Parents who face the dilemma of whether to protect their young daughters with a vaccine aimed at a sexually transmitted infection that causes cervical cancer now face a new question: Should they do the same for their sons?
As evidence mounts of a rising number of other cancers linked to the human papillomavirus, or HPV, a debate has intensified over whether to give the vaccine to males.
Advocates say vaccinating boys and men can prevent them from passing on the virus to their sexual partners.
Critics still question the long-term safety and effectiveness of Merck & Co.’s Gardasil, despite studies indicating that its risks and lasting power are within the range of other vaccines.
But a newer wrinkle in the debate is the discovery in recent years that oral HPV infections — most likely acquired from oral sex with multiple partners—significantly increase the risk of head and neck cancers.
The rate of oral cancers is rising so steadily, especially in men, that, if the trend continues, there may be more oral cancers in the United States caused by HPV in 10 years than by tobacco or alcohol, a major study concluded last year.
“We should be investing our care and dollars in preventing HPV infection instead of treating the cancers,” said Dr. Thom Loree of Roswell Park Cancer Institute.
Physicians at the cancer center have begun publicly touting the benefits of the vaccine on males after seeing an increase in the number of throat cancers they treat annually over the last decade. HPV was associated with about 55 percent of the tumors.
Although many researchers believe Gardasil can protect against oral and other cancers linked to HPV infections, including rarer cancers of the penis and anus, studies that might provide compelling evidence have yet to be completed.
HPV, a family of more than 100 viruses, is the most common sexually transmitted infection. An estimated 20 million Americans are infected, and at least half of all men and women acquire a genital HPV infection at some point in their lives, according to the Centers for Disease Control and Prevention.
In most cases, there are no symptoms and the infection goes away. But some types of HPV cause genital warts and cancers.
HPV-associated cancers occur most often in the cervix, with about 10,000 cases and 3,700 deaths each year. There are about 1,000 deaths each year among U. S. men from HPV-linked cancers.
The Food and Drug Administration approved Gardasil in 2006 for women ages 9 to 26 to prevent cervical, vulvar and vaginal cancers caused by HPV. The federal Advisory Committee on Immunization Practices recommends that all girls be vaccinated at age 11 or 12 and those ages 13 to 26 be given “catch up” vaccinations.
Merck has applied to the FDA to use the vaccine on boys and men ages 9 to 26. The official indication would be for prevention of genital warts and other lesions, although pediatricians would be free to discuss with parents the potential for protection against cancers.
The immunization advisory committee met in June to discuss vaccination of males, including whether it is cost-effective, and plans to vote on the matter in the fall.
Gardasil protects against four strains of HPV, including two that account for 70 percent of cervical cancers and two others that account for nearly all cases of genital warts.
Experts say restricting the vaccine to girls makes it less effective at reducing infections.
“There are many direct and indirect benefits to vaccinating men for HPV, although it’s important that we look at whether it’s cost-effective,” said Dr. Gale Burstein, medical director of epidemiology and surveillance and STD control for Erie County. Burstein, a pediatrician who specializes in adolescent medicine, also consults for Merck and GlaxoSmithKline, which has applied to the FDA to market its competing Cervarix vaccine in the U. S.
Another Buffalo-area physician, Dr. Michael Terranova, chairman of the Buffalo Area Pediatric Society, also sees benefits in immunizing boys. “It’s a good vaccine,” he said. “You would eliminate thousands of cases of genital warts and cancers.”
Critics, though, point out that unlike mandated vaccines, only about 25 percent of teenage girls get Gardasil and that vaccinated women must continue regular Pap tests to detect precancerous lesions because Gardasil does not protect against other strains of HPV that cause cervical cancer.
This, in turn, raises doubts about the vaccine’s cost-effectiveness, particularly when a Pap test ranges from $6 to $16 and the three recommended doses for Gardasil cost $375.
“This is a very expensive vaccine with limited effectiveness,” said Diana Zuckerman, president of the National Research Center for Women and Families. “For men, we know that the vaccine will prevent genital warts. How much are we willing to pay to prevent genital warts?”
Critics note that most cases of HPV clear on their own and raise doubts about the lasting power of the vaccine. They also question its safety.
Merck counters that research shows immunity lasts at least 8.5 years, and that proof of enduring protection has not been a requirement of other vaccines.
As of May 1, more than 24 million doses of Gardasil were distributed in the United States. There were 13,758 reports of adverse events, with 7 percent considered serious, according to the government’s Vaccine Adverse Event Reporting System.
