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Kamis, 18 Desember 2008

Male circumcision lowers cervical cancer risk: study

WASHINGTON (Reuters) – Three studies published on Wednesday add to evidence that circumcision can protect men from the deadly AIDS virus and the sexually transmitted virus that causes cervical cancer.

The reports in the Journal of Infectious Diseases are likely to add to the debate over whether men -- and newborn boys -- should be circumcised to protect their health and perhaps the health of their future sexual partners.

Dr. Bertran Auvert of the University of Versailles in France and colleagues in South Africa tested more than 1,200 men visiting a clinic in South Africa,

They found under 15 percent of the circumcised men and 22 percent of the uncircumcised men were infected with the human papilloma virus, or HPV, which is the main cause of cervical cancer and genital warts.

"This finding explains why women with circumcised partners are at a lower risk of cervical cancer than other women," they wrote in their report.

A second paper looking at U.S. men had less clear-cut results, but Carrie Nielson of Oregon Health & Science University and colleagues said they found some indication that circumcision might protect men.

The circumcised men were about half as likely to have HPV as uncircumcised men, after adjustment for other differences between the two groups.

PREVENTING AIDS

In the third report, Lee Warner of the U.S. Centers for Disease Control and Prevention and colleagues tested African-American men in Baltimore and found 10 percent of those at high risk of infection with HIV who were circumcised had the virus, compared to 22 percent of those who were not.

"Circumcision was associated with substantially reduced HIV risk in patients with known HIV exposure, suggesting that results of other studies demonstrating reduced HIV risk for circumcision among heterosexual men likely can be generalized to the U.S. context," they wrote.

Studies supporting circumcision to reduce HIV transmission had all been done in Africa and U.S. studies were less clear.

Dr. Ronald Gray of Johns Hopkins University in Baltimore and colleagues said they found the reports encouraging.

"In the United States, circumcision is less common among African American and Hispanic men, who are also the subgroups most at risk of HIV," they wrote in a commentary.

"Thus, circumcision may afford an additional means of protection from HIV in these at-risk minorities."

But they noted that the American Academy of Pediatrics does not recommend routine circumcision for newborns.

"As a consequence of this AAP decision, Medicaid does not cover circumcision costs, and this is particularly disadvantageous for poorer African American and Hispanic boys who, as adults, may face high HIV exposure risk," Gray and colleagues wrote.

"It is also noteworthy that circumcision rates have been declining in the U.S., possibly because of lack of Medicaid coverage."

Medicaid is the state-federal health insurance program for the poor and disabled.

Thirty-three million people globally are infected with AIDS, which has no cure and no vaccine. HPV is the most common sexually transmitted infection in the world, with 20 million people in the United States infected. It causes cervical cancer, which kills 300,000 women globally every year.

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Effectiveness of peer-led sex education questioned

NEW YORK (Reuters Health) – Among 13 to 14 year-old girls who received either peer-led or teacher-led sex education, abortion rates by the age of 20 were the same -- 5 percent -- regardless of the education method, a study shows.

This may "temper high expectations" regarding the long-term impact of peer-led sex education, Judith Stephenson, of University College London, and colleagues comment in PLoS Medicine, a journal from the Public Library of Science.

However, there were some indications that the peer-led program reduced unwanted pregnancies, and Stephenson's group suggests further investigation of pupil-led sex education programs as part of a broader strategy to minimize teenage pregnancies.

"Peer-led sex education is widely believed to be an effective approach to reducing unsafe sex among young people, but reliable evidence from long-term studies is lacking," Stephenson and colleagues note.

The Randomized Intervention trial of Pupil-led sex Education, known as the RIPPLE trial, compared the efficacy of peer-led versus teacher-led sex education delivered to over 9000 male and female 8th grade students in the United Kingdom.

Peer-led sessions, conducted by specially trained older students, focused on information similar to that offered in the teacher-led program.

