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FDA Delays Approving 365-Day-A-Year Pill

June 30, 2006

WASHINGTON — Health officials have delayed approving a new birth-control pill that can stop many women from menstruating when taken without interruption throughout the year, its manufacturer said Wednesday.

Wyeth had hoped the Food and Drug Administration would approve Lybrel on Tuesday, following a previous extension of the review period for the pill.

Instead, the FDA delayed action, saying it wanted more data on how the company’s proposed manufacturing method for the pill affects its shelf life, Wyeth said. The agency also seeks more information on the pregnancy rates, bleeding patterns and dropout rates of participants in studies of the pill, according to the Madison, N.J.-based company.

The FDA plans a public meeting this year to discuss the pill, Wyeth said. That is an apparent reference to a meeting of one of the outside panels of experts the regulatory agency relies on for advice.

If ultimately approved, Lybrel would become the first birth-control pill meant to be taken by women 365 days a year, without breaks or sugar pills. In clinical trials, 70.8 percent of women were period-free by their seventh month on the pill, though some still experienced breakthrough bleeding or spotting, according to Wyeth. The trials suggested the pill was 98 percent effective in preventing pregnancies.

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10 factors linked to rise in obesity

June 28, 2006

What do pollution, birth-control pills and air conditioners have in common?

Your expanding waistline, some scientists suggest.

In a controversial new look at the causes of America’s obesity epidemic, 20 researchers from eight states report that 10 often-overlooked factors could contribute to our growing girth. But proving that — and doing something about it, if true — will be another matter.

Pollution? It can disrupt the body’s hormones and cause it to store more fat, they said.

Birth-control pills? Along with steroids, antidepressants and some other medications, they tend to promote weight gain.

Air conditioners? We burn more calories when we’re hot, the scientists said, and tend to eat less then, too.

Even doing good may have a downside: Smokers tend to weigh less than non-smokers. As smoking rates decline, the needle on the national scale creeps up.

Not getting enough sleep can also do dieters in: Sleep deprivation is associated with increased appetite.

The study, which appears in Monday’s International Journal of Obesity, immediately met with praise from some experts who have long argued obesity is probably due to many factors. But it was criticized by others, who said the paper downplays the roles that calorie consumption and exercise play.

“We are not saying for an instant that what you eat and how much energy you expend don’t matter. They are the primary determinants of how fat one is,'’ stressed David B. Allison, director of the University of Alabama at Birmingham’s Clinical Nutrition Research Center and one of the study’s authors. “What we are saying is there are many influences on how fat one becomes.'’

During the past two decades, obesity has become much more prevalent in the United States, with an estimated 30 percent of adults — more than 60 million people — now classified as obese, according to the Centers for Disease Control and Prevention.

Obesity is associated with an increased risk of a number of diseases, including type 2 diabetes, coronary heart disease and some cancers.

As obesity rates soar, attention has focused on the accessibility of snack foods and sodas and the reduced opportunities for physical activity in our society.

But the study authors question whether that is short-sighted, possibly resulting in “well-intentioned but ill-founded proposals for reducing obesity rates'’ at a time when all the causes aren’t clear.

Many of the factors they cite in their report, which is a review of more than 100 obesity studies, aren’t easy to control.

Children born to older mothers may be set up to be overweight. The same may be true if their grandmothers overate before giving birth, the researchers said.

Curvy, slightly overweight women tend to be more fertile than their string-bean skinny counterparts and reproduce more, the study also explains, meaning that future generations of children are more likely to inherit fat genes.

Reason No. 10? People are slightly more likely to choose mates of their own body style — thin with thin, rotund with rotund. Even though the effect is small, the scientists said, this could gradually skew society toward fatness.

“They left out global warming. I’m saying that in jest,'’ said a skeptical Dr. Thomas Robinson, director of the Center for Healthy Weight at Lucile Packard Children’s Hospital at Stanford.

While Robinson said some of the explanations, such as sleep deprivation and smoking cessation, are plausible causes of weight gain, others may have little if any influence. Further, they do little to inform the public on how to lose weight and keep it off.

“These are really far-fetched explanations for something that’s really simple: People are eating more and moving less,'’ agreed Marion Nestle, professor of nutrition at New York University and author of “What to Eat.'’

“I think this is a report that will get a lot of attention because no one wants to talk about calories. Everyone is looking for an excuse.'’

The study doesn’t attempt to address just how much each of the 10 factors influences obesity, Allison said. Nor does it focus on all the possible causes. Working the swing shift and not breast-feeding have been implicated in some studies. So has an increase in childhood depression, a decrease in dairy consumption and eating meat from livestock that were fed hormones.

