Des Moines Register

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Hormone replacement dispute rages
Wyeth Pharmaceuticals has filed a petition with the FDA to restrict the plant-based compounds.

DAWN SAGARIO
REGISTER STAFF WRITER


March 18, 2006



There's a new conflict brewing over hormone replacement therapy.

At the center of the debate: Bioidentical hormones — custom-made, plant-based prescriptions women use as alternatives to synthetic hormone therapies.

On one side is drug manufacturer Wyeth Pharmaceuticals — maker of hormone-replacement therapy drugs Prempro and Premarin — which has filed a petition with the Federal Drug Administration to restrict the plant-based compounds.

On the other side are the compounding pharmacies who make the drugs, the health care professionals who prescribe them and the patients in Iowa and nationwide who take them.

They say Wyeth is trying to remove competition in the hormone replacement therapy market.

That leaves women like Jan Castagnoli concerned about losing access to the compounded hormones. Castagnoli began taking them three years ago, when the drug Prempro was unsuccessful in easing her menopausal symptoms. A friend told her about Dr. Jean Lorentzen, a physician in Boone who specializes in bioidentical hormones.

Since Castagnoli began taking the hormones prescribed by Lorentzen, she says her life has made a 180-degree turn.

"I have no desire to go back to synthetic drugs at all," said Castagnoli, 54, who lives in Waukee.

In its petition, Wyeth claims some compounding pharmacies are misleading women by telling them they are safer and more effective hormone alternatives. The manufacturer also claims the hormones have been "illegally" mass-produced instead of tailored to individual needs.

The public has until April 4 to send comments to the FDA about the petition.

Advocates for bioidentical hormones, including health care professionals and patients in Iowa, say Wyeth's petition will limit women's health-care options. Some local patients, who credit the individualized formulations with dramatically increasing the quality of their lives, say they would consider getting them outside the United States if they could no longer get them here.

Maggie McGill, 59, of Windsor Heights has been on "natural" hormone therapy for three months. She said she'd be willing to look for the drugs in another country, "but I'm optimistic that won't happen."

FDA evaluates petition
Resolution may not come for months, even years. After the comment period, the FDA evaluates the petition, a process that can take several weeks to more than a year, depending on how complex the issue is, said Laura Alvey, spokeswoman for the agency.

If a petitioner is dissatisfied with the results, the case can be taken to court, she said.

Candace Steele, director of global public relations at Wyeth Pharmaceuticals, said the company's petition is aimed only at pharmacies mass-producing and marketing prescriptions, instead of making customized drugs for individual women.

If the FDA gets involved and these plant-based hormone drugs come under its jurisdiction, it could affect access, but no one knows how much.

Right now, the compounding of bioidentical hormones by pharmacies is regulated by the state.

Wyeth also disputes claims that bioidentical hormones are safer and more effective than other synthetic hormone replacement drugs already on the market, Steele said.

"We're doing this because it could be an important health risk for women."

Josh Wenderoff, a spokesman for the International Academy of Compounding Pharmacists, said women should be concerned about the potential impact of Wyeth's petition. The group represents about 1,800 pharmacists, pharmacy technicians, physicians and patients nationwide, and in Canada and Australia.

Far-reaching consequences
"It would have far-reaching consequences for all patients who rely on bioidentical hormones," Wenderoff said. "Wyeth is asking the FDA to impose far-reaching restrictions on the preparation of bioidentical hormones that would restrict patients' access to them."

One physician at the University of Iowa is concerned that women are getting false information about the hormones.

"There simply isn't any scientific evidence that compounded estrogen preparations are either safer or more effective than estrogen obtained through some commercially available preparation," said Dr. Susan Johnson, director of the university's menopause clinic.

"It's likely that all estrogens (bioidentical and synthetic) have the same risk profile."

Estrogen alone in any form can cause blood clots and increased risk of stroke. A combination of estrogen and progestin can also cause heart attack and breast cancer.

No research has been done to study the bioidentical versus synthetic hormone replacement therapy.

Wyeth's critics say the company is seeking to recoup considerable financial losses stemming from declining sales of hormone-therapy replacement drugs Prempro and Premarin.

In 2002, Prempro, a combination of estrogen and progestin, was found in a large federal study to increase the risk of breast cancer, stroke, heart attack and blood clots. The study was halted three years early because of the findings.

Comparing the first six months of 2002 and 2003, Prempro prescriptions declined 66 percent and Premarin 33 percent, according to the Journal of the American Medical Association.

In the wake of the results from the Women's Health Initiative study, millions of women nationwide questioned the safety of their hormone-replacement drugs. Some stopped hormone therapy completely; others turned to plant-based alternatives.

"My belief is it is about the bottom line" and Wyeth's financial losses, said Carolyn Walker, a family nurse practitioner at Prevention & Healing of Iowa in Urbandale.

Walker, who prescribes bioidentical hormones, says between 85 to 90 percent of her patients see her for hormone imbalance. Some come from out of state to get treatment.

She and pharmacist Sue Horton, owner of Central Iowa Compounding in Urbandale, are longtime proponents of bioidentical hormones. They estimate that within the last seven years, they've taught 3,500 to 4,000 individuals about these alternative therapies in adult education classes. Both are outraged with Wyeth's petition.

Surge in interest
They say they've seen a surge in interest in bioidentical hormones as women demand individualized health care. That includes an in-depth history, lab tests to determine different hormone levels, and the customized, compounded hormones.

