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From: B. Harris)
Subject: Re: breast cancer and alcohol?
Date: Sun, 21 Sep 1997

In <603kor$> (Joan Livingston
Attorney at Law) writes:

>	Some of the "studies" that showed "no" increase in breast
>cancer/estrogen/HRT were:
>	-too short term to show up the cummulative effect of the
>estrogens and/or other hormone medications.
>	- included women who took any estrogen containing drug at any
>time in their lives, such as 6 months of birth control pills when they
>were 20 and thereby diluting the breast cancer incidence among those
>who were taking it more steadily and later in life.
>	Read carefully, Cathe, even my posts.
>Joan L.


    By and large the studies which show the increase in breast cancer
mortality are those which also show a decrease in cardiac mortality,
and total mortality.  There is exactly as much evidence for the good
effects as the bad, and for the fact that the good outweighs the bad
for most women.

   I'm amused that the package insert for these things requires the
company to say that there is evidence that the healthier women who took
hormones in the epidemiological studies, were healthier to begin with
than those who decided not to.  Indeed.  Hormone-taking women are
slightly better educated, have fewer children, make more money, etc,
etc.  In fact, by gosh, they have a bigger risk for breast cancer to
begin with, also.  Except the FDA doesn't make the drug company mention

    Here's why not: the package insert for a drug is written by lawyers
with lawsuits in mind, and balanced treatments of biological theories
are not the purpose.  Avoiding liability by overdoing the potential
dangers is the purpose.   This is to the drug company's best interests,
and it's in the government's best interests, giving both deniability if
the side effects hit the fan later.  A package insert for a drug is
very much like what the S.E.C. makes sellers of stock write for
potential investors.   The problem that arises from this kind of thing
is that of all liability, however: when you critically examine evidence
of benefits for an action without just as critically examining evidence
for your risk, you take an unnecessary risk.   Somebody ought to remind
the FDA that there really are penalties for crying wolf and exagerating
risks-- that it's not something you can do willy nilly without
consequences.   Not doing anything is risky, too.  At least for the

    But the FDA is a political animal, and it knows that there are few
consequences to IT in delaying approval of a drug too long, or making a
drug sound nearly worthless, for too long.  People don't think of
themselves as dying from lack of drug, because usually they never know
about the drug or the particular use for it.  They think of themselves
or their loved ones as having died of the disease.   And so they have
died of disease, but it's not the one they are thinking of.
Calcification of the Government is not something you can write on a
death certificate.   The political penalties for delaying a drug too
long are almost nil.  By contrast, the political penalties associated
with passing off on a drug too early, are immense.   So which is the
FDA going to lean towards?

                                       Steve Harris, M.D.

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