The Case of Synthroid A: Marketing a Drug Coming Off Patent

A correlation between scarcity of iodine in the environment and an increased prevalence of goitre was published some 30 years later 13. This was followed by further trials of iodine supplementation in three Departments of France where problems with goitre were especially severe. These were largely successful, and it was reported in 1869 that about 80% of cases of goitre responded favourably to treatment 14.

Our treatment regimen addresses the root cause of hypothyroidism, adrenal fatigue, menopause, perimenopause, low testosterone, allergies, and candida. An early comparative study by McGavack and Reckendorf in 1956 pointed out that L-thyroxine and desiccated thyroid were similar in their effects, with L-thyroxine resulting in an euthyroid state within an average of 19.2 days (at very high doses) and desiccated thyroid achieving this goal in 21 days. Other chapters of this book, especially chapters, “Administration and Pharmacokinetics of Levothyroxine”, and “Pharmacodynamic and Therapeutic Actions of Levothyroxine” will touch on specific aspects of thyroid hormone homeostasis relevant to their subjects of interest. To describe the historical refinements, understanding of physiology and clinical outcomes observed with thyroid hormone replacement strategies.

The emergence of levothyroxine as a treatment for hypothyroidism

Guidelines written by those who prefer L-T4 have found its potency a reason to flatly discourage the use of L-T3 entirely, even though L-T4 also can cause harm and symptoms if overdosed. Indeed, most of the so-called “side-effects” of T3, if not due to cortisol/adrenaline issues, are errors in dosing. As with any medication, we are responsible to adapt the dose to the patient’s metabolic state and overall health.

More researchers and clinicians are recognizing that the current L-T4 monotherapy results in potential loss of Free T3 and a certain percentage of patients are still symptomatic. A combination therapy achieves T3 and T4 thyroid hormone levels in serum that are closer to those found in untreated, healthy subjects. Despite this tarnished history, many physicians continue to prescribe Synthroid and other brands of synthetic thyroid hormone and remain opposed to Armour Thyroid. If synthetic thyroid hormone costs twice as much and is less effective, why do they use it? In my opinion, it is largely due to the massive marketing campaigns of the pharmaceutical companies that hold patents on these drugs.

Kellogg School of Management

  • Dextrothyroxine is the mirror form of levothyroxine with the opposite, non-natural chirality.
  • A correlation between scarcity of iodine in the environment and an increased prevalence of goitre was published some 30 years later 13.
  • A combination therapy achieves T3 and T4 thyroid hormone levels in serum that are closer to those found in untreated, healthy subjects.
  • Synthroid is a man-made hormone, identical to the hormone made by the thyroid gland and has the same effect on the body.

Because of lack of specificity (for example, low BMR in malnutrition), BMR was used in conjunction with the overall clinical impression; a low BMR in the setting of high clinical suspicion would secure a diagnosis and justify treatment (21, 22). Cases of myxedema were reported in the mid–19th century but were not initially connected with a deficiency from the thyroid gland until surgeons identified incident myxedema after thyroidectomy (11). Initial treatment strategies were largely insufficient and primarily symptom directed, including hot baths and institutionalization (12). The significant morbidity and mortality in the absence of efficacious treatment were clear, and thus the need to “replace” the thyroid through surgical transplantation or oral or intravenous routes was established. Thyroid transplant had some early successes, but for many patients symptoms recurred and the procedure even had to be repeated (13).

Towards the Modern Era in the Management of Hypothyroidism

Practitioners who use T3 need to be aware of its pharmacokinetic effects, the serum Free T3 “curve” in a graph over time, which is easy to find in the more recent literature (see Jonklaas et al, 2015; Saravanan et al, 2007). The discovery of a workable TSH test in the mid 1970s was a key development in the diagnosis and management of hypothyroidism. Levels of T4 and T3 are low in the setting of hypothyroidism, and the synthroid pork pituitary responds by increasing the secretion of TSH in an attempt to correct this, leading to an abnormally high TSH level 25.

Levothyroxine

Semon in his autobiography4 says only that his ‘extremely bold assertion was received with polite scepticism’, though he writes of antagonism towards him in his early career. Nonetheless, his very astute idea of the commonality of these conditions caught on, one senior member at the meeting suggesting that British surgeons be canvassed for their experience of thyroidectomy. The following month the Society set up a committee, which included Semon, to investigate the whole matter. Indeed, Semon’s role in the unfolding thyroid story deserves much better recognition. Over the 20th century, desiccated thyroid extract (DTE / NDT) was purified and its use as a pharmaceutical more carefully regulated. Concerns over irregular or inconsistent batches of DTE arose in the 1960s and 1970s, but processes have been further refined since then.

Side effects

  • When it is remembered that these injections have to be personally administered for the remainder of the patient’s life by the medical attendant, these risks, however slight in regard to a single application they may appear, become immensely magnified when a long series has to be taken into account.
  • In another study comparing l-thyroxine monotherapy versus desiccated thyroid, in which both groups had a normal TSH, many patients preferred desiccated thyroid and lost weight (60).
  • The following month the Society set up a committee, which included Semon, to investigate the whole matter.
  • Secondly, the application of the remedy sometimes produces alarming immediate symptoms, such as loss of consciousness and tonic spasm; and remoter effects, such as indurated swellings and abscesses at the seat of injection, have followed the use of even the most carefully prepared extract.

When you have hypothyroidism, the thyroid doesn’t produce, or can’t produce enough thyroid hormones. When your thyroid hormone level decreases, it results in your body’s system slowing down, including your metabolism, which may lead to symptoms such as sensitivity to cold, weight gain, and fatigue. To document that this was a result of trends toward lower doses, an unblinded study tracked well-being according to various doses and found that the highest well-being was achieved at supraoptimal doses, resulting in a suppressed TSH (65). In a call to the public, a 1997 British Thyroid Foundation newsletter asked readers to recount personal history of residual hypothyroid symptoms. More than 200 patients responded, 54 of whom specifically mentioned that they did not feel well despite normal serum markers of thyroid function (67, 68).

Accordingly, our story begins in the latter half of the nineteenth century, when these pioneering observations were being made, continues to the current management of hypothyroidism with LT4 and concludes with a brief review of outstanding research issues in this fast-moving field. 1 provides a timeline of key events along this journey, and these important advances are described below. Physicians hesitated to use l-thyroxine monotherapy over concern that it could result in a relative T3 deficiency, despite growing discontent with potency of natural thyroid products (39) and reduced cost of l-thyroxine, such that the 2 treatments were approximately equivalent (36, 41). The seminal discovery of peripheral T4-to-T3 conversion in athyreotic individuals largely obviated this concern (42). This laid the foundation for the corollary that treatment with l-thyroxine could replace thyroid hormone in such a way that the prohormone pool would be restored and the deiodinases would regulate the pool of active T3.

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