Citizens Speak

 The following is a sample of feedback that I have received recently.

 

From Jeffry F.

I support your application to the Canadian Federal Government to adopt ivermectin as a therapeutic under emergency use provisions to help save lives in this pandemic. The clinical evidence is overwhelmingly. We also support the FLCCC. How can I assist you?

I don't have much patience for politics and it appears to me the global practise of diplomacy has eroded to non-existence. Science should be the deciding factor and the existing IVM clinical reports are demonstrably conclusive.  Ōmura Satoshi's report published last week should be front page news yet no one is talking about it and its hard to find even with a google search. Have you read his latest release?  http://jja-contents.wdc-jp.com/pdf/JJA74/74-1-open/74-1_44-95.pdf. 

From Ondrej H.

Thank you very much for arranging the ivermectin petition. My name is Ondrej H. and I work at University of Toronto. Over the past few months I have been promoting the use of ivermectin for the treatment of Covid-19. I have been able to get in touch with researchers in Australia, many leading doctors in US and some doctors in Europe. I'm originally from Slovakia. Me and others have been able to make ivermectin available there - maybe you saw that Slovakia became the 1st EU country to approve ivermectin for both prophylaxis and treatment of Covid-19. It has subsequently been widely discussed in the neighboring Czech Republic too. 

In March, Czech Republic purchased ivermectin for 20,000 patients.

From Joanne S.

 I have sent petition to all friends and family with this note along other information about Ivermectin: “This is a petition to the House of Commons initiated by a Professor Emeritus at Queens University, Kanji Nakatsu. His endorsement of Ivermectin, after a 44-year career as a professor of pharmacology and toxicology, is additional assurance to me of both the utility and the safety of this drug.”

... politicians don’t realize they could be heroes if they supported and facilitated this initiative has been one of the biggest puzzles of all to me in the pandemic. I’ve sent letters and emails to dozens of them suggesting this.

 From: Carolina Venditti

To:Premier Doug Ford, Minister of Health Christine Elliott, Prime Minister Justin Trudeau, Minister of Health Patty Hajdu, NDP Leader Jagmeet Singh, PC Leader Erin O'Toole, MP Mark Gerretson, MP Dean Allison

I am writing this letter in support of the use of ivermectin, both as a prophylaxis and as a treatment for COVID-19. As a mother of two young children and the wife of a front-line worker, it is frustrating and infuriating to know that there is currently a medication which could not only treat persons with COVID-19, but also be of use prophylactically, and yet this medication (i.e., ivermectin) is not being made readily available to all Canadians.

With a doctorate in Biomedical and Molecular Sciences, I understand the information presented in scientific publications (of which there are MANY), which describe both ivermectin’s safety [i.e., ivermectin is approved by the United States Food and Drug Administration and by Health Canada as an anti-parasitic drug and has been used for years to treat billions of persons globally, for example those diagnosed with scabies or malaria (reviewed by Kircik et al., 2016)] and its efficacy [i.e., randomized controlled trials, systematic reviews and many case reports have shown that this anti-parasitic drug displays anti-viral and anti-inflammatory properties which can effectively treat persons diagnosed with COVID-19 (Carvallo et al., 2020; Elgazzar et al., 2020; Gorial et al., 2020; Hashim et al., 2020; Khan et al., 2020; Mahmud, 2020; Morgenstern et al., 2020; Niaee et al., 2020; Portmann-Baracco et al., 2020; Rajter et al., 2020; Robin et al., 2020; Spoorthi V, 2020 and reviewed in Kory et al., 2020)]. While the data are unquestionably compelling and substantiate the use of ivermectin as a treatment for COVID-19, you certainly do not need to read my reiteration of the information, which has so clearly been presented time and time again by numerous scientists, doctors and prominent scientific groups, including the FLCCC Alliance (Available at: https://covid19criticalcare.com/ivermectin-in-covid-19/).

The use of ivermectin to treat patients diagnosed with COVID-19 is not a new concept. Brave doctors globally have been prescribing this medication over the course of this past year as an attempt to combat the effects of the pandemic. Data are available to show that, in countries where ivermectin has been provided to patients diagnosed with COVID-19, death rates due to the virus have dropped immensely [e.g., several states in Argentina, the state of Alto Parana in Paraguay, the state of Uttar Pradesh in India (reviewed by Juan Chamiea) and in Peru (Chamie, 2020)].

