Tamoxifen was shown long ago to lower the risk of getting breast cancer,
but women were never really keen on using it for prevention since the
side effects mentioned above really tipped the scale. Therefore, a need
for a safer alternative became a priority. But just a few days ago, the
results of another trial called RUTH, which was studying the
effectiveness of raloxifene for heart disease prevention in at-risk
women, were released and have lessened the hope that it will indeed
become that much-sought-after alternative to Tamoxifen.
Raloxifene did not lower the risk of heart disease among the trial
participants and it appeared to increase the risk of blood clots.
Although the drug, unlike Tamoxifen or estrogen, did not raise the risk
of stroke, the women who did have a stroke were slightly more likely to
die from it if they were taking Raloxifene. These results were highly
unexpected because previous clinical trials (MORE - Multiple Outcomes of
Raloxifene) showed a heart disease benefit among the women who were at
high risk.
The problem with MORE wasn't that the trial or its design were faulty
and a complete fluke, it was that the researchers looked at the OVERALL
heart disease outcomes first (part of the originial protocol), which
were neutral but THEN went back and divided the women up according to
their heart risk and found a benefit for the higher risk women.
This is a prime example of why subgroup analyses, PARTICULARLY when they
weren't factored in to the original trial design, lack true power to
prove a cause and effect if they contrast with the overall results. And
Lilly did recently get into big trouble for promoting Raloxifene as
heart protective ($36 million worth of trouble to be exact!) before
clinical trial data were in. This example also illustrates why I
personally think Wyeth, the makers of Premarin and Prempro, should be
treading more lightly themselves since they too have overemphasized
insignificant subgroup results of the WHI hormone trials.
Nevertheless, Raloxifene isn't all bad. It does lower breast cancer risk
as well as fractures of the vertebra. It too, according to RUTH, did not
increase uterine and endometrial cancer, which are a huge pitfall of
Tamoxifen and unopposed estrogen use in non-hysterectomized women. And
it certainly is a good thing that the necessary data are in to support
the appropriate use of this drug. Like estrogen, Raloxifene has failed
as a general health tonic and does pose some serious risks. But it's
probably not as disheartening as it may seem, since we really are
starting to enter an age of thinking where we realize a single pill
isn't going to shield us from all ailments and keep us healthy.
Jonathan Raymond
Correspondent
Books on Cancer
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