Although studies have yet to show that Gardasil prevents oral cancers, scientists remain optimistic that it can. “No one can make a claim that it will do anything for other cancers. But there is no reason to believe it won’t work,” said Dr. Maura Gillison, a leading expert on HPV and oral cancers.
Researchers attribute the rise in HPV-associated cancers, especially oral cancers among younger white men, largely to changes in sexual attitudes. The greatest risk factor for developing a cancer from an HPV infection is multiple sexual partners, Gillison said. All of which may add a challenging twist for doctors if the vaccine is approved for males.
“Talking to boys or their parents about protecting girls from cancer is not going to get them to take the vaccine. They have to see a direct benefit,” said Dr. Cynthia Rand, who has studied public perceptions toward HPV vaccination.
Written by Henry L. Davis
The Buffalo News
July 12, 2009
Tuesday, July 14, 2009
Accidents Happen. Be Prepared.
On July 13, 2009, the U.S. Food and Drug Administration (FDA) approved the Plan B® One-Step, a new emergency contraception pill. Plan B One-Step gives women the option of helping to prevent an unplanned pregnancy with a single dose instead of two doses. It will be available in about a month.
Emergency contraception (also known as the morning after pill) is a safe and effective way to prevent pregnancy after unprotected intercourse. It can be taken up to five days (120 hours) after unprotected intercourse.
Accidents happen. Did you have intercourse without using protection? Did you forget to use your birth control correctly? Did the condom break, leaving you worried about becoming pregnant? If so, emergency contraception might be a good choice for you.
The FDA has also made Plan B available from drugstores and health centers without a prescription for women and men 17 and older (previously, it was available to people 18 and older). If you are interested in getting Plan B and are 17 or older, you can now get it directly from either a Planned Parenthood health center or from your local drugstore. If you are younger than 17, you'll need to go to Planned Parenthood, other health center, or private health care provider for a prescription.
We all like to be prepared. That is why it's a great idea to keep some Plan B in your medicine cabinet or bedside table in case of an accident. Having the morning after pill on hand will let you take it as soon as possible after unprotected intercourse, when it is most effective. If you are younger than 17, you can ask your health care provider for a prescription that you can fill ahead of time.
Post from Planned Parenthood Action Center
Emergency contraception (also known as the morning after pill) is a safe and effective way to prevent pregnancy after unprotected intercourse. It can be taken up to five days (120 hours) after unprotected intercourse.
Accidents happen. Did you have intercourse without using protection? Did you forget to use your birth control correctly? Did the condom break, leaving you worried about becoming pregnant? If so, emergency contraception might be a good choice for you.
The FDA has also made Plan B available from drugstores and health centers without a prescription for women and men 17 and older (previously, it was available to people 18 and older). If you are interested in getting Plan B and are 17 or older, you can now get it directly from either a Planned Parenthood health center or from your local drugstore. If you are younger than 17, you'll need to go to Planned Parenthood, other health center, or private health care provider for a prescription.
We all like to be prepared. That is why it's a great idea to keep some Plan B in your medicine cabinet or bedside table in case of an accident. Having the morning after pill on hand will let you take it as soon as possible after unprotected intercourse, when it is most effective. If you are younger than 17, you can ask your health care provider for a prescription that you can fill ahead of time.
Post from Planned Parenthood Action Center
Wednesday, July 1, 2009
NYS Political Chaos Hurts Women
For the past week, we've been watching the political circus that has become our state government, glued to our computer screens for the unfolding story. But there's another story that hasn't yet been told.
While you saw two men cross the aisle, I sat in the New York Senate chamber and saw three years of hard work and real coalition-building in the service of women's health go up in smoke. While you watched the lights go out in the Senate chamber, I watched the state go dark on reproductive rights.
Because last Wednesday, the Reproductive Health Act -- landmark legislation to codify Roe vs. Wade in New York -- was scheduled to be voted upon in the Senate. NARAL Pro-Choice New York and other advocates had commitments from 34 senators, across party lines, to pass a clean, amendment-free bill.
With passage of this legislation, every woman in New York would have been assured that her fundamental right to choose abortion would be protected. Critically, the Reproductive Health Act would also have clarified that a woman would be allowed to have an abortion if her health or life was endangered. The bill, which has been loudly debated for three years, was going to be voted on quietly and respectfully so that each senator could fully vote his or her conscience.
