On the patient’s side of the debate, those who have crushing fatigue and cognitive decline have found it difficult to agitate for change as a group and to persist individually in seeking better therapy options. If the L-T4 does not work for us, it will make us too exhausted to seek alternatives. Patients want to trust their doctors. For many, there is little choice but to be compliant.
Through the public dissemination of scientific knowledge, patient support websites, and social media forums, more thyroid patients are becoming aware of alternative treatments. As time goes by, thyroid patients will become more educated, more organized as groups, and more of us will search for doctors willing to supervise a trial of these medications.
The American Thyroid Association surveyed over 12,000 international hypothyroid patients in an online survey in 2017 and found that among this group, there were users of all three major treatment modalities: desiccated thyroid extract (DTE), L-T4/T3 combination therapy, and L-T4 therapy. T4 therapy had the lowest and DTE received the highest patient satisfaction rating, despite patients’ perception of DTE’s limitations as well.
When a symptomatic thyroid patient is persistent and lucky enough to have a doctor willing and able to prescribe either synthetic combination therapy or DTE, our Canadian health care system is not designed to support it. Like the researchers who write the combination therapy studies, doctors often mistakenly treat L-T3 and DTE as if they were biologically equivalent to L-T4 medication.
For example, doctors are often unaware of the swift rise and fall in T3 serum levels within 5 hours following a dose. The pharmaceutical dynamics of synthetic and animal-derived T3 are not insurmountable barriers to its use. Patients who understand their medication and want it to have best effect will be willing to take multiple doses throughout the day to maintain appropriate T3 levels and avoid large peaks and troughs that interfere with their function.
But the most misunderstood aspect of L-T3 medication that prevents its effective medical use is its early and benign effect of TSH suppression due to the pulsatile oral dosing of synthetic L-T3 hormone and T3’s powerful effect on Thyrotropin Releasing Hormone (TRH) which regulates TSH. The pituitary gland will be satiated long before the patient’s body has achieved euthyroid status, and when the pituitary gland starts to be satisfied, doctors put a halt to dose increases, which means that we remain hypothyroid.
Doctors are told to prevent a low TSH due to the mistaken belief that a low TSH, independent of excess thyroid hormones, can “cause” osteoporosis or heart disease (see our rationale and our reference list). Guidelines continue to presume that low TSH invariably indicates hyperthyroidism regardless of euthyroid T3 and T4 levels.[118 (Sec. 29)] But in T3-based therapies, a low TSH coexists with a truly “euthyroid” state, as we discuss in our section on Low TSH.
Free T4 and Free T3 are necessary as indicators for blood levels during combination therapy. Signs and symptoms will assist in discovering the patient’s optimal set point, dosages, and timing of doses throughout the day.
We must allow L-T3 based therapies to actually work the way they are supposed to work, to improve health. Every medication has unique pharmacokinetic properties, and it is unrealistic and unfair to require L-T3 oral doses to affect the body in exactly the same way as L-T4.
If the medical system will not allow L-T3 therapy to fully satisfy the pituitary gland of this unfortunate group of patients, their trial of this alternative will likely be unsatisfactory. Perhaps some doctors secretly hope the patient will be less satisfied so that the patient reluctantly returns to L-T4 therapy. This is not right.
This exaggerated fear of overdose signified only by TSH rather than thyroid hormone euthyroidism is a strong bias against patient well being. By imposing on us the model of the healthy HPT axis, which no longer applies to us (see our section on Low TSH and Reference Ranges) It imposes an artificial limitation that currently handicaps all therapies, including L-T4.
One must have an equal fear of thyroid hormone deficiency and the damage it wreaks on the long term health and daily lives of patients. Because of an insufficient fear of hypothyroidism, the medical system has condemned many patients to long-term suffering in a state of perpetual “subclinical” hypothyroidism on all therapies, including this time-tested mode of therapy.
We hear anecdotes that some patients have gladly signed a waiver that states the potential unknown risks of their T3-based therapy. If that is what is required, so be it.
In this mode of therapy, it is absolutely necessary for patients to have more agency and control over fine-tuning their dose and its timing to their circadian rhythm, metabolic rate, and other signs and symptoms. We must be able to manage our thyroid hormone levels or we cannot function and live fruitful lives.
The next challenge is the market access to T3-based thyroid hormone therapies due to the lack of competition and the small customer base in Canada. As of June 2018, the Canadian market had only one manufacturer of animal-based desiccated thyroid hormone, Thyroid by ERFA, and only one manufacturer of synthetic T3 hormone, Cytomel by Pfizer. In contrast, both the UK and the United States have a variety of manufacturers supplying each of these hormone preparations. Compounding pharmacies in Canada also have access to synthetic T3 hormone powder in regular and slow-release formulations, but these are likely limited in their suppliers as well.
As a result of the limited market and supply, patients who depend on these hormones for optimal health have suffered disruptions in supply followed by shortages and subsequent price hikes. In 2017, ERFA had a disruption in their supply of desiccated thyroid that led to a shortage at pharmacies and panicking patients. In 2018 Pfizer has initiated pre-planned manufacturing and supply disruptions for its 5mcg and 25mcg Cytomel pills and they plan to resume distribution of the latter in June 2019.
We must protect patients from gross price inflation such as occurred in the United Kingdom with the inflation of Liothyronine (L-T3) price by over 6000% between 2006 and 2016. This resulted in legal action against Concordia, the Canadian drug firm responsible for overcharging the National Health Service. In a House of Lords debate in June of 2018, speakers vividly described how patients were being denied prescriptions for T3 and being forced to return to less effective L-T4 monotherapy, unless they could themselves arrange for individualized agreements in writing between an endocrinologist, family physician, and the health region office, to secure their T3 treatment. Some doctors resorted to offering desperate patients private T3 prescriptions so that patients could find their own suppliers on the international market. Many patients turned to international travel and the internet to find sources for their essential T3 medication. Lord Hunt concluded the debate by pointing out that because the government and national health service had failed to stop the price increases, health regions were forced to put in place clinical restrictions on T3 prescriptions in order to manage their budgets, and the patients were the victims.
Canadian patients who flourish better on desiccated thyroid or L-T3 hormone therapy may lose their access to their therapy if they move to a different Canadian city or province, or if their doctor retires or moves.
If the Canadian medical system cannot accommodate a healthy range of thyroid hormone therapies, more patients will resort to self-medicating and self-testing through an increasing market for such products and services online. Prices will increase for thyroid patients who will become merely customers, and such patients who can afford it will also have to bear the costs and risks of their own treatment. Meanwhile, these underground patients’ therapy will be invisible to our health care system and it will appear that we do not have a problem. By doing little to improve thyroid therapy, we will foster inequity and unequal access to the hormones necessary for a healthy life.
Next section: Challenges: Research
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