By Sharyl Attkisson
Aug 2009
(CBS) Amid questions about the safety of the HPV vaccine
Gardasil one of the lead researchers for
the Merck drug 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.”