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Merck's Gardasil Claims Questioned

May 13, 2008 | Parker Waichman Alonso LLP

Gardasil, the controversial cervical cancer vaccine developed and marketed by Merck & Co., has been hyped as a means to eliminate almost all types of cervical cancer.  Merck has been so aggressive in its campaign to encourage Gardasil vaccination that roughly 20 states are considering making the vaccine mandatory for young girls.  But a new report at foodconsumer.org is questioning many of the claims Merck is making about Gardasil, as well as the company's efforts to force the vaccine on young girls.

Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of Human Papillomavirus (HPV) that cause cervical cancer.  Merck said that would have the effect of eliminating most cervical cancers.  But the foodconsumer.org report takes issue with those claims.  According to the article, Gardasil was only tested against pre-cancerous lesions, which potentially lead to cervical cancer, but not cervical cancer.  Thus, Gardasil trial results offered no direct evidence to prove the vaccine is effective in preventing cervical cancer.  What's more, the Gardasil clinical trials were conducted for a short term only.   No one knows if a Gardasil booster is needed after 5, 10, or 20 years.

Merck has also claimed that Gardasil is virtually side-effect free, with pain and swelling at the injection site the most common reactions.  But according to foodconsumer.org, by October, 2007, the US government had received 3,461 reports of side and adverse effects including 11 cases in which women died after receiving Gardasil.  Despite such reports, the FDA has no intention of conducting a safety review for Gardasil.

The foodconsumer.org article also criticizes Merck for its efforts to make Gardasil mandatory for girls ages 11 and 12.  For one thing, the report claims Gardasil clinical trials did not include a large enough number of girls age 11 and 12 for whom the vaccine is recommended.   Because of this, the trial results including efficacy and safety may not be applicable to the age group of girls.

Those concerns echo others raised by Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil.  Last week in an interview with a Florida TV station, Dr. Harper criticized Merck's efforts to make Gardasil mandatory.  In the interview, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.