In a recent blog post, we focused on research showing that clinical guidelines are influenced by drug companies to the detriment of patients. In The Best Clinical Guidelines Money Can Buy: A Look at Guidelines Bias and Thyroid Treatment, we talked about a British Medical Journal article from 2013 that pointed out the vast majority of guidelines authors have financial ties to the drug companies whose products they are recommending. Now, we have evidence of this unfortunate process in action, with the recent publication of the American Thyroid Association (ATA) "Guidelines for the Treatment of Hypothyroidism" in the journal Thyroid. (PDF format).
There are so many things wrong with these Guidelines that we could write volumes, but let’s cut to the chase. Here are five ways the new ATA hypothyroidism guidelines hurt thyroid patients.
1. The ATA’s Conflict of Interest Makes the Guidelines Findings Questionable at Best
While the ATA goes out of its way to assert that there are no financial conflicts of interests, as patient advocate Mary Shomon points out in her article, the ATA itself receives a substantial amount of financial support from three drug companies – Pfizer, AbbVie, and Akrimax – that make levothyroxine, the drug that the guidelines claim are the “standard of care.”
How can the ATA claim a lack of bias and no conflict of interest, when its own balance sheet depends on support from the very drug makers who make the drug they are claiming is superior?
2. The ATA Diminishes the Importance and Role of T3 for Hypothyroid Patients
In the prestigious European Journal of Endocrinology, a 2009 article reported on T4 monotherapy, versus the addition of T3. The research found that the addition of T3 was “superior to monotherapy by evaluating several quality of life, depression and anxiety rating scales as well as patients own preference.” (EJE Abstract)
In 2013, the equally prestigious Journal of Clinical Endocrinology and Metabolism published results of a randomized, double-blind, crossover study conducted by endocrinologists at the U.S. government’s Walter Reed National Military Medical Center, affiliated with the National Institutes of Health (NIH). In that study, which compared natural desiccated thyroid to levothyroxine in treating hypothyroidism: patients on the natural desiccated thyroid lost weight, and had significant symptom improvement, compared to those on levothyroxine only. Almost half the patients preferred the natural desiccated thyroid, versus levothyroxine, compared to only 19 percent who preferred the levothyroxine. (JCEM Abstract).
Study author Dr. Thanh Hoang said: “We now know that once-daily desiccated thyroid extract is a safe alternative treatment for patients with hypothyroidism who are not satisfied with levothyroxine treatment. It’s an option for them to try, and also desiccated can cause modest weight loss in these patients as well.”
These research findings, while overlooked by the Task Force, are no surprise to patients and integrative practitioners. There is no question that many hypothyroid patients benefit from T4/T3 combination therapy — where T3 is added to their levothyroxine treatment — or as treatment with natural desiccated thyroid drugs.
Yet the ATA guidelines claim that the effect of T3 on patients is “unknown.” They go on to say that there is “no consistently strong evidence for the superiority of alternative preparations (e.g. levothyroxine-liothyronine combination therapy, or thyroid extract therapy, or others) over monotherapy with levothyroxine, in improving health outcomes.”
Even if one accepts the questionable conclusion that there is “no evidence for the superiority” of alternatives, at minimum, what is clear is that there is no evidence for the superiority of levothyroxine. Yet the guidelines still maintain that “levothyroxine should remain the standard of care for treating hypothyroidism.”
3. Patients Get A Mental Health Referral Instead of Resolution of Symptoms
According to the guidelines, “referral to a mental health professional should be considered if the severity of the symptoms is not sufficiently explained by the severity of the biochemically-confirmed thyroid dysfunction or another medical condition.”
In plain English? If your doctor feels that your blood tests do not suggest a “severe” thyroid dysfunction, and yet you have persistent, troublesome symptoms, you should be referred for mental health evaluation and treatment.
To the Task Force, the idea of “biochemically-confirmed thyroid dysfunction” relies solely on the TSH test. As long as a hypothyroid patient on levothyroxine has a TSH level within the reference range — even if the patient has low levels of T3 (the active thyroid hormone) or elevated thyroid antibodies (evidence of autoimmune Hashimoto’s disease) — continuing symptoms are not related to the thyroid, but are instead “somatization disorder,” which according to the Task Force, inordinately affects women, especially those who have a history of physical or sexual abuse. They state:
In patients with persistent complaints of hypothyroidism, and chronic pain and malaise, all organic causes should be ruled out, followed by referral to a mental health practitioner to screen for somatoform disorder. Patients suspected of somatoform disorders should be provided with sensitive discussion in which the referral is explained, in which trust is maintained. Patients should understand and appreciate that their symptoms are not factitious, and are “real” and may have causes that are rooted in psychological trauma, rather than an organic problem with physiologic causes.
Instead of thoroughly and optimally treating patients hypothyroidism to minimize symptoms, the guidelines recommend a mental health referral!
