[NVIC] One Less? Evaluating the High Cost of GARDASIL

[Guest guest]

December 17, 2007

National Vaccine Information Center

NVIC E-news

www.nvic.org

www.vaccineawakening.blogspot.com

One Less? Evaluating the High Cost of GARDASIL (SEE WEBPAGE FOR LINKS TO

MANY ARTICLES EMBEDDED IN BELOW ARTICLE)

by Barbara Loe Fisher

To view a TV news story on the HPV Vaccine controversy, click here:

http://www.wusa9.com/video/player.aspx?aid=53002 & sid=65760 & bw=

The debate about whether all young girls should routinely be vaccinated

with HPV vaccine continues to be a big topic of discussion in homes and

doctors' offices around the country. At the same time, reports of serious

reactions to Merck's HPV vaccine, GARDASIL, continue to pile up. Last

month, a young 15 year old soccer player

http://www.nbcactionnews.com/news/local/story.aspx?content_id=fabcbaad-8971-

4db0-8ed1-42ccbc106f20

and star athlete in Kansas almost died within three hours of being injected

with GARDASIL. In September, a 12 year old Florida girl who played softball

and ran cross country suddenly collapsed shortly after getting a shot of

GARDASIL and became paralyzed.

http://www.injuryboard.com/national-news/did-gardasil-vaccine-cause-a-12-yr-

olds-paralysis.aspx?googleid=28460

Twenty-eight American women, who were pregnant when they were injected with

GARDASIL vaccine, have miscarried their babies.

http://www.foxnews.com/story/0%2C2933%2C315466%2C00.html

Last year at this time, Merck was giving marching orders to lobbyists

http://www.nvic.org/Diseases/HPV/pr022107HPV.htm

and teaming up with politicians to ram school mandates for 11 year old

girls to get injected with three doses of its new and very expensive HPV

Vaccine, GARDASIL. Never mind that GARDASIL had only been studied in less

than 1200 girls under age 16 in pre-licensure clinical trials and was not

tested for safety in combination with other vaccines like meningococcal and

TdaP vaccines routinely given to pre-adolescents today.

http://www.nvic.org/Diseases/HPV/pr022107HP V.htm

Merck failed to make the case that the only opposition to the proposed

mandates was coming from parents who did not want their pre-teen daughters

to get a vaccine for a sexually transmitted disease because of religious

beliefs and moral convictions. NVIC argued that, beyond the moral and

parental rights issues, there was a legitimate case to be made that

GARDASIL should not be mandated because of outstanding product safety

issues. At the end of the day, parents across the nation made it made it

clear that they did not want three doses of a poorly tested vaccine for a

sexually transmitted infection that cannot be acquired in the school

setting to be added to school mandates that already include dozens of doses

of vaccines.

The proposed HPV vaccine mandates failed in all the states in 2007 but

that did not prevent GARDASIL from becoming a blockbuster new product for

Merck and it does not mean that Merck and pro- forced vaccination

proponents will not try again in 2008 to get laws passed requiring its use.

One Wall Street guru has predicted the $300 million Merck made this year

will grow to more than $4 billion.

http://www.thestreet.com/funds/tv-recap/10388133.html

In fact, brisk GARDASIL sales was one reason why, despite the $4.85 billion

the drug maker had to pay for patients injured by painkiller Vioxx, the

company turned a profit in 2007. http://www.msnbc.msn.com/id/22096748/

NVIC issued three reports in 2007 analyzing GARDASIL reaction reports

being filed in the federal Vaccine Adverse Events Reporting System (VAERS)

by nurses, doctors and patients. To date, the FDA VAERS data reveal that

more than 4,000 GARDASIL adverse events have been reported to VAERS through

October 2007. Descriptions of these vaccine reaction reports can be viewed

and VAERS database searches made on NVIC's website at

http://www.medalerts.org/vaersdb/index.html.

