Re: ~*Online WACOC News 2006 July 19*~
- From: "DGSaba" <dgsaba@xxxxxxx>
- Date: 19 Jul 2006 05:00:49 -0700
Women and Children of CFIDS
WACOC
A partial excerpt from:
NVIC HPV Vaccine News Briefs
http://www.nvic.org
National Vaccine Information Center Newsletter E-NEWS
July 18, 2006
In this issue
:: HealthWrap: Risks, Rewards and Rx's
:: A New Vaccine for Girls, But Should It Be Compulsory?
:: A Shot, Or Not: Sorting Out the Facts on New HPV Vaccine
:: Steep Learning Curve for HPV Vaccine?
"The [HPV] vaccine has shown 'spectacular
results,' and the side effects seem
negligible, he added. "Every mother in America should
consider vaccinating her daughter against this," -
Thomas Wright, M.D.
"Merck and the FDA have not been completely
honest with the people about the
pre-licensure clinical trials," said NVIC president
Barbara Loe Fisher.
"Merck's pre- and post-licensure marketing strategy
has positioned mass use
of this vaccine by pre-teens as a morality play in
order to avoid talking
about the flawed science they used to get it
licensed. This is not just
about teenagers having sex, it is also about whether
Gardasil has been
proven safe and effective for little girls."BL Fisher Note:
HPV infection is asymptomatic and is cleared naturally
by the majority of men and women who experience it.
Rarely, HPV infection becomes persistent and, after
many years, can cause cervical cancer in women.
Most cervical cancers are prevented in the U.S. with
routine pap smears.
Merck's pre-licensure clinical trials for their
HPV vaccine,Gardasil, were methodologically flawed.
Merck used a potentially reactive aluminum containing
placebo to mask the magnitude of the Gardasil's
reactivity. It appears that only about 900 pre-
adolescent girls participated in the clinical trials.
Merck and the FDA know nothing about the ability of
Gardasil to cause long term health problems,
particularly autoimmune disorders such as rheumatoid
arthritis, in young girls (see an analysis of pre-
licensure clinical trials with citations at www.nvic.org
(http://rs6.net/tn.jsp?t=lgdp5wbab.0.jcsy6wbab.oblmlwbab.2805&ts=S0196&p=http%3A%2F%2Fwww.nvic.org%2F))
The CDC's recommendation for universal use of
HPV vaccine by all pre-adolescent girls is a profit-
making enterprise for Merck and it is a potential
health risk for little girls, who may or may not ever
become HPV infected. And, if a girl does become HPV
infected after becoming sexually active when she
gets older, she will have a very low risk of becoming
chronically HPV infected. And if she becomes
chronically HPV infected, she will have an even lower
risk of developing cervical cancer unless she fails to
get regular pap smears. Because of routine pap
screening in America, there has been a 75 percent
decline in cervical cancer since the 1950's. Cervical
cancer now accounts for only one percent of all
cancers in American women.
Spending billions of dollars to vaccinate every 9
year old girl in America with an HPV vaccine which
has not been proven to be safe or necessary is
ridiculous.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
HealthWrap: Risks, Rewards and Rx's
United Press International, June 30, 2006
By DAN OLMSTED
UPI Senior Editor
WASHINGTON, June 30 (UPI) -- Two
developments this week -- the
recommendation of a new anti-cancer vaccine for
American girls, and new
warnings about an antibiotic's side effects -- show
how hard it is to get
the risk-benefit ratio exactly right.
Thursday, an advisory committee of the Centers
for Disease Control and
Prevention urged that all preteen girls get a three-
shot regimen of
Gardasil, the recently approved vaccine against
human papillomavirus (HPV),
which in turn is the most frequent cause of cervical
cancer.
The same day French drug maker Sanofi-aventis
added a warning about risk of
liver damage to its antibiotic Ketek, which treats
respiratory infections.
Ketek has been the focus of an unusual face-off
between the Food and Drug
Administration and U.S. Sen. Charles Grassley, R-
Iowa, and other
legislators. Grassley has been highly critical of the
FDA's oversight of the
drug.
In fact, Grassley went to the FDA headquarters -
- the first time he has done
that since 1983 -- to personally demand answers
after saying the agency
wouldn't make a fraud investigator available to
discuss an agency probe.
