June 4, 2001

SOURCE: Gray Panthers

WASHINGTON, June 4 -- A growing coalition of consumer organizations plans to question Abbott Laboratories about its apparent efforts to mislead the media, physicians and patients on issues relating to the safety and efficacy of its Synthroid® medication for thyroid disease.

The Wall Street Journal reported Friday that the FDA is considering removal of the product from the market after the agency found that ``Patients taking Synthroid have experienced significant, unintended variations in their doses of levothyroxine sodium,'' and ``these variations are not conducive to proper control of hypothyroidism.''

Abbott responded with media statements from Leonard Wartofsky, M.D., an endocrinologist who offered praise for the product. Abbott failed to inform the media that Dr. Wartofsky is a paid consultant to the company, and is past president of the American Thyroid Association. Phone calls to the Association's toll-free number (800-542-6687) are answered by Abbott Laboratories.

Abbott also issued a media release that cited support for Synthroid from the Endocrine Society and Thyroid Cancer Survivors' Association. The release failed to report that both groups obtain significant funding from Abbott.

Abbott failed in its statements to address critical issues raised by the FDA in an April 26, 2001 letter, in which the agency also determined ``Synthroid cannot be generally recognized as safe and effective because it is of no fixed composition,'' and ``Synthroid has a history of problems.'' FDA indicated in 1997 that Synthroid would need to be removed from the market by August 2001 because it has ``the potential to cause serious health consequences to the public.''

FDA-Approved Products Can Meet Patient Needs If Synthroid Is Removed From The Market

Abbott has indicated that patients may be harmed should the FDA pull Synthroid from the market. This view is refuted by a manufacturer of an FDA- approved alternative for Synthroid, who told the FDA it can meet 100% of U.S. patient need after 60-90 days notice from the FDA. In addition, the FDA approved a second product last week.

Patients May Safely Switch From Synthroid to FDA Approved Alternatives

Abbott also indicated that switching patients from non-FDA approved Synthroid to Unithroid or other approved FDA thyroid products may present safety issues for patients. But the Gray Panthers has obtained data from industry analyst firm Scott Levin that indicates over 10 percent of all prescriptions for Synthroid are already routinely switched without problems.

In addition, physicians in several areas of the country indicated this week that patients are requesting alternatives to Synthroid and are better stabilized on the FDA approved products.

``I haven't had any problems switching patients from Synthroid,'' stated Los Angeles endocrinologist Ken Henbo, M.D. ``I switch them when their prescriptions come up for renewal because I think they should be on a drug approved by the FDA.''

Dr. Marla Haller of Columbus, OH stated, ``I've fiddled a lot with thyroid dosing for my own son. Now that he has been switched from Synthroid, he is a lot more stable. If I have a patient with fluctuation, I am more inclined to switch to a more stable drug.''

``A big concern for me is that patients can maintain level blood tests on Synthroid, but still feel bad from one month to the next,'' according to family practitioner Anne Spencer Doran, M.D., of Richmond, VA. ``Many of my patients have switched to Unithroid, which made a remarkable difference.''

Dr. Doran indicated that three-quarters of her patients have already switched or will switch from Synthroid. ``I just don't think it's true,'' Dr. Doran stated in reaction to Abbott's message about switching patients from non-approved Synthroid. ``People are doing much better by switching over.''

``We're disappointed that Abbott is misleading the public rather than answering direct questions about the safety of Synthroid,'' stated Gray Panthers Executive Director Tim Fuller. ``It's time for the FDA to step in and clear up growing consumer confusion over Synthroid.''