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SCIENCE-FOR-THE-PEOPLE  February 2007

SCIENCE-FOR-THE-PEOPLE February 2007

Subject:

Re: Merck Suspends Lobbying for Vaccine

From:

Mitchel Cohen <[log in to unmask]>

Reply-To:

Science for the People Discussion List <[log in to unmask]>

Date:

Mon, 26 Feb 2007 02:05:30 -0500

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (483 lines)

I have read nothing that says there is a direct
cause and effect relationship between HPV and cervical cancer.

Gardasil is a corporate money-making scam from
beginning to end. Listen to Meerck's ads. It's
based on scare tactics with disclaimers that it
doesn't necessarily prevent all (i.e. your)
cancer. Absolutely disgraceful, no, criminal,
that they are targeting young women.

Merck is claiming Gardasil will protect young
girls and women from four strains of human
papillomaviruses, *which in some cases is believed* to lead to cervical cancer.

I have yet to see anything, including the Merck
commercials, that actually state that a
cause/effect relationship has been shown.

No mention anywhere of the relationship between
cervical cancer and environmental toxins and pesticides.

In previous comments, Michael Balter stated that
these concerns and those of Jonathan's were
"parodies of what a discussion by progressives of
the cervical cancer controversy might look like."
Thank Marx that thousands of parents across the
country rejected Michael Balter's ridicule and
took these concerns seriously, creating a
movement that blocked the mandatory vaccination
of pre-teen and early teen girls.

In reality, Meerck rushed through the H.P.V.
vaccine to help pay for its Vioxx losses. Vioxx,
the painkiller taken off the market in 2004
because it was linked to cardiovascular problems, was also made by Merck.

I repeat a few sentences that I posted at the
beginning of our debate about this that have gone unanswered:

The claim is being made that the research studies
themselves were tainted. (Why Michael Balter has
not commented on this is fascinating, since it is easy enough to check.)

We are told that 90 percent of the people in the
control group were not given true placebos, but
actually "given injections containing an aluminum
salt adjuvant (vaccine enhancer) that is also a
component of GARDASIL. ... Alum adjuvants are
suspected to be responsible for Gulf War disease
and other possible vaccination-related complications."

So basically the claim here is that the number of
women in the control group developing genital
warts was INCREASED BY THE SO-CALLED PLACEBO.
This is a very serious claim -- if this turns out
to be true, it is astounding, as is the assertion
that NONE (ZERO) of the women in the control
group actually developed cervical cancer. In that
case, the comparison is totally flawed and there
would zeno basis for this vaccine whatsoever! The
author writes that "this vaccine’s supposed
efficacy is based on the fact that the vaccinated
group ended up with far fewer cases (5 vs. about
200) of genital warts and “precancerous lesions”
(dysplasias) than the alum injected “control” subjects."

FURTHERMORE, NOT A SINGLE SUBJECT IN THE CONTROL
GROUP ACTUALLY CONTRACTED CERVICAL CANCER, MUCH
LESS DIED OF IT. So it cannot be said that X
numbers died of cervical cancer from the control
group, while Y numbers died from cervical cancer
in the Gardasil group. Instead, this vaccine’s
supposed efficacy is based on the fact that the
vaccinated group ended up with far fewer cases (5
vs. about 200) of genital warts and “precancerous
lesions” (dysplasias) than the alum injected
“control” subjects. The MOST that can be said of
this vaccine is that it reduces genital warts --
but even there, because of the tainted Control Group, even that is not clear.

Because the tests included just four years of
follow up at most, the long term effects and
efficacy of this vaccine are completely unknown
for anyone. All but the shortest term effects are
completely unknown for little girls. Considering
the tiny size of youngster study, the data about
the short term side effects for girls are also dubious.

Even if we subscribe to the theory that HPV
causes cervical cancer, there is ZERO hard data
from Meerck's own study showing that this vaccine
reduces cervical cancer rates or cervical cancer mortality rates.

***********************************
Now, let's talk about what it means to inoculate CHILDREN with this vaccine.

Reported Adverse Events from the Gardasil Vaccine
Human Papilloma Virus Vaccine Safety

Analysis of Vaccine Adverse Events Reporting System Reports:
Adverse Reactions, Concerns and Implications

(Report from National Vaccine Information Center)

On June 8th 2006, the Food and Drug
Administration (FDA) announced the approval of
GARDASIL, and on June 29th the Advisory Committee
on Immunizations Practices (ACIP) voted to
recommend adding GARDASIL human papilloma virus
vaccine to the Centers for Disease Control's
national childhood recommended immunization
schedule. On July 14th the first report of a
serious reaction to the vaccine was filed with
the federal Vaccine Adverse Event Reporting System (VAERS).

