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Followers call him a miracle worker. Detractors say he risks women's lives. A pioneer of natural progesterone cream will make stops around the bay area.
By SASHA TALCOTT
© St. Petersburg Times, published February 16, 2003
One year ago, doctors diagnosed Margy Ward with fibroids in her uterus, possibly a sign of cancer. The solution: total hysterectomy.
Ward could feel the hard lumps in her belly, and she saw on the sonogram the tumor-like growth that her doctor feared could eventually kill her.
But as a devout Christian, Ward believed that God would not want her to lose her reproductive organs if the cancer diagnosis turned out negative. She found a new doctor, who put her on an unconventional treatment used mostly as a symptom-reliever for menopause: natural progesterone cream.
Now, her fibroids are in remission. Doctors found no signs of cancer. And the controversial elixir called natural progesterone has won itself another loyal convert.
"There's not a day that goes by that I don't thank the Lord for the miracle he has done in my body," said Ward, 55, of Valrico. "I didn't have surgery. I still have my uterus and my ovaries. I'm proof that cream works."
Dr. John R. Lee, the California pioneer of natural progesterone cream for women in menopause, is scheduled to speak at three locations in Clearwater, Tampa and Brandon next weekend.
His millions of followers call him a guru and a miracle worker. His detractors, including much of the medical profession, say he risks women's lives with a snake oil that ultimately could prove to be dangerous.
Seven months after a decisive study linked hormone replacement therapy with breast cancer risks, Dr. Lee's natural progesterone cream and other alternative treatments for menopausal symptoms have skyrocketed in popularity.
"The present system is broken and it's killing you," Lee said in an interview. "There's a terrible problem here. I'm trying to educate people on how to get well."
Across the country, companies that make herbal and botanical treatments for menopause say they have seen business rise as much as 40 percent since the study's findings were released in July.
Makers of Promensil, a red clover supplement marketed to relieve hot flashes, night sweats and breast tenderness, estimate that sales are up 30 percent since July. Promensil controls about 80 percent of the narrow red clover market and about 5 to 7 percent of the wider $100-million menopause supplement market.
Owners of other menopause supplement companies also say sales are up in the past seven months.
But because the government regulates dietary supplements lightly, some doctors worry that women turned off by synthetic hormones will begin taking herbs that could be harmful to their health.
In a November study, researchers at Columbia and George Washington universities found that only soy and black cohosh seem to work against menopausal symptoms. Popular herbs like dong quai, red clover, ginseng and oil of evening primrose have no measurable effect, the researchers found.
"Supplement manufacturers have seen this as an opportunity to promote supplements," said Adriane Fugh-Berman, an assistant clinical professor at George Washington School of Medicine and the study's co-author.
Several studies even have indicated that dong quai could be dangerous, particularly if women take it with anti-coagulant drugs.
For nearly 40 years, women treated menopause with a combination of estrogen and progestin, a synthetic form of progesterone derived from horses' urine.
Doctors used the combination hormone replacement therapy, or HRT, as it is commonly called, as the panacea for menopausal symptoms to treat everything from hot flashes to osteoporosis. Sales of Wyeth pharmaceuticals' Premarin, one of the leading synthetic progestins, topped $2-billion in 2001.
By July 2002, about 6-million American women were taking the hormones.
Then the picture changed almost overnight. The National Institute of Health abruptly halted a definitive study in July, citing an increased risk of breast cancer, heart disease and strokes for patients taking hormones.
It was one of the most dramatic flip-flops in modern medicine.
"It was a complete turnaround," said Palm Harbor gynecologist S. Tatiana Goodwin, who is giving a free lecture on hormone replacement therapy this week. "Every gynecologist was going up a tree going, 'Gee, now what?' It has really been a mess to untangle this."
Goodwin said she has removed about 75 percent of her patients from hormone replacement therapy since the study. Some have tried herbal supplements. Others make do with nothing at all.
The cataclysmic Women's Health Initiative trial left menopausal women and their doctors pouring over inconclusive studies, searching for answers. For a devoted corps of women, Dr. Lee's teachings fill that void.
Tampa mother Cindy Krueger, 47, said she began taking natural progesterone cream 10 years ago to alleviate the severe cramps and nausea she had experienced during her period since she was 14. Krueger said she often would be doubled over with pain.
Now, thanks to natural progesterone, Krueger says the cramps are gone. She has attended every one of Dr. Lee's lectures since he first visited the Tampa Bay area three years ago.
"I'm following the ways of the Yoda," she said."He speaks the truth. That's the bottom line."
Organizers of Dr. Lee's Tampa Bay area lectures said they expect 4,200 women to attend his three Tampa Bay area seminars next weekend, which generally last for several hours.
"He's literally looked upon as being a guru in safe alternatives to hormone replacement therapy," said John Tice, president of Kokoro, LLC, which makes Women's Balance Creme. "Women just flock around him. He has an extremely strong and loyal following."
Dr. Lee argues that most menopausal women already have enough estrogen in their bodies -- it's progesterone that they lack. As women age, he theorizes, they experience a condition called 'estrogen dominance,' in which they do not get enough progesterone to counteract the excessive estrogen in their bodies.
This condition leads to menopausal symptoms and, later, to breast cancer and other problems, he says.
"It's been a scam," Lee said. "People are finally realizing they've been lied to all these years. No one's saying that the best alternative is natural progesterone."
