[NVIC] ACIP Chair Says No HPV Vaccine Mandate

[Guest guest]

February 28, 2007

National Vaccine Information Center

e-news

" We have endorsed a mandate because the vaccine — Merck’s Gardasil — looks

highly effective against strains that cause 70 percent of all cervical

cancer....The strongest arguments against moving ahead quickly tend to be

practical and financial. States have typically used school mandates for

vaccines that are already in wide use, and it is possible that unexpected

side effects could emerge (though any mandate could be suspended if that

happened). Health professionals also need to be certain that there are

stable supplies, adequate insurance coverage, ample public money to

vaccinate low-income children and physician support. " - Editorial, The New

York Times (Feb. 26)

" The chairman of the federal panel that recommended the new

cervical-cancer vaccine for pre- teen girls says lawmakers should not make

the inoculation mandatory, as the District and more than 20 states,

including Virginia, are considering. Jon Abramson, chairman of the Centers

for Disease Control and Prevention's advisory committee on immunization

practices (ACIP), also said he and panel members told Merck & Co., the drug

Gardasil's maker, not to lobby state lawmakers to require the vaccine for

school attendance. " I told Merck my personal opinion that it shouldn't be

mandated, " Dr. Abramson told The Washington Times. " And they heard it from

other committee members. " ...... ACIP is the only entity in the federal

government to issue immunization recommendations and does not recommend a

vaccine be made mandatory; those decisions are left to the states. But the

committee's recommendation on the use of a vaccine often plays the lead

role in whether states will act to make it part of their mandatory vaccine

list, said Barbara Fisher, president of the National Vaccine Information

Center, which is opposed to laws making Gardasil mandatory. " They are the

signal for states to act, " she said. " The committee knows that and I think

they see people getting upset about it. " - Lopes, The Washington

Times (Feb. 27)

" Based on this analysis, Dunne et al found the overall prevalence of HPV

(any type) infection was 26.8% in females 14 through 59 years of age....the

combined prevalence of [vaccine types] HPV-6, HPV- 11, HPV-16 and HPV-18

was 3.4%....the combined prevalence of the 2 high-risk types, HPV-16 and

HPV- 18 [most associated with cervical cancer] was approximately

2%....Follow-up prevalence studies will be important not only to evaluate

[quadrivalent HPV] vaccine effectiveness but also to address the question

of whether other high-risk oncogenic HPV types will fill the ecological

niche created by the expected decline in HPV-16 and HPV-18. Studies of

cost-effectiveness of the vaccine have used HPV prevalence estimates from

selected populations, including some outside of the United States. Now it

will be important to assess the cost-effectiveness of the vaccine using

these new prevalence data from US females. " - Editorial, JAMA (Feb. 28)

" Even among women most likely to be infected - sexually active 18- to

25-year-olds - these two cancer-causing HPV strains were relatively

uncommon, infecting 3.5 percent. Experts say these findings, published

today, do not change the conclusion that the public-health benefits of

vaccination are worth the cost. But the new data may create confusion and

fuel controversy over whether to mandate inoculation of pubescent girls. At

least 20 states are considering proposals. The study supports the notion

that there should not be a " rush to make this vaccine mandatory, " said

Chaiken, a Dallas lawyer representing six parents who are suing the

Texas governor over his order requiring vaccination of sixth-grade girls.

Barbara Loe Fisher, president of the National Vaccine Information Center, a

nonprofit advocacy group that contends all vaccines pose risks the public

is not warned about, said she was " shocked " by the new data. " This is not

what most people in America who have looked at publicity for this vaccine

were led to believe, " she said. " - Marie McCullough, Philadelphia Inquirer

Barbara Loe Fisher Commentary:

A study was published in http://jama.ama-assn.org today's Journal of the

American Medical Association (JAMA) estimating the population prevalence of

HPV infection in American women aged 14 to 59 years old. What the CDC study

authors found was an overall prevalence of HPV (any type) infection in 26.8

% of the American females studied, with 3.4% infected with one of the four

HPV types in Merck's quadrivalent vaccine and 2% infected with one of the

two vaccine types (HPV 16 and 18) associated with cervical cancer. The

study noted that 90 percent of all HPV infections are cleared from the body

and do not become chronic. This means that less than one quarter of one

percent of all American women are at risk for chronic infection with one of

the two HPV types associated with cervical cancer which are contained in

Merck's GARDASIL vaccine.

