FDA relents from midodrine withdrawal plan

NEW YORK – Federal regulators have backed off a plan to remove a Shire PLC low blood-pressure treatment from the market after warning in August that the drug has not been proven effective.
Food and Drug Administration representative Sandy Walsh said in an emailed statement that the agency will continue to allow access to ProAmatine, also known as midodrine, "while the necessary data is collected and the legal issues get sorted out."
Roughly 100,000 U.S. patients received prescriptions for ProAmatine or generic versions last year, according to the FDA. The drug is approved to treat orthostatic hypotension, a type of low blood pressure that causes patients to become dizzy or faint when standing upright.
Last month, the FDA proposed withdrawing the drug from the market and giving Shire, which is based in Ireland, an opportunity to schedule a hearing to discuss the matter. It had approved ProAmatine in 1996 based on promising early results in treating low blood pressure. But a mandatory follow-up study to actually prove the long-term benefits of the drug was never conducted.
Shire acquired the drug when it bought Roberts Pharmaceuticals in 2000. Shire spokeswoman Jessica Mann said the drugmaker did conduct follow-up trials and submitted data in 2005 that it believes showed its effectiveness. The company plans to continue to work with the FDA.
Shire had said it was planning to withdraw the drug from the market by Sept. 30. But the company no longer intends to do so.
"It's our goal to do what we can to ensure that this treatment is still available to patients," Mann said.
The FDA's letter marked the first time it threatened to pull a drug off the market due to missing follow-up data, though it has long held that power. FDA spokeswoman Sandy Walsh said in an e-mail the issue "continues to evolve," and that it will know more in the coming weeks.
Copies of the letter also were sent to five generic drugmakers who make the drug, including Mylan Inc. and Novartis AG unit Sandoz Inc. The generic versions would also be subject to a market withdrawal, unless their manufacturers complete the study requested by the FDA.

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WHO wants faster, more flu vaccine production

HONG KONG – The vaccine used to contain the recent swine flu pandemic was effective, but health authorities will need to ramp up the speed and volume of production during the next global outbreak, a World Health Organization official said Monday.
The WHO declared last month that the swine flu pandemic that started in June 2009 was over, after it killed about 18,600 people worldwide, far less than the worse-case scenarios in which authorities said millions could die.
The widespread use of vaccines was critical in limiting the number of casualties, with studies showing they offered protection in up to 95 percent of cases, WHO official David Wood said at a news conference on the sidelines of an influenza conference in Hong Kong.
Some 350 million doses of the vaccine were administered worldwide, according to WHO figures.
"That gives us considerable hope for the future, for the future pandemics, that the technologies that we have to actually make the vaccines are" effective, said Wood, the quality and safety team co-ordinator for the WHO's immunization and vaccines department.
But while vaccines became available six months after the H1N1 virus strain behind the pandemic was identified in April 2009, that was still too late for some countries, he said. In the case of the U.S., vaccination started on Oct. 5, 2009 — weeks after a second wave of cases hit as schools resumed, U.S. Centers for Disease Control and Prevention flu expert Nancy Cox told reporters.
The WHO is studying ways to make vaccines more quickly, Wood said without offering specifics, adding that technological breakthroughs will also speed up the process.
"In the short term, we'll be able to make some gains of weeks that Nancy was talking about that can make all the difference. In the longer term, we may even have these new technologies that shorten our lag more significantly, so I'm quite optimistic," Wood said.
The WHO official also said the global healthy body is working on increasing global production capacity beyond the centers of Europe, America and China, targeting countries like India, Indonesia, Thailand, Brazil and Mexico.
The WHO was accused by some of hyping the pandemic, prompting excessive buying of vaccines and antiviral drugs that enriched drug companies. Asked about such accusations, Wood said the organization only advised countries to vaccinate high-risk groups, like health care workers and pregnant women.
"I believe that the recommendations that came from the organization were proportionate to the risks that we had at the time," he said.

