The politics of an STD vaccine for girls
Meghan Chambers was thirty-eight years old in May of 2006.
Married, the mother of three daughters, Chambers was also dying of cervical cancer.
“She was always on the internet, looking for different suggestions, different kinds of treatments. Anything, she would say, to stay alive a little while longer,” her older sister Karen says.
“Then she found this article in the Los Angeles Times about a cancer vaccine, a vaccine for cervical cancer. She wanted to know where that vaccine had been when she needed it.”
“We talked about it for awhile, but then, we just got quiet,” Karen remembers. “I mean, what do you say in a situation like that?”
Less than three months later, Meghan Chambers died as one of nearly 4,000 American women who succumb to cervical cancer each year.
“It’s funny,” her sister says. “I got a letter from my daughter’s school a few weeks ago, talking about the same vaccine. I guess these girls, my daughter and my nieces, are going to have a better chance than my sister did. Hopefully everyone’s daughters and nieces will.”
“I know it’s pointless to say I wish the vaccine had been around to save my sister’s life,” Karen says. “But I do. I really do.”
Under a compromise law passed in Indiana this past spring, schools are required to send letters to parents of all sixth-grade girls informing them about the link between human papillomavirus (HPV), a sexually transmitted disease carried by more than 50 percent of all sexually active adults, and cervical cancer.
The letter also discusses the availability of the HPV vaccine Gardasil which has been shown to prevent cervical cancer in clinical studies.
While the original bill would have required the girls to actually receive the HPV vaccine, the final legislation only requires schools to send home a two-page letter explaining that Gardasil protects against some types of HPV.
According to Dr. Charlene Graves, medical director of immunization programs for the state health department, the letter was vetted by around some 50 experts, including pediatricians and school nurses, before being sent to parents.
“It is important for families to understand what HPV is about and what vaccination can do, and information in the fact sheet is to acquaint them with that,” according to Dr. Graves.
It’s a more conservative view of the vaccine than that of Dr. Stephen Tharp, of the Indiana Cancer Consortium, who spoke in favor of the vaccine during the last legislative session.
“It’s the first vaccine we’ve ever had that prevents cancer. This is an opportunity to save lives.”
The Gardasil controversy
Across the country, there is a debate as to whether or not girls should be required to receive the HPV vaccine, particularly after the 2006 recommendation by the national Advisory Committee on Immunization Practices (ACIP) that the vaccination be given to all girls ages 11 and 12.
The debate in states has centered — in large part — on mandatory school vaccine requirements. If the vaccine becomes mandatory, legislators must address who pays for and gets the vaccine, including Medicaid, SCHIP coverage, and uninsured youth, and whether to require coverage by insurance plans.
There are also questions concerning the absolute fortune Merck Pharmaceuticals stands to make if the vaccine is mandated. According to a study conducted by the U.S. Centers for Disease Control (CDC), “Health freedom organizations and other critics of the political power of pharmaceutical companies have vocally denounced the mandatory vaccination scheme as Merck’s way of using forced drugging to pay for Vioxx lawsuits.”
Indiana Senate President Pro Tem David Long, (R-Fort Wayne), is not one who thinks Merck’s bank account should be part of the vaccine debate. “It’s a vaccine against cancer,” Long said last February during the legislative debate. “People need to focus on that and not worry about who manufactures it or who provides it. Every vaccine in this country and in the world is produced by a drug company. It’s just an attempt to distract the discussion.”
The most vocal opponents of the vaccine, however, are those who worry that a vaccine that prevents women from contracting HPV, a sexually-transmitted disease, will inspire a false sense of security and a license for promiscuity.
But as Indiana health commissioner Judy Monroe told told members of the Associated Press earlier this year, “There’s no evidence that seat belts have increased reckless driving. There is no evidence that when we get tetanus shots, we seek rusty nails.”
The first cancer vaccine
Cervical Cancer is the second most prevalent type of cancer among women around the world. It involves cancer of the cervix, the lower part of the uterus that connects the uterus it to the vagina. Cancer of the cervix often develops slowly over many years, beginning in the lining of the cervix.
According to the CDC, every year approximately 300,000 women worldwide die from cervical cancer. In America, 3,700 American women die each year from the disease, with another 10,000 -to 12,000 new cases diagnosed every year. More than seventy percent of these cases are attributable to the human papillomavirus, or HPV.
More than half of all sexually active adults are infected with HPV, approximately 20 million people in the United States, with 6.2 million new cases each year. According to the CDC, “Genital HPV is the most common sexually transmitted infection in the United States.” Currently there is no treatment for HPV, only treatment for related health problems.
This year, Merck Pharmaceuticals introduced an HPV vaccine, Gardasil, that has shown to be 100 percent effective against cervical cancer in clinical trials, explaining a large part of Merck’s rationale for marketing the drug as a cancer vaccine rather than an STD vaccine.
