" The National Vaccine Information Center yesterday
warned state officials to investigate the safety of a breakthrough cancer
vaccine as Texas became the first state to make the vaccine mandatory for
school-age girls. Negative side effects of GARDASIL, a new Merck vaccine to
prevent the sexually transmitted virus that causes cervical cancer, are being
reported in the District of Columbia and 20 states, including Virginia. The
reactions range from loss of consciousness to seizures. "Young girls are
experiencing severe headaches, dizziness, temporary loss of vision and some
girls have lost consciousness during what appear to be seizures," said Vicky
Debold, health policy analyst for the National Vaccine Information Center, a
nonprofit watchdog organization that was created in the early 1980s to prevent
vaccine injuries." - Gregory Lopes, The Washington Times, Feb. 3,
2007
"Lawmakers should have been allowed to hear from doctors,
scientists and patients before the state implemented such a sweeping mandate,
said state Sen. Jane Nelson, chairwoman of the health and human services
committee. "This is not an emergency," said Nelson, adding that she plans to ask
Attorney General Greg Abbott for an opinion on the legality of Perry's order.
"It needs to be discussed and debated." Three other Republican lawmakers filed
bills that would override the mandate, and several others were working on
similar legislation." - Liz Austin Peterson, Associated Press, Feb. 5,
2007
"Dr. Patricia Sulak, a professor of obstetrics-gynecology at
the Texas A&M Health Science Center College of Medicine, said health-care
providers she knows were shocked by the order. "It's such a new vaccine — they
haven't had time to explain it to patients," said Sulak. "I think everyone was
happy with the CDC's Advisory Committee for Immunization Practices'
recommendation that it be routinely given. But this makes it seem like it's
being shoved down people's throats." Hinchey [president- elect of Texas Medical
Association] and others emphasized that although the vaccine is considered safe,
there are questions of whether there is enough experience with it to warrant a
mandate. They say that some girls eventually may experience rare adverse effects
not yet identified." - Todd Ackerman, Houston Chronicle, Feb. 7,
2007
"Of the more than 25,000 patients who participated in clinical
trials of Gardasil, only 1,184 were preteen girls. "That's a thin base of
testing upon which to make a vaccine mandatory," says Barbara Loe Fisher,
co-founder of the National Vaccine Information Center, an advocacy group that
lobbies for safer vaccines.....Merck acknowledges that it doesn't know yet
whether an initial vaccination will offer lifetime protection or whether
patients will need booster shots. So far, the company has shown only that the
vaccine lasts five years.....As part of its lobbying campaign, Merck has been
funding Women in Government, a Washington, D.C.-based advocacy group made up of
female state lawmakers....Merck declined to say how much money it has funneled
into its lobbying campaign, or contributed to Women in Government. "Parents
should be concerned that the only company that makes this vaccine is pushing
behind the scenes for mandatory laws," says Maryann Napoli, associate director
for the Center for Medical Consumers, a consumer group based in New
York.....Mandatory vaccination across the U.S. would make Gardasil an automatic
blockbuster for Merck at a time when the patents on some of its bestselling
drugs are expiring and it's desperate to replace their revenue streams.
Gardasil's sales in 2006 were $235 million." - John Carreyrou, Wall
Street Journal, Feb. 7
CLICK HERE
Barbara Loe
Fisher Commentary:
There is a
an old saying in politics: Don't count your chickens before they are hatched.
Texas Governor Rick Perry should have remembered that old saying before crowning
himself King and wielding his executive branch power like a scepter over the
Texas legislature in order to force all little girls in Texas to get three doses
of Merck's HPV vaccine, GARDASIL.
The funny thing about it is that Merck
had launched a massive PR/advertising blitz for GARDASIL on TV and in magazines
and, with a little help from some friends, was successfully simultaneously
introducing bills in multiple states with a military precision not seen since
the invasion of Iraq. It was breathtaking in scope and public health officials,
many doctors, politicians and editors were giving GARDASIL a standing ovation as
the greatest advancement in the history of vaccines and cancer prevention. Flush
with the victory of having convinced the FDA that GARDASIL should be fast-
tracked into early licensure in the summer of 2006 and with unanimous blessing
by the CDC's Advisory Committee on Immunization Practices (ACIP) that GARDASIL
should be used by all pre-adolescent girls, Merck was on a roll.
