Here is a new vaccine for human papillomavirus or HPV.
Take a look at one place you find this virus. It's a monkey virus.
Coincidentally the same monkeys
that were used to make the polio vaccine.
Med Citation
Articles by Wood, C. E.
Articles by Cline, J. M.
Cervical and Vaginal Epithelial Neoplasms in Cynomolgus Monkeys
C. E. Wood, H. Borgerink, T. C. Register, L. Scott and J. M. Cline
Comparative Medicine Clinical Research Center, Wake Forest University Health
Sciences, Winston-Salem, NC
Papillomavirus-associated cervical cancer is the second most common neoplasm in
women but has rarely been reported in animals. This report describes cervical
and vaginal intraepithelial neoplasms identified in routine histologic specimens
obtained from 20 (5.2%) of 385 female cynomolgus macaques (Macaca fascicularis)
being used in long-term studies. Lesion incidence was similar in both control
and hormonally treated animals (4.7% and 5.5%, respectively). Neoplasms included
benign vaginal papillomas, mild to severe intraepithelial dysplasias, and two
invasive cervical carcinomas. Common morphologic features included koilocytosis,
nuclear atypia, and expansion of the basal epithelium. Selective staining of
lesions with at least one of three papillomavirus antibodies was observed in all
cases (20 of 20). In contrast, immunostaining of lesions was negative for
Epstein-Barr–related virus proteins (0 of 20). The unique similarities between
the observed lesions and those seen in women suggest that macaques may provide a
suitable animal model for study of papillomavirus oncogenesis.
Request reprints from Dr. C. E. Wood, Comparative Medicine Clinical Research
Center, Wake Forest University Health Sciences, Medical Center Boulevard,
Winston-Salem, NC 27157-1040 (USA). E-mail: chwood@wfubmc.edu.
The cynomolgus monkey is best known as the first clinical test
animal for the development of the polio vaccine. They are involved in WNPRC
studies of infectious disease, reproduction and other areas.
Do we really need this vaccine? Merck wants to
make it a law we take it?
Updated: 4:52 p.m. ET Jan 30, 2007
AUSTIN, Texas - Merck & Co. is helping bankroll efforts
to pass state laws requiring girls as young as 11 or 12 to receive the
drugmaker’s new vaccine against the sexually transmitted cervical-cancer virus.
Cathie Adams, president of the conservative watchdog
group Texas Eagle Forum, said the relationship between Merck and Women in
Government is too cozy.
“What it does is benefit the pharmaceutical companies,
and I don’t want pharmaceutical companies taking precedence over the authorities
of parents,” she said.
Product Detail
MPL® adjuvant, our flagship adjuvant, is a derivative of the lipid A molecule
found in gram-negative bacteria, and has been observed to be a potent
immunostimulant. Licenses for MPL adjuvant have been granted to several
affiliates of GSK and to Wyeth-Lederle Vaccines for development in over 20
disease targets. Vaccines that incorporate MPL adjuvant have completed or are
now in late-stage clinical trials to protect against infection from:
herpes virus;
hepatitis B virus; human papilloma virus;
malaria; and
respiratory syncytial virus. Technical Description
MPL adjuvant is a proprietary form of monophosphoryl lipid A, a derivative of
bacterial endotoxin, one of the most potent immunostimulants known. Prepared
from a heptoseless mutant of Salmonella minnesota, MPL is chemically similar to
lipid A but lacks an acid-labile phosphoryl group and a base-labile acyl group.
MPL retains the beneficial biological activities of lipid A but with a safety
profile suitable for evaluation in pediatric applications.MPL may be a key
component of vaccines using technologies such as recombinant and synthetic
antigens. While vaccines incorporating these antigens are considered safer than
previous attenuated or killed whole-cell vaccines, many of them are poorly
immunogenic in the absence of a potent adjuvant. MPL has demonstrated utility
with peptide, bacterial sub-unit and synthetic polysaccharide antigens. Vaccines
for infectious diseases and allergy desensitization containing this microbially
derived adjuvant have demonstrated that MPL is well tolerated in human clinical
trials involving thousands of doses.Clinical Experience with MPL
In GSK's clinical trial involving nonresponders and comparing Engerix-B with the
new vaccine containing our MPL adjuvant, investigators measured seroconversion
rates (protective antibody levels) one month after each of three vaccine doses;
at zero, one and six months. After the first dose, 78% of the group given the
new vaccine seroconverted versus 59% of the Engerix-B. After two doses, 96%
versus 76% seroconverted. After the third and final treatment, 98% of patients
receiving the vaccine containing MPL adjuvant seroconverted compared to only 81%
of patients given Engerix-B.In a multicenter study of healthy individuals, more
than 98% of those vaccinated with Engerix-B containing MPL adjuvant achieved
protective anti-hepatitis B antibody levels after just two doses, whereas three
doses of the current Engerix-B product were required to obtain a similar level
of protection.Mechanism of Action
MPL activates cells of the monocyte/macrophage lineage and stimulates release of
several cytokines, including IL-1, IL-12, TNFa and GM-CSF. Presumably through
the action of these cytokines, lymphoid and antigen-presenting cells, including
dendritic cells, are recruited to the local lymphoid organs where efficient
immuno-enhancing cellular interactions can take place. These initial events
mediated by MPL induce a strong TH1-type of cellular response characterized by
increased production of IFN-g and IL-2. In turn, IFN-g promotes the production
of complement fixing antibodies (i.e., IgG2a in the mouse), a hallmark of
responses mediated by MPL.MPL enhances immune responses to a variety of viral
and bacterial antigen types, including peptides, proteins, polysaccharides and
tumor cell lysates. Antigens successfully tested in preclinical studies include
hepatitis B surface antigen, tetanus toxoid, trivalent split influenza, and a
recombinant protein derived from the saliva-binding region of an adhesion
protein of Streptococcus mutans. MPL produced striking results in studies with
capsular polysaccharide antigens from organisms such as Hemophilus influenza b,
several strains of pneumococcal bacteria and the Vi antigen from Salmonella
typhi.
Clinical Trials
MPL adjuvants have completed Phase III clinical trials with GlaxoSmithKline
hepatitis vaccines. This document is intended to provide only an overview of
Corixa's product candidates. For complete information, please refer to the
company's Annual Report on Form 10-K, press releases and other public
information.
Vaccine prevents cervical cancer
By Rita Rubin, USA TODAY
An experimental vaccine against cervical cancer has moved a step
closer toward becoming the first cancer vaccine of any kind on the
market. Scientists are reporting Friday that the vaccine was 100%
effective in preventing cervical cancer and precancerous changes
tied to two types of a common sexually transmitted virus. "It's a
very impressive finding," Christopher Crum, director of women's and
perinatology pathology at the Brigham and Women's Hospital in
Boston, said Thursday.
A WOMAN'S RISK
An estimated 10,370 women in the USA will be diagnosed with cervical
cancer in 2005, and 3,710 are expected to die. A look at a woman's
risk of developing the cancer, by age group:
Birth to 39: 1 in 636
40 to 59: 1 in 340
60 to 79: 1 in 368
Lifetime: 1 in 130
Source: American Cancer Society, Cancer Facts & Figures 2005
The report is the first from a large-scale
trial of a cancer vaccine. In April, researchers published similarly
encouraging results from a smaller study of the Merck vaccine.
Spokeswoman Janet Skidmore said Thursday that
Merck plans to apply to the Food and Drug Administration by year's end
for permission to sell the vaccine. "There is the potential it could
be available late next year, assuming all goes well," she said.
The vaccine, called Gardasil, targets human
papillomavirus (HPV) types 16 and 18, thought to cause 70% of cervical
cancers, and HPV types 6 and 11, associated with 90% of genital warts
cases. Up to 70% of sexually active women will become infected with
HPV, which clears up on its own more than nine times out of 10.
Lasting infection causes virtually all cervical cancers.
In April, the researchers suggested that the
vaccine might be most effective in 10- to 13-year-olds, who are not
likely to be infected with HPV.
Preteens and adolescents, sexually active or
not, could receive the HPV vaccine along with the other shots they're
required to get, said co-investigator Kevin Ault, an Emory University
obstetrician/gynecologist who did his research when at the University
of Iowa.
It would be just as important to vaccinate boys
as girls, Ault said. He cited the rubella vaccine to illustrate his
point. All babies are immunized against rubella to prevent them from
spreading the disease to pregnant women, because it can cause birth
defects.
Skidmore says Merck is testing the vaccine in
girls and boys as young as 9. The FDA will decide whether it should be
sold for use in preteens, she says. The latest findings from the company-funded
study, being presented at the Infectious Diseases Society of America
meeting in San Francisco, involved more than 12,000 females, ages 16
to 23. They were randomly assigned to receive either the three-shot
vaccine or dummy shots.
The analysis began a month after they received
their last shot and continued for an average of 16 months. None of the
females who received the vaccine was found to have precancerous
changes or cervical cancer, compared with 21 of those who received the
dummy shots. GlaxoSmithKline also is testing a vaccine
against cervical cancer but has not yet reported results.
So they've made a vaccine for a vaccine induced disease.
Great.
Texas Governor Perry took Merck money before mandating
cervical vaccine David Edwards and Mike Sheehan
Published: Thursday February 22, 2007
http://www.rawstory.com//news/2007/TX_Gov._Perry_took_Merck_money_0222.html
Texas Gov. Rick Perry (R) says that it's just a coincidence that he and eight
other lawmakers received donations of $5,000 each from Merck lobbyists just a
few days before mandating the drug giant's HPV cervical cancer vaccine for all
females in Texas ages 12 and up.
"There's been a lot of pressure about the implications of vaccinating young
girls against sexually-transmitted diseases," says CNN's Ali Velshi in the video
below, "some people thinking that that encourages promiscuity at that age."
