New Health Legislation Could Limit Your Doctor's Ability to Write Prescriptions

I was 49 when the effects of menopause hit. At the time I was running an arbitrage department at a Wall Street Investment firm enjoying a dream career. And then it all changed. Menopause, with all its ensuing hormonal shifts, not only impacted me physically -- the hot flashes, the sleepless nights -- but emotionally as well. My mood swings were so difficult and all of a sudden I started to question my own abilities.

My initial interactions with doctors weren't helpful. I heard anything from take a Prempro (a synthetic hormone) and you'll be fine, to this is what happens at your age: Live with it. But I'm a woman who likes to do her own research and no matter what doctors said, I knew there had to be a better way to navigate the changes. I began to find out everything I could about hormone replacement therapy. That led me to bioidentical hormones.

Bioidentical hormones are manufactured to have the same molecular structure as the hormones made by your own body. By contrast, synthetic hormones are intentionally different. Drug companies can't patent a bioidentical structure, so they invent synthetic hormones that are patentable (Premarin, Prempro and Provera being the most widely used examples). Once I started to take them, my life felt familiar. I felt like me again. Now Sen. Ted Kennedy is proposing legislation that, if successful, could very well disrupt the balance I and so many others have worked so hard to create.

While it hasn't yet come to the floor of the Senate, Kennedy has proposed the Safe Drug Compounding Act of 2007. The bill would allow the FDA to monitor your doctor and pharmacist, and decide when -- or if -- they can provide their patients with medications that they both know determine quality of life.

What's at issue are compounded pharmaceuticals like bioidentical hormones. Simply put, compounded pharmaceuticals means that rather than be given a one-size-fits-all medication that I have to cross my fingers and hope works, my doctor prescribes medications to the exact dosage my body requires. Without that precision, I know that the quality of my life would not be nearly as good.

And the same is true for all the AIDS patients, autistic patients and others who depend on a doctor prescribing medications that fit a body's unique chemical makeup. Of all the problems with our healthcare system, why Sen. Ted Kennedy, D-Mass., wants to tinker with this literally life-saving provision is mind-boggling.

Proponents of the bill would argue that what they're doing is protecting patients by allowing the FDA to be the watchdog that determines the benchmarks of safety. They are saying because there are so many compounding pharmacies, patients can't be sure they are getting exactly the right dosages. They are also concerned about the sterility of facilities.

But the real reason this bill is being pushed is that big pharmaceutical companies lose profit when they can't mass produce a drug. Like the difference between a dress that's made to order and a dress that's off the rack, it's easier to mass produce a drug -- guesstimating that most people will need about this dosage -- rather than tailoring each prescription to the patient. But unlike a poorly fitting dress that you need to have taken in or up, improperly offered meds can cost a person the quality of their her or his life, or worse.

Why does this matter so much? In my case, I am one of over 40 million women between the ages of 40 and 60 in the United States. About 25 million women worldwide enter menopause annually. It is estimated that by the year 2030, that number will increase to 47 million women per year. Hormone depletion leads to diseases of aging -- type I diabetes, heart disease, cancer, osteoporosis and reduction in brain function. This needs to be addressed so that boomers can age healthfully. And bio-identical hormones -- compounded pharmaceuticals -- is the best and most current weapon we have available to us.

If we added all the people who are living with HIV/AIDS, the hospice patients, infants and young children with conditions like gastroesophageal reflex disease (GERD) and people who are extremely allergic or sensitive to fillers, dyes and additives in medicines, the numbers of people who stand to be hurt by this bill is staggering. All because it reduces profit margins.
Time and again, we've seen where pharmaceuticals have chosen profits over people. Time and again, we've seen medications rushed to market -- medications, which by the way, were FDA approved -- only to have them called back when people died. It seems to me that both entities need to focus their energy on shoring up their own internal processes so that they do a better job of reducing morbidity, rather than potentially adding to, which is what passage of this bill could do.

We don't have to stand idly or quietly by. At very least, we can email and fax each of our senators and Congress members and ask them to oppose the Kennedy Drug Compounding Bill. (Go to www.projectfans.org to find your local representative's contact information).

If we all do all part we can protect our right to choose.