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Hormone Replacement Therapy: Marketing of Beauty-Focused Drug Stirs Debate over Women's Safety

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Hormone Replacement Therapy: Marketing of Beauty-Focused Drug Stirs Debate over Women's Safety

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Marketing of Beauty-Focused Drug Stirs Debate over Women's Safety
Hormone Replacement Study Sparks Fears Over Health Risks
San Jose Mercury News
Monday, September 9, 2002

Before the current
controversy over hormone replacement therapy, many women and their
doctors devoutly believed -- with scant scientific evidence -- that the
drugs could not only ease menopause symptoms but also hold a bit of
aging at bay, keeping skin smooth and young looking. That belief has
been so pervasive that the pharmaceutical firm Pfizer started testing a
drug called FemHRT in hundreds of American and Canadian women to see if
that's the case.

Now it's a new world for hormone
therapy, and amid growing concerns over the safety of the drugs,
Pfizer's timing couldn't be worse.

FemHRT may soon
come under tighter federal restrictions as regulators reassess all
hormone medications. Pfizer says its form of HRT, and its skin study,
are safe. But some doctors, researchers and women's health activists
wonder whether Pfizer's beauty-focused trial is inappropriate -- or
even obsolete.

"My concern is that
pharmaceutical companies are looking for other ways to market these
drugs," said Dr. Garnet Anderson, co-principal investigator of the
major study that recently exposed new HRT risks.

"That's
the wrong public health approach." It's hardly unusual for
pharmaceutical companies to test their drugs after approval, looking
for new benefits of the medicine. If those new "indications" get
federal approval, drug makers can use them to differentiate their
products in the marketplace.

But these days, the
existence of Pfizer's FemHRT skin trial is touching a nerve. Scientists
have long wanted to know whether hormones really do offer beauty
benefits. But the trial infuriates some women's health advocates, who
see it as yet another example of the drug industry capitalizing on
women's fear of aging to sell more of a product whose risks are only
now being quantified.

"Realistically, there's just
too much concern on the part of health care providers and consumers
about known risks," said Dr. Hector Medina, an
obstetrician-gynecologist at El Camino Medical Group who has prescribed
FemHRT to his patients. "To address whether cosmetic end points are
reached or not really seems a little bit superfluous." Such concerns
reflect just how much the beliefs surrounding HRT drugs and menopause
treatment are shifting, changing the marketplace for companies such as
Pfizer almost overnight.

In July, a massive federal trial of Prempro,
a combination hormone therapy of estrogen and progesterone used by
millions of women and made by Wyeth, a competitor of Pfizer, was shut
down because of small but significant risks of breast cancer, stroke
and heart disease.

In August, federal regulators
announced a "major reassessment" of all hormone therapies for
menopausal women, a move that could profoundly change how they are
marketed and prescribed. The influential American College of
Obstetricians and Gynecologists advises "caution" in using all HRT,
even though the federal trial focused only on Prempro.

From Pfizer's perspective, its FemHRT trial is safe and legitimate.

The risks highlighted in the recent major HRT study applied only to Prempro,
and cannot be projected onto FemHRT or any other hormone therapy on the
market, a Pfizer spokeswoman said. There are more than half a dozen
combination hormone therapies commonly prescribed, including brands
such as Premphase and Ortho-Prefest.

FemHRT holds a much smaller market share than Prempro,
however, and Pfizer has needed to be able to claim additional benefits
to increase sales. One of those benefits, it was thought, might improve
skin. Other HRT research studies had shown mild skin improvements with
hormone therapies including estrogen creams and skin patches, but few
experiments have been conducted rigorously, with a placebo group.

The
company has no plans to stop or modify the skin tone trial. But Pfizer
has asked its outside researchers to inform patients about the outcome
of the federal trial and update their patient consent forms, said
spokeswoman Susan Yarin.