He reports though that "this thing is coming undone by word, rumor and report of
connection between Rick Perry's office and Merck."
The main lobbyist for Merck previously worked as Chief of Staff for Gov. Rick
Perry. Several other states are considering making the vaccine mandatory, thanks
in part to Merck's aggressive lobbying.
The World Health Organization
(WHO) is promoting this drug that has serious side effects. Here are some of
the reasons why.
Did you know that 80% of cases of cervical cancer occur in low-income
countries? That means that only 20% happen in the more developed countries
like the US. Worldwide there are 500,000 new cases each year and 250,000
deaths. What this means is that 50,000 deaths occur in the developed
countries of the world.
The average age of a woman with cervical cancer is 48. The effectiveness
or dangers of this vaccine will not be known for at least a decade. Let's
put things into perspective. Cervical cancer results in just 3,700 deaths
nationally every year compared to heart disease, which kills over 300,000
women annually.
So this means that cervical cancer deaths in the United States are 1.5%. I
believe that our percentage is so low because we have women go to their
doctors yearly and get checked for this awful disease and catch it early. If
we are at such a low percentage then why is Merck pushing so hard for this
vaccine? Why has the FDA put this vaccine on the fast track to approval when
all the testing is not finished?
In my last article about Merck I told you about the law suits because of
Vioxx. This drug was also put on the fast track and look at the damage and
deaths that it has caused.
This is what the WHO had to say about corruption in the pharmaceutical
market.
Dr. Jerome Kassirer, a former editor of the New England Journal of
Medicine (NEJM), contributed an article to the report documenting his own
experiences with the long financial tentacles of the pharmaceutical
industry.
In the United States, 90,000 pharmaceutical representatives ply doctors with
gifts and junkets. The US $2 billion spent annually just on free meals and
other hospitality events would dwarf many health budgets in African
countries.
"Yet the doctors receiving all these gifts are unanimous in insisting it has
no effect on their practice," said Kassirer, a professor at Tufts University
School of Medicine in the United States.
Kassirer also points to a famous decision by the US Food and Drug
Administration (FDA) to keep the drugs Vioxx and Bextra on the market after
concerns were raised over cardiovascular risks. Most of the panelists on the
FDA committee, it later emerged, had financial ties to the manufacturers. If
these panelists had declared a conflict of interest and refrained from
voting, the decisions would have gone the other way.
The web of payments can entrap whole governments, Kassirer said, for example
by enlisting them to fight in support of the industry's corner against
generic manufacturers.
In country after country, however, the evidence suggests that losses of
public funds are significant. In the United States, both Medicaid and
Medicare — government-run health insurance organizations — estimate that
4-10% of their budget is lost to overpayment.
Here is a little known fact about the Gardasil trials. Gardasil contains
225mcg of aluminum. In the clinical trials aluminum was placed in the
placebo instead of a saline.
Merck made a major goof up in their Gardasil report (9682302), in that it
did have one chart with a saline placebo group. All the other charts there
are only columns for Gardasil and placebo. I am going to assume that they
placed the saline group and the aluminum group together for the other
charts. Do we have another Vioxx cover-up here, maybe?
Table 6
Vaccine-related injection-site and Systemic Adverse Experiences*
As you can see, Merck skewed the numbers by adding the Saline group with the
Aluminum group. As you also notice by the differences in the three groups,
Aluminum plays a major part in the side effects. It looks to me, the lay
person, that Merck purposely skewed the numbers to reflect that the
side-effects were minimal. My personal opinion is I don't think so!!!!!
Gardasil has 225 mcg of aluminum (as amorphous aluminum hydroxyphosphate
sulfate adjuvant) I took this right from the Merck report that is 10 pages
long that I now have in my Merck file.
Here is what Dr. Mercola has to say about aluminum hydroxide.
The aluminum hydroxide used in many vaccines has been linked to symptoms
associated with Parkinson's, ALS and Alzheimer's.
Aluminum hydroxide, which stimulates immune response, has been used for 80
years in vaccines such as those for hepatitis A and B, and the Pentacel
cocktail for diphtheria, pertussis, tetanus, polio and meningitis.
Scientists discovered the link after injecting mice with an anthrax vaccine
developed for the first Gulf War. After 20 weeks, a fifth of the mice
developed a skin allergy, and memory problems increased by 41 times compared
to a placebo group. Also, inside the brains of mice, 35 percent of the cells
that control movement were destroyed.
U.S. drugmakers are currently testing aluminum hydroxide as an additive in
flu shots, even though a recent study of the efficacy of avian flu vaccine
found that it only worked roughtly 50 percent of the time, and then only at
a dose roughly 12 times what is typically given for a seasonal flu vaccine.
Now, I do not want you to think that aluminum and the toxicity is something
that is new. It is not. They have known about aluminum in the scientific
circles for years. I have some publications that are over 25 years old.
It is very disturbing to me to know that the pharmaceutical community knew
about this toxin and still administered it to my children and grandchildren
when they were vaccinated. My parents used to get a yearly flu shot and they
both had Alzheimer's disease for years before they passed. How irresponsible
can a company be to put this in the vaccines? This is worse than anything
that the cigarette companies have done.
Histochemical localization of aluminum in the rabbit CNS
G. Y. Wen1 and H. M. Wisniewski1
(1) New York State Office of Mental Retardation and Developmental
Disabilities, Institute for Basic Research in Developmental Disabilities,
1050 Forest Hill Road, 10314 Staten Island, NY, USA
Received: 7 May 1985 Accepted: 9 July 1985
"Summary: Aluminum was observed in the nucleolus, interchromatin
granules, rough endoplasmic reticulum, free ribosomes, euchromatin, and the
heterochromatin of the neuron. The association of aluminum with the
first four r-RNA-containing cellular components and with the last two
DNA-containing chromatins suggests the association of aluminum with
the nucleic acids. The aluminum may interfere with the normal mechanism of
the protein synthesis of r-RNA and of the transcription or gene modulation
of DNA. Aluminum was also observed in the astrocytic process and in
the nuclei of endothelial cells, pericytes, and the muscle cells of the
blood vessels. The detection of aluminum in the pyrimidal cells of
the cerebral cortex and hippocampus and in the spinal cord neurons, was
observed 1 h after i. v. injection, indicating a rapid entry of
aluminum from the injection site through the blood-brain barrier
(BBB) to the neurons. Using Morin stain, pyramidal neurons of the cerebral
cortex and hippocampus, motoneurons of spinal cord, ganglion cells, and
bipolar cells of retina and Purkinje cells of cerebellum, exhibited yellow
fluoroscence, with peak intensitiy at 560 nm. Tangles were observed in these
six types of neurons. The granule cells of hippocampus and cerebellum and
the photoreceptors of the retina exhibited green fluorescence with the peak
intensity at 490–500 nm. Tangles were not observed in these three types of
neurons."
The Evidence That Aluminum Causes AD Is Compelling25
Aluminum was found to be toxic to the nervous system of
animals over 100 years ago. Injecting aluminum into the brains of
sheep was reported in 1965 to result in changes in the brain that
showed a "striking resemblance" to AD in people. In 1973, brains of
AD patients were found to contain more aluminum than people dying
without this disease. About the same time, kidney patients on dialysis were
found to suffer, sometimes fatal, brain damage (encephalopathy) from
aluminum in their antacids (these antacids are used to bind phosphates
in their intestines). More than 100 toxic actions of aluminum
have been identified and many are damaging to the human brain.
Savory J, Garruto RM. Aluminum, tau protein, and Alzheimer's
disease: an important link? Nutrition. 1998 Mar;14(3):313-4.
According to the Merck product manufacturer insert, there was 1 case of
juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis,
and 1 case of reactive arthritis in 11,813 Gardasil recipients plus 1 case
of lupus and 2 cases of arthritis out of 9,701 participants primarily
receiving an aluminum containing placebo. Clinical trial investigators
dismissed most of the 102 Gardasil and placebo associated serious adverse
events, including 17deaths that occurred in the clinical trials as
unrelated.
The national Vaccine Information Center (NVIC), Sums the situation up
correctly: "With cervical cancer causing about one percent of all cancer
deaths in American women due to routine pap screening, it was inappropriate
for the FDA to fast track Gardasil. It is way too early to direct all young
girls to get three doses of a vaccine that has not been proven safe or
effective in their age group."
And Micholas Regush wrote in Vaccine Madness back in 1992, states that "rare
spontaneous or chemically induced chromosome abnormalities which are
consistently observed in HPV DNA-negative and positive cervical cancers
induce cervical cancer."
"[C]arcinogens may be primary inducers of abnormal cell proliferation rather
than HPV [Human papillomavirus]." "Since proliferating cells [cancer cells
dividing wildly] would be more susceptible to infection than resting cells,
the viruses would just be indicators rather than causes of abnormal
proliferation."2
I also have a four page document from The Institute on Money in State
Politics. According to this document Merck spent $2,460,352 to state-level
candidates and party committees. New Jersey, Florida, California and
Pennsylvania received more than $1 million or 44%.
To date, Gov. Rick Perry as received $21,000 from the pharmaceutical
giant's political action committee. Perry was second only to former
California Gov. Gray David, who received $28,000.
According to this report the state of Texas received $158,143 in campaign
contributions.
I have about 100 pages about Merck and Gardasil and it made interesting
reading.
Merck stands to make billions on the United States citizen by having
legislation passed forcing this toxic vaccine on our innocent youth. It is
my opinion that they are using this as a way to pay for all the lawsuits
that have been filed in the Vioxx cases. I personally do not want to pay for
that out of my hard earned dollars. I would rather spend that money on more
fruits and vegetables rich in anti-oxidants for my family. Foods that are
rich in anti-oxidants help build a better immune system that helps ward off
disease. I believe that all families would rather do that than spend $360
for a vaccine that might work for 4–5 years and then have to pay for
boosters after that.