4. The Guidelines’ “Ethics” Seem Focused on Taking Away Patient Choice
The guidelines have a section discussing doctors’ ethical obligations in treating hypothyroidism. According to the Task Force, the “relevant ethical principle in the treatment of hypothyroidism is the Principle of Beneficence, which guides healthcare providers to maximize clinical benefits and minimize clinical harms.”
There is also the “Principle of Non-Maleficence, the obligation not to intentionally introduce harm to patients, or intentionally initiate a therapy that is known to have no therapeutic effect.”
Okay, since most of us weren’t ethics majors, what are they really saying?
Here is it: “offering patients formulation of thyroid hormones or other preparations that are known to be inferior to the standard of care, potentially futile, or even harmful, contravenes the Principles…”
Essentially they are stating that it is unethical for doctors to offer patients anything other than levothyroxine!
The Guidelines go on to suggest that patients who are “requesting inappropriate therapies” do not have “full decision-making capacity” and must be protected by physicians.
In the context of hypothyroidism, patients may express a preference to feel well and be restored to euthyroid levels, yet refuse synthetic L-T4 (levothyroxine) therapy because it is not “natural”. This stated preference could indicate the patient does not understand and appreciate the pharmacologic properties of L-T4, which can be explained as restoring “natural” physiologic function. In this common example, the patient’s preference can be understood as a preference not to have drug side effects or be harmed. Respecting the patient’s preference, in this context, would be to ensure the patient has a truer understanding of hypothyroidism and L-T4 action; only when the patient understands and appreciates that choosing thyroid extract therapy rather than L-T4 could expose them to certain risks such as elevated serum T3 levels, would this constitute informed refusal of standard therapy.
This seems to suggest that patients who would refuse levothyroxine treatment, or request T3 or natural thyroid, just haven’t been “informed” enough to know what they are doing, and may not be qualified to make decisions for themselves.
5. The Task Force Is Threatening Integrative Practitioners
The Task Force doesn’t stop at suggesting that patients who want treatment other than levothyroxine are somehow misinformed or incapable of autonomous decision making. They seemingly want to blame and punish physicians as well.
The Guidelines state:
When Beneficence and Non-Maleficence are violated, there may be legal consequences and licensure revocation, as these ethical violations constitute medical negligence.
The Task Force is not only saying that levothyroxine is the standard of care, but it is implying that physicians offering and prescribing T3 and/or natural desiccated thyroid may face legal consequences or revocation of their licenses.
There’s another surprise in the section on ethics. The Guidelines state:
Practitioners who state they are experts in treating hypothyroidism when they have no demonstrable accredited training or board certification (e.g. “integrated medicine”) violate professional ethical standards of practice, as it overtly deceives patients. Additionally, competently trained medical experts who misuse their medical knowledge to personally profit, deceive patients, or purvey non-standard, risky innovative therapies in hypothyroidism are violating basic standards of care.
This is basically a declaration of war by the ATA on integrative practitioners, most of whom are not board certified endocrinologists, and who are more likely to utilize T3 and natural desiccated thyroid drugs.
To summarize, the ATA’s Hypothyroidism Guidelines pose obvious impediments to thyroid patients, in five ways:
- The ATA, which has taken substantial money from companies that make levothyroxine, convened a Task Force which then conveniently found that levothyroxine is the “standard of care.” This may potentially make it more difficult for patients to find doctors who will prescribe anything besides levothyroxine, and insurers and HMOs that will cover drug treatment options besides levothyroxine.
- The ATA Task Force Guidelines ignored research regarding the superiority or equivalence of T3 and natural desiccated thyroid, and then said that that because there isn’t evidence that T3/natural desiccated thyroid is superior, levothyroxine is therefore superior and is the “standard of care.” Again, this may make it far more difficult for patients to find doctors who will prescribe anything besides levothyroxine, and may discourage insurers and HMOs from covering drug treatment options besides levothyroxine.
- The ATA Task Force Guidelines claim that patients who suffer from continuing thyroid symptoms, but who have a TSH in the reference range on levothyroxine treatment, warrant referral for mental health evaluation and potential somatic disorder. This means instead of getting optimal treatment – which some practitioners feel should include T3 and/or antibodies testing, and treatment with T3 or natural thyroid drugs — patients may find themselves more likely to be referred for mental health evaluation, and potentially receive antidepressants or anti-anxiety medications, instead of thyroid treatment.
- The ATA Task Force Guidelines claim that medical ethics prohibit prescribing drugs (namely, T3 and natural desiccated thyroid) that are “inferior to the standard of care” and that patients who “requesting inappropriate therapies” like these drugs do not have “full decision-making capacity” and should be protected by physicians. This could result in more practitioners refusing patient requests for T3 and/or natural desiccated thyroid drugs.
- The ATA Task Force Guidelines warns that doctors who prescribe T3 and natural desiccated thyroid drugs could face legal consequences or revocation of their medical licenses. This is likely to discourage open-minded physicians from prescribing T3 and/or natural desiccated thyroid, fearing legal or professional censure or even loss of their medical licenses.