Vera--Mandatory Gardasil Produces Backlash_USA Today Editorial / NYT Letters

Subject: 
Vera--Mandatory Gardasil Produces Backlash_USA Today Editorial / NYT Letters
Posted By: 
TNT MadDog
Date: 
Sunday, February 11, 2007 08:44 pm

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
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FYI

\"American schoolgirls have the right to a free education without
being
forced into a new and controversial vaccination program.
What kind of people supply schoolgirls to a pharmaceutical
company, allowing
it to earn millions a year on [vaccine] mandates?\"
(Elizabeth Beiter, NYT letter)

An editorial in USA Today (below) criticizes Texas Gov. Rick
Perry who \"is
so enthusiastic about Gardasil that a week ago, he ordered all
girls in the
state to be immunized before entering sixth grade, as of
September 2008.
(Parents can opt out for religious and other reasons.)\"

USA Today correctly notes that the move was \"prompted in part by
a vigorous
lobbying campaign by Merck, which stands to earn billions of
dollars if the
vaccine is required.\" Conflicts of interest involving Texas
governor Perry
were reported
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ndeed.

Merck invested heavily in lobbying efforts--including funding
Women in
Government, an organization of state legislators--as reported by
The Wall
Street Journal
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Those lobbying efforts have been dubbed the \"Help Pay for Vioxx\"
litigation
campaign.

USA Today cites scientific uncertainty about the vaccine\'s
safety, noting
FDA\'s poor performance in tracking adverse effects--as
demonstrated by the
catastrophe caused by Merck\'s pain killer, Vioxx ; failure to
debate the
issue; the nature of the disease which, unlike communicable
diseases such as
polio or smallpox, is not spread by casual contact. Therefore,
there is no
justification for mandating the vaccine rather than allowing
parents to make
the decision for their daughters.
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Below is Rick Perry\'s defense of his position.

In sharp contrast to the USA Editorial and the report in The Wall
Street
Journal, an editorial in The New York Times, \"A Vaccine to Save
Women\'s
Lives\" (Feb. 6) extolled both the vaccine and the governor for
his mandatory
order.

The Times\' editorial reflects an ideological faith-based belief
rather than
a reasoned appraisal of scientific evidence.

Five letters to the editor in today\'s Times expressed
disagreement with that
embarrassing editorial.
One of these letters from Deborah Kamali, M.D., a professor of
obstetrics
and gynecology at the University of California, San Francisco,
delivers a
knock out to the governor:
\"Most deaths from cervical cancer in this country are in women
who are not
adequately screened (with a simple Pap smear). In Texas,
underscreening in
African-American and Hispanic women probably accounts for their
disproportionately high rates of cervical cancer.\"

The Times owes its readers an in-depth report about the science
and politics
that drive Merck\'s frenzied marketing of a vaccine that will
hardly make a
dent in saving lives and may, possibly, increase deaths if it
leads women to
believe Merck\'s marketing hype.

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

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USA TODAY
Rush to require cancer shot threatens to promote backlash
Fri Feb 9, 6:59 AM ET

Thanks to vaccines, devastating diseases such as smallpox and
polio have
been virtually eradicated in the USA. That wouldn\'t have happened
if states
hadn\'t required immunizations for serious contagious viruses
before a child
can attend school.

Now there\'s a new vaccine, one with potential to prevent cervical
cancers
that kill 3,700 women each year in the USA and 300,000 worldwide.
Called
Gardasil, it is manufactured by Merck & Co. and was approved in
June by the
U.S. Food and Drug Administration.

Texas Gov. Rick Perry is so enthusiastic about Gardasil that a
week ago, he
ordered all girls in the state to be immunized before entering
sixth grade,
as of September 2008. (Parents can opt out for religious and
other reasons.)
Prompted in part by a vigorous lobbying campaign by Merck, which
stands to
earn billions of dollars if the vaccine is required, legislators
in 23 other
states and the District of Columbia have proposed mandating
vaccination
against HPV for girls as young as 11.

