September 10, 2009 11:33 AM

HPV Vaccine Endorsed for Males

By
Jonathan LaPook, M.D.
(CBS)  Gardasil, already a $1-billion vaccine marketed worldwide to young women, was endorsed Wednesday for use in young men, too, reports CBS News medical correspondent Dr. Jon LaPook.

Studies of more than 5,000 boys and men found Gardasil was 89 percent effective at preventing genital warts which affect an estimated 1 million American men and women. The same virus also causes rare cases of anal, genital and oral cancers in men.

"This vaccine in the future may help to prevent cancers caused by HPV in males as well as females," said Dr. Anna Giuliano, an investigator in the clinical trial in Gardasil for males. "I think this is a tremendous opportunity for our sons."

But Shoshana Blasko wonders if it is worth giving a vaccine for an infection that usually clears up on its own.

"Without further research I am very uncomfortable giving it to my children," Blasko said.

She's aware of a recent study finding Gardasil was generally safe in females but was linked to side effects including rare cases of blood clots. Her son Evan doesn't think he needs protection against a sexually transmitted virus.

"Twelve-year-olds aren't going to be having sex so there's no point to get the vaccine," Evan said.

Doctors agree preventing a virus that causes both infection and cancer makes sense. But some are unconvinced this vaccine is the answer. The series of three shots costs $390.

"I would love my daughter and my son to get a vaccination that would prevent any kind of HPV, but it has to be at no cost, and I don't mean financial cost, I mean at no health risk cost," said Dr. Jacques Moritz, the director of gynecology at St Luke's Roosevelt Hospital in New York.

No serious side effects have been reported in males. The drug maker Merck, which paid for the study, is seeking approval for use in boys and young men, ages 9 to 26.

Copyright 2009 CBS. All rights reserved.
Add a Comment
by momofGG September 10, 2009 10:47 AM EDT
This story is NOT accurate. I was at the meeting yesterday and there was a boatload of questions concerning the "control" in Gardasil being aluminum. They did NOT endorse the vaccine and, in fact, stated that they needed to provide more long-term data to prove safety of this vaccine. Get your facts straight! Or quit reporting!
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by goffredo29 September 10, 2009 9:50 AM EDT
Okay Dr. LaPook, here's the story that isn't being told. Thousands of men, me included have alreadly gotten the HPV vaccine "off label" and out of pocket because it prevents penile cancer, anal cancer, certain throat cancers as well as genital warts, not because we were doing something noble for the opposite sex. For some reason Merck has dragged its feet and subjected men to an interminable campaign of misplaced blame for women's ills in their marketing of Gardasil while keeping it out of reach for men who can't afford it. Finally it looks like that all may be over.
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by rf35 September 10, 2009 3:46 AM EDT
I do hope this gets full approval from the FDA. It is disappointing that this vaccine was marketed only to females when HPV doesn't discriminate based on gender. If it prevents just one case of cancer in a man, I'd say it is worth it. Now the problem will be getting insurance companies to agree to cover the cost of the vaccination. They would rather gamble on the chance that the man never develops the cancer, or that they could claim it as a pre-existing condition when it comes time to pay for the cancer treatment.
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by tincup356 September 9, 2009 9:11 PM EDT
I would avoid ANY drugs that the "government " says we need to take,,,,the studies on this drug were paid for by Merck....that should tell you enough,,,lobby dollars get test reports that are custom fit to make a sell, and HIDE potential problems,,,,why do people think there have been so many recalls on so called miracle drugs in the last few years?,,,because R&D was made up in the first place , just to get approval, and HUGE profits,,,,How many BILLIONS did they make off of each drug BEFORE it was recalled?If you trust what these greedy,lobby dollar criminals are trying to give you as the honest truth,,,,,,you are taking a huge chance with your life and health. The FDA needs to be investigated for approving drugs that later prove to be dangerous,,,,someone must be held responsible, it is fraud at the VERY LEAST, and as much as homicide in others.
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by goffredo29 September 9, 2009 8:21 PM EDT
In the meantime, there are thousands of men who have already gotten the vaccine "off label" and out of pocket because they couldn't wait for the plodding promotional campaign Merck had unleashed targeting only female recipients to make way for men who want to avoid penile, anal and some throat cancers as well as genital warts. If guys had to wait for the CDC to rally to their health issues, they'd all be dead. Same for most other health organizations.
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