Parents, Reporters Pull Plug on Merck's Legislative Strategy

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Wed, 7 Feb 2007 21:04:19 -0800 (PST)

[NVIC] Parents, Reporters Pull Plug on Merck's Legislative

Strategy

 

 

Vaccine Center Issues Warning

The Washington Times

February 3, 2007

 

by Gregory Lopes

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The National Vaccine Information Center yesterday warned state

officials to investigate the safety of a breakthrough cancer vaccine

as Texas became the first state to make the vaccine mandatory for

school- age girls.

 

Negative side effects of Gardasil, a new Merck vaccine to prevent the

sexually transmitted virus that causes cervical cancer, are being

reported in the District of Columbia and 20 states, including

Virginia. The reactions range from loss of consciousness to seizures.

 

" Young girls are experiencing severe headaches, dizziness, temporary

loss of vision and some girls have lost consciousness during what

appear to be seizures, " said Vicky Debold, health policy analyst for

the National Vaccine Information Center, a nonprofit watchdog

organization that was created in the early 1980s to prevent vaccine

injuries.

 

Following federal approval of the vaccine in July 2006, a storm of

legislation was introduced across the nation that would make the

vaccine mandatory in schools. The District and Virginia are part of a

group of at least 17 states considering such legislation. A measure

had been introduced in Maryland, but it was shelved last week over

concerns about the mandatory language in the bill.

 

Yesterday, Texas Gov. Rick Perry signed an order making Texas the

first state to require the vaccine. Girls ages 11 and 12 would receive

the human papillomavirus (HPV) vaccine before entering the sixth grade

starting in September 2008.

 

The American Cancer Society estimates there were 9,710 new cases of

cervical cancer in the United States in 2006. The District's cancer

control center estimates a total of cervical cancer cases in the city

last year, and the American Cancer Society estimates that last year

Maryland and Virginia each had 210 cases of cervical center.

 

Merck began marketing Gardasil last year after the Food and Drug

Administration approved it for females ages 9 to 26. The vaccine is

the first of its kind to build immunity against two strains of HPV,

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

 

The vaccine is not effective in men, who can get cancer from other

strains of HPV.

 

Its side effects were reported to the Vaccine Adverse Event Reporting

System, a federal reporting system for consumers to notify federal

regulators of bad reactions to medications. The adverse events began

being reported in July 2006, when an advisory panel to the Centers for

Disease Control and Prevention recommended girls ages 11 and 12

receive the series of shots.

 

The types of side effects reported are not cause for alarm, according

to the American Cancer Society.

 

" We have not been informed of an instance that would call into

question the overall safety of the vaccine, " said Debbie Saslow,

director of breast and cervical cancer control at the American Cancer

Society, adding that about 70 similar events had been known in October

2006.

 

Likewise, the CDC will not alter its approval of the vaccine despite

the number of adverse events revealed through the reporting system.

 

" A report to the Vaccine Adverse Event Reporting System does not

necessarily mean the adverse event was serious or that it was caused

by the vaccine, " said CDC spokesman Curtis Allen. " This vaccine has

been tested around the world and has been found to be safe and effective. "

 

Merck is heavily promoting the vaccine through its salespeople

imploring doctors to provide it and running TV ads urging young women

to get vaccinated so there will be " One Less " cancer patient.

 

But physicians disagree with public health officials over whether

Gardasil is the panacea for cancer. Clayton Young, an obstetrician/

gynecologist in Texas, objects to Merck's claim that Gardasil will

prevent cervical cancer.

 

" There is no proof Gardasil will stop cervical cancer, " he said. " They

haven't been studying it long enough to make that claim. "

 

Merck spokesman Chris Loder said the vaccine is effective for five

years and the Whitehouse Station, N.J., drug maker is not sure how

long afterward the vaccine will work. Critics point out that an

additional booster shot may be necessary.

 

Advocates for a mandatory vaccine say that although the vaccine does

not prevent all causes of cervical cancer, Gardasil is an effective

vaccine against the most prevalent cause and therefore is a correct

public health measure.

 

Gardasil is delivered in three separate injections that cost $120 to

$150 per injection. Blue Cross Blue Shield, an omnipresent health

insurer in the Mid-Atlantic region, covers the vaccine for girls in

the federally recommended age groups.

 

Merck revenue from Gardasil reached $155 million for the fourth

quarter of 2006 and $255 million for the entire year.

 

Texas Gov. urged against cancer order

Wyoming News, WY

Associated Press

February 7, 2007

 

By LIZ AUSTIN PETERSON

 

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AUSTIN, Texas - Several key Republicans urged Gov. Rick Perry on

Monday to rescind his executive order making Texas the first state to

require girls to be vaccinated against the sexually transmitted virus

that causes cervical cancer.

