Cervical cancer vaccine deemed safe, but questions remain
A government study deemed Gardasil safe for cervical cancer prevention, but questions remain about complications and effectiveness.
Wed, Aug 19 2009 at 4:00 PM
DRUG IN QUESTION: Gardasil is the first vaccine to prevent cervical cancer. (Photo: ZUMA Press)
When pharmaceutical giant Merck & Company debuted Gardasil three years ago, it was hailed as a public health breakthrough that could save millions of lives. The vaccine was immediately foisted upon young girls and their parents through a series of ads proclaiming that recipients could be “one less” victim of cervical cancer.
Although some serious complications have been linked to the vaccine, including at least 20 deaths and two cases of Lou Gehrig’s disease, a government report recently found that Gardasil has a safety record on par with that of other vaccines. More common complications include fainting episodes and an increased risk of potentially fatal blood clots.
The study, performed by the Centers for Disease Control and Prevention along with the Food and Drug Administration, concluded that there is no way to tell if the complications were a direct result of the vaccine.
Although the study deemed Gardasil safe, the authors note that their analysis is based on imperfect data drawn from reports made to a voluntary surveillance database. Most of these reports were filed by Merck & Company and did not include enough information to warrant further investigation.
Experts disagree on whether the risks outweigh the benefits, with some doctors noting that routine screening will catch human papillomavirus (HPV), a sexually transmitted virus that can cause some types of cervical cancer, and that vaccinating healthy young girls may not be necessary. An editorial accompanying the study in the Journal of the American Medical Association also questioned whether the vaccine will reduce cervical cancer fatalities.
“I wouldn’t accept much risk of side effects at all in an 11-year-old girl, because if she gets screened when she’s older, she’ll never get cervical cancer,” Dr. Charlotte Haug, an infectious disease expert from Norway, told The New York Times.
“You don’t have to die from cervical cancer if you have access to health care.”
Merck was pleased with the report, stating that it confirms their favorable safety profile of the vaccine and that screening alone is not the answer. The company is awaiting an upcoming FDA decision on whether Gardisil, currently approved for females ages 9 to 26, could be expanded to include males of the same age to reduce HPV transmission to women.