C
carmen.sutra@hotmail.com
Guest
Lawmakers looking to force preteen girls to take Gardasil, a new
vaccine against a virus that causes cervical cancer, are targeting the
wrong age group, cancer data shows.
Middle-school girls inoculated with the breakthrough vaccine will
be no older than 18 when they pass Gardasil's five-year window of
proven effectiveness -- more than a decade before the typical cancer
patient contracts the sexually transmitted human papillomavirus (HPV).
Infectious disease specialists and cancer pathologists say the
incubation period for HPV becoming cancer is 10 to 15 years -- meaning
the average cervical cancer patient, who is 47, contracted the virus
in her 30s and would not be protected by Gardasil taken as a teen.
"It is a delicate balancing act," said Debbie Saslow, director of
breast and cervical cancer control at the American Cancer Society. "If
the vaccine is given at too young an age, it may wear off. Yet if it
is given too late, it won't work."
Merck & Co. is still studying the longevity of Gardasil, the lone
HPV vaccine on the market, which won approval from the Food and Drug
Administration in June. But that hadn't impeded its lobbying efforts.
Legislators in at least 20 states and cities, including Virginia and
the District of Columbia, are considering HPV vaccinations for girls
11 to 13 as a requirement for school attendance. Texas already has
done so.
"We are doing further tests and follow-up. But right now, we know
it is effective for five years," said Dr. Richard Haupt, executive
director of medical affairs in Merck's vaccine division.
Gardasil, a $360 series of three shots over six months, protects
against two HPV strains that cause nearly 70 percent of cervical
cancer cases. It also prevents two other strains linked to 90 percent
of genital warts cases.
Merck, which did not respond to repeated requests for its HPV
incubation statistics, unexpectedly suspended its lobbying campaign
yesterday.
"Our goal is about cervical cancer prevention. ... We're concerned
that our role in supporting school requirements is a distraction from
that goal," Dr. Haupt told the Associated Press.
By the numbers
Dr. Joseph Bocchini, chairman of the committee on infectious
disease of the American Academy of Pediatrics, says HPV can take up to
20 years to cause cervical cancer.
"It can occur more rapidly, but very commonly, it is a 20-year period
before it leads to cancer," said Dr. Bocchini, whose group has
endorsed HPV vaccinations on 11- and 12-year-olds but has withheld
support for its mandated use.
Even when applying a longer 20-year incubation period, requiring
Gardasil for sixth-grade girls, as nearly all the legislation does,
would not prevent the overwhelming majority of cervical cancer cases
in the U.S.
American Cancer Society numbers show that from 2000 to 2003, more
than 70 percent of cervical cancer patients were older than 40 --
still outside Gardasil's five-year protection window if given to sixth-
graders.
Merck is working on a booster shot to extend Gardasil's five years
of protection.
"We are aware of some evidence of immune memory. But if a booster
shot is necessary, it would likely be another dose of Gardasil," Dr.
Haupt said.
None of the HPV vaccine legislation being considered addresses the
potential for booster inoculations that could fall outside the
enforcement mechanism -- rules that bar students from school unless
they have the required shots.
Vaccine boosters vary in longevity. A hepatitis B booster is
required every 10 years, while others can provide lifelong immunity.
Lawmakers pushed HPV legislation to the fast track after the
Advisory Committee on Immunization Practices, run by the Centers for
Disease Control and Prevention, in July endorsed such an inoculation
for girls 11 to 12.
"The point in vaccinating kids 9 to 12 is not to reduce number of
cases found in that age group, but to vaccinate prior to beginning
sexual activity," said CDC spokesman Curtis Allen. "The benefits of
the vaccine decrease as women age because they are more likely to have
already been infected by one of the HPV strains."
Seventy percent of females are sexually active by age 18,
according to the CDC.
But based on cancer statistics, cervical cancer incubation
periods, and the five-year life-span of Gardasil, state lawmakers --
who have billed the inoculations as a cure to cervical cancer -- would
have a much greater effect on cervical cancer rates by mandating its
use later.