Problems with a clinical trial of the drug's safety
were outlined in a May
article in The Wall Street Journal.
A Sanofi official told the Journal this week
that "the medical benefits
outweigh the risk" of Ketek, even as the FDA
said, "We clearly now
understand that there is a risk of serious liver injury
with Ketek."
The risk from Gardasil, according to some critics,
is a moral hazard -- it
might tend to encourage premarital, and possibly
dangerous, sexual activity.
The advisory committee's recommendation means
that at least some -- and,
plausibly, most -- states will make it mandatory for
school attendance and
pay for those who can't afford it.
Colorado-based Focus on the Family told United
Press International's Mara
Gordon it is not opposed to the HPV vaccine for
individuals, but state
mandates prevent families from making the choice
themselves.
"This is not a disease that you're going to
communicate, transmit or
contract sitting in a classroom," said Linda Klepacki, a
sexual-health
analyst for Focus on the Family, a culturally
conservative organization.
"You really have to go out and get it."
While the FDA says the vaccine is very safe,
others are raising questions
about that as well. The National Vaccine
Information Center
(http://rs6.net/tn.jsp?t=lgdp5wbab.0.jcsy6wbab.oblmlwbab.2805&ts=S0196&p=http%3A%2F%2Fwww.nvic.org%2F),
a group that
favors choice and greater informed consent in U.S.
immunization policy,
issued a statement earlier in the week calling on the
CDC committee to
reject mandating the vaccine.
NVIC said clinical trials by manufacturer Merck
were inadequate.
"Merck and the FDA have not been completely
honest with the people about the
pre-licensure clinical trials," said NVIC president
Barbara Loe Fisher.
"Merck's pre- and post-licensure marketing strategy
has positioned mass use
of this vaccine by pre-teens as a morality play in
order to avoid talking
about the flawed science they used to get it
licensed. This is not just
about teenagers having sex, it is also about whether
Gardasil has been
proven safe and effective for little girls."
Merck, on the contrary, said the trials -- and the
FDA approval followed by
the CDC recommendation -- show its safety has been
established.
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~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
A New Vaccine for Girls, But Should It Be Compulsory?
The New York Times, July 18, 2006
By RONI RABIN
Around the time report cards came home this
spring, federal health officials approved another new
vaccine to add to the ever-growing list of
recommended childhood shots ? this one for girls and
women only, from 9 to 26, to protect them from
genital warts and cervical cancer.
One of my own daughters, who just turned 9,
would be a candidate for this vaccine, so I?ve been
mulling this over. A shot that protects against cancer
sounds like a great idea, at first. States may choose
to make it mandatory, though the cost for them to
do so would be prohibitive.
But let?s think carefully before requiring young
girls to get this vaccine, which protects against a
sexually transmitted virus, in order to go to school.
This isn?t polio or measles, diseases that are easily
transmitted through casual contact. Infection with
this virus requires intimate contact, of the kind that
doesn?t occur in classrooms.
Besides, we already know how to prevent
cervical cancer in this country, and we?ve done a
darn good job of it. In the war against cancer, the
battle against cervical cancer has been a success
story.
Why, then, did federal health officials recommend the
inoculation of about 30 million American girls and
young women against the human papillomavirus, a
sexually transmitted disease that in rare cases leads
to cervical cancer?
Vaccine supporters say that some 3,700
American women die of cervical cancer each year,
and close to 10,000 cases are diagnosed. Cervical
cancer has a relatively high survival rate, but every
death is tragic and treatment can rob women of their
fertility.
Still, you have to see the numbers in context.
Cervical cancer deaths have been dropping
consistently in the United States ? and have been
for decades.Cervical cancer has gone from being one of the top
killers of American women to not even being on the
top 10 list. This year cervical cancer will represent
just 1 percent of the 679,510 new cancer cases and
1 percent of the 273,560 anticipated cancer deaths
among American women. By contrast, some 40,970
women will die of breast cancer and 72,130 will die of
lung cancer.According to the American Cancer Society Web
site, ?Between 1955 and 1992, the number of cervical
cancer deaths in the United States dropped by 74
percent.? Think about it: 74 percent.