( Click here and here to access the GARDASIL reaction reports directly)

See webpage http://www.vaccineawakening.blogspot.com/ for better links to

the above

On August 15, 2007, NVIC wrote a letter to the Centers for Disease

Control accompanied by a detailed NVIC analysis of increased GBS

http://www.nvic.org/Diseases/HPV/HPVHOME.htm

and other serious adverse event reports in VAERS that have occurred when

GARDASIL is given at the same time with meningococcal vaccine (Menactra) ,

asking the CDC to issue an advisory to doctors and parents to be cautious

when administering GARDASIL with Menactra. The CDC quickly dismissed the

significance of the increased risk of injecting GARDASIL simultaneously

with Menactra and refused to alert anyone to the potential increased risk.

Now a new study, which was funded by Kaiser (CDC's research partner) and

authored by researchers with financial ties to vaccine manufacturers, has

been published in a medical journal in a pro-active pre- damage, damage

control attempt to dismiss the serious autoimmune and other negative health

outcomes following HPV vaccination as " a coincidence. "

Because teenagers and adult women can talk (while babies cannot), those who

are in the business of hyping HPV vaccination for profit and power know

they will have a much bigger problem covering up the brain and immune

system damage that occurs when healthy girls and women are injected with

HPV vaccine. Just like Merck tried to make opposition to HPV vaccine

mandates all about sex, so public health officials and doctors promoting

HPV vaccination are going to try to sweep HPV vaccine reactions under the

carpet using the unscientific but convenient " coincidence " defense.

Lost in all the hype for young girls to be " One Less " is discussion of the

basic facts about HPV infection in America :

* The majority of women clear the HPV virus from their bodies naturally but

women with risk factors, such as HIV infection, smoking, long-time use of

oral contraceptives, and co-infection with herpes simplex virus or

chlamydia, are at higher risk for chronic HPV infection.

* Between 1955 and 1992, cervical cancer deaths in American women dropped

by 74 percent due to routine pap smears.

* There are about 9,800 new cases of cervical cancer annually diagnosed in

the U.S., which represents .007 percent out of the approximately 1,372,000

new cancer cases of all types diagnosed.

* There are about 3,700 deaths in mostly older American women annually

attributed to HPV- related cervical cancer, which is about .006 percent of

the approximately 570,000 cancer deaths that occur in the U.S.

* Most cervical pre-cancers develop slowly, so nearly all cervical cancers

can be prevented with regular pap smear screening and prompt treatment.

GDSL

Play the video

GDSL injured

Parents of 15 year old Marissa Omon say, that the HPV vaccine almost

killed their daughter and significantly altered her life

----------

" We already are asking our children to get more than 50 doses of vaccines

by age twelve! " says the National Vaccine Information Center's Barbara Loe

Fisher. If you have a daughter, there maybe one more vaccine on the list.

Twenty-six states and the District of Columbia have introduced legislation

requiring girls, as young as eleven, to get the vaccine that could prevent

the Human Papillomavirus. " As a mother you kind of want to wrap your child

in bubble wrap and just protect them from anything you can. " Janet Riessman

says protecting her daughter, Sage, from the virus which can cause cervical

cancer was an easy decision. " For me it was all prevention. " But some

parents and even healthcare advocates have questions about safety. Barbara

Loe Fisher tells dvmMoms.com, " It was only studied on less than 1,200 girls

under the age of 16. " This HPV vaccine has been on the market for little

over a year. There have already been more than 4,000 reported adverse

reactions and at least three people have died. The FDA and the CDC say

these numbers may not tell the full story. And they claim most reactions

have been minor. " The 4,000 adverse events that have been reported could be

just the tip of the iceberg, " says Loe Fisher. She says half of those

reactions were serious enough to send girls to the emergency room. She's

concerned about making the HPV vaccine mandatory. " - Lesli , WUSA-TV

(November 28, 2007) http://www.wusa9.com/rss/local_articl

e.aspx?storyid=65760

" A Lawrence couple is furious over a new government-approved vaccine

designed to prevent a type of cancer. They say it almost killed their

daughter and significantly altered her life. 15-year-old Marissa Omon is an

athlete. The daughter of a Nigerian soccer player she played basketball,

volleyball and track, until now. Surgeons put a defibrillator inside her

chest Monday night fearing her heart could stop at any moment. " HPV

[vaccine] cost my daughter. It almost cost her her life, " said Edem Omon.

