Art by Jose Carmona
I heard about Gardasil because my friend was in the ‘one less’ commercial, she told me about it,” said 16-year-old Lillian Oquendo from Brooklyn. Lillian has recently undergone the first dose of Merck’s new vaccine, Gardasil, which prevents the four strains of HPV (Human Papillomavirus) that most commonly cause genital warts and cervical cancer in women. “I figured, why not?” she said, “I’m not really stressed about risks. If it will help protect me, it’s probably safe. My mom was cool with it.”
Teenage girls get their sex education from diverse sources. Often, in New York City, the information does not come from their schools, where health classes are either absent or focus only on pregnancy prevention and select STDs like gonorrhea, chlamydia and HIV/AIDS. Much of the current buzz about HPV has come from television ads featuring girls who want to be “one less” – one less death due to cervical cancer. While many girls have seen the ad, which features energetic girls jumping rope while chanting “on-e-l-e-s-s, I’m gonna be one less,” some girls are still confused about the details of the virus and of the vaccine.
Jaene Knight is an 11th grader at Urban Assembly Media high school in Manhattan. She claims that the only sex education that she has received was a single day of workshops at the beginning of her junior year. Students were taught the dangers of HIV/AIDS and the importance of condom use, but did not learn about HPV, despite the fact that 50-75 percent of American men and women will become infected in their lifetime. Jaene’s classmate, 16-year-old Megan Fernandez, also claimed that she had not heard about HPV until she saw the TV ads. “I know it has something to do with cervical cancer,” she said, “but I want to know more about how you get it.”
Although there is no standardized health curriculum that includes education about HPV, many New York City schools do teach their kids about the risks that they face. Beth Israel Medical Center partners with Washington Irving High School to offer a school-based clinic providing mentoring and peer education to students. Washington Irving High School Senior Simmone Leslie, after learning about HPV in a jeopardy game in her health class, worked with other students to petition the city to get the vaccine offered at her school’s free clinic. She has already received the first dose of the vaccine. “I would encourage any female who is a teenager to go out and get this shot,” she said. “It doesn’t hurt to go that extra mile and get that shot done.”
A GREEN LIGHT FOR IRRESPONSIBLE SEX?
Dr. Ed Lewis, a pediatrician in Rochester, New York, has experienced a torrent of interest in the HPV vaccine from adolescent girls and their mothers. He has presently given out several hundred doses, some girls already on their second dose, which is offered two months after the first dose has been administered.
“The most common misconception I’ve heard is that people don’t need [the vaccine] if they’re not sexually active or have been exposed to or infected with HPV. But they should still get it to protect themselves,” Dr. Lewis said.
The vaccine protects girls and women against four major strains of HPV; however, according to the Centers for Disease Control (CDC), there are about 40 strains of the virus. Several healthcare providers have suggested that this number is actually even higher, closer to 90 or 100 different strains. The vaccine protects against the two strains that cause about 70 percent of cases of cervical cancer and the two strains that cause about 90 percent of cases of genital warts.
“Even if a girl has been infected with HPV, she should still get the vaccine to prevent against the type of HPV that causes cervical cancer,” Dr. Lewis said.
“My mom would probably not want me to get it because she’d think it would promote sex or something,” said 17-year-old Che’te Bey from Long Island City, Queens. Christian groups like Focus on the Family have opposed mandatory administration of the vaccine fearing it will promote promiscuous behavior and girls will feel better protected when they have sex early or have sex with multiple partners.
“I wish that I had been vaccinated,” said Sara Edmunds, a woman who currently has a strain of HPV that leads to cervical cancer. “I wish that we all had. I wish that the FDA hadn’t sat on the vaccine for a while before approving it, and I wish that all 11 and 12 year old girls can get vaccinated now.”
“Is the vaccine a green light to go have irresponsible sex? No. It is to protect girls from potentially contracting a serious disease,” said Dr. Gale Blakley, an ObGyn, at the Helen B. Atkinson Center in Harlem and the Associate Medical Director for Women’s Services at the Community Healthcare Network in New York City. She also warns that just because someone has been vaccinated, they should not forget about the dangers of cervical cancer altogether.