But two days earlier, the Republicans -- with the help of Sen. Pedro Espada and Sen. Hiram Monserrate, both Democrats, ostensibly -- engineered a coup that took down the pro-choice Senate leadership and attempted to reinstate the same anti-choice Republicans who've been blocking pro-choice legislation for 40 years.
This maneuver appears to have effectively derailed the bill -- ironically, as both Monserrate and Espada are co-sponsors of the Reproductive Health Act.
One would think that Monserrate, of all people, might want to make women's issues a priority. One would think Espada, whose health center serves low-income women, might want to make women's health a priority. One would think that Sen. Dean Skelos, who really ought to be noticing the national trend away from Bush-era extremism, might want to make women's issues a priority.
Women's health and rights matter in New York. Polls have repeatedly shown that nearly three quarters of New Yorkers (across all party lines and demographics) support the Reproductive Health Act.
Yet the anti-choice Republican leadership has maintained a stranglehold on the Senate, kowtowing to fringe interests. The behavior of Skelos reveals the lie behind his so-called coalition and its claim of bipartisanship and reform. New Yorkers thought they had pro-choice leadership in the state Senate, a decision that Skelos and his cronies are now effectively rejecting at their peril.
Women in New York have held a powerful role in swinging elections toward Democrats and moderate Republicans. No statewide elected official in over a decade has been anti-choice. You simply do not win in New York by taking that position.
Regardless of who leads the Senate in the coming weeks, we call upon legislators of both parties to come together and pass a clean Reproductive Health Act, without larding it up with amendments that could compromise women's health.
The Reproductive Health Act is ready. Women are waiting. Let's finish the story.
Written by Kelli Conlin for the Albany Times Union 6/16/2009
Kelli Conlin is president of NARAL Pro-Choice New York.
While you saw two men cross the aisle, I sat in the New York Senate chamber and saw three years of hard work and real coalition-building in the service of women's health go up in smoke. While you watched the lights go out in the Senate chamber, I watched the state go dark on reproductive rights.
Because last Wednesday, the Reproductive Health Act -- landmark legislation to codify Roe vs. Wade in New York -- was scheduled to be voted upon in the Senate. NARAL Pro-Choice New York and other advocates had commitments from 34 senators, across party lines, to pass a clean, amendment-free bill.
With passage of this legislation, every woman in New York would have been assured that her fundamental right to choose abortion would be protected. Critically, the Reproductive Health Act would also have clarified that a woman would be allowed to have an abortion if her health or life was endangered. The bill, which has been loudly debated for three years, was going to be voted on quietly and respectfully so that each senator could fully vote his or her conscience.
But two days earlier, the Republicans -- with the help of Sen. Pedro Espada and Sen. Hiram Monserrate, both Democrats, ostensibly -- engineered a coup that took down the pro-choice Senate leadership and attempted to reinstate the same anti-choice Republicans who've been blocking pro-choice legislation for 40 years.
This maneuver appears to have effectively derailed the bill -- ironically, as both Monserrate and Espada are co-sponsors of the Reproductive Health Act.
One would think that Monserrate, of all people, might want to make women's issues a priority. One would think Espada, whose health center serves low-income women, might want to make women's health a priority. One would think that Sen. Dean Skelos, who really ought to be noticing the national trend away from Bush-era extremism, might want to make women's issues a priority.
Women's health and rights matter in New York. Polls have repeatedly shown that nearly three quarters of New Yorkers (across all party lines and demographics) support the Reproductive Health Act.
Yet the anti-choice Republican leadership has maintained a stranglehold on the Senate, kowtowing to fringe interests. The behavior of Skelos reveals the lie behind his so-called coalition and its claim of bipartisanship and reform. New Yorkers thought they had pro-choice leadership in the state Senate, a decision that Skelos and his cronies are now effectively rejecting at their peril.
Women in New York have held a powerful role in swinging elections toward Democrats and moderate Republicans. No statewide elected official in over a decade has been anti-choice. You simply do not win in New York by taking that position.
Regardless of who leads the Senate in the coming weeks, we call upon legislators of both parties to come together and pass a clean Reproductive Health Act, without larding it up with amendments that could compromise women's health.
The Reproductive Health Act is ready. Women are waiting. Let's finish the story.
Written by Kelli Conlin for the Albany Times Union 6/16/2009
Kelli Conlin is president of NARAL Pro-Choice New York.
Subscribe to:
Posts (Atom)