Recent news coverage regarding the newly approved and heavily promoted human papillomavirus (HPV) vaccine, Gardasil, has left some in the general public questioning both the safety and efficacy of the vaccine. Gardasil was heralded as an important life-saving vaccine in an extensive marketing campaign by its manufacturer, Merck, when it was approved for use 2 years ago. However, in 2008, the news media began reporting a few cases of what were assumed to be serious reactions to the vaccine. At the same time, some in the medical community raised questions regarding how much is known about Gardasil and the second HPV vaccine, Cervarix (from GlaxoSmithKline), which has been approved for use in other countries and is currently awaiting approval in the US. Will it prevent not only cervical lesions but also cervical cancer and death? How long will the protection provided by the vaccine last? How will vaccination affect a womens natural immunity from HPV? How will the vaccine affect other oncogenic strains of HPV? Dr. Haug concluded, “With so many essential questions still unanswered, there is good reason to be cautious about introducing large scale vaccination programs. Instead, we should concentrate on finding more solid answers through research rather than base consequential and costly decisions on yet unproven assumptions.” Others in the medical community argue that Gardasil is an important primary prevention tool that will keep girls from having abnormal Papanicolaou (Pap) test results in the first place. “How ethical would it be to withhold a vaccine until you've had 20 years' worth of follow- up?” asks Man Waxman, MD, MPH, professor of obstetrics and gynecology at the University of New Mexico Health Science Center in Albuquerque, who treats women with abnormal test findings. “With any luck, this vaccine will put me out of practice.” The Centers for Disease Control and Prevention (CDC), the American Cancer Society (ACS), and other major medical associations recommend the Gardasil vaccination for girls starting at age 11 or 12 years and catch up vaccinations until at least age 18 years (there are some differences of opinion as to whether it is cost-effective beyond that age). Nationwide, a number of states have provided funds for vaccination programs, and 24 states have introduced legislation mandating the vaccines for schools. Both Washington, DC, and Virginia have enacted such legislation, but the latter is now considering a bill that would delay that requirement, according to the National Conference of State Legislatures. Elsewhere, the Canadian government has provided $300 million to its provinces to implement an HPV vaccination program, and the British National Health Service began administering Cervarix to all 12-year-old and 13-year-old girls this past fall. “The CDC wanted to get a simple message to people—if you're 12, you should get your HPV vaccine,” says Diane Harper, MD, professor of obstetrics and gynecology at Dartmouth Medical School in Hanover, New Hampshire, who was a principal investigator on the clinical trials for both Gardasil and Cervarix. “The problem was, that sounded like an edict, and people began asking questions. Now they need to understand more of the nuances involved with the vaccine.” One myth that has been perpetuated, she notes, is that girls have to receive the vaccine before they become sexually active or develop an HPV infection. “The data we've had is that women who've had antibodies to [age] 16 or 18 but do not currently have an infection will have 100% efficacy from the vaccine,” she says. “That information has become lost—in part because of the public health message goal of targeting 12-ycar-olds.” Dr. Harper notes that 1 of the motivations for that message was to encourage girls that age to visit their pediatricians for regular health screenings because of the many health issues for which they are at risk, such as obesity and drug abuse. In the process of giving that message, the indications for HPV vaccinations have been misconstrued, she says. Meanwhile, safety concerns about Gardasil were raised by parents and several watchdog groups when some cases of serious adverse reactions were reported.The CDC and US Food and Drug Administration (FDA) monitor these reports through the Vaccine Adverse Events Reporting System (VAERS). As of August 31, 2008, there were 10,326 VAERS reports of adverse events after Gardasil vaccination in the US. Of these, 94% were considered to be nonserious, and 6% were considered to be serious.The serious reactions included reports of Guillain-Barré syndrome (GBS) and blood clots, as well as 27 deaths. The CDC monitors the safety of vaccines through both the VAERS system and the Vaccine Safety Datalink, a project with 8 hcalthcare organizations located throughout the country to study patterns in reports and determine whether they are indeed vaccine-related side effects. In October 2008, the CDC released its latest findings from a controlled study to the US Advisory Committee on Immunization Practices, reporting that the Gardasil vaccine is considered safe. “The adverse event reports themselves do not show cause and effect,” explains John Iskander, MD, MPH, acting director of the CDC's Immunization Safety Office. “We saw no evidence of any excess risk for Gardasil.” GBS, for example, occurs approximately 1 to 2 of every 100,000 people in their teens, and the rate of reported adverse events was no higher than that of the general population. In addition, there was no common pattern to the deaths that would suggest they were caused by the vaccine. The CDC wanted to get a simple message to people—if you're 12, you should get your HPV vaccine. The problem was, that sounded like an edict, and people began asking questions. —Diane Harper, MD That answer is not good enough for Barbara Loc, who heads the National Vaccine Safety Information Center, a nonprofit watchdog group that advocates for safer vaccines. She says she has spoken with the parents of children whose symptoms sound similar, including debilitating fatigue, headaches, joint pain, tingling in the limbs, and even paralysis. “I thought the report issued in October seemed like a dismissal of these adverse events,” she says.