|Implemented in this survey?|
In late 2006, Democratic Assemblywoman Sally Lieber introduced a bill that would require all girls entering sixth grade to be vaccinated against human papillomavirus (HPV) beginning in July 2008. The bill would add HPV to a list of ten other infectious diseases against which schoolchildren in California must be vaccinated. After introduction in March 2007, the bill was withdrawn by its current sponsor, Democrat Ed Hernandez, who plans to reintroduce a revised version of the bill at a later date.
Human papillomavirus, HPV, is the most common sexually transmitted infection in the U.S., with 24.9 million women currently infected. More than 30 different strains of the virus can be transmitted sexually. Many of the strains do not cause symptoms; however, infection with certain strains causes genital warts and cervical cancer. In fact, HPV infection is the top cause of cervical cancer, accounting for more than 80 percent of all cases. The rate of HPV infection is highest among 20 to 24-year-olds, 44% of whom are infected with the virus. In the U.S., approximately 10,000 new cases of cervical cancer are diagnosed each year.
In June 2006, Gardasil, manufactured by pharmaceutical company Merck, became the first licensed anti-HPV vaccine when it was approved in an expedited review by the Food and Drug Administration. (Such review is reserved for new drugs that serve an unmet need.) The vaccine protects against four strains of HPV: HPV 6, 11, 16 and 18; the first two cause 90% of all genital warts cases and the latter two are responsible for 70% of all cervical cancer cases. Gardasil, which is administered in three shots over six months, is nearly 100% effective against the viral strains it targets.
Nearly three-fourths of the 6.2 million new HPV cases that occur each year in the U.S. occur in young women between ages 15 and 24. California Assembly Bill 16, considered by the Assembly's Health Committee in March, would mandate the vaccine for girls entering sixth grade on or after July 1, 2008, in order to curb transmission of the virus among adolescents.
In California, 900,000 girls and women between ages 14 and 24-nearly 40 percent of this segment of the population-are currently infected with HPV. Each year, roughly 1,600 women in the state are diagnosed with cervical cancer and 400 women die of the disease. Incidence is highest among Hispanic women and mortality is highest among Black women in the state. AB 16 aims to reduce HPV infections by ensuring widespread vaccination before the onset of sexual activity in adolescents. Reducing HPV prevalence would, in turn, reduce cervical precancer and cancer rates and the costs associated with prevention and treatment. Prevention and treatment of cervical diseases caused by HPV currently cost the U.S. approximately $4 billion a year, according to the Centers for Disease Control and Prevention (CDC).
Mandating vaccination for school enrollment is widely regarded by public health experts as the most effective means of vaccinating the greatest number of children. The tactic is widely employed to ensure widespread coverage with measles, mumps, rubella, hepatitis and polio vaccines, to name a few. In California, according to the State Health and Safety Code, children must be vaccinated against ten different diseases to enroll in public or private school.
California state law does, however, permit parents to opt out of vaccination requirements on religious, moral or medical grounds. This option would apply to the HPV vaccine should a mandate pass. To obtain an immunization exemption on medical grounds, a parent must present the school district with a signed statement from the child's physician explaining why the child cannot be vaccinated. To obtain a "personal beliefs" exemption, parents must sign an affidavit upon registering their children for school. In the event of a disease outbreak, as defined by the state health department, the state can require parents of unvaccinated children to keep their children temporarily out of school. Though a personal beliefs exemption is fairly easy to obtain, few parents have opted for them thus far. A CDC analysis published in 2001 indicated that less than 2 percent of students in California schools had obtained legal exemptions to measles-containing and hepatitis B vaccines.
School districts; Insurance companies; State health coverage plans for the poor and uninsured;, Families with school-age children; Pharmaceutical companies that manufacture or plan to manufacture HPV vaccines
|Degree of Innovation||traditional||innovative|
|Degree of Controversy||consensual||highly controversial|
|Structural or Systemic Impact||marginal||fundamental|
|Public Visibility||very low||very high|
This is probably an example of policy getting ahead of the science - in other words, a rush to judgement to apply a technological/medical solution to a social problem without a great deal of supporting evidence.
Shortly after Gardasil was approved in June 2006, the federal Advisory Committee on Immunization Practices (ACIP) recommended that girls between ages 11 and 12 be vaccinated against HPV and that girls between 13 and 26 be given a "catch-up" vaccination. Federal law authorizes the 15-member Advisory Committee on Immunization Practices (ACIP) to recommend vaccines and stipulate who should receive them, when and how. The committee also determines whether the vaccine should be made available through Vaccines for Children, the federal program that makes immunizations accessible to low-income children. (The HPV vaccine is available through the program.) ACIP's recommendations aren't binding, but its endorsement is critical for a vaccine to become widely available.
