Vera--Mandatory Gardasil Produces Backlash_USA Today Editorial / NYT Letters

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org and http://ahrp.blogspot.com

 

FYI

 

" American schoolgirls have the right to a free education without

being

forced into a new and controversial vaccination program.

What kind of people supply schoolgirls to a pharmaceutical

company, allowing

it to earn millions a year on [vaccine] mandates? "

(Elizabeth Beiter, NYT letter)

 

An editorial in USA Today (below) criticizes Texas Gov. Rick

Perry who " is

so enthusiastic about Gardasil that a week ago, he ordered all

girls in the

state to be immunized before entering sixth grade, as of

September 2008.

(Parents can opt out for religious and other reasons.) "

 

USA Today correctly notes that the move was " prompted in part by

a vigorous

lobbying campaign by Merck, which stands to earn billions of

dollars if the

vaccine is required. " Conflicts of interest involving Texas

governor Perry

were reported

http://ahrp.blogspot.com/2007/02/facts-behind-mercks-mandatory-vaccine.htmlI

ndeed.

 

Merck invested heavily in lobbying efforts--including funding

Women in

Government, an organization of state legislators--as reported by

The Wall

Street Journal

http://online.wsj.com/article/SB117082394405400647.html.

Those lobbying efforts have been dubbed the " Help Pay for Vioxx "

litigation

campaign.

 

USA Today cites scientific uncertainty about the vaccine's

safety, noting

FDA's poor performance in tracking adverse effects--as

demonstrated by the

catastrophe caused by Merck's pain killer, Vioxx ; failure to

debate the

issue; the nature of the disease which, unlike communicable

diseases such as

polio or smallpox, is not spread by casual contact. Therefore,

there is no

justification for mandating the vaccine rather than allowing

parents to make

the decision for their daughters.

http://ahrp.blogspot.com/2007/02/drugmakers-hurry-sales-delay-safety.html

 

Below is Rick Perry's defense of his position.

 

In sharp contrast to the USA Editorial and the report in The Wall

Street

Journal, an editorial in The New York Times, " A Vaccine to Save

Women's

Lives " (Feb. 6) extolled both the vaccine and the governor for

his mandatory

order.

 

The Times' editorial reflects an ideological faith-based belief

rather than

a reasoned appraisal of scientific evidence.

 

Five letters to the editor in today's Times expressed

disagreement with that

embarrassing editorial.

One of these letters from Deborah Kamali, M.D., a professor of

obstetrics

and gynecology at the University of California, San Francisco,

delivers a

knock out to the governor:

" Most deaths from cervical cancer in this country are in women

who are not

adequately screened (with a simple Pap smear). In Texas,

underscreening in

African-American and Hispanic women probably accounts for their

disproportionately high rates of cervical cancer. "

 

The Times owes its readers an in-depth report about the science

and politics

that drive Merck's frenzied marketing of a vaccine that will

hardly make a

dent in saving lives and may, possibly, increase deaths if it

leads women to

believe Merck's marketing hype.

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

http://www.usatoday.com/news/opinion/editorials/2007-02-08-our-view_x.htm

USA TODAY

Rush to require cancer shot threatens to promote backlash

Fri Feb 9, 6:59 AM ET

 

Thanks to vaccines, devastating diseases such as smallpox and

polio have

been virtually eradicated in the USA. That wouldn't have happened

if states

hadn't required immunizations for serious contagious viruses

before a child

can attend school.

 

Now there's a new vaccine, one with potential to prevent cervical

cancers

that kill 3,700 women each year in the USA and 300,000 worldwide.

Called

Gardasil, it is manufactured by Merck & Co. and was approved in

June by the

U.S. Food and Drug Administration.

 

Texas Gov. Rick Perry is so enthusiastic about Gardasil that a

week ago, he

ordered all girls in the state to be immunized before entering

sixth grade,

as of September 2008. (Parents can opt out for religious and

other reasons.)

Prompted in part by a vigorous lobbying campaign by Merck, which

stands to

earn billions of dollars if the vaccine is required, legislators

in 23 other

states and the District of Columbia have proposed mandating

vaccination

against HPV for girls as young as 11.