"Just as hormone therapy
is known to have an effect on bones, it's known to have an effect on
skin," Yarin said. "It's a natural thing to look at that." But some
doctors say such research reflects an old way of thinking about HRT
that is no longer valid. For decades, hormones have been regarded as a
relatively benign elixir for menopausal women, routinely prescribed,
taken for years and invested with near-mystical powers to forestall the
ravages of age.

To some scientists' dismay, the
hormones evolved into an almost permanent "replacement" for the
hormones women stop producing as they age. Taking the pills became a
way of life believed to prevent osteoporosis, heart disease and some
cancers -- rather than short-term treatment for menopause symptoms like
hot flashes and mood swings.

That world view
collapsed with the shutdown of part of the federal trial, known as the
Women's Health Initiative. Now, federal health officials and some
menopause experts are trying to take the "replacement" out of hormone
replacement therapy, emphasizing instead that it should be used only
for short-term relief of symptoms.

In the medical
and research communities, reaction to the FemHRT skin tone study has
ranged from outrage to approval and many guarded responses in between.

Researchers
agree that Pfizer did the right thing -- the required thing -- by
asking its investigators to inform patients of the new data from the
nationwide trial. But was updating patient consent forms enough? Some
scientists are torn because they want to know whether hormones do
improve the skin. But they are reluctant to give women new incentives
to take hormones long term.

"So many women cite
improved skin as a reason they're taking these hormones," said Dr.
Marcia Stefanick, a Stanford University professor of medicine and a
lead researcher with the Women's Health Initiative. "It's a claim
without any scientific base, yet it has been presented over and over as
another reason to take hormones." But now, she said, the study seems
off-point. "What we'd really like to do at this point is work out what
is a reasonably safe, short-term time frame for taking these hormones,"
she said.

Stefanick added that the researchers who
conducted the trial noted small but elevated risks of heart attacks and
blood clots in women taking Prempro as early as one year into the trial -- the same length of time as the FemHRT trial.

"The
risks were small, but are they worth these unproven benefits to skin?"
Stefanick said. "I wouldn't want to have beautiful skin and get a heart
attack or stroke or breast cancer. It wouldn't be worth it to me." Yet
Dr. Robin Kroll, director of the Menopause Center of Seattle, takes a
different stance.

"To halt all investigation into
different hormone replacement therapies would not make any sense
medically," she said. "To say that because one study showed this with Prempro,
that all other research should end would be an incredible disservice to
the female population." The estrogen and synthetic progesterone in
FemHRT are very different from Prempro, Kroll emphasized.

The
problem, many scientists say, is that while everyone can agree the
hormones are different, no one can say with any certainty whether all
hormone therapies carry the same risks.

"I think
it's a pretty skewed view of what's important in women's health, to
continue a trial of a combination of hormones that's pretty similar to
what's been proven to harm women," said Cynthia Pearson, executive
director of the National Women's Health Network and a longtime critic
of the routine use of HRT.

Diane Bonneau, a
52-year-old Maine woman who has taken FemHRT for two years to control
her hot flashes and headaches, said she is thinking "long and hard"
about stopping in light of the Women's Health Initiative study. But
given how the drug helps her menopause symptoms, it's a tough choice.

"I'd be willing to risk a small health risk to feel well," she said.

Bonneau
said that although she has good skin tone, she also has rosacea, or
skin ruddiness, that seems to have worsened while she has been on
FemHRT.

"I don't think it's a good idea," she said
of the FemHRT skin study. "Women should be taking this medication
primarily for their hot flashes, not cosmetic reasons. It doesn't
surprise me that they'd do a study, though. They need a gimmick, right?"

If
Pfizer does detect skin improvement because of FemHRT, it's difficult,
in the current wave of scrutiny of hormone therapies, to know how the
U.S. Food and Drug Administration will respond.

The
agency's reassessment of hormone therapy labeling and marketing "is
part of a basic trend at the FDA to be tougher on things that aren't
going to be major medical benefits," said Jim McCamant, editor at large
of the Berkeley-based Medical Technology Stock Letter. "If the trial
hadn't already been started, Pfizer would never do it."