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Judicial Watch • FDA Favors Drug Co. Over Public Safety

FDA Favors Drug Co. Over Public Safety

FDA Favors Drug Co. Over Public Safety

MARCH 21, 2008

Catering to a powerful drug company, the government agency responsible for protecting public health and safety will expedite expanded approval of a controversial cervical cancer vaccine already linked to the deaths of nearly a dozen girls and serious adverse reactions in thousands of others.

The Food and Drug Administration (FDA) will speed up its own process to expand the use of Gardasil, manufactured by pharmaceutical giant Merck, from its current approved use in females ages 9 to 26 up to the age of 45. The vaccine has been promoted as a sort of miracle shot that can prevent certain strains of cervical cancer caused by Human Papillomavirus (HPV).

The reality is that is has been linked to at least a dozen deaths nationwide and thousands of adverse reactions, many of them as critical as paralysis and other serious circulatory problems. Rather than fulfill its duty by warning the public of the vaccine’s potentially serious and deadly consequences, the FDA concealed it for more than a year.

Through the Freedom of Information Act Judicial Watch forced the agency to make public the alarming Gardasil Vaccine Adverse Event Reporting System (VAERS) that lists information about the young victims nationwide. The agency in charge of protecting them didn’t seem terribly interested in exposing the vaccine’s dangers while Merck conducted its aggressive advertising and lobbying campaign to make it mandatory for school-aged girls.

Two states—Texas and Michigan—have already passed laws making Gardasil mandatory for girls ages 11 and 12 and other state and local governments are considering similar legislation. This is outrageous considering the controversy surrounding the vaccine, which was approved by the FDA in June 2006.

Now the agency is hurrying up to approve broader use of the vaccine, which no doubt comes with major profits. Gardasil already had fourth-quarter global sales of $339 million, boosting Merck’s total global vaccine revenue to $1.1 billion. It wouldn’t be surprising if the FDA brass is in bed with Merck. After all, top officials at the agency have for years violated federal disclosure laws by concealing meetings with influential drug company executives, lobbyists and patient groups.

The FDA has also faced a series of scandals involving its failure to enforce many federal laws because it would negatively affect the profits of the wealthy companies that pay it hundreds of millions of dollars in “fees.” The appalling negligence has even been documented in a scathing congressional report that confirms the FDA allows companies that annually pay it more than $400 million in fees to compromise public safety.


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