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Compounding pharmacies tailor hormone replacement therapies

Tuesday, May 28, 2002

By Deborah Mendenhall, Post-Gazette Staff Writer

Registered Nurse Carol Intrieri didn't like the idea of swallowing a pill made from horse urine, but heeded her doctor's advice and took the estrogen drug Premarin to ease the night sweats, hot flashes and dry skin symptoms of menopause.

John A. Yakim of Yakim's Compounding Pharmacy in Plum is mixing drugs the old-fashioned way to provide women with menopausal therapies that match the hormones in their bodies. (Andy Starnes, Post-Gazette)

But when the first migraine headache assaulted her a week later, Intrieri threw away the Premarin, and asked her doctor about natural alternatives.

He sent her to Yakim's Compounding Pharmacy in Plum, where for six years a father and son team of registered pharmacists have blended natural plant hormones that are identical to those in a woman's body, individually for each patient.

"Drug companies live in a one-size-fits-all world," said John G. Yakim, son of pharmacy owner John A. Yakim. "It's like when you try to buy a pair of shoes and can only get size six or seven. We can make a six and three-quarters. Compounding pharmacists work with physicians to tailor hormones to fit the patient."

While it may sound experimental, compounding raw materials into medicine for individual patients was common in United States pharmacies until about 50 years ago, when major drug companies began packaging and selling mass-produced drugs suitable for large numbers of people.

Compounding has always been common in Europe, but only a handful of those pharmacies are left in the Pittsburgh area.

Premarin, the most widely prescribed HRT drug, turns the ripe old menopausal age of 60 this year, and it is experiencing some hot news flashes of its own.

Recent studies have called into question the long-held belief that it prevents heart disease and bone loss. And some doctors who once believed that women should take HRT all their lives, now suggest lower doses and that women stop taking it after five years.

That advice, coupled with Premarin's side effects of weight gain, migraines, possible blood clots and an increased risk for cancers, have sent more women searching for natural alternatives.

In 2000, 47 million Premarin prescriptions were dispensed, making it the second most frequently dispensed prescription, according to IMS Health, which tracks the industry. But many women stop taking it shortly after they start; one source estimates 100,000 women quit every month.

Because estrogen therapy can increase the risk of uterine cancer, doctors often prescribe progestin to be given a few days each month to protect the uterus. This is often offered in combination drugs, such as PremPro.

Elissa Illuminati, 51, began looking for natural HRT because she already had a higher chance of developing cancer, and didn't want to increase it.

She already was having night sweats, anxiety and hot flashes last year when a hysterectomy sent her into immediate menopause. Working with the Yakims, her gynecologist wrote a prescription for compounded hormones.

"I didn't even realize how bad I felt until I starting taking the hormones and realized how good I was feeling," said Illuminati, a partner in the interior decorating firm Design Group North in Wexford.

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"Many of my friends are on synthetic hormones and have experienced terrible side effects. I've had no weight gain, my hot flashes have disappeared and I see an improvement in my skin."

Intrieri said she can't be certain her migraine was caused by Premarin, but it provided a good reason to look for something else.

Through research she learned that compounding pharmacies used plant hormones that are biologically identical to those found in a woman's body.

"As a nurse, I know that bio-identical means it is specifically formulated for a woman," said Intrieri, 54 of Murrysville who works as a school nurse for the Gateway School District.

"What amazes me is I know that physicians who prescribe Premarin for women will make sure the vet gives medication specifically formulated for their dogs.

"I am not a horse. Don't give me horse estrogen. Sixty years ago they didn't know any better. But today, they do."

National author and speaker Dr. Christiane Northrup, agrees that horse urine is something that "nature never intended you to put in your body."

The source for the hormones does matter, agree Yakim and Jeffrey Mustovic, registered pharmacist and owner of Evans City Apothecary, a compounding pharmacy.

Plant hormones start out structurally similar to five basic human sex hormones -- estrone, estradiol, estriol, progesterone and testosterone -- and are manipulated in laboratories to be identical to those found in humans.

"That means the molecules are structurally the same," Yakim said.

Horse hormones, however, are meant to take care of a 600-pound animal, Mustovic said.

He points to an April 1999 article in the medical journal, U.S. Pharmacist which quotes data from Premarin maker Wyeth.

It says that Premarin has 10 hormonal compounds that contain estrogen, and more than 200 unknown components.

"We don't know what they do, no one has taken the time to isolate them and they're all in that pill," said Mustovic.

Mustovic said he likes to dissolve a pill in water and pass it to skeptics, because absent the thick coating, the pill smells like a barnyard.

He has compounded natural plant hormones since 1996 and his first patients were his mother and grandmother.

When compounding pharmacies receive them, the plant hormones are micronized, dry powder particles. A pharmacist generally uses all five hormones in formulas, but not always.

"You and your sister and your mother will be very similar, yet you are very different, and so are your needs," Yakim said.

"We make the hormones fit the patient and balance them."

Elissa Illuminati of Downtown is among women who have decided to use compounded estrogens to ease her menopause symptoms. (Bob Donaldson, Post-Gazette)

The patient's need is determined through an assessment that pharmacists do, consultation with the physician and through blood, saliva and urine tests that measure the body's current hormone levels.

The treatment, usually in pill form, costs between $40 and $60 a month, and insurance rarely pays for it. Many women say it's worth the expense.

"It costs me $60 a month, and it is the best $60 I've ever spent," said Illuminati.

Yakim said patients will tell doctors what is going on in their bodies, but that few pause to listen.

"One of the things that we have that the physician doesn't have is time," he said. "We spend a lot more time with female customers."

Dr. Eugene Scioscia Jr., chairman of Obstetrics and Gynecology at Allegheny General Hospital said health-care reimbursement is not set up to allow doctors to spend a lot of time discussing menopause therapies with patients.

"This subject is extremely complicated," Scioscia said "There are a lot of options out there, but the way the health system is structured right now, it doesn't promote this sort of time for patient information and advocacy."

He estimates it would take at least an hour to sit down and discuss a patient's options on menopause therapies, but he typically has just 12 minutes per patient, and much of that time is taken up with a gynecological exam.

"Consequently this issue is being brought to them in bits and pieces," he said.

"Physicians should be their source for this information, but advice doesn't get paid for. The physician is trapped in this system. Harm is being done in terms of patient care."

A medical professional herself, Intrieri is well aware of the issues, and believes strongly that patients should become knowledgeable about conditions such as menopause, and make their preferences known to doctors.

"Too many women set their physicians on a pedestal, and that is dangerous," she said.

"Women need to take an interest in their own bodies."

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