In Canada, when diagnosed with COVID-19, people are sent home with no recourse. Patients are returning to the hospital when the effects of the virus have worsened (e.g., they cannot breathe easily on their own); burdening our healthcare system, specifically the hospitals and their intensive care units. It is evident that we require some form of early home treatment. Even without the evidence from large, multi-centre efficacy trials, we should be using ivermectin as a treatment option.

I urge you to review the data. I urge you to provide this cheap, safe and highly effective medication to all Canadians for the treatment of COVID-19. I, like many others I know, have purchased food-grade veterinary ivermectin, should the need arise for my family to use it; we should not need to do this.

Thank you,

C. Venditti

Ph.D., Biomedical and Molecular Sciences Concerned Canadian mother of two and wife of a front-line worker

a Available at: https://covid19criticalcare.com/ivermectin-in-covid-19/epidemiologic-analyses-on-covid19-and-ivermectin/

References:

Carvallo, H.E., Hirsch, R.R., and Farinella, M.E. (2020). Safety and Efficacy of the combined use of ivermectin, dexamethasone, enoxaparin and aspirin against COVID-19. medRxiv.

Chamie, J. (2020). Real-World Evidence: The Case of Peru. Causality between Ivermectin and

COVID-19 Infection Fatality Rate.

Elgazzar, A., Hany, B., Youssef, S.A., Hafez, M., and Moussa, H. (2020). Efficacy and Safety of Ivermectin for Treatment and prophylaxis of COVID-19 Pandemic.

Gorial, F.I., Mashhadani, S., Sayaly, H.M., Dakhil, B.D., Almashhadani, M.M., Aljabory, A.M., Abbas, Hassan M, Ghanim, M., and Rasheed, J.I. (2020). Effectiveness of Ivermectin as add on Therapy in COVID-19 Management (Pilot Trial). medRxiv.

Hashim, H.A., Maulood, M.F., Rasheed, A.M., Fatak, D.F., Kabah, K.K., and Abdulamir, A.S. (2020). Controlled randomized clinical trial on using Ivermectin with Doxycycline for treating COVID-19 patients in Baghdad, Iraq. medRxiv.

Khan, M.S.I., Khan, M.S.I., Debnath, C.R., Nath, P.N., Mahtab, M.A., Nabeka, H., Matsuda, S., and Akbar, S.M.F. (2020). Ivermectin Treatment May Improve the Prognosis of Patients With COVID-19. Archivos de Bronconeumología

Kircik, L.H., Del Rosso, J.Q., Layton, A.M., and Schauber, J. (2016). Over 25 Years of Clinical Experience With Ivermectin: An Overview of Safety for an Increasing Number of Indications. Journal of drugs in dermatology : JDD 15, 325-332

Kory, P., MD, Meduri, G. U., MD, Iglesias, J., Varon, J., Berkowitz, K., MD, Kornfeld, H., MD, Vinjevoll, E., MD, Mitchell, S., MBChB, Wagshul, F., MD, and Marik, P. E. (2020). Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19. https://doi.org/10.31219/osf.io/wx3zn

Morgenstern, J., Redondo, J.N., De Leon, A., Canela, J.M., Torres, N., Tavares, J., Minaya, M., Lopez, O., Placido, A.M., and Castillo, A. (2020). The use of compassionate Ivermectin in the management of symptomatic outpatients and hospitalized patients with clinical diagnosis of COVID-19 at the Medical Center Bournigal and the Medical Center Punta Cana, Rescue Group, Dominican Republic, from may 1 to august 10, 2020. medRxiv

Niaee, M.S., Gheibi, N., Namdar, P., Allami, A., Zolghadr, L., Javadi, A., Karampour, A., Varnaseri, M., Bizhani, B., and Cheraghi, F. (2020). Ivermectin as an adjunct treatment for hospitalized adult COVID-19 patients: A randomized multi-center clinical trial.

Portmann-Baracco, A., Bryce-Alberti, M., and Accinelli, R.A. (2020). Antiviral and Anti Inflammatory Properties of Ivermectin and Its Potential Use in Covid-19. Arch Bronconeumol.

Rajter, J.C., Sherman, M.S., Fatteh, N., Vogel, F., Sacks, J., and Rajter, J.J. (2020). Use of Ivermectin is Associated with Lower Mortality in Hospitalized Patients with COVID-19 (ICON study). Chest.

