Levothyroxine, A Multi-Million Dollar Prize

Is the golden goose really up for grabs? Could one of the most prescribed drugs in the US be removed from the market? The FDA denial of the citizen's petition of Knoll Pharmaceutical (former maker of Synthroid) has released a torrent of comment and criticism from all sides. With the potential for removal of a major competitor, smaller companies are making a move for their share of the market.

Jerome Stevens Pharmaceuticals (JSP), makers of UnithroidTM, has requested that Synthroid be removed from the market. In a letter to the FDA dated May 11, JSP representatives contend that the makers of Synthroid would not be able to comply with the August 14, 2001 deadline for approval. Citing the reasons set forth by in the FDA letter of denial, the letter states "Based upon the above conclusions, we believe public health is jeopardized by permitting the continued marketing of Synthroid TM. The letter continues to say that JSP would increase production of its own product to fill in the void left by removing a competitor from the market.

In an open letter to patients, Abbott Laboratories promises that Synthroid will remain available and contends that the product is both safe and effective. "Synthroid's 42-year history of trusted use by both physicians and patients, coupled with clinical studies done on the drug over the years, shows that Synthroid has earned its place in thyroid therapy. Results of these studies have been published in highly respected medical publications such as the New England Journal of Medicine and the Journal of the American Medical Association (JAMA). Synthroid is and has been the most-prescribed therapy for the treatment of hypothyroidism."

As reported in an earlier article, many respected agencies have come to the defense of Synthroid. The American Thyroid Association, The Endocrine Society, and ThyCa (Thyroid Cancer Survivors' Association). In an interesting adendum to the press release issued by The Endocrine Society, it was acknowledged that these organizations "all receive unrestricted educational grants from many pharmaceutical companies, including Abbott Laboratories. However, this support does not in any way affect the organizations' opinions on this issue.

The American Academy of Clinical Endocrinologists, as reported in an earlier bulletin also supports Synthroid. Interesting to note that Synthroid is listed as one of their website sponsors. Abbott Laboratories (Knoll), one of many other drug manufacturers, is a member of AACE's corporate advisory board.

Abbott Laboratories recently filed suit against Watson Pharmaceuticals requesting a court injunction to stop what they term as false advertising. Watson has an exclusive agreement with JSP to market Unithroid.

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