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Gardasil is a vaccine for 4 types of HPV developed by Merck. It is currently being marketed to parents as a way to “protect your daughter’s future from cervical cancer and genital warts”. In fact, on the Merck web site for Gardasil, the vaccine is headlined as “the only cervical cancer vaccine.” (Appendix A, p 1) Merck is also involved in an intensive state-by-state lobbying campaign to have Gardasil mandated for girls as young as 9. (Appendix B)

Is Gardasil a “cervical cancer vaccine”?

No. Gardasil has no effect on cervical cancer whatsoever.

Does Gardasil actually “protect your daughter’s future from cervical cancer and genital warts”?

No, it doesn’t.

Why not?

Gardasil offers SOME protection against SOME of the Types of HPV that have been linked to cervical cancer.

There are over 40 Types of HPV, and 15 of them have been linked to cervical cancer and/or genital warts. Gardasil has been developed to vaccinate against the 4 Types that have the highest correlation with cancer and genital warts.

However, unlike the smallpox vaccine, for example, Gardasil does not grant full immunity to those 4 Types of HPV. Additionally, in the studies offered to the FDA in Merck’s application for approval, data indicated that Gardasil MAY INCREASE your daughter’s risk of developing cervical disease if she already had one of the relevant strains of HPV at the time of vaccination (Appendix E, p13 & 25).

Gardasil offers no protection against the other 11 strains of HPV that have been linked to cervical cancer. Those strains currently account for 30% (Appendix A, p6, Appendix B, p8) of the diagnosed cervical cancer cases. The continuing potential risk for the non-vaccine strains has led the FDA to require that Merck conduct further studies to determine whether the long-term effect of Gardasil will be nothing more than a shifting in the dominant cancer-linked HPV strains (Appendix C, p1 & 7).

How does Gardasil work?

Like other vaccines, Gardasil stimulates the body to produce antibodies to protect the person from getting the virus when they are exposed to it. There must be enough antibodies in the blood to protect against infection when an exposure happens. The antibodies remain in the blood for some period of time, and the protection remains in effect as long as enough antibodies are there. Some protections last for a lifetime, so the vaccine does not need to be repeated. Others require periodic booster shots to ensure that enough antibodies remain in the blood to protect against infection. The level of antibodies can be measured through a blood test. It is reported as a Titer count.

To determine the duration of effectiveness of a vaccine, one needs to know what Titer count is necessary to ensure protection against the disease, and how long that Titer count will be maintained through a vaccination.

What Titer count is needed to protect my daughter against HPV?

Merck doesn’t know.

Its testing data indicates that Gardasil elevates the Titer count for the 4 Types of HPV targeted. It also indicates the Titer count drops after 7 months and continues dropping until 24 months post-vaccination. The studies only report Titer count levels for 36 months. Merck states that because so few subjects were tested, and therefore too few disease cases developed, they were unable to establish the minimum antibody levels necessary to protect against clinical disease caused by the 4 Types of HPV Gardsil targets. (Appendix D, p5)

Drug recalls will always occur because it is impossible to test drugs on a large enough number of people to uncover all extremely rare side effects (one would have to test millions, the equivalent of a general release). The question is "Is the benefit of this drug discovered in clinical testing large enough to justify releasing it to the public?" If the answer is yes, the drug is released and any side effects tracked. If disturbing trends show up, the drug is recalled.

If we did not release any medication without making absolutely certain it had no side effects, we would not have any medications. We have excellent treatments and even cures for many conditions that previously were fatal. All of these were made possible by careful studies followed by public release.

And there is a LOT of money to be made.

Well of course. It is a business. Drug manufacturers are not in it for charity. I don't begrudge them their profits because it is profits from drug sales that drive research and development of new drugs. Usually only a few drugs a company makes turn a profit, some never recoup their R&D costs and run a loss. Blockbuster drugs that make large sales are necessary in order to subsidize research for these other drugs, which otherwise would never be made.