“I believe there should be more robust study of these vaccines in postmarketing surveillance.” It is currently approved for use in the US for females ages 9 to 26 years. It is routinely recommended for 11-year-old and 12-year-old girls and for girls and women ages 13 to 26 years who have not yet been vaccinated. It is given in 3 shots over 6 months and costs approximately $375 for the full series. It may or may not be covered by insurance. The total cost is typically $400 to nearly $1000 when markup and office visits are included. (Children aged 18 years and younger may be eligible to getthe vaccine for free through the Vaccines for Children [VFC] program if they are Medicaid eligible, uninsured, American Indian, or Alaska native.) It is 95% to 100% effective against HPV types 6, 11, 16, and 18. HPV types 16 and 18 cause approximately 70% of cervical cancers. HPV types 6 and 11 cause approximately 90% of genital warts. HPV types 6 and 11 cause 20% to 50% of vulvar cancers and 60% to 65% of vaginal cancers. Reports of nonserious adverse events after Gardasil vaccination have included fainting, pain and swelling at the injection site (the arm), headache, nausea, and fever. To prevent injuries related to fainting, the CDC recommends patients stay seated for up to 15 minutes after vaccination. Sources: CDC and FDA Loe says she plans to push the issue more in 2009, mising questions such as whether Gardasil is safe to administer in combination with the other vaccines given to adolescent girls and whether there could be some subgroup of girls that is particularly susceptible to these serious side effects. Dr. Harper and other scientists interviewed for this article maintain that the vaccine is generally quite safe. “Rare events will always happen, and we'll never have enough numbers to prove causality,” Dr. Harper notes. She adds that if people have concerns about these rare events because they have a family history of neurologic or autoimmune disorders, they do not have to get the vaccine. “If you get your regular Pap screening, you will have the same protection against cervical cancer as if you got the vaccine,” she notes. Becatnse the vaccine only works against the viruses that cause approximately 70% of cervical cancers, women still need to undergo regular Pap screenings.At the same time, questions linger regarding how long the vaccine will remain effective and whether booster shots will be needed. Studies suggest the vaccine is effective for at least 5 years, but Dr. Harper notes that antibodies dramatically declined even at 3 years. Merck is currently conducting studies in Sweden and Finland that will answer additional questions about the safety and efficacy of the vaccine, but those restilts will not be available for at least 8 years, she notes. tn the US, although the FDA and CDC have good systems in place, there is a shortage of funds to provide adequate surveillance, says Debbie Saslow, PhD, director of breast and gynecologic cancer at the ACS. “There has been a lot of reliance on industry to do follow-up trials, and we'd like to see more requirements put on the companies that are doing these studies.” she adds. Determining how protective 2 doses of the vaccine would be instead of 3; Developing an oral version of the vaccine; and Creating an international funding mechanism for the vaccine in developing countries in which cervical cancer is a leading cause of cancer-related death and few women are screened. 1. Haug CL. Human papillomavirus vaccination—reasonsforcaution. N EngI J Med. 2008;359:861-862. Some 27% of college students surveyed at a large university reported symptoms of tanning dependence, with symptoms similar to those of alcohol and drug addiction.The study also found that tanning dependent students were more likely to be thin and smoke cigarettes than others, suggesting avenues for research into possible links among risky behaviors. The study, conducted by researchers at the Fox Chase Cancer Center in Philadelphia, Pennsylvania, was published in the American Journal of Health Behavior. “Adolescents and young adults tend to put themselves at risk for later skin cancer by exposing themselves to high levels of ultraviolet radiation,” says study author Carolyn Heckman, PhD, an associate member at Fox Chase Cancer Center. “By understanding possible reasons why, we hope to develop innovative interventions to help prevent these risky behaviors.” Dr. Heckman and her colleagues recnnited 400 students and other volunteers at Virginia Commonwealth University in Richmond, Virginia, during the spring semester of 2006. Participants took part in an online survey that assessed tolerance to tanning (the need to tan increasingly frequently), withdrawal from tanning (discomfort when not having tanned recently), and difficulty controlling the behavior despite awareness of its negative impact such as freckles, wrinkles, and precancerous lesions. The survey also asked about health related behaviors such as body mass index, smoking, and exercise. “The media and lay public may know tanning dependence as ‘tanorexia,’ alluding to similarities to both substance addictions and body image disorders like anorexia,” Dr. Heckman says. “There is some evidence that ultraviolet (DV) tanning dependence may have biological underpinnings like other addictions—such as the production of endorphins.” The researchers also found that nearly 40% of those surveyed had used tanning booths and that the mean age when tanning booths were first used was 17 years. 1. Hecknan CJ, Wilson DB, Ingersoll KS. The influence of appearance, health, and future orientations on tanning betavior. Am J Health Behav. 2009;33:238-243.