These new HPV prevalence data seriously call into question the cost benefit

ratio for GARDASIL, particularly when taking into account short and long

term serious vaccine reactions being reported to the Vaccine Adverse Event

Reporting System (VAERS), such as five cases of Guillain Barre Syndrome

(GBS) and cases of syncope with seizures, facial paralysis and other signs

of brain and immune system dysfunction. The Editorial in JAMA also

questioned whether the two HPV types in the vaccine would be replaced by

the other HPV types associated with cervical cancer, limiting the vaccine's

effectiveness. On May 18, 2006, the FDA staff questioned this possibility,

as did NVIC in its Feb. 24, 2007 press release ( go to

<http://rs6.net/tn.jsp?t=mk7ad6bab.0.jcsy6wbab.oblmlwbab.8914 & ts=S0233 & p=htt

p%3A%2F%2Fwww.nvic.org%2F>www.nvic.org).

The Washington Times reports that ACIP chairman Jon Abramson and other

committee members did not want GARDASIL mandated. If this is true, then

ACIP should have stated that fact clearly when they made their

recommendation in the summer of 2006 that all 11 year old girls get the

vaccine. In light of newly published HPV prevalence data and the fact that

Merck only studied GARDASIL in a few hundred eleven year old girls for a

few years, together with reports of serious adverse events such as GBS

coming into VAERS, the CDC's ACIP members should be more worried about

unanimously recommending GARDASIL for routine use with inadequate

supporting evidence.

Finally, The New York Times came out with another editorial endorsing the

HPV vaccine mandates, despite the growing list of outstanding scientific

questions about the vaccine's necessity, safety and effectiveness. The New

York Times is behind the times with its knee jerk endorsement of school

mandates for this vaccine. Whoever wrote the editorial is particularly

cruel to endorse mandates while acknowledging that " it is possible that

unexpected side effects could emerge, though any mandate could be suspended

if that happened. " Is the New York Times editorial staff going to take

responsibility for the children who are required to take GARDASIL and

suffer serious side effects already reported to VAERS, or the children who

will be injured if it is eventually revealed that GARDASIL has more

" unexpected side effects? " American children should not be viewed as guinea

pigs by drug companies, health officials, doctors, politicians or newspaper

editors.

To hear a 30 minute interview explaining the scientific and policy issues

relating to proposed HPV vaccine mandates, listen to a tape of the

www.wnyc.org/shows/bl/episodes/2007/02/22

Feb. 22 Lehrer show on WNYC radio entitled " Strange Bedfellows " .

Describing the show, WNYC says " At least 20 states are considering

mandatory vaccination of young girls against the sexually transmitted virus

that causes cervical cancer. But the backlash has been fast and

furious--and has led to some unlikely alliances. Barbara Loe Fisher,

co-founder and president of the National Vaccine Information Center, and

Moira Gaul, director of women's and reproductive health at the

http://www.frc.org/get.cfm?c=HOME Family Research Council, talk about

their opposition to mandatory vaccination. Sheila Krumholz, executive

director, Center for Responsive Politics, http://www.opensecrets.org/

talks about the lobbying efforts and legislative influence of the

pharmaceutical industry. "

GS

http://washingtontimes.com/business/20070226-115014-2031r.htm

CDC doctor opposes law for vaccine

The Washington Times

By Lopes

THE WASHINGTON TIMES

Published February 27, 2007

The chairman of the federal panel that recommended the new cervical-cancer

vaccine for pre-teen girls says lawmakers should not make the inoculation

mandatory, as the District and more than 20 states, including Virginia, are

considering.