Merck
was on a roll until parents, who were being threatened with state mandates
forcing their little girls to get three doses of GARDASIL, started to object
after taking a closer look at the evidence for the safety, efficacy and costs of
GARDSIL to prevent 3700 cases of cervical cancer every year that can be
prevented with routine pap screening and early treatment of pre-cancerous signs.
Some legislators and investigative reporters started asking questions. It was
revealed that Merck was, in effect, funding the political effort to get many
states to mandate the vaccine. The National Vaccine Information Center issued a
press release on Feb. 1 questioning how Merck could possibly know whether it was
safe to give GARDASIL to little girls when they only studied less than 2,000 of
them in pre-licensure clinical trials and when reports were already coming into
VAERS that indicated some pretty serious health events were occurring after
GARDASIL vaccination. Some legislators in some states pulled state mandate
proposals or modified them to include opt-in provisions for parents.
Then Merck choked, convincing the Governor of Texas to put on his cowboy
hat and perform the Heimlich maneuver. But what they didn't count on was public
opinion when it comes to messing around with the democratic process and
freedom.
After PROVE's Dawn Richardson stood her ground against HPV
vaccine mandates in Texas on NBC's "Today Show"and legislators and doctors alike
told "King Perry" on Tuesday that he had gone too far, today an MSNBC poll of
more than 85,000 responders shows that the majority of Americans do not think
HPV vaccine mandates are right.
Actually, the Governor of Texas and Merck
may have done America a favor: the debate about the threat to freedom and the
democratic process posed by forced vaccination policies, the influence of
corporations in the political process, and abuse of power by the chiefs of
executive branches of government is now being openly discussed.
Let
freedom ring.
Vaccine
Center Issues Warning
The
Washington Times
February 3, 2007
by Gregory Lopes
Click
here for the URL:
The National
Vaccine Information Center yesterday warned state officials to investigate the
safety of a breakthrough cancer vaccine as Texas became the first state to make
the vaccine mandatory for school- age girls.
Negative side effects of
Gardasil, a new Merck vaccine to prevent the sexually transmitted virus that
causes cervical cancer, are being reported in the District of Columbia and 20
states, including Virginia. The reactions range from loss of consciousness to
seizures.
"Young girls are experiencing severe headaches, dizziness,
temporary loss of vision and some girls have lost consciousness during what
appear to be seizures," said Vicky Debold, health policy analyst for the
National Vaccine Information Center, a nonprofit watchdog organization that was
created in the early 1980s to prevent vaccine injuries.
Following
federal approval of the vaccine in July 2006, a storm of legislation was
introduced across the nation that would make the vaccine mandatory in schools.
The District and Virginia are part of a group of at least 17 states considering
such legislation. A measure had been introduced in Maryland, but it was shelved
last week over concerns about the mandatory language in the bill.
Yesterday, Texas Gov. Rick Perry signed an order making Texas the first
state to require the vaccine. Girls ages 11 and 12 would receive the human
papillomavirus (HPV) vaccine before entering the sixth grade starting in
September 2008.
The American Cancer Society estimates there were 9,710
new cases of cervical cancer in the United States in 2006. The District's cancer
control center estimates a total of cervical cancer cases in the city last year,
and the American Cancer Society estimates that last year Maryland and Virginia
each had 210 cases of cervical center.
Merck began marketing Gardasil
last year after the Food and Drug Administration approved it for females ages 9
to 26. The vaccine is the first of its kind to build immunity against two
strains of HPV, which lead to 70 percent of cervical cancer cases in the United
States.
The vaccine is not effective in men, who can get cancer from
other strains of HPV.
Its side effects were reported to the Vaccine
Adverse Event Reporting System, a federal reporting system for consumers to
notify federal regulators of bad reactions to medications. The adverse events
began being reported in July 2006, when an advisory panel to the Centers for
Disease Control and Prevention recommended girls ages 11 and 12 receive the
series of shots.