 

Gardasil may well be the huge medical breakthrough it appears to

be. But a

rush to make it mandatory, less than eight months after FDA

approval, could

have detrimental consequences. Among the reasons to move more

deliberately:

 

..Scientific uncertainty. The history of new drugs and vaccines is

that

unexpected adverse events might not be detected until after

millions of

people have used them, and the FDA does a poor job of tracking

post-approval

effects.

 

Merck's Vioxx, a blockbuster painkiller drug, was withdrawn in

2004, five

years after it was introduced, after studies revealed significant

heart

risks. A vaccine made by Wyeth, to prevent a highly contagious

rotavirus

that can cause severe diarrhea and vomiting in children, was

withdrawn in

1999, just over a year after it was approved, because of safety

concerns.

 

So far, every indication is that Gardasil, the world's first

anti-cancer

vaccine, has only rare and minor side effects. Clinical trials of

more than

11,000 females ages 9 to 26 showed it was 100% effective in

preventing

cervical cancers linked to two types of human papillomavirus

(HPV), a

sexually transmitted disease. But no one will know the complete

picture

until more people are vaccinated for more time. At the moment,

Gardasil is

so new that scientists aren't sure how long it's effective for.

 

..Public unawareness. Little public education about the HPV

vaccine has

occurred. Support appears strong, but 25% of parents in a recent

California

study expressed reservations. Mandating Gardasil now could spark

an

anti-vaccine backlash that would result in fewer girls getting

immunized

against cervical cancer and other diseases. Perry's executive

order

short-circuited a legislative debate that could have convinced

many Texans

of the vaccine's merits.

 

..Nature of the disease. HPV is spread only by intimate sexual

contact. It

isn't in the same class of contagious diseases such as measles,

mumps and

diphtheria that can spread easily to children in the classroom.

Because some

parents are uneasy about vaccinating pre-teens for a sexually

transmitted

disease, the issues need to be handled delicately.

 

With more public education and real-life experience, these qualms

may soon

be overcome and the vaccine may well deserve to be included on

lists of

required immunizations.

 

