You probably heard the news.
The FDA leveled another shot at compounding
pharmacies on January 9th, 2008.
(http://www.fda.gov/bbs/topics/NEWS/2008/NEW01772.html
) - and AGAIN they were using their tired
ideas about the safety of hormone
replacement. No, they're not upset with the
drug makers who use mare urine and chemistry
to make substances that have never naturally
been found in the human body. They are again
voicing a concern that real human hormones
are potentially harmful. It seems that
something like this pops up every few
months. Those who want to stop compounding
pharmacists will do practically anything to
make their point - even if their point is
illogical or harmful.
We are referring to the
hormone substances that are BIOlogically
IDENTICAL to the ones we make in our
own bodies (estrone, estradiol, estriol,
progesterone, testosterone, cortisol,
insulin, thyroid).
Here's a snippet from the FDA
website:
The FDA's action today does
not target pharmacists who practice
traditional pharmacy compounding and who do
not make false or misleading claims about
compounded products. Traditional pharmacy
compounding typically involves preparation
of a drug for an individual patient by a
pharmacist in response to a valid
prescription from a licensed practitioner.
This compounding follows a practitioner's
decision that his or her patient has a
special medical need that cannot be met by
FDA-approved drugs. The FDA's current view
on human drug compounding is addressed in
its compounding Compliance Policy Guide,
available at
http://www.fda.gov/cder/pharmcomp/default.htm
The FDA also responded today
to a citizen petition from Wyeth (Madison,
New Jersey) asking the FDA to take
regulatory action against compounding
pharmacy operations that produce compounded
"BHRT" drugs. Other stakeholders, including
healthcare providers and consumer groups,
have also raised concerns about "BHRT"
drugs.
Notice the short phrase, “…responded
today to a citizen petition from Wyeth…”.
In the end, this is NOT something the
officials at FDA just dreamed up. They are
responding – as they are expected to do – to
a petition from a “citizen”, a drug maker;
the one company most directly at risk when
bioidentical hormones are preferred over
their horse concoctions and chemical
alternatives. The FDA, like most government
oversight agencies, responds when there are
complaints. In this situation the complaint
comes from a drug maker, not a citizen who
claims to have been harmed bioidentical
hormones. We must keep in mind that the
people at Wyeth are citizens and they have a
right to file a complaint. In response to
their complaint, someone has an obligation
to respond to their complaint. In this case,
the FDA has that obligation.
Wyeth has a stake in this
argument and they have rights to file
petitions, just like the rest of us. Now
that it’s on the table again have the
opportunity to respond again.
With or without long-term
studies – funded by a drug company – logic
and results are on the side of those of us
who know the benefits of using a real
hormone vs. one that comes from a horse. The
FDA comments focus on estriol.
Loyd V. Allen, Jr., Ph.D., R.Ph. has
this comment about estriol;
Estriol is a component of the
human body, has been commercially available
in the past and has a USP monograph. This
subject needs to be followed and special
attention paid to ensure that the true facts
are posted and to help ensure the rights of
physicians to prescribe and patients to
receive compounded HRT. As a reminder from
last year, Human Hormone Replacement Therapy
(Patterned after Human Insulin) may be an
alternative.
I must also point out that
one drug maker sells a product called
CORTEF. It contains cortisol, or
hydrocortisone – the exact adrenal hormone
our bodies make. Other drug companies make
levothyroxine (T4) and
liothyronine (T3), both hormones that
are identical to the thyroid hormones we
make in our bodies.
If it is logical and accepted
to use those “bioidentical” hormone
products, why the big stink over estriol? It
might have something to do with the
potential loss in market share if estriol –
a hormone that cannot be patented. What
happens to the market for horse estrogens
and synthetic compounds if estriol is
accepted as a standard replacement? Good
point.
If you’re concerned about
bioidentical hormones the FDA has published
a paper that you may review – all you need
is a pdf reader on your computer. It can be
found at
http://www.fda.gov/consumer/updates/bioidenticals010908.pdf
While I agree with the factual content of
this paper, I am unhappy about the “tone” of
the writing. It seems to suggest a negative
bias toward bioidentical hormone use. The
writers are entitled to their opinion – and
it shows in the paper. Many of us disagree
with their opinion.
I conclude that the war
between horse urine and synthetic hormones
vs. bioidentical hormones continues. There
are no universal conclusions. If there were
the FDA wouldn’t be so ready to respond as
they have. The argument will continue until
someone PROVES which approach is best. Until
then we’ll have to rely on logic and
positive outcomes from those who choose
bioidentical hormones over the others. This
topic will gain attention every so often –
just so we don’t forget that Wyeth has a
major stake in keeping people away from
bioidentical hormone replacement.
I know what I mean when I use
the word, BIOIDENTICAL. The FDA – with the
urging of the aforementioned petitioner –
says we shouldn’t use the term because it is
not well defined. I “Googled” the word and
got over 250,000 responses. At least a large
number of us know what it means – even if
the FDA and some drug makers don’t.
And here's a
bonus today. Dr. Jeffrey Dach has done an
outstanding job casting the light of truth
on the latest FDA report. Please make time
to click on the link below and read his
excellent piece.
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