Dr. Jon Abramson, chairman of the Centers for Disease Control and

Prevention's advisory committee on immunization practices (ACIP), also said

he and panel members told Merck & Co., the drug Gardasil's maker, not to

lobby state lawmakers to require the vaccine for school attendance. " I told

Merck my personal opinion that it shouldn't be mandated, " Dr. Abramson told

The Washington Times. " And they heard it from other committee members. "

Dr. Abramson said he opposes mandating Gardasil, which prevents the

cervical-cancer-causing human papillomavirus (HPV), because the sexually

transmitted HPV is not a contagious disease like measles and he is not sure

states can afford to inoculate all students. " The vaccines out there now

are for very communicable diseases. A child in school is not at an

increased risk for HPV like he is measles, " Dr. Abramson said.

In addition, Dr. Abramson said a discussion about making the vaccine

mandatory should not be had until states show the money is available to

vaccinate every child, adding, " I don't see that yet. "

Taken in a series of three shots at $120 each, Gardasil is the most

expensive vaccine on the market. About 45 percent of children would be

eligible for free vaccines from the federal Vaccinations for Children

program, while the other 55 percent would depend on the state programs and

insurance companies.

The ACIP, a 15-member panel charged with developing vaccine schedules and

dosages, recommended Gardasil for 11- and 12-year-olds in July, spurring

Merck's lobbying efforts and the legislative push to make the HPV vaccine

mandatory for sixth-grade girls.

Merck suspended its lobbying efforts last week amid criticism from parents,

who said it would interfere with control over their children, and from

conservative groups that said it would encourage premarital sex. Merck

responded yesterday to Dr. Abramson's comments with a statement it had made

previously. " We have had ongoing discussions with a number of key public

health experts and listened to their thoughts regarding the timing for

school requirements of the HPV vaccine. We do not want any misperception

about Merck's role to distract from the ultimate goal of fighting cervical

cancer, so Merck has re-evaluated its approach at the state level and we

will not lobby for school requirements for Gardasil. "

Gardasil is nearly 100 percent effective against two strains of HPV that

lead to 70 percent of cervical cancer cases in the United States. Nearly

11,000 cervical-cancer cases occur in the U.S. each year, killing more than

3,700, according to the American Cancer Society. But cancer data show that

lawmakers looking to force pre-teen girls to take Gardasil, the lone

vaccine on the market, are targeting the wrong age group.

Middle-school girls inoculated with the breakthrough vaccine will be no

older than 18 when they pass Gardasil's five-year window of proven

effectiveness -- more than a decade before the typical cancer patient

contracts HPV, The Washington Times reported last week.

Infectious disease specialists and cancer pathologists say the incubation

period for HPV becoming cancer is 10 to 15 years -- meaning the average

cervical cancer patient, who is 47, contracted the virus in her 30s and

would not be protected by Gardasil taken as a teen.

Dr. Abramson said the panel thinks the vaccine will last for at least 10

years. Even if it provides 10 years of protection, it would still leave

girls given the inoculation in the sixth grade vulnerable during their late

20s and early 30s, when most cervical-cancer patients contract HPV. At that

point, another round of Gardasil would be necessary.

Merck is still studying Gardasil's longevity and the potential for a

booster shot.

ACIP is the only entity in the federal government to issue immunization

recommendations and does not recommend a vaccine be made mandatory; those

decisions are left to the states. But the committee's recommendation on the

use of a vaccine often plays the lead role in whether states will act to

make it part of their mandatory vaccine list, said Barbara Fisher,

president of the National Vaccine Information Center, which is opposed to

laws making Gardasil mandatory. " They are the signal for states to act, "

she said. " The committee knows that and I think they see people getting

upset about it. "

Earlier this month, Texas became the first state to enact an HPV vaccine

law when Gov. Rick bypassed the state Legislature and signed an

executive order mandating all girls entering sixth grade be inoculated. Mr.