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Expert warns of complacency after swine flu fizzle

HONG KONG – A leading virus expert urged health authorities around the world Sunday to stay vigilant even though the recent swine flu pandemic was less deadly than expected, warning that bird flu could spark the next global outbreak.
A World Health Organization official also defended the U.N.'s health body against accusations that it wasted governments' money and enriched pharmaceutical companies with its strong warnings during the swine flu outbreak's early days last year.
WHO declared the swine flu pandemic over last month. The latest death toll is just over 18,600 — far below the millions that were once predicted. The head of the global health body has credited good preparation and luck, since the H1N1 swine flu virus didn't mutate as some had feared.
But speaking to reporters on the sidelines of an influenza conference in Hong Kong, researcher Robert Webster warned against complacency.
"We may think we can relax and influenza is no longer a problem. I want to assure you that that is not the case," said Webster, chairman of the virology and molecular biology department at St. Jude Children's Research Hospital in Memphis, Tennessee.
Webster predicted that the next pandemic could be sparked by a virus that spreads from water fowl to pigs and then onto humans — such as the H5N1 strain of bird flu, which has killed 300 people over the past seven years. He noted that after several years of decline, the number of bird flu cases in humans increased in 2009, lifted by an uptick of cases in Egypt.
"H5N1 can kill 61 percent of humans infected, but it doesn't know how to spread from human to human. But don't trust it because it could acquire that capacity. So we must stay vigilant," he said.
Sylvie Briand, head of WHO's global influenza program, said its surveillance has shown that the bird flu strain isn't capable now of jumping between humans except in rare cases of close personal contact, but echoing Webster, warned: "These are viruses that are evolving. They are changing all the time."
Both experts said it was difficult to predict when — or if — bird flu might set off a new pandemic.
"We don't understand enough about the virus to make predictions," Webster said.
University of Hong Kong microbiologist Malik Peiris said scientists are closely monitoring mutations by influenza viruses — including bird flu viruses — but it's hard to determine which mutations are most likely to spread among humans.
Briand also defended WHO against accusations that it hyped the swine flu pandemic, saying it was acting with limited information when the virus first surfaced and adjusted its response when it became clear the outbreak wasn't as serious as expected.
WHO received at least $170 million from member states to deal with the outbreak, some of which was invested in immunization programs long after the virus strain was known to provoke only mild illness in most of those infected. Governments spent many times that amount buying vaccines and antiviral medicines that are now being junked.
European legislators have repeatedly accused WHO of overstating the danger of swine flu and playing into the hands of the pharmaceutical industry, which has earned millions from the outbreak since it began in April 2009.
"We prepared for the worst and hoped for the best. And as the information became available, there was adaptation of the plan and adaptation of the recommendations in order to really tailor the response to the reality," Briand said. "But it took some time."

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Cholera kills 41 in Central African nation of Chad

N'DJAMENA, Chad – Health officials in Chad say an outbreak of cholera in the Central African nation has killed at least 41 people.
Mahamat Mamadou Adji said Friday that there have been nearly 600 confirmed cases of the fast-moving infection that causes diarrhea in victims, leading to severe dehydration.
The outbreak in Chad come as officials in the neighboring countries of Nigeria and Cameroon also have expressed concern about cholera deaths.
In Nigeria, health officials say more than 350 people have been killed in only three months.
Cholera is highly contagious yet easily preventable with clean water and sanitation. But Nigerian health officials say in many areas, wells remain uncovered, allowing tainted water to flow into the communities' drinking water supplies.

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Lack of Sleep May Be Linked to Childhood Obesity

MONDAY, Sept. 6 (HealthDay News) -- Infants and preschoolers who don't get enough sleep at night are at increased risk for later childhood obesity, a new study suggests.
The researchers also found that daytime naps are not an adequate substitute for lost nighttime sleep in terms of preventing obesity.
The study included 1,930 U.S. children, ages 1 month to 13 years, who were divided into two groups -- younger (ages 1 month to 59 months) and older (ages 5 to 13 years). Data on the children was collected at the start of the study (baseline) in 1997 and again in 2002 (follow-up).
At the follow-up, 33 percent of the younger children and 36 percent of the older children were overweight or obese. Among the younger children, lack of sufficient nighttime sleep at baseline was associated with increased risk for later overweight or obesity.
Among the older children, the amount of sleep at baseline was not associated with weight at follow-up. However, a lack of nighttime sleep at follow-up was associated with increased risk of a shift from normal weight to overweight and from overweight to obesity, the study found.
The findings "suggest that there is a critical window prior to age 5 years when nighttime sleep may be important for subsequent obesity status," wrote Janice F. Bell of the University of Washington in Seattle, and Frederick J. Zimmerman of the University of California, Los Angeles.
"Sleep duration is a modifiable risk factor with potentially important implications for obesity prevention and treatment," the authors concluded. "Insufficient nighttime sleep among infants and preschool-aged children appears to be a lasting risk factor for subsequent obesity, while contemporaneous sleep appears to be important to weight status in adolescents. Napping had no effects on the development of obesity and is not a substitute for sufficient nighttime sleep," they added.
The study is published in the September issue of the journal Archives of Pediatrics & Adolescent Medicine.
More information
The Nemours Foundation has more about children and sleep.

