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DECEMBER 20, 2008
TheStory
Back Beat Goes OnGoes On
- The Beat In This Issue
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DECEMBER 20, 2008
As these products are the first to allow prevention of a form of cancer through
vaccination, their approval generated huge public attention and resulted in significant
pressure on healthcare authorities to make the $360 three-dose Gardasil regimen widely
available to teenage girls. Massive ad campaigns such as “One Less” ads on TV and in
leading magazines for Gardasil have increased Big Pharma’s ability to sell the HPV
vaccines to the unsuspecting public. Although most cases of cervical cancer in the
developed world can be prevented through the existing pap smear screening programs,
the expensive HPV vaccination has been recommended and is reimbursed for teenage
girls across the US and Europe. Cervarix has been approved for use in 67 countries.
In 2007, at least 24 states and D.C. introduced legislation to specifically mandate the
HPV vaccine for school (California and Maryland withdrew their bills.) Is this decision
driven more by public pressure and by the exciting opportunity to vaccinate against
cancer rather than by real medical need? And the United States is turning immigrants into
guinea pigs. Once the Centers for Disease Control (CDC; Advisory Committee for
Immunization Practices) issued recommendations for HPV vaccination with Gardasil, the
U.S. Citizenship and Immigration Services then required all female immigrants to receive
the HPV vaccine. Ouch!
Cont. on Page 7
TAKE ACTION
Take action: The FDA took action 01/09/2008 on the behalf of Wyeth, a major
pharmaceuticals manufacturer, to prohibit the use of estriol in compounded medicines.
An easy way to take action is to go to http://www.iacprx.org/site/PageServer?
pagename=home_page and lobby on behalf of a bill to be introduced to Congress
stating that banning of estriol is “not in the public interest.” The web address is the
home page of the International Association of Compounding Pharmacists.
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DECEMBER 20, 2008
Now the New York Times has said it too, in a November 25, 2008 article, in which it was reported
that a six-year study of breast cancer in Norway found more invasive cancers in women screened
every two years than in women who were not screened until the sixth year. The study suggests that
a significant number of cancers in the control group regressed and went away without treatment,
but would have been detected with more frequent screening.
The study also noted that even invasive cancers may sometimes go away without treatment and in
larger numbers than anyone ever believed. If the results are replicated, it could eventually be
possible for some women to opt for so-called watchful waiting, monitoring a tumor in their breast to
see whether it grows. “The issue is the unintended consequences that can come with our
screening,” a Harvard physician said, meaning biopsies for lumps that were not cancers or, it now
appears, sometimes treating a cancer that might not have needed treatment. “In general we tend to
underplay them.”
In her book, Sex, Lies and Menopause, T.S. Wiley argues that statistically breast cancer kills half of
all women diagnosed with it within five to ten years after diagnosis no matter how early it’s detected.
Women only increase their odds of getting breast cancer with annual mammograms.
It’s pretty apparent to any of us paying attention that the government isn’t terribly interested in
women’s health or our comfort levels on any issue. The last time we were between this rock
and a hard place, we, together, took control. It was 1840, in London for Elizabeth Cady
Stanton, and again in 1848 in Seneca Falls, New York (read article). It was 1851 in Akron, Ohio
for Sojourner Truth. It was 1860 in New York for Susan B. Anthony. It was 1915 in New York for
Alice Paul, 1935 for Mary McLeod Bethune, 1963 for Betty Freidan, 1971 for Gloria Steinem.
Maybe it will be 2008 for us. It could be.
It’s time to do it again. TS Wiley has addressed the Senate on the validity of Compounded
Hormones, acquired not one, but two IRB numbers sanctioning studies on the Wiley Protocol
and is in discussion with representatives of the upcoming continuation of the WHI starting this
fall.
NOW ALL WE HAVE TO DO IS PAY FOR IT. If you’d like to contribute to finding an answer to
the issues of safety and efficacy in hormone replacement for women sooner than later…click
here PAGE 4
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DECEMBER 20, 2008
Planetarium Corner
In Roman mythology the Moon was represented by Diana, the hunter goddess. The Moon is the earth's
companion satellite, though some astrologers believe that it approaches being a planet in its own right. The Moon
is large enough for its gravity to affect the Earth, stabilizing its orbit and producing the regular ebb and flow of the
tides. The Moon is familiar to us for its different phases, waxing and waning in appearance in an unchanging
cycle. The Moon orbits the earth in about 28 days, spending a fleeting 2.33 days in each of the signs of the
zodiac. The lunar day syncs up with its orbit around Earth in such a manner that the same side of the moon
always faces the Earth and the other side, known as the "dark side of the moon" faces towards space.
Dr Mary Bluntzer of Dallas Texas won last season as favorite physician and Westmoreland’s
Pharmacy in New Albany Indiana won for favorite pharmacy.
Send us an email with your votes and stay tuned!
RESOURCES
Sex Lies and Menopause | Lights Out: Sleep, Sugar,
A book of feminist medicine and Survival
In this revolutionary work -- a The light bulb put us out of sync
landmark that signals the true with nature. Way back when,
beginning of feminist medicine -- a people spent the summer sleeping
doctor, a philosopher, and a scientist less and eating heavily in
prove that by postponing marriage preparation for winter because light
and motherhood, women have triggers the hunger for
accelerated the aging process, carbohydrates. Now, with light
resulting in earlier menopause and, available 24 hours a day, we gulp
ultimately for thousands, earlier down food all year long.
death.