Oh, on the way to looking up other things, I found what the Brits are going
to have to pay for this travesty. They are going to pay 450 pounds which in
US dollars is $880. Can anyone say rip off, I sure can.
Merck is exploiting the gay community with this vaccine in the UK. They are
going to play on the fears of gay men and have them get a vaccine that has
not even finished its clinical trials for safety. Here are some excerpts
from that article.
LONDON (Reuters) — Homosexual men in Britain are requesting treatment
with Merck & Co Inc's new HPV vaccine Gardasil, with dozens immunized in
recent weeks, a London clinic said on Friday.
"We started offering vaccination to gay men in January and recently we've
been giving about 10 a week," said Dr Sean Cummings of the Freedomhealth
clinic in London's Harley Street.
Since many sexually active people are already contaminated with HPV,
patients are swabbed before vaccination to determine which, if any,
sub-types of HPV they may be carrying.
"If you've got a full house (of HPV sub-types) then there is no point in
immunizing," Cummings said.
However, some experts said the benefits of vaccinating men were not yet
clear.
The Terrence Higgins Trust, Britain's leading HIV and AIDS charity, said the
case for mass vaccination in men would depend on the outcome of further
clinical trials.
Gardasil costs 450 pounds ($880) for a three-dose course at the
Freedomhealth clinic, which has a reputation as a specialist in gay men's
health.
At least in the UK they are going to wait for further clinical trials before
they start any mass vaccination of gay men.
What is wrong with this country? Why are we mandating mass vaccinations of
our young girls? Can anyone say it could be for the money? I guess we are
getting off cheap with paying only $360.
BREAKING NEWS:
Neurological disorders affect 1 billion people: WHO
Tue Feb 27, 2007 1:22PM EST
GENEVA (Reuters) — Neurological disorders ranging from migraines to
epilepsy and dementia affect up to one billion people worldwide and the toll
will rise as populations' age, the World Health Organization (WHO)
warned on Tuesday.
The number of people suffering from Alzheimer and other debilitating
dementias, currently some 24.3 million people, is expected to double every
20 years, with prevalence levels rising in developing countries, it said.
In a report entitled "Neurological Disorders: Public Health Challenges," the
United Nations agency urged that neurological care become part of
basic health care so that underdetected disabilities are diagnosed and
treated, especially in Africa.
At this point I want to repeat what Dr. Mecola had to say about aluminum.
"The aluminum hydroxide used in many vaccines has been linked to
symptoms associated with Parkinson's, ALS and Alzheimer's."
Maybe the WHO and the UN should ban the use of aluminum in the vaccines that
people are getting through their health initiatives. What a concept to
preventative medicine.
Gardasil is the biggest and the best scam since the rising gasoline prices.
We as citizens of the United States of America need to demand that Merck
take Gardasil off the market and insist that our Government investigate the
"illegal" practices of the pharmaceutical giants and our elected officials
in taking campaign contributions as legal bribes to pass legislation.
These sanctioned practices by our government officials needs to stop
and so do they. These people are harming the United States citizens in more
ways than one.
They ALL need to be removed from office before they can do any more
damage to our democratic way of life. I say we remove the Hillarys and the
Obamas and the Kennedys and the Shumans and all of them. They have
consorted with the enemy within, opened our boarders to terrorists and
illegals that suck our economy and health care system dry.
Wake up America! It is time for us become strong again with honest and
trustworthy leadership that will not make up lies for a dollar.
Call your legislators today and demand the removal of Gardasil legislation
forever. Don't let Merck or any drug company run our country and hurt our
youth for money.
Call Merck today and tell them to stop using aluminum in any and all
vaccines because it is dangerous to the health of the people.
Lawrence A. Bossidy, Retired Chairman and Chief Executive Officer, Honeywell
International Inc. Director, J.P. Morgan Chase & Co. and Berkshire Hills
Bancorp, Inc. Merck Director since 1992.
AFA.Net/activism
Richard T. Clark, CEO and president, Merck & Co., Inc., 2005; president,
Merck Manufacturing Division, 2003-2005; chairman, Medco Health Solutions,
Inc., 2002-2003; chairman, president and CEO, Medco Health Solutions, Inc.
(formerly Merck-Medco Managed Care, L.L.C.), 2000-2002; executive vice
president and COO, Merck-Medco, 1997-2000; senior vice president, Quality
Commercial Affairs, MMD, 1997. Joined Merck in 1972.
Merck & Co., Inc.
One Merck Drive
P.O. Box 100
Whitehouse Station, NJ 08889-0100 USA
Phone: 908-423-1000
Monday-Friday 8:30 AM — 5:30 PM ET
Cynthia Janak is a
freelance journalist, mother of three, foster mother of one, grandmother of
five, Pharmanex executive, Chamber of Commerce member. Her expertise is as
an administrative professional. Her specialties are adoptee and genealogy
research and research journalism. Hobbies: Writing prose, crocheting,
Conservative Studies, and rehabbing houses. She is a freelance journalist
for the Empire Journal. You can contact Cynthia Janak at
cj1951@ameritech.net
On July 4th, 1776, we declared
our independence from England. We wanted to be a nation that was governed by
the people for the people.
It has been over 200 years since we had a king rule this country and it has
been great. We have freedom and a government that is composed of
legislative, executive and judicial branches. This form of government is
"supposed" to protect us from any individual becoming so powerful that he
rules by decree instead of going through the process that we hold dear.
But what is happening today? We have politicians that are circumventing the
system that our forefathers so carefully put in place to prevent a monarchy
in this country. How are they doing that? What our elected officials are
doing is enacting executive orders and writing statements that change laws
or bypass the legislative process. This is happening more and more in all
the executive branches of our government in this country.
The most recent abuse of this power is the governor of Texas. Governor
Perry, through an executive order, has mandated that female children receive
a vaccine that could be harmful. He bypassed the opinion of the people and
of the legislature which was in opposition to this mandate. They did not
want to put into law forced vaccinations of Gardasil, a Merck & Co. product.
Before we get into this any further, let's look at who Governor Rick Perry
really is. First and foremost he is a west Texas rancher who became governor
because President Bush resigned the governorship to run for president. He
has since this time in 2000 been re-elected to the governorship.
Let's go back to May of 1995. There was an incident that involved the abuse
and death of a hog at the Tyler County Fair. I know it doesn't sound like
much but this will help show you the mind set of this man.
This is what happened. A young man put a water hose down the throat of a hog
that he entered in the fair to add more weight to the animal. This is a far
cry from encouraging the animal to eat or drink. Needless to say, the hog
died.
Then Governor Bush sent then Commissioner of Agriculture Rick Perry to
investigate the abuse. Perry sent two staffers to do the investigation into
the alleged abuse. These staffers came back to report that the incident was
"accidental." Here is an excerpt from the letter to then Governor Bush. "The
underlying issue which has created a whirlwind of attention is whether or
not an animal has the same rights as a human being."
What has this to do with shoving a hose down an animal's throat? Nothing!!!
To me this is the opposite of the removal of a feeding tube and staving a
person to death. Perry, with his comment, basically, condoned this action by
the youth. To me this shows that he has little regard for a living creature.
Guilt by association, on Sunday, June 25th, 2000 there was an article in the
Easton, Maryland, The Sunday Star, titled "Bush scandals, bad policy." I
would like to know why this article or something similar did not run in
other newspapers. I was glad that I was sitting down when I read the
article. It showed me that Bush caters to the big business and not so much
to the people.
One example is Metabolife's Washington lobbyist gave $141,000 to Bush's
gubernatorial campaigns and $100,000 for his presidential campaign. At the
time, Metabolife's Ephedrine products were linked to 8 deaths but for some
reason stricter limits on the drug were dropped.
In the same article it states that $1.5 million was given to Perry in
contributions and loans to give him the edge over John Sharp. This money was
provided by James Leininger. Leininger was a supporter of "tort deform"
which made it impossible for anyone to sue big business. Can you say we have
a big business connection here?
Don't worry. I am going to tie all of this together in the end.
Now we come to pharmaceutical giant Merck who put a product on the market
call Vioxx. On August 22nd, 2005, CNNMoney reported that Merck lost its
first lawsuit in regards to Vioxx. One of the arguments by Lanier the
attorney for widow Carol Ernst was that Merck concealed information about
the health risks associated with the drug to protect sales.
What did Merck say about this, they said that Vioxx did not cause Ernst's
death. They asserted that arrhythmia had not been linked in the Vioxx
studies.
Can you say that the drug came on the market too soon? I can.
This article also states that Merck has 4,200 product liability lawsuits
that represent about 7,500 plaintiff groups had been filed. In May of 2005,
Judge Eldon Fallon told reporters that lawsuits could reach 100,000.
A tiny bit about the company Merck. Merck (MRK) Reuters article dated
January 30, 2007's headline is "Merck profit falls, hurt by charges, generic
Zocor." A summary of the article is that generic drugs are hurting their
profit. The other item that is hurting Merck are the "tens of thousands of
lawsuits" that are filed because of Vioxx adverse side effects.
One other thing about Merck, they pay Richard T. Clark, CEO and President
$4,160,106 for the year of 2005, Judy C. Lewent, CFO, Exec. VP., $1,946,700
for the year of 2005. There are more officers that receive over a million a
year but I did not feel the need to list all of them here. Now remember this
does not include the gift stock options that they receive.
Now, I am going to take you down the path of the vaccine, Gardasil by Merck.