“We do not claim that all of the additional explanations definitely are contributors,'’ the study authors wrote, but only that they are as plausible as diet and exercise “and deserve more attention and study.'’

J. Justin Wilson, a research analyst for the Center for Consumer Freedom in Washington, agreed. The center is a non-profit coalition of consumers, restaurants and the food industry.

“The media and activists have homed in on a few unfavored food groups — fast food, soda, high fructose corn syrup'’ he said. “They seem to ignore that obesity is far more complicated than that, and this study is an indication of that.'’

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Free Prescription Drug Plan Helps Cover Birth Control Costs When Insurance Won’t

June 26, 2006

Many American women are still faced with paying for the cost of prescription birth control out of their own pockets, because their insurance companies don’t cover the drugs. The new free prescription drug card available through www.YourRxCard.com helps these women by offering a discount on prescription birth control in the same method as their discounts on any other prescription drugs. The free card can also be used with insurance plans to help the patient receive the lowest prescription drug cost possible.

as of February 2006, [only 23 states require insurers that cover prescription drugs in general to provide coverage of the full range of FDA-approved contraceptive drugs and devices.
Cover My Pills, sponsored by Planned Parenthood’s Fair Access to Contraception (FAC) project, states that nearly 70% of American women in their childbearing years (”age 15-44 on average”), are sexually active and do not wish to become pregnant at the current time. The organization also shares that 95% of women in the US use some kind of contraception during their lifetime, and more than half of those women use prescription birth control.

Yet, even with the high demand by American women for prescription birth control, Cover My Pills reports that “as of February 2006, [only 23 states require insurers that cover prescription drugs in general to provide coverage of the full range of FDA-approved contraceptive drugs and devices.” While the number of insurance companies covering prescription birth control drugs has improved in recent years, this demonstrates the fact that coverage is still a problem for women in many areas. The free prescription drug card from www.YourRxCard.com aims to serve as a simple solution to this complex and debated problem

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Today Sponge returns as birth control method

June 20, 2006

After being approved for use in 1983, the Today Sponge became the largest-selling over-the-counter female contraceptive in the United States, only to be pulled from the market in 1995 because of problems at the manufacturing facility.

The move inspired a “Seinfeld� episode in which Elaine lamented the loss of her favorite birth control.

Now produced at a new facility by New Jersey-based startup company Allendale Pharmaceuticals, which bought manufacturing rights in 2000, the Sponge last year began returning to pharmacy shelves, including Walgreens and CVS stores, and will be stocked by Wal-Mart beginning next month, Allendale said.

Despite the Sponge’s demand, there’s no shortage of alternative contraceptives. Most popular among those for women is still the pill – which requires a prescription – and for men the condom, say health care workers. Pills are typically either progestin-based or contain both estrogen and progestin.

“The pill has always been and still remains the No. 1 choice for most women,� said Dr. Chik Amechi, the chief OB/GYN at St. Joseph Hospital and the head of Allen County OB/GYN Associates PC, 800 Broadway.

In addition to preventing pregnancy, the pills provide women with a tool to regulate periods, either by reducing them or eliminating them altogether.

When used correctly, the pill’s rate of effectiveness exceeds 99 percent. Other hormone methods the NuvaRing and Ortho Evra patch, which are gaining in popularity, are equally effective, Amechi said.

Still, potential users of such contraceptives are cautious.

“The idea of a vaginal ring still scares some women off,� said Molly Daley, clinic assistant at Planned Parenthood of Indiana’s Fort Wayne clinic in Parkwest Center on West Jefferson Boulevard. Like the pill and the patch – which women can wear discreetly and need to replace weekly – the ring uses hormones to reduce the chances of pregnancy.

That means there are potential side effects.

“(For) anybody on hormones, (it) is recommended that they be monitored� by a health care provider, said Judy Harris, an educator and trainer for Planned Parenthood. Side effects include headaches, chance of blood clotting, increased – and sometimes painful – breast tenderness, nausea and weight gain.

Harris said that neither she nor the agency advocates one birth control method over another, but that doesn’t mean all are equally effective. Planned Parenthood of America’s Web site lists abstinence as the only method that is 100 percent effective.

“When I talk about birth control, I always bring in abstinence as a form of birth control,� Harris said. But as with other measures, the effectiveness relies greatly on the person’s commitment, motivation and follow-through, she said. Among sexually active women not using any birth control method, 85 out of 100 women can expect to become pregnant within one year.