The types of side effects reported are not cause for
alarm, according to the American Cancer Society.
"We have not been
informed of an instance that would call into question the overall safety of the
vaccine," said Debbie Saslow, director of breast and cervical cancer control at
the American Cancer Society, adding that about 70 similar events had been known
in October 2006.
Likewise, the CDC will not alter its approval of the
vaccine despite the number of adverse events revealed through the reporting
system.
"A report to the Vaccine Adverse Event Reporting System does not
necessarily mean the adverse event was serious or that it was caused by the
vaccine," said CDC spokesman Curtis Allen. "This vaccine has been tested around
the world and has been found to be safe and effective."
Merck is heavily
promoting the vaccine through its salespeople imploring doctors to provide it
and running TV ads urging young women to get vaccinated so there will be "One
Less" cancer patient.
But physicians disagree with public health
officials over whether Gardasil is the panacea for cancer. Clayton Young, an
obstetrician/gynecologist in Texas, objects to Merck's claim that Gardasil will
prevent cervical cancer.
"There is no proof Gardasil will stop cervical
cancer," he said. "They haven't been studying it long enough to make that
claim."
Merck spokesman Chris Loder said the vaccine is effective for
five years and the Whitehouse Station, N.J., drug maker is not sure how long
afterward the vaccine will work. Critics point out that an additional booster
shot may be necessary.
Advocates for a mandatory vaccine say that
although the vaccine does not prevent all causes of cervical cancer, Gardasil is
an effective vaccine against the most prevalent cause and therefore is a correct
public health measure.
Gardasil is delivered in three separate
injections that cost $120 to $150 per injection. Blue Cross Blue Shield, an
omnipresent health insurer in the Mid-Atlantic region, covers the vaccine for
girls in the federally recommended age groups.
Merck revenue from
Gardasil reached $155 million for the fourth quarter of 2006 and $255 million
for the entire year.
Texas
Gov. urged against cancer order
Wyoming News, WY
Associated Press
February 7,
2007
By LIZ AUSTIN PETERSON
Click
here for the URL:
AUSTIN,
Texas - Several key Republicans urged Gov. Rick Perry on Monday to rescind his
executive order making Texas the first state to require girls to be vaccinated
against the sexually transmitted virus that causes cervical
cancer.
Lawmakers should have been allowed to hear from doctors,
scientists and patients before the state implemented such a sweeping mandate,
said state Sen. Jane Nelson, chairwoman of the health and human services
committee.
"This is not an emergency," said Nelson, adding that she plans
to ask Attorney General Greg Abbott for an opinion on the legality of Perry's
order. "It needs to be discussed and debated."
Three other Republican
lawmakers filed bills that would override the mandate, and several others were
working on similar legislation.
Perry defended his decision, saying his
fellow conservatives were wrong to worry that mandating the vaccine will trample
parents' rights and promote premarital sex.
"Providing the HPV vaccine
doesn't promote sexual promiscuity any more than providing the Hepatitis B
vaccine promotes drug use," Perry said in a statement. "If the medical community
developed a vaccine for lung cancer, would the same critics oppose it claiming
it would encourage smoking?"
Perry has ordered the Texas Health and Human
Services Commission to adopt rules requiring Merck & Co.'s new Gardasil
vaccine for girls entering the sixth grade as of September 2008. The vaccine
protects girls against strains of the human papillomavirus that cause most cases
of cervical cancer.
Texas allows parents to opt out of inoculations by
filing an affidavit objecting to the vaccine on religious or philosophical
reasons, but critics say the order still interferes with parental
rights.
"I don't think the government should ever presume to know better
than the parents what to do with children," Republican Lt. Gov. David Dewhurst
said.
Perry also directed state health authorities to make the vaccine
available free to girls ages 9 to 18 who are uninsured or whose insurance does
not cover vaccines. And he ordered Medicaid to offer Gardasil to women ages 19
to 21.
