Comment from Stephanie Sanders

This comment is in support of the Alliance for Pharmacy Compounding’s citizen petition asking the FDA to allow desiccated thyroid extract to remain readily and easily available to those with prescriptions for it. In the letter submitted to this petition as Exhibit A, there are concerning statements that need to be addressed. First, the FDA state that they are "unaware of any studies demonstrating the safety and effectiveness of ADT products." I have attached 4 such studies to this comment for their perusal. Summarizing those, DTE is effective at treating hypothyroidism. When compared to levothyroxine or combination of synthetic T3/T4, DTE reduced or eliminated more hypothyroid symptoms and was widely preferred over the use of synthetic thyroid hormones. Additionally, one study found that 21-34% of patients taking levothyroxine still experienced a poor quality of life due to persistent hypothyroid symptoms, even if their blood test results were satisfactory. This shows that a significant portion of patients would benefit from having options including DTE. I encourage the FDA to read these studies and make themselves aware of the clinical evidence of the safety and efficacy of DTE products. In addition to these previous studies, currently the FDA should be aware of the North Star study recently finished by Neuvosyn Laboratories (Acella Pharmaceuticals) wherein they tested their DTE product (North Star) to find a dose that would produce the same results as levothyroxine. They completed that study successfully, meaning that not only is their DTE product safe by FDA standards, but it also has a dose that is similarly effective as levothyroxine. These results, along with the studies attached to this comment, assuage any concerns on the safety and efficacy of DTE products both current and future. Secondly, the FDA discuss in their letter (Exhibit A) that they have concerns with inconsistent potencies from batch to batch and the potential for viral or microbial contamination. However, all of the citations they use which cover these concerns (citations 8-12) are from papers published prior to 1985. This is disingenuous at best and very concerning you would cite such outdated data. In 1985 the US Pharmacopeia changed how DTE pills were to be tested. It switched testing from looking at the iodine content (which explains the differing potencies) to testing the actual T3 and T4 content. Since 1985, the content of the active ingredients in DTE (T3/T4) are known, and batch to batch potency issues are no longer a significant problem. If the FDA is still concerned about this, it would be best to find recent citations, rather than citing outdated papers. Finally the FDA states that they are aware of "over 500 adverse event reports associated with ADT products from 1968 to 2025." That means that on average ADT products have had 8.7 adverse events per year in a 57 year period. Considering that average number of AEs, and using the statistic that 1.5 million people are taking DTE, the rate of risk for an AE while taking DTE is 0.00058%. Even if we assume that only 1 out of every 100 AEs are actually reported, the rate of risk is still 0.058% which is extremely low. In comparison, Heparin, a commonly used blood thinner derived from pig intestine, has a reported 30% chance to cause thrombocytopenia, which would be a significant adverse event that can lead to patient death. Yet, the FDA is not seeking to ban Heparin. Taking this data together, the FDA does not have a scientific backing to completely ban the use of DTE in America. Synthetic thyroid medications do not work for me. I wish they did. I have tried them, but hypothyroid symptoms persist. DTE has been the ONLY medication to work for me. On DTE, I am able to live a normal life. I have been on DTE over 15 years with NO adverse events or problems with potency. For me and millions of others, DTE is perfectly safe, perfectly consistent, and perfectly effective. Please do not ban this medication. It affects every cell in one’s body. Without this medication I cannot get off the couch - no ability to exercise or go about daily tasks; my mind stops functioning normally - no ability to drive, to read, to go about a normal day, in fact you press your hands on your head and beg the Lord to clear it. It is torture. Not one system of the body is unaffected. I am 61 years old. If you take this medication away, I will be in a nursing home within a year and if the Lord is kind death will come sooner rather than later. I watched my aunt be denied this medication by her doctor. I’ve seen firsthand how this will go - nursing home and a slow, unhappy death. You know this medication is safe and effective. DTE medications, which are the only option for a significant subset of people, MUST continue to be available. I’m living proof it is safe and effective. Do not ban this medication. Grant each of the actions requested by the Alliance of Pharmacy Compounding.