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BOTTOM LINE: Controversial HPV Vaccine Stirs Up Yet More Trouble



 
 
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Old August 19th 07, 10:49 PM posted to misc.kids.health,misc.health.alternative,talk.politics.medicine,ca.politics,sci.med.nursing
Ilena Rose
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Default BOTTOM LINE: Controversial HPV Vaccine Stirs Up Yet More Trouble

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Controversial HPV Vaccine Stirs Up Yet More Trouble
from Bottom Line


Last year when I wrote about the HPV vaccine, developed to fight the
human papillomavirus, a sexually transmitted virus that can cause
cervical cancer, I voiced concern about its safety and efficacy given
that it was new and had been approved very quickly by the FDA (see
Daily Health News, January 23, 2006). Many of these concerns remain,
while new politically based controversies have arisen. Led by Texas
(which since changed course), numerous states jumped to propose making
the vaccination mandatory for all girls entering the sixth-grade.
Given, however, that HPV is normally transmitted sexually, not through
casual contact as is the case with other viruses (such as measles,
mumps and rubella, for instance) in which childhood vaccines are
mandated, this enthusiastic legislative response appears to be driven
by politics and corporate greed rather than public health concerns,
some speculate.

BIG PHARMA STRIKES AGAIN

Consumer advocacy groups and the news media are quick to blame Merck,
manufacturer of the vaccine, for the tactics it employed in promoting
the vaccine's use. First and foremost, the vaccine was tested in only
a small sample of girls under 16 (fewer than 1,200) and as a new
vaccine it has no track record for safety, I was told by Barbara Loe
Fisher, president of the National Vaccine Information Center (NVIC), a
national, non-profit, educational organization dedicated to the
prevention of vaccine injuries and deaths. Secondarily, she adds, the
majority of Americans do not want state governments forcing this kind
of decision upon their families. There was clearly a groundswell of
opposition to the mandated vaccine from all sides, hence the bill for
it being overturned in the state of Texas. Some oppose it due to
safety concerns... others because it tramples on parents' rights. A
recent survey confirmed this opposition. In a University of Michigan
Health System poll, only 44% of parents supported the mandatory HPV
vaccine. The rest were neutral or opposed. Nonetheless, the
manufacturers have succeeded in promoting their extraordinarily
profitable materials as "necessary for the public's safety."

QUESTIONABLE MARKETING TACTICS

There's no doubt that vaccines mean big money for big business. In
June 2006, pharmaceutical giant Merck received approval for its
vaccine, sold under the name "Gardasil," from the US Food and Drug
Administration (FDA) after clinical trials showed very positive
results, leading the FDA to speed its approval under its "priority
review process." Shortly thereafter, the Centers for Disease Control
and Prevention (CDC) issued a recommendation for its use in girls ages
11 and 12, followed within a few months by a huge advertising campaign
from Merck, featuring young girls jumping rope and chanting "I want to
be one less, one less" on TV and in magazines. Simultaneously, the
company launched an aggressive behind-closed-doors lobbying effort in
state after state to require the vaccination for all girls entering
sixth grade or of middle-school age. The projected revenue for
Gardasil should the mandates pass is hundreds of millions of dollars
per year.

Serious questions about a conflict of interest arose in Texas earlier
this year. Literally the same day Governor Rick Perry's chief of staff
met with Merck execs, the drug company made a significant contribution
to Perry's campaign (as well as those of eight other Texas
legislators). One of the Merck lobbyists in Texas is the governor's
former chief of staff, and the governor is also closely aligned with
Women in Government, a non-profit bi-partisan advocacy group of women
legislators that receives money from Merck. Similar concerns have
arisen in other states, including Florida, Virginia and Maryland,
suggesting that Merck is more or less buying its way into the
mandates.

Then there is the fact of Merck's recent poor track record for drug
safety. Multi-million dollar lawsuits continue against the company for
its osteoarthritis medication rofecoxib (Vioxx), abruptly pulled from
the market in 2004 after causing heart attacks and stroke. It turned
out that Merck had been aware of these cardiovascular risks for years,
but covered them up. (Interestingly, Vioxx received a six-month
priority review just as Gardasil did.) Now there are safety questions
about another Merck drug, alendronate (Fosamax), which is used to
treat osteoporosis. (For more on the dangers of Fosamax, see the
January 18, 2007 issue of Daily Health News.)