Cervical cancer rates are less than one per 100,000 women until
age 20 and then begin to pick up in the late 20s and early 30s. Thus,
women who likely contracted HPV in their early 20s could be protected
by Gardasil taken at 17 or 18.
GlaxoSmithKline is developing another HPV vaccine, Cervarix, which
has not been licensed but is expected to be released later this year.
It is effective for 4? years, according to an April 2006 study in
Lancet, a British medical journal.
Risk vs. reward
Dr. Mona Saraiya, a medical epidemiologist in the Division of
Cancer Prevention and Control at the CDC, says nearly all sexually
active woman are exposed to HPV.
"However, only a few will get an infection that stays and won't go
away, and only a portion of those will get a precancerous lesion. At
that point, only a few will eventually develop cervical cancer," Dr.
Saraiya said.
Fewer than one-hundredth of 1 percent of the 108 million U.S.
women older than 18 (0.009 percent) get cervical cancer and even fewer
die from it. There were an estimated 9,700 new cervical cancer cases
and 3,700 fatalities in 2006, according to the American Cancer
Society.
But the fact that very few U.S. women are affected by cervical
cancer, statistically speaking, hasn't stopped the rush by lawmakers
to push mandatory HPV vaccines for school girls.
Earlier this month, Texas became the first state to enact an HPV
vaccine law when Gov. Rick Perry bypassed the Legislature and signed
an executive order mandating all girls entering sixth grade be
inoculated. Mr. Perry drew fire when it was revealed that his former
chief of staff was lobbying for Merck. Lawmakers are trying to reverse
the order.
In Maryland, HPV legislation was pulled days after a Baltimore Sun
report on Merck's lobbying efforts in Annapolis. The bill's sponsor,
state Sen. Delores Kelley, Baltimore County Democrat, cited the
growing burden on families because of the high costs of mandatory
vaccinations.
Virginia Delegate Phillip A. Hamilton, Newport News Republican,
sponsored the HPV-vaccination legislation that his state's House
passed earlier this month and is expected to become law.
"What was intriguing to me was that it was a cancer vaccine," he
said.
Mr. Hamilton, who has received contributions from Merck in the
past, said the pharmaceutical company played no role in his decision
to the sponsor the bill.
"It was a positive step. It was about preventing cancer, nothing
else," Mr. Hamilton said.
D.C. officials have just begun hearings on a proposal to require
HPV vaccinations before girls turn 13 and to create an HPV reporting
program in the city's Department of Health.
Merck has waged an extensive lobbying campaign in statehouses, and
has helped raise the profile of HPV through a large-scale
communications campaign, highlighted by the "Tell Someone" TV ad being
shown on channels with high-teen viewership, such as MTV.
Wall Street analysts predict that Gardasil, which is projected to
generate $2 billion to $4 billion this year without state mandates,
will help offset losses Merck endured after it pulled Vioxx off the
market in 2004.
Vioxx, an FDA-approved anti-inflammatory drug for osteoarthritis
and acute pain that was used by 2 million people, was linked to
increased risk of heart attack and stroke.
"Merck's goal is to support efforts to implement policies that
ensure that Gardasil is used to achieve what it was designed to do:
help reduce the burden of cervical cancer -- the second-leading cancer
among women around the world -- and other HPV-related diseases for as
many people as possible, and as quickly as possible," Merck said about
its lobbying efforts.
Fast track vs. family values
Merck's lobbying efforts and the legislative push for mandatory
HPV vaccinations have attracted the attention of pro-family groups
such as Focus on the Family, which supports HPV vaccinations but says
they should not be mandatory. Other conservative groups such as the
Family Research Council say requiring HPV inoculations is tantamount
to endorsing premarital sex.
"Because HPV infection is caused by sexual activity, it is not
transmitted by casual contact and therefore is not in the same class
as other diseases like polio for which mandatory, school-based
vaccination is a public-health imperative," Family Research Council
President Tony Perkins said in an alert sent to its members to lobby
Mr. Perry to rescind his Texas order.
