From the archive, originally posted by: [ mmm ]

http://www.msnbc.msn.com/id/17246920/

Drugmaker stops lobbying efforts for STD shots
Merck criticized by parents and doctors for pushing cervical cancer vaccine

Updated: 7:32 p.m. CT Feb 20, 2007
TRENTON, N.J. – Merck & Co., bowing to pressure from parents and
medical groups, is immediately suspending its lobbying campaign to
persuade state legislatures to mandate that adolescent girls get the
company’s new vaccine against cervical cancer as a requirement for
school attendance.

The drug maker, which announced the change Tuesday, had been
criticized for quietly funding the campaign, via a third party, to
require 11- and 12-year-old girls get the three-dose vaccine in order
to attend school.

Some had objected because the vaccine protects against a sexually
transmitted disease, human papillomavirus (HPV), which causes cervical
cancer. Vaccines mandated for school attendance usually are for
diseases easily spread through casual contact, such as measles and
mumps.

“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.

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.

Timing of Merck’s push questioned
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.

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.

Gardasil will have bigger effect in poor countries
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 were down in after-hours trading on the New York Stock
Exchange, falling 35 cents to $44.15 after rising 22 cents in regular
trading to close at $44.50.