Over over six years, and with 12,000 young girls receiving the vaccine worldwide, in addition to its effectiveness against cervical cancer, the trials also showed a 99 percent efficacy in preventing genital warts and a 95 percent efficacy in preventing abnormal and precancerous lesions. There is also some evidence that the vaccine is effective against some types of mouth, throat, anal, vulvar and vaginal cancers.
It has been less than a decade since young women first began receiving the vaccine; and thus it is still unclear what its longevity is. How long the drug continues to be effective and whether “booster” shots would be required at some point for patients are both unknown.
Additionally, both men and women carry HPV. In order for HPV, and cervical cancer, to be eliminated, boys would eventually need to receive the vaccine as well. Trials are currently underway testing Gardasil on young men under 25.
According to the National Cancer Institute, “Widespread vaccination has the potential to reduce cervical cancer deaths around the world by as much as two-thirds… FDA-approved Gardasil has prevented nearly 100 percent of the precancerous cervical cell changes caused by the types of HPV targeted by the vaccine for up to four years after vaccination.”
The opposition to mandating
Despite the success of Gardasil in clinical trials, there is significant opposition to mandating it as a vaccine.
For many, the biggest deterrent is its cost. The vaccine is given as three injections over a six-month period at a total cost of $360. There are also side effects, though they are similar to other immunization reactions. The vaccine can cause pain, swelling, itching and redness at the injection site; plus fever, nausea and dizziness.
Some are critical of Merck’s advertising blitz, as well as the financial gain the company stands to make if millions of American girls receive the $360 injections.
As a result, and at the recommendation of the CDC, Merck has recently pulled most of its print and television advertising, and considerably reduced lobbying state governments for mandatory vaccines.
In February of this year, when many state legislatures, including Indiana’s, were debating mandatory Gardasil vaccines, Merck released a statement saying it would greatly reduce its advocacy and advertising efforts for the vaccine and re-evaluate its lobbying program, which has “generated fierce debate with some religious organizations saying it could encourage promiscuity and parents groups questioning the need for such a widespread vaccination program.”
There is also criticism of Merck’s decision to market the drug as a cancer vaccine rather than an STD vaccine. In fact, Gardasil does prevent the sexually transmitted HPV virus, four strands of which are known to cause 70 percent of cervical cancer cases.
Other groups worry that misconceptions about Gardasil as an STD vaccine will result in increased promiscuity and a false sense of protection against unwanted pregnancy, as well as sexually transmitted diseases such as chlamydia, syphilis, gonorrhea, trichomoniasis, HIV and infertility. Gardasil is quite specific and limited in its effectiveness against HPV only.
The relative newness of the drug also has some reserving their endorsement. With only five years of data to support the drug’s effectiveness, the American Academy of Pediatrics has not yet endorsed mandatory vaccinations. According to Dr. Joseph Bocchini, chairman of the committee on infectious disease of the American Academy of Pediatrics, HPV can take up to 20 years to cause cervical cancer. Bocchini said in a recent interview that the AAP has withheld endorsement from Gardasil because there is currently no evidence that it will remain effective for the entire 20-year incubation period. Like other detractors, Bocchini points out that the vaccine, which has a 5-year effectiveness span currently, would offer no protection in the overwhelming majority of cervical cancer cases in the United States for two more decades.
The debate continues
This past legislative session, a group of female senators, Republican and Democrat, introduced Senate Bill 327, which would have required “female students who are entering grade 6 beginning in the 2008-2009 school year to be immunized against human papillomavirus (HPV) infection to help prevent cervical cancer.”
What was initially seen as a bi-partisan move to improve women’s health, however, quickly deteriorated into a debate about morality, drug company profits, and sexual abstinence as the only safe sexbehavior.
According to Micah Clark, of the American Family Association of Indiana, the vaccine “prevents the Human Papillomavirus, (HPV) from turning into cervical cancer. HPV is a sexually transmitted disease (STD) that is also responsible for anal cancer among homosexual men and genital warts among both men and women.”
“The fact that HPV, unlike polio or measles, is a behaviorally spread disease makes this a hot-button issue among for some parents,” says Clark, who also believes that the opposition has been portrayed simplistically.
“My contention is over a false message of safety,” Clark told his supporters this spring when he urged them to contact legislators and express opposition to the pending legislation to make the vaccine mandatory.
“Condoms do not protect against HPV. The vaccine is only 70 percent effective, and the length of its effectiveness is not fully known. Therefore, without an accompanying abstinence message, and adequate information about the limitations of the vaccine, [the legislation] is incomplete.”
Clark, and his supporters, and all of those who opposed mandating a cancer/STD vaccine for school-aged girls were successful in defeating the original legislation that would have made the vaccine mandatory. As a result, the final legislation only requires schools to send home a fact sheet and ask parents to voluntarily participate in an effort to see how prevalent HPV is before legislators decide to require the vaccine.
But Indiana isn’t alone in its reluctance. While approximately 40 states have introduced legislation mandating the vaccine, only Virginia has passed a law requiring the vaccine for all girls entering sixth grade, allowing parents to opt out if they choose.
