Examining the FDA’s
HPV Vaccine Records
Detailing the Approval Process, Side-Effects,
Safety Concerns and Marketing Practices of
a Large-Scale Public Health Experiment
June 30, 2008
The significant differences between the saline placebo and the vaccine raisequestions as to how Merck’s use of an aluminum-containing placebo may have affected the safety trials. The National Vaccine Information Center reports that “A reactive placebo can artificially increase the appearance of safety of an experimental drug orvaccine in a clinical trial,” adding that “although aluminum adjuvants have been used invaccines for decades, they were never tested for safety in clinical trials.”
It is difficult to draw an accurate conclusion from Merck’s data, raising questions about Gardasilvaccine safety.
Gardasil was approved in large part due to the unanimous vote of support itreceived from the Vaccines and Related Biological Products Advisory Committee(VRBPAC) in May 2006. VRBPAC is a special advisory panel created by the FDA to evaluate new biological material, including vaccines. While the FDA is not required toapprove drugs that are recommended by the committee, they usually do.
The meeting took place on May 18, 2006, and the primary speakers were Merck representatives Dr.Eliav Barr and Dr. Patrick Brill-Edwards. Merck was required to submit numerous reports and documentation of trial procedures to the FDA both before and after the meeting took place, but the statements of Merck’s representatives paint a far more optimistic picture of the vaccine than their own reports justify.
Dr. Patrick Brill-Edwards, Merck’s Director of Worldwide Vaccines RegulatoryAffairs, was the main speaker at the meeting. In his opening statement he said “Merck proposed that studying cancer itself isn’t feasible, because it takes too long and it disadvantages too many women.”
Merck scientists not only did not bother to study cancer, they do not even knowwhether their own vaccine is carcinogenic. In a report to the FDA on testing protocol, Merck wrote that “Gardasil has not been evaluated for the potential to causecarcinogenicity or genotoxicity.”
One would think that any cancer vaccine that has been approved by the FDA ought to at least not cause cancer. Given that Gardasil works by causing spontaneous reactions and cell mutation, its potential to cause cancer is certainly a matter that warrants further study.