U.S. advisers recommend Gardasil HPV shots for boys

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Gardasil, a Human Papillomavirus vaccine, is displayed at the Girls to Women Health and Wellness clinic in Dallas, Texas March 6, 2007.

Credit: Reuters/Jessica Rinaldi

By Julie Steenhuysen

CHICAGO | Tue Oct 25, 2011 5:43pm EDT

CHICAGO (Reuters) - Boys should be routinely vaccinated against the human papillomavirus or HPV in an effort to protect them from oral, anal and penile cancers, and to extend protection of girls from cervical cancer, U.S. vaccine advisers said on Tuesday.

The Advisory Committee on Immunization Practices, which advises the U.S. Centers for Disease Control and Prevention, voted unanimously to recommend routine use of Merck & Co's Gardasil in 11- and 12-year-old boys to fight the sexually transmitted virus, with 13 yes votes and one abstention.

Previously, the CDC had said doctors are free to use the vaccine in boys but had stopped short of recommending routine vaccination.

Boys aged 13-21 who have not been vaccinated should be given a catch-up dose of the vaccine, which is given in a three-dose series. Men aged 22 through 26 may be vaccinated but the vaccine is not recommended for routine use, the panel said.

Currently, the CDC recommends HPV vaccinations made by Merck and GlaxoSmithKline for girls and women between the ages of 11 and 26.

The prior recommendations were based largely on evidence that the vaccine protects boys from genital warts but the new recommendations reflect several studies showing the vaccine helps prevent cancers in boys as well, Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases, said in a conference call with reporters.

The HPV vaccine offers an opportunity to decrease the burden of HPV in both males and females, Schuchat said.

"In addition to providing a direct benefit to boys, there is also the potential that the vaccine will reduce the spread of HPV from males to females," she said.

Schuchat noted that the HPV vaccine currently is not being as widely used among girls as hoped and vaccinating boys could help reduce transmission of HPV to girls.

POLITICAL CONTROVERSY

During the meeting, CDC experts advised the panel there is no evidence the vaccine can cause "mental retardation," a concern raised by Republican congresswoman Michele Bachmann in a Republican presidential candidate debate.

The U.S. medical community repudiated Bachmann's claim, which she made as a swipe at a rival, Texas Governor Rick Perry, who issued an executive order in 2007 mandating girls get the HPV vaccine as part of a school immunization program.

Perry's order was later overturned.

The committee's strong recommendations, which are subject to CDC approval, likely will mean insurance companies will begin paying for the vaccine when used in boys.

"Today's ACIP recommendations will help to provide greater access to Gardasil for males," said Dr. Mark Feinberg, chief public health and science officer, Merck Vaccines.

Insurance companies have largely considered the CDC's prior policy recommendation for boys as optional and some have refused to cover the shots for boys.

"I think it's a worthwhile vaccine," said Dr. Jay Siwek, a professor of family medicine at Georgetown University Medical Center, who was not part of the panel.

Siwek said the only downside of the vaccine is cost, which is $360 for a course of three shots.

In his own practice, Siwek tells parents the vaccine protects against cancers that occur in boys -- mostly mouth and throat -- and it helps protect girls from cancer as well.

Dr. Robert Haddad of Dana-Farber Cancer Institute, said there has been a epidemic of HPV-related head and neck cancers.

"HPV is a cause of many cancers so it is really important to support endeavors to vaccinate," he said.

The approval, which only applies to Merck's vaccine, may bolster sales of Gardasil, which have stalled amid competition from a rival GlaxoSmithKline product and because many younger women already have been immunized with Gardasil, limiting the market size.

Gardasil's sales hit $1.1 billion worldwide in 2009 and have been hovering in that range.

(Reporting by Julie Steenhuysen in Chicago, Editing by Sandra Maler and Bill Trott)

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U.S. advisers recommend diabetics get Hep B vaccine

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n">(Reuters) - U.S. vaccine advisers on Tuesday voted to recommend routine vaccination for Hepatitis B for adults with diabetes under the age of 60 and said people older than 60 "may" get the vaccine as well.

The Advisory Committee on Immunization Practices, which advises the U.S. Centers for Disease Control and Prevention, voted 12-2 to include diabetics in the high-risk group of unvaccinated adults that should get vaccinated.

This is the first time the panel made a recommendation for people with diabetes, after studies showed those under the age of 60 were more than twice as likely to get infected with Hepatitis B than those without diabetes. Studies found no observed significant increase of Hepatitis B in diabetics over the age of 60.

