I've usually been a supporter of the annual Thyroid Awareness Month activities, but truly, this year's campaign seems to be a thinly disguised marketing effort whose main purpose is to prevent insurers and patients from switching to lower-cost alternatives to Synthroid, and reflects little concern for the health of America's thyroid patients.
To provide some sort of medical justification for this "don't change brands" recommendation, the campaign has rolled out all this concern about product stability and its impact on patients. Here's AACE President Carlos Hamilton, as quoted in the press release:
"Small differences do exist among various thyroid brands that can have a significant effect on patient health, especially among elderly patients, patients with thyroid cancer or cardiovascular conditions, or patients who are or become pregnant."
Interestingly, though, these same concerns about the health effects of the potency and quality of levothyroxine drugs (especially Synthroid) were the last things on the minds of these same groups just a few years ago.
In 2001, the FDA denied Synthroid's requests to bypass the required New Drug Application process, stating that "...patients using Synthroid have experienced significant, unintended variations in their doses of levothyroxine sodium...these variations are not conducive to proper control of hypothyroidism." In response, the American Thyroid Association, the Endocrine Society, and the Thyroid Cancer Survivor's Association (ThyCa) issued a press release, calling for the continued availability of Synthroid, and disregarding the FDA's concerns, calling them "logistical, not medical." The FDA had clearly specified concerns with Synthroid. Thyroid cancer survivors were receiving erratic doses of Synthroid, which was not suppressing TSH as needed to prevent potential cancer recurrence. Elderly patients were receiving fluctuating batches of Synthroid that could shift them from hyperthyroidism to hypothyroidism and back. Women were getting unreliable batches that might not maintain safe levels TSH levels for conception and a healthy pregnancy and fetus.
There were public calls for Synthroid to be taken off the market until quality concerns were resolved. But the endocrinologists and patients groups were not only not concerned about the quality, safety and patient issues, they went out with national campaign of press releases and media outreach to actively support Synthroid, despite the FDA's serious quality concerns.
What's changed?
Nothing. The motivation is to protect sales of Synthroid. Back in 2001, everything was focused on keeping Synthroid on the market. In 2003, the focus is on eliminating competition. Synthroid was the third most prescribed drug in the U.S. in 2003, earning its manufacturer an estimated $900 million dollarsin U.S. sales. But several brand name levothyroxines are now available at far lower prices than Synthroid. And, in 2003, the FDA approved a number of generic, less expensive levothyroxine drugs, as bioequivalent to Synthroid. So given the availability of other brand name and generic levothyroxine drugs, at substantially lower prices, Synthroid faces stiff competition, and their market share and profit levels are in jeopardy. Naturally, Synthroid's manufacturer, and the professional and patient groups that rely on that drug company's financial support, are all anxious to protect that market share, chiefly by discouraging thyroid patients, the majority of whom are on Synthroid, from switching to alternatives.
Synthroid consistently costs substantially more than its competitors and the generics. For example, as of January 13, 2005, a 30-day supply of Synthroid 88 mcg is $13.99, $3.00 more than the $10.99 cost for the same quantity and dose of brand name Levoxyl, and $5.00 more per month than the $8.99 monthly cost for the same quantity and dose of brand name Levothroid, or many of the generic levothyroxine drugs. (Source: Drugstore.com.).
There is no justification why Synthroid costs so much more than its competition. For that reason, the manufacturer is always looking for reasons why it can charge more per month than competing levothyroxine drugs.
They charged a lot more for Synthroid back in the 1990s too. At that time, it was because of the prevailing dogma that Synthroid was better, and the competing brands and generics were inferior.