 

Lawmakers should have been allowed to hear from doctors, scientists

and patients before the state implemented such a sweeping mandate,

said state Sen. Jane Nelson, chairwoman of the health and human

services committee.

 

" This is not an emergency, " said Nelson, adding that she plans to ask

Attorney General Greg Abbott for an opinion on the legality of Perry's

order. " It needs to be discussed and debated. "

 

Three other Republican lawmakers filed bills that would override the

mandate, and several others were working on similar legislation.

 

Perry defended his decision, saying his fellow conservatives were

wrong to worry that mandating the vaccine will trample parents' rights

and promote premarital sex.

 

" Providing the HPV vaccine doesn't promote sexual promiscuity any more

than providing the Hepatitis B vaccine promotes drug use, " Perry said

in a statement. " If the medical community developed a vaccine for lung

cancer, would the same critics oppose it claiming it would encourage

smoking? "

 

Perry has ordered the Texas Health and Human Services Commission to

adopt rules requiring Merck & Co.'s new Gardasil vaccine for girls

entering the sixth grade as of September 2008. The vaccine protects

girls against strains of the human papillomavirus that cause most

cases of cervical cancer.

 

Texas allows parents to opt out of inoculations by filing an affidavit

objecting to the vaccine on religious or philosophical reasons, but

critics say the order still interferes with parental rights.

 

" I don't think the government should ever presume to know better than

the parents what to do with children, " Republican Lt. Gov. David

Dewhurst said.

 

Perry also directed state health authorities to make the vaccine

available free to girls ages 9 to 18 who are uninsured or whose

insurance does not cover vaccines. And he ordered Medicaid to offer

Gardasil to women ages 19 to 21.

 

Doctors say Perry's vaccine mandate for girls is premature

They hail inoculation for cancer-causing virus but cite liability,

cost concerns

Houston Chronicle

 

 

By TODD ACKERMAN

 

Click here for the URL:

 

Gov. Rick Perry's order requiring schoolgirls to get inoculated

against a sexually transmitted virus linked to cervical cancer may be

unpopular with social conservatives, but another important group also

is lining up against it: doctors.

 

From, among others, the Texas Medical Association and the American

Academy of Pediatrics, many doctors are saying it's too early to

mandate the vaccine, which was approved for use last June. It protects

against four strains of the human papillomavirus that cause 70 percent

of cervical cancers.

 

" We support physicians being able to provide the vaccine, but we don't

support a state mandate at this time, " said Dr. Bill Hinchey, a San

Antonio pathologist and president-elect of the TMA, which represents

41,000 physicians. " There are issues, such as liability and cost, that

need to be vetted first. "

 

Other reasons cited by doctors in Texas and across the country include

the vaccine's newness; supply and distribution considerations; the

possibility opposition could snowball and lead to a reduction in other

immunizations; the possibility it could lull women into not going for

still-necessary cervical cancer screenings; gender-equity issues; and

the tradition of vaccines starting as voluntary and becoming mandatory

after a need is demonstrated.

 

Hinchey said that TMA leadership expressed their concerns to Perry on

Tuesday. He said the TMA arrived at its position after debating the

issue in committees in recent days.

 

A spokeswoman for Perry reiterated Tuesday that the governor stands by

the order. She said he is listening to the discussion but thinks the

vaccine is safe and effective.

 

Unexpected opposition

 

Perry touched off a firestorm Friday when he issued the order, which

requires girls receive the three-shot vaccination to enter sixth

grade, starting in September 2008. Social conservatives said a mandate

makes sex seem permissible. Others complained Perry was circumventing

the legislative process, where bills to make the vaccine mandatory had

been filed.

 

Opposition from doctors was less expected. Virtually all hail the

vaccine as a great breakthrough and call for the highest possible

proportion of girls and women — and boys and men, eventually — to get

immunized in hope of one day eliminating the virus.

 

" But education needs to come first, " said Dr. Joseph Bocchini,

chairman of the AAP's committee on infectious disease. " Much of the

public doesn't know about HPV and its link to cervical cancer and

other diseases. You can't put a mandate ahead of that. "

 

HPV is the most common sexually transmitted infection in the United

States, infecting 6.2 million new people a year. Though the immune

system usually clears the infection, it can lead to cervical cancer,

cancer of the penis and anus, and genital warts. Although cervical

cancer is declining in the United States, there are 9,710 new cases a

year and 3,700 annual deaths attributed to it. Worldwide, it's the

second most common cancer in women, resulting in 233,000 deaths a year.

 

Point of contact an issue

 

The 60,000-member AAP circulated a statement last week that lays out

many concerns about a mandate. The statement, written before Perry's

order, notes that 24 states and the District of Columbia have

introduced or prefiled legislation requiring adolescent girls to get

the vaccine.

