Petition follow-up letter to Hon Patty Hajdu

 

                                                                                                                      2021 May 09

Hon Patty Hajdu, Minister of Health

House of Commons

Ottawa, ON K1A 0A6

Dear Minister Hajdu:

re: petition and non-prescription status of ivermectin

My purpose in writing to you today is to request reclassification of ivermectin to a non-prescription drug. I have written to you before about the potential of ivermectin to substantially reduce the number of cases of COVID-19 as well as its effectiveness in treating the viral illness.

1. Canadians want access to ivermectin. Recently, I initiated a petition to the Government of Canada (e-3265) "to urgently examine the evidence in favour of ivermection and give due consideration to making ivermectin available immediately to Canadians as a schedule II medication, which can be obtained directly from a pharmacist." It garnered 4850 signatures by April 24, 30 days after it was initiated; even after the petition closed to signatures, I received messages and phone calls with regrets for not signing on time. In all likelihood, this petition will be directed to your office.

2. Ivermectin should be a critical complement to present tools. This drug can function as a complement to vaccines in critical ways. Firstly, it offers treatment in the early stages of this disease for which current drugs, such as tocilizumab, are marginally effective and unaffordably expensive. Secondly, it can protect individuals while they await protection by vaccines. Thirdly, it offers protection for those who cannot be vaccinated. On the basis of international data, we could reduce the daily death toll from 56 to less than 20.

3. There are risks if we do not make ivermectin more available. During the petition signature period, I heard from many Canadians who had sought ivermectin primarily for COVID-19 prophylaxis. Some were able to acquire ivermectin intended for human consumption through their doctors, some purchased veterinary ivermectin and others were unable to acquire ivermectin to satisfy their needs. Clearly there is a significant demand for ivermectin in Canada. Moreover many Canadians are taking ivermectin that is formulated for pets and farm animals. While the active ingredient is identical among the different forms, there are risks associated with the doses that could be taken if a person makes a calculation error and there are risks from the other components of veterinary drug products. For example, one paste for horses contains 1.87% ivermectin and 14.03% praziquantel. One way to avoid these risks to Canadians would be to increase the availability of ivermectin intended for human consumption.

4. Ivermectin offers substantial benefits to individuals. In a nutshell the British Ivermectin Recommendation Development panel estimated that ivermectin reduces the risk of contracting COVID-19 by 88%, and reduces the risk of death by 65-92%. I am sending the 100+ page manuscript by e-mail. These estimates are similar to those made by other summary reviews.

5. Ivermectin can protect populations. Because of its effectiveness as a prophylactic for COVID-19, ivermectin can reduce the burden of disease on complete populations. This is illustrated in the graph below from the peer-reviewed paper of Kory et al (American Journal of Therapeutics: May Jun 2021 - Volume 28 - Issue 3 - p e299-e318), which shows how deaths in various Peruvian states decreased after widespread use of ivermectin.

6. Protection from SARS CoV-2 variants. If a mutation occurs in the part of the virus targeted by antibodies, a variant could escape protection by vaccines. In comparison, ivermectin works though an action on a transporter in human cells (importin) and will maintain its effectiveness even against variants with multiple amino acid substitutions.

7. Preparing for future viruses. Ivermectin by virtue of its mechanism of action is very likely to be effective against other viruses. In fact, ivermectin has been observed to be effective against Dengue virus both in vitro and in vivo. If we have ready access to protection against a future viral threat, it could be stopped before it becomes a national epidemic.

Making ivermectin non-prescription.

How? Ivermectin can be converted to non-prescription status under Section 8 of Exceptions of Health Canada's Guidance Document - Determining Prescription Status for Human and Veterinary Drugs. Therein example 3 shows how in the case of flu vaccines "greater availability better served public health and obtaining individual prescriptions was not practical for the healthcare system." A case can be made for applying the same logic to ivermectin. In terms of preventing disease, ivermectin with its ~88% effectiveness compares well with influenza vaccines which "can be as effective as 60% depending on the year." Ivermectin compares well with the effectiveness of vaccines (70-94%) that have been approved for use against COVID-19 in Canada.

Safety. Moreover ivermectin is far safer than most over-the-counter Canadian drugs. With billions of people treated with ivermectin since 1992, there have been just 5252 reports of adverse effects to Vigiaccess.org. For acetaminophen (Tylenol) since 1992 there have been 159,613 adverse effect reports, or 30-fold more than ivermectin. Currently, patients with mild COVID are often sent home with instructions to take Tylenol and return if your breathing becomes laboured. If ivermectin were readily available, they could be sent home to take ivermectin, which would probably cure them. In the USA Sklice (ivermectin) lotion, 0.5% was converted to OTC status on 2020 October 27.

Efficiency. If ivermectin were non-prescription, thousands of hours of doctors time required to write prescriptions would be obviated. Moreover most doctors know little about ivermectin and are reluctant to prescribe it. In fact many doctors are afraid of penalties for prescribing ivermectin in spite of the fact that Health Canada has stated that "Healthcare practitioners may prescribe drugs, including ivermectin, outside of their authorized indications". There would be essentially no cost to governments of making ivermectin non-prescription because it would paid for individual consumers.

Logistics. Presently the only distributor of human ivermectin in Canada has allowed the drug supply to lapse making it widely unavailable and back-ordered until December. Health Canada should convert ivermectin to non-prescription status and invite Canadian generic companies to fill the shortfall.

In closing, on behalf of Canadians, I request that the Minister of Health immediately order conversion of ivermectin to non-prescription status. While we dither, people die. And as a nation we have blood on our hands.

Yours sincerely,

Kanji Nakatsu,

Professor Emeritus Pharmacology,

Queen's University

 

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)