Delegate John J. Welch III, Virginia Beach Republican, opposes his
state's measure for several reasons.
"I think parental rights are paramount. They should trump
everything," Mr. Welch said.
"When we have a drug that can cure cancer, of course I'm all for
it," he said. "But given the fact the drug is so new, I don't think
that the commonwealth should mandate it."
Once a major killer in the U.S., cervical cancer has been nearly
wiped out since the creation of the Pap test, which detects
precancerous lesions and early cancer and is credited with a 74
percent drop in cervical cancer deaths since 1955.
The CDC says most cervical cancer diagnoses in the U.S. are in
women who either have never had a Pap test or have not had a Pap test
in the previous five years. Those inoculated with Gardasil still will
have to have regular Pap tests for the disease, which is hard to
detect because it does not usually cause pain.
Cervical cancer does have high mortality rates in low-income
regions of U.S. and poor nations where health care coverage is not
routine. Cervical cancer is the fifth most common cancer among women
worldwide, according to the World Health Organization, and kills about
230,000 women a year, most in developing countries. Because of these
figures, public health officials still back use of the vaccine.
"The vaccine is not nearly as effective as vaccines for mumps or
measles, but it is an important step forward in public health," said
Dr. John Swartzberg, director of public health policy at the
University of California at Berkeley. "The vaccine will decrease the
two most common strains of HPV that cause cancer, and we'll be left
with strains that have far less potential to cause cancer. In this
case, the benefits outweigh the risks."
What we don't know
As with any new drug, there are potential risks that short-term
studies used for federal approval don't detect.
Dr. Clayton Young, an obstetrician-gynecologist in Texas, is
concerned that Gardasil will actually strengthen cancer-causing
strains of HPV.
"My concern is that we are pushing ourselves into something worse
than we already have," Dr. Young said. "Vaccinating for only two
strains may lead to an increase in infection with other and possibly
more aggressive strains."
Gardasil is effective against two of 10 carcinogenic HPV strains.
Those two strains dominate the current statistics, estimated to have
caused 6,800 new cervical cancer cases in 2006, while the other eight
strains combined affected 2,900 women.
The probability of additional cancer-causing HPV strains leading
to as many cervical cancer cases as today is minute, said Dr. Haupt,
executive director of medical affairs in Merck's vaccine division.
Despite Merck's doubt, the company is studying the additional
cancer-causing HPV types in Scandinavian countries, where national
cancer registries allow drug companies to track people with the
disease.
"It is an important issue to us," Dr. Haupt said. "But we think
the two types of HPV that Gardasil work for are unique, and if other
types become more common, they will not cause cancer at the same rate
and won't over time."
Physicians also point to concerns about Gardasil that cast doubt
on the vaccine's overall capability to stop cervical cancer from
occurring in females. For instance, clinical trials for the vaccine's
effectiveness at preventing cervical cancer did not include the age
group of girls for whom the vaccine is being recommended by federal
regulators.
"The number one problem with the vaccine is that it has not been
tested adequately on the group that is recommended to get it," said
Dr. Joseph DeSoto, a fellow in the American Institute of Chemists and
a physician-scientist at the National Institutes of Health.
According to Merck's clinical study documents on Gardasil, 20,541
women ages 16 to 26 participated in four studies. The documents show
some data is available on 9-year-old girls related to immune responses
to the vaccine but not whether it prevents cancer.
Because most 9-year-old girls are not sexually active, it is not
possible to test the effectiveness of Gardasil against cervical
cancer, Mr. Haupt said. Instead, the clinical trials measured antibody
responses against HPV as a proxy for cervical cancer.
Merck conducted two clinical trials that involved 1,121 girls ages
9 to 15, according to Merck's labeling documents for Gardasil.
"The clinical trials tested younger girls, but they only looked at
immune response to the vaccine, not whether it prevented cervical
cancer," Dr. Young said. "It has not been studied long enough to know
that it prevents cervical cancer."
