With the release of Gardasil, Merck’s new vaccine for human papillomavirus (HPV), public health providers were ecstatic. HPV, an extremely common sexually transmitted virus, can cause genital warts and cancer — most notably cervical cancer, the second leading cause of cancer death among women in the United States. In 2007, 11,000 women are expected to be diagnosed with cervical cancer and almost 4,000 will die.
Pap smears save lives in U.S.
While still a major killer, rates of new cervical cancer and cervical cancer-related deaths have fallen dramatically since the 1950s when Pap smears were introduced and became widely available. Globally, a different picture emerges. Every year, 493,000 new cervical cancer cases occur, causing 274,000 deaths — 80 percent of cervical cancer deaths occur in developing countries, where access to routine Pap screens is not available.
Given these statistics, it is clear why public health professionals are excited about a vaccine that could dramatically reduce the number of deaths from cervical cancer, both at home and abroad. Their excitement, however, was quickly soured when pharmaceutical giant Merck began an intense lobbying campaign to mandate vaccination to all 11- and 12-year-old girls.
Low risk vaccine, say experts
The Food and Drug Administration approved the HPV vaccine on June 8, 2006. Eighteen days later, the Centers for Disease Control’s Advisory Committee for Immunization Practices (ACIP) unanimously voted to recommend the use of the vaccine in 9- to 26-year-old women. There are over 100 strains of HPV that can affect humans, and these are divided in two groups: high-risk and low-risk for cancer. The low-risk strains are not believed to cause cancer, but may result in genital warts. With 6.2 million new infections yearly, approximately 20 million Americans, ages 15-49, are currently infected with at least one strain of HPV — half of these are sexually active 15- to 24-year-olds. The majority of these infections are asymptomatic and clear up on their own without causing cancer, precancerous lesions, or genital warts; however, 1 percent of sexually active adults have visible genital warts at any given time.
The new vaccine is designed to protect against HPV strains 6, 11, 16, and 18. HPV 6 and 11 cause 90 percent of genital warts while HPV 16 and 18 cause 70 percent of cervical cancers. Authorities recommend the vaccine, a series of three shots given over a six-month period, be given to women before they begin sexual activity. According to the CDC, there have been no deaths caused by administering the vaccine, but, as is the case with any vaccine, people may experience unexpected allergic or other serious reactions. These, however, are extremely rare. Also, it is unknown if the effect of the vaccine “wears-off” with time or if other strains of HPV will become bigger players in cervical cancer and/or genital warts as the vaccine knocks out the current major players.
Drug company tactics cause problems
Major problems emerged when Merck unleashed its armies of lobbyists on state capitols across the country. Merck was not content only with broad enthusiasm of health professionals for their product — they wanted states to mandate that all school-aged girls be required to receive this new vaccine. Parents and civil rights groups balked at this aggressive marketing strategy. Far-right religious groups took the opportunity to escalate their opposition to any measure that potentially makes sex safer and reduces the risk of sexually transmitted diseases. The furor of the opposition to the mandates reflected badly on the vaccine, and parents became afraid to vaccinate their children.
Vaccine, yes; mandates, no
Currently, the American Academy of Pediatrics and the American Academy of Family Physicians support giving the vaccine to children, but oppose mandates that would require girls to receive the vaccine prior to continuing school. The evidence so far demonstrates that this vaccine is safe and can have a large positive effect on preventing genital warts and cervical cancer in women, but more evidence is needed before such a new vaccine can be mandated.
The most important step parents can take to protect their children is to find a pediatrician they trust, develop a relationship with him or her, and jointly reach decisions that are specific to their child. If a child has a “medical home” in one pediatrician’s office, the child will more likely receive all the necessary prevention services (such as vaccines) and develop good health behaviors as she grows up.
Flávio Casoy is between his third and fourth year of medical school and currently serves as the Jack Rutledge Fellow for the American Medical Student Association.