School vaccination requirements are determined at the state level, and state legislatures typically rely on ACIP's recommendations before requiring a vaccine for school enrollment. In some states, Health Departments can mandate a vaccine, but they rely on legislation to allot funding.
In California, state Assemblywoman Sally Lieber, D-Mountain View, introduced a bill on December 4, 2006 that would require girls to be vaccinated against HPV to enter sixth grade, starting in 2008. The bill would amend the section of California's Health and Safety Code that outlines other immunizations required for school attendance. Lieber removed her name from bill after learning that her husband owned stock in Merck, the company that makes the only currently licensed HPV vaccine. (GlaxoSmithKline plans to submit its own HPV vaccine, Cervarix, for FDA approval this year.) The bill's current author is Ed Hernandez, D-West Covina. Hernandez's campaign received funds from Merck in 2006, but the lawmaker insists the contribution has not influenced his sponsorship of the bill.
The bill met with controversy when legislators took it up in mid-March. Lawmakers expressed concern over the vaccine's recent arrival on the market, pointing out that little was known about its long-term effects-and effectiveness. Many also expressed concern over its manufacturer's lobbying efforts, which included a campaign to encourage states to mandate the vaccine. In March, Hernandez withdrew his HPV bill from the Assembly and announced plans to reintroduce it, with modifications, later in the spring.
|Implemented in this survey?|
Massachusetts passed the first compulsory immunization law, targeting smallpox, in 1809. Since then, school-related immunization mandates have helped curb nearly a dozen once-epidemic infectious diseases in the U.S., including measles, mumps, rubella, whooping cough and polio.
HPV vaccine-related legislation was widely predicted by public health experts prior to Gardasil's approval. In fact, 39 states have introduced HPV-related legislation since the vaccine's approval, and 21 states have considered (or are considering) requiring vaccination for school attendance.
Many lawmakers, including Lieber, have stated that they were encouraged to support mandates because the vaccine presented a unique opportunity to prevent cancer. Outside observers, however, have pointed to Merck's concerted efforts to persuade lawmakers to take up such legislation. Following the vaccine's approval, Merck launched a direct-to-consumer ad-campaign featuring the logo "one less"-implying one less cervical cancer case for each woman vaccinated. The ads aired across the country, including in California. At the same time, Merck launched a national effort to convince states to mandate the vaccine for school enrollment. As part of the lobbying campaign, Merck hired independent lobbyists in states across the nation. The company also funded a group called Women in Government, which is comprised of female lawmakers who promote education on health issues. The group posted sample HPV mandate legislation on its website. (Lieber is not a member of the group and has not met with Merck lobbyists.)
Michigan was the first state to introduce HPV-related legislation following Gardasil's approval and the initiation of Merck's campaign. The bill would have required girls entering sixth grade to be vaccinated, but failed by a narrow margin. In February, Texas became the first state to mandate the vaccine when governor Rick Perry issued an executive order requiring the vaccine for sixth grade girls. The Texas legislature is now voting on whether to reverse the measure, following revelations about Perry's ties to Merck: one of Merck's Texas lobbyists, Mike Toomey, is a longtime friend of Perry's and his former chief of staff. Perry had also received $5,000 in campaign funds from Merck.
Two other state legislatures, in New Mexico and Virginia, have approved measures requiring the vaccine for school; both bills await governor approval. Both sponsors of California's proposed mandate have insisted that Merck's influence had nothing to do with their support for the bill. In February, following the controversy in Texas, Merck announced that it would cease its lobbying efforts in all states.
Approach of idea The idea of mandating vaccination for school enrollment to ensure widespread coverage is not new; ten other vaccines are mandated for school enrollment in California. The HPV vaccine, contrary to the arguments of some of the current bill's opponents, would also not be the first mandated vaccine to prevent a sexually transmitted disease; vaccination against Hepatitis B, which is transmitted by sexual contact and intravenous drug use, is also mandated by the state for entry into kindergarten. However, the timing of the HPV vaccination bill is unusual; most vaccines are not mandated for school until they have been available for at least four years.
|State Legislature||very supportive||strongly opposed|
|Assemblywoman Lieber||very supportive||strongly opposed|
|Assemblyman Hernandez||very supportive||strongly opposed|
|California Medical Association Foundation||very supportive||strongly opposed|
|American Academy of Pediatrics||very supportive||strongly opposed|
|Parents groups||very supportive||strongly opposed|
|Social conservative groups||very supportive||strongly opposed|
|Poverty advocates||very supportive||strongly opposed|
|Vaccine safety groups||very supportive||strongly opposed|
|Private Sector or Industry|
|Merck Pharmaceuticals||very supportive||strongly opposed|
Merck & Co., Gardasil's manufacturer, hired independent lobbyists and financed a campaign by a non-profit group called Women in Government that lobbied states to pass HPV vaccine legislation.
