I sat at a picnic table listening to various mothers discussing their hectic schedules trying to keep up with teenage daughters, all on the same sports team. When one mother told of squeezing in an appointment that morning to get her daughter the HPV shot that her doctor recommended, the conversation turned to the necessity to "protect" their girls in such troubling times. I stayed quiet, hoping to learn the values guiding these parents' decisions. Predictably, they had not thought through the issues, nor did they know the facts.
Those mothers were merely following doctors' recommendations and that of all the experts. Gardasil, the HPV vaccine, was approved in 2006 by the U.S. Food and Drug Administration for females as young as nine and up to age 26. It has been marketed as a protection against four types of the human papillomavirus (HPV). Merck, the company that makes Gardasil, claims that the drug will protect against two types of HPV that cause 70 percent of cervical cancers and two types that cause 90 percent of genital warts. Every federal health authority recommends the shots and, according to the Centers for Disease Control and Prevention (CDC), about a quarter of the nation's 13-17 year olds have received the immunizations. The vaccine is on the CDC's vaccine schedule for 11- and 12-year-old girls, and the American Academy of Pediatrics recommends it.
Even so, some physicians remain wary of the trend to give young children a new, largely untried drug. A study in a journal of the American Association for Cancer Research revealed that about half of the doctors in a survey of over a thousand physicians in Texas did not routinely recommend Gardasil for their pre-teen patients.
What those Texas doctors suspected, we now know for sure - that serious concerns are legitimate regarding the use of Gardasil. The highly-promoted, so-called breakthrough vaccine that was recommended for all girls and given to numerous children and teens to prevent possible future cases of cervical cancer, is related to "adverse events" experienced by thousands of girls after taking the vaccine.
In a just-released article in the Journal of the American Medical Association, federal researchers report that after analyzing 12,424 "adverse events" [out of the 13,758 reports of problems as of May 1] voluntarily reported by girls vaccinated with Gardasil that two problems are common. One - fainting - is not inherently serious, but can be if the girl falls and hits her head. The other side effect - "dangerous blood clots" - is quite troubling. Most of the problems with Gardasil (93 percent) are minor: headache, nausea, and fever. But a disturbing seven percent included hospitalization, permanent disability, life-threatening illness, or death.
"Adverse events" is a terribly clinical sounding description of such tragic outcomes. Perhaps more people should read the personal account of Jenny, a University of California, Berkeley professor's daughter who lost her life after getting the shot. (See Jenny's blog here)
Few parents would want their child to be among the 39 deaths to girls who had just taken the Gardasil shot. Nor would most parents want their child to take the risk of hospitalization, disability, or a life-threatening illness. Accurate information has not been forthcoming, including the fact that many additional reported cases of "adverse effects" had too few details. Thus, those cases were excluded from the study.
Even with the new information, numerous questions remain about the safety as well as the efficacy of the drug. Further, there are questions about the marketing of the drug. In fact, cervical cancer is relatively uncommon in the United States. The American Cancer Society reports under 4,000 deaths per year compared to the 250,000 deaths in other areas of the world, primarily in poor countries.
Plus, there are questions about Merck's grants to professional medical associations who promoted the vaccine's use without fully explaining the risks involved with taking the drug. Some doctors ask if the big push to sell Gardasil is Merck's method of making up the lost sales after their popular anti-pain medication Vioxx was banned. These facts raise questions about the appropriateness of recommending such a high-risk drug for widespread use among American children and teenagers.
In the wake of all the side effects, Merck has added warnings to the label on the drug. The warnings on all the labels state that some children receiving Gardasil have subsequent problems, such as autoimmune diseases, musculoskeletal disorders, paralysis, and seizures. Further, some doctors worry that not enough young girls were included in the clinical trials of the drug; they believe that there is really no way to know how pre-teen and teenage girls will react to such a high-powered vaccine. Merck acknowledges that the drug is effective for only five years, so giving the drug to 11 to 12 year olds hardly seems warranted.
Critics are especially concerned about the risk-benefit ratio of taking the HPV vaccine. Gardasil is very costly and most physicians recommend that women continue to get Pap smears, even if they have taken Gardasil. The known benefit of the regular Pap smear screening in preventing most cases of cervical cancer makes the benefit of the HPV risk uncertain.
In fact, Those mothers around that picnic table and the thousands of other parents concerned about the well-being of their daughters need to have all the facts and know the risks involved before subjecting their little girls to this new vaccine. States need to have these facts before discussing the possibility of mandating the vaccines for all pre-teen and teenage girls.