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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Group Tells the FDA to Restrict the Use of Compounded Hormones
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<blockquote data-quote="Nelson Vergel" data-source="post: 191988" data-attributes="member: 3"><p>On Wednesday July 1, 2020, the National Academies of Science, Engineering, and Medicine (NASEM) released a report titled “The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use (2020).” First announced in September 2018, the report was commissioned and funded by the Food and Drug Administration (FDA), and the results align with FDA’s thinking that compounded hormone therapies pose a public health concern. Click here for a summary of NASEM’s recommendations: <a href="https://www.pccarx.com/pdf_files/PA_NASEM-cBHT-Recommendations_07-20.pdf" target="_blank">https://www.pccarx.com/pdf_files/PA_NASEM-cBHT-Recommendations_07-20.pdf</a></p><p></p><p>The report contains several deeply concerning recommendations, including that the use of compounded HRT be restricted and all reviewed hormone therapies be considered by FDA to be placed on the agency’s Difficult to Compound List. The report suggests this recommendation is included because compounds are not FDA-approved products and thus lack the population-based bioavailability data and labeling that FDA-approved products have. The recommendations also call for labeling requirements equivalent to FDA boxed warnings, which is counter to federal statute in the Drug Quality Security Act.</p><p></p><p>What are our primary concerns?</p><ul> <li data-xf-list-type="ul">PCCA is concerned that the report overstates the risks and minimizes the benefits of compounded therapies.</li> <li data-xf-list-type="ul">We agree that more trials should be funded to assess the safety, efficacy and bioavailability of compounded hormone preparations, and that the entire scientific community will benefit.</li> <li data-xf-list-type="ul">The committee seems to have ignored the many practitioners who testified about patient monitoring and titration of dosing which produces, in essence, patient-specific bioavailability data, simply because it was not done as part of a large-scale clinical trial. Individual patient bioavailability studies are unrealistic; rather, individual patients are evaluated by their doctors who monitor their lab values, symptoms, quality of life, and other parameters in assessing the value of the therapy.</li> <li data-xf-list-type="ul">The report’s recommendations enter into the practice of medicine. The recommendations attempt to:<ol> <li data-xf-list-type="ol">Remove the ability of the physician to determine what is best for each individual patient</li> <li data-xf-list-type="ol">Minimize the role of the physician in diagnosing, treating and following up with the patient</li> </ol></li> <li data-xf-list-type="ul">The logic employed by NASEM would:<ol> <li data-xf-list-type="ol">Discourage patients from taking an active role in their own health care</li> <li data-xf-list-type="ol">Lead to the end of off label prescribing or the use of any dosage of a drug that is not explicitly described in an approved product’s package insert</li> </ol></li> </ul><p>[URL unfurl="true"]https://www.womenshormonenetwork.org/nasem-report-on-the-clinical-utility-of-compounded-bioidentical-hormones?fbclid=IwAR1N8B9_NGClDXw8tExxs6mLEttJjqcYEEfp_I9OqcKHG48COoujGq8M90w[/URL]</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 191988, member: 3"] On Wednesday July 1, 2020, the National Academies of Science, Engineering, and Medicine (NASEM) released a report titled “The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use (2020).” First announced in September 2018, the report was commissioned and funded by the Food and Drug Administration (FDA), and the results align with FDA’s thinking that compounded hormone therapies pose a public health concern. Click here for a summary of NASEM’s recommendations: [URL]https://www.pccarx.com/pdf_files/PA_NASEM-cBHT-Recommendations_07-20.pdf[/URL] The report contains several deeply concerning recommendations, including that the use of compounded HRT be restricted and all reviewed hormone therapies be considered by FDA to be placed on the agency’s Difficult to Compound List. The report suggests this recommendation is included because compounds are not FDA-approved products and thus lack the population-based bioavailability data and labeling that FDA-approved products have. The recommendations also call for labeling requirements equivalent to FDA boxed warnings, which is counter to federal statute in the Drug Quality Security Act. What are our primary concerns? [LIST] [*]PCCA is concerned that the report overstates the risks and minimizes the benefits of compounded therapies. [*]We agree that more trials should be funded to assess the safety, efficacy and bioavailability of compounded hormone preparations, and that the entire scientific community will benefit. [*]The committee seems to have ignored the many practitioners who testified about patient monitoring and titration of dosing which produces, in essence, patient-specific bioavailability data, simply because it was not done as part of a large-scale clinical trial. Individual patient bioavailability studies are unrealistic; rather, individual patients are evaluated by their doctors who monitor their lab values, symptoms, quality of life, and other parameters in assessing the value of the therapy. [*]The report’s recommendations enter into the practice of medicine. The recommendations attempt to: [LIST=1] [*]Remove the ability of the physician to determine what is best for each individual patient [*]Minimize the role of the physician in diagnosing, treating and following up with the patient [/LIST] [*]The logic employed by NASEM would: [LIST=1] [*]Discourage patients from taking an active role in their own health care [*]Lead to the end of off label prescribing or the use of any dosage of a drug that is not explicitly described in an approved product’s package insert [/LIST] [/LIST] [URL unfurl="true"]https://www.womenshormonenetwork.org/nasem-report-on-the-clinical-utility-of-compounded-bioidentical-hormones?fbclid=IwAR1N8B9_NGClDXw8tExxs6mLEttJjqcYEEfp_I9OqcKHG48COoujGq8M90w[/URL] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Group Tells the FDA to Restrict the Use of Compounded Hormones
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