At the
http://www.medalerts.org site, there is a link to "National Vaccine
Information Center." This site provides the public with the resource to
research different vaccines. I found that there were 82 reports of adverse
reactions reported in regards to this vaccine.
There are several articles and papers to read about this drug that Texas,
Governor Perry wants to inflict on the female youth of his state. My focus
is going to be on the side effects that have been reported. All the reports
I am going to reference the patient had no preexisting conditions.
Days since Vaccination — 0–1 hr. after vaccination — pt reported to feel
dizzy, weak, vision went black for a few seconds, got pale with purple lips.
Days since Vaccination — 0 — Vasovagal syncope(drop in blood pressure)
shortly after receiving hep A and Gardasil vaccine, fell, hit nose on a
drawer, loss of consciousness, sent to ER in transport broke nose.
Days since Vaccination — 0 — ...complained of pains, numbness. Started
walking down hall fainted and had tonic/clonic movement (grand mal seizures)
for 15 sec.
Days since Vaccination — 0 — immediately after the injection...the patient
experienced pain and stinging at the injection site that lasted about 2
minutes and radiated the arm. The patient also reported feeling faint
following the injection and experienced swelling.
Days since Vaccination — 0 — At the time of the vaccination the patient
experienced extreme pain at the injection site and fainted.
Days since Vaccination — 0 — Vaccine given after physical. Patient fainted,
vasovagal (drop in blood pressure), hit head on carpeted cement floor. Loss
of consciousness 1 min, had tonic (stiffening of the limbs) posturing of
right hand only some shaking.
Days since Vaccination — 0 — Patient said right deltoid area, became red,
swollen, quarter size hard knot, achy, painful to raise arm.
Days since Vaccination — 0 — Immediately after vaccine administration
patient had syncopal episode with tonic posturing fell from table. Responded
with gentle stimulation versus normal 5 minutes post regaining full
consciousness.
Explanation of terms:
Vasovagal Syncope — Vasovagal syncope is not a serious or life
threatening condition, but in effect an abnormal reflex. This results in a
drop in blood pressure leading to decreased blood flow to the brain
resulting in dizziness or fainting.
The symptoms in vasovagal syncope are slightly different for each person,
but often include many of the following characteristics:
Most episodes occur while standing, occasionally sitting and almost
never lying down
Patients often describe feeling very warm and sweaty before blacking
out
Nausea and rarely vomiting can precede episodes
Observers often describe the patients as pale ("white as a sheet")
Patients are usually unresponsive ("out") for less than a minute
Patients may have some twitching while unresponsive, but seldom shake
violently, bite their tongue or lose control of bowel and bladder
function. The latter are more suggestive of a primary seizure.
After regaining consciousness, patients are usually immediately aware
of their surroundings, who and where they are
After an episode, patients often feel somewhat dizzy and report
feeling tired for as much as 24 hours
Patients that learn to recognize the warning signs can avert losing
consciousness by sitting or lying down promptly.
tonic/clonic movement — Generalized tonic clonic seizures (grand mal
seizures) are the most common and best known type of generalized seizure.
They begin with stiffening of the limbs (the tonic phase), followed by
jerking of the limbs and face (the clonic phase).
During the tonic phase, breathing may decrease or cease altogether,
producing cyanosis (blueing) of the lips, nail beds, and face. Breathing
typically returns during the clonic (jerking) phase, but it may be
irregular. This clonic phase usually lasts less than a minute.
Some people experience only the tonic, or stiffening phase of the seizure;
others exhibit only the clonic or jerking movements; still others may have a
tonic-clonic-tonic pattern.
Incontinence may occur as a result of the seizure. The tongue or inside of
the mouth may be bitten during the episode; breathing afterwards may be
noisy and appear to be labored. Contrary to popular belief, nothing should
be placed in the mouth during the seizure; turning the patient on one side
will help prevent choking and keep the airway clear.
Following the seizure, the patient will be lethargic, possibly confused, and
want to sleep. Headache sometimes occurs. Full recovery takes minutes to
hours, depending on the individual.
After this I went to find out about the drug Gardasil from one of my
favorite sites, WebMD. (My suggestion to everyone reading this is to
request your doctor to check in the PDR (Prescription Drug Reference) for
the specifics and side effects of any drug that is going to be prescribed.
Doctors are good healers but they cannot know everything about every drug or
vaccine that is out there today.)
First the uses for Gardasil.
"This medication is a vaccine used to prevent cervical cancer, genital
warts and abnormal tissue growth in the vagina/cervix that can lead to
cancer in women. These conditions are commonly caused by certain types of
human papillomavirus (HPV).
This medication does not protect against all types of HPV, only the types in
the vaccine. (2 HPV 16 & HPV 18) It is used to prevent the diseases and will
not treat active cervical cancer, genital warts or other diseases caused by
the types of HPV in the vaccine.
Side Effects of Gardasil.
Redness, itching, swelling, bruising, and pain at the injection site may
occur. Fever may also occur. If any of these effects persist or worsen, tell
your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she
has judged that the benefit to you is greater than the risk of side effects.
Many people using this medication do not have serious side effects.
Tell you doctor immediately if any of these rare but very serious side
effects occur, joint pain/swelling.
A very serious allergic reaction to this drug is rare. However, seek
immediate medical attention if you notice any symptoms of a serious allergic
reaction, including: rash, itching, swelling, severe dizziness, trouble
breathing.
Precautions of Gardasil.
Before receiving this medication, tell your doctor or pharmacist if you
are allergic to it: or to other vaccines; or if you have any other
allergies.
Before receiving this vaccination, tell your doctor or pharmacist your
medical history, especially of: immune system problems,. (e.g. HIV
infection), bleeding disorders (e.g. hemophilia, thrombocytopenia), current
fever/illness.
Interactions of Gardasil.
Before receiving this vaccination, tell your doctor or pharmacist of all
prescription and nonprescription/herbal products you may use, especially of:
"blood thinners" (e.g. warfarin), cancer chemotherapy, coricosteroids (e.g.
prednisone, dexamethasone), drugs that weaken the immune system (e.g.
cyclosporine, tacrolimus).
Notes for Gardasil.
As with any vaccine, this vaccine may not fully protect everyone who
receives it.
Getting this vaccine does not replace cervical cancer screening. Continue to
have regular obstetrician/gynecologist checkups.
Now I want to make a comparison between what Merck and Medical News Today
says about the vaccine.
Merck:
There were no discontinuations due to serious vaccine-related adverse
events. Adverse events were higher among those who received GARDASIL
compared with placebo recipients. The most common vaccine-related adverse
event reported was local discomfort at the injection site.
Medical News Today:
The most common injection site and systemic adverse events were pain and
headache, respectively.
This is interesting considering what the "National Vaccine Information
Center" had to say about the side effects. Can anyone say cover-up for
profit?
The ingredients of Gardasil.
Each 0.5-mL dose of the vaccine contains approximately 225 mcg of
aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant), 9.56 mg
of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg
of sodium borate, and water for injection. The product does not contain a
preservative or antibiotics.
I want to bring your attention here to the aluminum that is used in this
vaccine. From what I have read this type of aluminum is used to help with
absorption of the vaccine. My question to you is where does the aluminum go
after it has done its job? I am not a scientist and I would like the answer.
This is what I found on this.
This was taken from an article about "Aluminum and the Prevention of
Alzheimer's Disease by Dr. Joseph Mercola.
The cause of AD is unknown. However, environmental influences appear to
be important. Aluminum is a widely recognized
nerve toxin. It has been found in increased concentrations in all AD
affected tissue. Recent scientific studies provide four independent lines of
compelling evidence that implicate aluminum's
role in the cause of AD.
The last bit of information about this wonderful vaccine is that the price
tag is high. This is what Merck had to say about that.
Manufacturer Merck & Co. has set the price at $360 for a series of three
injections, and it is often covered by insurance.
I am going to tie this all together for you. This governor Perry has no clue
how harmful this vaccine could be to the female youth of his state. If he
had done his research into the vaccine as I have done today we would not
have an executive order mandating this abuseof young women.
Here is a company that has a history of lawsuits because of its drugs but
yet this governor ignores this well known fact. For some reason he is
looking the other way and is going to turn over your children and hard
earned money to this Pharmaceutical Giant. Maybe it could be because the
normal person would never expose their children to such a harmful vaccine
knowingly.
Governor Perry should have listened to what the people and the legislature
had to say about making this mandatory. But he did not. The King wanted his
way and had little intention of listening to the legislature of his state.
What does that say to me, volumes! This act by this King of Texas is in
violation of the rules that govern this wonderful country. From what I have
seen today, in my opinion, it looks as if the contributions of the big
business lobby are guiding his actions. It is my opinion that he wanted to
keep the money rolling in for his re-election campaign.
How many of our young people are going to have to die from anaphylactic
shock or be confined to a nursing home for brain damage because of lack of
blood to the brain before this drug is taken off the market? How many more
Terry Schiavo's do we have to have out there?
My reason for writing this article is to let the people of this wonderful
country, the United States of America, know that the King has returned to
rule this country and we were all sleeping when it happened.
You need to take action now because we no longer have any time left to save
the United States of America. Look at who you have in your government. Check
out what bills they have passed and what is in them. Look at what your
governors are doing with their executive order privilege which is to be used
only in cases of emergency. And lastly, and it pains me to say this but,
look at the executive orders and the statements that our President has put
in motion. It makes me weep and pains my heart.
We hired all of these individuals to protect our rights under the
Constitution as United States Citizens. We pay these people their salaries
to do the work that we hired them to do. It has come the time to fire all of
them and start anew so we can bring back the greatness that this country
once was again.
Don't let a King run this country by decree. Stop
the trend now.