A 16-year-old Illinois girl was vaccinated July
7th and 13 days later developed symptoms
eventually diagnosed as Guillian-Barre Syndrome.
A 14-year-old girl in the District of Columbia
was vaccinated on July 11th and complained of
severe pain immediately following the injection,
fell off the examining table and experienced a 10
to 15 second fainting spell ending up in the
emergency room with a headache and speech
problems. The report of this reaction, the first
in the nation, was filed on July 14th, 15 days after the ACIP vote.

Six months later, 82 reports of GARDASIL
reactions have been submitted to VAERS on behalf
of at least 84 young girls and 2 boys.[1]
Reaction reports have come in from 21 states and
the District of Columbia.[2] Reactions were
reported for children and young adults ranging in
age from 11 to 27. Of the reports indicating what
day the vaccine was given and the reaction
occurred, 63 percent stated that the reaction
occurred the same day the vaccine was given. All
but three of the reports were for reactions that
occurred within one week of vaccination.

This document is divided into three sections. The
first section describes reaction reports for a
number of reported adverse events: neurological
symptoms including syncopal episodes and
seizures, arthralgia and joint pain,
Guillian-Barre Syndrome, and other immunological
reactions. The second section addresses concerns
related to vaccinating individuals already
infected with HPV. The last section discusses
issues that need to be addressed by government
regulators and the manufacturer and
considerations for clinicians and consumers.

Reported Adverse Events

Presumably, the reactions described below
occurred after the first dose of GARDASIL.
GARDASIL is given in a three-dose series. None of
the reports stated that the children and adults
experiencing problems had previously been vaccinated with GARDASIL.

Syncopal Episodes and Seizures. One-quarter of
all reports filed after GARDASIL vaccination were
for neurologic adverse events including loss of
consciousness, syncope, syncopal events and
seizures. An additional five reports included
symptoms of dizziness and feeling faint.

Syncope is defined as a temporary suspension of
consciousness due to generalized cerebral
ischemia (inadequate blood flow and lack of
oxygen). The reports of syncopal episodes and
their descriptions are remarkable. A physician
from Washington State reported that in one
morning, three patients experienced syncopal
episodes. On August 8th another physician's
office reported that two patients experienced
syncopal episodes on the same day.

Although these reports did not detail what
happened to the individuals experiencing these
syncopal episodes, other reports did. The
14-year-old DC girl mentioned earlier experienced
a syncopal episode combined with amblyopia (poor
vision in one eye), abnormal speech, vomiting, and headache.

Also experiencing vision problems, a 17-year-old
New York girl reported feeling dizzy and her
vision went "black for a few seconds" and she
turned pale and lips turned purple and she also
had fever and chills. Similar to the DC girl, on
July 18th immediately after being vaccinated, a
22-year-old Kentucky woman experienced slurred
speech accompanied by pallor and shock.

On August 29th, two hours after being vaccinated,
a 15-year-old New York girl who had a history of
asthma and was on four asthma medications
experienced difficulty swallowing prompting a
visit to the emergency room. On August 17th, 15
minutes after being vaccinated, a 14-year-old
Pennsylvania girl passed out in the car on the way home.

Most of the reports do not describe what happened
as a result of the syncopal episode but a few do.
One 11-year-old Florida girl fell from the
examining table and two Washington girls fell - a
16-year-old girl fell and hit her head on a
carpeted concrete surface and a 14-year-old girl fell down and broke her nose.

Whether the 22 girls who experienced syncopal
episodes actually experienced atonic seizures
cannot be determined from these reports. Four
girls, however, displayed observable seizure
activity. The 11-year-old Florida girl who fell
from the table also displayed "tonic posturing."
Tonic posturing is a type of seizure where
sustained contraction of muscles in the legs and
arms occurs and consciousness is impaired.

The 16-year-old Washington girl who fell and hit
her head on the floor lost consciousness for one
minute and displayed tonic posturing of her right
hand. Additionally, a 15-year-old girl from
Virginia was described as having "a mild
seizure." In California, a 13-year-old girl was
walking down the hall after her vaccination, fell
and had a 15-second tonic/clonic seizure.
Tonic/clonic seizures are also known as "grand mal" seizures.

Additionally, there were reports of dyskinesia
(difficulty or distortion in performing voluntary
movements) and hypokinesia (slow or diminished
movement of the body musculature) both of which have neurological implications.

