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APRIL 13, 2006

SMALL BIZ

By David E. Gumpert

Hormone Battle: Big Pharma vs. Small Biz

The debate surrounding prescription hormones for women has pitted drug

company Wyeth

against small pharmacies and makers of alternative therapies

Over the last four years, medical experts have been doing battle when it

comes to the dangers of prescription hormones for women. A

major study four years ago suggested that taking such hormones, the bulk

made by Big Pharma company Wyeth (WYE ), could lead to

increased risk of breast cancer and heart problems. Now a new study, just

out in the Journal of the American Medical Association

and similarly replete with controversy, suggests that the risks were

overstated.

While the medical experts have been at each other's throats, another battle

over hormones for women, this one akin to a high-intensity

guerrilla war, is being waged on the Internet and in doctors' offices and

small pharmacies around the country. This one pits Wyeth, with

nearly $19 billion annual sales, against small pharmacies around the

country, and also pits conventional medicine against alternative

therapies.

The conflict came out of the shadows last October when Wyeth, the largest

single maker of prescription hormones, filed a complaint with

the federal Food & Drug Administration asking it to take action against

small pharmacies that make what it and doctors refer to as

bioidentical hormones from soy and other plant materials. It has expanded

into hand-to-hand combat between the competing interests.

PEACEFUL COEXISTENCE? While Wyeth clearly expected to improve its position

in the multibillion-dollar market for women's

hormonal products, the episode thus far shows signs of having the opposite

effect. The FDA has yet to rule on Wyeth's complaint, but

the huge corporation has stirred up a hornet's nest of opposition from women

and doctors around the country, who see it as a classic

case of Big Pharma throwing its weight around against small businesses and

seeking to remove an important element of choice for

suffering patients.

While Big Pharma and makers of nutritional supplements and so-called natural

products generally co-exist as uneasy competitors in the

health-care marketplace, sometimes they do battle, especially when one or

the other feels it is suffering financially or sees a potential

competitive opening. Not long after Merck (MRK ) withdrew arthritis drug

Vioxx from the market in 2004 because of concerns it caused

heart problems, supplement maker Metagenics began promoting a supplement,

Kaprex, as " a safer option: GI friendly joint relief without

the heartbreak. "

In its October complaint to the FDA, Wyeth sketched a picture of marketplace

problems growing out of a major 2002 study by the

Women's Health Initiative (WHI) casting doubt on prescription hormones used

to counter the effects of menopause. " The study received

a huge amount of publicity in the lay press, leaving many women with

questions and concerns, " Wyeth states. Wyeth doesn't say it, but

the " questions and concerns " had to do with possible increases in risk for

breast cancer and heart disease growing out of the hormone

therapy.

HIGH DEMAND. " In the wake of the WHI findings, women with concerns about HT

(hormone therapy) have become targets for vendors

offering unproven alternatives as a false remedy. In that regard, many

pharmacies are manufacturing and marketing " bio-identical "

hormone therapies, which they are promoting as risk-free alternatives to

FDA-approved HT products.... In reality, though, these products

are plant-derived...and further processed to resemble human hormones.... "

A big problem, notes Wyeth, is that " the market for [customized] products

has grown...in light of media attention and promotion through

talk shows and publications such as Suzanne Somers' books, The Sexy Years

and Slim and Sexy Forever, as well as advertising in the

lay press and on numerous Web sites. " In other words, sales of the

non-prescription bio-identical hormonal products have soared, while

sales of Wyeth's prescription formula declined, from something in excess of

$1 billion in 2002, to $850 million by 2004. They recovered a

bit to $908 million last year, says a Wyeth spokesperson.

Once Wyeth filed its petition with the FDA, which calls for " seizures,

injunctions and/or warning letters " for offenders, the smaller

businesses making the customized medications, along with physicians, began

fighting back. On a Web page headlined, " Preserve Your

Right to Choose Bioidentical Hormones, Women's Health America/Madison

Pharmacy Associates, a 35-employee Madison (Wis.)

producer of the bioidentical hormones asks, " Why is Wyeth Pharmaceutical

taking this kind of action? The issue is supposedly safety,

but doctors and pharmacists across the country, including Women's Health

America/Madison Pharmacy Associates believe the real

issue is profits. "

GRASSROOTS SUPPORT. The company urged women to write the FDA with their

experiences using the company's products, and

their opposition to Wyeth. (The deadline for comments was Apr. 4.) Write the

FDA the women did. One of them, Teri, said she has been

taking hormone replacement medications customized for her by a pharmacy for

four months.

Hormone Battle: Big Pharma vs. Small Biz

http://www.businessweek.com/print/smallbiz/content/apr2006/sb20060...

" I can not tell you how wonderful they are, " she wrote. " My hot flashes,

night sweats, mood problems, weight problems, have all

disappeared. " She had previously tried Big Pharma prescription hormones,

but, " My body did not tolerate them and the side effects were

worse than the symptoms I was trying to get rid of. " Courtney told a similar

tale. She said she has been taking a customized hormone for

six months and " it alleviates PMS, dysmenorrhea, and depression. "

On and on the comments posted over the last six months to the FDA's Web site

go, nearly 2,000 in total, and they nearly all tell a similar

story: Women say they are at long last gaining relief from problems of

menopause and related difficulties thanks to the plant-based

products compounded for them by pharmacies, usually at the recommendation of

a physician or other health-care provider.

(To access the letters, ) Most of the writers came to the same

conclusion as JoAnne: " PLEASE don't take away yet another

right to choice in favor of drug companies. "

NO DECISION. Dr. Chris Foley, an internist based in Vadnais Heights, Minn.,

and someone who recommends the customized

hormones to his patients, calls Wyeth's efforts " a perfect example of Big

Pharma pushing real health efforts into the dirt. "

He points to a study he oversaw by a graduate pharmaceutical student at the

University of Minnesota in 2004 indicating that half of

women who receive prescriptions from their doctors for conventional products

like Wyeth's don't even have the prescriptions filled for

fear of cancer and possible side effects, while 96% of women follow through

on getting the bioidentical hormones that are recommended

to them.

The FDA, for now, says it's not sure what to do. In a Mar. 31 response to

Wyeth, it stated that it " has been unable to reach a decision on

your petition because it raises complex issues requiring extensive review

and analysis by Agency officials. " That suggests a ruling could

be many months off -- plenty of time for patients, doctors, and small

businesses to throw more mud at Big Pharma.

Gumpert is author of Burn Your Business Plan! What Investors Really Want

from Entrepreneurs and How to Really Start Your Own

Business. His Web site is www.davidgumpert.com

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