Follow-up through the age of 20.5 years showed 7.5 percent of girls taught in peer-led session had unintentional pregnancies compared with 10.6 percent of those taught in teacher-led sessions. This difference wasn't significant from a statistical standpoint, but the reduction in unintended pregnancies before age 18 was significant -- 7.2 percent versus 11.2 percent.

As noted, however, the investigators found no difference in the number of girls having abortions, and there were no differences in teens' reports of unprotected first sex, pressured sex, sexually transmitted diseases, contraception practices or use, or in the percentage of boys or girls reporting sex before age 18.

In a related commentary, Dr. David A. Ross, from the London School of Hygiene and Tropical Medicine, points out that the use of actual, rather than self-reported abortion and pregnancy data is the major strength of the Ripple trial.

However, "it does not tell us how effective either intervention was relative to no sexual health education," Ross told Reuters Health. Therefore, development and rigorous evaluation of approaches to reduce teens' adoption of risky sexual behaviors should continue, he said.

SOURCE: PLoS Medicine, November 2008.

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Safe Sex

It's been exactly 15 years since the FDA first approved "female condoms," but it still hasn't found its niche, except perhaps in the sex trade. In fact, while engineers at Apple have already released the next iteration of the 18-month-old iPhone, there hasn't even been a second-generation product of the lady-centric contraceptive.

But the Chicago-based Female Health Company is hoping to change that. Its redesigned product, which contains a softer type of rubber called nitrile as well as adhesive foam, is being reviewed by the FDA and, if approved, could be available for sale in the U.S. sometime next year. As a "Class 3 Medical Device," female condoms are held to the same rigorous FDA standards as pacemakers, heart valves and silicone breast implants, with clinical trials costing as much as $6 million. Male condoms, which are Class 2 devices, are much cheaper to produce and need only pass breakage tests. (See the 50 best inventions of 2008.)

Complaints about female condoms are not so different from those about the male version: slippery, noisy, awkward, uncomfortable. "The yuck factor was a problem," Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, told the New York Times last year when explaining the device's failure to catch on. Then there's the stigma associated with buying condoms, a topic even the Golden Girls once addressed.

Of course, the history of protected sex, in the broadest sense, used to be a whole lot yuckier. Take the practice of women in ancient Egypt, who resorted to using crocodile dung as a spermicide. Modern research has shown that crocodile dung actually created optimum conditions for sperm because of its alkalinity, but the sheer grossness of the practice might have worked if only to completely ruin the mood. (See pictures of animal attraction.)

In the 1540s, an Italian doctor named Gabriele Fallopius - the same man who discovered and subsequently named the fallopian tubes of the female anatomy - wrote about syphilis, advocating the use of layered linen during intercourse for more "adventurous" (read: promiscuous) men. Legendary lover Casanova wrote about his pitfalls with medieval condoms made of dried sheep gut, referring to them as "dead skins" in his memoir. Even so, condoms made of animal intestine - known as "French letters" in England and la capote anglaise (English riding coats) in France - remained popular for centuries, though always expensive and never easy to obtain, meaning the device was often re-used.

In 1844, Charles Goodyear patented the process of vulcanizing rubber, inadvertently ushering in an entirely new era in contraception - condoms as thick as bicycle tires and still considered re-usable. But getting one's hands on this new-fangled "technology" became a whole lot harder in 1873, when Congress passed the Comstock Law, prohibiting the transportation of obscene material like prophylactics and pornography. (See pictures of pin-up queen, Bettie Page.)

The 1930s saw the invention of latex as well as the invention of the first-ever female condom in the U.S., the "Gee Bee Ring." In 1965, the Supreme Court ruled that married couples had the constitutionally protected right to contraception; in 1972 that same right was extended to unmarried couples. (Ireland prohibited condom sales until 1978, the Catholic Church still condemns them).

