Bio-Identical Hormones

02/16/09 6:03pm

HOT news FLASH Concerning Female Hormone Replacement

Bringing more heat to the already hot topic of bio-identical hormone replacement, the FDA recently warned several compound pharmacies concerning the use of the word bio-identical and the use of Estriol, a naturally occurring form of estrogen in the female, in compound formulations.

Much of the controversy began when Wyeth filed a citizens complaint against the use of such compounds. Wyeth is more than just an average American citizen. They are the multi-billion dollar producer of concentrated pregnant mare urine known by the trade name Premarin and the synthetic Progestin known as Provera. Premarin and Provera came under fire when the 2002 Women's Health Initiative study showed that the use of these compounds increased the risks of breast cancer, heart disease and Parkinson's.

Now if the so-called citizen's issue is a semantic concern, then I will gladly replace the word individualized for bio-identical and continue to offer hope and solutions to women facing PMS, postpartum depression, perimenopause and menopause. However I will not stand quiet, if Estriol use, a listed and approved drug in the US Pharmacopeia, is not continued to be allowed in compound formulations, or if the right for physicians to prescribe compounded medications is eliminated.

A major talk show and others opposed to compound formulations raise the argument that compounding has become a $5 billion a year business. They also raise the premise that it is unsafe because of three associated deaths and it is not regulated by the FDA. They fail to mention that the FDA regulated US pharmaceutical industry is a $280 billion a year business and conservative estimates attribute 200,000 associated deaths a year to pharmaceutical use.

As a physician, I am thankful for pharmaceutical medications and I use them when indicated. I also know and support the value of compounded medicines. Here are a few thoughts to consider:


COMPOUND PHARMACIES ARE UNREGULATED BY THE FDA

FDA regulation does not guarantee safety as seen in the recent findings surrounding the cox-2 inhibitors.

Compound pharmacies use products that are closely regulated and tested. The pharmacies themselves are also closely regulated by the State Boards of Pharmacies and your personal doctor.

I have used the same compound pharmacy with the same compound pharmacists for over five years because I know he quality of the pharmacy and pharmacists.

COMPOUNDS AND DELIVERY METHODS FOR MEDICATIONS

I can be more physiologic with what I prescribe (give you back closer to what your body naturally makes). For example, your thyroid naturally makes T4 and T3. Traditional pharmaceutical replacement with Synthroid or Levoxyl only provides T4. With compounding, I can replace T4 and T3.

I can individualize the dose of medications based on what you actually need.

I can individualize the delivery system to bypass the GI and hepatic/portal system and use smaller overall doses.

I can target delivery to local areas rather than having to use a systemic approach.


BOTTOM LINE

Why do I chose to use a compound pharmacy? Because compounding makes pharmacologic and physiologic sense; and ultimately, it's not who makes the 280 billion dollars, its about what makes sense!