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From the Los Angeles Times

Gardasil vaccine doubts grow

The safety and effectiveness of the HPV vaccine 
Gardasil as a preventive cervical cancer 
treatment for girls are questioned in a report.

By Linda Marsa
Special to The Times

August 11, 2008

Sandra Levy wants to do everything she can to 
safeguard the health of her 11-year-old daughter 
-- and that, of course, includes cancer 
prevention. She has had her child inoculated with 
one shot of Gardasil, the human papilloma virus 
vaccine that may prevent cervical cancer. But 
now, she says, she has serious reservations about 
going ahead with the next two injections of the 
course.

"It's very confusing, and we really don't know if 
it's 100% safe," says Levy, of Long Beach. "I'm 
not against vaccines, but I don't want to do 
anything that would harm my daughter."

Though most medical organizations strongly 
advocate using the HPV vaccine, some doctors and 
parents, like Levy, are asking whether the 
vaccine's benefits really outweigh its costs. 
They say they aren't convinced that the expensive 
shots offer any more protection than preventive 
measures already available -- principally, 
regular screening via the Pap smear test.

A handful worry that blanket immunizations of the 
nation's adolescents could backfire by lulling 
them into a false sense of security that leads 
them to neglect regular screening. If that 
happened, vaccination could eventually boost 
cervical cancer rates instead of lowering them.

In addition, because Gardasil protects only 
against the HPV strains linked most strongly to 
cervical cancer, "we don't know if it will make a 
difference in the ultimate rates of cancer," says 
Abby Lippman, an epidemiologist at McGill 
University in Montreal who has researched the HPV 
vaccine. "The jury is still out on how much 
benefit we're actually going to get with this 
vaccine."

A report released in June stirred up more doubts. 
Although cause and effect were not proved, the 
report listed serious events -- such as seizures, 
spontaneous abortions and even deaths -- among 
teens, preteens and young women who had earlier 
had Gardasil shots.

As a result, the decision -- to vaccinate or not? 
-- has become controversial. Sorting through the 
pros and cons can be daunting for many parents.

Promoted on TV

Since its approval in June 2006, Gardasil has 
been promoted via TV ads featuring girls jumping 
rope and chanting "One less, one less," a 
reference to the promise that they won't be 
another statistic. The vaccine has been hailed by 
physicians' groups as a breakthrough that could 
potentially eradicate cervical cancer in the U.S. 
within a generation.

The American College of Obstetricians and 
Gynecologists recommended that girls get the 
required series of three doses (given over a 
six-month period) at age 9 or older; the American 
Academy of Pediatrics and the Centers for Disease 
Control and Prevention recommended the same, with 
a starting age of 11 or later. (Because HPV is 
normally spread by intimate contact, the vaccine 
is considered most effective when given before 
the beginning of sexual activity. It will not 
eradicate HPV if someone is already infected.)

Since 2006, about 8 million females in the U.S. 
have received at least one shot of Gardasil, 
according to the vaccine's maker, Merck & Co. of 
Whitehouse Station, N.J., which based these 
estimates on data from government and private 
insurers. Of the 100 known strains of HPV, about 
30 cause cancer or genital warts. Two -- HPV-16 
and HPV-18 -- are responsible for 70% of cervical 
cancers. Pre-market studies showed that the 
vaccine is 90% to 100% effective in thwarting the 
transmission of these two strains and two others, 
which are linked to 90% of genital warts.

The vaccine is expensive. It costs $360 for the 
series of three shots, and administrative fees 
can add $100 or more. Though insurance companies 
sometimes cover costs, the overall expense for 
vaccinating the nations' teenagers could run into 
billions, a bill that will affect taxpayers as 
the shots are given to recipients of government 
health programs and health insurance premiums 
rise.

The price may not be worth it, says Dr. Karen 
Smith-McCune, an obstetrician and gynecologist at 
the UC San Francisco School of Medicine. Because 
it takes years for cervical cancer to develop, it 
is easily preventable as long as HPV infection is 
detected early. Though the cancer is common in 
developing countries and kills more than 280,000 
women worldwide every year, it is much less of a 
health threat in the U.S., she says, where 11,000 
women are diagnosed with the disease annually, 
and about 3,700 will die of it.

The comparatively low U.S. incidence of cervical 
cancer is due to one of the public health 
system's triumphs: widespread use of Pap smears, 
which detect abnormal cervical cells so they can 
be removed before they turn into cancers. 
Adoption of the Pap test caused a reduction of 
cervical cancer rates by 74% between 1955 and 
1992, according to the American Cancer Society. 
Rates continue to drop by 4% each year.

