medicalnewstoday.com/articles/212981.php
[5] https://www.ncbi.nlm.nih.gov/pubmed/21208106
[6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4737517/
[7] https://www.ncbi.nlm.nih.gov/pubmed/17520365
[8] https://www.ontario.ca/page/medication-coverage-results/?q=rifaximin
[9] http://www.health.gov.on.ca/en/pro/programs/drugs/how_drugs_approv/how_drugs_approv.aspx
[10] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4734998/
[11] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4425030/
[12]https://www.medicinenet.com/small_intestinal_bacterial_overgrowth_sibo/article.htm#associated_sibo_types_of_other_diseases_or_conditions_associated_with_it
[13] http://www.cdhf.ca/en/statistics
[14] https://mpkb.org/home/pathogenesis/microbiota
[15] https://en.wikipedia.org/wiki/Human_microbiota
[16] https://www.npr.org/sections/health-shots/2012/06/13/154913334/finally-a-map-of-all-the-microbes-on-your-body
[17] https://www.ncbi.nlm.nih.gov/pubmed/18705796
[18] http://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1002693
[19] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4348668/
[20] https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/h-pylori-fact-sheet
[21] https://fixyourgut.com/h-pylori-evil-mastermind-or-ally-part-1/
[22] http://www.cdhf.ca/en/statistics
[23] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4566437/
[24] https://en.wikipedia.org/wiki/Microbial_toxin
[25] https://www.ncbi.nlm.nih.gov/pubmed/3281562
[26] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3153206/
[27] https://en.wikipedia.org/wiki/Microbial_toxin
[28] https://www.uptodate.com/contents/clinical-manifestations-and-diagnosis-of-irritable-bowel-syndrome-in-adults?search=ibs&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2
[29] https://digestive.templehealth.org/content/IBS.htm
[30] https://www.mayoclinic.org/diseases-conditions/irritable-bowel-syndrome/multimedia/irritable-bowel-syndrome/vid-20084703
[31] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5347643/
[32] https://www.siboinfo.com/overview.html
[33] https://fixyourgut.com/treatment-of-gerd-protocol-1-sibo/
[34] https://www.physiology.org/doi/10.1152/physrev.00045.2009
[35] https://www.ncbi.nlm.nih.gov/pubmed/22424233?dopt=Abstract&holding=npg
[36] http://www.jnmjournal.org/journal/view.html?uid=798&vmd=Full
[37] https://www.ncbi.nlm.nih.gov/pubmed/18456568
[38] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3038963/
[39] https://onlinelibrary.wiley.com/doi/full/10.1002/art.38892
[40] https://link.springer.com/article/10.1007/s11926-013-0407-2
[41] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4951142/
[42] http://www.pnas.org/content/108/7/3047.full
[43] http://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1003726
[44] http://www.gastrojournal.org/article/S0016-5085(98)70540-2/fulltext
[45]https://journals.lww.com/jcge/Abstract/2017/11000/Postinfection_Irritable_Bowel_Syndrome__The_Links.6.aspx
[46] http://www.openaccessjournals.com/articles/the-gut-microbiome-dysbiosis-and-its-potential-role-in-psoriatic-arthritis.pdf
[47] https://www.ncbi.nlm.nih.gov/books/NBK7670/
[48] http://www.gutmicrobiotaforhealth.com/en/home/metabolic-conditions/
[49] http://www.mynewgut.eu/research
[50] https://www.siboinfo.com/overview.html
[51] http://www.cdhf.ca/en/statistics
[52] https://www.webmd.com/digestive-disorders/ss/slideshow-how-gut-health-affects-whole-body
[53] http://www.mynewgut.eu/



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