"I think a lot of women are taking charge of their own health care. The baby boomer women are demanding this," Horton said.

About 65 percent of her clientele take bioidentical hormones.

Johnson said she has no qualms about women taking bioidentical hormones, which can be pricey because they are customized, as long as they are taking the appropriate dose. Because the prescriptions are made by individual pharmacists, she said, there are concerns with getting accurate doses.

"There isn't the same kind of quality control that you would have in a plant where a drug is manufactured under FDA guidelines."

Lorentzen has been prescribing bioidentical hormones since 1996. She said some of Wyeth's concerns may be legitimate, including a failure to include information on the risks of taking estrogen. But Lorentzen said that as far as she knows, Iowa compounders provide that information to patients.

"I'm just very concerned about further restricting physicians' rights to prescribe an individualized therapy for a patient for any reason," she said. "I don't think a third party should second-guess what a physician agrees to prescribe and what a patient agrees to take.

Prescribing compounded hormones gives her the ability to tweak the prescription dosages and the form of medication to fit each patient profile.

"I would not want to see women lose the right to have their hormone prescriptions individualized," Lorentzen said. " I think it's a clinical tool that is really needed."

Women tell their stories



Maggie McGill, 59
Windsor Heights

Maggie McGill began taking Premarin 20 years ago after a hysterectomy, then stopped completely after five years. McGill said her mother's breast cancer diagnosis, coupled with research she had read about the increased risk of breast cancer among women taking Premarin, sealed her decision.

Thereafter, her journey to find a remedy to alleviate nagging hot flashes and increase her quality of life was tough.

"I tried diet, some herbal remedies, and these were all in combination with increased exercise," she said. "Nothing worked."

A nurse practitioner recommended bioidentical hormones, derived from plants. Working with Sue Horton at Central Iowa Compounding in Urbandale, McGill eventually was put on a regimen of three creams — progesterone, estrogen and testosterone. She remained on the drugs for four years.

Then results from a federal study in 2002 found that a combination of estrogen and progestin (a synthetic form of progesterone) increased the risk of breast cancer, heart attack and stroke, and she reconsidered.

"I think I panicked," said McGill of her decision to go off the bioidentical hormones completely for two years. Again, life became miserable for the retired elementary school principal. About three months ago, she decided to get back on the bioidentical hormone regimen.

"Women in the generation before mine were more accepting of this (symptoms of menopause)," said McGill, who now pays about $90 monthly for her prescriptions with little insurance coverage.

"But I think that women in this day and age are aware that you don't have to live like this as a woman."


Barbara Rosberg, 52
Dallas County

After Barbara Rosberg found a lump in her breast, she said her doctor was "adamant" about taking her off the estrogen patch she'd been wearing since a hysterectomy.

With encouragement from her physician, Rosberg then visited Dr. Jean Lorentzen in Boone to discuss bioidentical hormones.

"I was in her office within a week, went through an extremely thorough bloodwork," said Rosberg, who has been taking bioidentical hormones for about two years. "I can tell you I feel better at 52 years old than I did at 25. My mind is clearer, I have more energy and do a decent job keeping up with my grandkids and working."

Before, Rosberg said severe night sweats and hot flashes woke her several times each night. She was lethargic during the day and had trouble concentrating.

The plant-based hormones seemed to cause headaches and water retention, Rosberg said, but stopped after a change in her prescriptions. She also said she exercises and eats healthfully.


Jan Castagnoli, 54
Waukee

Five years ago, Jan Castagnoli says she no longer recognized the person she had become. She had started taking Prempro, a hormone replacement drug. After two years of being on the medication, life seemed to only be getting worse.

She took antidepressants, had trouble sleeping at night, was often sick, cried often, gained weight and suffered joint pain.

"I didn't want to face people; I didn't want to talk to anybody," she said. "I didn't feel good inside . . . so I projected a very unkind disposition. I couldn't find any goodness."

Nearly three years ago, a friend told her about Dr. Jean Lorentzen, a physician in Boone who specializes in bioidentical hormones. Now, Castagnoli's regimen includes a host of hormones, as well as vitamins and supplements.

She said she has the energy to exercise regularly, do weightlifting and cardio workouts. She has lost 22 pounds, no longer has joint pain and is on a lower dose of antidepressant.

The cost of feeling well isn't cheap. It costs Castagnoli about $300 a month, with insurance covering three prescriptions.

"I feel like I'm about 30," she said. "I'm 150 percent better than I was before I started this."


Bioidentical hormone replacement Q&A


Q. What is bioidentical hormone replacement therapy?
A. These are plant-based, or "natural," alternatives to commercially available hormone replacement therapy. They are prescribed by a doctor or other health care professional, and are individualized formulations made at compounding pharmacies.

Q. How are bioidentical hormones different from other synthetic hormone drugs already on the market?
A. Health care professionals who prescribe and dispense bioidentical hormones say they have the same structure as the human body's steroids, with some women experiencing fewer side effects than with traditional hormone therapy. Premarin, an estrogen drug from Wyeth Pharmeceuticals, is made from the urine of pregnant mares.

Q. What forms can bioidentical hormones be taken in?
A. They include oral, slow-release capsules, topical creams, capsules and lozenge-like medications that dissolve under the tongue or in the cheek.

Q. Does insurance cover the cost of bioidentical hormones?
A. It depends on your specific insurance plan. Some women say they pay from almost $100 to $300 a month for these hormones, with insurance covering little of the cost.