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TUESDAY, May 22 (HealthDay News) -- Lybrel, a birth-control pill that does away with a woman's monthly period, was approved Tuesday by the U.S. Food and Drug Administration.

The estrogen-progestin hormonal pill differs from traditional birth-control pills in that it does not include the "week off" of placebo pills that leads to a cessation of artificial hormones and bleeding.

Lybrel is described as "continual contraception" but it "works the same way as the 21-days on, seven-days off [pill] cycle -- it stops the body's monthly preparation for pregnancy by lowering the production of hormones that make pregnancy possible," Dr. Daniel Shames, deputy director of the FDA's Office of Drug Evaluation III, at the Center for Drug Evaluation and Research, explained at a press conference late Tuesday.

A majority of women who decide to take Lybrel will encounter unscheduled bleeding, or spotting, that in most cases tapers off over the first year of use, Shames said. In the primary clinical trial leading up to approval, 59 percent of women who took Lybrel for one year reported no bleeding or spotting during the last month of the trial.

In terms of safety, two one-year clinical trials involving more than 2,400 18-to-49-year-old women showed no increased risk of endometrial cancer among those taking Lybrel. The risks of other side effects linked to the birth-control pill -- primarily blood clots -- were similar to those seen in other contraception regimens, Shames said.

"We don't expect any surprises in terms of long-term use of this product," he added, although he noted that the FDA has requested that the drug's maker, Wyeth Pharmaceuticals, conduct post-marketing studies to keep tabs on Lybrel's long-term safety.

Despite some women's reticence to do away completely with their monthly period, gynecologic experts agreed that there was no physiological "downside" to a period-free life. In fact, one expert noted that, for decades, many American women have been pharmaceutically ending their periods with more traditional birth-control pills with no resulting problems.

"There were other products, such as the long-acting progestin, Depo-Provera, that was given by injection," said Dr. Michael Petriella, vice chairman of obstetrics and gynecology at Hackensack University Medical Center, in Hackensack, N.J. "Women who were using that for contraception wouldn't get their period at all while on that product."

And for years, "some physicians have been allowing some women to take the Pill off-label -- allowing them to take two packages continuously, for example," Petriella said.

Another expert noted that the "period" women get while on conventional birth-control pills isn't connected to a natural cycle of egg production, anyway.

"It's not a natural period. It's an artificially induced period that happens because she stops taking the hormones for seven days. So, she gets some vaginal bleeding," explained Dr. Camelia Davtyan, an internist specializing in women's health and an associate professor of medicine at the University of California, Los Angeles.

In fact, a no-period pill like Lybrel could have been a contraceptive norm for women from the get-go, Davtyan said. However, the doctors and pharmaceutical companies who developed the birth-control pill back in the 1960s assumed that women would want a regimen that mimicked the monthly cycle.

"I guess they were trying to make it seem as 'real' as possible and cause as little change as possible in a woman's life," Davtyan said.

But times have changed, and newer contraceptive products such as Seasonale -- a contraceptive pill that cuts the number of periods to just four a year -- have already been readily embraced by some American women over the past decade.

Davtyan said she has recently noticed a big shift in her patients' attitudes toward their period.

"They want convenience, and they tell me that they'd just rather not have the bleeding altogether so that they don't have any limitations with sports, with having to use pads, tampons," she said. "And the younger the woman, the more likely that she will want her periods stopped. It's very possible that this will be the wave of the future."

But Petriella said many women still feel a strong psychological attachment to their period and do not want to give it up, however inconvenient it may be.

"Sometimes [ending periods] is just emotionally uncomfortable for women," he said. "They don't feel right about not having their period. For those women, obviously Lybrel and other such products are not good products for them."

Petriella believes that, at least in the short-term, Lybrel will appeal to only a minority of women. They include those with menstruation-linked conditions such as endometriosis and menstrual migraine, or those who have already tried -- and liked -- period-limiting products such as Seasonale, he said.

As with any pharmaceutical contraceptives, women who decide to go on Lybrel may experience random breakthrough bleeding, Davtyan said.

So, for the 59 percent of women who have no bleeding or spotting after one year, "I think Lybrel is a great deal," Davtyan said. "For the remainder, if they have the patience to hang in there for a few months, the spotting might abate. There will be an occasional patient that will continue to spot, and then, clearly, it's a better deal to have a scheduled period than to start spotting at an unknown time and maybe in an uncomfortable circumstance."

Women who decide to resume their monthly cycle -- for example, those who wish to become pregnant -- can typically expect to resume their normal cycle within days of stopping Lybrel, Shames said. He said that short timespan to resumption of ovulation could leave women who skip or miss pills open to unplanned pregnancy, so the FDA is advising that women consider a second form of birth control while on Lybrel, as a safeguard.

