Prompt Reviews of Hormone Therapy
to growing doubts about the safety and value of hormone replacement
therapy in women after menopause, two federal agencies are reviewing
what is known about the drugs and what women and their doctors
should be told about them.
The National Institutes of Health said this week that it would
hold a public meeting on Oct. 23 and 24 in Bethesda, Md., to discuss
questions about the therapy. The Food and Drug Administration is
reviewing the labeling of hormones.
The goal of the October meeting, said Dr. Vivian Pinn, director
of the institutes' Office of Women's Health, is to address confusion
in the wake of a federal study last month that found increased
health risks from one hormone combination taken by millions of
women. Dr. Pinn said participants would also discuss whether recent
findings from that study, the Women's Health Initiative, could be
generalized to similar products.
Researchers, doctors and the public will be invited, she said,
along with representatives from drug companies, professional groups
and federal agencies.
The meeting was announced discreetly on Tuesday on the Web site
of the Food and Drug Administration (www.fda.gov/cder/drug/safety/WHI_statement.htm),
tucked into the end of a statement on the need to reassess the risks
and benefits of hormone therapy. Yesterday, after The
Washington Post published an
article about the meeting, the health institutes put a notice on its
Web site (www4.od.nih.gov/orwh) saying the meeting would take place
but providing no details.
Increased concerns about hormone replacement therapy and the
labeling of the drugs arose in July after the health institutes
abruptly halted a large clinical trial of Prempro, a combination of
estrogen and progestin made by Wyeth. Women taking the drug had
slightly more cases of breast cancer, heart attacks and strokes than
those taking a placebo, and those risks were not counterbalanced by
the drug's benefits, a slight decrease in the incidence of hip
fractures and colon cancer.
Another arm of the trial, involving women taking estrogen alone,
is continuing because the evidence shows neither an overwhelming
risk nor an overwhelming benefit. Women who have had hysterectomies
generally take estrogen without progestin. For others, taking
estrogen alone can lead to uterine cancer.
Prempro is approved for the prevention of osteoporosis and for
the relief of symptoms of menopause, like hot flashes, but doctors
had hoped it might also protect against heart disease and other
diseases of aging, including Alzheimer's. Many women were advised to
start taking Prempro at menopause and to continue for the rest of
But Prempro is not the only hormone replacement on the market,
leaving many doctors and women with questions about whether other
drugs, which are slightly different formulations, have similar
risks. There are also questions about who should take Prempro and
for how long.
Prempro's label was written on the basis of older studies that
did not provide the sort of precise information as the new study.
Those studies did indicate possible risks of heart attacks, strokes
and breast cancer, however, and that is included on the drug's
Now, the food and drug agency is looking at the new data.
"We are going to conduct a review of the data from the Women's
Health Initiative study and evaluate the product and the product
labeling in light of those data," said Susan Cruzan, an agency
Ms. Cruzan said the agency would also consider whether there
should be changes in labeling for formulations of the hormones made
by other companies. But she added that the work had just begun.
"Until we have more details, there's not a whole lot we can say,"
Ms. Cruzan said.
Dr. Bruce Burlington, the head of regulatory affairs at Wyeth,
said the company was already planning to change Prempro's label. The
company began meeting with the drug agency officials as soon as the
results from the Women's Health Initiative were announced.
"We told them we needed to get warnings out and solid information
out," Dr. Burlington said.
In addition to changing its label to reflect the more detailed
information provided by the Women's Health Initiative study, he
said, Wyeth would send letters to about half a million doctors
informing them of the study's findings.
Dr. Burlington said that Wyeth expected to participate in the
health institutes' meeting in October. But he added, "We don't have
an agenda and we don't have an invitation as yet."