Flim-flam artists could learn something from the pharmaceutical industry. An FDA advisory panel just recommended approving Gardasil vaccines to prevent genital warts in boys as young as age nine. Never mind that genital warts are about as common among middle-school boys as opera buffs are. Never mind that the vaccine hasn't undergone extensive long-term testing, that the long-term effects (and effectiveness) of vaccinating young kids won't be known for decades, or that it costs an average of $500 per series of shots. And never mind that Gardasil may cause as many problems as it prevents. The fact is that Merck, the Gardasil manufacturing company, has somehow convinced plenty of people that the vaccine not only is good but also necessary, leading some two dozen states to seriously consider mandating it for girls starting at age 10 (before parent groups in most of those states shot the idea down). You can bet boys will be next on the bill.
Leading up to the approval, the FDA committee reviewed three studies involving 5000 boys, aged 9-26, from various countries. The researchers found that Gardasil was 89% effective in preventing genital warts related to the sexually transmitted disease HPV -- at least for subjects who were free of HPV at the time of vaccination. Those who had been exposed to HPV experienced no such benefit. But why vaccinate to prevent warts, which, though ugly, hardly constitute a medical crisis? The rationale is that HPV can also lead to throat and anal cancers later on, and so better safe than sorry. Plus, infected men can spread HPV to women, and infected women have a higher risk of cervical cancer.
But scientists don't really know if the vaccine prevents cancer in men down the road; they only know that it prevents warts in the short run. According to Dr. Janet Englund, an infectious disease pediatrician and chair of the HPV Working Group of the CDC's Advisory Committee on Immunization Practices (ACIP), "It is true we don't know for sure about the vaccine's long-term ability to prevent high-grade cancer. My assessment, my personal viewpoint, is there is very good evidence for both reduction of [precancerous] cervical intraepithelial neoplasia -- it is really clear -- and that there is reduction of genital warts."
But this statement may be a bit overblown. A closer look at the research indicates that, in fact, the vaccine doesn't even protect against all strains of HPV virus. In fact, according to Dr. Charlotte Haug who edits the Journal of the Norwegian Medical Association, "If it were a perfect vaccine you would never have to think about cervical cancer again. But it is effective against two of the strains of the virus, and there are at least 20 cancer-causing strains out there. It is true these strains cause 70% of cervical cancers, but what happens when we take these two strains away? If you kill the weeds in your lawn, there will not always be a hole there. Something will take their place."
But back to boys, who don't get cervical cancer. Reports estimate that about 250,000 men develop genital warts each year. Anal cancer, however, affects only about 5,300 people annually, and penile cancer accounts for only 0.1% of deaths from cancer in US males. So given the numbers, the chief benefit -- and only proven benefit -- of administering Gardasil to boys is possible wart prevention and perhaps some residual benefit to the girls those boys have sexual relations with -- as long as that sex happens within a few years of the vaccine.
According to a "former" Gardasil advocate and vaccine developer, Dr. Diane Harper of Princeton University, the vaccine might, in fact, wear off in as little as five years. That means that the vaccinated nine-year olds better have sex by ninth grade in order to get their money's worth. Dr. Harper cautions (and this is a biggie), "The rate of serious adverse events is on par with the death rate of cervical cancer.Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year."
If that's true, the fact that Gardasil is not only widely prescribed for girls but now is on the way to being approved for boys is mind-boggling. The researchers insist that the vaccines cause only minimal health risks, with fever, injection site reactions, and headache the most common adverse effects. But up to seven percent of girls receiving the vaccine have had serious reactions, including fainting and blood clots according to data provided by VAERS (the vaccine adverse event reporting system). The actual number of serious reactions probably runs much higher. VAERS only includes incidents reported after the fact, and many events probably go unreported.
And Dr. Harper points out that risk of death from the vaccine can't be ignored. "Parents and women must know that deaths occurred," she said. "Not all deaths that have been reported were [made public], one-third of the death reports were unavailable to the CDC, leaving the parents of the deceased teenagers in despair that the CDC is ignoring the rare but real risk of death surrounding the administration of Gardasil."
All of these factors led Pharmaceutical Executive to give Gardasil the 2006 "brand of the year" award for "creating a market out of thin air." Even the Journal of the American Medical Association recently ran an editorial claiming that Merck influenced professional medical associations to overstate the vaccine's benefits. Apparently, the drug company teamed with these associations to create "educational material" that was then widely distributed to doctors, who, according to researcher Dr. Shirley Rothman, "May not know that this education is not being done by a group of experts in the field but that it is all being orchestrated by the drug company."
You've gotta hand it to them. Those drug companies do know how to create markets -- aiming to scare parents of fourth graders into wanting to vaccinate their boys against genital warts. And you've really got to wonder what the members of that FDA committee smoked before making their recommendation for approval.