Both Davtyan and Petriella stressed that young women who are considering a pharmaceutical end to their period should not be concerned that doing so will harm their health.

"Remember, there's no real physiological value to hold on to the period that a woman has while she is taking the Pill, unless it is a psychological value, which I respect," Davtyan said.

More information

There's more on various forms of birth control at the U.S. Food and Drug Administration.

TUESDAY, May 22 (HealthDay News) -- Worried about jet lag? Researchers think they might have just the ticket to perk you up: Viagra.

While it's too early to know if it will work in humans, Argentinean researchers are reporting that the drug sildenafil -- better known by the brand name Viagra -- appears to reduce symptoms of jet lag in hamsters.

Viagra does come with potential side effects, and some men might not appreciate experiencing a temporary respite from erectile dysfunction at 30,000 feet. Still, a sleep specialist called the research promising.

"We do need more effective therapies for jet lag and for sleep difficulties that occur as a consequence of shift work," said Dr. Robert Vorona, an associate professor at Eastern Virginia Medical School who's familiar with the study findings.

In the study, researchers administered small doses of sildenafil to hamsters before adjusting the cycles of light and dark they lived in. This reset their body clocks as if they'd taken a six-hour plane trip to the east.

The hamsters recovered 25 percent to 50 percent more quickly from the equivalent of human jet lag, needing less time to synchronize themselves to the new schedule, said Dr. Diego Golombek, a researcher with the Universidad Nacional de Quilmes in Buenos Aires. He said sildenafil worked at least as well as melatonin, a jet-lag treatment.

But the drug didn't help hamsters who underwent a simulation of westward jet travel.

The findings were published in this week's Proceedings of the National Academy of Sciences.

The drug, originally developed to treat high blood pressure and angina, might alleviate jet lag by interfering with a molecule that sends signals to the hamster brain's body clock mechanism, Golombek said.

But the potential impact on humans isn't clear, and Golombek said people shouldn't rush out to prevent jet lag with doses of Viagra. For one thing, Viagra can cause side effects such as low blood pressure.

As for the next step, Golombek said "a full-scale clinical trial has to be performed in humans, which is indeed quite expensive and time-consuming. Jet-lag trials might involve laboratory simulations, but we also need 'the real thing,' which means testing pharmacological treatments on long-haul air travel."

And that, he added, will take even more time.

More information

For more information on jet lag, visit the National Sleep Foundation  .

MONDAY, May 14 (HealthDay News) -- HIV uses a particularly clever mechanism to infect immune system cells, a new study finds, while a second study reveals that certain gene combinations may help slow the progression to AIDS.

Both findings point to intriguing new ways of thwarting HIV, experts say.

"Our immune systems are very effective at fighting HIV -- they are just not quite effective enough," explained Rowena Johnston, vice president of research at the Foundation for AIDS Research (amfAR) in New York City.

She believes the new insights could someday lead to interventions that boost human immune responses to the virus that causes AIDS.

In one study, published May 13 in Nature Immunology, a British team focused on a key point of contact between HIV and immune system agents called dendritic cells. These cells are found in abundance in the mucosal linings of the mouth, genitalia or rectum.

"We are interested in dendritic cells in HIV infection because when you become HIV-positive through sexual activity, they are probably the first cells that HIV encounters," said Johnston, who was not involved in the study. "So, dendritic cells are critical in determining the next step" of whether HIV infection takes hold or not, she said.

In their research, the British scientists found that HIV latches onto a particular surface receptor protein, called DC-SIGN, as it binds with the dendritic cell. That link-up triggers a biochemical signaling cascade that virtually ensures the virus' continued success, the team found.

"[We] found several idiosyncratic aspects of this signal that could favor HIV-1 replication," explained lead researcher Alison Simmons, a clinician scientist at the Weatherall Institute of Molecular Medicine in Oxford. "These include repression of factors that facilitate normal immune responses and activation of factors allowing more effective viral transmission to bystander immune cells."

As HIV grabs onto dendritic cells, it also travels to its ultimate goal, the immune T-cell. The widespread destruction of these T-cells causes the terrible immune deficiency of AIDS.

By binding with dendritic cells via DC-SIGN, HIV evades immune detection early in infection and begins its deadly spread, Simmons said. "It likely is the way in which HIV-1 gains an initial foothold in the body," she said.

The discovery opens up new opportunities for AIDS research, because the inhibition of this DC-SIGN-HIV connection "really is a prime candidate for a drug therapy target," Johnston said. Simmons added that the finding also adds impetus to developing preventive HIV vaccines aimed at the mucosal lining.

