On March 19, 2019, The Government of Canada responded to thyroid patients petition “Petition E-1819 (HYPOTHYROIDISM)“,
The petition gained 5644 e-signatures over the 3 months it was permitted to run, August 27 to December 25, 2018.
It was presented by MP Diane Finley in the House of Commons March 19, 2019.
TEXT OF THE PETITION
PETITION TO THE GOVERNMENT OF CANADA
The government needs to protect equitable access, supply and a fair marketplace for the full range of thyroid hormone pharmaceuticals, not only the synthetic T4 and T3 used since the 1950s, but also animal-derived hormone extract in medical use since the 1800s and approved by Health Canada;
In monitoring, our patients’ health depends on moving beyond a single test, the thyroid stimulating hormone (TSH). Unsatisfactory responses to thyroid medication have often been dismissed as unrelated to thyroid parameters whenever the TSH is in normal range, but we now know that under a normal TSH can hide suboptimal levels of T3, the form of thyroid hormone that has genomic activity in every cell. Subtle reductions in T3 thyroid hormone can worsen conditions such as diabetes, heart disease, mental illness, obesity and osteoporosis; and
Doctors require more education on various medication options and professional freedom to choose tests and treatments for an individual patient’s needs. It is also time to review the product monographs for all thyroid medications in Canada to reflect recent research.
We, the undersigned, citizens of Canada, call upon the Government of Canada to protect the health of citizens on lifelong therapy for hypothyroidism by protecting equitable access to all thyroid drugs approved by Health Canada and by ensuring that doctors receive more education on various medication options and professional freedom to choose tests and treatments for an individual patient’s needs.
PETITION NO. 421-03104 By: Ms. Finley (Haldimand-Norfolk)
DATE: JANUARY 28, 2019
PRINT NAME OF SIGNATORY: MS. PAM DAMOFF
Response by the Minister of Health
Minister or Parliamentary Secretary
The Government of Canada is committed to strengthening Canada’s health care system and to supporting the health of Canadians. This includes working with the provinces and territories to improve the affordability, accessibility and appropriate use of prescription drugs.
The management of prescription drugs in Canada is a shared responsibility. The Federal Government is responsible for assessing the safety, efficacy and quality of prescription drugs before authorizing them for sale in Canada. Provincial and territorial governments are responsible for the delivery of health care for their residents, including determining which prescription drugs are reimbursed and under what conditions.
In addition, the professional freedom of doctors to choose tests and treat individual patients is also a matter of provincial and territorial jurisdiction and falls under the appropriate provincial or territorial College of Physicians.
With regards to the choice of therapies now available on the Canadian market, under the Food and Drugs Act and Regulations, all products that are sold or marketed in Canada and that make a therapeutic claim need to be approved by Health Canada either as a drug, a medical device or as a natural health product. The drug authorization process is
initiated when a manufacturer submits an application to Health Canada for review. Every submission is then reviewed by scientists to assess the product’s safety, efficacy and quality. The process to gain access to the Canadian market is initiated by industry; Health Canada does not have the authority to compel a company to market a particular product in Canada.
Health Canada is actively working toward improving timely access to drugs and devices though the Regulatory Review of Drugs and Devices (R2D2). Through R2D2, Health Canada is expanding the priority review process to decrease review times for products needed by the health care system, including drugs for rare diseases, generics, biosimilar drugs and biologics. Health Canada has also collaborated with health technology assessment organizations to reduce the time between Health Canada approvals and reimbursement recommendations.
On the particular issue of thyroid drugs, animal-derived thyroid tablets are currently approved for sale in Canada under the brand name Thyroid. Thyroid contains both levothyroxine (T4) and triiodothyronine (T3). Thyroid is sold by ERFA Canada Inc. as 30 mg, 60 mg and 125 mg tablets under drug identification numbers (DIN) 00023949, 00023957 and 00023965, respectively. The Prescribing Information for Thyroid can be accessed at https://pdf.hres.ca/dpd_pm/00034857.PDF.
During the drug authorization process, a submission sponsor will submit to Health Canada their proposed product monograph for the drug in question; a product monograph provides valuable information for physicians and patients on safe use of the product and is an important tool to educate physicians and patients on available and suitable treatment options. Upon verification that the product monograph is accurate and substantiated by the appropriate evidence, the product monograph is included as part of a product’s labelling, and Health Canada also makes it available through its
Drug Product Database, available here: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp.
After a product is on the market, companies may make a submission to Health Canada to modify a product monograph, based on new data or evidence regarding the safe use of the product. In certain circumstances, Health Canada can also compel companies to make changes to a product monograph, based on new data or evidence regarding the safe use of the product. Through these actions, the Government of Canada continues to work with provincial and territorial governments and other key partners to improve the accessibility of needed prescription drugs.
