There are actually two sets of conclusions in the NASEM HRT Report. One set, in Table 9-1 Summary of Key Conclusions Related to the Clinical Utility of cBHT, is labeled as "Key Conclusions" and the other "conclusions" are simply provided in boxes throughout the report (there are ten more of these). There is overlap of these, so we will first look at the "Key Conclusions from the Report." Also provided are the report chapters from which they came.

We will cover these Key Conclusions in four issues due to their length and will also maintain the Clinical Utility definitions that parts of the conclusions are used to support. In later issues, we will comment on the conclusions and recommendations from the report.

Safety and Effectiveness
(First four of eight in this category and does not include 5 other conclusions not considered "key".)

• Strengthening federal and state regulatory oversight, as well as requirements for transparency and disclosure of conflicts of interest, could contribute to safer, more effective use of compounded preparations, including compounded bioidentical hormone therapy. (Chapter 3)

• Currently, cBHT preparations are not adequately labeled. Missing information includes, but is not limited to, a description of the preparation's instructions for use, contraindications, potential adverse effects, boxed warnings, and the identity of the person and company responsible for a compounded preparation's quality and safety. This lack of information undermines safe and effective use by patients and prescribers. (Chapter 5)

• cBHT pellet formulations may be difficult to compound given the complexity of drug delivery mechanism, lack of required bioavailability testing, insufficient guidance for compounders, and the need for specialized equipment. Given the broad scope of available cBHT pellet formations marketed for use, and questions regarding difficulty in compounding, there are concerns for safety and effectiveness. (Chapter 5)

• The paucity of reliable pharmacokinetic and bioavailability data for cBHT preparations as compared to FDA-approved drug products compromises the ability to evaluate the safety, efficacy, and product-to-product variability of cBHT preparations. (Chapter 6)

Also of interest, this week, we received the following photo:
(Courtesy of Roger Rose BoomerRog@outlook.com)

The 1947 patent that started it all with conjugated estrogens is listed below: [The patent number is listed on the side of the bottle above (not shown).]

Patented Oct. 2, 19477                                                     2,429,398
UNITED STATES PATENT OFFICE
2,429,398
HORMONE EXTRACTS

Arthur Stanley Cook, Outremont, and Gordon A. Grant, Montreal, Quebec, Canada, assignors, by mesne assignments, to Ayerst, McKenna & Harrison, Limited, New York, N.Y., a corporation of New York
No Drawing. Application May 23, 1944, Serial No. 536,960.
12 Claims. In Canada August 20, 1943 (CL. 167-74.5)

Example 1 in the patent starts with "About 25 gallons of urine freshly obtained from pregnant mares and containing water-soluble oestrogenic activity occurring in unhydrolyzed form were preserved with an alcohol chloroform mixture..."

Next week, we will continue looking at the "Conclusions" from the findings of the NASEM HRT Report.

Did You Know ...

...that the following has been said?

"The grass may be greener on the other side of the fence, but don't break your neck climbing over"!

Thought of the Week (on Contentment)

Contentment lodges oftener in cottages than in palaces.

An old Spanish proverb says:

"Since we cannot get what we like, let us like what we can get."

Socrates said:

"He is richest who is content with the least, for content is the wealth of nature."

In closing, Samuel Adams sums a lot of it up in his statement:

"The fountain of content must spring up in the mind; and he who has so little knowledge of human nature as to seek happiness by changing anything but his own disposition, will waste his life in fruitless efforts, and multiply the griefs which he purposes to remove."

Join the CNL!

IJPC would like to invite all compounding pharmacists and technicians to join the Compounders' Network List (CNL) - an e-mail-based resource for sharing compounding information with your peers.

Go to the following website for more information and to join.

https://ijpc.com/cnl

Looking Back

Feel your face,
As you ride by,
Now don't you think,
It's time to try,
     Burma-Shave