Gardasil Researcher Speaks Out
Posted: Wed Mar 24, 2010 9:43 am
Gardasil Researcher Speaks Out
Submitted by
http://healthfreedoms.org/author/dk/>Drew
Health Freedom Alliance have been skeptical in the past about giving young girls the new HPV vaccine. It now
seems we are joined in our
criticism by one of the lead researchers for the Merck drug who is speaking out about its risks, benefits and
aggressive marketing.
Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the
vaccine to prevent cervical
cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to
get Gardasil approved, and
authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to
Merck. It's highly unusual for a
researcher to publicly criticize a medicine or vaccine she helped get approved. Dr. Harper joins a number of
consumer watchdogs, vaccine
safety advocates, and parents who question the vaccine's risk-versus-benefit profile. She says data available
for Gardasil shows
that it lasts five years; there is no data showing that it remains effective beyond five years. This raises
questions about the CDC's
recommendation that the series of shots be given to girls as young as 11-years old. "If we vaccinate 11 year
olds and the protection doesn't
last. we've put them at harm from side effects, small but real, for no benefit," says Dr. Harper. "The benefit
to public health is nothing,
there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least
15 years, and over 70% of all
sexually active females of all ages are vaccinated." She also says that enough serious side effects have been
reported after Gardasil use that
the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually
entirely curable when detected
early through normal Pap screenings.
Dr. Scott Ratner and his wife, who's also a physician, expressed similar concerns as Dr. Harper in an
interview with CBS News last year.
One of their teenage daughters became severely ill after her first dose of Gardasil. Dr. Ratner says she'd
have been better off getting
cervical cancer than the vaccination. "My daughter went from a varsity lacrosse player at Choate to a
chronically ill, steroid-dependent
patient with autoimmune myofasciitis. I've had to ask myself why I let my eldest of three daughters get an
unproven vaccine against a few
strains of a nonlethal virus that can be dealt with in more effective ways."
Merck and the Centers for Disease Control and Prevention maintain Gardasil is safe and effective, and that
adequate warnings are
provided, cautioning about soreness at the injection site and risk of fainting after vaccination. A new study
in the Journal of the American
Medical Association found while the overall risk of side effects appears to be comparable to other vaccines,
Gardasil has a higher
incidence of blood clots reported. Merck says it continues to have confidence in Gardasil's safety profile.
Merck also says it's looking
into cases of ALS, commonly known as Lou Gehrig's Disease, reported after vaccination.
ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord. Merck
and the CDC say there is
currently no evidence that Gardasil caused ALS in the cases reported. Merck is also monitoring the number of
deaths reported after Gardasil:
at least 32. Merck and CDC says it's unclear whether the deaths were related to the vaccine, and that just
because patients died after the
shots doesn't mean the shots were necessarily to blame.
According to Dr. Harper, assessing the true adverse event risk of Gardasil, and comparing it to the risk of
cervical cancer can be tricky
and complex. "The number of women who die from cervical cancer in the US every year is small but real. It is
small because of the success of
the Pap screening program."
"The risks of serious adverse events including death reported after Gardasil use in (the JAMA article by CDC's
Dr. Barbara Slade) were
3.4/100,000 doses distributed. The rate of serious adverse events on par with the death rate of cervical
cancer. Gardasil has been
associated with at least as many serious adverse events as there are deaths from cervical cancer developing
each year. Indeed, the risks of
vaccination are underreported in Slade's article, as they are based on a denominator of doses distributed from
Merck's warehouse. Up to a
third of those doses may be in refrigerators waiting to be dispensed as the autumn onslaught of vaccine
messages is sent home to parents the
first day of school. Should the denominator in Dr. Slade's work be adjusted to account for this, and then
divided by three for the number
of women who would receive all three doses, the incidence rate of serious adverse events increases up to five
fold. How does a parent
value that information," said Harper.
Dr. Harper agrees with Merck and the CDC that Gardasil is safe for most girls and women. But she says the side
effects reported so far call for
more complete disclosure to patients. She says they should be told that protection from the vaccination might
not last long enough to provide a
cancer protection benefit, and that its risks - "small but real" - could occur more often than the cervical
cancer itself would.
"Parents and women must know that deaths occurred. Not all deaths that have been reported were represented in
Dr. Slade's work, one-third of
the death reports were unavailable to the CDC, leaving the parents of the deceased teenagers in despair that
the CDC is ignoring the very
rare but real occurrences that need not have happened if parents were given information stating that there are
real, but small risks of death
surrounding the administration of Gardasil."
She also worries that Merck's aggressive marketing of the vaccine may have given women a false sense of
security. "The future expectations
women hold because they have received free doses of Gardasil purchased by philanthropic foundations, by public
health agencies or covered by
insurance is the true threat to cervical cancer in the future. Should women stop Pap screening after
vaccination, the cervical cancer rate
will actually increase per year. Should women believe this is preventive for all cancers - something never
stated, but often inferred
by many in the population- a reduction in all health care will compound our current health crisis. Should
Gardasil not be effective for more
than 15 years, the most costly public health experiment in cancer control will have failed miserably."
CDC continues to recommend Gardasil for girls and young women. The agency says the vaccine's benefits outweigh
its risks and that it is an
important tool in fighting a serious cancer.
Dr. Harper says the risk-benefit analysis for Gardasil in other countries may shape up differently than what
she believes is true in
the US. "Of course, in developing countries where there is no safety Pap screening for women repeatedly over
their lifetimes, the risks of
serious adverse events may be acceptable as the incidence rate of cervical cancer is five to 12 times higher
than in the US, dwarfing the
risk of death reported after Gardasil."
http://www.cbsnews.com/stories/2009/08/ ... com/storie
s/2009/08/19/cbsnews_investigates/main5253431.shtml
Submitted by
http://healthfreedoms.org/author/dk/>Drew
Health Freedom Alliance have been skeptical in the past about giving young girls the new HPV vaccine. It now
seems we are joined in our
criticism by one of the lead researchers for the Merck drug who is speaking out about its risks, benefits and
aggressive marketing.
Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the
vaccine to prevent cervical
cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to
get Gardasil approved, and
authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to
Merck. It's highly unusual for a
researcher to publicly criticize a medicine or vaccine she helped get approved. Dr. Harper joins a number of
consumer watchdogs, vaccine
safety advocates, and parents who question the vaccine's risk-versus-benefit profile. She says data available
for Gardasil shows
that it lasts five years; there is no data showing that it remains effective beyond five years. This raises
questions about the CDC's
recommendation that the series of shots be given to girls as young as 11-years old. "If we vaccinate 11 year
olds and the protection doesn't
last. we've put them at harm from side effects, small but real, for no benefit," says Dr. Harper. "The benefit
to public health is nothing,
there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least
15 years, and over 70% of all
sexually active females of all ages are vaccinated." She also says that enough serious side effects have been
reported after Gardasil use that
the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually
entirely curable when detected
early through normal Pap screenings.
Dr. Scott Ratner and his wife, who's also a physician, expressed similar concerns as Dr. Harper in an
interview with CBS News last year.
One of their teenage daughters became severely ill after her first dose of Gardasil. Dr. Ratner says she'd
have been better off getting
cervical cancer than the vaccination. "My daughter went from a varsity lacrosse player at Choate to a
chronically ill, steroid-dependent
patient with autoimmune myofasciitis. I've had to ask myself why I let my eldest of three daughters get an
unproven vaccine against a few
strains of a nonlethal virus that can be dealt with in more effective ways."
Merck and the Centers for Disease Control and Prevention maintain Gardasil is safe and effective, and that
adequate warnings are
provided, cautioning about soreness at the injection site and risk of fainting after vaccination. A new study
in the Journal of the American
Medical Association found while the overall risk of side effects appears to be comparable to other vaccines,
Gardasil has a higher
incidence of blood clots reported. Merck says it continues to have confidence in Gardasil's safety profile.
Merck also says it's looking
into cases of ALS, commonly known as Lou Gehrig's Disease, reported after vaccination.
ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord. Merck
and the CDC say there is
currently no evidence that Gardasil caused ALS in the cases reported. Merck is also monitoring the number of
deaths reported after Gardasil:
at least 32. Merck and CDC says it's unclear whether the deaths were related to the vaccine, and that just
because patients died after the
shots doesn't mean the shots were necessarily to blame.
According to Dr. Harper, assessing the true adverse event risk of Gardasil, and comparing it to the risk of
cervical cancer can be tricky
and complex. "The number of women who die from cervical cancer in the US every year is small but real. It is
small because of the success of
the Pap screening program."
"The risks of serious adverse events including death reported after Gardasil use in (the JAMA article by CDC's
Dr. Barbara Slade) were
3.4/100,000 doses distributed. The rate of serious adverse events on par with the death rate of cervical
cancer. Gardasil has been
associated with at least as many serious adverse events as there are deaths from cervical cancer developing
each year. Indeed, the risks of
vaccination are underreported in Slade's article, as they are based on a denominator of doses distributed from
Merck's warehouse. Up to a
third of those doses may be in refrigerators waiting to be dispensed as the autumn onslaught of vaccine
messages is sent home to parents the
first day of school. Should the denominator in Dr. Slade's work be adjusted to account for this, and then
divided by three for the number
of women who would receive all three doses, the incidence rate of serious adverse events increases up to five
fold. How does a parent
value that information," said Harper.
Dr. Harper agrees with Merck and the CDC that Gardasil is safe for most girls and women. But she says the side
effects reported so far call for
more complete disclosure to patients. She says they should be told that protection from the vaccination might
not last long enough to provide a
cancer protection benefit, and that its risks - "small but real" - could occur more often than the cervical
cancer itself would.
"Parents and women must know that deaths occurred. Not all deaths that have been reported were represented in
Dr. Slade's work, one-third of
the death reports were unavailable to the CDC, leaving the parents of the deceased teenagers in despair that
the CDC is ignoring the very
rare but real occurrences that need not have happened if parents were given information stating that there are
real, but small risks of death
surrounding the administration of Gardasil."
She also worries that Merck's aggressive marketing of the vaccine may have given women a false sense of
security. "The future expectations
women hold because they have received free doses of Gardasil purchased by philanthropic foundations, by public
health agencies or covered by
insurance is the true threat to cervical cancer in the future. Should women stop Pap screening after
vaccination, the cervical cancer rate
will actually increase per year. Should women believe this is preventive for all cancers - something never
stated, but often inferred
by many in the population- a reduction in all health care will compound our current health crisis. Should
Gardasil not be effective for more
than 15 years, the most costly public health experiment in cancer control will have failed miserably."
CDC continues to recommend Gardasil for girls and young women. The agency says the vaccine's benefits outweigh
its risks and that it is an
important tool in fighting a serious cancer.
Dr. Harper says the risk-benefit analysis for Gardasil in other countries may shape up differently than what
she believes is true in
the US. "Of course, in developing countries where there is no safety Pap screening for women repeatedly over
their lifetimes, the risks of
serious adverse events may be acceptable as the incidence rate of cervical cancer is five to 12 times higher
than in the US, dwarfing the
risk of death reported after Gardasil."
http://www.cbsnews.com/stories/2009/08/ ... com/storie
s/2009/08/19/cbsnews_investigates/main5253431.shtml