Cynthia Janak is a
freelance journalist, mother of three, foster mother of one, grandmother of
five, Pharmanex executive, Chamber of Commerce member. Her expertise is as
an administrative professional. Her specialties are adoptee and genealogy
research and research journalism. Hobbies: Writing prose, crocheting,
Conservative Studies, and rehabbing houses. She is a freelance journalist
for the Empire Journal. You can contact Cynthia Janak at
cj1951@ameritech.net
Ten reasons why HPV vaccine is 'murky' issue
Sunday, February 4, 2007
The word "cancer" triggers emotions ranging from fear to empathy to panic.
But we cannot let our emotions cause us to spend money or create mandates
without careful research. We need to evaluate claims of drugmakers, lobbyists
and lawmakers when they seek money for cancer prevention efforts.
Here are 10 reasons why we are skeptical about efforts to mandate for school
girls the HPV vaccine against the sexually transmitted cervical-cancer virus.
10. Merck and Co. (the manufacturer of the vaccine) has funneled money through
Women in Government, an advocacy group made up of female state
legislators around the country.
9. Sen. Connie Lawson, the General Assembly's No. 1 advocate for the
vaccine, is a member of Women in Government.
8. A top official from Merck's vaccine division sits on Women in
Government's business council.
7. Women in Government President Susan Crosby, a former Indiana state
legislator, said the vaccine could "eliminate a cancer." Yet Gardasil, is NOT a
cancer vaccine. It is a vaccine for a virus; specifically for four of the more
than 100 types of HPV, two of which cause 70 percent of cervical cancer in
women, and two that cause 90 percent of genital warts.
6. Merck could generate billions in sales if Gardasil - at $360 for the
three-shot regimen - were made mandatory across the country. Depending on how
many girls are Medicaid-eligible in each state, much of that money could come
from Medicaid dollars - even if the vaccine is recommended, not mandated.
5. The top 10 leading killers of women in the U.S. are heart disease,
stroke, lung cancer (more than 70,000 deaths of women per year), respiratory
diseases, Alzheimer's, breast cancer, diabetes, accidents, flu/pneumonia and
colon cancer. About 3,700 U.S. women die of cervical cancer each year; that is
about 1/8th of the number of women who die from colon cancer, the No. 10 killer
of U.S. women.
4. Because the vaccine was only studied for 3 1/2 years, the long-term
effectiveness and safety of this vaccine has yet to be determined. It took years
for thalidomide and Vioxx (also a Merck product) to demonstrate their most
negative side effects.
3. Pap smears have dramatically reduced cervical cancer deaths in the U.S.
But Gardasil does not protect against all cancers of the cervix. If the number
of Pap smears go down because of women's false sense of security, the number of
cervical cancer deaths could go UP!
2. Scarce health care dollars should be spent in the most effective way
possible. We believe an investment of billions could be better spent in efforts
to battle the top 10 killers of women. (See No. 6 and No. 5.)
1. With an issue as "murky" as this, our little girls should not be guinea pigs.
OUR VIEW is written on a rotating basis by Grace Housholder, Dave Kurtz,
Matt Getts and Michael Marturello. Publisher Terry Housholder is also a member
of the editorial board. We welcome readers' comments.
Experimenting On Teen Girls
March 7, 2007 by Phyllis Schlafly
It all looked so easy. Just hire lobbyists who have access to the right public
officials, make strategic campaign contributions, and finance a front for women
to carry your message.
This wasn't a typical advertising campaign to sell the new vaccine for HPV
(human papillomavirus), called Gardasil, by repetitive commercials on the
television network evening newscasts. The real money to be made from this drug
depends on government mandating and funding it for all girls.
Marketing costs of inducing state governments to require all teenage girls to be
given this vaccine would be just pennies compared to the billions of dollars
that would flow to Merck. The profits could even be enough to bail out Merck
from its potential billion-dollar liabilities on Vioxx (which is why some say
that HPV stands for Help Pay for Vioxx).
So Merck hired Texas Governor Rick Perry's former chief-of-staff to carry the
ball. On the slowest news day of the year in Texas, the Friday before the Super
Bowl, Governor Perry issued an Executive Order requiring young girls to receive
Merck's HPV vaccine in order to enter the sixth grade.
The Associated Press reported, based on documents, that Perry's current
chief-of-staff Deidre Delisi discussed Merck's HPV vaccine with aides on Oct.
16. On the very same day, Merck's political action committee donated $5,000 to
Perry's reelection campaign plus an additional total of $5,000 to eight Texas
lawmakers.
Meanwhile, Merck financed a new "Women in Government" organization, composed of
women state legislators, to push for the vaccine. Does it evade regulations
against lobbying if women legislators are merely "educating" each other?
Recently released staff emails reveal that Governor Perry's aides were
themselves shocked by his mandate. Commenting on the first draft of his
Executive Order, one aide said, "that first line sounds almost like a Merck
commercial."
Perhaps Perry's rush to put a mandate in place was to preempt the Texas
legislature from holding hearings that would expose how senseless this mandatory
vaccination of 11-year-old girls would be. Hearings would reveal that this
vaccine has not been shown to prevent a single case of cancer.
"I believe that their timing was a little bit premature so soon after [the
vaccine's] release, before we have a picture of whether there are going to be
any untoward side effects," says Dr. Anne Francis. She chairs the usually
pro-vaccination American Academy of Pediatrics committee.
Merck's HPV vaccine was approved by the FDA only eight months ago, based on
minimal testing (including few tests with young girls), and it has largely
unknown risks and benefits. Even in the best case scenario, it would protect
against only some strains of HPV, leaving girls vulnerable to many other
sexually transmitted diseases.
The Association of American Physicians and Surgeons, the Texas Medical
Association, and the American Academy of Pediatrics do not support this vaccine
mandate. State legislatures in Michigan, Indiana and Maryland have declined to
make this vaccine mandatory.
Governor Perry is so far unapologetic. He wrapped himself in a new version of
Hillary Clinton's "for the children" excuse, arguing that his mandate is "for
young ladies who are dying of cancer."
But the average age of diagnosis of cervical cancer is 48. Not even Merck claims
that inoculating an 11-year-old girl will protect her against sexually
transmitted diseases five, ten, twenty and thirty years later.
"I got hammered in church this morning on the Merck thing, and it was just
Saturday," Perry's Chief Clerk Greg Davidson emailed the day after the Executive
Order was issued. "Do we have any talking points or stats or anything that can
help me fight through Sunday. This is brutal."
No list of talking points can justify forcing this vaccine on schoolchildren for
a disease that is not contagious in the classroom environment. Follow the money.
The HPV vaccine requires three shots priced at $360, not counting the costs of
separate doctor visits and administrative expenses. Sexual abstinence costs zero
dollars and, unlike the vaccine, is 100 percent protective against sexually
transmitted diseases.
The U.S. government spends billions of dollars to promote teenage abstinence
from illegal drugs, and forces the tobacco companies to spend billions to
promote teenage abstinence from smoking. Why not put a fraction of the
government's proposed vaccine costs into promoting teenage abstinence from sex?
Instead, the Perry mandate would force the vaccine on good girls who don't
engage in premarital sex and don't need the vaccine. At the same time, girls who
receive the vaccine will be given a false sense of security that will be even
more costly to them than the high-priced vaccine is to the public.
The backlash against the mandate caused Merck to announce that it is suspending
its lobbying campaign to make this vaccine compulsory, and the Texas Legislature
is trying to cancel Perry's Executive Order. Stay tuned; Merck's lobbying
campaign has to shift gears, but it isn't going away because too much money is
involved.
Texas governor backs down on HPV
vaccine bill
Won't veto legislation to block required cancer shots for sixth-grade girls
Thank God for men like Dennis Bonnen
I'm posting a quote from him from this article...
http://www.msnbc.msn.com/id/18575675
Republican Rep. Dennis Bonnen bristled at the
governor’s criticism of his bill.
“We should not and are now not going to offer the
165,000 11-year-olds in Texas up to be the study group for Merck to find out
what the implications of this vaccine would be for these girls,” he said.
And Gov. Rick Perry said on Tuesday he won’t veto
a bill that would block state officials from following his order that all
sixth-grade girls be vaccinated against a virus that causes cervical cancer.
A win for the little girls of Texas.....
Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine
Event Reports Obtained from FDA Detail 1,637 Adverse Reactions to Gardasil
(Washington, DC) -- Judicial Watch, the public interest group that investigates
and prosecutes government corruption, today released documents obtained from the
U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of
Information Act, detailing 1,637 reports of adverse reactions to the vaccination
for human papillomavirus (HPV), Gardasil. Three deaths were related to the
vaccine. One physician’s assistant reported that a female patient “died of a
blood clot three hours after getting the Gardasil vaccine.” Two other reports,
on girls 12 and 19, reported deaths relating to heart problems and/or blood
clotting.
As of May 11, 2007, the 1,637 adverse vaccination reactions reported to the FDA
via the Vaccine Adverse Event Reporting System (VAERS) included 371 serious
reactions. Of the 42 women who received the vaccine while pregnant, 18
experienced side effects ranging from spontaneous abortion to fetal abnormities.
Side effects published by Merck & Co. warn the public about potential pain,
fever, nausea, dizziness and itching after receiving the vaccine. Indeed, 77%
of the adverse reactions reported are typical side effects to vaccinations. But
other more serious side effects reported include paralysis, Bells Palsy,
Guillain-Barre Syndrome, and seizures.
“The FDA adverse event reports on the HPV vaccine read like a catalog of
horrors,” stated Judicial Watch President Tom Fitton. “Any state or local
government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine
for young girls ought to take a look at these adverse health reports. It looks
as if an unproven vaccine with dangerous side effects is being pushed as a
miracle drug.”
Judicial Watch filed its request on May 9, 2007, and received the adverse event
reports from the FDA on May 15, 2007. Judicial Watch has posted the adverse
event reports below.