Condom use waned in the 1960s after the introduction of the birth control pill and remained stagnant until the arrival of the AIDS virus in the 1980s, when sales exploded, jumping 33% in the U.S. in 1987. Today, some 6 billion condoms are sold worldwide each year, though sales have plateaued in the past decade - policy experts blame "prevention fatigue" while condom-makers (the ones targeting men anyways) have responded by becoming increasingly creative, or perhaps ridiculous. What began as a simple choice between lubricated, ribbed or custom-fit now includes flavored, novelty (Star Wars prophylactic anyone?) and glow-in-the-dark. One can even purchase condom accessories like the $28 Condo-M, a plastic and aluminum bedside container. (Think Pez dispenser for grown-ups). Even the presidential campaign spawned Barack Obama and John McCain-themed condoms with corresponding slogans ("Who says experience is necessary?" for the former, "Old, but not expired" for the latter). (Read about permanent birth control.)

The origin of the word "condom" is unknown, though the story of a certain Dr. Condom in 19th century England remains one of the more persistent myths. The term at least trumps "intravaginal pouch," a phrase suggested in lieu of "female condom" by an FDA panel tasked in the early 1990s with reviewing an early prototype of the women's contraceptive.

See the Year in Health, from A to Z.

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Health Tip: Having Sex Despite Illness

(HealthDay News) -- People who have a chronic illness -- which may include heart disease, diabetes or asthma -- may have ongoing pain or fatigue that can hinder a healthy sex life.

The American Academy of Family Physicians offers suggestions for how to enjoy sex, despite having a chronic illness:

* Figure out what time of day you feel healthiest and most energized, and plan sex around those times.
* Try to get plenty of rest, and make yourself feel as relaxed as possible.
* Don't have sex within two hours of eating.
* If you take pain medicine, take it at least 30 minutes before having sex.
* Drink only limited amounts of alcohol, and don't use tobacco. Both can affect sexual performance.

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FDA panel set to weigh new female condom

WASHINGTON (Reuters) – A new, potentially less expensive version of the female condom faces U.S. regulatory review this week when a Food and Drug Administration advisory panel weighs whether they adequately prevent pregnancy, HIV and other sexually transmitted diseases.

The FC2 Female Condom, made by Female Health Co, is made with a synthetic rubber using a process similar to male condoms that the company says is less labor intensive and should reduce its current cost.

Male condoms, which come in a variety of brands and cost consumers between 50 cents and $2 a piece, are far more widely used than their female counterpart, which costs between $2.80 and $4.

Chicago-based Female Health is seeking FDA approval to market the new version. On Thursday, the agency will seek a recommendation from its panel of outside experts before later making its final decision.

"The whole idea is to increase access," said Mary Ann Leeper, an adviser and former president of the company.

But FDA regulatory staff questioned whether the company should have conducted specific trials to show how well the FC2 prevents women from contracting diseases or becoming pregnant.

Female Health said it did not conduct such studies because FC2 uses a new material but is otherwise similar to the version already on the U.S. market, the FDA staff said in documents released on Tuesday ahead of the panel meeting.

The company "asserts that such studies are not necessary. This is an important review issue," the staff wrote.

The company said it also looked at durability of the new material, a synthetic rubber called nitrile. The original condom uses polyurethane.

Both versions are comprised of a sheath with a closed ring on one end that is inserted near the cervix and an open ring on the outer end that stays outside the woman's body.

Conducting another trial would have taken five more years and cost millions of dollars, Female Health's Leeper said.

"The design is exactly the same, how you use it is exactly the same ... we just don't believe there is any more information required," she said.

FDA approval could help boost sales in the United States, which make up just 10 percent of the female condom's 34.7 million unit sales in 2008, according to Female Health Co.

"We haven't been able to market the product," Leeper said. But Female Health is seeking to partner with another company, perhaps a male condom manufacturer or a drugmaker invested in human immunodeficiency virus (HIV) awareness, she said.

Most of its U.S. sales are to aid agencies, including the U.S. Agency for International Development, which Leeper said needs FDA to approve FC2 before it can distribute it abroad.

The bulk of the condom's use is in other countries, particularly in Africa where public health agencies provide it to help prevent the spread of the HIV virus.