Assemblywoman Lieber has publicly stated that she drafted the HPV mandate for California because of the unique opportunity it presented to prevent cancer with a vaccine-something that has never before been possible. Lieber has also cited encouragement from her mother, Phyllis Lieber, in explaining why she drafted the bill.
Merck representatives requested a meeting with Lieber before she introduced the HPV bill, but Lieber declined. Lieber did meet with Women in Government, unaware of their ties to Merck. Hernandez, the bill's current sponsor, denies any influence from Merck and has stated that he supports the measure because it's "the right thing to do." As of February, Merck had abandoned its HPV mandate lobbying campaign.
|State Legislature||very strong||none|
|Assemblywoman Lieber||very strong||none|
|Assemblyman Hernandez||very strong||none|
|California Medical Association Foundation||very strong||none|
|American Academy of Pediatrics||very strong||none|
|Parents groups||very strong||none|
|Social conservative groups||very strong||none|
|Poverty advocates||very strong||none|
|Vaccine safety groups||very strong||none|
|Private Sector or Industry|
|Merck Pharmaceuticals||very strong||none|
Because the HPV vaccine is so new, its manufacturer still cannot say how long it will confer protection. And though safe in clinical trials, the vaccine's long-term safety is still unknown. There is also currently only a single HPV vaccine on the market, which, some analysts predict, could translate into hundreds of millions of dollars in sales for Merck, which has lobbied heavily in favor of state mandates. Such concerns seem likely to destine AB 16, as currently written, for the same fate as Michigan's vaccination mandate bill. However, ACIP's endorsement, and the speed with which many state legislators introduced HPV-related bills, has led many experts to predict that HPV legislation will eventually pass in many states, including California. Ultimately the majority of such legislation-including California's-may not mandate the vaccine for school attendance, but would, rather, promote education about the vaccine. While many medical groups, including the American Academy of Pediatrics and the American Cancer Society, advocate HPV immunization, many also stop short of supporting a school-related mandate, though such positions may change if the vaccine proves itself safe and effective for the long-term.
Benson, C. "Lawmakers doubts shelve bill requiring HPV vaccine." Sacramento Bee, Mar. 14, 2007.
California Healthline. "CMA Promotes HPV Vaccination." California HealthCare Foundation (www.californiahealthline.org), Jan. 25, 2007.
California Healthline. "HPV Vaccine Bill Raises Ethical Concerns." California HealthCare Foundation (www.californiahealthline.org), Feb. 6, 2007.
California Healthline. "Majority of MDs to Recommend HPV Vaccine for Children."
California HealthCare Foundation (www.californiahealthline.org), Nov. 30, 2005. Centers for Disease Control and Prevention. "Quadrivalent Human Papillomavirus Vaccine." Morbidity and Mortality Weekly Report, Mar. 12, 2007.
Dailard, C. "The Public Health Promise and Potential Pitfalls of the World's First Cervical Cancer Vaccine." Guttmacher Policy Review, Winter 2006, Vol. 9, No. 1
Edwards, K. "State Mandates and Childhood Immunization." Journal of the American Medical Association, Dec. 27, 2000, Vol. 287, No. 24.
Folmar, K. "Bill pushes vaccine; parents talk of morality." San Jose Mercury News, Jan. 1, 2007.
Hart, L. "Texas HPV vaccine mandate meets swift resistance." Los Angeles Times, Feb. 25, 2007. "HPV and HPV Vaccine: Information for Healthcare Providers." Centers for Disease Control and Prevention, August 2006. At www.cdc.gov/std/hpv/STDFact-HPV-vaccine-hcp.htm.
"HPV Vaccine." National Conference of State Legislatures, March 21, 2007. At www.ncsl.org/programs/health/hpvvaccine.htm
Kaiser Family Foundation. "HPV Vaccine: Implementation and Financing Policy." Women's Health Policy Facts, Jan. 2007.
Lawrence, S. "Vote delayed on bill requiring girls to be vaccinated against HPV." San Francisco Chronicle, March 13, 2007.
Lieber, S. Assembly Bill No. 16. At http://info.sen.ca.gov/pub/bill/asm/ab_0001-0050/ab_16_bill_20061204_introduced.html.
Nasseri, K. et al, eds. "Cervical Cancer in California: A Special Report." Public Health Institute 2006. At www.ccrcal.org/PDF/CervicalCancer06-9-12-06.pdf.
"Tracking the Hidden Epidemics. Trends in STDs in the United States." Centers for Disease Control and Prevention. At www.cdc.gov/std/Trends2000/hpv.htm.
Conis, Elena and Carol Medlin
Elena Conis, MS and Carol Medlin, PhD
University of California, San Francisco