Angelina Jolie, thrust into early menopause following preventive cancer surgery, said she's using “bio-identical” hormones — a choice that's raised new questions about the safest therapies for easing menopause symptoms.
Jolie, 39, said in a New York Times op-ed piece Tuesday that she had consulted both Eastern and Western doctors, looking for “natural ways” to deal with her cancer risk.
It's unclear what specific types of hormones Jolie might be taking, but without hormone replacement therapy, she'd cope with the typical symptoms of menopause: hot flashes, vaginal dryness, insomnia and mood swings. Because she’s experiencing menopause much earlier than the average age of 51, she also would be at risk for early osteoporosis and cardiovascular problems.
“Bio-identical” means a lab-made hormone meant to be molecularly similar to the estrogen and progesterone produced in women's bodies. There are dozens of hormone products on the market, and hormone replacement therapy available today is very different from formulations sold in the 1990s and earlier.
The Food and Drug Administration approves some plant-based hormones, but cautions about using those made by unregulated compounding pharmacies that cater to women who are uneasy about taking hormones.
“In fact, bio-identical is not a scientific term,” said Dr. Lauren Streicher, assistant clinical professor of obstetrics and gynecology at Northwestern University’s medical school and co-author of “The Essential Guide to Hysterectomy.” “It is a term originally made up by savvy market research gurus to describe hormones distributed by compounding pharmacies.”
The Food and Drug Administration warns that some claims made by the sellers of compounded, bio-identical hormones — namely, that they're safer than “dangerous prescription drugs” — are unproven and that they mislead women and health care professionals.
Jolie carries a mutated version of the BRCA1 gene that increases her risk for breast and ovarian cancer. In 2012, she had a double mastectomy. Last week, she underwent a laparoscopic bilateral salpingo-oophorectomy to remove her ovaries and fallopian tubes.
“It is not possible to remove all risk, and the fact is I remain prone to cancer,” she wrote. “… I feel feminine, and grounded in the choices I am making for myself and my family. I know my children will never have to say, ‘Mom died of ovarian cancer.’”
Jolie, the mother of six, will be unable to conceive more children but women with an intact uterus, as she has, can bear children via in vitro fertilization (IVF)
To curb the symptoms of menopause, Jolie says she wears a “clear patch” that delivers bio-identical estrogen. She also has a progesterone IUD to help prevent uterine cancer.
“We do not know whether Ms. Jolie is on an FDA-approved product, or an compounded one,” said Pauline M. Maki, president of the North American Menopause Society. “Given that she is using a patch, it is likely an FDA-approved form.”
In fact, when it comes to the type of patch Jolie revealed she's wearing, compounding pharmacies cannot legally manufacture or sell them, said Dr. Shira Miller, a Los Angeles holistic menopause and anti-aging physician.
The FDA approves a plant-based hormone therapy in patch form (17-beta estradiol); compounding pharmacies can only sell drugs that are not available commercially, she said.
Hormone replacement therapy comes in a variety of forms, including conjugated equine estrogens like Premarin (pregnant mare’s urine), synthetics and those made from plants like soy and yams. Its delivery can be a pill, cream or patch.
FDA-approved hormones are sold by prescription only and generally covered by insurance; compounded hormones do not require a prescription.
“[Bio-identicals] are not any better or safer than hormones that are FDA-approved,” said Dr. Rebecca Starck, chairman of regional obstetrics and gynecology at the Cleveland Clinic. “Truthfully, it’s a marketing tool that gives women the impression they are safer or healthier.”
“I would argue safety from the FDA products [is] more robust, and they monitor adverse outcomes,” Starck added. “I would be concerned about how these compounds are made and would want to assure women are getting the appropriate dosage.”
Compounding pharmacies came under scrutiny in 2012 when 64 people in 20 states died from meningitis after drugs used for spinal steroid injections were contaminated with a fungus at a Massachusetts facility.
According to Bernie Noe, a naturopath physician from Montpelier, Vermont, women who take bio-identicals are routinely tested for blood levels of those hormones.
While some of his patients take these unregulated hormones, “we cannot conclusively say they are safer,” Noe said.
He often recommends natural remedies for menopause symptoms, including Siberian rhubarb. “Hormones [of any type] are always my last choice.”
As the debate rages, other medical experts call the push behind bio-identical hormones an example of “brilliant" marketing.
“[The word] was catchy, it sounded natural, and it also sounded like something different than the duplicate FDA-approved plant-derived hormone products produced and distributed by commercial pharmacies,” said Streicher.
“And it worked. A $1 billion industry was launched … and supported by women who distrusted the pharmaceutical industry and were desperate to feel better.”