Robin, R.C., Alam, R.F., Saber, S., Bhiuyan, E., Murshed, R., and Alam, M.T. (2020). A Case Series of 100 COVID-19 Positive Patients Treated with Combination of Ivermectin and Doxycycline. Journal of Bangladesh College of Physicians and Surgeons, 10-15.

Spoorthi V, S.S. (2020). Utility of Ivermectin and Doxycycline combination for the treatment of SARS-CoV2. International Archives of Integrated Medicine 7, 177-182. 

 

 From Donna Klay

Hello Dr. Nakatsu,

I am a family physician who has worked in Devon, Alberta for almost 39 years. I am reaching out to you as I saw the petition you started regarding the use of Ivermectin for the treatment of Covid 19. Unfortunately, I just became aware of the petition and did not have a chance to sign it before it closed. 

I have used Ivermectin for a handful of patients and found it to be amazing at reducing the symptoms of Covid 19 almost immediately. It is hard to obtain, as most pharmacies report there is a shortage of supply (why this should be is a whole other topic).

I agree 100% with your push to get Ivermectin approved and available to patients. I am bewildered that our governing professional colleges and Health authorities are turning a blind eye to this safe, simple and effective treatment that, if used appropriately, would go a long way to easing the health burden of this pandemic.

Donna Klay, MD. CCFP

Devon, Alberta

From Y.D.

please add that Merck's price for Molnupiravir would be near to but less than $3000/ treatment.. to compete with Remdesivir.. which explains why Merck opposes the use of IVM for Covid. i miilion treatments at S3000 a pop is not small money.. but 1miilion at S2 each.. is peanuts

 

 

E-message to Political Leaders

 

2021 April 16

Doug Ford, Premier of Ontario, Christine Elliott, Minister of Health (Ontario), Justin Trudeau, Prime Minister of Canada, Patty Hajdu, Minister of Health (Canada), Jagdeep Singh, NDP Leader, Erin O’Toole, PC leaders, Mark Gerretson, MP for Kingston and the Islands   c.c. Dean Allison, MP for Niagara West

Dear Honourable Leaders:

It’s time to look outside of the box, by that I mean the vaccine box. As good as they are, vaccines and hygiene practices alone are not solving the pandemic problem as it is described every day by the news media. It’s time to look at pharmaceutical help in general, and at ivermectin in particular. I am attaching a copy of one of the best meta-analyses on ivermectin for COVID-19; it is the British Ivermectin Review Panel report led by Dr. Tess Lawrie a veteran of over 50 Cochrane Systematic Reviews. The key information is that ivermectin as hospital treatment is 68% effective in reducing deaths and 86% effective as a prophylactic. Moreover, a number of physicians outside of Canada have reported excellent success with this drug; for example an Idaho doctor, Ryan Cole, reported that all 42 of the patients that he treated with ivermectin rebounded within two days.

What is the potential benefit? Ivermectin could relieve the hospitals immediately. It could save lives. It could save the health of health care workers. It could save $billions. It would cost $thousands.

What is the risk of toxicity? Ivermectin has been used against parasites in developing countries for 2-4 billion people over 40 years. Since 1992, 16 deaths and 4673 adverse events were reported to VigiAccess for ivermectin compared with remdesivir’s 417 deaths and 5489 adverse events since 2020. Ivermectin is probably safer than Aspirin.

Why have ivermectin benefits been muffled? I suggest that WHO cannot afford to irritate Merck, the donor of all the ivermectin needed for the WHO parasite program. While ivermectin is off-patent, Merck has potentially profitable anti-virals such as molnupiravir in development. As ivermectin effectiveness as a prophylactic is similar to that of vaccines, it is a financial risk to COVID-19 vaccine vendors.

How is ivermectin approval impaired? Opponents simply insist that gold standard large-scale, randomized, double-blind, placebo-controlled trials are required. Such trials are beyond the resources of virtually all teams in developing countries where the research has been instigated by independent doctors and scientists.

Why have federal and provincial advisory bodies not approved ivermectin? To a large extent, these panels have taken advice from WHO because of its global imprimatur. Moreover they do not have the experience or expertise of Dr. Lawrie’s Evidence Based Consultancy.