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DECEMBER 20, 2008
Back Story- continued
Circadian rhythms are the body's intrinsic time-tracking system, which anticipates
environmental changes and adapts to the appropriate time of day. They regulate a host
of body functions, from sleep patterns and hormonal control to metabolism and
behavior.
All human genes are regulated by circadian rhythms. Disruption of these rhythms can
profoundly influence human health and has been linked to insomnia, depression, heart
disease, cancer and neurodegenerative disorders. Researchers recently found that a
single amino acid activates the genes that regulate circadian rhythms, a very precise
molecular control. As sunset occurs, the light shifts and stimulates the rise of melatonin,
making you very sleepy. Rising melatonin cools you off, causing you to huddle together
for warmth, drifting into REM sleep. The brain sorts and tags the mind’s perceptions and
you move into a deeper sleep state during which your brain activity shifts to immune
system maintenance. Going to sleep with the sunset means a whole-body melatonin
bath and a sharp increase in prolactin. One of prolactin’s major effects is to enhance
production of T cells and Natural Killer (NK) cells, the first line of defense against cancer
and other diseases. Dark bedrooms help, and so does eating with the season, which
means high protein and low carbohydrates during the winter.
Research bears out the impact of losing even a few hour of sleep each night. Increased
risk of accidents, fatigue making you prone to depressive symptoms or not enough
energy to exercise, and even chemical changes stimulating your brain to eat more and
to eat more salty and sugary food are the consequences. A recent study suggests that
regular physical activity can lower a woman's overall risk of cancer – but only if she gets
a good night's sleep. Otherwise, lack of sleep can undermine exercise's cancer
prevention benefits. As we get older, the amount of nightly sleep that we need remains
the same as when we were younger. Older adults produce and secrete less melatonin,
the hormone that promotes sleep. They are more sensitive to changes in their
environment, such as noise, and this will cause them to awaken. A study published in
the December 1 issue of the journal SLEEP found that altered levels of both sex
hormones and gonadotropins may contribute to sleep disturbances in postmenopausal
women and confirmed the results of previous studies indicating that higher body
temperature is associated with poorer sleep quality. According to the results, lower
estradiol (E2) and higher luteinizing hormone (LH) levels were significantly correlated
with indices of poor sleep quality, with relationships between LH and quality of sleep
being stronger than those for E2.
Make a resolution for 2009: 9.5 hours of sleep in a dark quiet room in winter for
hibernation time. For more information, check out T.S. Wiley’s research on sleep.
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DECEMBER 20, 2008
HPV Vaccine- continued
HPV causes cervical cancer and genital warts. It is a sexually transmitted disease. The
statistics show that during 2007, an estimated 11,100 new cases will be diagnosed and
approximately 3,700 women will die from cervical cancer. Over 500,000 new cases of
genital warts are diagnosed annually in the United States. Overall an estimated 6.2
million new HPV infections occur every year among persons aged 14--44 years. Of
these, 74% occur among those aged 15--24 years. More
Globally, cervical cancer is the second most common cause of cancer death in women,
with an estimated 510,000 newly diagnosed cervical cancer cases and 288,000 deaths.
The highest rates of cervical cancer have been observed in regions of Africa, Central
and South America, and Micronesia.
The idea is simple; the HPV vaccine triggers the immune system’s natural defenses and
the immune system prevents infections by the HPV types against which the vaccine is
protective. Vaccinate enough people before they get infected and the HPV types
commonly associated with genital warts and rare cervical cancer get knocked back.
Because it can take 20 years for cervical cancers to show up, the clinical studies
assessing effectiveness of the HPV vaccine evaluated tissue changes that may lead to
cervical cancers. Or the changes may resolve without intervention. The point is we
don’t know whether the HPV vaccine works to prevent cervical cancer and we won’t
know for decades. The licensing of Gardasil occurred almost a full year before the
results of the Phase III clinical trials were first published!
Because HPV is sexually transmitted, the HPV vaccine recommendations target girls
ages 11-12 but as young as age 9 and include “catch-up” vaccination in females ages
13 to 26. How will the HPV vaccine affect these preadolescent girls, given that the only
clinical trials conducted in this age group have been on the immune response? The
studies that assessed effectiveness involved 15- to 24-year-old women. How long will
protection last? Will boosters be required? Exactly how effective will the vaccine be?
Does it make sense to target only one sex in prevention strategies against a sexually
transmitted infection?
How will HPV vaccination affect screening practices? Since the HPV vaccines protect
against only two of the cancer-causing types of HPV, women must continue to be
screened for cervical lesions. Vaccinated women may feel protected from cervical
cancer and may be less likely than unvaccinated women to be screened. (More)
A cost-effectiveness analysis concluded that under certain assumptions, vaccinating 12-
year-old girls is associated with an incremental cost-effectiveness ratio of $43,600 per
quality-adjusted life year (a measure of both the quality and the quantity of life lived after
a medical intervention) gained, whereas adding a catch-up program for older girls and
women is not cost-effective. The assumptions, however, may not be valid; for example if
the protection of the vaccine wanes after 10 years vaccination is much less cost-
effective and screening is more effective than catch-up programs. (See New England
Journal of Medicine.)
We don’t know enough to answer these questions. We won’t know enough to answer
these questions and many more for a very long time. You choose.
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