Note that the report referred to is the Judicial Watch report I referred to
in an earlier post; the reporter has failed to tell readers that this is
hardly a disinterested group but funded by Richard Mellon Scaife an
arch-conservative. This is a bad piece of reporting, and by someone I used
to know well in LA.


On Mon, Aug 11, 2008 at 8:15 PM, Phil Gasper <[log in to unmask]> wrote:

> aug11,0,2785988.story
>  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."
>  [log in to unmask]

Michael Balter
Contributing Correspondent, Science
Adjunct Professor of Journalism,
Boston University

Email: [log in to unmask]

Balter's Blog: