Image: Elizabeth Alsgaard
Damian Dovarganes  /  AP
Elizabeth Alsgaard, 52, shown outside her Los Angeles home, sought alternative remedies to ease her menopause symptoms.
updated 10/25/2009 12:19:29 PM ET 2009-10-25T16:19:29

Editor's note: Ten years and $2.5 billion in research have found no cures from alternative medicine. Yet these mostly unproven treatments are now mainstream and used by more than a third of all Americans. This is one in an occasional series examining their use and potential risks.

Miserable in menopause, Elizabeth Alsgaard pondered an awful choice: Drenching hot flashes or hormone therapies that might raise the risk of cancer. What former actress Suzanne Somers raved about held much more appeal — custom-mixed "bioidentical" hormones, just like ones the body makes.

"Anything I can put into my body that's natural has to be better," said Alsgaard, a California audiologist who admitted having "no knowledge base to go on other than fear" when she took Somers' advice.

Millions of women have tried custom-compounded hormones or herbal supplements like black cohosh and red clover since 2002, when a big federal study found risks from traditional hormone replacement therapy, or HRT.

Alternative remedies are especially popular with upscale, educated women who like to research and find their own solutions to medical problems. They like the idea of personalized treatments versus off-the-shelf prescription drugs.

However, instead of a safer option, they are getting products of unknown risk that still contain the estrogen many of them fear, women's health experts say.

"Misinformation is rampant" about bioidenticals, said Dr. JoAnn Manson, preventive medicine chief at Harvard-affiliated Brigham and Women's Hospital in Boston. "It really is buyer beware."

She and other experts explain:

  • "Bioidentical" is a marketing term that has no accepted medical meaning. Its implied benefit is not unique to alternative remedies; many prescription drugs contain hormones that chemically match estrogens and progesterones made naturally by the body.
  • Custom-compounded hormones are not approved by the federal Food and Drug Administration and have not been proved safe or effective. They may carry the same cancer and heart risks as traditional treatments and have had even less testing to find out.
  • Hormone preparations do not need to be customized for each woman; a few standard doses work for almost everyone, medical experts say. The saliva tests that some women are given to tailor formulas are of dubious value because hormone levels fluctuate widely throughout the day.
  • Compounding pharmacists use such different methods that a customized prescription can contain widely varying amounts of hormones depending on who fills it.
  • Many compounders use estriol, a form of estrogen not approved for sale in the United States. The FDA is in a battle with compounding pharmacies over its use.

The bottom line?

"Women need to understand there's no rigorous evidence these preparations are any more effective or any safer than traditional hormone therapy. In fact, there's much less evidence for efficacy and very little research on long-term safety," said Manson, who has no industry ties and was a key researcher in the big federal study that warned women in 2002 of the health risks from long-term hormone use.

Quack medicine?
For years, medical groups have warned against custom-compounded hormones. The American College of Obstetricians and Gynecologists has denounced claims about their safety. The American Medical Association has urged more FDA oversight. The Federal Trade Commission has filed complaints against online sellers who made health claims for natural progesterone creams without supporting evidence.

In 2001, the government tested 29 products from compounding pharmacies and found that one-third did not meet standard quality benchmarks, including potency problems, Manson writes in her book, "Hot Flashes, Hormones and Your Health."

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That has not stopped their popularity, and Somers has promoted them in several best-selling books and on "The Oprah Winfrey Show" earlier this year.

"I laugh when they call me a quack," said Somers, who rubs hormones on her arms, injects them vaginally and takes some 60 supplement pills each day. In a phone interview, Somers said she is not trying to play doctor but to share with women what worked for her.

Battle with FDA
The issue flared last year, when the FDA declared that custom-mixed hormones were no safer than traditional treatments and warned pharmacies to stop using estriol, which is not approved in the United States for any use. (Most traditional menopause therapies use a different form of estrogen with a similar name — estradiol.)

The industry claimed it was being persecuted and fought back. In full-page ads in major newspapers, several alternative medicine groups claimed that estriol is safe, criticized "synthetic, hyper-expensive" prescription drugs, and asked, "Why is the FDA so hostile to 'natural' medicine?"

There are several thousand compounding pharmacies in the United States and hormones are a significant part of their business, said L.D. King, executive director of the International Academy of Compounding Pharmacists in Missouri City, Texas. No one knows how many women use these products, but "we believe the FDA action on the estriol issue would have affected hundreds of thousands of women," King said.

A group of nine compounding pharmacies sued the FDA. After a murky ruling by a federal court in Louisiana centering on federal versus states' authority, neither side appealed, King said.

"It gets complicated and there's not a win," he said. "We continue to advocate that FDA's action is wrong."

Alsgaard was not aware of the flap. She was 52 and living in San Diego when she stopped taking birth control pills, and menopause symptoms "hit me like a brick wall." Her doctor, a specialist in women's health, urged traditional hormone replacement therapy.

Video: Suzanne Somers: ‘I saw my death’ (on this page) "She was just so aggressive it really flipped me out," said Alsgaard, who feared a cancer risk from the pills. After reading one of Somers' books, Alsgaard went to a different doctor specializing in bioidentical hormones.

