HealthWrap: Risks, rewards and Rx's
By DAN OLMSTED
UPI Senior Editor
WASHINGTON, June 30 (UPI) -- Two developments this week -- the recommendation of a new anti-cancer vaccine for American girls, and new warnings about an antibiotic's side effects -- show how hard it is to get the risk-benefit ratio exactly right.
Thursday, an advisory committee of the Centers for Disease Control and Prevention urged that all preteen girls get a three-shot regimen of Gardasil, the recently approved vaccine against human papillomavirus (HPV), which in turn is the most frequent cause of cervical cancer.
The same day French drug maker Sanofi-aventis added a warning about risk of liver damage to its antibiotic Ketek, which treats respiratory infections.
Ketek has been the focus of an unusual face-off between the Food and Drug Administration and U.S. Sen. Charles Grassley, R-Iowa, and other legislators. Grassley has been highly critical of the FDA's oversight of the drug.
In fact, Grassley went to the FDA headquarters -- the first time he has done that since 1983 -- to personally demand answers after saying the agency wouldn't make a fraud investigator available to discuss an agency probe.
Problems with a clinical trial of the drug's safety were outlined in a May article in The Wall Street Journal.
A Sanofi official told the Journal this week that "the medical benefits outweigh the risk" of Ketek, even as the FDA said, "We clearly now understand that there is a risk of serious liver injury with Ketek."
The risk from Gardasil, according to some critics, is a moral hazard -- it might tend to encourage premarital, and possibly dangerous, sexual activity. The advisory committee's recommendation means that at least some -- and, plausibly, most -- states will make it mandatory for school attendance and pay for those who can't afford it.
Colorado-based Focus on the Family told United Press International's Mara Gordon it is not opposed to the HPV vaccine for individuals, but state mandates prevent families from making the choice themselves.
"This is not a disease that you're going to communicate, transmit or contract sitting in a classroom," said Linda Klepacki, a sexual-health analyst for Focus on the Family, a culturally conservative organization. "You really have to go out and get it."
While the FDA says the vaccine is very safe, others are raising questions about that as well. The National Vaccine Information Center, a group that favors choice and greater informed consent in U.S. immunization policy, issued a statement earlier in the week calling on the CDC committee to reject mandating the vaccine.
NVIC said clinical trials by manufacturer Merck were inadequate.
"Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials," said NVIC president Barbara Loe Fisher. "Merck's pre- and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls."
Merck, on the contrary, said the trials -- and the FDA approval followed by the CDC recommendation -- show its safety has been established. |