Edem Omon is convinced his healthy, athletic teenage daughter Miranda

almost died because of a vaccine doctors gave her to prevent cervical

cancer....Edem said he reluctantly allowed a doctor to give her the HPV

vaccine. " He convinced me the drug was safe, " said Edem. Less than three

hours later, while practicing basketball at Free State High School, Miranda

suddenly collapsed. Her heart stopped. Paramedics needed a defibrillator to

revive her. Miranda was rushed to Children's Mercy where she spent several

days unable to walk or talk. Doctors ran a battery of tests, CT scans,

x-rays and biopsies. They could find no explanation for Miranda's sudden

heart problem. They say they do not believe the HPV vaccine has anything to

do with it. " - Larry Seward, KSHB- TV (November 13, 2007)

http://www.nbcactionnews.com/news/l

ocal/story.aspx?content_id=fabcbaad-8971-4db0- 8ed1-42ccbc106f20

" Bell says she had seen ads for the vaccine so after consulting

with her doctor she agreed to have her 12-year-old daughter, Brittany

vaccinated. Two months ago the Florida girl suddenly collapsed. Her mother

says Brittany used to play softball and run cross country. Now she can't

feel her legs. Kelley Dougherty of Merck tells IB News that paralysis is

not one of the recognized side effects of Gardasil use and is not even on

the warning label. " - Jane Akre, Injuryboard.com (November 14, 2007)

http://www.injuryboard.com/national-

news/did-gardasil-vaccine-cause-a-12-yr-olds- paralysis.aspx?googleid=28460

" Since June 2006, when the HPV vaccine Gardasil was approved by the Food

and Drug Administration, there have been 28 reported cases in which

pregnant women miscarried after receiving the vaccine. Nonetheless, based

on the clinical trials done prior to approval of the drug - which indicated

that miscarriages among pregnant women given Gardasil were statistically

consistent with miscarriages among women given placebos and in the general

population - the FDA remains convinced the vaccine is safe and is not

further investigating its effect on pregnant women. In May, a 24-year-old

woman suffered a miscarriage, which an investigator in a report issued to

the federal government said, " may have been caused by Gardasil because the

patient received the injection within 30 days of the pregnancy. " In July, a

17-year-old girl from Texas was unaware she was pregnant when she got her

second dose of Gardasil. She miscarried, but the cause of the miscarriage

hasn't been determined, according to a report. The reasons for two other

miscarriages this year in Florida - one by a 16-year-old and another by a

24-year-old both - are undetermined, according to reports. But it is known

that both women had Gardasil vaccinations shortly before the miscarriages. "

- Fred Lukas, CNS News.com (Decekmber 6, 2007)

http://www.foxnews.com/story/0% 2C2933%2C315466%2C00.html

" 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 or considered for

implementation in many industrialized countries......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.... " - -Anne Siegrist, MD et al., Pediatr Infect

Dis J. 2008;26(11):979-984

https://profreg.medscape. com/px/getlogin.do?

urlCache=aHR0cDovL3d3dy5tZWRzY2FwZS5jb20vdm lld2FydGljbGUvNTY1ODQ5

(subscription required)

One Less?

WUSA-TV, Channel 9 in Washington, D.C.

November 28, 2007

by Lesli

Click here for the URL:

CLICK HERE TO VIEW VIDEO OF STORY: (dvmMoms.com) -- Wiping out cervical

cancer with just three shots. That's what some say the HPV vaccine could do

in the future.

The human papillomavirus (HPV) can lead to cervical cancer and even genital

warts in young women. Several states have considered making this vaccine

mandatory for sixth grade girls across the country. It's an issue that is

generating debate in doctor's offices and beyond.

