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It's hot and humid, but I still love
the summer. I
really enjoy a Thursday evening in NYC walking home late
from work -- observing all the "outfits" ready
to make a night of it. My favorites are the "dates" or "looking
for dates" in the cafes and on the streets. The women
usually have their favorite summer dress or (fancy) shirt
on with jeans and heels they have trouble walking in. (they
need lessons from me and Kelly) The guys (a solid 75%) are
using product in their hair and are paying much more attention
to their attire then every before - we're not talking kakis
(although still common), very metro-sexual around here -
but I like it. I keep asking myself if this says something
obvious about a guy (like "trouble") -- but then
realize that I'm being judgmental - maybe it's just "evolved". Our
building has a small courtyard and often the tables are occupied
with neighbors drinking a bottle of wine and hanging out
with friends. It's very sweet.
This month, I'm going to keep it
short. (LOL) We'll
look at the big news in July about the birth control patch. Then
I'll report on an interesting JAMA study that shows that
HRT for a great deal of women only delays symptoms of menopause
- and finally, the controversy continues for HRT.
THE PATCH
Considering hormonal
birth control has been around for more than 30 years, why
is any increased death rate acceptable? That's pretty
much what "Experts" are
saying about the recent deaths from the hormone patch. In
November of 2002 - Time Magazine chose the hormone patch
as one of the "coolest inventions". Because
of once a week dosing, it quickly became a popular form of
birth control. See 2002 Johnson & Johnson press release
(J&J owns Ortho-McNeil, maker of the patch) http://www.jnj.com/news/jnj_news/20021111_094741.htm.
In 2004, it is estimated that 800,000
women used the patch. Last
month, AP broke the story that there have been 23 deaths
related to the patch, 3 times as many as expected from birth
control pills. 17 of these deaths are related to blood clots
- the most serious concern with hormone birth control. Blood
clots generally start in the legs and can be dangerous if
they move to the heart, lungs or brain.
As the AP article points out, blood
clots are an acceptable side effect of birth control pills
- it is known that higher amounts of estrogen promotes
blood coagulation or thickens the blood. But how much is acceptable? (Side
note: how could they ever have thought that HRT would be
beneficial for heart health in menopausal women if this is
a known effect of estrogen in the blood? True, it's
arguable that women of transition age are estrogen deficient,
but unless every woman is prescribed the exact amount needed
individually (highly improbably), is it not obvious that
estrogen and heart health would not go together? Am
I missing something?)
The main points in the AP piece are as follows:
- The AP
found that before the patch was approved, the FDA was aware
that nonfatal blood clots from the patch were three times
that of the pill. The AP then found that since the patch
has come out, deaths also appear to be at least three times
as high.
- A woman on
the pill who does not smoke and is under 35 has between
a 1 and 3 in 10,000 risk of having a non fatal blood clot. Risk
of dying from a blood clot is 1 in 200,000.
- For the
patch it's 12 in 10,000 for a non-fatal clot and death
rates appear to be 3 in 200,000.
- In
2000, doctors at the FDA reviewing clinical trials of
the wafer-thin, plastic patch warned that blood clots
could be a problem if it was approved.
- Even with the FDA
warning, the patch was approved with no requirements
for follow-up beyond routine FDA reviews of reports called
in by consumers, doctors and manufacturers.
Why the difference? It is believed that it could
be the ways hormones are absorbed - even though the amount
of hormones is similar for either prescription. In
the pill they are conjugated through the liver - taken by
the patch, they are directly absorbed into the skin.
Those defending the patch claim that
these risks are in line with what they expected and that
no further investigation is needed as they are very low. They also claim that
pregnancy has a much higher death rate than the patch - so
don't get off it. (sorry, that one's lame - it implies the
patch is the only option to prevent pregnancy) They also
state that more information will be known as more and more
women use the patch - for now, there is no reason for concern.
(how comforting) And finally the MD's associated with Ortho
claim that it is safer than the pill. (that one you got to
read for yourself, it sounded like double talk to me) None
of this defense is convincing to me (ya think?) but I've
provided links for you to read for yourself - In all seriousness,
I'm particularly upset by the fact that no follow up studies
were required -- AGAINST what the FDA's own researcher advised. If
you get along with the pill, (I never did) it's clear that
it is safe - why not stick with tried and true?