Arthralgia, Joint Pain and Fever. Arthralgia is
defined as pain in the joints. Concerns about
arthritis were raised during the GARDASIL
clinical trials. Reports of arthralgia in one or
more joints accompanied by fever were noted in
five instances from four young girls and women in
Wisconsin, Texas and New York, and one 18-year-old New York male.

Guillain-Barre Syndrome. Reports state that two
recently vaccinated 16-year-old girls - one from
Illinois and the other from Mississippi - were
diagnosed with Guillian-Barre Syndrome (GBS)
following vaccination with GARDASIL. In both
cases, the onset of symptoms occurred 13 days
after vaccination. According to the National
Institute for Neurological Disorders and Stroke:

GBS is a serious disorder in which the body's
immune system attacks part of the peripheral
nervous system. The first symptoms of this
disorder include varying degrees of weakness or
tingling sensations in the legs. In many
instances, the weakness and abnormal sensations
spread to the arms and upper body. These symptoms
can increase in intensity until certain muscles
cannot be used at all and, when severe, the
patient is almost totally paralyzed. …
Vaccinations can trigger onset of GBS.[3]

The Illinois girl described earlier was
vaccinated on July 7th and symptoms were evident
by July 20th. The girl also experienced gait
abnormalities (trouble walking properly),
asthenia (weakness without loss of strength),
paresthesia (burning, prickling, tingling or
numbness sensation usually felt in the hands,
arms, feet and legs), and hyperkinesia (abnormal
increase in muscle movement). The Mississippi
girl was vaccinated on July 31st and by August
13th she had increasing numbness and tingling in
her feet and hands and was subsequently evaluated
by a neurologist and diagnosed with GBS. The
current health status of these girls is not known.

In both of these cases, the girls were also
vaccinated with Aventis Pasteur's Menactra, a
vaccine for meningococcal infections. Menactra
has previously been associated with
Guillain-Barre Syndrome, and the FDA and others have issued alerts.

Other Adverse Reactions.

Additionally, a number of other reactions to
GARDASIL are noted in VAERS reports and they
include: urticaria (hives); pruritus (itching);
macular and papular rashes; blisters and vesicles
near the injection site; swollen arms;
lymphadenopathy (swollen lymph nodes); red, hot
swollen knots at injection site; burning,
stabbing, severe and radiating pain at the
injection site and in the affected limb during
and after injection; nausea and vomiting;
infections and skin ulcers, and other allergic reactions.


To read the rest of this report go to
http://www.909shot.com/Diseases/HPV/HPVrpt.htm

