June 15, 2001

Source: Gray Panthers

WASHINGTON, June 15 -- Gray Panthers Executive Director Tim Fuller sent a letter today inviting Abbott Laboratories officials to attend a public forum to discuss the FDA's concerns regarding the safety and efficacy of the company's thyroid drug Synthroid. In April, the agency issued a letter to Abbott that stated, ``Synthroid cannot be generally recognized as safe and effective because it is of no fixed composition.'' To date, Abbott has failed to respond to the agency's specific concerns.

The Gray Panthers' public forum on Synthroid will take place June 21, 2001, from 2-4 p.m., in the Elbert Room of the Hyatt Regency Hotel in Denver, CO. The location and date were chosen to coincide with the Endocrine Society annual meeting.

Following is the text of the invitation letter, dated June 15, 2001, sent to David Pizutti, M.D., Vice President, Global Medical Affairs, of Abbott Laboratories, by Tim Fuller, Executive Director of the Gray Panthers:

I am in receipt of your letter dated June 7, 2001. I am sorry that you either misinterpreted or failed to receive my letter of May 29 in response to your first letter of May 18, and am hopeful we can quickly clear up all of the outstanding issues regarding the safety and efficacy of Abbott Laboratories' Synthroid product.

My earlier letter made it clear that we are not concerned with ``regulatory'' matters involving Synthroid. Rather we are concerned about the specific, clear, and unambiguous findings by the FDA in its April 26, 2001 rejection of your GRAS/E petition that Synthroid may pose significant health risks to patients.

We also attempted to make clear that our only intent is to provide Abbott Laboratories with an opportunity to respond to these concerns in a way that is meaningful for my members and others who rely on thyroid medicine. It is not meaningful to my members or thousands of patients who have expressed concern about Synthroid to claim that a phone call to the Gray Panthers answering machine constitutes a responsible attempt by Abbott Laboratories to address the very serious FDA findings.

Further, we remain confused by your characterization of the FDA's determinations as bearing no relationship to the safety and efficacy of Synthroid. This characterization appears to lack credibility, as evidenced by the thousands of phone calls and emails we are both receiving.

It may be helpful to reiterate the specific findings contained in the FDA letter for which we hope Abbott Laboratories can provide clear responses:

    1.  "Synthroid cannot be generally recognized as safe and effective
        because it is of no fixed composition."  In particular, please address
        the FDA finding that the formula for Synthroid "has been changed
        numerous times throughout its marketing history," and that Synthroid
        can presumably never be deemed safe and effective without submission
        of a New Drug Application (NDA) as the FDA further stated that "to be
        generally recognized as safe and effective there must be some
        consistent drug product for experts to recognize."  We also would
        appreciate a response to the FDA determination (see FDA letter
        footnote 5) that "there may be additional changes (to Synthroid) which
        have not been disclosed to the Agency."

    2.  "Synthroid has a history of problems."  Specifically, we would
        appreciate a response to the FDA's finding of numerous instances in
        which Synthroid lots were recalled, and to the FDA's determination
        that "Synthroid has not been reliably potent and stable."

    3.  "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."