(A recent study, published in the New England Journal of Medicine, also
questioned the general effectiveness of Gardasil.)
SEX VIRUS VACCINE LINKED TO THREE DEATHS
Sunday June 24,2007
Lucy Johnston
THREE deaths have been linked to the controversial sex virus jab
health officials want to give to all 12-year-old girls.
Doctors suspect the jab, which protects against a sexually transmitted human
papilloma virus that causes cervical cancer, may also be linked to 1,700
“adverse reactions”.
Reports from the US, where the Gardasil vaccine has been used for nearly a
year in some states, reveal that three
victims died soon after receiving the injection. They were aged 12, 19 and 20.
They seem to have suffered blood clots or heart attacks. Hundreds of others
suffered what could be adverse side effects, including paralysis, seizures and
miscarriages.
The news comes just days after the Department of Health announced the drug
would be added to the childhood immunisation programme from autumn 2008.
The findings have alarmed UK health experts. Jackie Fletcher from the vaccine
damage support group Jabs, said: “Trials of this jab have mostly been on
adults, so we don’t have any idea of the long-term effect on children.”
Dr Peter Mansfield, a former GP who runs the Good HealthKeeping clinic in
Lincolnshire, said: “It’s absolutely wrong that girls of 12 should be given
this jab.”
Dr John Oakley, a west Midlands GP said the trials for Gardasil had been so
limited that the children taking it would be like “guinea pigs”.
The manufacturers, Sanofi Pasteur MSD, had not planned to release the data,
but it was obtained under freedom of information laws by lobbyists Judicial
Watch. The findings read like “a catalogue of horrors”, said its president,
Tom Fitton.
Other serious possible side effects include paralysis, seizures and
neurological conditions such as Bell’s palsy and Guillain-Barré Syndrome,
which leaves patients paralysed for months and can kill.
Gardasil has stirred up a huge controversy. There is excitement because it is
the first vaccine to be approved to fight cancer – but moral campaigners say
it will encourage teenagers to have sex early.
Others have argued that boys, who also carry the virus, should be vaccinated
as well.
A spokesman for the Medicines and Healthcare products Regulatory Agency (MHRA),
meanwhile, said no “proven, serious new risks have been identified” by the
findings, but said the effects would be monitored when Gardasil is used in the
UK.
Nicholas Kitchin, medical director of Sanofi Pasteur MSD, said the fact that
symptoms were reported after a vaccination did not necessarily mean they were
caused by the vaccine.
http://www.express.co.uk/printer/view/11110
Gardasil administered in conjunction with the meningococcal vaccine, Menactra,
increases risk.
FYI
Judicial Watch and the National Vaccine Information Center (NVIC) have
separately issued updates involving serious adverse event reports about Merck's
HPV (Gardasil) vaccine.
Most serious are a statistically significant risk linking Gardasil when
co-administered with other vaccines, in particular, meningococcal vaccine (Menactral).
NVIC reports: "as of May 31, there have been 2,227 Gardasil adverse events filed
with VAERS, including 13 suspected or confirmed cases of GBS (two more GBS
reports were made in June for a total of 15) and 239 cases of syncope
(fainting with temporary loss of consciousness), many of which
resulted in head injuries and fractures. Seven deaths have been reported after
receipt of Gardasil."
A total of 1,930 reported Gardasil adverse events involved administration of
Gardasil alone, and 135 adverse events involved co-administration of Gardasil
with Menactra.
What justification do officials of the Center for Disease Control and Prevention
offer for their encouragement to physicians to co- administer Menactra and other
vaccines with Gardasil when severe adverse event reports should raise alarms
about safety ?
CDC officials' record of massive waste and inappropriate perks---as documented
in a report by Sen. Tom Coburn, a practicing physician and ranking member of the
Senate Subcommittee on Federal Financial Management Gov't Information and
International Security--give one little trust in CDC policies.
Cervical vaccine trial on babies: report
Email Print Normal font Large font August 27, 2007 - 8:09AM
A doctor who played a key role in trials of a cervical cancer
vaccine is proposing testing it on babies.
Suzanne Garland, the director of microbiology and infectious diseases at the
Royal Women's Hospital in Melbourne, is flying to the US to meet with drug
companies and will discuss trialling the vaccine on babies up to a few months
old, Fairfax newspapers report.
Professor Garland said there were benefits to immunising babies instead of
schoolgirls, but one of the questions that would need to be answered was how
long the vaccine would last, and whether a booster shot would be necessary years
later.
The vaccine has been tested in children only over the age of 10.
"Information has been received … concerning a 12 year old female with a history
of aortic and mitral valve insufficiency … who on 01-MAR-2007 was vaccinated IM
into the left arm with a first does of Gardasil … On 01-MAR-2007 the patient
presented to the ED with ventricular tachycardia and died."
"Initial and follow-up information has been received from a physician concerning
an 'otherwise healthy' 13 year old female who was vaccinated with her first and
second doses of Gardasil. Subsequently, the patient experienced … paralysis from
the chest down, lesions of the optic nerve…At the time of the report, the
patient had not recovered."
The flood of adverse reactions during 2007 reported to the FDA through the
Vaccine Adverse Event Reporting System, included 347 serious reactions. "Of the
77 women who received the vaccine while pregnant, 33 experienced side effects
ranging from spontaneous abortion to fetal abnormities. Other serious side
effects continue to be reported including, paralysis, Bells Palsy,
Guillain-Barre Syndrome, and seizures," Judicial Watch said. And these numbers
may not even include all the cases, Judicial Watch said. It filed a lawsuit this
week against the FDA for failing to fully respond to its requests for
information involving the vaccine. Specifically Judicial Watch wanted access to
correspondence between Merck and the FDA regarding the vaccine, communications
between the FDA and GlaxoSmithKline, which is working on a similar vaccine,
called Cervarix, and reports by consumers, health professionals and others
regarding problems with the HPV vaccine. When the organization's
investigation into the HPV vaccine issue arose, and the first reports starting
coming in, Fitton described it as "a catalog of horrors." One earlier report,
No. 275438-1, describes the reaction as coronary artery thrombosis, sudden
cardiac death. "Given Gardasil vaccine dose #1 3/12/07. Collapsed and died on
3/26/07… Echocardiogram revealed very enlarged right ventricle, small left
ventricle as well as large blood clots within both the right atrium & right
ventricle." Another report noted that the woman was vaccinated and "died of a
blood clot 8 hours after getting the Gardasil vaccine." Officials with the
Abstinence Clearinghouse noted in a position paper that groups including the
Texas Medical Association, the American Academy of Pediatrics, the Association
of American Physicians and Surgeons, and the American Academy of Environmental
Medicine have come out publicly against mandatory vaccination. "The reasoning of
these medical associations is clear. They are not opposed to medical progress,
and certainly support all efforts to combat life-threatening diseases. The
problem, as these organizations see it, lies in the fact that the drug only went
through three and a half years of testing, leaving the medical community
somewhat in the dark as to what serious adverse effects might result in the long
term," the group said. "Along with the potential of serious adverse effects is
the question of efficacy. There is evidence that after approximately four years,
the vaccine's potency significantly declines. The long-term value of the vaccine
has yet to be determined; if it wears off within six years, will girls and women
need to repeat the battery of injections they originally received?" the
organization wondered. Michigan was the first state to introduce a plan to
require the vaccine to be given to young girls, but the proposal failed. Ohio
also considered a failed plan in 2006. Then in 2007, after Merck's aggressive
lobbying campaign and contributions to Women in Government, lawmakers in at
least 39 states and the District of Columbia worked on sponsoring such plans.
Human Papilloma Virus Immunization in Adolescent and Young Adults: A Cohort
Study to Illustrate What Events Might be Mistaken for Adverse Reactions
Claire-Anne Siegrist, MD;* Edwin M. Lewis, MPH;† Juhani Eskola, MD;‡
Stephen J. W. Evans, MSc;§ Steven B. Black, MD||
Background: The large-scale implementation of human papilloma virus
(HPV) immunization will be followed by cases of autoimmune diseases occurring
in temporal association with immunizations. To anticipate events that might be
mistakenly assumed to be caused by immunization, their prevalence was
monitored before vaccine introduction. Method: Cohort study carried out within a database of female
adolescents (n = 214,896) and young adults (n = 221,472) followed in the pre-HPV
vaccine era (2005), computing rates of emergency consultations,
hospitalizations and outpatient consultations, and estimation of risks of
coincident associations. Results: Immune-mediated conditions were a frequent cause (10.3%) of
emergency room consultation by adolescent girls. Nonallergic immune-mediated
conditions affected 86 per 100,000, diabetes ranking first. In 2005, 53 per
100,000 adolescents and 389 per 100,000 women were hospitalized for diseases
of presumed autoimmune origin, thyroiditis being the most frequent diagnosis.
If HPV immunization had been used with 80% coverage, 3 per 100,000 adolescents
would have required emergency care for asthma/allergy within 24 hours and 2
per 100,000 for diabetes within 1 week of an injection. The risks of
hospitalization in temporal association with immunization are 4 times higher
for thyroiditis than for multiple sclerosis or Guillain-Barré's syndrome, and
more than 20 times higher in young women than in adolescents. Conclusion: The distinction between HPV vaccine-caused adverse
reactions and events only observed by chance in temporal association is
difficult. The prior use of population-based data allows for identification of
issues of potential concern, for monitoring the impact of large-scale
interventions and for addressing rapidly vaccine-safety issues that may
compromise vaccine programs.
