TRENTON, N.J., Jan. 6, 2009

Cervical Cancer Vaccine - For Boys?

Drugmaker Merck Seeks To Expand Market For Anti-STD Injection Gardasil

  • Play CBS Video Video Girls Vaccines For Boys?

    Doctors will soon vaccinate young boys with Gardasil, a vaccine traditionally administered only to girls, in the hopes of limiting HPV cases among women in the future. Dr. Emily Senay reports.

  • Video Protecting Girls Against HPV

    Dr. Emily Senay discusses the new human Papillomavirus vaccine, Gardasil, and how it can prevent young girls from developing cervical cancer later in life.

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    Meg Oliver reports on the FDA-approved cervical cancer drug, Gardasil, declining pregnancy rates among teenage girls and a study, which says that vitamins do not slow mental decline in older people.

  • Drugmaker Merck is seeking to expand the market for its popular cervical cancer vaccine Gardasil to include boys. The vaccine targets four common viruses, which cause genital warts and cancers in both men and women.

    Drugmaker Merck is seeking to expand the market for its popular cervical cancer vaccine Gardasil to include boys. The vaccine targets four common viruses, which cause genital warts and cancers in both men and women.  (AP)

  • In-Depth STD Facts

    Who gets them, their symptoms and treatment.

(AP)  Drugmaker Merck & Co. has asked federal regulators to approve use in males for its vaccine against the human papillomavirus, which causes cervical and other sexually transmitted cancers.

The application was submitted in late December, Merck spokeswoman Amy Rose said Tuesday.

It was long planned as part of Whitehouse Station, N.J.-based Merck's strategy to increase the market for Gardasil. It prevents infection with the sexually transmitted virus and thus cancers of the genital organs.

Gardasil, launched in 2006 for girls and young women, quickly became one of Merck's top-selling vaccines, thanks to aggressive marketing and attempts to get states to require girls to get the vaccine as a requirement for school attendance.

However, it is one of the priciest vaccines on the market, typically costing $360 for a three-dose regimen.

Gardasil had 2007 sales of $1.5 billion, but sales began slowing in the second half of 2008, after a government-funded Harvard study concluded it was cost-effective for girls but not for women in their 20s.

The U.S. Food and Drug Administration has two months to decide whether the application for use in males meets its standards. Reviews can then take 10 months or more.

The application includes research data from a Merck study including about 4,000 males, ages 16 to 26; Gardasil prevented 90 percent of cases of penile cancer and genital warts caused by the four common virus strains targeted by the vaccine.

The agency approved use of Gardasil in females ages 9 to 26 years old in June 2006, but last June rejected expanding that to include women ages 27 to 45. The vaccine has since been approved for use by young women in dozens of foreign countries.

A rival vaccine called Cervarix, made by Britain's GlaxoSmithKline, is approved in many foreign markets, but generally lags behind Gardasil in sales. It is still awaiting approval in this country.

© MMIX The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.
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by kodysdad May 3, 2009 12:56 PM EDT
C'mon people the Gardasil vaccine has to be safe otherwise the FDA would ban the use of it. The FDA just yesterday banned Hydroxycut after 1 death. If there had been any Gardasil deaths the FDA would have quickly banned it too. Besides, pharmaceutical products are under much more scrutiny than supplements or vitamins. So they would never release any vaccine or drug if it were not safe, right?

Oops. 29 deaths, dozens of paralizations, countless more cases of young girls with serious side effects. That's just for Gardasil. Don't look up the facts on Viagra. Not good. People are dying. But these are "acceptable losses." The families are paid large sums of money. That is how this game is played. Don't take my word. Look up the facts in medical journals and mainstream medical websites. I live in Texas you have heard the slogan "Don't mess with Texas." Well, don't mess with Texan's kids. No way in hell will my daughter or son will be getting this vaccine. Furthermore, the CDC's vaccine schedule for infants thru 18 years is legalized child abuse. Shame on us (the parents) for letting this train get so far off the tracks.
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by brainteaser2 January 8, 2009 8:36 PM EST
Little girls get HPV from little boys. To disrupt the infectious circle boys and girls need vaccination. In the future I am also confident that HPV will also be identified as a cause of prostate CA.
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by garbosmed January 7, 2009 9:26 PM EST
And as for the other 5 percent of adverse events (more than 14,000 reported to VAERS as of November), how about death and paralysis. That''s pretty serious, eh?

And then there''s this: "November 18, 2008 (LifeSiteNews.com) %u2013 Gardasil, the vaccine being pushed by governments around the world to combat the spread of human papillomavirus (HPV), has been linked in Fiji with 3 cases of outbreaks of genital warts among primary school students."