" We already are asking our children to get more than 50 doses of vaccines

by age twelve! " says the National Vaccine Information Center's Barbara Loe

Fisher.

If you have a daughter, there maybe one more vaccine on the list.

Twenty-six states and the District of Columbia have introduced legislation

requiring girls, as young as eleven, to get the vaccine that could prevent

the Human Papillomavirus.

" As a mother you kind of want to wrap your child in bubble wrap and just

protect them from anything you can. " Janet Riessman says protecting her

daughter, Sage, from the virus which can cause cervical cancer was an easy

decision. " For me it was all prevention. "

But some parents and even healthcare advocates have questions about safety.

Barbara Loe Fisher tells dvmMoms.com, " It was only studied on less than

1,200 girls under the age of 16. "

This HPV vaccine has been on the market for little over a year. There have

already been more than 4,000 reported adverse reactions and at least three

people have died. The FDA and the CDC say these numbers may not tell the

full story. And they claim most reactions have been minor.

" The 4,000 adverse events that have been reported could be just the tip of

the iceberg, " says Loe Fisher. She says half of those reactions were

serious enough to send girls to the emergency room. She's concerned about

making the HPV vaccine mandatory.

A group of Bowie pediatricians have the vaccine available, but differ who

should get it and why. And then there's the issue of sex.

Pediatrician, Dr. Jeannine tells dvmMoms.com, " Kids do experiment. I

think it's going to be very important to get them covered. "

But her colleague, Dr. Pettus-Bellamy, says, " If they're not

exhibiting that behavior, do they need the vaccine? Parents need to set the

bar....we need to talk more about abstinence as an option. "

Janet Riessman knows her daughter can only be exposed to the virus through

sex. She has no plans to talk about that yet. But her daughter, Sage, does

know one thing. " It's preventing some type of cancer my mom told me. So, I

guess that's good. I won't get that type of cancer now. "

Her mother made an informed decision. That's about the only thing most can

agree on in this debate. Ultimately, parents have to determine whether

being one less is the right thing, right now.

Teen falls ill after vaccine injection

KSHB-TV 41 (NBC Action News)

November 13, 2007

by Larry Seward

Click here for the URL:

LAWRENCE, Kan. - A Lawrence couple is furious over a new

government-approved vaccine designed to prevent a type of cancer. They say

it almost killed their daughter and significantly altered her life.

15-year-old Marissa Omon is an athlete. The daughter of a Nigerian soccer

player she played basketball, volleyball and track, until now.

Surgeons put a defibrillator inside her chest Monday night fearing her

heart could stop at any moment.

" HPV cost my daughter. It almost cost her her life, " said Edem Omon.

Edem Omon is convinced his healthy, athletic teenage daughter Miranda

almost died because of a vaccine doctors gave her to prevent cervical cancer.

Three weeks ago Miranda took a physical. Edem said he reluctantly allowed a

doctor to give her the HPV vaccine.

" He convinced me the drug was safe, " said Edem.

Less than three hours later, while practicing basketball at Free State High

School, Miranda suddenly collapsed. Her heart stopped. Paramedics needed a

defibrillator to revive her. Miranda was rushed to Children's Mercy where

she spent several days unable to walk or talk.

Doctors ran a battery of tests, CT scans, x-rays and biopsies. They could

find no explanation for Miranda's sudden heart problem.

They say they do not believe the HPV vaccine has anything to do with it.

" I do believe it's safe, " said Dr. Dattel.

Dattel is not Miranda's doctor but said he's never heard of any major side

effects caused by HPV, only soreness and fever.

" HPV vaccine was thoroughly tested before the FDA approved it and I do

think for that reason it is safe, " said Dattel.

Miranda is still in Children's Mercy. If all goes well she could go home

this week but doctors will not allow her to play competitive sports that

she loves.

Did Gardasil Vaccine Cause a 12-yr-olds Paralysis?

Injuryboard.com

November 14, 2007

by Jane Akre

Click here for the URL:

There isn't a single person who watches television that hasn't seen the ads.