Introduction
Concerns about supposed adverse effects of vaccines seem to occur
regularly. Usually the evidence for the adverse effect leading to the scare
derives from some case reports rather than from trials or carefully conducted
comparative studies. Spontaneous reports of suspected adverse drug reactions,
including those to vaccines, remain an important source of new information for
monitoring the safety of medicines. However, suspicion about an event does not
demonstrate causality. Many suspected adverse drug reactions are simply
coincident in time with administration of the drug or vaccine.
During the next few years, there will be vaccines introduced to groups of
people who have not traditionally been vaccinated. Pandemic flu vaccine may be
given to age groups who have not been, in large scale, recipients of vaccines.
The human papilloma virus (HPV) disease burden and the outstanding efficacy
profile of the novel HPV vaccines are such that these vaccines are currently
being implemented[1] or considered for implementation in many
industrialized countries. Surveys predict that vaccine acceptance will be
high, despite significant misunderstanding about HPV infection, cervical
cancer screening, and the sequelae of HPV infection.[2-5] The
interest of parents, young women, and health care providers in HPV vaccines
will doubtless be strongly supported by large-scale promotional events led by
2 competing major pharmaceutical companies. This should result in rapid
vaccine uptake by adolescents targeted by national immunization programs. In
addition, catch-up immunizations will be implemented in some countries for
young women, as prior exposure to HPV does not prevent vaccine-induced
efficacy against other HPV genotypes.[6] Altogether, this is
expected to lead to a rapid uptake of HPV vaccines by adolescent girls and
young women in industrialized countries able to afford them.
The rapid large-scale implementation of a vaccine in the young adult
population of industrialized countries is not without precedent. In the early
1990s, the recommendation to immunize adolescents with hepatitis B vaccines (HBV)
was supported by such vigorous promotional efforts in France that it rapidly
led to the immunization of 20 million individuals, mostly adolescents and
young adults.[7] A few years later, reports of temporal association
between HBV immunization and the onset of multiple sclerosis (MS)[8]
were sufficient to fuel major vaccine-safety controversies associating HBV
immunization to MS and other autoimmune diseases.[9] Public
confidence was lost and national HBV vaccination efforts interrupted. A decade
later, the existence of an increased risk of MS after HBV immunization in
adults has still not been demonstrated.[10] However, as the best
epidemiology studies may never exclude the existence of a risk, the debate
continues, especially in France,[11] where HBV vaccine coverage
remains below 25%.[12] This vaccine-safety issue spread
internationally, including in developing countries, despite worldwide efforts
for explanation and reassurance.[13] More recently, the large-scale
implementation of a quadrivalent conjugate vaccine against meningococcal
disease (Menactra) in adolescents led to 5 cases of Guillain-Barré's syndrome
within 6 weeks of immunization. Although this did not exceed the expected
baseline incidence, it was sufficient for the U.S. authorities to launch an
alert.[14] A year later, an update indicated that because of the
ongoing risk for meningococcal disease and the limitations of the data
indicating a small risk for Guillain-Barre syndrome after a vaccination with
quadrivalent conjugate vaccine against meningococcal disease, current Centers
for Disease Control and Prevention recommendations remained unchanged.
[15]
The novel HPV vaccines (Gardasil and Cervarix) share similarities with HBV
vaccines. Both HPV and HBV vaccines are recommended as a 3-dose schedule given
in at least 6 months, and include aluminum salts (Gardasil) or a new potent
adjuvant (Cervarix) for which large-scale surveillance data is not yet
available. Gardasil is produced by yeast, as was one of the HBV vaccines used
in France in the 1990s. Both vaccines protect against sexually transmitted
viral infections that may result in cancer (ie, will be implemented on a large
scale not only in adolescents but also in the young adult population).
Although the safety profile of the 2 HPV vaccines appears to be as excellent[16,17]
as that of HBV vaccines,[13] they have formally been tested on less
than 50,000 women. Thus, their safety databases are limited and rare (<1 per
10,000), severe adverse events may not yet have been identified. Consequently,
reports of immune-mediated diseases issued from the postmarketing surveillance
could be considered as possible adverse events, at least initially. These
signals will be difficult to address given the limited availability of the
incidence of most immune-mediated diseases in the adolescent and young adult
population.
We are concerned that the large-scale implementation of HPV vaccines in
industrialized countries could reactivate the vaccine-safety debates linking
vaccination to autoimmune diseases. This could possibly represent a major
issue for the sustainability of HPV immunization programs in industrialized
countries, and consequently for their implementation in developing countries
where they are most needed.[18] To anticipate the crisis and
identify the potential danger signals, we have computed the utilization of
health resources by the entire female adolescent and young adult population
registered within the Northern California Kaiser Permanente (NCKP) Medical
Care Program health maintenance organization (HMO) during 2005 The number of
emergency consultations, hospitalizations, and outpatient consultations were
used to identify the most frequent immune-mediated conditions, ie, those most
likely to be temporally associated with a putative HPV vaccine administration.
Methods
Databases
NCKP maintains administrative databases to capture all inpatient and
outpatient (including emergency department) utilization within the HMO. The
utilization databases contain the date of admission or visit, International
Classification of Diseases (ICD)-9 coded diagnoses, and a unique
identification number.
Data Retrieval
Rates of emergency department, inpatient, and outpatient utilization were
collected for females 9-18 years of age, likely to be targeted by adolescent
immunization programs, and 19-30 years of age, who will be considered for
catch-up immunization. To compute rates of utilization, the denominator was
estimated by membership at the midpoint of the evaluation year, on June 30,
2005 (9-18 years of age, n = 214,896, adolescent group; 19-30 years of age, n
= 221,472, adult group). The frequencies were computed with the first instance
of each diagnosis code for each individual.
Selection of Target Diseases
For this report, we selected ICD-9 codes for immune-mediated diseases,
considering that the biologic plausibility of a vaccine-induced trigger would
markedly enhance the notification of temporal associations and thus the
likelihood of signal generation.
Risks of Temporal Association Between Events and a Hypothetical HPV
Immunization
The risk of coincident temporal association between medical conditions and
a hypothetical HPV immunization was estimated under various assumptions. The
distribution of medical events during the year was assumed as random, without
any influence of season or month. We assumed a 0-1-6 months vaccine schedule,
as officially recommended, and defined several time windows (from 1 day to 6
weeks after each putative vaccine dose) during which a previous HPV
immunization would likely be considered as a triggering or precipitating
event. The proportion of subjects with expected temporal associations between
a medical event and trigger administered at 0-1-6 months intervals was
calculated by dividing the yearly rate of event by the number of corresponding
at-risks periods, taking into consideration overlapping periods. It was
corrected for vaccine coverage likely to be reached in the adolescent (80%)
and the young adult (40%) population.
Statistical Analyses
Rates of specific immune-mediated disease conditions were used to calculate
the aggregate rates of immune-mediated events requiring medical attention in
the adolescent or young adult population, respectively.
Results
Rates of Emergency Consultations for Immune-Mediated Conditions in Female
Adolescents and Young Women
The demand for an emergency room (ER) consultation reflects either a recent
onset or a recent exacerbation of a preexisting disease condition, 2
situations that inevitably lead to a search for putative precipitating events.
Among 12,443 ER consultations required by 214,896 adolescent girls (aged 9-18)
followed during 2005 in the NCKP Medical Care Program HMO, 35% resulted from
infections and 30% from psychologic or psychiatric conditions (not shown).
Immune-mediated conditions were the third most frequent cause (1277, 10.3%) of
ER consultation by adolescent girls (
Table 1 ). Asthma conditions ranked first among atopic/allergic
conditions, cumulating to a rate of 325 per 100,000 ER consultations. This
included 183 per 100,000 ER consultations for acute IgE-mediated allergic
reactions, including a few cases (3.7 per 100,000) of anaphylactic shock.
Nonallergic immune-mediated conditions were frequent (86 per 100,000,
Table 1 ). The first cause of ER consultation for nonallergic immune
disease was juvenile- or adult-onset diabetes (51.3 per 100,000). In 2005,
only 4 girls followed in the NCKP HMO required ER medical care for systemic
lupus erythematosus (SLE) and none for MS. Emergency consultations for
immune-mediated diseases were also frequent (837 per 100,000) in young women
likely to be targeted by HPV catch-up immunization strategies (
Table 1 ). Asthma or other IgE-mediated allergic reactions also ranked
first (366 and 302 per 100,000, respectively). Among diseases presumably of an
autoimmune nature, diabetes, Bell palsy, and SLE had the highest rate of ER
consultation (
Table 1 ).
Rates of Hospitalizations for Autoimmune Diseases in Female Adolescent and
Young Adults.
The need for hospitalization also reflects either a recent disease onset or
a recent exacerbation of a disease condition sufficiently severe to require
inpatient medical care. In 2005, the hospitalization rate of adolescent girls
for diseases of presumed autoimmune origin reached 53 per 100,000 (
Table 2 ). Thyroiditis, an autoimmune process in adolescents and young
adults, was the most frequently encoded diagnosis. In contrast, episodes of MS
or optic neuritis were relatively rare (3.7 per 100,000). The same ranking was
obtained by the computation of outpatient consultations required by adolescent
girls throughout 2005 (
Table 2 ), confirming the relative disease burden of these immune-mediated
conditions. Of note, thyroiditis generated a 10-fold higher utilization of
medical resources than any other condition in this category.
During the same period, the rate of hospitalization of young women for
autoimmune conditions reached 389 per 100,000 (
Table 2 ). Thyroid disorders also ranked as the first cause of
hospitalization for autoimmune-mediated diseases. SLE ranked next, whereas
MS-like conditions required hospitalization rates of 12 per 100,000. Again,
the computation of outpatient consultations provided a similar ranking (
Table 2 ), confirming the relative importance of the burden of these
conditions on medical resources and their occurrence at a markedly higher rate
in young women than in adolescents.