Gardasil may well be the huge medical breakthrough it appears to
be. But a
rush to make it mandatory, less than eight months after FDA
approval, could
have detrimental consequences. Among the reasons to move more
deliberately:

.Scientific uncertainty. The history of new drugs and vaccines is
that
unexpected adverse events might not be detected until after
millions of
people have used them, and the FDA does a poor job of tracking
post-approval
effects.

Merck\'s Vioxx, a blockbuster painkiller drug, was withdrawn in
2004, five
years after it was introduced, after studies revealed significant
heart
risks. A vaccine made by Wyeth, to prevent a highly contagious
rotavirus
that can cause severe diarrhea and vomiting in children, was
withdrawn in
1999, just over a year after it was approved, because of safety
concerns.

So far, every indication is that Gardasil, the world\'s first
anti-cancer
vaccine, has only rare and minor side effects. Clinical trials of
more than
11,000 females ages 9 to 26 showed it was 100% effective in
preventing
cervical cancers linked to two types of human papillomavirus
(HPV), a
sexually transmitted disease. But no one will know the complete
picture
until more people are vaccinated for more time. At the moment,
Gardasil is
so new that scientists aren\'t sure how long it\'s effective for.

.Public unawareness. Little public education about the HPV
vaccine has
occurred. Support appears strong, but 25% of parents in a recent
California
study expressed reservations. Mandating Gardasil now could spark
an
anti-vaccine backlash that would result in fewer girls getting
immunized
against cervical cancer and other diseases. Perry\'s executive
order
short-circuited a legislative debate that could have convinced
many Texans
of the vaccine\'s merits.

.Nature of the disease. HPV is spread only by intimate sexual
contact. It
isn\'t in the same class of contagious diseases such as measles,
mumps and
diphtheria that can spread easily to children in the classroom.
Because some
parents are uneasy about vaccinating pre-teens for a sexually
transmitted
disease, the issues need to be handled delicately.

With more public education and real-life experience, these qualms
may soon
be overcome and the vaccine may well deserve to be included on
lists of
required immunizations.

