Another example might help to understand Marilynn Marchione's deceptive statement. Aspirin is FDA approved for over the counter sales. If the compounding pharmacy crushes the aspirin tablet and places the powder into capsules, the aspirin becomes non-FDA approved aspirin, even though it is the same stuff. Starting to make sense now?
Marilynn Marchione falsely claims that bioidentical hormones have not been proven safe and effective as required for FDA approval process. Take a look at the list of bioidentical prescription hormones above. These are all FDA approved and proven safe and effective, indicating Marilynn Marchione's statement is false.
They may carry the same cancer and heart risks as traditional treatments and have had even less testing to find out.
Marilynn Marchione is wrong again. The French Cohort study, showed no increased cancer in the bioidentical group. Again, look at, Dr Holtorf's article in Postgraduate Medicine listing 196 research articles showing Bio-identical Hormones are associated with lower risk, and are more efficacious than synthetic counterparts.
Less Heart Disease Risk on Calcium Score Studies
Two calcium scoring studies showed no increased risk of heart disease associated with bioidentical hormones. A study of CAT calcium scores by JoAnn E. Manson in the June 2007 JAMA actually showed less heart disease in the women taking unopposed estrogen (they had hysterectomies and were not given the synthetic progestins). These same results had already been published 2 years previously in a calcium score study by Budoff in J Womens Health 2005.
Hormone preparations do not need to be customized for each woman; a few standard doses work for almost everyone, medical experts say.
I don't know who Marilyn's medical experts are, but I have found dosage varies for bioidentical hormones just as dosage varies for any other drug. Pick up any medical pharmacology text book. What you find is drug dosage varies according to age, body weight, genetics, and hepatic metabolism of the drug. For hormones, the amount of sex hormone binding globulin is another variable that determines hormone dosage. This idea of standard dosing is regurgitated drug company propaganda.
The saliva tests that some women are given to tailor formulas are of dubious value because hormone levels fluctuate widely throughout the day.
Again the above statement is an oversimplification that is misleading. Saliva testing for cortisol is done with 4 samples to catch the diurnal variation. Saliva testing normally shows salivary cortisol levels are highest in the morning and lowest in the evening before sleep. Regarding sex hormones, in young cycling females, hormones vary according to a monthly pattern of ovulation, called the menstrual cycle, with estrogen and progesterone peaking around day 19-21 of the cycle. In older, post menopausal women who are no longer ovulating, menstrual cycles have stopped and hormone levels typically decline to low levels. As a general rule, wild daily hormone fluctuations simply do not happen for post-menopausal woman. Rather, hormone levels decline to low levels, and since ovulation has stopped, hormone levels don't change much from day to day.
Compounding pharmacists use such different methods that a customized prescription can contain widely varying amounts of hormones depending on who fills it.
This is a completely wrong and misleading statement. If a prescription for hormone cream is sent to two different compounding pharmacies, and the two creams analyzed, they should have the same amounts of hormones. If they don't, then something is wrong and needs to be fixed. Each compounding pharmacies should be making the exact same formulation when given the same prescription. I have found that when dealing with the larger national compounding pharmacies, quality control is better, and formulations are more consistent between pharmacies.
Many compounders use estriol, a form of estrogen not approved for sale in the United States. The FDA is in a battle with compounding pharmacies over its use.
Estriol is commonly use in compounding hormone preparations, and like many other natural compounds used for many years, approval was grandfathered in. Formal FDA approval was not required nor was it requested. Medical research shows that of the three estrogens, estriol, is the safest and most protective.
The bottom line? "Women need to understand there's no rigorous evidence these preparations are any more effective or any safer than traditional hormone therapy.
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