Pros and Cons of Synthroid Coverage

Regarding “Longtime Drug’s New Troubles,” July 23: This was the first article in any U.S. newspaper that I have seen which accurately reflects the tenor of the FDA letter to the makers of Synthroid in denying its petition to escape regulation.

Even better, this article is the only one I have seen to note that the organizations speaking out in favor of allowing Synthroid to continue to be sold are all funded by the makers of Synthroid.

The FDA does not get everything right, but this latest effort to regulate thyroid medications should be applauded. Congratulations on creating good journalism in a sea of disinformation. May it continue.

KATHY REILLEY

Richmond, CA

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Shari Roan’s article on the Synthroid issue was wonderful. You have stood up and told the whole story, when every single other media source has failed to see or report the big picture. You have done the millions of Americans with thyroid disease a tremendous service.

LAURA GOIST

Youngstown, Ohio

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Overall I thought this was a good article, but I thought you should have said something about T3. The article made it sound like T4 was the only thing needed for thyroid deficiency.

Actually, T4 is not very active biologically, and must be converted to the biologically active form (T3) by the liver. Some people are unable to do this conversion well, and should take T3 in addition.

BOB SPENCER

Santa Monica

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Your recent article on Abbott Laboratories’ thyroid drug, Synthroid, mischaracterizes several aspects of the situation and unfortunately adds to patients’ confusion.

The article states that Knoll Pharmaceutical Co., the former marketer of Synthroid, tried to “bypass” the Food and Drug Administration’s process. Knoll did not try to bypass FDA’s 1997 request of levothyroxine sodium manufacturers.

In 1997, the FDA gave thyroid drug manufacturers the choice of submitting either a New Drug Application (NDA), or another type of application, a “citizen petition.” Knoll chose the second option.

On April 26, the FDA denied Knoll’s petition. Abbott, which acquired Knoll in March, notified the agency that it would submit an NDA for Synthroid before the Aug. 14 deadline. We are doing just that.

Furthermore, Abbott is complying fully with the FDA’s new guidelines on levothyroxine sodium drugs.

We expect our NDA for Synthroid to receive regulatory clearance and be approved. Moreover, the FDA’s recent guidelines assure patients that Synthroid will remain on the market while the agency reviews the NDA. In fact, we have a high volume of Synthroid on the market, and are confident there will be a sufficient supply of Synthroid on the market for patients.

The article also references the quality of Synthroid. At no time has Knoll nor Abbott compromised the quality of Synthroid.

In fact, since 1997, in the two most recent FDA inspections of the Synthroid manufacturing facilities, the FDA found no issues with the manufacturing process of the product.

DAVID PIZZUTI, M.D.

Vice president Global Medical Affairs

Abbott Laboratories