From today's New York Times. Offered as part of the discussion.

February 26, 2007
 A Necessary Vaccine

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

Three weeks ago we applauded Gov. Rick Perry 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.

On 2/25/07, Phil Gasper <[log in to unmask]> wrote:
> 07022100221.html
> *Merck Suspends Lobbying for Vaccine*
> The Associated Press
> Wednesday, February 21, 2007; 7:52 AM
> TRENTON, N.J. -- Pediatricians, gynecologists and even health insurers all
> call Gardasil, the first vaccine to prevent cervical cancer, a big medical
> advance.
> But medical groups, politicians and parents began rebelling after
> disclosure of a behind-the-scenes lobbying campaign by Gardasil's maker,
> Merck & Co., to get state legislatures to require 11- and 12-year-old girls
> to get the three-dose vaccine as a requirement for school attendance.
> Some parents' groups and doctors particularly objected because the vaccine
> protects against a sexually transmitted disease, human papilloma virus,
> which causes cervical cancer. Vaccines mandated for school attendance
> usually are for diseases easily spread through casual contact, such as
> measles and mumps.
> Bowing to pressure, Merck said Tuesday that it is immediately suspending
> its controversial campaign, which it had funded through a third party.
> "Our goal is about cervical cancer prevention, and we want to reach as
> many females as possible with Gardasil," Dr. Richard M. Haupt, Merck's
> medical director for vaccines, told The Associated Press.
> "We're concerned that our role in supporting school requirements is a
> distraction from that goal, and as such have suspended our lobbying
> efforts," Haupt said, adding the company will continue providing information
> about the vaccine if requested by government officials.
> Whitehouse Station-based Merck launched Gardasil, the first vaccine to
> prevent cervical cancer, in June. It protects against the two virus strains
> that cause 70 percent of cervical cancer and two strains that cause most
> genital warts.
> Sales totaled $235 million through the end of 2006, according to Merck.
> Last month, the AP reported that Merck was channeling money for its
> state-mandate campaign through Women in Government, an advocacy group made
> up of female state legislators across the country.
> Conservative groups opposed the campaign, saying it would encourage
> premarital sex, and parents' rights groups said it interfered with their
> control over their children.
> Even two of the prominent medical groups that supported broad use of the
> vaccine, the American Academy of Pediatricians and the American Academy of
> Family Practitioners, questioned Merck's timing, Haupt said Tuesday.
> "They, along with some other folks in the public health community, believe
> there needs to be more time," he said, to ensure government funding for the
> vaccine for uninsured girls is in place and that families and government
> officials have enough information about it.
> Legislatures in roughly 20 states have introduced measures that would
> mandate girls have the vaccine to attend school, but none has passed so far.
> However, Texas Gov. Rick Perry on Feb. 2 issued an executive order requiring
> Texas girls entering the sixth grade as of 2008 get the vaccinations,
> triggering protests from lawmakers in that state. Parents there could opt
> out for their daughters if they state religious or philosophical objections,
> but several Texas lawmakers want to have parents opt in instead of opting
> out.
> Perry defended his order Tuesday, a day after lawmakers in Austin held a
> lengthy hearing on the issue but failed to act on a bill to override the
> order.
> Dr. Anne Francis, who chairs an American Academy of Pediatrics committee
> that advocates for better insurer reimbursement on vaccines, called Merck's
> change of heart "a good move for the public."
> "I believe that their timing was a little bit premature," she said, "so
> soon after (Gardasil's) release, before we have a picture of whether there
> are going to be any untoward side effects."
> Given that the country has been "burned" by some drugs whose serious side
> effects emerged only after they were in wide use, including Merck's
> withdrawn painkiller Vioxx, Francis said, it would be better to wait awhile
> before mandating Gardasil usage.
> She said she also was concerned about requiring a vaccine for a disease
> that is not communicable and so does not have a big public health impact.
> While doctors expect Gardasil to have a huge effect in poor countries where
> women do not get Pap smears, in this country those tests limit the incidence
> of cervical cancer to about 9,710 new cases and 3,700 deaths each year.
> The National Vaccine Information Center has been publicizing reports of
> side effects _ mostly dizziness and fainting _ in several dozen people
> getting Gardasil, which is approved for use in females ages 9 to 26. The
> center, a group of parents worried that vaccines harm some children,
> questions whether the vaccine was tested in enough young girls.
> Officials with the Centers for Disease Control and Prevention, however,
> say that reports of side effects through the end of January don't raise any
> red flags.
> The vaccine also is controversial because of its price _ $360 for the
> three doses required over a six-month stretch. Because of that cost and what
> pediatricians and gynecologists say is inadequate reimbursement by insurers,
> many are choosing not to stock the vaccine or requiring surcharges to
> administer it, increasing the cost for many families and making the vaccine
> hard to come by.
>  Merck shares fell 37 cents to $44.13 in after-hours trading Tuesday after
> rising 22 cents to close at $44.50 on the New York Stock Exchange.


Michael Balter
Contributing Correspondent, Science
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