A second study goes a long way to explain the variance in disease progression among people infected by HIV. That work, published May 13 in Nature Genetics, focused on two-gene combos that influence the workings of the human immune system as it meets up with the virus.

Comparing the genes of more than 1,500 HIV-positive individuals, a team led by Mary Carrington, principal investigator at the U.S. National Cancer Institute and SAIC in Frederick, Md., found that particular combinations of two genes -- KIR3DL1 and HLA-B -- confer some protection against AIDS progression.

"The variation in those two genes can explain why some people are doing better than others," Carrington said. "There are many combinations of these two genes, and depending on the combination that you have, it's either greater or lesser protection."

KIR3DL1 genes are active on natural killer (NK) cells, which swing into action as part of the "innate" immune system -- the body's less-specific but more immediate line of defense against invading pathogens.

If you get a scratch, for example, "you'll see the area immediately get red and feel warm to the touch -- that's the innate immune system," Johnston explained. Unlike the more targeted "adaptive" immune system, which vaccines take advantage of, this innate system "doesn't need any training," she said. "It recognizes that HIV is a 'foreign thing' and that it should be fought."

The innate system is a rather blunt instrument, though, so it typically doesn't spot and kill all the HIV. "It's a first step," Johnston said. Later on, more efficient "adaptive" immune system cells, such as T-cells, can mop up HIV -- unless, as happens in AIDS, the virus takes them over first.

In the new study, Carrington's team discovered that certain gene combinations confer a more robust "innate" NK cell response, and that response may also help boost the efficiency of adaptive immune system T-cells.

NK cells "are going to start killing HIV-infected cells before cytotoxic T-cells come around," Simmons said. "They appear earlier in the process, and that's why we think that people who have the good [gene] combinations have a jump-start -- they are controlling the virus before you generate the adaptive immune response."

While the discovery has no immediate therapeutic applications, "one thing that we can think about is, can we somehow treat the individual in some way to stimulate NK cell activity early after infection?" Carrington said. In such a situation, "timing is everything," she said.

Johnston said she was also impressed by the connection Carrington's team found between the innate and adaptive immune systems, mediated, in part, by these two genes. "That point of contact may vastly influence your course of HIV," she said.

More information

For more on the fight against HIV/AIDS, visit amfAR  .

THURSDAY, March 29 (HealthDay News) -- As 24 states consider laws that would require girls entering sixth grade to be vaccinated against the cervical cancer-causing human papillomavirus (HPV), the morality behind the move has taken center stage.

However, public health experts note that a medical debate is going on about whether mandating a vaccine for a disease that is not highly contagious is smart or cost-effective.

Some experts support mandating vaccination for all girls, while others support voluntary use of the vaccine. Conservative groups and some parents have also voiced the concern that immunizing girls against HPV -- which is transmitted sexually -- might lead to more premarital sex. Other experts worry that mandating the vaccine, called Gardasil, will open the floodgates to the compulsory use of other shots as they are developed.

Countries elsewhere are also considering widespread use of the vaccine. On Wednesday, Italy became the first European nation to offer the HPV vaccine free to its citizens. Health officials there said they will launch a campaign to encourage the immunization of 12-year-old girls, but the shot will not be mandatory.

Routine, voluntary use of the vaccine in young girls does have the support of most major U.S. medical groups. In fact, on Thursday, the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practice formally recommended use of the Gardasil vaccine for girls aged 11 and 12, and for females aged 13 to 26 who have not yet been immunized.

Members of the American Academy of Pediatrics' (AAP) Committee on Infectious Diseases have described the vaccine as safe and effective in preventing cervical cancer, but they also stopped short of recommending mandatory vaccination.

"The vaccine is an important vaccine, and it has the ability to decrease cancer," said Dr. Robert Frenck, a professor of pediatrics at Cincinnati Children's Hospital and a member of the AAP committee.

"My concern is that HPV is a different kind of transmission than diseases we normally look at for mandating vaccines," Frenck said. "Diseases such as measles or chickenpox are transmitted by casual contact. With HPV, it's not a casual contact."

In addition, Frenck believes there will be significant economic consequences for states if the HPV vaccine is mandated. Pending bills that mandate the vaccine have provisions for the state to pay for immunization, he noted. That could turn out to be very expensive.

"Right now, the three-dose series is approximately $120 a dose -- that's $360 for the full series," he said. Without extra funds, the cost of the vaccine would strain already overburdened public health systems, he said.

Another expert is also against mandating the vaccine, but this time for medical reasons.