Hepatitis B is a serious disease that could turn chronic and lead to liver damage or cancer. Although it cannot be cured, it can be prevented with a vaccine.

The CDC has recommended routine vaccination of children and adolescents since 1991. The recommendation also apply to unvaccinated adults at risk of getting infected, such as people with chronic liver or kidney disease, men who have sex with men, people with more than one sex partner or those whose jobs expose them to human blood.

Two Hepatitis B vaccines are available in the United States: Engerix-B by GlaxoSmithKline and Recombivax by Merck & Co's. Dynavax Technologies Corp's has another Hepatitis B vaccine for adults, Heplisav, in clinical trial.

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Boys should get HPV vaccine, CDC advisers say

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CDC: Tests on thousands of people show "no serious safety concerns" The advisory committee votes to recommend males ages 11 to 21 be vaccinatedHPV is the number one sexually transmitted disease in the nation The HPV vaccine has been approved for males since 2009

Atlanta (CNN) -- A federal government advisory committee voted Tuesday to recommend that males ages 11 to 21 be vaccinated against the human papilloma virus, which is blamed for thousands of cases of cancer among women and men.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices said the vaccine series can be started as early as age 9.

Twelve members of the committee voted in favor of a recommendation that 11- and 12-year-old boys be vaccinated; one member abstained.

In a separate vote involving males age 13 to 21, eight voted in favor; five against, and one abstained. The same recommendation said men ages 22 through 26 may be vaccinated.

Much of the debate focused on whether it would be cost-effective to vaccinate boys against HPV. The vaccine is administered over a six-month period in three doses, each of which costs about $120.

Dr. S. Michael March, clinical professor of pediatrics at the University of Southern California and a member of the group that devised the recommendations, said the cost to vaccinate 11- and 12-year-old boys would be $38 million. "We have the money, we just have to set the priorities," he said. "If we don't, I don't know who will."

HPV is the most common sexually transmitted disease in the United States. At least half of sexually active people will get it at some point in their lives.

Why vaccinate middle schoolers? Experts say that it's important to immunize people before they become sexually active. According to the Guttmacher Institute, which studies sexual health, 13% of 15-year-olds have had vaginal sex. By 19, that figure has risen to 70%. The vaccine is less effective after a person is sexually active.

Study: Males should get HPV vaccine too

The HPV votes took place as part of the advisory committee's meeting in Atlanta. The vaccine is 89% effective against genital warts in males and 75% effective against anal cancer in males, according to CDC.

The HPV vaccine is already recommended for females between the ages of 9 and 26 to reduce the risk of cervical cancer. The CDC recommends girls also get the vaccine at age 11 or 12.

The Food and Drug Administration approved the first HPV vaccine, Gardasil, in 2006. A second vaccine, Cervarix, was approved in 2009.

Gardasil protects against most genital warts and anal, vaginal and vulvar cancers, all of which are associated with HPV, according to the disease agency.

Although the vaccine has been approved for males since 2009, it hasn't been as heavily promoted for them.

Increase in oral cancers linked to HPV

One reason for the push now is that girls aren't getting vaccinated in the numbers doctors had expected. "If the boys are also immunized, it reduces the transmission back and forth," said Dr. William Schaffner, chairman of the Department of Preventive Medicine at Vanderbilt University, who attended the CDC meeting as an adviser but not a voting member.

In addition, the committee voted to recommend that men who have sex with men up to age 26 be vaccinated against HPV because that would protect them from cancers of the penis and rectum.

There also is growing evidence that HPV is responsible for a recent increase in head and neck cancer. A study published this month found approximately 70% of all oropharyngeal cancers are caused by HPV. Oropharyngeal cancers are those that form in the middle of the throat behind the mouth, an area that includes the back third of the tongue, the soft palate, the side and back walls of the throat and the tonsils.

This year, the American Academy of Pediatrics added the HPV vaccine to its list of recommended vaccines for boys.

The HPV vaccine became a political hot potato when Republican presidential contender Michele Bachmann criticized fellow Republican contender and Texas Gov. Rick Perry's support of the vaccine for girls. In 2007, he signed an executive order that required Texas schoolgirls to receive vaccinations against HPV. The order ended up not being implemented.

The CDC notes that the FDA has licensed the vaccines as safe and effective. "Both vaccines were tested in thousands of people around the world. These studies showed no serious safety concerns. Common, mild adverse events reported during these studies include pain where the shot was given, fever, dizziness, and nausea," according to the CDC website.