By comparison, contraceptive-effectiveness studies have found that of 100 women correctly using the Sponge, nine will become pregnant within one year. The rate is higher for women who have given birth.

While markedly better than no birth control at all, the Sponge – designed to block sperm from entering the cervix – is substantially less effective than most major types of birth control, studies show.

With perfect use, effectiveness rates vary from male condoms (about two in 100), female condoms (five in 100) to sterilization (less than one in 100), or even continuous breastfeeding, which postpones ovulation, (less than one in 100), according to a 2000 study publishing in the 18th Edition of “Contraceptive Technology� and posted on Planned Parenthood’s Web site.

But continuous breastfeeding – which can be effective for six months after a woman has given birth – like some other methods require more discipline and even circumstantial cooperation to work. Essentially postponing ovulation, it is contingent on a woman’s not having had a period since giving birth, regular breastfeeding – at least six times daily on each breast – and overall consistency of application.

More common methods, such as rhythm or fertility awareness, also known as natural family planning, also require a high level of discipline. Practicing couples must closely monitor the woman’s fertility and avoid sexual activity at certain times of the month accordingly. Such methods are accepted by the Roman Catholic Church and other religious groups that don’t approve of other types of birth control.

Proponents point out that such methods – which are up to 99 percent effective if undertaken consistently and correctly – not only fit into a larger moral framework but also have no physical side effects. But opponents counter that there is no safety net to prevent pregnancy when couples don’t follow the schedule or make monitoring errors, which can render the rhythm method pragmatically less effective than other major forms of birth control.

Typical use of fertility-awareness periodic abstinence, which is not always consistent or correct, results in a 25 percent pregnancy rate, according to the study published in “Contraceptive Technology� by lead author James Trussell.

“We’ve never considered that an effective method,� Amechi said. He said some couples he sees are disciplined and motivated enough to make it work but the majority can’t because most of the time sex is spontaneous.

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Japan to aid Karen birth control

June 14, 2006

The Japanese government will provide $59,270 (2.27 million baht) in assistance for family planning for more than 100,000 Karen refugees who have fled to the Thai-Myamar border, the Japanese embassy announced on Thursday.

The aid will be handed over next Monday to the Planned Parenthood Association of Thailand (PPAT), a non-govermental organisation.

An estimated 140,000 refugees from the ethnic Karen minority are living in temporary camps along the Thai border where they have sought safety from the Burma military who have been waging a campaign against both their guerilla forces and the civilian population to end the Karens’ five-decade-old struggle for the autonomy of the Karen State.

The latest offensive has reportedly razed more than 2,000 Karen villages, sending 15,000 new “displaced persons” to the border over the past three months.

The growing border population faces numerous health and social challenges, not the least of which is a rising population.

“While new refugees are still coming in, the increasing population in refugee camps on account of the high birth rate has become an issue,” said a Japan Embassy statement, explaining the need for its aid initiative.

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Pharmacist who refused to dispense birth control can’t sue employer

June 11, 2006

MADISON, Wis. — A federal judge has dismissed a Roman Catholic pharmacist’s claim that he was fired by Wal-Mart Stores Inc. for refusing to fill birth-control prescriptions and that the dismissal violated his religious freedom.

The June 1 ruling said Wal-Mart had accommodated Neil Noesen’s religious opposition to birth control by having other pharmacists fill prescriptions.

But U.S. District Judge John Shabaz said Noesen went too far by putting customers who called about birth control on hold indefinitely and by refusing to get service for those who showed up in person.

Noesen, 32, could not be located for comment for this story.

An attorney who represented Medical Staffing Network, the agency that placed Noesen at the Wal-Mart store, said the ruling was among the first in the country to deal with religious accommodations for pharmacists.

“It demonstrates there has to be a balance between accommodating someone’s religious beliefs while at the same time providing a service and allowing people access to medical care,” attorney Stephanie Adler said.

Wal-Mart spokesman John Simley said the company was pleased with the ruling.

“These cases are rare, but when they do happen, we are careful to make accommodations. We also have a responsibility to customers to ensure that their prescriptions are filled,” he said.

According to the judge’s ruling, Noesen refused to leave the Wal-Mart store and eventually was dragged out in a wheelchair by police. He was convicted last month of resisting arrest but was acquitted on a disorderly conduct charge stemming from that incident.

Noesen also was sanctioned by the state Pharmacy Examining Board for refusing to fill a contraceptive prescription or transfer it while working at another store in 2002. The board reprimanded him and forced him to attend ethics classes

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