" One Less " is the campaign theme created by drug maker Merck to promote

Gardasil. Approved by the FDA in June, 2006, Gardasil is being aggressively

marketed to parents of pre-teen girls as young as nine, as a way to " guard "

against cervical cancer and genital warts caused by Human Papillomavirus

(HPV) type 6, 11, 16 and 18.

The Merck campaign has been tremendously effective.

The Centers for Disease Control (CDC) recommends all 11 and 12-year-old

girls receive a Gardasil injection.

By September 2006, the state of Michigan approved a measure requiring girls

about to enter the sixth grade be vaccinated with Gardasil. [note from

NVIC: this measure was shelved]

And beginning next fall, all Texas girls ages 11 and 12 will be required to

receive the three Gardasil injections according to a February, 2007

executive order signed by conservative Republican Texas Gov. Rick .

[Note from NVIC, this executive order was withdrawn by after the

Texas legislature rejected it] Parents groups and lawmakers had objected to

the order in the belief the mandated vaccine condones premarital sex and

supersedes parent's authority in raising their own children.

Bell says she had seen ads for the vaccine so after consulting

with her doctor she agreed to have her 12-year-old daughter, Brittany

vaccinated. Two months ago the Florida girl suddenly collapsed. Her mother

says Brittany used to play softball and run cross country.

Now she can't feel her legs.

Kelley Dougherty of Merck tells IB News that paralysis is not one of the

recognized side effects of Gardasil use and is not even on the warning label.

Dougherty says, " Over 25,000 individuals have been tested with Gardasil and

the majority of problems would occur within the timeline of six years so far. "

What Bell didn't know was the Gardasil has been linked to

thousands of adverse reports including paralysis and 11 deaths.

In August, the non-profit Washington, D.C. government watchdog group,

Judicial Watch filed a request asking the FDA for all adverse events

reports linked to Gardasil injections.

By September, Judicial Watch had an additional 1,800 reports of suspected

reactions to Gardasil, bringing the advers e report total to 3,461 and 11

deaths. Among them:

· " 20-Jun-2007: Information has been received.... concerning a 17 year old

female who in June 2007.... was vaccinated with a first dose of

Gardasil....During the evening of the same day, the patient was found

unconscious (lifeless) by the mother. Resuscitation was performed by the

emergency physician but was unsuccessful. The patient subsequently died. "

· " 12-Jun-2007: 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. "

· 28-Aug-2007: 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. "

Judicial Watch has sued the FDA for failing to comply with its FOIA on

whether lawmakers and drug company lobbyists for Merck or Glaxo have

encouraged the FDA to approve the drug.

Dee Grothe, a project manager at Judicial Watch tells IB News, " our main

conclusion is that parents need to be making the decision about whether

they should vaccinate their children, the government should not be

mandating that because there are numerous concerns bout the vaccine. "

In August, the National Vaccine Information Center, a clearinghouse for

information on vaccines, reported that Gardasil given with the

meningococcal vaccine could put patients at risk for Guillain-Barre

syndrome (GBS). GBS allows the body's immune system to attack the nervous

system causing paralysis and muscle weakness.

There is other information that Bell didn't have.

No one can really say if the drug is effective over time.

It is supposed to be given before girls are sexually active. What if that

doesn't happen for five or 10 years. Does Gardasil still work? No one knows.

Then there is the moral question- does giving Gardasil send the wrong

message to our young girls that they can be promiscuous without

consequences? New partners are associated with an increased risk in HPV and

Gardasil doesn't protect against HIV.

Numerous studies find that HPV is transmitted through skin contact, not

through bodily fluids.

A report in the New England Journal of Medicine finds using condoms is

effective in preventing HPV.

Are parents about to discuss condom use with their 12-year-olds? Is getting

another inoculation just easier?

Bell didn't hear these arguments. Now she has filed an injury

claim with the government, not drug maker Merck.

It turns out that Merck put Gardasil on the National Vaccine Injury

Compensation Fund about six months after it hit the market.