Temporal Associations Between Specific Disease Conditions and a
Hypothetical HPV Immunization Regimen
All the above-mentioned events occurred in the pre-HPV immunization era.
Consequently, none may be considered as an HPV vaccine-induced adverse event.
The likelihood of an external factor being considered as a potential
triggering/precipitating factor essentially results from temporal
associations.[19,20] We thus estimated the likelihood of temporal
association that would occur in pure coincidences, in the absence of any
causal relationship, with the putative administration of 3 doses of a saline
placebo administered at 0, 1, and 6 months intervals. Rates of ER consultation
or hospitalization were computed by specific time windows to estimate the
likelihood that an event would occur within a given interval after an
injection. For psychologic reasons, the likelihood for an association to be
considered as causally related is inversely proportional to the time elapsed
between exposure to the putative factor and the onset/exacerbation of the
disease. Based on biologic plausibility, we considered time windows of 1 day,
1 week, and 6 weeks after any injection putatively administered according to a
0-1-6 months schedule to all adolescents and young women (
Table 3 ).
Correcting the rates obtained in
Table 3 for likelihood of exposure to an injection trigger predicts that
if 80% of NCKP adolescent girls had been injected with a saline placebo in
2005, 3 per 100,000 would have required ER medical care for asthma or allergy
within 24 hours of an injection. Two per 100,000 adolescent girls seen in the
ER department for diabetes would have been within 1 week of an injection, and
hospitalizations for autoimmune diseases would have occurred within 6 weeks of
an injection in 10 per 100,000 adolescents. Of even greater concern, if a
catch-up program reaching only 40% of young adult women had been implemented,
28 per 100,000 patients requiring hospitalization for the recent onset or
exacerbation of thyroiditis would have been within 6 weeks of an injection.
That such figures would not trigger vaccine-safety signals thus appears as
most unlikely.
Discussion
Anticipating future vaccine-safety concerns at the time of
the enthusiastic implementation of novel vaccines effective against cancer may
seem odd. However, history has taught us that the life and death of
immunization programs can occur rapidly. As a recent example, the Food and
Drug Administration approved in 1998 a new recombinant Lyme vaccine that
reduced new infections in vaccinated adults by nearly 80%. Just 3 years later,
the manufacturer voluntarily withdrew its product from the market amid media
coverage, fears of vaccine adverse events, and declining sales.[21]
To date, there is no evidence that this Lyme vaccine would have caused the
adverse events that led to its withdrawal. We are concerned that history may
repeat itself with any large-scale vaccine introduction in an adult
population, HPV vaccines being the closest to this important step.
Immunizations activate the immune system, which may be
considered as sufficient to blame vaccines, should the onset or the
exacerbation of immune-mediated diseases occur in temporal association with an
immunization,[22] despite some evidence to the contrary.[23]
The prevalence of autoimmune diseases in the young adult female population is
not low. As an example, it is estimated that SLE occurs in 1 of 2000 Americans
and in as many as 1 of 250 young African American women (NIAID, Understanding
autoimmune diseases,
http://www.wrongdiagnosis.com/artic/understanding_autoimmune_disease_niaid.htm),
whereas MS affects 1 in 700 persons in the United States and 1 in 1200 in
Europe.[24] Unfortunately, baseline disease incidences are not
established for most diseases, and country, ethnic, and age-group specific
incidences are largely lacking. Consequently, it will be difficult to monitor
globally the impact or to demonstrate the lack of impact-of a large-scale
immunization program on the incidence of autoimmune conditions. This was
unfortunately illustrated by the allegation of a causal relationship between
hepatitis B immunization and MS, which a decade of negative or inconclusive
studies[25,26] has not yet settled. As autoimmune conditions have
already been included in the adverse events section of the Gardasil Summary of
Product Characteristics, one can predict that conditions occurring in temporal
associations will be reported as potentially associated with HPV immunization.
Temporal association is required for vaccine-safety
signals/concerns to be raised. However, additional factors are at play. This
is best illustrated here by the fact that diseases that have most frequently
been reported in temporal association with immunization, such as MS, SLE, or
Guillain-Barré's syndrome are not the most frequent autoimmune conditions in
adolescents or young women. This is likely to reflect the influence of
additional factors including the severity of the disease and the absence of an
alternative cause to the disease conditions. The data presented here suggest
that reporting is also largely influenced by a notification bias resulting
from the perception by the medical community that certain conditions (such as
Guillain-Barré's syndrome for example) are much more likely than others (such
as diabetes or thyroiditis) do to be triggered by exposure to infection or
immunization. This implies that many new temporal association signals could be
generated by effective pharmacovigilance systems.
Certain national health authorities are aware of the fact
that the upcoming implementation of large-scale adolescent and adult HPV
immunization programs will inevitably lead to the observation of disease
conditions occurring in close temporal association with injections (Swiss
Federal Office of Public Health,
www.cfv.ch). They expect at least some of these cases to be notified to
their pharmacovigilance systems, and fear that their interpretation will be
made difficult by the lack of data on age-specific baseline incidence of
disease, limiting the capacity of performing observed versus expected cases
analyses. Consequently, clusters of cases or reports, possibly resulting from
biased perceptions and notification processes, are likely to result into
danger signals requiring the initiation of complex epidemiologic studies. One
may unfortunately predict that certain issues may remain without conclusive
answers for many years and exert a profound influence on the sustainability of
HPV immunization programs.
The simple approach described in this report offers many
advantages compared with the collection of individual reports resulting from
temporal associations. First, the computation of medical resource utilization
provides population-based data, which is particularly powerful for the
assessment of infrequent events, as it may be extended to large parts of the
population. Second, it may readily be repeated at regular intervals-providing
a rapid tool for the monitoring of any disease condition, by the comparison of
pre- and postintervention rates. Third, it is not limited by working
hypotheses or triggered by a few individual case reports. As an example, we
would not have predicted immune-mediated thyroiditis to be as frequent in
adolescents and young women as was observed. Should this concern arise because
of adverse event notification, rapid answers could be provided by comparing
the rate of ER consultation and hospitalizations before and after the
implementation of HPV immunization. This approach is not limited to
immune-mediated diseases. We observed that gynaecologic conditions resulting
into abnormal uterine bleeding or pain are frequent in adolescent and much
more so in young women (not shown). Should a first episode of abnormal uterine
bleeding in adolescents or fertility issues in HPV-immunized young women be
attributed at some point to the recent administration of a uterine-targeting
vaccine, population-based data could provide rapid answers. Lastly, such
population-based approaches allow an estimation of the likelihood of disease
conditions in various age groups. For example, the much higher risks of
coincidental associations with autoimmune diseases that is expected in the
young women compared with the adolescent population is worth considering at
time of implementation of catch-up strategies in young women.
Predicting the future is difficult, and this study has
limitations. The autoimmune conditions that may generate concerns may not be
in our list. They could, however, be readily included into similar analyses,
now or in the future. The data are from one single year, which does not allow
for fluctuations or temporal variations of medical disorders. The utilization
of medical resources is notoriously influenced by a number of factors, and may
not reflect true disease prevalence. Diseases resulting into more than 1
hospitalization/consultation could have affected the data-which may be
corrected by using unique patient identification numbers. The use of
identification number would also allow discriminating between new onset of
diseases and relapses, defined by the occurrence of a given ICD code before
the suspected triggering event. A related potential limitation of our study is
that the reason for a patient to seek medical care may not necessarily imply a
relapse or exacerbation of an underlying condition. Consequently, rates of
outpatient consultations, in particular, are likely to be less reliable than
demand for emergency care or hospitalization. Rates of medical resource
utilization will also differ from one population to another. Thus, it is
important that the rates indicated here be not taken as figures against which
to compare a given safety signal. Indeed, the objective of this study is not
to provide universally valid baseline incidence rates of diseases in
adolescent or young women at a national or international level. Its objective
is to issue an alert for similar analyses to be run in as many populations and
country settings as possible, before and after the implementation of
large-scale interventions.
The apparently unavoidable future vaccine-safety issues, allegations, and
debates warrant taking specific actions for HPV immunization programs to be
sustained for many years. This includes a better evaluation of adolescent
health, and the estimation of population-based incidence/prevalence rates in
the pre-HPV vaccine era, to allow a rapid distinction between real
vaccine-induced adverse events and alleged concerns. It also includes
educational efforts to increase understanding that coincidence is not
causality, and thus improve handling of putative vaccine-associated adverse
events by the medical community, including by gynecologists who have been less
involved with immunization issues than have pediatricians or general
practitioners.
Table 1. NCKP Emergency Room Utilization by Female Adolescent and Young
Women
In my last article about Merck I told you about the law suits because of
Vioxx. This drug was also put on the fast track and look at the damage and
deaths that it has caused.
The Evidence That Aluminum Causes AD Is Compelling25
I also have a four page document from The Institute on Money in State
Politics. According to this document Merck spent $2,460,352 to state-level
candidates and party committees. New Jersey, Florida, California and
Pennsylvania received more than $1 million or 44%.
Lawrence A. Bossidy, Retired Chairman and Chief Executive Officer, Honeywell
International Inc. Director, J.P. Morgan Chase & Co. and Berkshire Hills
Bancorp, Inc. Merck Director since 1992.
Richard T. Clark, CEO and president, Merck & Co., Inc., 2005; president,
Merck Manufacturing Division, 2003-2005; chairman, Medco Health Solutions,
Inc., 2002-2003; chairman, president and CEO, Medco Health Solutions, Inc.
(formerly Merck-Medco Managed Care, L.L.C.), 2000-2002; executive vice
president and COO, Merck-Medco, 1997-2000; senior vice president, Quality
Commercial Affairs, MMD, 1997. Joined Merck in 1972.