The female version gives women their own option for protection and allows them to insert a condom before intercourse. Most other countries have already adopted the newer version, the company has said.

It also offers other advantages over the male condom, according to the company, including greater protection by covering part of a woman's outer genitals.

Shares of Female Health Co. were up nearly 5 percent, or 13 cents, at $2.98 on the American Stock Exchange.

(Editing by Gerald E. McCormick, Derek Caney and Bernard Orr)

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New rule for health providers stirs objections

WASHINGTON – The Bush administration, in its final days, issued a federal rule Thursday reinforcing protections for doctors and other health care workers who refuse to participate in abortions and other procedures because of religious or moral objections.

Critics say the protections are so broad they limit a patient's right to get care and accurate information. For example, they fear the rule could make it possible for a pharmacy clerk to refuse to sell birth control pills without ramifications from an employer.

Under long-standing federal law, institutions may not discriminate against individuals who refuse to perform abortions or provide a referral for one. The administration's rule is intended to ensure that federal funds don't flow to providers who violate those laws, Health and Human Services officials said.

"Doctors and other health care providers should not be forced to choose between good professional standing and violating their conscience," said HHS Secretary Mike Leavitt.

The rule requires recipients of federal funding to certify their compliance with laws protecting conscience rights.

Despite multiple laws on the books protecting health providers, the administration argued that the rule was needed "to raise awareness of federal conscience protections and provide for their enforcement."

But many groups described the rule as a last-minute push designed to make it harder for women to get services such as contraception or counseling in the event they are pregnant and want to learn all of their options.

Several medical associations, more than 100 members of Congress, governors and 13 attorneys general were among the many thousands who wrote the department to protest the rule after it was proposed. Opponents didn't like the rule any better after it was finalized.

"In just a matter of months, the Bush administration has undone three decades of federal protections for both medical professionals and their patients," said Nancy Northup, president of the Center for Reproductive Rights. "It replaced them with a policy that seriously risks the health of millions of women, then tried to pass it off as benevolent."

Abortion opponents hailed the regulation because they said the lack of regulation had resulted in confusion and a lack of awareness.

"This is a huge victory for religious freedom and the First Amendment," said Tony Perkins, president of the Family Research Council.

The administration estimated the cost of complying with the rule at $43.6 million annually, which is spread throughout the hundreds of thousands of health providers subject to the rule — from hospitals and physician offices to medical schools and pharmacies.

Several lawmakers have promised to take up legislation that would overturn the rule once Congress reconvenes in January. Another option is for the Obama administration to issue new regulations that would trump it. The rule will take effect on Jan. 18, two days before Obama takes office.

Obama's transition team did not specifically address the rule Thursday, but spokesman Nick Shapiro issued a statement that said Obama "will review all eleventh-hour regulations and will address them once he is president."

While campaigning in August, Obama criticized the proposal: "This proposed regulation complicates, rather than clarifies the law. It raises troubling issues about access to basic health care for women, particularly access to contraceptives," he said.

The 127-page rule disputed concerns that the protections being proposed were too broad and would affect too many workers in the health care industry, not just doctors or nurses involved with an abortion or sterilization.

"These laws are intended to protect the conscience rights of all individuals participating in health care services, and research programs and activities receiving certain federal funds, or that are administered by the department," the rule said.

Opponents consistently described the rule as a last-minute effort that would reduce access to health care services, particularly access to birth control.

"Making birth control more — not less — accessible is the best way to prevent unintended pregnancies and reduce abortion," said Rep. Nita Lowey, D-N.Y.

Others said the rule would go so far as to protect providers who refuse to give rape victims emergency contraceptives.

The Planned Parenthood Federation of America said about 200,000 people submitted comments opposing the rule, including about 90,000 comments from its supporters.

"This midnight regulation, issued in the last days of the Bush administration, undermines this country's fragile health care system as well as patients' access to health care information and services," said the group's president, Cecile Richards.

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On the Net:

Health and Human Services Department: http://www.hhs.gov

Planned Parenthood: http://www.plannedparenthood.org

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