While the vaccine is effective in preventing the two main strains of HPV that lead to cervical cancer, there are still 12 or more other strains that can result in the disease. Dr. Blakley estimates that close to 99 percent of all cases of cervical cancer are caused by some kind of HPV infection. She urges patients to get vaccinated, but to also get pap smears on a regular basis (1-2 times per year). Pap smears can detect cervical cancer in its early stages and consequently save lives. “Now with this vaccine coming on board, the vaccine along with the Pap smear, we’re going to see even fewer cases of cervical cancer in the near future,” Dr. Blakley said.
WHO IS COVERED AND WHO IS NOT?
Gardasil is the most expensive preventative vaccine on the market. At $120 per shot –$360 for the three-shot regimen – questions arise as to who can afford the vaccination and who cannot.
“A lot of physicians are concerned about the costs of the vaccine. Insurance companies might not cover the full cost of [Gardasil],” said pediatrician Dr. Ann Hellerstein. The Federal Vaccines for Children program (VCF) will provide the vaccination free to females under the age of 19 who are either uninsured, on Medicaid, or who are either American Indian or Alaskan Natives. Doctors and the FDA are recommending that Gardasil be administered largely to 11 year olds, as they are also getting vaccinated that year for Tetanus/Diphtheria among other immunizations.
While the recommended age for administration is 11-12, Gardasil has been approved up until the age of 26. Unfortunately for the 3 out of 10 women age 19-26 who are uninsured, trying to protect oneself against cervical cancer could mean some hefty out-ofpocket expenses.
Many, but not all, public and private insurance companies plan to cover the HPV vaccine, and policies about who will be covered and to what extent has yet to be determined. Presently, Empire Blue Cross Blue Shield has confirmed that they will cover the costs of the Gardasil vaccine for teenagers. Additionally, Merck offers a little-known patient assistance program for women aged 19-26 who are uninsured or underinsured. The program requires an application process and forms demonstrating income. To qualify, women must be low income (below 200 percent of the poverty line), be uninsured and see a private physician who already distributes other Merck products.
Currently in New York City, Planned Parenthood and New York State Department of Health-run clinics do not offer the vaccine for free or reduced prices yet; however, both organizations expect to offer the vaccine in 2007.
The Facts on HPV and Cervical Cancer
HPV is a sexually transmitted disease that causes up to 70 percent of cervical cancer cases in women. The vaccine is effective in preventing the two main strains of HPV that lead to cervical cancer. However, a dozen or more other strains exist that can result in the disease.
Condoms significantly reduce many HPV transmissions, but cannot protect against open sores located in areas not covered by a condom. It is possible to contract HPV without engaging in unprotected sexual intercourse. Clinical tests have shown that the HPV vaccine will only provide protection for four years. It is administered in a three-shot regimen, spread out over a time period of five to seven months.
The HPV vaccine introduces particles of the dead virus into the bloodstream, and the human body develops antibodies to these particles. Women never run the risk of accidentally contracting the virus through the vaccine to because the virus is never alive in their system.
Women should get Pap smears, which can detect pre-cancerous cells, one to two times per year. The American Cancer Society and the American College of Obstetrics and Gynecology suggest that women begin having Pap smears three years after their first sexual contact and no later than the age of 21.
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HPV Vaccine Mandates Risky and Expensive
Vaccine Safety Group Finds Serious Reactions, High Costs
SOURCE: National Vaccine Information Center
PRNewswire
February 31, 2007
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VIENNA, Va., Feb. 1 /PRNewswire-USNewswire/ -- The National Vaccine
Information Center (NVIC), the nation's leading vaccine safety and
informed consent advocacy organization, is urging state legislatures
to investigate the safety and cost of mandating Merck's HPV vaccine
(GARDASIL) for all pre- adolescent girls before introducing
legislation amending state vaccine laws. In an analysis of reports
made to the federal Vaccine Adverse Event Reporting System (VAERS)
since the CDC's July 2006 universal use recommendation for all young
girls, NVIC found reports of loss of consciousness, seizures, joint
pain and Guillain-Barre Syndrome. In a separate evaluation of costs
for young girls being vaccinated in private pediatrician offices, NVIC
discovered that parents living in the Washington, D.C. area will be
paying between $500 and $900 to have their daughters receive three
doses of GARDASIL.