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Keep Health in Mind When Planning School Day Menus

MONDAY, Sept. 6 (HealthDay News) -- As parents prepare for their children's return to school, they need to remember that healthy meals and snacks are essential for learning.
"Parents can make the school day easier for their children by providing nutritious and yummy breakfasts, lunches and snacks that promote optimal learning. Everyone is in a rush in the morning, but it only takes a few minutes on Sunday to plan healthy meals to fuel your child's week," Karin Richards, director of the Exercise Science and Wellness Management program, and director of Health Sciences at the University of the Sciences in Philadelphia, said in a university news release.
Richards offered the following advice for parents as they plan breakfast, lunch and snacks for their school-age children:
Include at least three types of foods into each meal, making sure to include some type of protein and complex carbohydrates, such as whole wheat bagels or pasta. The complex carbohydrates will provide energy while the protein will satisfy your child's appetite for a longer period of time.
Bring your child to the market with you and let him or her choose one fruit or vegetable each week. Encourage kids to try new and interesting produce such as kiwi, papaya and edamame.
Monitor portion size. Three to four ounces of meat (about the size of your palm) is plenty. Adjust the amount based on your child's age and activity level.
Add more vegetables into your child's diet, even if you have to sneak them in. For example, try zucchini bread, veggies with low-fat dip, or shred carrots into tomato sauce and soups.
For beverages, suggest low-fat milk or water. If you child prefers juice, make sure it's 100 percent juice.
More information
The Nemours Foundation has more about children and healthy eating.

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New test seen as big advance in diagnosing TB

Scientists are reporting a major advance in diagnosing tuberculosis: A new test can reveal in less than two hours, with very high accuracy, whether someone has the disease and if it's resistant to the main drug for treating it.

The test could revolutionize TB care and replace the 125-year-old process used now, which is slow and misses more than half of all cases, experts say. A better test would be a powerful tool to curb TB in poor countries, where most people spread the lung disease before they are diagnosed and treated, and many don't return for follow-up doctor visits to get test results.

In the United States, it could be a big help in inner city clinics, where diagnosing a drug-resistant strain on someone's first visit enables proper treatment right away.

"You can tell the patient before they leave the office if they have TB and if it's drug-resistant. It's transformational," said Dr. Peter Small, head of TB programs at the Bill & Melinda Gates Foundation, which helped fund the work, along with the U.S. government.

The World Health Organization will meet with experts over the next few days to review results and plan steps forward, says a statement from one of its TB experts, Dr. Mario Raviglione.

"These results suggest that it has the potential to revolutionize TB care, and WHO will treat it as a top priority," the statement says.

A study of the test was published online Wednesday by the New England Journal of Medicine.

TB kills about 1.8 million people a year and increasingly is caused by bacteria that are resistant to one or more drugs. The best test — growing the bacteria in a lab dish from a mucus sample — takes a week or more, so the most common approach is to look for bacteria in a sample under a microscope. That misses many cases, tells nothing about drug resistance, and doesn't usually give an answer before a patient leaves the clinic.

"It's antiquated," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "If you have 50 patients in a clinic and one person looking at a microscope it could take hours and hours."

The government set out to develop a better test with a host of partners: Cepheid, a California-based diagnostics company; the University of Medicine and Dentistry in New Jersey, and the Foundation for Innovative New Diagnostics, a Swiss-based nonprofit group supported by the Gates Foundation.

