Insurance Letter Supporting Pellet Therapy

Date:

To Whom It May Concern:

Hormone replacement therapy by pellet implantation has been used with great success in the United States, Europe and Australia since 1938 and found to be superior to other methods of hormone delivery (Greenblatt 49, Mishnell 41, Stanczyk 88).  It is not experimental.   Pellets deliver consistent, physiologic levels of hormones and avoid the fluctuations of hormone levels seen with other methods of delivery (Greenblatt 49, Thom 81, Stanczyk 88).  Estrogen delivered by subcutaneous implants maintains the normal ratio of estradiol to estrone (Thom 81, Stanczyk 88, Owen 92, Cravioto 01). 

Hormones delivered by the subcutaneous implants bypass the liver, do not affect clotting factors and do not increase the risk of thrombosis (Notelovitz 87, Seed 00). Bioidentical testosterone delivered subcutaneously by pellets is cardiac protective, unlike oral, synthetic testosterone (Sands 97, Worboys 00).

Testosterone and estradiol delivered by pellet implantation, does not adversely affect blood pressure, lipid levels, glucose or liver functions (Burger 84, Barlow 86, Notelovitz 84, Stanczyk 88, Davis 95, 00, Sands 97, Seed 00, Cravioto 01).

Pellets are superior to oral and topical hormone therapy with respect to relief of menopausal symptoms (Staland 78, Cardoza 84).  Estradiol and testosterone implants have consistently been shown to improve insomnia, sex drive, libido, hot flashes, palpitations, headaches, irritability, depression, aches, pains, and vaginal dryness (Staland 78, Thom 81, Brincat 84, Davis 95, 00, Cravioto 01). 

Hormone replacement therapy with estradiol and testosterone implants is superior to oral and topical (both the patch and gel) hormone replacement therapy for bone density (Savvas 88, 92, Davis 95, Anderson 97).  The pellets not only prevent bone loss but actually increase bone density (Savvas 88, Studd 90, Garnett 91, Savvas 92, Naessen 93, Holland 94, Studd 94, Davis 95, Anderson 97, Seed 00, Panay 00). There is more data on hormone implants and bone density than any of the bisphosphanates.

Testosterone implants in women have been shown to improve lethargy, depression, loss of libido, hot flashes without attenuating the beneficial affects of estradiol on cardiac and lipid profiles (Sands 97, Seed 00).   Testosterone delivered by subcutaneous implants does not increase the risk of breast cancer (Dimitrakakis 04, Tutera 06, Natrajan 02) as does oral, synthetic methyl-testosterone (Tamimi 06).

Pellets do not have the same risk of breast cancer as Prempro or synthetic Methy-testosterone.  In fact, studies show a reduction in the incidence of breast cancer with the implantation of testosterone pellets, with or without estradiol pellets (Dimitrakakis 04, Tutera 06).  Hormone replacement therapy with a 20 mg estradiol pellet has been shown to have a lower risk of breast cancer than patients without hormone replacement therapy (Davelaar 91).  Even after over 20 years of therapy with hormone implants, the risk of breast cancer is not increased (Gambrel 06).  In breast cancer survivors, hormone replacement therapy with pellet implantation does not increase the risk of cancer recurrence or death (Natrajan 02) as does estrogens in combination with the synthetic progestins (Habits Trial 04).

Hormone replacement therapy with pellet implantation has an extremely low incidence of side effects  (Cardoza 84, Barlow 86, Ganger 89, Pirwany 02)) and high compliance rate (Gambrell 06).  It has been shown to be extremely effective in the treatment of migraine headaches (Magos 83). 

Testosterone replacement therapy in men with subcutaneous implants (pellets) has been show to be extremely effective, convenient and safe (Handelsman 90, 92, 97, Kelleher 01, 04, Conway 88, Jockenhoval 96,  Zacharin 03, Schubert 03, Dunning 04). 

FDA approval is required for ‘drugs being marketed to the public’.  Pellets, in the United States are compounded and not ‘marketed to the public’.  FDA approval does not guarantee efficacy or safety.  Testopel® is an FDA approved pellet.  However, it is only available in a 75 mg. dose, which is often not optimal.   The estradiol and testosterone used in the hormone implants are USP (United States Pharmacopeia) certified. 

I hope this allays any concerns you have about what I feel is medically the best preventative treatment for my patient. Prevention and treatment of disease with pellet implantation is the best and most cost effective therapy I am able to offer to my patients.  I have been using hormone implants for over three years in clinical practice and treated over 2,000 patients with pellets implants. The data clearly supports their clinical efficacy and safety.  All articles quoted are available full text upon request. 

Sincerely,

Brian B. Dursteler, MD, FACS