 

Among the statement's points is that mandating a vaccine for a disease

not spread by casual or occupational contact — and currently only

available to one gender — represents a departure from past practice.

Such school immunization requirements came into existence, it says, to

protect schoolchildren from outbreaks of contagious disease in that

setting, not to compel vaccination. (The quickest a vaccine has gone

from approval to mandatory in Texas was the chickenpox vaccine, which

took 5 1/2 years.)

 

The statement also says the costs of such a program will further

strain state vaccine programs already short on resources. It says

states that choose to add the HPV vaccine to school entry programs

should provide additional funding and insurance coverage.

 

Perry's order said the vaccine would be covered under the federal

Vaccine for Children program, which supplies vaccines to those

uninsured, underinsured or on Medicaid or the Children's Health

Insurance Program. The order said nothing about coverage by private

insurers, many of whom aren't yet including the shot in their popular

plans. The vaccine costs from $120 to $200 a shot.

 

Reaction from doctors

 

Dr. Patricia Sulak, a professor of obstetrics- gynecology at the Texas

A & M Health Science Center College of Medicine, said health-care

providers she knows were shocked by the order. " It's such a new

vaccine — they haven't had time to explain it to patients, " said

Sulak. " I think everyone was happy with the CDC's Advisory Committee

for Immunization Practices' recommendation that it be routinely given.

But this makes it seem like it's being shoved down people's throats. "

 

Hinchey and others emphasized that although the vaccine is considered

safe, there are questions of whether there is enough experience with

it to warrant a mandate. They say that some girls eventually may

experience rare adverse effects not yet identified.

 

One medical ethicist was willing to give Perry's order a chance.

 

" Perry gave a classic public-health- ethics rationale for the

program, " said Laurence McCullough, a professor in Baylor College of

Medicine's Center for Ethics and Health Policy. " But he needs to

present to the legislature a cost analysis and funding source so other

priorities are not displaced. "

 

McCullough added that Perry likely would have avoided controversy if

he'd signed on to proposed legislation and led public debate rather

than issuing an executive order.

 

 

todd.ackerman@ chron.com

 

Moves to Vaccinate Girls For Cervical Cancer Draw Fire

As Merck Lobbies States To Require Shots, Some Fret Over Side Effects,

Morals

The Wall Street Journal

February 7, 2007; Page D1

 

By JOHN CARREYROU

 

Click here for the URL:(subscription required)

Bills being drafted in some 20 U.S. states that would make a

cervical-cancer vaccine mandatory for preteen girls are sparking a

backlash among parents and consumer advocates.

 

The bills coincide with an aggressive lobbying campaign by Merck &

Co., the maker of the only such vaccine on the market. Called

Gardasil, the three- shot regimen provides protection against the

human papillomavirus, a sexually transmitted virus that is responsible

for the majority of cases of cervical cancer.

 

If the state bills become law, they would guarantee the Whitehouse

Station, N.J., drug maker billions of dollars in annual revenue from

the vaccine.

Proposed legislation varies from state to state, but the bills

generally would require girls to show proof that they have received

the inoculation in order to enter school. A number of immunizations --

including those for measles, chicken pox and polio -- are mandatory

for U.S. schoolchildren because they block highly contagious diseases

that can be spread easily in a group setting. But HPV is different

because it is transmitted sexually. At $360 for the three shots,

Gardasil is also costlier than many vaccines (a measles-mumps- rubella

shot costs about $42.85 per dose, for instance), though it is

generally covered by insurance.

 

Conservative Christian groups have long voiced opposition to the

vaccine, saying it would conflict with their message of abstinence

because it would, in effect, condone premarital sex. However, concern

has spread beyond the religious right as momentum has grown for making

inoculation mandatory. A growing number of parents are worried about

exposing their children to the unforeseen side effects of a new

vaccine to protect them from a disease that is no longer very common

in the U.S. and often doesn't develop until much later in life.

 

Tina Walker, the mother of an 11-year-old girl in Flower Mound, Texas,

says she would prefer to wait until the vaccine has been on the market

for several years before subjecting her child to it. " We are the

guinea pigs here, " she says.

 

Last week, Texas Gov. Rick Perry issued an executive order mandating

that the vaccine be administered to all girls entering the 6th grade

in the state as of September 2008. The Texas executive order, which

includes an opt-out clause for religious or other " reasons of

conscience, " enabled the governor to bypass what would have likely

been a heated debate in the Texas Legislature.

 

Many of the state bills contain opt-out clauses, but a few don't. The

bill pending in Florida would bar students ages 11 or 12 from being

admitted to public or private school in the state unless they can

provide proof that they have been vaccinated or that their parents

opted them out after receiving information about cervical cancer and

the vaccine.