"The vaccine is too new to be thinking about mandates," said Dr. Jon Abramson, a professor of infectious diseases at Wake Forest University Medical School and chairman of the CDC's immunization practices committee.

His committee doesn't consider recommending mandating a vaccine until it has been available for a long period of time, so that they can properly judge the demand, Abramson said. "We never discussed mandates, because it was way too early," he noted.

Because HPV is sexually transmitted, it also doesn't present the same risk as diseases that are transmitted by more casual contact, he added. "Most of the things we have mandates for are things that are high-risk in a school setting," Abramson said. "If someone walks into a school with measles, it's going to rapidly spread to those who aren't protected. Hopefully, you are at lower risk for HPV in school."

Money is also an issue. "I am very opposed to kids being kicked out of school, because parents can't afford the vaccine, and states can't pay for it," he said.

Finally, most state-proposed mandates include an easy way for parents to waive the HPV vaccine requirement. That worries Abramson, because it might make it easier for parents to opt out of other mandated vaccines, as well. "That will harm our other vaccines," he said.

Mandates aside, Abramson said he does support young girls being voluntarily vaccinated against cervical cancer. "My two daughters have already gotten their first dose," he said.

Because the vaccine is only effective before someone is exposed to HPV, girls should start being vaccinated when they are 11 or 12, Abramson said. "The reason for that is that there was data presented to us [on the CDC advisory committee] that showed that by the time kids enter ninth grade, 25 percent of males and females are sexually active," he said.

Despite some public opposition to mandates, many medical professionals feel strongly that the vaccine should be mandated, because it can prevent up to 70 percent of cervical cancers.

"HPV is responsible for a significant amount of morbidity and mortality related to venereal warts and to the development of pre-invasive and invasive cancer of the cervix," said Dr. Ralph Anderson, chairman of obstetrics and gynecology at the University of North Texas Health Center.

There are about 10,000 new cases of cervical cancer diagnosed in the United States each year, and about 4,000 women die of cervical cancer each year, Anderson noted.

"If the vaccine was given universally, it would eliminate about 90 percent of the venereal warts, and it would eliminate about 70 percent of the cases of cancer of the cervix," Anderson said. "About 30 percent of the types of cervical cancers are caused by one of the types of HPV not represented in the vaccine."

To those who think that money is an issue in mandating the vaccine, Anderson said they need to prove that it costs more to vaccinate girls than to treat them for cervical cancer later in life.

"It costs $300 to get the vaccine. If you get cancer of the cervix, it will probably cost $100,000 to treat it, and then a lot of those people die," he said. "Show me that it's more expensive to give the vaccine than not give the vaccine. The cost concern is a smokescreen."

Anderson believes Gardasil will go a long way to stemming the current "epidemic" of HPV infection. "In their lifetime, 75 percent of U.S. women will be exposed to the HPV virus. At any one time, about 25 percent have been infected with the virus," he said. "If that's not epidemic proportions, I don't know what is."

Not all the objections to mandating the vaccine are medical. Others have voiced political and moral objections.

"It's an end run around parental rights," said Wendy Wright, president of Concerned Women for America, a conservative lobbying group. "Parents know what's best for their daughters. Even with an opt-out option, it puts the parents in a position where they have to justify themselves to government officials," she said.

Wright also objects to the vaccine, because it has not been proved to be safe for the general population. "It could be putting people at risk with the assumption that since the government approved it, and it's being mandated by the states, it must be safe," she said. "But they really can't say that for certain."

She also questioned the need for Gardasil in the first place. According to Wright, the threat of cervical cancer has diminished significantly with the use of regular Pap smears and more effective treatment.

HPV is sexually transmitted, so Wright believes there's a clear way to avoid it: Practice abstinence. "The best prevention is being sexually responsible," she said. "That means being abstinent outside of marriage and faithful inside of marriage."

In addition, women should continue to get regular Pap tests as recommended, she said. "The vaccine should be a third option," Wright said.

Strong negative reaction from some segments of the public to state mandates caused pharmaceutical giant Merck, which makes the vaccine, to pull back on lobbying efforts advocating mandated vaccination. Repeated calls to Merck for comment were not returned.

Wright is also concerned that mandating the vaccine will lead to mandates for other vaccines. "That's what happened with the hepatitis B vaccine," she said. "It kind of slipped through in the early 1990s. The public health community rammed that through."

Abramson agreed that vaccines for other cancers should not be mandated. Mandated vaccines should be limited to those diseases that are highly contagious and spread by casual contact, he said. "Right now, I am not willing to cross that line," he said.

More information

For more information on cervical cancer, visit the American Cancer Society  .