Smith-McCune and other critics of Gardasil also 
note that up to 90% of HPV infections in 
adolescents clear up on their own -- meaning that 
cervical cancer will not develop even in most 
women infected with the most aggressive type of 
HPV. In other words, a woman's risk of developing 
cervical cancer is already extremely low, and the 
immune system normally makes short work of HPV 
without outside help.

Even if women get the vaccine, they still need to 
continue annual Pap screenings because they could 
contract other cancer-causing HPV strains that 
the vaccine does not fight.

"The crux of it is that we know how to prevent 
cervical cancer," Smith-McCune says. "One of the 
key questions is whether this huge outlay of 
money for the vaccine is a better strategy than 
reaching out to the women who aren't getting Pap 
tests and follow-ups."

Studies inconclusive

It is not yet proven that Gardasil actually 
prevents cervical cancer, which can take a decade 
to develop after HPV infection, because tests of 
the vaccine before the FDA greenlighted it didn't 
run long enough to prove that conclusively. "Even 
though it guards against two HPV strains, the 
other HPV types need to be taken into account," 
Smith-McCune says. "It will take a long time 
before we know the true efficacy of the vaccine."

Even doctors who helped devise the vaccine point 
out that Pap screening may be more effective in 
cutting cervical cancer rates. "If we vaccinate 
every single 12-year-old, it should reduce by 
half the number of cervical cancers in the next 
35 years," says Dr. Diane Harper, director of the 
Gynecologic Cancer Prevention Research Group at 
Dartmouth Medical School in Hanover, N.H., and a 
lead researcher in the development of the HPV 
vaccine. "With Pap screening, we've reduced it by 
nearly 75%."

Then there is the issue of side effects. When the 
vaccine was tested in more than 11,000 females 
age 9 to 26 before its FDA approval, no serious 
ones emerged, though some subjects felt soreness 
at the injection site and, in rare instances, 
fainted after the shot.

But an analysis released June 30 by the 
Washington, D.C.-based public interest group 
Judicial Watch raised some red flags. Judicial 
Watch obtained records from the FDA's Vaccine 
Adverse Event Reporting System (VAERS), a 
voluntary system used by doctors, patients and 
drug companies to report side effects with 
vaccines to the federal agency. The report 
revealed that since the vaccine's 2006 approval, 
when girls began getting it, nearly 9,000 had bad 
health events after receiving Gardasil. The 
incidents included 10 miscarriages, 78 severe 
outbreaks of genital warts and six cases of 
Guillain-Barré syndrome, an autoimmune disorder 
that can result in paralysis. There were also 18 
reported deaths.

Since the FDA's VAERS is known to catch perhaps 
10% of adverse events at best, according to a 
2004 report in the New England Journal of 
Medicine by the FDA, the actual numbers may be 
far higher.

It is difficult to prove whether the vaccine was 
the culprit behind these side effects -- just 
because two events happen, it does not mean that 
one caused the other, says Dr. Laurie E. 
Markowitz, an epidemiologist at the CDC who has 
had her own daughter vaccinated. The deaths, and 
all the other serious events, could have happened 
in the absence of the vaccine, she says.

Markowitz remains convinced the vaccine is safe. 
"The CDC and the FDA checked out these reports 
very carefully," she says. "And we've done 
calculations for the number of cases reported and 
the number of cases that you'd find in the 
general population, and we have not found an 
increase."

Given these caveats, should girls be getting the shots?

Most major medical groups still think Gardasil 
should be part of routine immunizations for 11- 
and 12-year-old girls.

Shots still strongly urged

There is more than the matter of cancer 
prevention, says Dr. Joseph A. Bocchini, chief of 
pediatric infectious disease at Louisiana State 
University Health Sciences Center in Shreveport 
and chairman of the American Academy of 
Pediatrics committee on infectious diseases. The 
vaccine could spare hundreds of thousands of 
women from the psychological trauma and physical 
pain of a cycle of follow-up tests when they have 
an abnormal Pap test result and the treatments 
for pre-cancerous lesions that can cause 
infertility.

"You can actually prevent these infections and 
the cervical abnormalities that require more 
invasive interventions," he says.

Whether the shots should be mandatory -- a step 
that has been considered by Texas, Michigan and 
Virginia -- is another issue. "This decision 
should be up to parents, and mandates are silly," 
says Harper of Dartmouth. "While the vaccine will 
improve the health of American women, its real 
benefit is in the developing world. And no matter 
what, Pap screening shouldn't be neglected. 
That's still our best safety net."

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