 

Merck says cervical cancer is the second-leading cancer among women

around the world, but the disease's prevalence is actually low in the

U.S. The American Cancer Society estimates that 11,150 women will be

diagnosed with cervical cancer and 3,670 will die from it in the U.S.

this year. That's equivalent to 0.77% of cancers diagnosed in the U.S.

and 0.65% of U.S. cancer deaths each year. By comparison, the society

estimates that 178,480 American women will get diagnosed with breast

cancer in 2007 and 40,460 will die from it.

 

Adding to some parents' concern, 82 adverse events among both teens

and adult women have been reported since Gardasil became available

last June. Many involve common immune-system responses to vaccines,

such as nausea, fever or rashes. But a number of patients suffered

syncopes, or fainting spells.

 

Richard Haupt, Merck's executive director of medical affairs, says the

syncopes are caused by patients' anxiety at having a needle stuck in

their arm and not due to any neuro-immune reaction to the vaccine. Mr.

Haupt adds that the number of adverse events is small compared with

the hundreds of thousands of doses of the vaccine administered so far

in the U.S.

 

However, with any newly approved drug or vaccine, side effects often

don't become apparent until a regimen has been on the market for a

while, leading some patient and consumer advocates to urge states to

hold off on requiring vaccination until Gardasil's safety is more

clearly established.

 

Of the more than 25,000 patients who participated in clinical trials

of Gardasil, only 1,184 were preteen girls. " That's a thin base of

testing upon which to make a vaccine mandatory, " says Barbara Loe

Fisher, co-founder of the National Vaccine Information Center, an

advocacy group that lobbies for safer vaccines.

 

Gardasil is approved for females ages 9 to 26, and the three-dose

regimen is the same for all age groups. The vaccine protects against

four strains of HPV that cause 70% of cervical cancer cases. So it

would not eliminate the need for vaccinated women to have regular Pap

smears to detect cancerous cells caused by other HPV strains. HPV is

also the virus that causes genital warts.

 

Merck acknowledges that it doesn't know yet whether an initial

vaccination will offer lifetime protection or whether patients will

need booster shots. So far, the company has shown only that the

vaccine lasts five years.

 

Merck started lobbying state legislatures to pass laws requiring

vaccination last year after the Centers for Disease Control and

Prevention's Committee on Immunization Practices recommended that all

girls get the vaccine when they turn 11 or 12. Another HPV vaccine,

called Cervarix, is in development from GlaxoSmithKline PLC, but so

far Gardasil is the only regimen on the market.

 

As part of its lobbying campaign, Merck has been funding Women in

Government, a Washington, D.C.- based advocacy group made up of female

state lawmakers. An executive from Merck's vaccine division, Deborah

Alfano, sat on Women in Government's business council last year, and

many of the bills across the country have been introduced by members

of the group.

 

Merck declined to say how much money it has funneled into its lobbying

campaign, or contributed to Women in Government. A spokeswoman for

Women in Government, Tracy Morris, declined to say how much it had

received from Merck. In Texas, one of Merck's lobbyists is Gov.

Perry's former chief of staff, and Merck's political action committee

contributed $6,000 to the governor's re-election campaign.

 

" Parents should be concerned that the only company that makes this

vaccine is pushing behind the scenes for mandatory laws, " says Maryann

Napoli, associate director for the Center for Medical Consumers, a

consumer group based in New York.

 

At a Merrill Lynch conference yesterday, Margaret McGlynn, the

president of Merck's vaccine division, acknowledged the company's

aggressive lobbying campaign but said, " States decide what works for

them. " She added that she had her own daughter vaccinated with

Gardasil and " immunizing females against cervical cancer is absolutely

the right thing to do. "

 

Mandatory vaccination across the U.S. would make Gardasil an automatic

blockbuster for Merck at a time when the patents on some of its

bestselling drugs are expiring and it's desperate to replace their

revenue streams. Gardasil's sales in 2006 were $235 million.

 

Cervical cancer is a much bigger problem in the developing world,

which accounts for more than 80% of cases of the disease. Merck says

it's committed to bringing the vaccine to developing countries, but

for now its availability is limited there to a few studies and

demonstration programs.

 

 

Write to John Carreyrou at john.carreyrou@ wsj.com

POINTS OF CONTENTION

 

Concerns over mandating shots:

 

• Some parents say a vaccine for HPV, the sexually transmitted disease

that can cause cervical cancer, effectively condones premarital sex.

 

• Long-term efficacy and risk of side effects are unclear. There have

been 82 reports of adverse events associated with the vaccine.

 

• Gardasil is typically covered by insurance, but is costlier than

many other common vaccines.

 

 

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