What have I done? A few colleagues and I have petitioned the Government of Canada, and the petition (e-3265) has over 2000 signatures in the three weeks since it was mounted on March 25. It will be presented to the House by MP Dean Allison. I have had signees tell me that they have obtained ivermectin through unconventional sources, such as meant for animals. As Canadians use unconventional ivermectin, we contribute to potential toxicities by depriving them of approved human product. This alone should prompt us to make it readily available to people; remember it is as safe as over-the-counter drugs such as Aspirin and Tylenol.

In closing, I ask that you immediately consider approving ivermectin use in our hospitals and community. To do anything less is wasteful and unethical; I don’t want our province and country to have blood on its hands.

Your sincerely,

Kanji Nakatsu

(While we dither, people die; ivermectin might have saved 40 of the 53 Canadians who died yesterday)

Response to the Ontario Science Table report “Recommended Drugs and Biologics in Adult Patients with COVID-19”

 

Response to the Ontario Science Table report “Recommended Drugs and Biologics in Adult Patients with COVID-19”

After reviewing the recommendations of the Clinical Practice Guideline Summary: Recommended Drugs and Biologics in Adult Patients with COVID-19, I am dismayed by the lack of consideration of ivermectin for both prevention and treatment of this disease. While it has recommended tocilizumab, the evidence for inclusion of ivermectin is much stronger. Accordingly, I ask that you reconsider your position on ivermectin.

It appears that the main strikes against ivermectin are (a) the majority of clinical trials supporting ivermectin for COVID-19 arose in developing countries, (b) lack of support from a gold standard large-scale, randomized, double-blind, placebo-controlled clinical trial and (c) World Health Organization (WHO) position.

Let me examine points (a) and (b) together. Whether it is acknowledged openly or not, research from unknown authors working in developing countries is not valued as highly as that originating in well-known institutions in the USA and Europe. It is doctors in developing countries who first observed the possible value of ivermectin because ivermectin is used widely primarily in developing countries. This is because these areas bear the greatest burden of parasitic diseases for which ivermectin was developed. It follows then that the trials were initiated by doctors working in environments with limited resources. Unfortunately this has resulted in many of the clinical trials on ivermectin lacking some of the features that panels like the Advisory Table deem essential. As ivermectin is well past its patent protection period, there is no major pharmaceutical company willing to invest in a gold standard trial to validate its effectiveness. But this does not mean that the research on ivermectin is without value, which I will address below.

The position on ivermectin taken by WHO is understandable when you consider the context in which it operates. Ivermectin has been generously donated by Merck for the treatment of parasitic diseases since 1987; one major recognition of the success of this program is the award of a Nobel Prize to Satoshi Omura (Japan) and William Campbell (Merck, USA). This ongoing support by Merck is of substantial value to WHO. Merck has decided not to pursue the application of ivermectin to COVID-19; this is understandable as the company has a major stake in seeing its new antiviral drug molnupiravir succeed. See Ridgeback Biotherapeutics and Merck Announce Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir - Merck.com In this context, it is easy to see that WHO cannot promote the use of ivermectin for COVID-19 without jeopardizing its anti-parasitic program. Under the circumstances, I urge the Advisory Table to weigh the WHO position very lightly.

Let me respectfully disagree with the statement “There is insufficient evidence to support the use of ivermectin in the treatment of critically ill patients with COVID-19 outside of clinical trials”. I bring my point of view as Professor Emeritus of Pharmacology after a 44-year career of teaching and research at Queen’s University; admittedly none of my research was on ivermectin or viruses. Nevertheless I entered the pandemic with an interest in vitamin D because of its evolution from a simple vitamin into a pro-hormone with many implications. See https://vitamindcovid.blogspot.com/2020/05/vitamin-d-covid-19-and-me.html. As the pandemic evolved, I became interested in ivermectin and read an abundance of the primary publications as well as meta-analyses regarding its use in COVID-19. Independently, I concluded that ivermectin could prevent ~90% of the cases and ~75% of the deaths. These numbers are similar to those contained in the meta-analyses performed by American and British groups with substantial resources and qualifications that far exceed mine. One of the British analysts, Tess Lawrie is perhaps the best qualified person to have lent her time to the question of ivermectin in COVID-19 being both research and medically trained, and having the experience of over 50 Cochrane Systematic Reviews under her belt.

