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