Merck's Gardasil Push Ignored Important QuestionsAug 20, 2008 | Parker Waichman LLP
In the past two years, Merck & Co. has been spending big to market its Gardasil vaccine, and the effort has been paying off. Catchy television commercials urging parents to make sure their daughter is "one less" victim of cervical cancer, coupled with aggressive lobbying of women’s group, medical societies and politicians has made Gardasil one of Merck's fastest growing products. But critics of Merck say that the company's Gardasil marketing campaign has created a panic about a type of cancer that - in Western countries anyway - is preventable through other means, and ignores serious questions about the vaccine's safety and effectiveness.
Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.
That's when Merck's Gardasil marketing campaign really took off. And according to a recent article in The New York Times, those efforts haven't just include catchy commercials. Hundreds of doctors across the country have been recruited and trained by Merck to give talks about Gardasil. The Times reports that those doctors can be paid as much as $4,500 for a lecture, with some making hundreds of thousands of dollars as a result of their Gardasil work. Merck has also held receptions for politicians and other officials where they are urged them to pass legislation that, among other things, would make Gardasil mandatory in many states.
Merck has seen a big payoff from these 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.
But critics of Merck say the company has overstated Gardasil's proven 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 say 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.
Then there are the reported Gardasil side effects. 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, which were reported to the Vaccine Adverse Event Reporting System (VAERS) 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.
No one can say for sure if any of these side effects are the result of Gardasil. But many believe the vaccine was not subject to enough pre-market scrutiny. According to The New York Times, the FDA expedited Gardasil's approval application, and gave it the ok in just six months. It was recommended by the 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. Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School, said that most vaccines take three years to get such a CDC recommendation, and then 5 to 10 more for universal acceptance.
Despite her work on the vaccine's development, Dr. Harper has been quoted in many media outlets criticizing the speed of Gardasil's approval, as well as Merck's marketing push. "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.”