posted August 11, 2007 09:09 PM
Controversial HPV Vaccine Stirs Up Yet More TroubleLast 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.
http://link.dhn.bottomlinesecrets.com/t/ZABA/0AL2/AZ/UU8MTI
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.)
http://link.dhn.bottomlinesecrets.com/t/Y2HA/0AL2/AZ/UU8MTI
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. http://link.dhn.bottomlinesecrets.com/t/FJXF/0AL2/AZ/UU8MTI
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 http://link.dhn.bottomlinesecrets.com/t/XCP9/0AL2/AZ/UU8MTI
Centers for Disease Control and Prevention, www.cdc.gov http://link.dhn.bottomlinesecrets.com/t/9DCB/0AL2/AZ/UU8MTI
US Food and Drug Administration, www.fda.gov http://link.dhn.bottomlinesecrets.com/t/27HF/0AL2/AZ/UU8MTI
Be well,
Carole Jackson
Bottom Line's Daily Health News
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"There is no use trying," said Alice; "one can't believe impossible things." "I dare say you haven't had much practice," said the Queen. "When I was your age, I always did it for half an hour a day. Why, sometimes I've believed as many as six impossible things before breakfast." Lewis Carroll