Gardasil is not a cancer vaccine and not necessary

Commentary by Judie Brown

An enormous amount of rhetoric has flowed over the past few weeks, all dealing with Gardasil, the newest vaccine from Merck Pharmaceutical. While Merck’s product has received the lion’s share of media attention, let me add that a second vaccine, GlaxoKline’s Cervarix, is designed to accomplish the same goals. Each vaccine is described being capable of providing women with protection from human papilloma virus.

It seems that in the rush to pressure state after state to mandate this vaccine, several of the real facts about Gardasil and Cervarix have somehow fallen off the radar screen. Well, it’s time to put those facts front and center. An informed decision about anything in today’s culture requires limited hyperbole and sufficient documentation.

This is especially true in the case of a vaccine that is being recommended for little girls as young as nine years of age. As the grandmother of 10, two of whom are little girls a bit older than nine, I have more than a passing interest in getting all the particulars myself and I’m certain you will feel the same once you hear the full story.

First, it isn’t cheap and there are side effects. The vaccine is given as three injections over a six-month period at a total cost of $360. The vaccine can cause pain, swelling, itching and redness at the injection site; plus fever, nausea and dizziness.

As advertised, it is claimed that Gardasil will protect the vaccinated patient from sexually transmitted HPV. However, the specifics regarding the vaccine are not quite that simple. There are more than 90 strains of HPV and the vaccine will protect a woman (or girl) from only four of those strains. Thus the vaccinated individual could still acquire HPV, a virus that can lead to cervical cancer.

Perhaps this is why some have suggested that Gardasil is an anti-cancer vaccine. That is a totally inaccurate description according to no less an authority than the American Cancer Society. The society tells us, “Cancer vaccines are thought of as active immunotherapies because they are meant to trigger your own immune system to respond. They are specific because they should only affect cancer cells. Vaccines don’t just boost the immune system in general; they cause the immune system to attack cells with one or more specific antigens.”

So Gardasil is not a “cancer” vaccine; it is a vaccine designed to protect against four strains of HPV, a virus that can lead to cervical cancer.

Gardasil will not protect against a myriad of other sexually transmitted diseases such as chlamydia, syphilis, gonorrhea and trichomoniasis as well as health problems like HIV and infertility. Gardasil is quite specific and limited in its effectiveness.

Dr. Joseph Bocchini, chairman of the committee on infectious disease of the American Academy of Pediatrics, says HPV can take up to 20 years to cause cervical cancer. His organization has withheld endorsement from Gardasil and one of the reasons is that the 20-year incubation period indicates that the vaccine, which has a 5-year effectiveness span, would offer no protection in the overwhelming majority of cervical cancer cases in the United States.

In fact, the American Cancer Society reports that from 2000 to 2003, more than 70 percent of the cervical cancer patients in America were older than 40 ? well outside Gardasil’s protection window.

So if the incubation period is 20 years, and the life span of the vaccine is five years, how many booster shots would have to be obtained by the female who is inoculated? Each of the doses of the vaccine runs $360 and it is feasible that a female could have to get at least 10 boosters for a total of $3,600. As one reporter wrote, this means big bucks for Merck.

As if corporate financial gain were not enough to make one suspicious of the argument that 9-year-old girls need this vaccine, Dr. Mona Saraiya, in a Washington Times interview, provides information that further weakens the demand for universal vaccination of pre-teens. Dr. Saraiya is a medical epidemiologist in the Division of Cancer Prevention and Control at the federal Centers for Disease Control in Atlanta. She says that “nearly all sexually active women are exposed to HPV.” Further, she says “only a few will get an infection that stays and won’t go away, and only a portion of those will get a precancerous lesion. At that point, only a few will eventually develop cervical cancer.”

The statistics are: Fewer than one-hundredth of one percent of the 108 million U.S. women who are 18 or over (that is, 0.009 %) get cervical cancer and even fewer die from it. The American Cancer Society reports that there were an estimated 9,700 new cervical cancer cases and 3,700 fatalities in 2006. The numbers suggest that it is overkill to make such a vaccine mandatory for any reason when the target population is nine-year-old girls.

Then there’s the matter of the clinical trials Merck carried out. Dr. Clayton Young, an obstetrician-gynecologist from Texas, explained how Merck went about doing the clinical trials prior to the government’s approval of Gardasil. “The clinical trials tested younger girls, but they only looked at immune response to the vaccine, not whether it prevented cervical cancer. It has not been studied long enough to know that it prevents cervical cancer.”

These facts may have contributed to a recent decision by Merck to cease its lobbying campaign to pressure each state legislature to mandate the vaccine for all school aged girls 9 years of age and older. Dr. Richard Haupt, Merck’s executive director for medical affairs, explained that the decision came after hearing from public health officials and medical organizations that the Merck campaign was counterproductive.

To summarize, it would appear that the facts ? all a matter of public record ? should lead a parent to conclude that it would be best to protect a very young daughter from the vaccine. After all, it is clear that even if the parent knows about the long-range program of inoculations that are sure to ensue, that parent also has to realize that there is no guarantee that the promised effect will occur. The young woman could still acquire human papilloma virus, cancerous cells and, God forbid, cervical cancer.

Perhaps the best thing Merck could do at this juncture is produce a fact sheet, educate parents and be honest about its new product.

Release issued: 23 Feb 07