OUR INITIAL THOUGHTS
This response skirts core issues by pointing to shared jurisdiction and then pushes certain issues to provincial and medical jurisdiction.
It focuses too much on the issue of drug approval and marketing.
While drug issues are an important issue and deserves further comment, we first want to draw attention to one glaring omission of federal jurisdiction over provincial health care plans.
It omits any mention of the Canada Health Act.
The Canada Health Act sets forth principles and processes to ensure health equity across provinces.
The act ensures that federal payments to provinces account for their adherence to the Act in terms of offering access to essential health services
Our provincial governments are denying access to Free T3 and Free T4 testing in hypothyroid therapy in provinces such as British Columbia, where patients are now being charged a fee for these tests.
The provinces are happily bowing to the pressure of the Choosing Wisely Canada campaign, which is partly funded by provincial governments.
Does Health Canada have no way of protecting us from medical blindness and bias that restricts therapy and testing options in hypothyroidism? Or does it have blind faith that these systems will always be evidence-based and benign?
Working hand in hand with Choosing Wisely Canada, The Canadian Society for Endocrinology and Metabolism (CSEM) has wrongfully declared our Free T3 and Free T4 tests “unnecessary” in the monitoring of thyroid therapy.
The CSEM confidently take this untenable stance on the basis of their faith in the American Thyroid Association’s (ATA) 2012 and 2014 guidelines for the treatment of hypothyroidism. The ATA have promoted a TSH-T4 paradigm for decades and they continually protect their stance. They engage in unreasonable fearmongering about T3-based thyroid hormone therapies, especially desiccated thyroid, and deny the value of Free T3 testing based on reasons irrelevant to the conditions of lifelong therapy. More importantly, they overlook decades of medical research on the health impacts of lower Free T3 levels and a low FT3/FT4 ratio, which they accept is a result of their favored T4 monotherapy.
Therefore, medical associations are not to be trusted when they set forth policies that enact restriction to FT3 and FT4 testing.
These are the very tests that can reveal thyroid medication underdose despite a normalized TSH.
These are the very tests that can indicate the failure of standard T4 monotherapy to raise FT3 levels sufficiently and therefore justify medical need for a thyroid patient to access T3-based medications.
By preventing FT3 and FT4 testing, provinces are undercutting the T3-based thyroid hormone pharmaceutical market. They are driving up the cost of these medications while denying them to patients who need them.
In addition, public health care insurance plans across Canada have different policies regarding thyroid pharmaceutical coverage, resulting in unequal financial access to different types of medications across Canada.
Let’s look more closely at the Canada Health Act.
Does it offer any hope for thyroid patients future efforts? Or does it set forth high ideals but a flawed system of regulations that provinces can weasel around?
CANADA HEALTH ACT
WHEREAS the Parliament of Canada recognizes:
—that it is not the intention of the Government of Canada that any of the powers, rights, privileges or authorities vested in Canada or the provinces under the provisions of the Constitution Act, 1867, or any amendments thereto, or otherwise, be by reason of this Act abrogated or derogated from or in any way impaired;
—that Canadians, through their system of insured health services, have made outstanding progress in treating sickness and alleviating the consequences of disease and disability among all income groups;
—that Canadians can achieve further improvements in their well-being through combining individual lifestyles that emphasize fitness, prevention of disease and health promotion with collective action against the social, environmental and occupational causes of disease, and that they desire a system of health services that will promote physical and mental health and protection against disease;
—that future improvements in health will require the cooperative partnership of governments, health professionals, voluntary organizations and individual Canadians;
—that continued access to quality health care without financial or other barriers will be critical to maintaining and improving the health and well-being of Canadians;
AND WHEREAS the Parliament of Canada wishes to encourage the development of health services throughout Canada by assisting the provinces in meeting the costs thereof;
NOW, THEREFORE, Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:
3 It is hereby declared that the primary objective of Canadian health care policy is to protect, promote and restore the physical and mental well-being of residents of Canada and to facilitate reasonable access to health services without financial or other barriers.
4 The purpose of this Act is to establish criteria and conditions in respect of insured health services and extended health care services provided under provincial law that must be met before a full cash contribution may be made.
5 Subject to this Act, as part of the Canada Health Transfer, a full cash contribution is payable by Canada to each province for each fiscal year.
7 In order that a province may qualify for a full cash contribution referred to in section 5 for a fiscal year, the health care insurance plan of the province must, throughout the fiscal year, satisfy the criteria described in sections 8 to 12 respecting the following matters:
(a) public administration;
(d) portability; and
10 In order to satisfy the criterion respecting universality, the health care insurance plan of a province must entitle one hundred per cent of the insured persons of the province to the insured health services provided for by the plan on uniform terms and conditions.