Doctors say Perry's vaccine mandate for girls is
premature
They hail inoculation for cancer-causing virus but cite
liability, cost concerns
Houston Chronicle
By TODD
ACKERMAN
Click
here for the URL:
Gov.
Rick Perry's order requiring schoolgirls to get inoculated against a sexually
transmitted virus linked to cervical cancer may be unpopular with social
conservatives, but another important group also is lining up against it:
doctors.
From, among others, the Texas Medical Association and the
American Academy of Pediatrics, many doctors are saying it's too early to
mandate the vaccine, which was approved for use last June. It protects against
four strains of the human papillomavirus that cause 70 percent of cervical
cancers.
"We support physicians being able to provide the vaccine, but we
don't support a state mandate at this time," said Dr. Bill Hinchey, a San
Antonio pathologist and president-elect of the TMA, which represents 41,000
physicians. "There are issues, such as liability and cost, that need to be
vetted first."
Other reasons cited by doctors in Texas and across the
country include the vaccine's newness; supply and distribution considerations;
the possibility opposition could snowball and lead to a reduction in other
immunizations; the possibility it could lull women into not going for
still-necessary cervical cancer screenings; gender-equity issues; and the
tradition of vaccines starting as voluntary and becoming mandatory after a need
is demonstrated.
Hinchey said that TMA leadership expressed their
concerns to Perry on Tuesday. He said the TMA arrived at its position after
debating the issue in committees in recent days.
A spokeswoman for Perry
reiterated Tuesday that the governor stands by the order. She said he is
listening to the discussion but thinks the vaccine is safe and
effective.
Unexpected opposition
Perry touched off a
firestorm Friday when he issued the order, which requires girls receive the
three-shot vaccination to enter sixth grade, starting in September 2008. Social
conservatives said a mandate makes sex seem permissible. Others complained Perry
was circumventing the legislative process, where bills to make the vaccine
mandatory had been filed.
Opposition from doctors was less expected.
Virtually all hail the vaccine as a great breakthrough and call for the highest
possible proportion of girls and women — and boys and men, eventually — to get
immunized in hope of one day eliminating the virus.
"But education needs
to come first," said Dr. Joseph Bocchini, chairman of the AAP's committee on
infectious disease. "Much of the public doesn't know about HPV and its link to
cervical cancer and other diseases. You can't put a mandate ahead of
that."
HPV is the most common sexually transmitted infection in the
United States, infecting 6.2 million new people a year. Though the immune system
usually clears the infection, it can lead to cervical cancer, cancer of the
penis and anus, and genital warts. Although cervical cancer is declining in the
United States, there are 9,710 new cases a year and 3,700 annual deaths
attributed to it. Worldwide, it's the second most common cancer in women,
resulting in 233,000 deaths a year.
Point of contact an
issue
The 60,000-member AAP circulated a statement last week that
lays out many concerns about a mandate. The statement, written before Perry's
order, notes that 24 states and the District of Columbia have introduced or
prefiled legislation requiring adolescent girls to get the vaccine.
Among the statement's points is that mandating a vaccine for a disease
not spread by casual or occupational contact — and currently only available to
one gender — represents a departure from past practice. Such school immunization
requirements came into existence, it says, to protect schoolchildren from
outbreaks of contagious disease in that setting, not to compel vaccination. (The
quickest a vaccine has gone from approval to mandatory in Texas was the
chickenpox vaccine, which took 5 1/2 years.)
The statement also says the
costs of such a program will further strain state vaccine programs already short
on resources. It says states that choose to add the HPV vaccine to school entry
programs should provide additional funding and insurance
coverage.
Perry's order said the vaccine would be covered under the
federal Vaccine for Children program, which supplies vaccines to those
uninsured, underinsured or on Medicaid or the Children's Health Insurance
Program. The order said nothing about coverage by private insurers, many of whom
aren't yet including the shot in their popular plans. The vaccine costs from
$120 to $200 a shot.
Reaction from doctors
Dr. Patricia
Sulak, a professor of obstetrics- gynecology at the Texas A&M Health Science
Center College of Medicine, said health-care providers she knows were shocked by
the order. "It's such a new vaccine — they haven't had time to explain it to
patients," said Sulak. "I think everyone was happy with the CDC's Advisory
Committee for Immunization Practices' recommendation that it be routinely given.