SERIOUS HEALTH CONCERNS PERSIST

Politics aside, Fisher continues to have health concerns about the HPV
vaccine, including...

Insufficient study. In Fisher's opinion, Merck and the FDA have not
been completely honest with the American people about the
pre-licensure clinical trials. The HPV vaccine has been studied in
fewer than 1,200 girls under age 16, yet is being recommended for all
girls 11 and 12.

Safety. There were 385 Gardasil adverse events reported to the federal
Vaccine Adverse Event Reporting System (VAERS) during the last six
months of 2006. These included collapse into unconsciousness and
seizures in the doctor's office after vaccination or in the next 24
hours. Two-thirds of those affected required additional medical care,
and nearly one-third of all reports (where age was reported) were for
girls 16 or younger. One out of four of these reactions occurred when
Gardasil was administered along with other vaccines. As a result, NVIC
is calling on the FDA and CDC to issue warnings that Gardasil should
not be combined with other vaccines, and that girls be monitored for
fainting, seizures, tingling, numbness and loss of sensation in the
fingers and limbs for 24 hours after vaccination.

Long-term effectiveness. At Merck's urging, the FDA agreed to
fast-track the HPV vaccine in February 2006, and it was approved that
June. Although testing was limited -- particularly in the age group
for which the mandate is proposed -- some speculate it was in Merck's
best financial interests to roll out the vaccine as soon as possible
so that it could achieve market domination before GlaxoSmithKline
introduced its own version. Rarely has a vaccine this new been granted
such a rapid and sweeping mandate after FDA approval, observes Fisher.
The process typically takes five to six years -- as it should, to
verify there are no long-term health risks.

Necessity. Fisher notes that cervical cancer causes less than one
percent of all cancers and cancer deaths (between 3,000 and 4,000 US
deaths annually). In contrast, tobacco is implicated in an estimated
438,000 American deaths each year.
So, I ask, if the government is going to legislate health, why not ban
tobacco? Why instead mandate a controversial vaccine that impacts only
a very narrow portion of the population, putting them at risk for side
effects?

Cost. At $360 for a three-shot regimen, Gardasil is unusually
expensive and not all insurance plans may cover it. However, if the
vaccine is mandated, insurance coverage is far more likely. Clearly
that will make the people at Merck very happy. Fisher points out that
because a competing HPV vaccine is in the pipeline, Merck is highly
motivated to seize and dominate the market before a rival
pharmaceutical firm steps in.

Public health impact. There is no evidence that the HPV vaccines will
eliminate all HPV strains or cervical cancer. The vaccine targets two
high-risk HPV strains that are known to cause cervical cancer and two
low-risk types that are know to cause genital warts. However, FDA and
CDC officials have questioned whether other high-risk HPV strains will
eventually replace those controlled by widespread use of the vaccine
and continue to cause disease. It is not knownn if boosters will be
needed and long-term safety is also unknown.
A PERSONAL DECISION

To find out whether legislation is under consideration in your state
to mandate the HPV vaccine for young girls, visit the Web site of the
National Conference of State Legislatures at
www.ncsl.org/programs/health/HPVvaccine.htm. If you learn that a
mandate may be instituted, most states allow exemption to vaccination
for medical reasons and for sincerely held religious beliefs. Only
about 17 states allow exemptions for personal or philosophical
beliefs. This may mean that your daughter would be excluded from
attending public school if you cannot obtain one of these exemptions.

In the long run, the HPV vaccine may or may not prove to be safe and
effective. Only time will tell -- and I'd argue, we need to let more
time pass before making such a big decision. In the meantime, meet
with your physician, review its pros and cons from unbiased sources,
and come to an independent decision about what's best for your family.
Be careful though, since all sides have strong opinions. Most
physicians are influenced by their specialty and state medical
societies, while consumer organizations questioning the safety of
vaccines are often influenced by personal experience with vaccine
reactions. The complexities of this issue may make it difficult to get
a clear answer from any single source. Ideally, this is a personal
decision that you should be able to make without inappropriate
government, social or medical interference.


Source(s):



Barbara Loe Fisher, President, National Vaccine Information Center,
www.909shot.com

Centers for Disease Control and Prevention, www.cdc.gov

US Food and Drug Administration, www.fda.gov

 




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