February 1998: Extracted from http://www.evista.com/DoctorLetter01.html?yes
Recently there have been some local media
reports questioning the safety of Evista® (raloxifene hydrochloride),
Lilly’s new drug for the prevention of postmenopausal osteoporosisThese
recent allegations are based on unsubstantiated claims and an
uninformed interpretation of findings in rodents (rats and mice).
The findings in
rodents do not translate into human health concerns for
several important scientific reasons. First, rodents
do not go through menopause. It is also well-established thatmice
are especially susceptible to development of ovarian tumors. Because
the animals were treated with raloxifene throughout their entire reproductive
lives, hormonal changes occurred that are known to cause ovarian tumors
in rodents. In contrast, raloxifene does not produce similar hormonal changes
in postmenopausal women. Additionally, other marketed products, including
one which has been on the market for more than 15 years, have produced
similar effects in rodents, but have not been found to cause an increased
risk of ovarian cancer in women.
The United States Food and Drug Administration (FDA), an
independent FDA advisory committee of experts in the field, and Lilly Research
Laboratories all rigorously reviewed the animal and human data for raloxifene
prior to the product’s approval and came to the same conclusion: Evista
is safe and effective for the prevention of osteoporosis in postmenopausal
women. Lilly supports the integrity of the FDA’s review and approval process.
Compare with this extract from The
Changing Years, Madeline Gray (1967)
Estrogens and cancer
Now to the most serious
question of all: Can the estrogens cause cancer? Because if they can, no
matter what else they can or cannot do, they are ruled out. Let me
start by making a strong statement: The. general answer to the question
is NO. Estrogen. alone cannot cause cancer in human beings. We don't know
what can, but none of the available evidence to date points to estrogen
alone. It must be estrogen combined with something else.
How you and
I got confused about this subject is as follows: Some
few years ago, around 1936 or before, a number of experiments were done
on cancer with mice. Some young female mice of a
special cancer-prone strain were injected with large quantities of estrogen;
others were not. The mice receiving the hormones did develop a higher
percentage of breast cancer than the mice that got none. Next, other experiments
were performed backward. The ovaries were removed from some of the mice
that had breast cancer. A certain percentage of the cancer did disappear.
Naturally people got
tremendously excited. An excess of female sex hormones causes breast cancer,
they cried. This proves that taking hormones is bad for mice, and probably
for women as well." Well, it didn't prove anything of the kind. For the
more cautious people soon remembered several things. First, they
remembered that the mice used were a special cancer-prone
strain of mice. Second, they remembered that the mice
used were all young, or of the age equivalent to menstruating women, not
equivalent to menopausal age. Third, the cancers were breast only,
not cancers of the uterus or womb. (!!!!!!
so? Tishy) And fourth, only a certain percentage
of the treated mice developed cancer. So other factors unquestionably had
to be involved.
What could these other factors
be? Heredity might be one. Some of the mice might have inherited the tendency
to breast cancer through their mother's milk. When other experiments were
done, sure enough-a hereditary "milk factor" was found to be involved.
Soon most scientists
had become convinced that several factors had to be at work simultaneously
to cause breast cancer in mice. Excess hormone stimulation was only one
of them; the mice had also to be of a cancerous strain, and they had to
receive the tendency through their mother's milk. Above
all, still other research convinced them, animals are so different from
humans that relating animal experiments to humans often produces false
reports, especially in the field of hormones.
What works in animals often does not
turn out to work in humans at all.
And yet: (extracted from Women and
the Crisis in Sex Hormones (Seaman and Seaman 1971)
Gusberg speculated that it was not the
dosage of ERT, nor the specific product, but long-term exposure that causes
harm. (Research completed in 1975 showed Gusberg to be correct on two points
out of three: Duration of use and high-dose levels are both significant
in producing cancer, while product differences appear to be inconsequential.
) Early as it was in the ERT game, by 1947 Gusberg had collected 29
cases of women whose endometria were profoundly disturbed by estrogen therapy
- 20 with a possibly premalignant condition called hyperplasia, which often
necessitates hysterectomy, and 9 with cancer itself. |