- Mitchel Cohen



At 01:15 AM 2/26/2007, Michael Balter wrote:
>This article makes clear that there are
>conflicting factors at play. 3700 deaths per
>year from cervical cancer (in the US) is more
>than died in 9/11, so I don't think anyone could
>claim that this is negligible. And the arguments
>of conservatives and the religious right amount
>to justifying a possible death sentence for
>girls who engage in sex that they do not approve
>of (the same argument will be made if there is
>ever an AIDS vaccine.) On the other hand, Merck
>obviously stands to make a lot of money from
>this so no surprise that they have been
>lobbying. I don't know what the death rates from
>cervical cancer are in poorer countries, but if
>they are indeed very high then perhaps Merck
>should be pressured to provide Gardasil for very
>cheap in those countries as the price for making
>its investment back in relatively rich
>countries. Just a thought. And btw, there is no
>question that HPV infection is the major risk
>factor for cervical cancer, so a vaccine is the
>only realistic way to prevent it, no matter who makes it.
>
>Michael
>
>On 2/25/07, Phil Gasper
><<mailto:[log in to unmask]>[log in to unmask]> wrote:
><http://www.washingtonpost.com/wp-dyn/content/article/2007/02/21/AR20>http://www.washingtonpost.com/wp-dyn/content/article/2007/02/21/AR20
>07022100221.html
>
>Merck Suspends Lobbying for Vaccine
>
>By LINDA A. JOHNSON
>The Associated Press
>Wednesday, February 21, 2007; 7:52 AM
>
>TRENTON, N.J. -- Pediatricians, gynecologists
>and even health insurers all call Gardasil, the
>first vaccine to prevent cervical cancer, a big medical advance.
>
>But medical groups, politicians and parents
>began rebelling after disclosure of a
>behind-the-scenes lobbying campaign by
>Gardasil's maker, Merck & Co., to get state
>legislatures to require 11- and 12-year-old
>girls to get the three-dose vaccine as a requirement for school attendance.
>
>Some parents' groups and doctors particularly
>objected because the vaccine protects against a
>sexually transmitted disease, human papilloma
>virus, which causes cervical cancer. Vaccines
>mandated for school attendance usually are for
>diseases easily spread through casual contact, such as measles and mumps.
>
>Bowing to pressure, Merck said Tuesday that it
>is immediately suspending its controversial
>campaign, which it had funded through a third party.
>
>"Our goal is about cervical cancer prevention,
>and we want to reach as many females as possible
>with Gardasil," Dr. Richard M. Haupt, Merck's
>medical director for vaccines, told The Associated Press.
>
>"We're concerned that our role in supporting
>school requirements is a distraction from that
>goal, and as such have suspended our lobbying
>efforts," Haupt said, adding the company will
>continue providing information about the vaccine
>if requested by government officials.
>
>Whitehouse Station-based Merck launched
>Gardasil, the first vaccine to prevent cervical
>cancer, in June. It protects against the two
>virus strains that cause 70 percent of cervical
>cancer and two strains that cause most genital warts.
>
>Sales totaled $235 million through the end of 2006, according to Merck.
>
>Last month, the AP reported that Merck was
>channeling money for its state-mandate campaign
>through Women in Government, an advocacy group
>made up of female state legislators across the country.
>
>Conservative groups opposed the campaign, saying
>it would encourage premarital sex, and parents'
>rights groups said it interfered with their control over their children.
>
>Even two of the prominent medical groups that
>supported broad use of the vaccine, the American
>Academy of Pediatricians and the American
>Academy of Family Practitioners, questioned Merck's timing, Haupt said Tuesday.
>
>"They, along with some other folks in the public
>health community, believe there needs to be more
>time," he said, to ensure government funding for
>the vaccine for uninsured girls is in place and
>that families and government officials have enough information about it.
>
>Legislatures in roughly 20 states have
>introduced measures that would mandate girls
>have the vaccine to attend school, but none has
>passed so far. However, Texas Gov. Rick Perry on
>Feb. 2 issued an executive order requiring Texas
>girls entering the sixth grade as of 2008 get
>the vaccinations, triggering protests from
>lawmakers in that state. Parents there could opt
>out for their daughters if they state religious
>or philosophical objections, but several Texas
>lawmakers want to have parents opt in instead of opting out.
>
>Perry defended his order Tuesday, a day after
>lawmakers in Austin held a lengthy hearing on
>the issue but failed to act on a bill to override the order.
>
>Dr. Anne Francis, who chairs an American Academy
>of Pediatrics committee that advocates for
>better insurer reimbursement on vaccines, called
>Merck's change of heart "a good move for the public."
>
>"I believe that their timing was a little bit
>premature," she said, "so soon after
>(Gardasil's) release, before we have a picture
>of whether there are going to be any untoward side effects."
>
>Given that the country has been "burned" by some
>drugs whose serious side effects emerged only
>after they were in wide use, including Merck's
>withdrawn painkiller Vioxx, Francis said, it
>would be better to wait awhile before mandating Gardasil usage.
>
>She said she also was concerned about requiring
>a vaccine for a disease that is not communicable
>and so does not have a big public health impact.
>While doctors expect Gardasil to have a huge
>effect in poor countries where women do not get
>Pap smears, in this country those tests limit
>the incidence of cervical cancer to about 9,710
>new cases and 3,700 deaths each year.
>
>The National Vaccine Information Center has been
>publicizing reports of side effects _ mostly
>dizziness and fainting _ in several dozen people
>getting Gardasil, which is approved for use in
>females ages 9 to 26. The center, a group of
>parents worried that vaccines harm some
>children, questions whether the vaccine was tested in enough young girls.
>
>Officials with the Centers for Disease Control
>and Prevention, however, say that reports of
>side effects through the end of January don't raise any red flags.
>
>The vaccine also is controversial because of its
>price _ $360 for the three doses required over a
>six-month stretch. Because of that cost and what
>pediatricians and gynecologists say is
>inadequate reimbursement by insurers, many are
>choosing not to stock the vaccine or requiring
>surcharges to administer it, increasing the cost
>for many families and making the vaccine hard to come by.
>Merck shares fell 37 cents to $44.13 in
>after-hours trading Tuesday after rising 22
>cents to close at $44.50 on the New York Stock Exchange.
>
>
>
>
>--
><http://www.michaelbalter.com>www.michaelbalter.com
>
>******************************************
>Michael Balter
>Contributing Correspondent, Science
><mailto:[log in to unmask]>[log in to unmask]
>******************************************

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