But this makes it seem like it's being shoved down people's throats."
Hinchey and others emphasized that although the vaccine is considered
safe, there are questions of whether there is enough experience with it to
warrant a mandate. They say that some girls eventually may experience rare
adverse effects not yet identified.
One medical ethicist was willing to
give Perry's order a chance.
"Perry gave a classic public-health-ethics
rationale for the program," said Laurence McCullough, a professor in Baylor
College of Medicine's Center for Ethics and Health Policy. "But he needs to
present to the legislature a cost analysis and funding source so other
priorities are not displaced."
McCullough added that Perry likely would
have avoided controversy if he'd signed on to proposed legislation and led
public debate rather than issuing an executive
order.
todd.ackerman@chron.com
Moves to
Vaccinate Girls For Cervical Cancer Draw Fire
As Merck
Lobbies States To Require Shots, Some Fret Over Side Effects, Morals
The Wall Street Journal
February 7, 2007; Page
D1
By JOHN CARREYROU
Click
here for the URL:(subscription required)
Bills being
drafted in some 20 U.S. states that would make a cervical-cancer vaccine
mandatory for preteen girls are sparking a backlash among parents and consumer
advocates.
The bills coincide with an aggressive lobbying campaign by
Merck & Co., the maker of the only such vaccine on the market. Called
Gardasil, the three- shot regimen provides protection against the human
papillomavirus, a sexually transmitted virus that is responsible for the
majority of cases of cervical cancer.
If the state bills become law, they
would guarantee the Whitehouse Station, N.J., drug maker billions of dollars in
annual revenue from the vaccine.
Proposed legislation varies from state to
state, but the bills generally would require girls to show proof that they have
received the inoculation in order to enter school. A number of immunizations --
including those for measles, chicken pox and polio -- are mandatory for U.S.
schoolchildren because they block highly contagious diseases that can be spread
easily in a group setting. But HPV is different because it is transmitted
sexually. At $360 for the three shots, Gardasil is also costlier than many
vaccines (a measles-mumps-rubella shot costs about $42.85 per dose, for
instance), though it is generally covered by insurance.
Conservative
Christian groups have long voiced opposition to the vaccine, saying it would
conflict with their message of abstinence because it would, in effect, condone
premarital sex. However, concern has spread beyond the religious right as
momentum has grown for making inoculation mandatory. A growing number of parents
are worried about exposing their children to the unforeseen side effects of a
new vaccine to protect them from a disease that is no longer very common in the
U.S. and often doesn't develop until much later in life.
Tina Walker, the
mother of an 11-year-old girl in Flower Mound, Texas, says she would prefer to
wait until the vaccine has been on the market for several years before
subjecting her child to it. "We are the guinea pigs here," she says.
Last
week, Texas Gov. Rick Perry issued an executive order mandating that the vaccine
be administered to all girls entering the 6th grade in the state as of September
2008. The Texas executive order, which includes an opt-out clause for religious
or other "reasons of conscience," enabled the governor to bypass what would have
likely been a heated debate in the Texas Legislature.
Many of the state
bills contain opt-out clauses, but a few don't. The bill pending in Florida
would bar students ages 11 or 12 from being admitted to public or private school
in the state unless they can provide proof that they have been vaccinated or
that their parents opted them out after receiving information about cervical
cancer and the vaccine.
Merck says cervical cancer is the second-leading
cancer among women around the world, but the disease's prevalence is actually
low in the U.S. The American Cancer Society estimates that 11,150 women will be
diagnosed with cervical cancer and 3,670 will die from it in the U.S. this year.
That's equivalent to 0.77% of cancers diagnosed in the U.S. and 0.65% of U.S.
cancer deaths each year. By comparison, the society estimates that 178,480
American women will get diagnosed with breast cancer in 2007 and 40,460 will die
from it.