By Gregory Lopes and Christopher M. Dolan
THE WASHINGTON TIMES
February 21, 2007
Jim McElhatton contributed to this report.
http://washingtontimes.com/national/20070221-123326-7587r.htm
vaccine against a virus that causes cervical cancer, are targeting the
wrong age group, cancer data shows.
Middle-school girls inoculated with the breakthrough vaccine will
be no older than 18 when they pass Gardasil's five-year window of
proven effectiveness -- more than a decade before the typical cancer
patient contracts the sexually transmitted human papillomavirus (HPV).
Infectious disease specialists and cancer pathologists say the
incubation period for HPV becoming cancer is 10 to 15 years -- meaning
the average cervical cancer patient, who is 47, contracted the virus
in her 30s and would not be protected by Gardasil taken as a teen.
"It is a delicate balancing act," said Debbie Saslow, director of
breast and cervical cancer control at the American Cancer Society. "If
the vaccine is given at too young an age, it may wear off. Yet if it
is given too late, it won't work."
Merck & Co. is still studying the longevity of Gardasil, the lone
HPV vaccine on the market, which won approval from the Food and Drug
Administration in June. But that hadn't impeded its lobbying efforts.
Legislators in at least 20 states and cities, including Virginia and
the District of Columbia, are considering HPV vaccinations for girls
11 to 13 as a requirement for school attendance. Texas already has
done so.
"We are doing further tests and follow-up. But right now, we know
it is effective for five years," said Dr. Richard Haupt, executive
director of medical affairs in Merck's vaccine division.
Gardasil, a $360 series of three shots over six months, protects
against two HPV strains that cause nearly 70 percent of cervical
cancer cases. It also prevents two other strains linked to 90 percent
of genital warts cases.
Merck, which did not respond to repeated requests for its HPV
incubation statistics, unexpectedly suspended its lobbying campaign
yesterday.
"Our goal is about cervical cancer prevention. ... We're concerned
that our role in supporting school requirements is a distraction from
that goal," Dr. Haupt told the Associated Press.
By the numbers
Dr. Joseph Bocchini, chairman of the committee on infectious
disease of the American Academy of Pediatrics, says HPV can take up to
20 years to cause cervical cancer.
"It can occur more rapidly, but very commonly, it is a 20-year period
before it leads to cancer," said Dr. Bocchini, whose group has
endorsed HPV vaccinations on 11- and 12-year-olds but has withheld
support for its mandated use.
Even when applying a longer 20-year incubation period, requiring
Gardasil for sixth-grade girls, as nearly all the legislation does,
would not prevent the overwhelming majority of cervical cancer cases
in the U.S.
American Cancer Society numbers show that from 2000 to 2003, more
than 70 percent of cervical cancer patients were older than 40 --
still outside Gardasil's five-year protection window if given to sixth-
graders.
Merck is working on a booster shot to extend Gardasil's five years
of protection.
"We are aware of some evidence of immune memory. But if a booster
shot is necessary, it would likely be another dose of Gardasil," Dr.
Haupt said.
None of the HPV vaccine legislation being considered addresses the
potential for booster inoculations that could fall outside the
enforcement mechanism -- rules that bar students from school unless
they have the required shots.
Vaccine boosters vary in longevity. A hepatitis B booster is
required every 10 years, while others can provide lifelong immunity.
Lawmakers pushed HPV legislation to the fast track after the
Advisory Committee on Immunization Practices, run by the Centers for
Disease Control and Prevention, in July endorsed such an inoculation
for girls 11 to 12.
"The point in vaccinating kids 9 to 12 is not to reduce number of
cases found in that age group, but to vaccinate prior to beginning
sexual activity," said CDC spokesman Curtis Allen. "The benefits of
the vaccine decrease as women age because they are more likely to have
already been infected by one of the HPV strains."
Seventy percent of females are sexually active by age 18,
according to the CDC.
But based on cancer statistics, cervical cancer incubation
periods, and the five-year life-span of Gardasil, state lawmakers --
who have billed the inoculations as a cure to cervical cancer -- would
have a much greater effect on cervical cancer rates by mandating its
use later.