CNN's Aaron Cooper, William Hudson and Saundra Young contributed to this report.

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HEALTH MANAGEMENT. FDA advisers cautiously on bone drug

NOBILITY PHILEX, Maryland | September 9, 2011 8: 24 pm EDT
NOBILITY PHILEX, Maryland (Reuters) - U.S. health advisers rejected it, takes how long women beat a class of drugs by millions to prevent bone fractures, but agreed that the labels uncertainty about the risks and benefits to be modified according to long-term use.
The food and drug had asked Administration to recommend whether a "drug holiday" or some period was justified, for a class of osteoporosis drugs known as bisphosphonates that unusual thigh fractures and other side effects in conjunction was brought two of its consultative bodies.
Now the consultants have at tailored hardened, making changes, on Friday coding with many indicating how often patients require a review they need medicine.
Panelists concerns again and again, that they have not enough evidence, to specific suggestions or conclusions to find, and some awareness of such uncertainties in the term recommended, as well as.
"I don't think that we restrict enough data to anything at this point have", said Dr. Maria Suarez Vacceans, Professor at the University of Texas MD Anderson Cancer Center and a member of.
In the year under review include Merck & co Fosamax, Warner Chilcott ACTONEL, BONIVA Roche and Novartis Reclast. This class of drugs was linked to osteonecrosis of the jaw or jaw bone death and possible increased risk of cancer.
Presented by the FDA and industry not paint studies consultants a coherent picture that whether benefits outweigh the risks bisphosphonates for longer than three to five years or how exactly each of these drugs take influenced various subgroups of patients, said.
"I'm used to dealing with ambiguous situations in a clinical setting, but as a result, this will be at different heights," said Brian Erstad, pharmacy Professor at the University of Arizona and a member of the drug safety and risk management advisory panel.
RISKS & BENEFITS
Some 4.5 million Americans age 55-filled recipes for bisphosphonates in 2009, mostly women after the menopause, osteoporosis, a progressive bone thinning condition that usually caused fractures in the hip, wrist or spine.
The use of drugs said FDA employees unusually femur associated with fractures, and increases the risk of jaw bone death that more people keep them orally. But she said that the evidence of an increased risk of cancer was incompatible.
BONIVA is available as an injection or a tablet, Aclasta is an injection, and other drugs are taken orally.
FDA researchers to stay their use found no advantage on the medication for five years and without loss of effectiveness from discontinued. Pharmaceutical companies, but warned that a comprehensive introduction to a break in the treatment of the FDA may expose patients to more fractures.
"Despite rare side effects, patients, the use of bisphosphonates have fewer fractures and low mortality, and this knowledge must be shared with our patients," said Dr. Robert Adler, an invited speaker and Professor of Endocrinology at the Virginia Commonwealth University.
With millions who reached taking the medication, the sale of Merck's Fosamax $3 billion in 2007, but sales plunged the competition from cheaper generics from early 2008 to $ 926 million in 2010 with the pill.
Analysts said mounting concerns bisphosphonates patients to Amgen Inc new medicine, Prolia, a different kind of osteoporosis drug can drive.
BAD REP
Orrel Lanter Fosamax Merck and the generic version, chemically as alendronate, has known nine years.
"I felt something go" snap-in "my leg." My right foot flopped out on the right side and my leg was a noodle which pain was unbearable, "the adviser told on Friday." In the emergency room was told her that she had an atypical femur fracture, which leads them to years bisphosphonates.
"I was crippled now links through this terrible drug happy healthy, very active in the free woman", Lanter said, which is now 68 and went out of the room, with a stick.
Since Merck Fosamax 1995 obtained the first Bisphosphonate for osteoporosis, the names of the drugs in this class were several reviews and changes.
In 2005, a warning of higher risk of osteonecrosis of the jaw was labels, and added in 2009, a deposit of gastrointestinal side effects. Earlier this year, the labels have been changed to add a warning of atypical femur fractures and Reclast the label now mentions an increased risk of kidney failure.
However, pharmaceutical companies agreed and some of the panelists, that some groups of patients, perhaps the highest risk, could benefit from bone fractures of longer-term use of such drugs.
Whether and how these problems now up to the is
FDA.
(Reporting by Alina Selyukh;) Additional reporting by Ransdell Pierson; (Editing by Tim Dobbyn)

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