Perhaps you've heard of the relatively new HPV vaccine, Gardasil. If you have a preteen or teenage daughter -- or if you've simply been conscious since the vaccine was approved in 2006 -- we'll assume you have. The vaccine has been marketed, quite heavily, as a way to protect against four strains of the human papilloma virus -- two types blamed for 70% of cervical cancers, and two types blamed for 90% of genital warts.
Almost as soon as doctors and their medical organizations began recommending it, however, push-back from consumers started -- with questions about the vaccine's effectiveness plus complaints about the cost, the number of shots required (three) and, oh right, the negative reactions. Some patients say they became dizzy after getting the vaccine; others reported headaches, fever and fainting. The vaccine was even suspected in some seizures and deaths.
Now, with more than 23 million doses having been administered in the U.S. by the end of last year, researchers with the federal Centers for Disease Control and Prevention, which recommended Gardasil, and the Food and Drug Administration, which approved Gardasil, have taken a look at the data on the adverse reactions to the vaccine. And they've found ... eh, it's safe.
They write: "Most of the AEFI rates [adverse events following immunization] were not greater than the background rates compared with other vaccines, but there was disproportional reporting of syncope [fainting] and venous thromboembolic events [blood clots]."
They conclude that most of the adverse events weren't very serious and that the vaccine has the potential to greatly reduce global HPV-related illnesses and deaths. (The number of deaths from cervical cancer is much higher elsewhere in the world; in the U.S., the pap smear screening reduced such deaths 74% between 1955 and 1992. The American Cancer Society expects just over 4,000 deaths from cervical cancer in the U.S. this year. More of that info here.)
Here's the short version of that new report, published today in the Journal of the American Medical Assn.
A related article, however, takes issue with the marketing of the vaccine and the professionalism of the doctors and medical groups who jumped behind it. Sheila Rothman and David Rothman of Columbia College write:
"By making the vaccine's target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the subpopulations most at risk practically ignored. The vaccine manufacturer also provided educational grants to professional medical associations (PMAs) concerned with adolescent and women's health and oncology. The funding encouraged many PMAs to create educational programs and product-specific speakers' bureaus to promote vaccine use. However, much of the material did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on risks and benefits. As important and appropriate as it is for PMAs to advocate for vaccination as a public good, their recommendations must be consistent with appropriate and cost-effective use."
And that's just when they're getting warmed up.
Taking into account both articles is a related editorial. It states: "Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she should be willing to accept only a small risk of harmful effects from the vaccine."
Here's the full version of that essay.
Also instructive, as a timeline, is previous L.A. Times coverage of the vaccine and the reaction to it.
December 2008: Low allergic reaction rate seen in Gardasil study
October 2008: Immigrants' advocates decry Gardasil requirement
March 2007: HPV: Men can get it too
February 2007: Millions of women carry HPV strains that vaccine can block
February 2007: HPV vaccine: Who chooses?
June 2006: Cervical cancer vaccine approved
-- Tami Dennis
Top photo: A teen gets a shot of the HPV vaccine. Photo credit: Associated Press
Lower photo: Gardasil. Photo credit: AFP/Getty Images