, who drew fire when it was revealed that his former chief of staff,

Mike Toomey, lobbies for Merck, said his order is based on the CDC

recommendation.

The Virginia General Assembly last week approved legislation that would

require that girls receive the Gardasil before entering sixth grade

starting Oct. 1, 2008. The legislation allows parents to opt not to have

their daughters vaccinated.

www.philly.com/mld/inquirer/living/health/16798039.htm

Cancer-virus strains rarer than first estimated

Just 2 percent of females 14-59 are infected, a new survey shows. Experts

still back HPV vaccine.

the Philadelphia Inquirer

February 28, 2007

By Marie McCullough

The first broad national snapshot of human papillomavirus infection shows

that two dangerous strains covered by the new cervical-cancer vaccine

infect just 2 percent of females ages 14 to 59, a lower prevalence than

previously estimated.

Even among women most likely to be infected - sexually active 18- to

25-year-olds - these two cancer- causing HPV strains were relatively

uncommon, infecting 3.5 percent. Experts say these findings, published

today, do not change the conclusion that the public-health benefits of

vaccination are worth the cost.

But the new data may create confusion and fuel controversy over whether to

mandate inoculation of pubescent girls. At least 20 states are considering

proposals. The study supports the notion that there should not be a " rush

to make this vaccine mandatory, " said Chaiken, a Dallas lawyer

representing six parents who are suing the Texas governor over his order

requiring vaccination of sixth-grade girls.

Barbara Loe Fisher, president of the National Vaccine Information Center, a

nonprofit advocacy group that contends all vaccines pose risks the public

is not warned about, said she was " shocked " by the new data. " This is not

what most people in America who have looked at publicity for this vaccine

were led to believe, " she said.

Merck & Co.'s Gardasil, which costs $360 for three shots, was approved in

June for females ages 9 to 26. Since then, human papillomavirus has shot

from obscurity to notoriety - without time for much public education about

this huge, ubiquitous family of viruses that come and go, usually

harmlessly, in sexually active people.

Gardasil protects against two " high-risk " HPV strains that cause

precancerous and cancerous cervical changes, plus two strains that cause

genital warts. (Soon, GlaxoKline expects approval of Cervarix, its

rival vaccine for just those two high-risk strains.)

While the new study shows a low prevalence of the two high-risk strains,

their virulence is clear: They are found in 70 percent of cervical cancers.

In the United States, screening programs have reduced annual

cervical-cancer deaths to 3,900. The disease remains a scourge worldwide,

killing 250,000.

The new study, conducted by researchers at the Centers for Disease Control

and Prevention, appears in today's Journal of the American Medical

Association. It is the first to measure prevalence at a single point in

time among a representative sample of the nation's 25 million females ages

14 to 59. Each of the 1,921 participants submitted a self- collected swab

of vaginal cells. The cells were analyzed for DNA of more than two dozen

strains of HPV. There are at least 100 known types.

In the past, most studies of HPV infection were limited to particular

groups of women - at clinics, on college campuses, or in vaccine trials.

These studies found double-digit rates for the two riskiest strains. A few

other HPV studies have looked at nationally representative groups, but

within limited age ranges. For example, a 2002 study of adolescent health

found 7.8 percent of sexually active 18-to-25-year-olds had the two

riskiest HPV strains.

The new data can serve as a baseline to see whether introduction of the

vaccine reduces cervical cancer in coming years, said Eileen Dunne, the

lead CDC researcher. " For us, this provides an opportunity to look at

trends over time, " she said.

Among the findings:

When both low- and high-risk strains are lumped together, HPV infection is

even more common than previous research suggested. A quarter of females in

the study were infected, including nearly half the participants ages 20 to 24.

The two genital-wart-causing strains were uncommon, with a combined

prevalence of 1.4 percent.

