Merck drug generates pre-release controversy

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Merck drug generates pre-release controversy By SHAWN RHEA Courier-Post Staff While some physicians hail Merck and Co.'s Gardasil, a vaccine that could prevent up to 70 percent of cervical cancer cases by blocking strains of the sexually transmitted human papillomavirus, others admit concern over a recommendation that the three-shot series be given to preteen, nonsexually active girls. "Some parents already have concerns about the safety of vaccines in general, so asking them to vaccinate their daughters against an STD when they aren't even sexually active is controversial," said Dr. Rottman, an obstetrician-gynecologist at UMDNJ's School of Osteopathic Medicine in Stratford. Though Merck's 10-year study of 27,000 clinical trial patients found Gardasil provided 100 percent protection against cervical cancer-causing strains of HPV in properly vaccinated

patients, the trial didn't determine how long the inoculation lasts or whether booster shots would be needed to continue protection. In addition, the vaccine was tested only in women 16 to 26 years old. A Food and Drug Administration advisory committee endorsed Gardasil on Thursday. In a unanimous vote the 13-member committee recommended the FDA approve use of the vaccine in 11- and 12-year-old girls, who typically have more responsive immune systems. "The questions that politicians and health care providers will be batting around now is who gets it, when do they get it and should we be screening for HPV before giving the vaccine," said Rottman. Physicians like Dr. s, an OB-GYN and medical director of Planned Parenthood of Southern New Jersey's Camden clinic, said parents of young girls should give serious consideration to the vaccine's potential to save lives. "There are more than 10,000 cases

of cervical cancer each year in the U.S., and close to 4,000 die," he explained. "True, we don't know the long-term effects, but if we can trust the FDA trials, (the vaccine) seems to have little side effects." But while OB-GYNs typically address sexual activity issues among young women, it will most likely be pediatricians and family doctors who will be administering the HPV vaccine should it be approved. An FDA decision is expected June 8. While some physicians expressed trepidation over recommending the vaccine, UMDNJ-SOM pediatrician Dr. Kaari believes its availability could be beneficial. "It's a difficult situation for parents to think of their children involved in sexual activity and take precautions to prevent (a future) STD," Kaari admitted. "But what parents have to look at is that the age of children becoming sexually active is becoming younger and younger." Reach Rhea at (856)

486-2475 or srhea@... Published: May 20. 2006 3:10AM

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