The number of cases diagnosed each year and
the number of deaths per year have continued to
drop, even though the population is growing.
cancers in the United States dropped by 4.5 percentFrom 1997 to 2003, the number of cervical
each year, while the number of deaths dropped by
3.8 percent each year, according to a government
Web site that tracks cancer trends, called SEER or
Surveillance, Epidemiology and End Results
(seer.cancer.gov/statfacts/html/cervix.html). This,
while many other cancers are on the rise.
If current trends continue, by the time my 9-year-old
daughter is 48, the median age when cervical cancer
is diagnosed, there will be only a few thousand cases
of the cancer in women, and about 1,000 deaths or
fewer each year, even without the vaccine.
The secret weapon? Not so secret. It?s the Pap
smear. A simple, quick, relatively noninvasive test
that?s part and parcel of routine preventive health
care for women. It provides early warnings of cellular
changes in the cervix that are precursors for cancer
and can be treated.
An American Cancer Society spokeswoman said
that most American women who get cervical cancer
these days are women who either had never had a
Pap smear or had not followed the follow-up and
frequency guidelines. So perhaps we could redirect
the public money that would be spent on this
vaccine ? one of the most expensive ever, priced at
$360 for the series of three shots ? to make sure all
women in the United States get preventive health
care.
Because even if you have the new vaccine,
which protects against only some of the viral strains
that may bring on cervical cancer, you still need to
continue getting Pap smears.
To be clear, I?m talking only about American women.
Sadly, hundreds of thousands of women worldwide
die of cervical cancer each year because they don?t
have access to Pap smears and the follow-up care
required. For them, and for American women at high
risk, the vaccine should be an option.
Black, Hispanic and some foreign-born women
are at higher risk, though rates have dropped
precipitously among blacks. Certain behavior ?
smoking, eating poorly, having multiple sexual
partners and long-term use of the pill, for example ?
are also associated with an increased risk. But most
people infected with the human papillomavirus clear it
on their own.
Vaccine supporters, including the American
Cancer Society, say the immunization will reduce
abnormal Pap test results, and the stress, discomfort
and cost of follow-up procedures and painful
treatments. That?s a strong argument for the vaccine.But vaccines carry
risks. In recent years, children
have been bombarded with new immunizations, and
we still don?t know the full long-term implications.
One vaccine, RotaShield, was removed from the
market in 1999, just a year after being approved for
infants.
Merck has tested the cervical cancer vaccine in
clinical trials of more than 20,000 women (about half
of them got the shot). The health of the subjects
was followed for about three and a half years on
average. But fewer than 1,200 girls under 16 got the
shots, among them only about 100 9-year-olds,
Merck officials said, and the younger girls have been
followed for only 18 months.
Public health officials want to vaccinate girls
early, before they become sexually active, even
though it is not known how long the immunity will
last.
But girls can also protect themselves from the
human papillomavirus by using condoms; a recent
study found that condoms cut infections by more
than half. Condoms also protect against a far more
insidious sexually transmitted virus, H.I.V.
So yes, by all means, let?s keep stamping out
cervical cancer. Let?s make sure women and girls get
Pap smears.
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~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
A Shot, Or Not: Sorting Out the Facts on New HPV Vaccine
The Washington Post, July 18, 2006
By January W. Payne
Washington Post Staff Writer
Last month's recommendation by the Centers for
Disease Control and Prevention (CDC) that all women
and girls ages 9 to 26 receive a new vaccine against
a common sexually transmitted infection is generating
questions to physicians, as women decide whether to
get a shot that experts say could dramatically reduce
the incidence of cervical cancer.The new vaccine targets HPV, or the
human
papillomavirus, the most common sexually transmitted
infection in the country and the cause of nearly all
cervical cancers. While doctors say most of the
questions they are hearing concern the vaccination
of children, some women are also asking if they
should be vaccinated and why."Many of the patients I see have already
had an
abnormal Pap" test, which is used to detect cervical
cancer, said Kenneth Noller, chairman of the
Department of Obstetrics and Gynecology at Tufts
University School of Medicine. "And their question
is, 'Does it make sense for me to be immunized?' "We posed that
question and others to experts
including Noller and the vaccine manufacturers.
Here's what we learned:How serious a problem is HPV?
