Hi All,
Well, this is a pretty touchy subject here. While I am all for preventative measures to illness, I also want to make sure that the 'cure' does not
cause adverse reactions that themselves now require treatment.
I have several concerns about Gardasil, and they have nothing to do with the vaccine preventing cervical cancer. My first concern with this product
is the fact that it has not been in research long enough, and for me certainly not long enough to make it
mandatory for young children. I
understand trying to establish a broader trial base, but at what cost?
Which brings me to my next concern about this vaccine, the side effects. Here is an article from Medical News Today:
The National Vaccine Information Center (NVIC), the nation's leading vaccine safety he National Vaccine Information Center (NVIC), the nation's
leading vaccine safety and informed consent advocacy organization, is urging state legislatures to investigate the safety and cost of mandating
Merck's HPV vaccine (GARDASIL) for all pre- adolescent girls before introducing legislation amending state vaccine laws. In an analysis of reports
made to the federal Vaccine Adverse Event Reporting System (VAERS) since the CDC's July 2006 universal use recommendation for all young girls, NVIC
found reports of loss of consciousness, seizures, joint pain and Guillain-Barre Syndrome.
...
Between July 2006 and January 2007, there have been 82 reports of adverse events filed with VAERS following receipt of GARDASIL by girls and boys
ranging in age from 11 to 27 years. Reaction reports have come from 21 states, including Virginia and the District of Columbia. All but three of the
reports were for adverse events which occurred within one week of vaccination and more than 60 percent occurred within 24 hours of vaccination.
"The most frequent serious health events after GARDASIL shots are neurological symptoms," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D.
"These young girls are experiencing severe headaches, dizziness, temporary loss of vision, slurred speech, fainting, involuntary contraction of limbs
(seizures), muscle weakness, tingling and numbness in the hands and feet and joint pain. Some of the girls have lost consciousness during what appears
to be seizures." Debold added "The manufacturer product insert should include mention of syncopal episodes, seizures and Guillain-Barre Syndrome so
doctors and parents are aware these vaccine adverse responses have been associated with the vaccine."
Source
While the article does not give details about how many out of the
total number of women had adverse reaction, it still makes me uneasy. I am
NOT saying that these reactions should be enough that the vaccine not be available to people who want it. I am saying that for such a short trial
period, this vaccine should not be mandatory. Parents and adults wishing to take the vaccine need to be properly educated about
all possible
side effects and other possible adverse reactions from other vaccines.
I say other vaccines because of this paragraph in the article:
AERS reports also indicate the doctors are administering GARDASIL to girls and women at the same with Tdap, DT, meningococcal (Menactra), hepatitis A,
and other vaccines, even though the Merck product insert states that, with the exception of hepatitis B vaccine, "Co-administration of GARDASIL with
other vaccines has not been studied." There is no publicly available information about how many of the 9 to 15 year old girls in Merck's pre-
licensure clinical trials received GARDASIL simultaneously with hepatitis B vaccine.
Source
Another problem I have with the vaccine is the approximate cost. It has to be taken in a series of three doses over a six month period of time. The
advertised cost of Gardasil is $360, thats $120 per dose. However the NVIC found that "...In a separate evaluation of costs for young girls being
vaccinated in private pediatrician offices, NVIC discovered that parents living in the Washington, D.C. area will be paying between $500 and $900 to
have their daughters receive three doses of GARDASIL."
Source
Merek is the sole producer of this vaccine, so there is no generic version available. (Although another company Glaxo- SmithKline Biologics, making a
similar vaccine called Cevarix, which the comp. hopes to be approved sometime this year.) Some insurance companies will cover the cost, but at this
time, not all insurance companies do. Low-income families will be offered the vaccination for free, as is the case with other required childhood
vaccines. My problem with the cost of Gardasil is how much money Merek plans to make off of the product, especially if it is made to be mandatory.
Merek is still reeling from its Vioxx losses in revenues and lawsuits. (Wiki on Vioxx here:
en.wikipedia.org...) According to this
article, Merek knew that there was significant heart risks associated with Vioxx, one year after it was approved by the FDA.
The truth has finally come out about Vioxx: insider emails published by the Wall Street Journal reveal that Merck, the maker of Vioxx, was fully aware
of the health risks of its COX-2 inhibitor anti-inflammatory drug as early as March, 2000. As is apparent from the published emails, there was a
concerted effort to bury the negative evidence and even distort the drug trials by excluding heart patients from the Vioxx studies so that, "...the
rate of cardiovascular problems for Vioxx patients would not be evident."
Source
It is a very interesting article to read, and it gives the reader some insights into how
dedicated the company can be when it comes to
marketing and pushing its product, regardless of significant risks towards the patient.
Now the company has a potential "cash cow" that will help them recover some of their losses. I cant help but wonder if they would push a product
that does as it is advertised, but causes the patient to "pay" in other detrimental ways, health wise.
[cont]