HPV vaccine talk shifts from fanfare to fear
■ Two years after the vaccine's approval, concerns about safety and the drug's marketing are raising questions in exam rooms.
By Victoria Stagg Elliott — Posted Sept. 15, 2008
Campaigns to promote the human papillomavirus vaccine and increase the number of people receiving it may have backfired, and physicians are dealing with growing doubt from patients over its efficacy and safety.
"Its image was damaged because it was pushed too fast and too hard," said Diane Harper, MD, MPH, professor of community and family medicine at Dartmouth Medical School in New Hampshire, and a principal investigator of several HPV vaccine trials. "It's a good vaccine, and people will benefit from it, but not every single person needs it right now."
Gardasil, a three-shot series that protects against four types of the virus, was approved by the Food and Drug Administration in June 2006 to much cheering by doctors and public health officials. That was followed a few weeks later by a recommendation from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices that girls ages 11 and 12 should receive it as routine care, although the series could be given to females ages 9 to 26.
More than 16 million doses have since been distributed, but distrust has been growing.
"In general, this vaccine has generated a fair amount of concern for people because it's a vaccine that prevents a cancer that is related to sexual activity," said Mark Goldstein, MD, chief of the division of adolescent and young adult medicine at Massachusetts General Hospital in Boston. "But [lately] there's been more doubt about the vaccine. There are more questions about the vaccine from the patients and from the press."
To alleviate these fears, physicians are spending more time discussing possible outcomes with patients.
"We take some time to review what these side effects really may be," Dr. Goldstein said. "And the majority of the patients, after they hear the discussion, go forward with the vaccine."
American Medical Association policy urges physicians to educate themselves and their patients about HPV vaccination and supports ACIP recommendations on its use.
Most experts suspect that patient doubts are an extension of the long-standing anti-vaccine movement and the result of parental discomfort at giving the shots to daughters who are not yet sexually active. But concerns also have been raised due to efforts backed by Merck & Co. Inc., the vaccine's manufacturer, to mandate the vaccine for school entry.
Those initiatives were opposed by most medical societies, including the American Academy of Family Physicians and the American Academy of Pediatrics, on the basis that it was too soon after approval to mandate the vaccine.
The company has since suspended such efforts, although lobbying for educational programs on cervical cancer continues.
"Merck's goal is to ensure that Gardasil is used to its fullest appropriate extent to help reduce the burden of cervical cancer and other HPV-related diseases in the United States. We ... do not want any misperception about Merck's role to distract from the ultimate goal of fighting cervical cancer," said company spokeswoman Tracy Ogden.
Safety concerns also have been raised. Earlier this year, media stories depicted girls fainting after receiving HPV vaccine, although fainting has not been proven to be unique to these shots. A paper in the May 2 Morbidity and Mortality Weekly Report found no one vaccine caused an increased risk of fainting among girls.
"Adolescent girls tend to faint more than almost any other population, whether it's a vaccine or drawing labs. It's a vasovagal reaction," said Colleen Kraft, MD, a pediatrician in Richmond, Va. She is immediate past president of the AAP's Virginia chapter and has supported efforts to mandate the HPV vaccine for girls entering sixth grade in her state.
Safety data reviewed
Judicial Watch, a conservative public interest group, also issued a report at the end of June detailing information on adverse events, including at least 18 deaths and 140 serious illnesses that occurred within three weeks of receiving the vaccine. The data were primarily gathered from the FDA's Vaccine Adverse Event Reporting System, although this does not prove causation.
After analyzing the data, the CDC and the FDA issued a joint statement in July saying the vaccine is safe and effective. But, as with any other vaccine, safety and efficacy would continue to be monitored, the agencies said.
"It's hard to say right now how effective it is. Making it mandatory is using the U.S. as a public health experiment," said Tegan Millspaw, a research associate at Judicial Watch. "There's definitely some issues that need to be looked into."
A paper published in the Sept. 9 Canadian Medical Assn. Journal raised the issue of serious allergic reactions and reported that the risk of anaphylaxis after vaccination was higher than that of other shots. Yet such reactions were still rare, with a rate of 2.6 per 100,000 doses. The accompanying editorial said this was "compelling evidence that the HPV vaccine is remarkably safe."
However, the scientific community has expressed doubt about the wisdom of rapid widespread adoption. An editorial in the Aug. 21 New England Journal of Medicine advocated caution because many questions still need to be answered about the long-term effects of the vaccine.
But other observers said it would be unethical to withhold the vaccine from those who want it.
"The end point is not going to be known for many years. No one can say how effective it will be," said Dr. Goldstein. "But is it ethical to withhold the vaccine for 10 or 20 years waiting for the results?"
Another HPV vaccine will most likely become available in the near future. GlaxoSmithKline is pursuing approval of Cervarix, its version of the vaccine with two viral types. Final data from the phase III study are expected to be released later this year.