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Saturday, June 15, 2013

Bioidentical Hormone Replacement Therapy

Dr. Kathryn Retzler

As a primary care physician who specializes in natural medicine, I think the most important role doctors can play is that of teacher – to provide complete, unbiased information so that patients can make their own informed decisions.

Following is a list of facts I provide my patients when they seek help for hormone imbalance symptoms:

Many women and men have significant symptoms as they age.

No two people are identical in terms of their hormone production or the symptoms of hormone imbalance they experience.

Eating a healthy diet, exercising regularly, minimizing stress, and avoiding environmental toxins are the foundations for preventing and managing hormone imbalance symptoms.

If symptoms of hormone imbalance persist, bioidentical hormone replacement therapy is an option that contains benefits and risks.

People have different medication needs and drug detoxifying capacities. Testing baseline hormone levels and following up with repeat testing after treatment is a reasonable way to determine whether a patient is receiving too much hormone. Symptom improvement usually determines if a patient is receiving enough medication.

Synthetic hormones have been shown to have serious health consequences including increased risk of breast cancer, blood clots, heart disease, and stroke. Synthetic oral testosterone has been shown to increase the risk for liver inflammation and liver cancer.

Bioidentical hormones are identical in structure to those made by the body. There is a large body of research involving the effectiveness of bioidentical estradiol, progesterone, and testosterone. Bioidentical hormones do carry risks, especially when administered in excessive dosages, outside of physiological levels; overall, however, they have a lower risk profile than their synthetic counterparts (this is especially true for bioidentical progesterone vs. progestins, and bioidentical testosterone vs. methyltestosterone). More research about long-term effects of bioidentical hormones needs to be done.

Bioidentical hormones are found in pharmaceuticals (e.g., bioidentical estradiol patches such as Climara or Vivelle, bioidentical progesterone such as Prometrium, and bioidentical testosterone such as Androderm, Androgel, or Testopel) as well as in individual preparations made by compounding pharmacists.

Compounded medications have been available since the 1930s. Organizations such as the Professional Compounding Centers of America (PCCA) provide continuing education seminars for pharmacists and physicians, as well as a source of FDA-approved ingredients subjected to quality assurance standards.

Treating hormone imbalance requires a comprehensive understanding of endocrinology and gynecology, as well as significant clinical experience.

I also share the following opinions with my patients

It makes sense to test baseline hormone production, and then if low levels and/or hormone imbalance symptoms deem necessary, to prescribe low dosages of bioidentical hormones that eliminate or minimize symptoms, or to bring a patient's hormone levels to within physiological range. There is no established protocol for such treatment and potential risks exist; therefore, a conservative approach to treatment is most prudent.

Choosing an doctor who listens, provides you with information, and respects your treatment decisions is your right and responsibility. Expect your physician to provide you with available research, benefits, and risks of any treatment you choose. Do not be afraid to question any treatment or to make your own healthcare decisions

For additional information about hormone imbalance symptoms, anti-aging and bioidentical hormones replacement therapy, please visit my clinic website at:


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Friday, June 14, 2013

Legislation Passed by the U.S. Senate HELP Committee Could Put Your BHRT At Risk–Again.
Written by:  Mymedsmatter.com

On May 22, 2013 the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) passed a bill, S.959 that contains provisions that threaten access to compounded Bioidentical Hormone Replacement Therapy (BHRT) by both patients and providers. The entire Senate could consider the bill as early as late June 2013.

This bill would give the Food and Drug Administration (FDA) broad and unprecedented powers to regulate compounding pharmacy, including the power to reduce or eliminate access to certain compounded medications used for BHRT. Here is a description of the main provisions of this legislation:

S.959 grants FDA the authority ban certain components of compounded BHRT if, in the opinion of the FDA, they pose “public health concerns.” In 2008, FDA took similar action against the female hormone estriol, a component contained in approximately 80 percent of all compounded estrogens. FDA’s action was in direct response to a request in a “Citizen Petition” filed by a drug company with synthetic hormones that competed with BHRT. FDA instituted import bans on estriol and sent warning letters to suppliers and pharmacies trying to prevent or limit women from obtaining BHRT with estriol. FDA was unable to enforce these actions. S.959 gives them that authority.

S.959 greatly expands the definition of a “copy” of a drug company product to include a “variation.” FDA is given expansive authority to determine the definition of variation, and would have the power to determine that compounded BHRT medications are copies of one-size-fits-all and synthetic hormones manufactured by drug companies. This could turn compounded BHRT into an illegal copy of a drug company product.

While there is an exception that allows a provider to continue to write prescriptions for the now illegal BHRT, under S.959 he or she would have to determine that BHRT produces a “clinic difference” in a patient’s treatment outcome as opposed to using the drug company product. While a doctor would be able to make this determination, the bill would allow the FDA to determine compliance.

In the past, FDA attempted to require practitioners to file costly and invasive Investigative New Drug applications (INDs) for certain compounded BHRT. The agency refused to recognize the considerable expense and bureaucratic procedures involved in setting up and IND. Instead, FDA dismissed legitimate concerns as “misconceptions that obtaining an IND is costly, cumbersome, and time consuming process.” A requirement for an IND for such commonly used medication is an unwarranted intrusion of federal bureaucrats into the patient/provider relationship. But it would be allowed under S.959.

For men, compounded testosterone therapy (both injectable versions and creams) could be determined to be copies of manufactured products. Even if a provider can justify a clinic difference in outcomes, S.959 would allow FDA to erect barriers to the prescribing of these medications.

FDA has demonstrated hostility towards BHRT in the past, and on its website it still has a consumer alert stating, “’BHRT’ is a marketing term not recognized by FDA.”  In the same alert, which was specifically requested by the drug company filing the Citizen Petition mentioned about, FDA denies the scientific fact that bioidentical hormones are identical to hormones made by the body.  With such contempt toward BHRT, giving FDA broad and sweeping powers over patient and provider access to these medications, as is contained in S.959, is frightening.
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