Concerns About Gardasil's Safety Still Circulate
Vaccines for HPV Are Associated with Rare but Serious Side Effects
Sep 17, 2009
On June 8, 2006, the U.S. Food and Drug Administration approved the drug Gardasil, the first vaccine designed to protect young women from human papillomavirus (HPV), which causes cervical cancer.
Gardasil was licensed following five clinical trials that enrolled 21,000 girls and women aged 9 through 26.
The FDA recently gave the preliminary nod to another HPV vaccine, Cervarix, which will probably enter the U.S. market soon. In addition, Merck – the manufacturer of Gardasil – is hoping for FDA approval to market its vaccine to boys and men.
Gardasil is a three-injection series that is designed to immunize women against HPV strains 6, 11, 16 and 18. These strains supposedly account for 90% of genital warts and 70% of all cases of cervical cancer in the United States.
Gardasil has been deemed safe by the FDA and the Centers for Disease Control and Prevention.
How is Vaccine Safety Monitored in the United States?
- The Vaccine Adverse Events Reporting System (VAERS), under the auspice of the FDA and the CDC and with the cooperation of health care providers throughout the U.S., monitors the safety of all licensed vaccines on the American market.
- Any health problem (“adverse event”) that occurs following the administration of a vaccine can be reported to monitoring agencies via the VAERS. Anyone can report an adverse event to VAERS; these reports are then analyzed by trained staff from the FDA and CDC.
- The Vaccine Safety Datalink (VSD) and the Clinical Immunization Safety Assessment (CISA) Network monitor patterns in adverse event reporting and conduct research on adverse events to determine if these events can, indeed, be caused by vaccines.
- As of May 1, 2009, 39 deaths had been reported to the VAERS following Gardasil administration. All of these deaths have been attributed to other causes following review by health officials. (CDC HPV Vaccine Review)
Why are People Afraid to Receive HPV Vaccinations (i.e., Gardasil)?
People avoid immunizations for a variety of reasons (religious objections, suspicions about manufacturers’ motivations, resistance to governmental interference in their private lives, etc).
In Gardasil’s case, the usual hesitation is enhanced by concerns about “collusion” between Merck – now well-known for legal troubles surrounding its blockbuster drug, Vioxx – and monitoring agencies. Under pressure from Merck’s lobbying campaigns, many states initially considered making immunization with Gardasil mandatory. This move, perceived by many as an effort to increase sales, was met with stiff resistance from consumers and their advocates.
Anecdotal reports of serious adverse events associated with Gardasil, including death, continue to circulate. Therefore, many parents aren’t convinced that their daughters’ safety is worth risking for an immunization that has yet to prove its worth.
Although Gardasil ostensibly confers protection against the most common cancer-causing strains of HPV, there are more than 30 strains of HPV known to infect humans, including 15 that cause cervical cancer.
Gardasil’s cost, at over $400 for the three-shot series, is prohibitive…particularly when one considers that long-term protection against HPV has not yet been demonstrated.
Some consumer watchdog agencies have challenged the integrity of Merck’s clinical testing methods, the approval process that brought Gardasil to the American market, the efficiency of adverse event reporting, and the thoroughness of reviewing those events. (Vaccine Safety Group Releases GARDASIL Reaction Report)
Finally – and some healthcare professionals might call this a gaping hole in public health policy – there is no protocol for screening for prior exposure to HPV before Gardasil is administered.
Gardasil does not cure pre-existing HPV infections. Some women who have had prior HPV exposure have experienced massive outbreaks of warts and/or precancerous cervical changes after receiving the vaccine. Thus, one might question the wisdom of universal immunization programs without a coexisting policy for screening. (US Food and Drug Administration, VAERS Line List Report – Vaccine Type: HPV, HPV4. June 10, 2008)
Gardasil and any other HPV vaccines that have yet to meet FDA approval will continue to generate skepticism among patients and consumer advocacy groups. Although immunization against HPV may eventually reduce the incidence of cervical cancer in the United States, for now many people believe that Gardasil is just another goldmine for the pharmaceutical industry.
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