As previously mentioned, the three sections of key conclusions include:


    Safety and Effectiveness
    Therapeutic Need
    Patient Preference

We have covered the first two topics, "Safety and Effectiveness" and "Therapeutic Need," in previous issues of the newsletter. This week, we will finish the "key conclusions" regarding "Patient Preference" as presented here.

COMMENTS

Even though there have been dozens of hormone-containing products evaluated for safety and efficacy and approved by the FDA, there is still a need for individual compounded preparations for millions of patients, as presented to the NASEM committee. There are many "specific medical circumstances" where cBHT is needed and are not limited to allergies to FDA product components.

One needs to consider enhancing patient compliance and outcomes using various dosage forms, patient-specific doses and dose variations, different routes of administration, different product components to achieve the patients desired response, etc. Many, if not most, patients have already tried FDA-approved products without the desired clinical response and so they change to cBHT; therefore, these patients have a significant therapeutic need and must not be ignored.

When one looks at the "conclusions" of the report, it is apparent that many of these are the requirements for mass-manufacturing of FDA-approved drugs and not for individual patient compounded medications encompassing hundreds of different cBHT formulations making compliance with FDA regulations impossible. It should also be noted that cBHT formulations have been successfully compounded for decades and are not difficult to compound.

Next week, we will look at the other "Conclusions" not considered as Key Conclusions of the report.

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Thought of the Week

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At the base,
No ingrown hair,
On neck or face.
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