So, giving someone the disease you''re supposed to be vaccinating against is a pretty big tipoff that something''s not quite right, wouldn''t you say?
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by garbosmed January 7, 2009 9:15 PM EST
"They should not receive the vaccine, plain and simple."
Yes, they should not receive the vaccine. But nobody at the CDC or FDA has said that, have they? And no tests have been done to see WHICH disorders might be a contraindication for vaccination, have they? Nor have any studies been done to see if the vaccine actually CAUSES the type of immune disorders or mitochondrial dysfunctions you talk about. Even the CDC was recently surprised to learn that mitochondrial dysfunction may be much more prevalent than previously thought. Another recent study showed that aluminum adjuvant affects the permeability of the blood-brain barrier, leaving a person more susceptible to other pathogens. So if you and the others who work for Merck are going to rush right out and vaccinate your kids with this garbage, that''s your choice. But choice is the key here -- don''t expect the rest of the world to follow you over the cliff, and don''t expect us to put up with government mandates for a vaccine that was never adequately tested in the first place. How in the world the FDA allowed clinical trials with no true placebo is just beyond me.
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by pjsurvivor1 January 7, 2009 6:09 PM EST
Many of the reports of health issues related to the vaccine have been overbloated and sensationalized by the media. While some girls have issues, it has usually been related to doctor negligence based upon providing this vaccine to someone who already is representing with an autoimmune disorder and/or been diagnosed. They should not receive the vaccine, plain and simple. But for otherwise healthy young women, more than 95 percent of all complaints have been about pain at the injection site or fainting.

I understand the autism issues that exist, but at the age peeople are getting the shot, they are really well beyond the age that autism is diagnosed. Its not like they are giving it to a two-year-old. It is going to people between the ages of 9 and 26, who would have already been diagnosed with autism by that age if they have a competent doctor.

Also, many of those who developed the shot and or work for Merck have vaccinated their own children against HPV. I for one plan to vaccinate my children.
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by garbosmed January 7, 2009 5:39 PM EST
True, Gardasil doesn''t have mercury. It has 225mg of aluminum adjuvant per dose, the most of any vaccine except for the anthrax vaccine. That same adjuvant has been studied scientifically and was shown to cause motor neuron death. In a recent Congressional report it was implicated in Gulf War Syndrome. Is it any wonder, then, that young pre-teen girls, who weigh much less than our soldiers in uniform, are becoming paralyzed at a rather alarming rate following this vaccine? This vaccine is an abomination. It should only be given to the people who approved it in the first place.
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by pjsurvivor1 January 7, 2009 4:58 PM EST
As to the point about Mercury being in the shots. If you have read antyhing lately, you would know that the Gardasil vaccine DOES NOT contain mercury or thimerosal, which is what all the debate with autism and other autoimmune disease has been about.

Thimerosal has also been removned from all children''s vaccines, including influenza.

As a national spokesperson for women''s health focusing on HPV and cervical cancer, I highly encourage people to checkout information regarding the Gardasil vaccine from viable sources not connected to the drug comapny. Gardasil has undergone more than 7 years of testing and known to be 99.7 percent effective if administered to girls/women before their first sexual experience. If it only saves half the women injected from getting cervical cancer and HPV, then it is a winner in my book!
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by pjsurvivor1 January 7, 2009 4:50 PM EST
BTW - the use of the Gardasil vaccine for boys will help them protect against head, neck, and throat cancers which are also caused by HPV. HPV also leads to oral, anal and brain cancers in some men and women.


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by pjsurvivor1 January 7, 2009 4:46 PM EST
OK - as a survivor of cervical cancer, I am appalled to see how much bad information there is out there about this vaccine and HPV in general. If there was a vaccine for breast cancer, I doubt we would see such negativity out there, cause breast cancer is more socially acceptible than cervical cancer or sexually-related cancers. How many womne would sign up to get a breast cancer vaccine if it became available.

While cancer cannot be transmitted sexually, the virus that causes cervical cancer can be transmitted and not just through sexual intercourse. It can be transferred through ANY form of sexual contact or via kissing orally withon someone who has an active infection. Second, it should be mandated for young women because it saves lives. Plain and simply. People fall to realize that 80 PERCENT OF ALL SEXUALLY ACTIVE PEOPLE IN THE U.S. HAVE OR HAVE HAD HPV. Of those 80 percent, 10 percent go on to develop cervical cancer, whether it is male, female, gay or stratight, married or not.

The vaccines isn''t a license for people to sexually irresponsible, but a way to protect them. Nobody deserves to be sujected to the ongoing medical mutilation of their female reproductive parts because of cancer. The testing, repeat surgeries, stimga, shame, phsychological damage are with your for life.
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by newsjunky5 January 7, 2009 2:57 PM EST
I''m OK with Texas(a mandatory state) using their schoolgirls as guinea pigs to test this (I don''t live there, and they''ll iron out the bugs/kill the kids and ban it before my daughter is old enough to need STD protection), but you should avoid taking any drug before it''s been on the market about 7 years, unless you already have a life-threatening illness.
I feel sorry for the girls and their parents who are forced to take it, and can''t afford to opt out with private school. This is a really big drug safety study, and Merck reaps profit during it, instead of paying a lot to fund a study before approval. Thanks, Texass
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