"She spoke at a physician's level, talked about metabolic things I didn't understand and sold me a couple hundred dollars of supplements I never took," Alsgaard said. "I was so desperate it was like, 'OK, OK, just give me whatever I need."'

Although Alsgaard did not use the supplements, she did spend about $1,000 for saliva tests, hormone creams and custom-compounded hormone pills the doctor prescribed. Six months later, she was still miserable.

Natural remedy
Disgusted with the doctor and in the middle of moving to Los Angeles, she found a new doctor and asked again for a natural remedy, believing those are safer than traditional hormone pills.

"He did a lot more extensive workup on me and put me on a bioidentical implant, a pellet implanted into the hip," she said.

Pellets containing estrogen, testosterone or both are the latest craze in this field. They are implanted just under the skin every few months under a local anesthetic, and are not FDA-approved for treating menopause. Problems that have been reported include difficulty removing the pellets if the therapy has to be discontinued, infection or pain at the injection site and fluctuating blood levels of estrogen, including a potentially high cumulative effect over several years.

Alsgaard did not know the pellets lack FDA approval. Her first, implanted in April, has done the trick, she said.

"I feel awesome. I have no night sweats, no hot flashes, no mood swings. After feeling so terrible, I'd forgotten how good it feels to feel normal," she said.

Whether her estrogen pellet is any safer than traditional estrogen pills is unknown.

Her physician, Dr. Kevin Pimstone, an internist at UCLA, said hormone pellets are "a very small part of my practice" — a few patients a month.

"I'm a really conventional doctor who offers this to patients who ask for it," he said. "I don't think there's any evidence that bioidentical hormones are any safer than conventional hormones."

© 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Video: Suzanne Somers: ‘I saw my death’

  1. Closed captioning of: Suzanne Somers: ‘I saw my death’

    >>> last november actress suzanne somers was diagnosed with full-body cancer . she highlights that experience in her newest book, "knockout," suzanne, good morning. my goodness. how long were you misdiagnosed? how long were you led to believe you had full body cancer ?

    >>> i was in the hospital for six days, confirmed by six doctors that i had full-body cancer and that when i refused chemotherapy i was told to get my things in order. it was really a very heavy experience. i mean in a way i have experienced what most people don't in that i saw my death and i started thinking about who i would give what to and how i'd prepare my family.

    >> this after having been properly diagnosed -- or having been diagnosed with breast cancer back in 2000 . you had that fear again. it was like a terrible moment. but then you discovered you did not have full body cancer and that really propelled you to write this book. you're on a mission with this book. what is that mission?

    >> when i was lying in the hospital thinking that it was the worst -- i'm a very upbeat, positive person. so it's just it was so many people confirming it, i said to my husband, you know, i've been keeping a file on doctors who are curing cancer . so i can get out of here. i said i don't know if they can do it with someone like me who was full body cancer . i know they're oshg working on tumors. if i get out of here, take me to houston or to new york, or to nevada, there are these doctors out there doing incredible work. and so when it turned out to be a misdiagnosis, they cut open my next, went in, took a piece of my lung, one of the so-called tumors around my heart, turned out it was not cancer at all. i spent the last year interviewing these doctors and their patients and so what nok "knockout" is is options. when you've diagnosed with cancer , you've been there twice now. you're only given standard of care . what i wanted to explore was, what if someone wanted to go alternative? what if somebody wanted to go integrative? what if somebody wanted to go nutritional. what if somebody wanted to go full-out standard of care . one of the interesting things about full-out chemotherapy, there are things you can take to make it less harsh, to make it more effective. i myself would only go alternative around when you read the patient testimonials, they're living with stage four and stage three cancers, pancreatic cancer . this is a book to me of hope. i wish this had been available when i had cancer .

    >> that said, and with all due respect, you know that many of the doctors and -- who you interview for this book are very controversial. in fact, there are records of controversy. i think it's probably fair, we really should tell our viewers about that, that one of them, the texas medical board tried to revoke his medical license . he was also investigated four times by the federal grand jury and was finally indicted by a fourth grand jury . and also another doctor was actually arrested in 2005 for prescribing human growth hormone to a government official who posed as a patient. so this kind of stuff might make people think, look, why are you giving attention, shining a light on doctors who are controversial about a subject that's so important?

    >> yeah, but what you have to understand, dr. brzezinski was sued by the fda . he fought the fda and won. dr. brzezinski is an incredible doctor. he escaped the ire curtain in poland. he discovered patients who have cancer across the board are always missing a certain peptide in their liver that controls cell multiplication. he's dwoesed his life to replicating that. he side. he's put that back. ep's completed phase two clinical trials in compliance with the fda . he has patients who have the worst brain tumors , he's having 50%, 60% response rate .

    >> he's lucky to have you speaking for him. these doctors are being interviewed in this book. but some of the things that you're saying in this book is that people with certain kinds of cancer really don't need chemotherapy. don't need radiation. this would go against what the american medical association says.

    >> i think what we have to look at. war on cancer according to the "new york times" is an abysmal failure.

    >> you call it a big business . a $2 billion a year business.

    >> right.

    >> are you suggesting that that's something that they're trying to --

    >> the death rate has only dropped 5% in 55 years. what other protocol would you access --

    >> i always run out of time with you. thank you.

    >>

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