Re: Add Statins to Birth Defects Ipledge program established for Accutane
- From: SJ Doc <predone@xxxxxxxxxxxxxxxxx>
- Date: Tue, 16 Aug 2005 11:41:24 -0400
On Tue, 16 Aug 2005 00:44:20 -0700, "Sharon Hope" wrote:
>Why stop there? Why not add statins to the birth defects risk
>mitigation registry and procedures?
I have to keep repeating that "There are no stupid questions"
mantra, but - damn it - I just can't hold onto my temper this
morning. That's a stupid question.
Cystic acne - the condition for which the retinoids (i.e.,
Accutane and its congeners) are used - occurs during the
childbearing years. The common use of the HMG-CoA
reductase inhibitors (the "statins") is in the later decades of
life. Except in relatively rare congenital disorders such as
the hyperlipoproteinemias, the statin drugs are not commonly
prescribed to women during the early decades of their
adult lives.
And it's not just the HMG-CoA reductase indicators that
are not to be used indiscriminately in women who might
become pregnant. Many commonly-prescribed classes of
drugs are considered relatively or absolutely contraindicated
during pregnancy. If you'll follow the arguments of conscien-
tious drug safety advocates like David Graham of the FDA,
Accutane and the retinoids present a special case, chiefly
because the use of these products - heavily driven by pharma
marketing - is disproportionate, indiscriminate, and simply
too goddam promiscuous.
Cystic acne is pretty damned bad, but it's not terribly common.
Plain old acne vulgaris is eminently susceptible to treatment with
topical therapy and with systemic medications that have very
little risk as teratogens (i.e., proclivity for causing birth defects)
compared with the retinoids. Too many cement-headed members
of my profession have been prescribing Accutane without
thinking too clearly, and too many patients have been "doctor-
shopping" to get Accutane because concerning their physical
appearance, women in their childbearing years altogether too
thoroughly fit that description from *As Good as It Gets*
("I think of a man, and I take away reason and accountability").
Putting Accutane and the other systemic retinoids on a
national registry similar to that established for thalidomide
(Thalomid, Celgene) is a recognition of the above-mentioned
fact. It's also a way to get both doctors and patients to
*think* about using these products before they do so.
As opposed to the statin drugs, the angiotensin converting
enzyme (ACE) inhibitors, the angiotensin receptor blockers
(ARBs), the fluoroquinolone antibiotics, the tetracyclines,
chloramphenicol, warfarin, and a bunch of other medications
about which both doctors and patients tend to think much
more clear-headedly, probably because patient demand for
these products is not driven by vanity.
Or have you got some sort of idiot fixation on the HMG-CoA
reductase inhibitors, you pharmacological illiterate?
--------------------------
Hygiene is the corruption of medicine by morality. It is
impossible to find a hygienist who does not debase his
theory of the healthful with a theory of the virtuous.
The whole hygienic art, indeed, resolves itself into an
ethical exhortation. This brings it, at the end, into
diametrical conflict with medicine proper. The true aim
of medicine is not to make men virtuous; it is to safeguard
and rescue them from the consequences of their vices. The
physician does not preach repentence; he offers absolution.
-- H.L. Mencken, The Smart Set, May 1919
.
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