Bells' attorney, Cronin tells First Coast News that, " The Federal

government would not put it on the list without medical scientific

justification. "

Dougherty tells IB News that it is standard practice that all of Merck's

new drugs are now put on the list. What we do know is that there are 100

different strains of HPV. Gardasil protects against four of them.

At $360 for the three-vaccines its one of the most costly of vaccinations

every marketed. Gardasil was added to the Vaccines for Children (VFC)

Program on November 1, 2006, providing coverage for many who do not have

private health insurance, according to Merck.

Already about 10 million Gardasil vaccinations have been distributed. At

last count 3,461 adverse reports have been sent to the government reporting

system, Vaccine Adverse Event Reporting System (VAERS). Brittany's is not

among them.

Merck is seeking approval from the FDA for the use of Gardasil for women up

to the age of 45, even though studies show about 80 percent of women at

that age already have HPV and in the majority of cases it's kept in check

by the body's immune system.

Gardasil i s being marketed aggressively to the rest of the world that's

approved Gardasil, so far including 85 countries.

GlaxoKline is poised push its version of the HPV vaccine, Ceravix into

the U.S. market. It's already available in Europe. Here Glaxo is confident

it will eventually capture half of $3 65 million as of June, 2007 for

Gardasil.

28 Women Miscarry After Receiving HPV Vaccine Gardasil; FDA Says No Reason

to Re-Examine Approval

CNS News.com December 06, 2007

by Fred Lucas

Click here for the URL:

(CNSNews.com) - Since June 2006, when the HPV vaccine Gardasil was approved

by the Food and Drug Administration, there have been 28 reported cases in

which pregnant women miscarried after receiving the vaccine.

Nonetheless, based on the clinical trials done prior to approval of the

drug - which indicated that miscarriages among pregnant women given

Gardasil were statistically consistent with miscarriages among women given

placebos and in the general population - the FDA remains convinced the

vaccine is safe and is not further investigating its effect on pregnant women.

In May, a 24-year-old woman suffered a miscarriage, which an investigator

in a report issued to the federal government said, " may have been caused by

Gardasil because the patient received the injection within 30 days of the

pregnancy. "

In July, a 17-year-old girl from Texas was unaware she was pregnant when

she got her second dose of Gardasil. She miscarried, but the cause of the

miscarriage hasn't been determined, according to a report.

The reasons for two other miscarriages this year in Florida - one by a

16-year-old and another by a 24- year-old both - are undetermined,

according to reports. But it is known that both women had Gardasil

vaccinations shortly before the miscarriages.

Gardasil is the vaccine to prevent the Human Papillomavirus (HPV), a

sexually transmitted disease and the leading cause of cervical cancer in

women. The package insert for Gardasil states there is " no evidence " the

vaccine will cause " impaired female fertility or harm the fetus. "

Most of the 28 reports of miscarriage, which were drawn from the Vaccine

Adverse Event Reporting System (VAERS), were attributed to " other medical

event. " VAERS reports contain raw, unanalyzed data sent by concerned

parties to the FDA and the U.S. Centers for Disease Control and Prevention.

The only Gardasil side effect the FDA has expressed concern about is

dizziness immediately after the shot, FDA spokeswoman Riley said.

" We've not seen signals " of a disproportionate problem with Gardasil and

pregnant women, she said.

" If you're pregnant, then it means you've been sexually active, " Riley

said. " So it would be somewhat dubious to get a vaccine you're supposed to

have before you're sexually active. "

While there is no conclusive evidence that any health problems have been

caused by the vaccine, Judicial Watch, the conservative government watchdog

group that obtained the VAERS reports through a lawsuit, is concerned that

the FDA is not scrutinizing the vaccine more closely.

Judicial Watch President Tom Fitton said his group wants to know more about

the FDA's approval of Gardasil and monitoring of potential problems with

the vaccine, which some states either have or are considering mandating for

school girls.

" Merck lobbied for these mandates, " Fitton told Cybercast News Service .

