Evista induces ovarian cancer in both mice and rats -
Reprinted
from the Chicago Tribune, April 19, 1998
New Drug Poses Risk of Ovarian Cancer
by Samuel S. Epstein M.D. & Pat Cody
Chicago, Illinois / Oakland, California
Eli Lilly's current full page color ads for Evista, a synthetic hormone
with both estrogenic and anti-estrogenic effects, in major national and regional
newspapers claim that it offers "a new way to prevent osteoporosis" while
admitting that "its effect on fractures is not yet known." The ads also claim
that "women taking Evista had no increased risks of breast and uterine cancers"
in contrast to hormone replacement therapy, and that it reduces LDL or bad cholesterol
blood levels. This should be welcome news to women worldwide, particularly as osteoporosis
has now reached epidemic proportions, affecting fifteen to twenty million American women
each year; osteoporosis causes over a million fractures including 250,000 hip fractures,
and killing some 50,000 elderly women from complications of their fractures.
While warning of some possible side effects, such as blood clots or hot
flashes, Lilly fails to warn of the more serious risks of ovarian cancer. A
company-sponsored publication in the December 4, 1997 issue of The New England Journal
of Medicine also ignores this risk. However, Lilly's pre-market clearance study
clearly shows that Evista induces ovarian cancer in both mice and rats. Furthermore,
carcinogenic effects were noted at dosages extending well below the recommended
therapeutic level. However, the study concluded: "The clinical relevance of these
tumor findings is not known." Lilly reached this conclusion despite the strong
scientific consensus that the induction of cancer in well-designed tests in two rodent
species creates the strong presumption of human risk. Nevertheless, Lilly fails to
disclose this critical information in its ads and in its "Warning" to patients.
Responding to such criticisms by Dr. Samuel Epstein on the January 12,
1998 "Jim Lehrer News Hour" program, a Lilly spokesman claimed that the
carcinogenic effects of Evista in the ovaries of sexually mature rodents are irrelevant to
such risks in post-menopausal women as their ovaries are inactive, and that no warning is
therefore necessary. However, apart from the fact that the rodent studies were
specifically designed to evaluate Evista's safety, ovarian cancer is a scientifically
documented complication of long-term estrogen replacement therapy in the post-menopausal.
Also disturbing is the claim that Evista poses no risks of breast and uterine cancers as
this is based on clinical trials over only some 40 months, a period totally inadequate to
possibly manifest any such risks.
Ovarian cancer strikes about 24,000 U.S. women every year, accounting
for 4% of all their cancers. About 15,000 women die from ovarian cancer annually, making
it the most lethal of all female reproductive cancers. Lilly's suppression of its own
evidence of ovarian cancer risks from Evista is reckless and threatening to women's health
and life. Equally reckless is FDA's December, 1997, marketing clearance, especially in the
absence of any requirement for warning. Such conduct clearly merits urgent Congressional
investigation. This drug should be withdrawn from the world market immediately. As
importantly, a "Cancer Alert" should be sent to the over 12,000 women who have
participated in U.S. and international clinical trials in the absence of fully informed
consent. The doctrine of informed consent is ethically and legally protective only when
all facts relevant to benefits and risks are affirmatively disclosed. This is clearly not
the case with women who have been involved in the Evista trials. These women should be
offered semi-annual lifelong surveillance for the early detection of ovarian cancer, at
Eli Lilly's expense.
Samuel S. Epstein M.D., University of Illinois School of Public Health, Chairman,
Cancer Prevention Coalition, Chicago, and co-author of The Breast Cancer Prevention
Program, Macmillan, 1997.
Pat Cody, President, DES Action, Oakland, California.
Note from the editor (Nora Cody) : With so much conflicting
information available, it can be difficult and frustrating to try and make the best
decision about taking hormones. For personal decisions about your own health care, I
encourage you to speak with your health care provider. Please do not send inquiries. For
thoughtful and reasoned discussion about hormones, menopause, and alternative approaches
to menopausal symptoms, I also recommend the newsletter A Friend Indeed. To
request more information about A Friend Indeed, you can contact its
publisher at afi@pangea.ca.
Related article:
- "The Breast Cancer Prevention Program", Samuel S.
Epstein, M.D.,
Book Review by Pat Cody
- Doctor claims new drug (Evista) poses risk for ovarian cancer
by Nora Cody
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