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Conclusions of the Judicial Watch Special Report
Examining The FDA's HPV Vaccine Records

June 30, 2008

While Gardasil may be an important medical advance, it is unwise to compromise the health and safety of the American public, especially children, by mandating or marketing it before sufficient tests are concluded.
June 30, 2008

Gardasil is such a new drug that it is impossible to say at this point how beneficial it may be. Most scientists, including Dr. Diane Harper, agree that booster shots will be needed, and guess that the original vaccine will be effective for at least five years. It is important to emphasize that regardless of how effective Gardasil is, it does not protect against all HPV strains and it will never eliminate the need for regular testing and Pap screening.

Gardasil’s safety for the general public is a serious concern. While no drug is ever completely risk-free, a careful analysis must be made as to whether the benefits are worth the costs. HPV, though potentially devastating, is quite often completely harmless.
Most HPV infections, even ones caused by high-risk strains, go away on their own and never develop into cancer. Even when they do, in most cases it takes years for cancer to occur and it is easily preventable as long as the HPV infection is detected early.

Even without Gardasil, cervical cancer deaths have decreased drastically in the past several decades. The American Cancer Society estimates that deaths from cervical cancer declined 74% between 1955 and 1992, and that the rate continues to decrease by about 4% each year. Also, most cases occur in women in their forties.
With these statistics in mind, one might ask whether Gardasil vaccination is absolutely necessary, especially for children.

At this point in time, we do not know if it will prevent cancer, or whether it will have unforeseen consequences. The American public must ask themselves if Gardasil is really worth the risk. Fast-tracking drugs and vaccines before their safety has been fully evaluated is unethical and dangerous, and until more tests have been completed on Gardasil no vaccination mandates should be established.
  • Gardasil has not been tested thoroughly enough to know whether it will be safe or effective in the long term.

  • Even if it shown that the Gardasil vaccine is effective, it is still unknown how long the vaccine lasts or if there will be a need for booster shots.

  • Regardless of its potential to help prevent HPV and cancer, Gardasil should never be administered without a prescreening for HPV since it has the potential to make existing cases worsen.

  • It is important that people remember that this vaccine will not eliminate the need for regular Pap screening. No vaccine is 100% effective, and Gardasil is designed to protect against only four strands of HPV.

  • While Gardasil may be an important medical advance, it is unwise to compromise the health and safety of the American public, especially children, by mandating or marketing it before sufficient tests are concluded.
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