CLINICAL THYROIDOLOGY FOR PATIENTS
A publication of the American Thyroid Association
Table of Contents
A Message to Patients Regarding Thyrogen
WHAT IS THYROGEN?
Thyrogen (recombinant human thyrotropin, rhTSH) is human TSH that is produced in the laboratory and used to produce high levels of TSH in patients after an intramuscular injection. This is mainly used in thyroid cancer patients before treating with radioactive iodine or performing a whole body scan and/or stimulated serum thyroglobulin test.
On May 24, 2010, Genzyme Corporation, which manufactures Thyrogen, entered into a Consent Decree of Permanent Injunction with the United States Food and Drug Administration (FDA) to resolve litigation in which the FDA has alleged that Genzyme manufactured, labeled and distributed drugs (Cerezyme, Fabrazyme and Thyrogen) at its Allston, Massachusetts facility in violation of current good manufacturing practice requirements for drugs. Genzyme has agreed to correct manufacturing quality violations and will turn over to the federal government $175 million in profits from the sale of products made at the plant. To date, these violations have not been associated with reports of adverse events in patients.
The consent decree requires Genzyme to move operations out of the Allston plant, which may result in restricted availability of these drugs. The consent decree is designed to permit Genzyme to provide for the United States market enough Thyrogen to meet the needs of patients for whom FDA considers the drug to be medically necessary. This restriction will remain in place until Genzyme transfers manufacturing operations to other manufacturing facilities operating in compliance with FDA regulations. This decree does not affect the availability of Thyrogen outside of the US.
While the FDA has developed a set of criteria to help healthcare professionals identify patients for whom Thyrogen is considered medically necessary, physicians are not being required to individually certify medical necessity. It is expected that if your physician determines that Thyrogen is indicated for the management of your thyroid cancer, then it will be available for your use.
WHAT THIS MEANS FOR PATIENTS
Before Thyrogen was available, all thyroid cancer patients that were treated with radioactive iodine or were undergoing diagnostic scanning/testing had to do so after thyroid hormone withdrawal (stopping thyroid hormone and becoming hypothyroid for a short time). Thyroid hormone withdrawal is still indicated in certain situations. However, Thyrogen offers the option for many thyroid cancer patients to undergo these procedures while staying on their thyroid hormone pills. Because of Genzyme’s agreement with the FDA, it is expected that Thyrogen will become less available than in the past, and some physicians may opt to stop using Thyrogen altogether until the FDA lifts the decree. You should discuss these options with your physician if you require either radioactive iodine treatment or diagnostic testing for your thyroid cancer.
Most importantly, there has not been any report of a patient having an unexpected adverse reaction to Thyrogen based on the manufacturing problems. We will keep you updated on this issue as it continues to evolve in the coming months.
— Alan P. Farwell, MD