For now, however, making it mandatory is premature. The vaccine
ought to be
available, at an affordable price, to everyone who wants it after
consulting
with a doctor. But sometimes, promotion of a medical advance can
move too
fast for its own good.
~~~~~~~~~~~~

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tm
My order protects life
Updated 2/8/2007 9:07 PM ET
By Rick Perry

As governor of Texas, I will do everything in my power to protect
public
health. The executive order I signed last Friday will help stop
the spread
of human papillomavirus (HPV) and prevent cervical cancer in
young women.

\\Some are focused on the cause of this cancer, but I remain
focused on the
cure. And if I err, I will always err on the side of protecting
life.
OUR VIEW: Rush promotes backlash

For the first time in history, a vaccine exists that can prevent
a deadly
cancer - the second most common form of cancer in women. The HPV
vaccine is
approved by the U.S Food and Drug Administration and the Centers
for Disease
Control and Prevention, and a second vaccine is expected on the
market
within the next year.

Research shows that the HPV vaccine is highly effective in
protecting women
against the four leading cancer-causing strains of HPV. Though
some might
argue that we should wait several years before requiring the
vaccine, I
believe such a delay unnecessarily risks the lives of young
women.
This is not the first vaccine Texas has required for a
non-contagious
disease. Years ago, Texas required inoculations to prevent the
spread of
Hepatitis B, spread primarily through sexual contact or shared
needles.

Even with this new requirement, parents can still choose to opt
out. But we
will never eradicate a disease that impacts 20 million Americans
with an
\"opt in\" provision because statistics show only one-quarter of
the eligible
population gets inoculated in such circumstances. The \"opt out\"
provision -
standard for all Texas vaccinations -will help us protect
three-quarters of
our young women.

Parents will still have the final word, and a full debate will
take place as
our health agency adopts implementation rules before the order
takes effect
in 19 months. And if Texas legislators want to debate and pass a
different
vaccine law, there is nothing standing in their way.
If we could stop lung cancer, would some shy away claiming it
might
encourage tobacco use? This is a rare opportunity to act, and as
a pro-life
governor, I will always take the side of protecting life.

Rick Perry, a Republican, is governor of Texas.

Copyright C 2007 USA TODAY, a division of Gannett Co. Inc
.

February 10, 2007
Requiring a Vaccine for Young Girls (5 Letters)
To the Editor:

Re \"A Vaccine to Save Women\'s Lives\" (editorial, Feb. 6):

I disagree with your suggestion that other states besides Texas
would be
wise to require the vaccination against the human papillomavirus,
or HPV
infection, a sexually transmitted virus that causes cervical
cancer.

Although I realize that this breakthrough could greatly reduce
the number of
cervical cancers, mandating the vaccination is a lawsuit waiting
to happen.

Because this is a new vaccine, some parents may be skeptical of
the
long-term side effects. What will happen 10, 20 or 30 years from
now may not
yet be known.

Although you note the \"opt out\" approach taken by Gov. Rick Perry
of Texas
in which vaccination is required but parents can seek an
exemption for
reasons of conscience or religious beliefs, recommending the
vaccine rather
than requiring it could prove to be just as effective without
violating the
parents\' right to decide affirmatively - at least until the
long-term
effects are known.

Amanda Styron
Raleigh, N.C., Feb. 7, 2007

.
To the Editor:

As desirable a thing as it may be to protect people from cervical
cancer, a
noncommunicable disease, it is a usurpation of government
authority to
dictate medical decisions that only individuals may make.

Schools may rightfully require that children undergo
immunizations that will
protect schoolwide populations from acquiring communicable
diseases, but
cervical cancer does not fall into this category.

However benevolent the intent, this is not a matter for Big
Brother.

Alan Katz
East Meadow, N.Y., Feb. 6, 2007

.
To the Editor:

I was surprised to see how quickly you expressed support of the
proposed
mandatory HPV vaccination policy in Texas, stating that the Merck
vaccine is
\"highly effective\" (editorial, Feb. 6).

The vaccine has not been proved to reduce cervical cancer. It is
moderately
effective at preventing certain pre-cancerous changes. There is
no long-term
safety or effectiveness data.

Most deaths from cervical cancer in this country are in women who
are not
adequately screened (with a simple Pap smear). In Texas,
underscreening in
African-American and Hispanic women probably accounts for their
disproportionately high rates of cervical cancer.

These adult women need access and coverage for screening.
Unfortunately,
there is no lobby for the Pap smear.

Deborah Kamali, M.D.
San Francisco, Feb. 6, 2007
The writer is an associate professor of obstetrics, gynecology
and
reproductive sciences at the University of California at San
Francisco.

.
To the Editor:

Women, young and less so, are infected with the human
papillomavirus by men,
young and less so.

Compulsory vaccination has a legitimate place in our health care
system. But
why should the government restrict its vaccinations to the
victims? Why not
include the carriers?

Sue Abercrombie
Portland, Me., Feb. 6, 2007

.
To the Editor:

American schoolgirls have the right to a free education without
being forced
into a new and controversial vaccination program.

Does the vaccine help young teenagers with multiple sexual
partners cope
with unplanned pregnancy, other sexually transmitted diseases,
sexual
assault, drug abuse, low self-esteem, boredom and depression?

Texas will pay hundreds of dollars per girl for the vaccination.
Why not
spend the money on health care, education about teenagers\' bodies
and
rights, enriching music, dance, art and science programs that
engage,
increase confidence and provide an alternative to sexual
activity?

What kind of people supply schoolgirls to a pharmaceutical
company, allowing
it to earn millions a year on such mandates?

Elizabeth Beiter
Milford, Conn., Feb. 6, 2007