" There are moral issues here. But the primary issue is public health and

safety. It's interesting why our government downplays the apparent adverse

reactions of Gardasil. Why are drugs with a distinct social agenda getting

less scrutiny in the approval process? "

Riley stressed that the numbers concerning the pregnancies must be placed

in context.

" Have they (Judicial Watch) compared that to a similar group of young

pregnant women of the same age group who haven't had Gardasil? " Riley said.

" There is always a certain percentage of children born with abnormalities

among any sampling. The only way to say if there is a causality

relationship is to compare one group to see if they have a higher rate than

another group. "

A total of 3,461 adverse reactions, including eight deaths, were reported

to the government through the VAERS system since the FDA approved the drug.

Reproduction studies were conducted on female rats at doses up to 300 times

the human dose, according to Merck. The tests on the lab rats showed no

adverse effect on reproduction or pregnancy. However, the company

literature on Gardasil said, " It is not known whether Gardasil should be

given to pregnant women. "

During Merck's clinical trials of 2,226 women, half got the Gardasil

vaccine, and the other half got a placebo or empty vaccine. In that group,

40 on Gardasil and 41 on the placebo had an adverse event in their pregnancy.

The most common adverse events were conditions that can result in cesarean

section or premature labor. The portions between the Gardasil and placebo

were comparable, Merck said.

Merck spokeswoman said 2 to 3 percent of the women who

became pregnant during the clinical trials had children with problems, and

roughly 15 percent of those had miscarriages. This, she said, mirrors the

general public of pregnant women, regardless of whether they had the vaccine.

Pointing to the fact that VAERS reports are raw data, she said there was

little reason to believe a causal relationship existed.

" It's what you see in the database of the general population, " told

Cybercast News Service . " VAERS are passive reports. It's plausible someone

would get the vaccine, leave the doctor's office and walk into a pole. You

could report that and VAERS would accept it. "

Much of the controversy surrounding Gardasil pertains to the fact that

three states - Massachusetts, New Jersey, and Virginia - are mandating

sixth-grade girls get the vaccine, and other states are considering such a

mandate.

The three states included an opt-out provision, which would let parents

choose not to have the vaccine administered to their child for religious or

other reasons.

Meanwhile, 38 other states this year passed or considered some type of

legislation either mandating, funding, or educating the public about the

vaccine, according to the National Council of State Legislatures. New

Hampshire and Alaska adopted a voluntary program that supplies the vaccine

for free to girls between ages 11 and 18 who want it.

Meanwhile, abroad, the British Department of Health approved a national

mandate for school girls to get the vaccine.

After the FDA approved Gardasil, the Advisory Committee on Immunization

Practices recommended routine vaccinations for girls ages 11 and 12. HPV

infects 20 million people in the United States, with about 6.2 million new

cases each year, according to the Centers for Disease Control and

Prevention. HPV is responsible for nearly 70 percent of cervical cancer

cases.

The American College of Pediatrics and the New England Journal of Medicine

have voiced opposition to mandating the vaccine.

Human Papilloma Virus Immunization in Adolescent and Young Adults: A Cohort

Study to Illustrate What Events Might be Mistaken for Adverse Reactions

Pediatr Infect Dis J. 2008 26(11):979-984

-Anne Siegrist, MD; Edwin M. , MPH; Juhani Eskola, MD;

J. W. , MSc; B. Black, MD;

Abstract

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 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.

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.

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. A few years later, reports of temporal

association between HBV immunization and the onset of multiple sclerosis

(MS) were sufficient to fuel major vaccine-safety controversies associating

HBV immunization to MS and other autoimmune diseases. 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. However, as the best epidemiology studies may

never exclude the existence of a risk, the debate continues, especially in

France, where HBV vaccine coverage remains below 25%. This vaccine-safety

issue spread internationally, including in developing countries, despite

worldwide efforts for explanation and reassurance. 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. 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.

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 as that of HBV vaccines, they have formally been

tested on less than 50,000 women. Thus, their safety databases are limited

and rare (

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.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.

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