If women use an over-the-counter progesterone cream to counteract their progesterone loss, their hormones will move back into balance and their symptoms will disappear, he said. The cream is sold in drugstores and natural food stores for about $10-$30 for three months' supply.
Unlike progestin, the synthetic hormone made of horse urine used in most hormone clinical trials, the progesterone in creams is made from soy and wild yam extract and is biologically identical to the progesterone produced inside a woman's body, Lee said.
Although proponents of natural progesterone cite reams of supporting evidence for the cream's powers, Dr. Fugh-Berman at George Washington University said only one credible independent study has tested its claims. That study, which attempted to determine whether progesterone cream offsets osteoporosis, found no evidence for that claim.
The study did, however, find that women experienced fewer hot flashes while using natural progesterone.
In addition, Fugh-Berman said no studies have determined the natural progesterone's long-term safety. Natural or not, she said, progesterone is a hormone -- and hormones are not safe.
"The bio-identical natural hormones are much more dangerous than the herbs," said Fugh-Berman, co-author of The Truth About Hormone Replacement Therapy. "We have no information on their long-term effects. This is something that's very misused in the alternative medicine community."
Dr. Ignacio Armas, a Brandon gynecologist who treats many of his menopausal patients with progesterone cream, said he has seen few negative side effects in his patients. Armas advocates an approach to menopause that includes, vitamins, calcium, exercise and progesterone.
"You can't look at the woman as a uterus and a cervix and ovaries," said Armas, who is treating Ward's fibroids. "You have to look at the whole woman and that takes time."
With the backing of Dr. Lee, progesterone cream sales shot up last year. Although Dr. Lee does not make profits from progesterone sales, cream makers sponsor some of his speaking engagements.
Sales of Pro-Gest cream, which dominates nearly three-fourths of the progesterone market, increased 41 percent last year. Its maker, Portland, Ore.-based Emerita, launched a national advertising campaign in 2003 targeting women seeking a more holistic approach to menopause.
As for Ward, she says her fibroids are continuing to shrink. Already, she has started her 20-year-old daughter on the cream. And she plans to attend Dr. Lee's lecture this week.
"God did it," Ward said. "He used the cream and he used Dr. Armas, but God did it. He knew I didn't want that hysterectomy."
TARPON SPRINGS: Wednesday: Gynecologist Dr. S. Tatiana Goodwin will discuss hormone replacement therapy at noon at Helen Ellis Memorial Hospital, 1395 S Pinellas Ave. The seminar is free, but reservations are necessary. Call (727) 943-3600.
BRANDON: Thursday: Dr. John Lee, 7 p.m., Crosstown Community Church, 10130 Causeway Blvd. (Tampa). Tickets available at Nature's Health Foods, 401 S Parsons Ave., $10 in advance, $15 at the door. (813) 681-2444.
TAMPA: Friday: Dr. John Lee, 7 p.m., A La Carte Event Pavilion, 4050 Dana Shores Drive. Tickets available at Abby's Health and Nutrition, 14374 N Dale Mabry, (813) 265-4951, and Nature's Harvest Market, 1021 N MacDill Ave., (813) 873-7428, $10 in advance, $15 at the door.
CLEARWATER: Saturday: Dr. John Lee, 7 p.m., Clearwater Harborview Center, 300 Cleveland St. Tickets available at Nature's Food Patch, 1225 Cleveland St., (727) 443-6703, $10 in advance, $15 at the door. (727) 443-6703.
PALM HARBOR: Tuesday, Feb. 25: Dr. S. Tatiana Goodwin, 6-7:30 p.m., will discuss hormone replacement therapy, 2851 Alt. U.S. 19 N. Free with reservations. (727) 784-0943.
PROGESTERONE CREAM: What it is: A plant-based progesterone cream that is biologically identical to the progesterone produced in the human body. The hype: The panacea for menopausal symptoms. Treats hot flashes, PMS and prevents breast cancer. What the experts say: Natural progesterone is still a hormone -- and no hormones have been proven safe.
BLACK COHOSH: What it is: A wildflower native to forests in North America. The hype: Treats hot flashes, night sweats and vaginal dryness. What the experts say: There is some limited evidence that black cohosh is effective in treating symptoms of menopause. No studies have examined its safety in the long term.
SOY: What it is: Soy products provide weak estrogen-like effects. The hype: Reduces hot flashes, stems osteoporosis. What the experts say: Limited studies indicate soy might reduce hot flashes by as much as 45 percent. The FDA recommends everyone eat 25 grams of soy daily. But while beans and tofu are safe, researchers have not determined the long-term safety of soy supplements.
RED CLOVER: What it is: A supplement that has been used to treat everything from eczema to whooping cough. It acts like a plant estrogen. The hype: Treats hot flashes, insomnia, anxiety and vaginal dryness. What the experts say: Several small studies indicate red clover has no effect on menopausal symptoms. Other studies, sponsored by companies that produce red clover, found it to be effective against menopausal symptoms.
DONG QUAI: What it is: A popular Asian herb. The hype: Controls hot flashes and vaginal dryness. What the experts say: Studies are mixed. But experts worry that dong quai might cause excessive bleeding for women taking anticoagulant drugs.
-- Sources: American College of Obstetricians and Gynecologists, North American Menopause Society