Cervical cancer rates are less than one per 100,000 women until
age 20 and then begin to pick up in the late 20s and early 30s. Thus,
women who likely contracted HPV in their early 20s could be protected
by Gardasil taken at 17 or 18.
GlaxoSmithKline is developing another HPV vaccine, Cervarix, which
has not been licensed but is expected to be released later this year.
It is effective for 4? years, according to an April 2006 study in
Lancet, a British medical journal.
Risk vs. reward
Dr. Mona Saraiya, a medical epidemiologist in the Division of
Cancer Prevention and Control at the CDC, says nearly all sexually
active woman are exposed to HPV.
"However, only a few will get an infection that stays and won't go
away, and only a portion of those will get a precancerous lesion. At
that point, only a few will eventually develop cervical cancer," Dr.
Saraiya said.
Fewer than one-hundredth of 1 percent of the 108 million U.S.
women older than 18 (0.009 percent) get cervical cancer and even fewer
die from it. There were an estimated 9,700 new cervical cancer cases
and 3,700 fatalities in 2006, according to the American Cancer
Society.
But the fact that very few U.S. women are affected by cervical
cancer, statistically speaking, hasn't stopped the rush by lawmakers
to push mandatory HPV vaccines for school girls.
Earlier this month, Texas became the first state to enact an HPV
vaccine law when Gov. Rick Perry bypassed the Legislature and signed
an executive order mandating all girls entering sixth grade be
inoculated. Mr. Perry drew fire when it was revealed that his former
chief of staff was lobbying for Merck. Lawmakers are trying to reverse
the order.
In Maryland, HPV legislation was pulled days after a Baltimore Sun
report on Merck's lobbying efforts in Annapolis. The bill's sponsor,
state Sen. Delores Kelley, Baltimore County Democrat, cited the
growing burden on families because of the high costs of mandatory
vaccinations.
Virginia Delegate Phillip A. Hamilton, Newport News Republican,
sponsored the HPV-vaccination legislation that his state's House
passed earlier this month and is expected to become law.
"What was intriguing to me was that it was a cancer vaccine," he
said.
Mr. Hamilton, who has received contributions from Merck in the
past, said the pharmaceutical company played no role in his decision
to the sponsor the bill.
"It was a positive step. It was about preventing cancer, nothing
else," Mr. Hamilton said.
D.C. officials have just begun hearings on a proposal to require
HPV vaccinations before girls turn 13 and to create an HPV reporting
program in the city's Department of Health.
Merck has waged an extensive lobbying campaign in statehouses, and
has helped raise the profile of HPV through a large-scale
communications campaign, highlighted by the "Tell Someone" TV ad being
shown on channels with high-teen viewership, such as MTV.
Wall Street analysts predict that Gardasil, which is projected to
generate $2 billion to $4 billion this year without state mandates,
will help offset losses Merck endured after it pulled Vioxx off the
market in 2004.
Vioxx, an FDA-approved anti-inflammatory drug for osteoarthritis
and acute pain that was used by 2 million people, was linked to
increased risk of heart attack and stroke.
"Merck's goal is to support efforts to implement policies that
ensure that Gardasil is used to achieve what it was designed to do:
help reduce the burden of cervical cancer -- the second-leading cancer
among women around the world -- and other HPV-related diseases for as
many people as possible, and as quickly as possible," Merck said about
its lobbying efforts.
Fast track vs. family values
Merck's lobbying efforts and the legislative push for mandatory
HPV vaccinations have attracted the attention of pro-family groups
such as Focus on the Family, which supports HPV vaccinations but says
they should not be mandatory. Other conservative groups such as the
Family Research Council say requiring HPV inoculations is tantamount
to endorsing premarital sex.
"Because HPV infection is caused by sexual activity, it is not
transmitted by casual contact and therefore is not in the same class
as other diseases like polio for which mandatory, school-based
vaccination is a public-health imperative," Family Research Council
President Tony Perkins said in an alert sent to its members to lobby
Mr. Perry to rescind his Texas order.
Delegate John J. Welch III, Virginia Beach Republican, opposes his
state's measure for several reasons.