Fifty to 75 percent of people who have ever had sex
will get HPV, according to the American Cancer
Society (ACS); nearly half of those cases will occur
in people ages 15 to 25.There are more than 100 types of HPV, which
infects
cells that line the surfaces of the cervix, vagina, skin,
anus, vulva, mouth, throat and the head of the
penis; about 30 types infect the genital area. While
most genital HPV infections are cleared by the
immune system -- usually causing no signs or
symptoms -- some infections persist and cause
genital warts, precancers and cancers of the cervix,
and other types of cancer. About 70 percent of HPV
infections resolve -- that is, go away -- within a
year; 90 percent disappear within two years,
according to the ACS. There are no treatments
available to cure HPV infections, though there are
methods used to treat cervical cell abnormalities
caused by the virus.Doesn't the Pap test detect cervical cancer? Why
do I need a vaccine?
You need both, say experts. The Pap test
detects cervical cancers -- including the small
percentage that aren't caused by HPV -- and
abnormal cells in the cervix, which could turn into
cancer over time, according to the CDC. If abnormal
changes are seen, women can be treated early to
prevent cancer from developing; if cervical cancer is
caught early, treatment is more likely to be
successful.There are an average of 9,710 new diagnoses of
cervical cancer and 3,700 deaths from the disease in
the United States each year, according to the CDC.
Medical experts hope the HPV vaccine will help
prevent many of these cancers from occurring.Who should be immunized?
Ideally, the vaccine should be given before
females have sex for the first time, because almost
any sexual encounter carries a risk of infection,
according to the CDC's Advisory Committee on
Immunization Practices. The committee recommended
that the vaccine routinely be given to girls age 11 or
12, because girls receive other vaccinations at that
age. The recommendation also allows for females as
young as 9 or as old as 26 to get the vaccine.Is just one type of HPV
vaccine available?
For now, yes. The Food and Drug Administration
(FDA) approved Gardasil, made by Merck, last month.
Cervarix, made by GlaxoSmithKline, is still undergoing
clinical trials; the company says it hopes to apply for
FDA approval by the end of the year.
Gardasil protects against four HPV types -- 16, 18, 6
and 11. Types 16 and 18 together account for about
70 percent of all cervical cancers; types 6 and 11
cause about 90 percent of genital warts cases. The
vaccine has been shown to be nearly 100 percent
effective in protecting against those four HPV strains
and is considered safe and largely free of side effects.
Cervarix is designed to protect against types 16 and
18 and may provide cross-protection -- that is, it
may protect against other HPV strains in addition to
the strains it's designed to target.Are there protective options for me
if I'm older
than 26?
Not yet -- but stay tuned. Merck is testing Gardasil
in women up to age 45; Cervarix has shown promise
in women up to age 55.
Does it do me any good to be immunized if I've
already had HPV or if I have it now?
Women up to age 26 should be vaccinated
regardless, advises the CDC committee. That's partly
because experts aren't certain whether having had
one strain of the virus gives you total immunity
against reinfection by that strain. Also, getting the
shot will protect you against any of the included
strains that you haven't had already, according to
Richard M. Haupt, executive medical director at
Merck.
The CDC committee recommended immunization
for women previously infected with HPV despite
conflicting findings on the likelihood of their
developing cervical lesions. In one of Merck's studies,
previously infected women who received the vaccine
had higher rates of precancerous lesions than those
in the placebo group; in two other studies, previously
infected women in the vaccine group had slightly
lower rates of precancerous lesions than did those in
the placebo group.
Because most people will get HPV at some time --
though they may never be aware of it -- routine
testing for the virus is not recommended. A DNA test
for the virus is FDA-approved for women older than
30; the test is also approved for women of any age
whose Pap tests show abnormalities.
How many shots are involved, and over what
time period are the shots administered?
Gardasil is given as three shots over a six-month
period.
How long am I protected once I've had the
shot?
No one is sure, but Gardasil appears to remain
effective for at least five years, according to Merck.
Cervarix has been shown to keep working for four
years, according to research published in The Lancet
in April. Longer-term studies need to be carried out
to see if booster shots are needed later in life.
I hear the vaccine is expensive. Are there
any options if I don't have insurance to help me pay
for it?
You're right, the vaccine isn't cheap. The three
shots included in Gardasil cost $360 Insurance
companies are expected to begin covering the
vaccine for those in recommended age groups within
months, according to Merck.
The CDC's Vaccines for Children program will
include the HPV vaccine, making it available to
uninsured kids and to children whose insurance
doesn't cover vaccines. To aid those 18 and over,
Merck has a program under development that will
make the vaccine available to lower-income
adults.
