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Science Forum Index » Medicine - Cancer Forum » lack of HPV vaccine efficacy???
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| HPVguy |
 Posted: Sat Dec 02, 2006 7:25 am |
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Researchers concerned about new HPV vaccine: Debate over Gardasil,
first vaccine to prevent cervical cancer
by Caroline Mattey
PUBLISHED 11/20/2006 9:42:29 AM
Editor's Note: Allen, a senior researcher at the National Cancer
Institute of NIH, agreed to share his opinions with the Black & White
on the condition of anonymity. Allen actively communicated with the
researchers who worked on the vaccine for Human Papillomavirus, and he
has read numerous FDA reports about it.
Recently, the media has highly publicized the release and promise of
Gardasil, a new vaccine for Human Papillomavirus. Despite generally
positive feedback from parents and doctors, some scientists remain
skeptical of the vaccine's merits.
Merck & Co., a pharmaceutical company, introduced Gardasil to the
market in the summer of 2006 as the first vaccine designed to prevent
cervical cancer, abnormal or precancerous cervical or vulvar lesions
and genital warts in females. The vaccine inoculates females ages 9-26
against Human Papillomavirus (HPV) types 6, 11, 16 and 18, which may
cause cancer or genital warts. The Center for Disease Control and
Prevention estimates that HPV infects an additional 6.2 million
Americans each year. Over 100 types of HPV exist and approximately 30
are transmitted through sexual contact. The vaccine prevents the
infection of the types of HPV that cause approximately 70 percent of
cervical cancers and 90 percent of genital warts.
Allen, a researcher at the National Cancer Institute of NIH, says he
does not believe that the vaccine will necessarily prevent the
development of cervical cancer. "Everything that has gone to the
media has to do with detecting the virus. If you examine a sample from
individuals who have been vaccinated, you can't detect the virus, so
they conclude that it's 100 percent effective. But if you take the
same individuals to see if you can detect intraepithelial neoplasias
[abnormal cells], you find there is no statistical difference between
those vaccinated and those with the placebo for the incidence of the
neoplasias. That's the problem. There are no differences in the
number of precancerous lesions."
A report published by the FDA stated that in one trial 75 participants
in the vaccinated group had neoplasias [abnormal cells] and 87 in the
placebo group had them. Researchers only found 16.9 percent fewer
neoplasias in the vaccinated group. The FDA did not immediately
respond to any contact attempts, but their report states that "the
degree to which cases of CIN2/3 [precancerous lesions] or worse due to
HPV types not associated with Gardasil might offset its efficacy
against vaccine-related HPV types has not been fully elucidated in the
studies."
Allen says neither the FDA nor Merck & Co. performed sufficient studies
when testing the length of effectiveness of the vaccine before
approving it. "They want to vaccinate children and they don't know
how long the vaccine will last. Even if it's effective and you
vaccinate a child who is nine or ten, how long will their protection
last? They never did the studies, so in ten years it may afford no
protection right when those girls are becoming adults."
Nurse Kathy Hanns works at a local pediatrician's office and says she
receives multiple phone calls every week inquiring about the vaccine.
"Now that college kids are back in school, we get about two or three
calls a week because there has just been so much information in the
media about it. You should start the vaccine before you are sexually
active, so we have had ten year olds' parents calling. Other parents
ask why boys aren't getting it."
Junior Mariel Schwartz says she plans to request an HPV vaccination at
her next doctor's appointment. "I think that it would be a good
idea for everyone to get the vaccine as early as possible before
cervical cancer becomes a significant issue that our generation is
faced with when we become more sexually active."
Doctor Sharon Scanlon, an internist and mother of Schwartz, says she
considers the vaccine a useful method of protection for her daughter.
"I am not reluctant for her to receive this vaccine. I think it's
a good idea for her to have this just like she had all the other
vaccines that have become available to prevent viruses. I view it like
Hepatitis B, which is a series of three injections and you give it to
young people before they are sexually active to hopefully prevent a
virus that could potentially harm them."
Pediatrician Dana Kornfeld says parents in general have not fielded
concerns about their younger daughters becoming more sexually active
after receiving the vaccine. "I haven't had any parents who have
been concerned about it, but I haven't really been offering it to the
11 or 12 year olds. I have been waiting to start talking about it
until the girls are 14 or 15. It is a theoretical concern though."
Teenagers will not necessarily change their behavior patterns after
receiving the vaccine, Schwartz says. "The decision to be abstinent
is a lot more based on issues like pregnancy or the type of
relationship you are in, and not whether or not you are at risk of
getting cervical cancer. The vaccine would just be a precaution for
either now or later on in life."
Despite some faith in the benefits of Gardasil, Scanlon says she
remains hesitant to use Gardasil because the FDA only recently approved
the vaccine in June 2006. "I am always a little nervous about giving
vaccines the first year that they are out, but it looks like it's
safe. I'm not in a huge rush, but I would like both of my daughters
to be immunized sometime within the next year."
FDA consumer safety officer Andrei Perlloni says the testing of
Gardasil did not reveal any common or serious side effects, but
patients should acknowledge the potential risks associated with every
vaccine. "A vaccine, like any medicine, could possibly cause serious
problems, such as severe allergic reactions. The risk of any vaccine
causing serious harm or death is extremely small. It is always
possible that unexpected and rare adverse events can occur when a
vaccine is used more widely."
Hanns says doctors may charge about $150 per dose, and administration
fees may further increase the price. "It is not always covered by
insurance at this point because it is new. We don't discourage it
because of the price, but we put it out there as an information point
for parents, but most people aren't balking about that."
Freshman Marija Valatkaite says the television commercials advertising
Gardasil have the wrong focus. "I personally don't think they are
as informative as they should be. They just say the same 'tell
someone' thing over and over and then at the end they say there is a
vaccine and then it's over. They are just stupid because you don't
need to know that cervical cancer is caused by a virus. You need to
know there is vaccine for it. "
Schwartz says the vaccine would act as insurance, protecting people
from the unpredictable future. "Unexpected things happen and people
make mistakes, and it is good to have the safety of a vaccine
regardless of what one's beliefs are." |
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