Interesting Article in NY Times that may help sales of Cenestin
Race to Fill Void in Menopause-Drug Market
September 1, 2002
By GINA KOLATA
In the eight weeks since the federal government announced
that it had halted a study of a popular hormone therapy
used by postmenopausal women, doctors say they have been
deluged by an ever-growing tide of promotional material for
anything and everything that could substitute for Prempro,
the drug used in the study.
The alternatives run the gamut: prescription drugs that
consist of slightly different hormone formulations,
nutritional supplements made of herbs and vitamins, soy
products said to be natural sources of estrogen, and even
what might be termed menopause accessories, such as one
company's "cooling comfort towelettes" to wipe the sweat
from hot flashes.
But many doctors and scientists say they are alarmed by the
profusion of Prempro substitutes. The trouble, they say, is
that these drugs and supplements have been studied less
than Prempro has. Their benefits and risks are simply
unknown.
That is especially true for nutritional supplements. Their
advertising receives far less government scrutiny than
claims for prescription drugs, which the Food and Drug
Administration regulates closely.
They are also sold without a doctor's guidance. "Everything
you've ever heard of is being marketed," said Dr. Wulf
Utian, the executive director of the North American
Menopause Society, "and it's being marketed to a confused
and vulnerable population."
Prempro, a combination of estrogens and progestin made by
Wyeth, has long dominated the menopause market. Until this
summer it was used by six million American women, many of
whom assumed they would be taking it for a lifetime to
protect against some effects of aging, like brittle bones.
But when the federal study, the Women's Health Initiative,
found that Prempro carried slight risks (of heart attack,
stroke and breast cancer) that outweighed its benefits (a
slightly lower risk of colon cancer and hip fracture), the
part of the study in which women were taking Prempro was
ended. A study in which women take estrogen alone
continues. A Wyeth spokesman, Doug Petkus, said sales of
Prempro had declined 25 to 30 percent.
Many companies appear to have rushed into the opening. "The
Women's Health Initiative Study wasn't out of my fingers
before the mailings started coming in," said Dr. Nanette
Santoro, a professor of obstetrics and gynecology at Albert
Einstein College of Medicine and the Montefiore Medical
Center in the Bronx. "It's what you expect in a capitalist
economy. You have people with products to sell."
Prempro, like other estrogen replacements, is clearly
effective against some symptoms of menopause, including hot
flashes and vaginal dryness. Dr. Isaac Schiff, chief of
obstetrics and gynecology at the Massachusetts General
Hospital, said the government's findings touched off "a
mild to severe panic" and left some women desperate for
alternatives.
"Now we are seeing the fallout," Dr. Schiff said. "They are
saying, `The hot flashes are killing me,' or `I don't feel
well.' " Some of his patients tell him they have lost
energy or a sense of well-being.
"They are trying to go back on estrogen," Dr. Schiff said.
But, he added, "They do not want to go on Prempro."
While the level of marketing for alternative drugs and
supplements is impossible to quantify in the short time
since the findings about Prempro were reported, Dr. Schiff
and others say they have been bombarded with fliers, e-mail
promotions and visits from drug salespeople. A similar
barrage is going out to patients, in the form of
advertisements in newspapers and magazines, in the mail and
on the Web.
The American College of Obstetricians and Gynecolgists has
warned its members that it is not necessarily safe to
switch women from Prempro to other prescription hormones,
adding, "Caution is warranted for different preparations,
and their safety should not be assumed in the absence of
conclusive data."
But prescription hormones are only part of the picture.
Doctors say they are particularly concerned about the
promotion of nutritional supplements.
The college of obstetricians, for example, cautions, "The
number and sophistication of most studies on alternative
therapies, including botanicals, do not meet the current
standards of evidence-based recommendations." It adds that
" `natural' does not mean safe or effective," and that
"potentially dangerous or lethal drug-herb interactions can
occur."
The National Institutes of Health's National Center for
Complementary and Alternative Medicine also cautions women
on its Web site, http: //nccam.nih.gov/health/alerts
/menopause/, about the claims being made for vitamins,
herbs and products like soy that contain plant estrogens.
"At this time, there is not enough scientific evidence to
determine whether these therapies are beneficial," the Web
site says. "In addition, we do not have sufficient
information to show whether these therapies are as safe or
safer than conventional drugs being used for menopausal
symptoms, osteoporosis or heart disease."
Makers of the supplements assert that they are safe and
effective. Gayle Engles, education director for the
Botanical Council, a nonprofit group that disseminates
information on herbal medicines, says that many of the
products have been in use for hundreds of years and that
some have been tested in scientific studies.
Still, Dr. Utian, of the menopause society, said that too
many companies were sending a message he paraphrased this
way: "The Women's Health Initiative has shown the other
stuff is garbage, but we have the answer."
He cited an e-mail promotion with the headline: "Women
Search for a Safe Alternative to Hormonal Replacement
Therapy. Scientific Research Already Has the Answer." The
company, SuperNutrition, says its vitamin and herb
combination called Menopause Multiple Blend prevents hot
flashes, strengthens bone, protects against heart disease,
prevents memory problems and, best of all, is "safe and
natural."
Makers of other products also advertise benefits that
groups like the National Institutes of Health say are not
demonstrated.
Whole World Botanicals advertises a Peruvian herb, maca,
asserting that it can relieve symptoms of menopause and
even help with "premenstrual syndrome" in younger women.
The herb, its maker claims, "contains no plant hormones,
unlike soy/genistein and black cohosh."
Zoe Foods says its soy cereals and bars "have helped
thousands of women overcome their menopausal symptoms."
Another company, SoyToy, claims its soy juicer makes milk
from soybeans in 25 minutes. Soy, it says, alleviates
symptoms of menopause, increases bone mass and decreases
the risk of heart disease.
GlaxoSmithKline, the large drug company best known for its
prescription drugs, touts the benefits of another diet
supplement, black cohosh, which it markets as Remifemin.
The package states that Remifemin is "drug free" and
"estrogen free" and that it is good for hot flashes, night
sweats, mood swings, irritability and related occasional
sleeplessness. A footnote informs consumers, "These
statements have not been evaluated by the Food and Drug
Administration."
Other companies offer custom blends of actual estrogens and
progestins. Individual states, rather than the F.D.A.,
normally regulate these products as they regulate
pharmacies.
Dr. Schiff, at Massachusetts General, pointed to a flier
from one such company, the Women's International Pharmacy,
advertising "bio-identical hormones" and "customized
prescriptions" and claiming that its product is safer than
hormones sold by drug companies. "They have no evidence for
that," Dr. Schiff said.
Makers of prescription estrogens and progestins take a
different tack, he said. Because those drugs are regulated
by the F.D.A., they may not make unproven claims.
"I have been bombarded with very subtle ads," Dr. Schiff
said. "They can't say their product is safer because they
don't have the evidence." Instead, he said, they try an
indirect approach: " `We make product ABC and we don't make
the product that was involved in the Women's Health
Initiative.' It is like having a bad relative and making
sure you don't sit next to them. They are pushing
themselves away from the table."
Dr. Marcia L. Stefanick of Stanford University, the
principal investigator for the Women's Health Initiative,
said some doctors were too quick to say that the risks of
Prempro were specific to Prempro but not to other
formulations of estrogens and progestins - or that
estrogens from plants were safe because they are "natural."
The estrogens in Prempro, Dr. Stefanick said, "are as
natural to the horse as the phytoestrogens are to the South
American yam." As for soy, she asked, "If it is natural to
a soy plant, does that make it natural to humans?"
nytimes.com |
