Access Restricted Have you noticed that in recent years many government programs are given names that tell you exactly what the program ISN'T going to do? For instance, a new senate bill called the Safe Drug Compounding Act would more accurately be named the Restricting Drug Compounding Act. And all women should be aware that this act takes direct aim at your freedom to choose a safe alternative to synthetic hormone replacement therapy (HRT). How low can they go? About a year ago I told you about a disgraceful petition submitted to the FDA by representatives for Wyeth Pharmaceuticals. The petition called for the agency to impose broad restrictions on bioidentical hormones. As the name implies, bioidentical hormones (derived from estrogen-like plant compounds) are identical to natural hormones in the body. The chemical makeup of synthetic HRT (which just happens to be manufactured by Wyeth) is not identical. In response to the 2006 petition, thousands of women submitted comments to the FDA, sharing their personal success stories about bioidentical hormone use. Eventually that petition was quietly shelved. But as we now know, the threat to this unique and very effective alternative care is far from over. Custom fit The Safe Drug Compounding Act threatens to put restrictions on bioidentical hormone use by giving the FDA broad control over medicines dispensed by compounding pharmacies. These specialized pharmacies prepare customized medications (such as bioidentical hormones) according to specific guidelines prescribed by doctors. So is there really a need for regulation of compounding pharmacies? No. They're already regulated. Compounding pharmacists are licensed, educated professionals with years of training. They cannot dispense medications, compounded or otherwise, without a doctor's prescription. In addition, all of the ingredients used by compounding pharmacists are approved drugs listed in the U.S. Pharmacopoeia National Formulary (USP/NF), an encyclopedia of each drug approved by the U.S. Pharmaceutical Convention. As you might guess, compounding pharmacies disrupt the lucrative health care pattern favored by drug companies: You're diagnosed, your doctor prescribes a drug, you fill the prescription, and (in the best case drug company scenario) you continue filling the prescription every month. No limits! The Safe Drug Compounding Act of 2007 (sponsored by Senator Ted Kennedy) is scheduled for a committee vote next week, March 28. So now is the time to voice our opposition to any law that will limit the use of compounded medicines. In short: Decisions about these medicines should be made by doctors, not by the government. You can easily express your opinion by visiting the U.S. Senate web site (senate.gov) where you'll find a listing of senators from your state, along with their telephone numbers and e-mail addresses. Let them know that you oppose unnecessary regulations that will limit our health care choices. And if you have a personal experience with compounded medications or bioidentical hormones, be sure to add those details too. For more information about compounding pharmacists and the Safe Drug Compounding Act, you can visit the web site for the International Academy of Compounding Pharmacists (iacprx.org). And you can read further information about bioidentical hormone use in the e-Alert "Where's the Shame?" (2/7/06), which includes a first person account from an HSI member named Seana who had a very successful outcome with this therapy. http://www.hsibaltimore.com/ealerts/ea200602/ea20060207.html | 