"I think parental rights are paramount. They should trump
everything," Mr. Welch said.
"When we have a drug that can cure cancer, of course I'm all for
it," he said. "But given the fact the drug is so new, I don't think
that the commonwealth should mandate it."
Once a major killer in the U.S., cervical cancer has been nearly
wiped out since the creation of the Pap test, which detects
precancerous lesions and early cancer and is credited with a 74
percent drop in cervical cancer deaths since 1955.
The CDC says most cervical cancer diagnoses in the U.S. are in
women who either have never had a Pap test or have not had a Pap test
in the previous five years. Those inoculated with Gardasil still will
have to have regular Pap tests for the disease, which is hard to
detect because it does not usually cause pain.
Cervical cancer does have high mortality rates in low-income
regions of U.S. and poor nations where health care coverage is not
routine. Cervical cancer is the fifth most common cancer among women
worldwide, according to the World Health Organization, and kills about
230,000 women a year, most in developing countries. Because of these
figures, public health officials still back use of the vaccine.
"The vaccine is not nearly as effective as vaccines for mumps or
measles, but it is an important step forward in public health," said
Dr. John Swartzberg, director of public health policy at the
University of California at Berkeley. "The vaccine will decrease the
two most common strains of HPV that cause cancer, and we'll be left
with strains that have far less potential to cause cancer. In this
case, the benefits outweigh the risks."
What we don't know
As with any new drug, there are potential risks that short-term
studies used for federal approval don't detect.
Dr. Clayton Young, an obstetrician-gynecologist in Texas, is
concerned that Gardasil will actually strengthen cancer-causing
strains of HPV.
"My concern is that we are pushing ourselves into something worse
than we already have," Dr. Young said. "Vaccinating for only two
strains may lead to an increase in infection with other and possibly
more aggressive strains."
Gardasil is effective against two of 10 carcinogenic HPV strains.
Those two strains dominate the current statistics, estimated to have
caused 6,800 new cervical cancer cases in 2006, while the other eight
strains combined affected 2,900 women.
The probability of additional cancer-causing HPV strains leading
to as many cervical cancer cases as today is minute, said Dr. Haupt,
executive director of medical affairs in Merck's vaccine division.
Despite Merck's doubt, the company is studying the additional
cancer-causing HPV types in Scandinavian countries, where national
cancer registries allow drug companies to track people with the
disease.
"It is an important issue to us," Dr. Haupt said. "But we think
the two types of HPV that Gardasil work for are unique, and if other
types become more common, they will not cause cancer at the same rate
and won't over time."
Physicians also point to concerns about Gardasil that cast doubt
on the vaccine's overall capability to stop cervical cancer from
occurring in females. For instance, clinical trials for the vaccine's
effectiveness at preventing cervical cancer did not include the age
group of girls for whom the vaccine is being recommended by federal
regulators.
"The number one problem with the vaccine is that it has not been
tested adequately on the group that is recommended to get it," said
Dr. Joseph DeSoto, a fellow in the American Institute of Chemists and
a physician-scientist at the National Institutes of Health.
According to Merck's clinical study documents on Gardasil, 20,541
women ages 16 to 26 participated in four studies. The documents show
some data is available on 9-year-old girls related to immune responses
to the vaccine but not whether it prevents cancer.
Because most 9-year-old girls are not sexually active, it is not
possible to test the effectiveness of Gardasil against cervical
cancer, Mr. Haupt said. Instead, the clinical trials measured antibody
responses against HPV as a proxy for cervical cancer.
Merck conducted two clinical trials that involved 1,121 girls ages
9 to 15, according to Merck's labeling documents for Gardasil.
"The clinical trials tested younger girls, but they only looked at
immune response to the vaccine, not whether it prevented cervical
cancer," Dr. Young said. "It has not been studied long enough to know
that it prevents cervical cancer."
By Gregory Lopes and Christopher M. Dolan
THE WASHINGTON TIMES
February 21, 2007
Jim McElhatton contributed to this report.
http://washingtontimes.com/national/20070221-123326-7587r.htm