"GARDASIL safety appears to have been studied in fewer than 2,000
girls aged 9 to 15 years pre-licensure clinical trials and it is
unclear how long they were followed up. VAERS is now receiving reports
of loss of consciousness, seizures, arthritis and other neurological
problems in young girls who have received the shot," said NVIC
President Barbara Loe Fisher. "At the same time, parents who take
their daughters to private pediatricians are going to be shocked to
find that they will be paying two to three times the widely publicized
$360 cost for the three-dose series. The cost is going to break the
pocketbooks of parents and break the banks of both insurance companies
and taxpayers, when the reality is that almost all cases of HPV-
associated cervical cancer can be prevented with annual pap screening
of girls who are sexually active."
Between July 2006 and January 2007, there have been 82 reports of
adverse events filed with VAERS following receipt of GARDASIL by girls
and boys ranging in age from 11 to 27 years. Reaction reports have
come from 21 states, including Virginia and the District of Columbia.
All but three of the reports were for adverse events which occurred
within one week of vaccination and more than 60 percent occurred
within 24 hours of vaccination.
"The most frequent serious health events after GARDASIL shots are
neurological symptoms," said NVIC Health Policy Analyst Vicky Debold,
RN, Ph.D. "These young girls are experiencing severe headaches,
dizziness, temporary loss of vision, slurred speech, fainting,
involuntary contraction of limbs (seizures), muscle weakness, tingling
and numbness in the hands and feet and joint pain. Some of the girls
have lost consciousness during what appears to be seizures." Debold
added "The manufacturer product insert should include mention of
syncopal episodes, seizures and Guillain-Barre Syndrome so doctors and
parents are aware these vaccine adverse responses have been associated
with the vaccine."
VAERS reports also indicate the doctors are administering GARDASIL to
girls and women at the same with Tdap, DT, meningococcal (Menactra),
hepatitis A, and other vaccines, even though the Merck product insert
states that, with the exception of hepatitis B vaccine,
"Co-administration of GARDASIL with other vaccines has not been
studied." There is no publicly available information about how many of
the 9 to 15 year old girls in Merck's pre- licensure clinical trials
received GARDASIL simultaneously with hepatitis B vaccine.
Although approximately half of all families in the U.S. select a
pediatrician in private practice to provide their children routine
care, including vaccinations, children can receive government
subsidized reduced cost or free vaccinations in public health clinics
through the Vaccines for Children program if they cannot afford to pay
for vaccinations administered by private pediatricians. NVIC's survey
of four private pediatric practices in the Virginia suburbs of
Washington, D.C. found that parents could be charged anywhere from
$525 to $930 for three GARDASIL shots depending upon whether the child
was a first-time or current patient. Costs for the vaccine plus an
administration fee ranged from $140 to $275 per shot with an
additional office visit charge that fluctuated between $35 and $185
depending upon whether a nurse or doctor saw the child.
HPV is the most common sexually transmitted infection in the U.S. and
most persons naturally clear the infection from the body without
symptoms. However, many years of chronic HPV infection is associated
with a higher risk of pre- cancerous changes in the cervix that can
lead to cancer unless diagnosed and treated promptly. High risk
factors for chronic HPV infection include smoking, long-term use of
oral contraceptives and co-infection with HIV, herpes and chlamydia.
There has been a more than 70 percent drop in cervical cancer deaths
in American women since the 1950's due to routine pap smears and
nearly all cervical cancers can be prevented with regular pap smear
screening and treatment.
In its product manufacturer insert, Merck states that "Vaccination
does not substitute for routine cervical cancer screening. Women who
receive GARDASIL should continue to undergo cervical cancer screening
per standard of care." Merck also states that "The duration of
immunity following a complete schedule of immunization with GARDASIL
has not been established."
For more information about HPV infection and GARDASIL safety,
including NVIC's five-page report on GARDASIL adverse event reports to
VAERS as well as a direct link to VAERS reports, go to NVIC's website
at http://www.nvic.org
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