Adding to some parents' concern, 82 adverse events among both
teens and adult women have been reported since Gardasil became available last
June. Many involve common immune-system responses to vaccines, such as nausea,
fever or rashes. But a number of patients suffered syncopes, or fainting
spells.
Richard Haupt, Merck's executive director of medical affairs,
says the syncopes are caused by patients' anxiety at having a needle stuck in
their arm and not due to any neuro-immune reaction to the vaccine. Mr. Haupt
adds that the number of adverse events is small compared with the hundreds of
thousands of doses of the vaccine administered so far in the
U.S.
However, with any newly approved drug or vaccine, side effects often
don't become apparent until a regimen has been on the market for a while,
leading some patient and consumer advocates to urge states to hold off on
requiring vaccination until Gardasil's safety is more clearly
established.
Of the more than 25,000 patients who participated in
clinical trials of Gardasil, only 1,184 were preteen girls. "That's a thin base
of testing upon which to make a vaccine mandatory," says Barbara Loe Fisher,
co-founder of the National Vaccine Information Center, an advocacy group that
lobbies for safer vaccines.
Gardasil is approved for females ages 9 to
26, and the three-dose regimen is the same for all age groups. The vaccine
protects against four strains of HPV that cause 70% of cervical cancer cases. So
it would not eliminate the need for vaccinated women to have regular Pap smears
to detect cancerous cells caused by other HPV strains. HPV is also the virus
that causes genital warts.
Merck acknowledges that it doesn't know yet
whether an initial vaccination will offer lifetime protection or whether
patients will need booster shots. So far, the company has shown only that the
vaccine lasts five years.
Merck started lobbying state legislatures to
pass laws requiring vaccination last year after the Centers for Disease Control
and Prevention's Committee on Immunization Practices recommended that all girls
get the vaccine when they turn 11 or 12. Another HPV vaccine, called Cervarix,
is in development from GlaxoSmithKline PLC, but so far Gardasil is the only
regimen on the market.
As part of its lobbying campaign, Merck has been
funding Women in Government, a Washington, D.C.- based advocacy group made up of
female state lawmakers. An executive from Merck's vaccine division, Deborah
Alfano, sat on Women in Government's business council last year, and many of the
bills across the country have been introduced by members of the
group.
Merck declined to say how much money it has funneled into its
lobbying campaign, or contributed to Women in Government. A spokeswoman for
Women in Government, Tracy Morris, declined to say how much it had received from
Merck. In Texas, one of Merck's lobbyists is Gov. Perry's former chief of staff,
and Merck's political action committee contributed $6,000 to the governor's
re-election campaign.
"Parents should be concerned that the only company
that makes this vaccine is pushing behind the scenes for mandatory laws," says
Maryann Napoli, associate director for the Center for Medical Consumers, a
consumer group based in New York.
At a Merrill Lynch conference
yesterday, Margaret McGlynn, the president of Merck's vaccine division,
acknowledged the company's aggressive lobbying campaign but said, "States decide
what works for them." She added that she had her own daughter vaccinated with
Gardasil and "immunizing females against cervical cancer is absolutely the right
thing to do."
Mandatory vaccination across the U.S. would make Gardasil
an automatic blockbuster for Merck at a time when the patents on some of its
bestselling drugs are expiring and it's desperate to replace their revenue
streams. Gardasil's sales in 2006 were $235 million.
Cervical cancer is a
much bigger problem in the developing world, which accounts for more than 80% of
cases of the disease. Merck says it's committed to bringing the vaccine to
developing countries, but for now its availability is limited there to a few
studies and demonstration programs.
Write to John Carreyrou at
john.carreyrou@wsj.com
POINTS OF
CONTENTION
Concerns over mandating shots:
• Some parents say a
vaccine for HPV, the sexually transmitted disease that can cause cervical
cancer, effectively condones premarital sex.
• Long-term efficacy and
risk of side effects are unclear. There have been 82 reports of adverse events
associated with the vaccine.
• Gardasil is typically covered by
insurance, but is costlier than many other common
vaccines.
*************************************************************
"TRUTH"
A Hard Pill to Swallow!
Special NEWS RELEASE!
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