Font ResizeIf a vaccine that prevents human papillomavirus infections gets approved for use in males, James Peterson plans to tell patients it can do more than protect them.
"As I discuss it and phrase it with young men and parents, I think what we'll be talking about is the potential to protect future partners," said Peterson, a family practice doctor with Foothill Family Clinic in Salt Lake City.
A Food and Drug Administration advisory committee recommended on Sept. 9 that the vaccine Gardasil be given to males ages 9 to 26 to prevent genital warts caused by the virus. A final decision from the FDA is expected by the end of the year.
John Kriesel, an infectious diseases specialist at the University of Utah School of Medicine, called the recommendation good news.
"Name another vaccine we only give to one sex," said Kriesel, who helped run clinical trials of the vaccine for girls in Utah.
"It was only a matter of time before the company was able to show effectiveness in boys, so that's good," he said.
More widespread use of the vaccine will reduce cervical cancer and, perhaps in a generation or two, wipe out genital warts, he said.
The vaccine was first approved for use in the U.S. in 2006 for girls and young women. It is effective against the four primary types of human papillomavirus that cause genital warts and related cervical, vulvar and vaginal cancers.
The vaccine is made by Merck & Co., which gave the
The human papillomavirus is one of the most common sexually transmitted diseases. Merck said that expanding use of the vaccine to males would reduce infections and deaths in women, resulting in an estimated 1.9 million fewer cases of genital warts and a thousand fewer cervical cancer deaths over 50 years.
Girls and women are routinely screened for the infection, but males are not.
"There's no male equivalent to a pap smear," Peterson said. To detect HPV in men, his clinic has used an instrument like a nail file to brush off skin from men's genitalia.
"It was effective," he said, "but it was tricky."
Peterson said another potential selling point is that Gardasil may have a protective effect against some anal, penile and oral cancers in men.
"Mercifully, those cancers aren't as frequent or common" as cervical cancer, he said. "But I've seen them, so I think that will be a real benefit for men down the road."
Health officials recommend it be given around ages 11 and 12, though it can be administered later -- preferably before a person becomes sexually active.
"In my practice, the majority of patients want and accept the vaccine when they heard about it," Peterson said. "One of the few hang-ups have been the cost."
The vaccine, given in a three-shot series over six months, costs about $375. Peterson said more insurance plans now cover the vaccine.
In Utah, lawmakers refused in 2007 to fund a program to distribute the vaccine to uninsured women, a gap filled by a $1 million donation from philanthropist Jon Huntsman Sr. That supply is gone, the Utah Department of Health confirmed Friday.
Karrie Galloway, executive director of Planned Parenthood Association of Utah, said providers can seek hardship grants from Merck and do have a few funding options, but cost is significant.
"It is an education process and it is also a financial commitment" for those without health insurance, Galloway said. "And when you don't have cancer, just the potential, and you're talking to a young age group that consider themselves invincible, it's a hard sell."
The vaccine is not recommended for individuals with hypersensitivity, specifically severe allergic reactions to yeast, according to Merck.
More than 90 percent of reported side effects, according to the Centers for Disease Control and Prevention, have been minor: headaches, pain and swelling at the shot site, fever, nausea, dizziness and fainting.
As of June, there have been 26 confirmed reports of death among females who received the vaccine, but the CDC said there is no evidence to suggest the vaccine caused the deaths.
In his practice, Peterson said the biggest complaint has been a sore arm where the shot was given.
The Gardasil vaccine, made by Merck & Co., prevents infections from four types of the human papillomavirus, which causes genital warts, cervical cancer and several other cancers. Each year, 6.2 million new cases of human papillomavirus infections are diagnosed. Currently, about 11,270 cases of invasive cervical cancer are diagnosed in the U.S. each year and approximately 4,000 women die annually from the disease, according to the American Cancer Society. Since 2006, more than 50 million doses of Gardasil have been distributed worldwide, including approximately 26 million doses in the U.S., a Merck representative said Friday. Utah data are not available.
Brooke Adams