One other note: In an article published in the North
American Menopause Society (NAMS) magazine last month (heavily
pharmaceutically sponsored) the authors basically slammed
HRT "bio-identical hormones" that women can get
in a compounding pharmacy - their main point was that these
hormones are delivered in mostly gels and lotions absorbed
by the skin and we don't have enough information about how
these are absorbed and used by the body. Just pointing
out the contradiction and how this point is being argued
both ways - one way to defend a drug and another way to discredit
an alternative.
http://wusatv9.com/health/health_article.aspx?storyid=41226
http://msnbc.msn.com/id/8565177/rebuttal
http://www.medicinenet.com/script/main/art.asp?articlekey=52626
WE KNEW THIS
from experience but
now it looks like an initial study published in JAMA has
confirmed our experience as women. The truth is that very
little is known about women who stop hormone therapy. The
theory has been to take HRT through the difficult years
- get through that time period and then stop HRT when it
should all be over. The idea was to "skip
over" the symptomatic period by taking hormones and
come out the other end symptom free. Well, it turns out that
most women's experience has been that HRT just postpones
the symptoms, it doesn't skip over them.
This study looked at a cross-section
of 8405 women that were advised to stop the estrogen plus
progestin as a result of the WHI study. They mailed them a survey 8-12 months
after the stop date. More than half the women with
vasomotor symptoms at baseline reported symptoms after the
therapy was discontinued - and this was at an older age of
69.1 after taking the therapy for 5 years. Further investigation
needs to be done as this study did not include women who
stopped taking it earlier or were unwilling to be randomized. However,
it does accentuate the point that women should take HRT for
the shortest duration possible and the alternative methods
to manage symptoms need to be considered.
http://jama.ama-assn.org/cgi/content/abstract/294/2/183?lookupType=volpage&vol=294&fp=183&view
http://www.4women.gov/news/english/526792.htm
CONTRAVERSY CONTINUES
You won't
see this on the nightly news, but the World Health Organization
(WHO), part of the UN, has added HRT to it's list of carcinogens,
updated from "potential
carcinogens". This comes after several recent
high-profile studies linking combination hormone replacement
therapy, or HRT, to breast cancer. The Organization puts
the breast cancer risk for those on HRT to 1 in 6, vs. 1
in 7 who don't use the drug. The cancer research agency also
concluded that a common type of birth control pill, taken
by about 10 percent of women of reproductive age, increases
the risk of more types of cancer than previously thought.
The scientists acknowledge that it's a complicated picture
and there are benefits to HRT. (see link below)
At the same time an interesting report
out of The Harvard School of Public Health and published
in the Journal of Epidemiology and Community Health this
month that centers around the question "Why
did concerns about HRT get overlooked, when are awareness
of these concerns dates back to the 1930's?" According
to the Dr. Koop website,
"The authors pinned their
paper around this question: "Why, for four decades,
since the mid-1960s, were millions of women prescribed powerful
pharmacological agents already shown, three decades earlier,
to be carcinogenic?"
The complicated
answer, as the authors see it, includes an industry that
is not tightly regulated; the ascendancy of individual as
opposed to collective risk; and the "gendering" of
hormones involving longstanding beliefs that sex hormones
explain women's and men's behavior and biology.
Socially
responsible research, they conclude, needs to include greater
transparency of funding; a public registry for all drug
trials; and a re-weighing of current prevention vs. future
risk."
Many experts argue that there is
a place for HRT in women's health and you can't look back
with a 2005 perspective. That
there are huge pros and cons on either side - it must be
an individual choice. I certainly agree that HRT must
be an individual choice as my bottom line is pro- "don't
be miserable". I would hate to see hormones unavailable
for those women who truly need them. However, the report
brings up a very valid point -- let's not forget that for
years menopause was touted as a "deficiency disease" and
only long term use hormones would keep us younger looking
sexually active and healthier. It didn't come from
nowhere.
http://msnbc.msn.com/id/8759578/
http://drkoop.com/newsdetail/93/527345.html
That's it for this month! As always,
check out our website for lots more information at www.oonahealth.com.
In Good Health,
The Oöna Team
Questions or comments? Write valerie@oonahealth.com
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