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Failure to fully document risks of osteoporosis drug is
'reckless' Chicago Tribune, Sunday, April 19, 1998
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Eli Lilly recently began running full-page color ads for Evista,
a synthetic hormone with both estrogenic and antiestrogenic effects,
in major national and regional newspapers Tile ads claim that Evista
offers "a new way to prevent osteoporosis," but at the
same time admit 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 conventional 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 15 million to 20
million American women each year; osteoporosis causes more than a
million fractures, including 250.000 hip fractures, and kills some
50,000 elderly women, from complications as a result 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 article in the Dec. 4, 1997
issue of The New England Journal of Medicine also ignores this
risk. Lilly's
pre-market clearance study, however, clearly shows that Evista
induces ovarian cancer in both mice and rats. Furthermore, carcinogenic
effects
were noted at dosages 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 one of us (Samuel Epstein) during
a broadcast of the "Jim Lehrer Newshour" earlier this
year [Jan. 12], a Lilly spokesman claimed that the carcinogenic
effects
of Evista in the ovaries of sexually mature rodents are irrelevant
to such risks in postmenopausal women, as their ovaries are inactive,
and, therefore, no warning is necessary. Apart from the fact that
the rodent studies were specifically designed to evaluate Evista's
safely. Ovarian cancer is a scientifically documented complication
of long term estrogen replacement therapy in post-menopausal women.
Also disturbing is the claim that Evista poses no risks of breast
and uterine cancers, based on clinical trials over only some 40
months, a period totally inadequate to possibly measure any such
risks.
Ovarian cancer strikes about 24,000 women in the United States
every year, accounting for 4 percent of all female cancers. About
15,000
women die annually from ovarian cancer, 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 the Food and Drug
Administration's December 1997 marketing clearance, especially
in the absence of any requirement for warning. Such conduct clearly
merits urgent congressional investigation, Evista should be withdrawn
from the world market immediately. As importantly, a "cancer
alert" should be sent to the more than 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.
More…
Evista Risks Ovarian Cancer
Evista Dangers press release
CONTACT:
Samuel S. Epstein, M.D.
Chairman, Cancer Prevention
Coalition
c/o University of Illinois at Chicago
School of Public Health, M/C 922
2121 W. Taylor Street
Chicago, IL 60612
epstein@uic.edu
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