By Michelle Gillen

February 2009 | Miami CBS4

Bio-identical Hormones are in demand like never before. But is what you see always what you get? CBS4 I-Team chief investigator Michele Gillen reveals a rare inside look at these plant based hormones made just for you. (Watch this video report)

Deanna Stolberg is a woman who has a lot of questions. "At this point we may be the guinea pigs of the next generation that finds out it was fabulous; or we may be that other story," Stolberg said.

At 50-years-old, Stolberg can't stop wondering about the safety and potency of the customized hormone crème she rubs into her wrists twice a day. As she demonstrated to CBS4 I-Team chief investigator Michele Gillen, "You just squirt a little on your arm." The white crème is a formula of hormones that are marketed as being biochemically similar those produced by a woman's body and have been prescribed by her doctor.

It's a ritual untold numbers of women, desperate to combat menopausal symptoms, are turning to.

And in record numbers many are choosing to have them customized, in compounding pharmacies, just for them. But even the most vocal proponents of these bio-identical hormones now tell Gillen they urge caution in how and where the prescriptions are filled, and who writes them.

Dr. Erika Schwartz told Gillen, "This is the key; it has to be prescribed by a physician who has experience and knows the compounder. You can't just go write a prescription, send it to the compounder and then you are left to your own resources. That's where the problem comes from."

Concerned, she says, about the accuracy of customized hormone prescriptions being filled today, Schwartz sent out the same bio-identical hormone prescription to 15 different compounding pharmacies across the country. None of them were in Florida. "And what I got back blew my mind", Schwartz told Gillen.

Visually alone, the hormone formulations that are supposed to be exact came back with different consistencies, color, and packaging. "You have to twist it and you're lucky if it comes out", exclaimed Schwartz. "Some of them aren't even labeled" she added. Her questions and concerns are shared by Ray Moreno, founder and chief pharmacist of the Universal Arts Pharmacy in Hialeah, Florida.

He says he is swamped with increasing calls from doctors and women asking about bio-identical hormone therapy. He says he understands why so many women are interested in turning to compounded hormones. "Many of these women cannot function and they are suffering so greatly", he explained to Gillen while giving her an all access tour of his laboratory.

But he is troubled, he said, that many women and doctors don't realize that these hormone cocktails are serious business." "These are real hormones. They have to be used judiciously."

Moreno's pharmacy is one of three in Florida that has been accredited by the Pharmacy Compounding Accreditation Board, the PCAB. He says the accrediting process, in his opinion, can guarantee a higher level of standards that can affect the entire compounding process.

Key issues he says includes patients and doctors need to ask about is where a pharmacist buys his chemicals, how they track their origin and lot. "If there, God forbid, needs to be a recall of that product we know exactly everybody that got that product, it would be tied to the prescription itself," Moreno said.

While more attention is directed to bio-identical hormone therapy, Dr Schwartz said she wants to enlist the help of mainstream medicine and Universities to forge a path of greater standardization for compounded products and academic study regarding bio-identical hormones for women. All with one goal, she said, "we need the truth, and we need the truth now, and we need to protect women now."

Here are some questions experts have shared with us for patients to consider when investigating hormone therapy:

• How experienced is your doctor in the field of menopause, hormone therapy, bio-identical hormones and oncology? If you are considering compounded bio-identical hormones, what experience has your doctor had with compounding pharmacies?
• What, if any, type of test have you taken (ex.blood, saliva) to investigate what your hormone levels are before receiving a prescription for hormone therapy?
• Has your test been reviewed by your prescribing doctor?
• Are you aware that bio-identical hormone therapy in FDA approved pill or patch form is available, by prescription, directly from manufacturers?
• If you decide to investigate compounded bio-identical hormones, how experienced is the compounding pharmacy your Doctor has chosen?
• Have you checked the background of the compounding pharmacy?