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Merck Criticized Over Gardasil Marketing

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Critics of Merck & Co.’s Gardasil marketing campaign say it ignores important questions over the vaccine’s safety and effectiveness. In the past two years, Merck has saturated the airwaves with catchy commercials, paid doctors as much as $4500 a pop to promote Gardasil via talks and lectures, and lobbied women’s group, medical societies and politicians to make Gardasil a mandatory vaccine for girls in many states. Those efforts have made Gardasil one of Merck’s fastest growing drugs, but many are beginning to wonder what the cost might be to public health.

For starters, many believe the vaccine was not subject to enough pre-market scrutiny. According to The New York Times, the Food & Drug Administration (FDA) expedited Gardasil’s approval application, and gave it the ok in just six months. It was recommended by the Centers for Disease Control (CDC) just weeks later.

A researcher who worked on Gardasil clinical trials told The New York Times that both the CDC and FDA acted too quickly. Despite her work on the vaccine’s development, Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School, has been quoted in many media outlets criticizing the speed of Gardasil’s approval, as well as Merck’s marketing push.

In a New York Times interview, Dr. Harper said that most vaccines take three years to get such a CDC recommendation, and then 5 to 10 more for universal acceptance. “In that time, you learn a lot about safety and side effects and how to use it,” Dr. Harper said. “Those getting it early should be the ones who really want it and willing to accept the risk.”

The rush to approve and market Gardasil might have contributed to the surprisingly high number of Gardasil side effects reported to the Vaccine Adverse Event Reporting System (VAERS). According to an analysis released June 30 by the Washington, D.C.-based public interest group Judicial Watch, there have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis. Earlier this week, Australian regulators said they were investigating three cases of pancreatitis that followed Gardasil administration.

Critics of Merck also say the company has overstated Gardasil’s true potential. Gardasil was only studied in clinical trials for five years. Some data from those trials indicated immunity may wane after three to five years. That means young girls immunized at 11 could have no protection by the time they enter college.

Others complain that Merck is exploiting fears of a type of cancer that can be easily prevented through regular Pap tests. In fact, cervical cancer has not been a major killer in western countries like the U.S. for decades. And Gardasil vaccination doesn’t even eliminate the need for regular Pap tests because it doesn’t protect against all forms of HPV.

Despite such concerns, Merck has seen a big payoff from its Gardasil marketing efforts. According to The New York Times, Gardasil has now been made available to the poorest girls in the country, up to age 18, at a potential cost to the United States government of more than $1 billion. Proposals to mandate the vaccine for girls in middle schools have been offered in 24 states, and one will take effect in Virginia this fall.

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