In New Mexico, the legislature passed the requirement of the vaccine for all 9-14 year old girls, with an option for parents to decline. The bill was vetoed by Gov. Bill Richardson.
In Texas, the governor issued an executive order requiring the vaccine, also allowing parents to opt out, but his measure was over-ridden by the Texas legislature, and is currently pending in the Texas Supreme Court.
Gardasil, like all drugs, is not 100 percent effective against anything, nor is it 100 percent effective for everyone. Supporters and opponents alike continue to call for more trials and more research into the effectiveness of the HPV vaccine for both young girls and young boys before they become sexually active.
For someone whose sister died of cervical cancer less than a year ago, arguments against the vaccine on financial and moral grounds are hard to swallow.
“Yes, my sister had sex. Lots of it I’m guessing,” Karen says. “But to say that she, or her daughters, or my daughter, or any one with a vagina shouldn’t be alive because they had sex is unfathomable to me.
“I know it’s new, and I know there are still a lot of questions about it,” she continues. “But so far, I like what I see. I’m like a one-woman PR firm telling everyone I know – get your daughters vaccinated! I don’t receive a dime from Merck. I don’t care who makes it. All I know is it may save lives. That’s good enough for me.”
The original version of Senate Bill 327 required all girls entering sixth grade to have had the HPV vaccine as a preventative measure against cervical cancer. The amended version which ultimately passed was significantly different:
DIGEST OF SB327: Immunization for school age girls.
Requires a school to: (1) provide certain information to each parent of a female child entering grade 6 concerning the link between cervical cancer and the human papillomavirus (HPV) infection and of the availability of an immunization; (2) collect written statements from the parent indicating whether the child has received or will not receive the immunization or chooses not to provide the information; and (3) file a written report with the state department of health (state department) stating the number of required female students who have or will receive the immunization, the number of female students who have not received the immunization, and the number of students who have not provided the information. Requires the state department to provide a school with the information on cervical cancer and HPV and prescribe the format for the written statement. Provides that a student may not be prohibited from enrolling, attending, or graduating from school for not providing the written statement to the school. (Passed April 16, 2007)
Cervical cander: 100% effective
Gardasil: Participants: 8,487, Cervical cancer incidents: 0
Placebo: Participants: 8,460, Cervical cancer incidents, 53
Abnormal and cancerous lesions: 95% effective
Gardasil: Participants: 8,487, Lesion incidents: 4
Placebo: Participants: 8,460, Lesion incidents: 83
Genital Warts: 99% effective
Gardasi:Participants 8,487, Genital wart incidents: 1
Placebo: Participants: 8,460, Genital wart incidents: 91
GARDASIL® (pronounced “gard-Ah-sill”)
Generic name: Human Papillomavirus (HPV)Vaccine
Manufacturer: Merck Pharmaceuticals
GARDASIL is a vaccine that helps protect against certain diseases caused by Human Papillomavirus (HPV). Specifically the vaccine has been shown to prevent cervical cancer, abnormal and precancerous cervical, vaginal and vulvar lesions and genital warts.
Gardasil will not protect against diseases due to non-vaccine HPV types. There are more than 100 HPV types; GARDASIL helps protect against 4 types (6, 11, 16, and 18). These 4 types were chosen because they cause approximately 70% of cervical cancers and 90% of genital warts.
GARDASIL is for girls and women 9 through 26 years of age. It is recommended that the vaccine be given before a girl becomes sexually active and risks exposure to HPV.
GARDASIL is given as an injection in three doses. Ideally the second dose is given two months after the first, and the third is given six months after the first dose. All three doses must be given.
For more complete information go to
www.mercvaccines.com and talk to your health care professional.
The League incorporates as the Maternal Health League of Indiana and opens the Maternal Health Clinic in Indianapolis. Only married women with two or more children are legally allowed to receive birth control medical care and information.
Federal Comstock Laws, which prohibited publication and distribution of information about sex, sexuality, contraception and human reproduction, lifted.
First year federal funding was used for family planning.
Unmarried women can receive reproductive care and information for the first time.
The Birth Control Pill was approved by the FDA for use by the public.
Griswold v. Connecticut struck down state laws that made birth control use by married couples illegal.
U.S. Supreme Court, in Roe v. Wade decision, recognizes woman’s right to privacy in health decisions and legalizes abortion in all 50 states.
The FDA approved the first dedicated use of pills specifically for the purpose of preventing ovulation, fertilization or implantation after unprotected intercourse.
In September, the early option abortion pill is approved by the FDA providing women more privacy to have an abortion at home. In France, it was called RU-486. In U.S. the brand name is Mifeprex®.
Planned Parenthood of Indiana begins offering the HPV vaccine for its patients.
For a more detailed history of women’s reproductive health in Indiana, consult The Faithful Few: A History of Planned Parenthood of Central Indiana, by Joseph F. Thompson, M.D