For now, however, making it mandatory is premature. The vaccine

ought to be

available, at an affordable price, to everyone who wants it after

consulting

with a doctor. But sometimes, promotion of a medical advance can

move too

fast for its own good.

~~~~~~~~~~~~

 

http://www.usatoday.com/news/opinion/editorials/2007-02-08-opposing-view_x.h

tm

My order protects life

Updated 2/8/2007 9:07 PM ET

By Rick Perry

 

As governor of Texas, I will do everything in my power to protect

public

health. The executive order I signed last Friday will help stop

the spread

of human papillomavirus (HPV) and prevent cervical cancer in

young women.

 

\Some are focused on the cause of this cancer, but I remain

focused on the

cure. And if I err, I will always err on the side of protecting

life.

OUR VIEW: Rush promotes backlash

<http://www.usatoday.com/news/opinion/editorials/2007-02-08-our-view_x.htm>

 

For the first time in history, a vaccine exists that can prevent

a deadly

cancer - the second most common form of cancer in women. The HPV

vaccine is

approved by the U.S Food and Drug Administration and the Centers

for Disease

Control and Prevention, and a second vaccine is expected on the

market

within the next year.

 

Research shows that the HPV vaccine is highly effective in

protecting women

against the four leading cancer-causing strains of HPV. Though

some might

argue that we should wait several years before requiring the

vaccine, I

believe such a delay unnecessarily risks the lives of young

women.

This is not the first vaccine Texas has required for a

non-contagious

disease. Years ago, Texas required inoculations to prevent the

spread of

Hepatitis B, spread primarily through sexual contact or shared

needles.

 

Even with this new requirement, parents can still choose to opt

out. But we

will never eradicate a disease that impacts 20 million Americans

with an

" opt in " provision because statistics show only one-quarter of

the eligible

population gets inoculated in such circumstances. The " opt out "

provision -

standard for all Texas vaccinations -will help us protect

three-quarters of

our young women.

 

Parents will still have the final word, and a full debate will

take place as

our health agency adopts implementation rules before the order

takes effect

in 19 months. And if Texas legislators want to debate and pass a

different

vaccine law, there is nothing standing in their way.

If we could stop lung cancer, would some shy away claiming it

might

encourage tobacco use? This is a rare opportunity to act, and as

a pro-life

governor, I will always take the side of protecting life.

 

Rick Perry, a Republican, is governor of Texas.

 

Copyright C 2007 USA TODAY, a division of Gannett Co. Inc

<http://www.gannett.com/> .

 

 

February 10, 2007

Requiring a Vaccine for Young Girls (5 Letters)

To the Editor:

 

Re " A Vaccine to Save Women's Lives " (editorial, Feb. 6):

 

I disagree with your suggestion that other states besides Texas

would be

wise to require the vaccination against the human papillomavirus,

or HPV

infection, a sexually transmitted virus that causes cervical

cancer.

 

Although I realize that this breakthrough could greatly reduce

the number of

cervical cancers, mandating the vaccination is a lawsuit waiting

to happen.

 

Because this is a new vaccine, some parents may be skeptical of

the

long-term side effects. What will happen 10, 20 or 30 years from

now may not

yet be known.

 

Although you note the " opt out " approach taken by Gov. Rick Perry

of Texas

in which vaccination is required but parents can seek an

exemption for

reasons of conscience or religious beliefs, recommending the

vaccine rather

than requiring it could prove to be just as effective without

violating the

parents' right to decide affirmatively - at least until the

long-term

effects are known.

 

Amanda Styron

Raleigh, N.C., Feb. 7, 2007

 

..

To the Editor:

 

As desirable a thing as it may be to protect people from cervical

cancer, a

noncommunicable disease, it is a usurpation of government

authority to

dictate medical decisions that only individuals may make.

 

Schools may rightfully require that children undergo

immunizations that will

protect schoolwide populations from acquiring communicable

diseases, but

cervical cancer does not fall into this category.

 

However benevolent the intent, this is not a matter for Big

Brother.

 

Alan Katz

East Meadow, N.Y., Feb. 6, 2007

 

..

To the Editor:

 

I was surprised to see how quickly you expressed support of the

proposed

mandatory HPV vaccination policy in Texas, stating that the Merck

vaccine is

" highly effective " (editorial, Feb. 6).

 

The vaccine has not been proved to reduce cervical cancer. It is

moderately

effective at preventing certain pre-cancerous changes. There is

no long-term

safety or effectiveness data.

 

Most deaths from cervical cancer in this country are in women who

are not

adequately screened (with a simple Pap smear). In Texas,

underscreening in

African-American and Hispanic women probably accounts for their

disproportionately high rates of cervical cancer.

 

These adult women need access and coverage for screening.

Unfortunately,

there is no lobby for the Pap smear.

 

Deborah Kamali, M.D.

San Francisco, Feb. 6, 2007

The writer is an associate professor of obstetrics, gynecology

and

reproductive sciences at the University of California at San

Francisco.

 

..

To the Editor:

 

Women, young and less so, are infected with the human

papillomavirus by men,

young and less so.

 

Compulsory vaccination has a legitimate place in our health care

system. But

why should the government restrict its vaccinations to the

victims? Why not

include the carriers?

 

Sue Abercrombie

Portland, Me., Feb. 6, 2007

 

..

To the Editor:

 

American schoolgirls have the right to a free education without

being forced

into a new and controversial vaccination program.

 

Does the vaccine help young teenagers with multiple sexual

partners cope

with unplanned pregnancy, other sexually transmitted diseases,

sexual

assault, drug abuse, low self-esteem, boredom and depression?

 

Texas will pay hundreds of dollars per girl for the vaccination.

Why not

spend the money on health care, education about teenagers' bodies

and

rights, enriching music, dance, art and science programs that

engage,

increase confidence and provide an alternative to sexual

activity?

 

What kind of people supply schoolgirls to a pharmaceutical

company, allowing

it to earn millions a year on such mandates?

 

Elizabeth Beiter

Milford, Conn., Feb. 6, 2007

 

 

 

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