June 21, 2001

Source: Gray Panthers

DENVER -- The Gray Panthers today announced it will take new steps to obtain a response from Abbott Laboratories to concerns raised by FDA about its Synthroid brand thyroid medication. The announcement was made during a public forum on the issue during a national conference for endocrinologists. Abbott Laboratories was invited to address the forum, but declined.

    The FDA issued a letter to Abbott on April 26, in which it stated that:

    * "Synthroid cannot be generally recognized as safe and effective because
      it is of no fixed composition," and "Synthroid has been changed numerous
      times throughout its marketing history."  FDA also noted that, "There
      may be additional changes to Synthroid which have not been disclosed to
      the agency."
    * "Synthroid has a history of problems," and "Synthroid has not been
      reliably potent and stable."
    * "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."

The Gray Panthers said other consumer organizations will ask Congress and the FDA to obtain a response from Abbott to issues raised in the letter, and that the groups may file Freedom of Information Act requests to obtain communications records between Abbott and the FDA.

``Abbott has found it easier to dismiss the concerns of my members -- 20 percent of whom rely on thyroid medication -- than to help them,'' stated Gray Panthers National Executive Director Tim Fuller. ``Hopefully Abbott will be more responsive to similar concerns raised by additional groups that are expressing concern over this issue.''

Abbott has never offered any response to the FDA findings, other than to claim they simply raise ``regulatory'' issues unrelated to safety. Abbott stated in a letter this week to the Gray Panthers, ``We wonder if you truly understand the context and implication of the FDA letter, since you continue to literally interpret the (agency's) words.''

``Abbott has raised corporate spin on Synthroid issues to a high art,'' stated Fuller. ``How should consumers interpret a clear, unequivocal, and specific government agency communication about drug safety other than through a 'literal' interpretation?''

Abbott has stated that it will submit a new drug application for Synthroid by August 14, 2001. In fact, the FDA required all thyroid medication manufacturers to obtain approval of all such applications by that date or face regulatory action. The requirement was delayed one year to accommodate the Synthroid manufacturer. Two other manufacturers met the deadline and received approvals.

    "This raises new questions," according to Fuller:

    * "Will FDA allow sales of unapproved thyroid medication after August 14?"
    * "Will Abbott change the formulation for Synthroid to obtain FDA
      approval, and if so, when will patients know and how will they be
      switched?"
    * "How long will the approval process take, and what if Synthroid is not
      approved?"

``Abbott is ducking every important question, including by criticizing those asking for answers,'' stated Fuller. ``The company's actions are simply bizarre.''

The Gray Panthers also dismissed endorsement of Abbott's actions by the American Thyroid Association, the Endocrine Society and ThyCA: Thyroid Cancer Survivors' Association, which are heavily funded by Abbott. ``I respect the intent of all physicians to look out for the best interests of their patients,'' Fuller stated. ``More and more physicians are telling me that they have real concerns, despite the views of their association.''

Source: Gray Panthers