By Sigrid Fry-Revere on 3.23.07 @ 12:07AM
Gardasil may be good for Merck -- but is this HPV vaccine good for Virginia girls?
There's nothing wrong with a drug maker publicizing its products
and their benefits, but the lure of lucrative government contracts
can prompt them to play fast and loose. In lobbying state lawmakers
to make its latest vaccine mandatory, Merck has greatly exaggerated
both the threat of a disease, and the ability of a drug to prevent
it.
The drug in question is Gardasil, a vaccine for four types of
human papillomavirus, two of which are responsible for 70% of
cervical cancer cases. The FDA approved Gardasil last year for use
against HPV in females aged 9 to 26.
Late last month, the Virginia legislature passed a bill
requiring all Virginia girls to be vaccinated against HPV before
entering sixth grade. Governor Tim Kaine told the Washington
Post that he plans to sign the bill, but he hasn't yet done
so. Maybe he's having second thoughts -- which he should,
considering the most recent data on HPV and Gardasil -- but if he
doesn't veto the bill by midnight on Monday, it will automatically
become law.
Virginia is only one in a series of states considering similar
mandates, which are quite a boon for Merck, as Gardasil is one of
the most expensive vaccines on the market. With a price tag of $360
for a series of three shots, vaccinating Virginia's sixth graders
would cost about $19 million a year.
Gardasil is not all it's cracked up to be. A recent study in the
Journal of the American Medical Association finds that
among women ages 14 to 24, the rate of all 37 types of sexually
transmitted HPV combined is 33.8% -- much lower than the 50% figure
cited on Merck's website. More importantly, the rates for HPV 16
and 18 -- the two types responsible for 70% of all cervical cancers
-- are astronomically lower: only 1.5% and 0.8%, respectively.
And even among those cases, American Cancer Society guidelines
published last month report that most HPV infections, even
carcinogenic ones, resolve without treatment. Approximately 75% of
infections in adults and 90% of those in adolescents disappear on
their own.
It's worth noting that the American Cancer Society sees its
fight against cervical cancer as a success story even without
Gardasil. When detected early through Pap testing, the survival
rate for the disease is over 90%.
In short, even without the vaccine, when early detection methods
are used, the number of girls who are actually at risk of dying of
cervical cancer from HPV 16 or 18 is extremely low. Most of the
time, the body takes care of the virus without any help
whatsoever.
Under these circumstances, is the Virginia legislature really
prepared to spend untold millions administering this vaccine? In
truth, it may well cause more harm than good.
What if the vaccine lulls young women into a false sense of
security? Gardasil only protects against the viruses responsible
for 70% of cervical cancers, and women may not realize the
necessity of regular Pap tests even when they've been vaccinated.
When women go for an annual Pap test, they are getting a general
check-up, not just a test for cervical cancer. As a result, many
pre-cancerous conditions for anything from cervical cancer to
breast cancer may go undetected, before it's too late.
Merck's drug trials followed women who received Gardasil for an
average of less than three years, so we know little of how long the
immunity lasts or the long-term risks that may be associated with
it. Children vaccinated in middle school could potentially lose
their immunity by the time they were seniors in high school.
Only last week, the New England Journal of Medicine
reported similar problems with the chickenpox vaccine. Not only did
the incidence of illness among those vaccinated against chickenpox
increase over time, so did the severity of the illness itself.
And what if some horrible side effect were to materialize later?
The possibility isn't as far fetched as you might think. In 1976,
swine flu caused only one documented death in the U.S., but the
vaccine administered by government mandate seriously injured or
killed hundreds. It turned out that the vaccine caused
Guillain-Barre Syndrome, a rare paralytic disease similar to polio,
with a 5% fatality rate and a 10% rate of permanent paralysis.
Mandatory Gardasil vaccinations certainly brighten Merck's
future, but it's not so clear that they're in the best interest of
Virginians. As a result, many pre-cancerous conditions may go
undetected before it's too late. In all but the clearest cases,
health risk assessments should be left up to individual families,
not only because making such determinations rightly rests with
families, but because it's simply not sensible policy to experiment
on such a large portion of our population all at once.
Mandating HPV vaccinations would bring Merck huge profits, at
the expense of ordinary Virginians -- or at least at the expense of
Virginia's little girls.
topics:
Law