Don't men and boys need to be vaccinated, too?
That would seem to make good sense, said
Noller, to further limit the spread of the virus and to
prevent rare cancers caused by the virus in men.
Both vaccine manufacturers plan to study their
vaccines for use in males, but at this point, they are
only approved for women and girls. There is currently
no approved method to test for HPV in men, and no
tests are approved for early detection of HPV-linked
cancers in men, reports the ACS. ·
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~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Steep Learning Curve for HPV Vaccine?
United Press International, July 11, 2006
By CHRISTINE DELL'AMORE
UPI Consumer Health Correspondent
WASHINGTON, July 11 (UPI) -- A new vaccine
protecting against viruses
responsible for cervical cancer, which becomes
available this fall for
adolescent girls, may face difficulties integrating into
existing
healthcare, experts said Tuesday.
The vaccine, Gardasil, protects against two
types of the sexually
transmitted human papillomavirus (HPV): 16 and 18,
which together cause 70
percent of cervical-cancer cases. In June the federal
Advisory Committee on
Immunization Practices recommended the vaccine be
given to 11- and
12-year-old girls, before they become sexually
active.
"This is a tough population to vaccinate -- it's
going to require very
unique approaches," said Dr. Thomas Wright, a
pathology professor at
Columbia University, during a World Cancer Congress
symposium.
In general, young adolescents have less access
to medical care than children
and infants, Wright said. Although vaccination visits
are recommended for
this age group, many pediatricians do not stress the
importance of an
adolescent visit.
It's also challenging to immunize adolescents
before first sexual activity,
which averages 16 in the United States. Studies have
shown about 50 percent
of girls will become exposed to HPV within three years
after onset of sexual
activity, allowing a narrow window for
vaccination.
In the European Union, school-based health clinics
have been overwhelmingly
successful in administering the Hepatitis B vaccine to
kids, reaching more
than 80 percent of students. However, since the
ACIP panel did not make
Gardasil mandatory to enter school, this approach is
unlikely to occur in
the United States.
To encourage the vaccine's adoption,
pediatricians may not describe the
vaccine as an anti-STD vaccine but rather a cancer-
prevention measure,
Wright said.
Since the vaccine's announcement, much
attention has centered around
conservative groups worried that an anti-STD
vaccine could encourage
promiscuous behavior.
But Wright told United Press International people
should be careful not to
overplay opposition to the vaccine, and parents
should be aware it is an
effective choice.
The vaccine has shown "spectacular results,"
and the side effects seem
negligible, he added.
"Every mother in America should consider
vaccinating her daughter against
this," he said.
Gardasil can be administered to women up to 26,
as not all those who are
sexually active will get HPV immediately.
Although the vaccine currently
shows no benefit for women who have already had
the HPV virus, studies are
under way to find out whether the vaccines could
prevent future infections.
Twenty million American adults carry an HPV
virus at any given time. Most of
the infections clear without harm, but a few become
cancerous, usually after
a 10- to 15-year time lag. About 3,700 women die of
cervical cancer yearly
in the United States; about 273,000 women die of
the disease worldwide, over
half of them in the developing world.
Wright also emphasized women should not halt
cervical-cancer screening, or
Pap smears, once vaccinated. The duration of the
vaccine's protection may
wane, and it does not protect against 30 percent of
cervical cancers not
caused by HPV 16 and 18.
Likewise, testing for the presence of HPV alone
is unlikely to be useful,
Wright said. Much of the technology is not widely
available or sensitive
enough to detect all HPV infections.
In developing countries, a major focus of the
symposium, cervical cancer is
the leading cause of cancer death -- mostly because
women are not screened
through routine Pap smears.
Although childhood immunizations are common
and successful in these nations,
an HPV vaccine will experience competition from
other vaccines perceived to
be life-saving, said Dr. Nathalie Broutet of the World
Health Organization's
Reproductive Health and Research Department.
Overall, an immunization to prevent cancer
should be heralded, said Dr. Mark
Kane, former director of the Children's Vaccine
Program at the Seattle-based
Program for Appropriate Technology in Health.
"This is one of the major medical achievements
of this century," Kane said.
"We ought to be excited to be at the beginning of a
discovery of this
magnitude."
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