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Voice of Experience

Voice of Experience: July 2023 | Health

Hormone Replacement Therapy

Bonnie Michelle Smith

Summary

  • Dive into the intricacies of hormone replacement therapy, particularly focusing on hormone pellets and their historical context.
  • This article highlights the challenges and lack of FDA approval for hormone pellets, discussing the role of Dr. Robert B. Greenblatt and the ongoing issues related to insurance coverage and accessibility.
Hormone Replacement Therapy
Tero Vesalainen via Getty Images

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Medicare does not cover hormone replacement therapy. In fact, many insurance companies do not cover hormone replacement therapy, categorizing it as being “medically unnecessary,” or merely “elective.” Hormone replacement therapy dosing methods can include pills, patches, creams, and pellets.

A little-known therapy under the hormone replacement therapy umbrella are hormone pellets or hormone implants. Smaller than a grain of rice, the tiny hormone pellet is inserted under the skin under local lidocaine for insertion with a trocar that resembles a pencil. The doctor uses a trocar to insert one or more of the pellets into a layer of fat tissue under the skin, typically in the buttocks or flank. The pellets then slowly dissolve and release the hormone into the patient’s body over time. The goal is to elevate hormone levels in the bloodstream for three to six months. The pellets provide a controlled release of hormones that ease menopause symptoms of hot flashes, dry vagina, brain fog, frequent urination, low sex drive, weight gain, insomnia, mood swings, anxiety, headaches, low energy, as well as provide benefits to your heart and bones.

Hormone pellets began to be in use in the 1930’s. Dr. Robert B. Greenblatt, MD who pioneered the birth control pill, was instrumental in bringing the technology from Europe to the United States. Dr. Greenblatt came from Canada to Augusta, Georgia, to work at the Medical College of Georgia in the early 1930’s.

When Dr. Greenblatt died in 1987, The New York Times reported his death, in its September 29, 1987, edition as follows: “Dr. Greenblatt, who came to the Medical College of Georgia 52 years ago as a research fellow, had received international recognition for his work in the sequential oral contraceptive pill and the oral fertility pill. He wrote or edited about 23 books, including ''Sex and Circumstance: Humanity in History,'' which was published this year and contained 44 vignettes detailing the sexual nature of people ranging from President Kennedy to Tchaikovsky.”

Dr. Greenblatt was the guru of hormones. He was to hormone replacement therapy what Peter Pan is to Peanut Butter.

Hormone replacement therapy, specifically estrogen and testosterone pellet therapy, has been a mainstay for menopause relief internationally for almost 90 years. Yet, hormone pellets still lack FDA approval. Doctors who can insert these tiny, life changing grains of rice size hormones are still hard to locate. Most doctors only insert them on the cash payment system at the same rate that has been charged since 1972: $45.00 per pellet, and a $130.00 to $150.00 insertion fee. For

3 or 4 pellets, that total insertion fee is about $330.00 every 3-6 months, depending on how quickly your body absorbs the pellets. That is still the same price as Dr. Greenblatt was charging in 1972 – pretty amazing when one considers how prices for most medicines and services have grown in breath-taking fashion in the same time period.

Frustratingly, the FDA refused to grant approval for hormone pellets back in the 1970’s and 1980’s. An FDA reviewer reasoned, “women almost became addicted to the hormones, so this was a medicine where women were basically taken advantage of.” So, of course, this was something the FDA would not approve. Estrapel, the first pelletized estrogen therapy pioneered by Dr. Greenblatt never got FDA approval.

Currently, no drug manufacturers in the United States make estrogen pellets under FDA approval. Instead, hormone pellets are made only by “compounding pharmacies.” Compounding pharmacies make non-FDA-approved customized medications that may not be commercially available. These pharmacies are generally subject to regulation and are monitored for quality purposes. Ninety years since their inception, hormone pellets with estrogen can only be legally obtained from a compounding pharmacy. Hormone estrogen pellets are not available commercially from CVS or Walgreens or any other national chain, even with a prescription. The FDA still has not approved hormone estrogen pellets for women.

My mother began getting her hormone pellets from Dr. Anthony E. Karpas, MD, who studied under Dr. Robert B. Greenblatt. Dr. Karpas was a brilliant physician, researcher, and scholar. His marriage to Dr. Geenblatt’s daughter also embraced Dr. Greenblatt’s hormone philosophy and his entire reproductive endocrinology approach to women’s hormonal health.

But for Dr. Karpas, my mother would not have had the quality of life she has today. Although Dr. Karpas is now long dead, my mother still gets her hormone pellets, not FDA approved or covered by her Medicare or Blue Cross Blue Shield, religiously every 4 months. If ever there was a non-physician expert on hormone pellets, it is my mother. She can tell you when the compounding pharmacy did not do as good a job on a batch of pellets, or if the pellets are past their expiration date like a gallon of milk.

I leave you with a non-scientific anecdotal case study. My mother had a total hysterectomy when she was 29 years old, followed by hormone replacement therapy. My former secretary, Miss D, also had a total hysterectomy at about the same age. Miss D did not get hormone replacement therapy because she was afraid that hormones caused cancer or would be bad for her heart. Miss D now resides at the Andersonville National Cemetery, Andersonville, Georgia. She was a tough as nails navy veteran, who might still be alive but for hormone replacement therapy.

My mother is petite, vibrant, sexy, sharp witted and still getting hormones. She is healthy, happy, and very much alive.

My non-scientific study may well be equal to, or even more credible as the World Health Organization study that used questionable sampling data. After Big Pharma learned of the Hormone Replacement Study, the data and sampling became corrupted to suit the narrative. It doesn’t help Big Pharma financially for women to get hormones to preventatively treat a wide array of health problems. Better to scare them so they can buy into all the other pharmaceuticals.

Remember the FDA reviewer’s ironic lament that “women might be taken advantage of."

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