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HPV Vaccine Warnings
US Government owns HPV vaccine patents
Financial Disclosures: Drs Schiller and
Lowy report that they are named
inventors on
US government–owned
HPV
vaccine
patents
that are licensed to
GSK
and Merck
and are entitled to limited
royalties as specified by federal law. Dr Dubin
is employed by
GSK
Biologicals,
the manufacturer of the vaccine
used in this trial. No other financial
disclosures were reported.
Moreover, Trials done on Costa
Rican citizens:
Funding/Support:
The Costa Rican
HPV Vaccine Trial is a
long-standing collaboration between
investigators in Costa Rica and the NCI.
The trial is sponsored and funded by the
NCI (grant N01-CP-11005), with
funding support from the National Institutes
of Health Office for Research on Women's
Health, and conducted with support
from the Ministry of Health of Costa Rica.
Vaccine was provided for our trial
by
GSK Biologicals, under a
Clinical Trials Agreement with the
NCI. GlaxoSmithKline also provided support for
aspects of the trial associated
with regulatory submission needs of
the company under grant FDA BB-IND 7920.
The AMA Journal of American
Medicine (JAMA) warns Legislators about
mandatory HPV vaccine:
Click here
to read the article (PDF 77k)
The ACIP recommendation supports making
quadrivalent vaccination the
standard of clinical care.
However, it
is important to emphasize
that
the vaccine is supported by
limited
efficacy and safety data.
Clinical trials have thus far involved a
relatively small population (<12 000
participants) for a limited period
of follow-up (5 years). The vaccine
has not been evaluated for
efficacy among younger girls (aged 9 to 15
years). Yet, if the vaccine were
required nationwide, it would be
administered to some 2 million
girls and young women, most of them between
11 and 12 years old and some as
young as 9 years old. The longer-term
effectiveness and safety of the
vaccine still need to be evaluated
among a large population, and
particularly among younger girls. Given that
the overall prevalence of HPV types
associated with cervical cancer
is relatively low (3.4%)
4 and
that the long-term effects are
unknown, it is unwise to require a young
girl with a very low lifetime
risk of cervical cancer to be vaccinated
without her assent and her parent's consent.
Consider the information a clinician can
honestly provide to a 12-year-old girl to
obtain her assent:
"The 3 injections will
probably
protect you from
an
infection that you can only get from sexual
contact, but
research has not shown how long the
protection will last or whether it might
have rare bad effects on your health."
Original proponent,
Dr.Diane Harper, Dartmouth Researcher Blasts HPV
marketing:
Click here to read the article
Medical Researcher Sides with HPV Scientist:
Click here to read the article
Bayh-Dole Act
The Bayh-Dole
Act had the practical and unintended
consequence of positioning our Universities
as free research arms of the Pharmaceutical
industry. At one time the patents developed
by Universities by taxpayer funded research
through grants such as provided by the
National Institutes of Health and the National
Cancer Institute belonged to "the people",
but not any more.
Contact
Eileen Dannemann, former director, National Coalition of Organized Women
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