Most infected females carried only one HPV type, but 16 percent had three

or more types.

Five HPV types known to cause cancer were more prevalent than the two in

the vaccine.

This last finding suggests that the types the vaccine wards off are somehow

more potent or persistent, said Haupt, Merck's executive director

of medical affairs.

Merck has been on the defensive over Gardasil recently. Last week, Merck

said it was stopping its campaign to lobby states for mandatory vaccination

of 11- and 12-year-old girls due to complaints from some parents, advocacy

groups and health officials.

Meanwhile, Fisher's advocacy group has been calling attention to reports of

" adverse effects " following vaccine administration. The CDC says these are

mostly minor and not necessarily caused by the vaccine.

Lawrence Stanberry, a University of Texas pediatrician who wrote an

editorial accompanying today's report in the medical journal, believes the

real problem is that the public has not had time to learn about the world's

first cancer vaccine. " Some have argued that we need greater safety data.

That's fine, " he said in an interview. " But I think what got short-

circuited was the ability to educate the public about the benefits of the

vaccine. "

See a pediatrician's answers about the HPV vaccine, plus related resource

links, via http://go.philly.com/hpv

Contact staff writer Marie McCullough at 215- 854-2720 or

mmccullough@...

A Necessary Vaccine

The New York Times

February 26, 2007

EDITORIAL

http://www.nytimes.com/2007/02/26/opinion/26mon1.html?_r=1 & oref=slogin

(registration required)

Debate over a new vaccine to prevent cervical cancer and genital warts has

reached a high pitch. State legislatures are debating whether to mandate

the vaccine or insist that its use be kept voluntary. The manufacturer

stopped a vigorous lobbying campaign lest it provoke more opposition than

support. And some health professionals who had been championing the vaccine

flinched at making it mandatory, at least for now.

Even so, state legislatures should require that all young girls be given

this vaccine, which protects against a virus that causes some 10,000 new

cases of cervical cancer in the United States each year — and 3,700 cancer

deaths.

Three weeks ago we applauded Gov. Rick for making Texas the first

state to require vaccinating young schoolgirls — ages 11 and 12 — against

the human papillomavirus. In the ensuing uproar, the Texas House has moved

to overturn his order, but the Virginia Legislature has approved a similar

mandate. Some 20 states have bills pending to require the vaccinations for

school attendance.

We have endorsed a mandate because the vaccine — Merck’s Gardasil — looks

highly effective against strains that cause 70 percent of all cervical

cancer. With more than two million doses already distributed, the reported

side effects have been mostly minor, such as dizziness or fainting. Many

parents who oppose a mandate are aghast at the thought of vaccinating such

young girls against a sexually transmitted disease. But the vaccine works

only if taken before a girl becomes infected. Social conservatives object

that the vaccine will encourage promiscuity, but it seems farfetched to

believe that protection from cervical cancer will change any girl’s

behavior. Others complain that a mandate will pre- empt parental rights to

make health decisions, but all vaccine mandates do that, to protect the

children and those they might infect.

The strongest arguments against moving ahead quickly tend to be practical

and financial. States have typically used school mandates for vaccines that

are already in wide use, and it is possible that unexpected side effects

could emerge (though any mandate could be suspended if that happened).

Health professionals also need to be certain that there are stable

supplies, adequate insurance coverage, ample public money to vaccinate

low-income children and physician support.

Merck deserves praise for developing Gardasil at a time when many companies

shun the vaccine business as risky and unprofitable. But it is charging

$360 for a three-dose regimen, a price that might come down if a competing

vaccine enters the market soon, as expected.

The vaccine could prevent thousands of new cases of cervical cancer

annually and hundreds of thousands of cases of genital warts and

precancerous growths. A mandate would force the health care system to get

cracking. And it is the best way to ensure that all children get the

vaccine, not just those who are aware of it and can afford it.

*************************************************************

National Vaccine Information Center

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