The American Front Line COVID-19 Critical Care Alliance (FLCCC) has a well-established website that deals exclusively with COVID-19- https://covid19criticalcare.com/. They are dedicated to exploring treatments and prophylaxis of the disease. FLCCC alliance, which comprises credible physicians and scientists, was founded by Paul Marik who has published more than 700 papers. Among their accomplishments is an excellent summary of the information regarding drug prevention and treatment of COVID-19; see https://covid19criticalcare.com/wp-content/uploads/2020/11/FLCCC-Ivermectin-in-the-prophylaxis-and-treatment-of-COVID-19.pdf. This paper has been accepted for publication in the American Journal of Therapeutics. Two groups from the UK have conducted meta-analyses of the data regarding ivermectin for COVID-19; one is led by Tess Lawrie and the other by Andrew Hill; as of today neither of these have been peer-reviewed and published. The British Ivermectin Recommendation Development panel has made their manuscript available to the public and has sent it to many governments around the world. It can be found at https://b3d2650e-e929-4448-a527-4eeb59304c7f.filesusr.com/ugd/593c4f_1324461135c749dab73ed7c71e47d316.pdf

Lawrie concludes that “ivermectin substantially reduces the risk of a person dying from COVID-19 by ... 65% to 92%” and it may reduce “COVID-19 infections, probably somewhere in the region of 88%.” “Placebo-controlled trials of ivermectin treatment among people with COVID-19 infection are no longer ethical and active placebo-controlled trials should be closed.” I haven’t seen a manuscript from Dr. Andrew Hill’s group but there are video presentations of their work available such as https://www.youtube.com/watch?v=AYW9LV6AK7w. There are other meta-analyses and sources of information such as https://c19early.com/, which maintains coverage of nine drugs that have been tested in COVID-19; interestingly tocilizumab is not covered. One way to appreciate the overall effectiveness of any treatment is to view Forest Plots, see below. The first two plots describe ivermectin while the third addresses tocilizumab. Clearly, ivermectin compares well with tocilizumab. Ivermectin should be recommended in the Science Advisory Table report for both prophylaxis and treatment of COVID-19.

Caution is required. There are a number areas in which caution is required. The first is with respect to potential toxicity of veterinary ivermectin products. People are buying such preparations for use by their families, as I have been told directly. I’m not so concerned about the ivermectin therein but I do have some concerns about other ingredients, especially in preparations made for topical use on animals. If human preparations are not made available, we run the risk of people using veterinary drugs. While we are on the topic of toxicity, I should mention that ivermectin is among the least problematic drugs available. According to data from the Vigiaccess international database of adverse effects of drugs, there were 1470 adverse effect reports for ivermectin in 2020; there were 5932 such reports for tocilizumab. These are raw data and do not take into account widespread use of ivermectin and the limited use of tocilizumab; thus, it is safe to assume that ivermectin is much, much safer than tocilizumab. The second issue that we should consider is legal liability. With the strength of evidence supporting ivermectin efficacy and its low risk of toxicity, the Province should make this drug available to its citizens. Not to do so could be considered criminal behaviour or at least unethical. The Province of Ontario doesn’t need a lawsuit on its hands in addition to the pandemic. I don’t think that this is alarmism because families in New York state have sued successfully to have parents treated with ivermectin. I recognize that the legal jurisdictions differ but I am aware of a current Ontario lawsuit involving COVID-19. A third consideration is cost. The actual cost of administering tocilizumab to a COVID patient in Ontario was not available to me but based on Canadian information obtained by internet searches, it would be in the thousands of dollars. In comparison, the Stromectol brand of ivermectin is estimated to cost less than C$100 when it is available. The generic equivalent would be much less although perhaps not as inexpensive the Indian cost of less than US$3.

Please note that I am not against the approval of tocilizumab. I support the use of vaccines, PCR tests, antibody tests, masks, social distancing and hand hygiene. With the appropriate use of ivermectin we could save many lives, prevent many cases of COVID-19 and save a ton of money not to mention getting our lives closer to a pre-pandemic normal.

 

 

 

Annex 1 is from British Ivermectin Recommendation Development report.

  

 

This figure is from https://c19ivermectin.com/

 

 

Figure 5 is from Khan FA et al. Systematic review and meta-analysis of anakinra, sarilumab, siltuximab and tocilizumab for COVID-19. Thorax 2021 Feb 12;thoraxjnl-2020-215266. doi: 10.1136/thoraxjnl-2020-215266. Online ahead of print.