The test they devised is simple enough to be done with minimal training. It requires only 15 minutes of manual labor, for taking the mucus sample, mixing it with chemicals and putting it in an inkjet-like cartridge that goes into a machine. The machine amplifies the DNA in the sample and checks for bits of bacterial genes.

The whole process takes less than two hours.

The study tried it on 1,730 patients with suspected TB in Peru, Azerbaijan, South Africa and India. The test successfully identified 98 percent of all confirmed TB cases and 98 percent of ones resistant to rifampin, one of the top drugs to treat the disease.

It correctly picked out nearly three-quarters of TB cases that were mistakenly declared negative from the microscope exam. And it accurately ruled out TB in 99 percent of people who did not have it.

Besides WHO endorsement, Cepheid will seek U.S. Food and Drug Administration approval for the test, which went on sale late last year in Europe. The test costs about $63 there, but the company has agreed to provide it for less than half that in poor countries, said John Bishop, Cepheid's chief executive officer. The machine costs around $30,000, but would be priced under $20,000 in poor countries, he said.

While the cost per test is higher, it doesn't take a sophisticated lab to do the test, so the overall cost may be lower, Bishop said. It also tells the diagnosis and drug resistance for that price.

The microscope-sample method costs a few dollars, plus $15 for drug-resistance testing, said Small of the Gates Foundation. He agreed that the new test may be viewed as more cost-effective because it's more accurate, fast and gives more information.

Further study is under way to see if the test can reveal multi-drug-resistant strains. If TB is resistant to rifampin, it's often resistant to another commonly used drug, Fauci said.

Testing for TB in someone who has symptoms is not the same as the TB screening skin tests that many people get. The skin test just shows whether someone has been exposed to TB at some time, and may warrant further testing to ensure they don't have a latent case.

___

Online:

Medical journal: http://www.nejm.org

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Exercise cuts genetic obesity risk by 40 percent: study

WASHINGTON (AFP) – Physical exercise can reduce a genetic predisposition to obesity by an average of 40 percent, a new study showed.

The research challenges the notion that an inherited propensity to obesity is impossible to overcome and boosts the case for the benefit of more exercise for anyone looking to shed some weight.

The study, published in this week's Public Library of American Science Medicine journal, is based on examination of 20,430 people living in Norwich, Britain.

It found most of the study's participants inherited between 10 and 13 genetic variants known to increase the risk of obesity, with some inheriting as many as 17 variants, and others as few as six.

Using modelling techniques, the researchers found that each genetic variant was linked to an increase in body mass index (BMI) -- a measure of body size based on both height and weight.

"Each additional genetic variant in the score was associated with an increase in BMI equivalent to 445 grams (1.6 ounces) in body weight for a person 1.70 meters (5.7 feet)," the study said.

For physically active individuals, the increase was just 379 grams (13 ounces).

That was "36 percent lower than in physically inactive individuals in whom the increase was 592 grams (21 ounces) per variant," the research found.

Each additional variant also raised the individual's chances of obesity 1.1-fold, but in physically active individuals, "the increased odds per variant for obesity risk were 40 percent lower."

Ruth Loos of Britain's Medical Research Council Epidemiology Unit, who carried out the research, said the study "challenged deterministic view of the genetic predisposition to obesity."

"Our findings further emphasize the importance of physical activity in the prevention of obesity," Loos said.

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For Bonobo Males, Mom Is the Best Wingman

To most human males, the thought of your mother anywhere near your sex life is probably horrifying. Not so for the bonobo, one of our closest primate relatives. A new study confirms that hanging out with mom boosts male bonobos' chances of getting intimate with a fertile female.

The study found that when their mothers are around, low- to mid-ranking bonobo males get more opportunities to mate. Mothers facilitated sons' presence in their social circle so they were able to interact with more females, and also chased away rival males who might try to break up their sons' blooming relationships.

The mothers aren't just busybodies, say the researchers. In fact, taking an active interest in their sons' love lives helps mothers pass on their own genes.

"If they support their sons, they can have more grandkids," study researcher Martin Surbeck, a biologist at the Max Planck Institute for Evolutionary Anthropology in Germany, told LiveScience.

Bonobo mama's boys

As any newlywed can tell you, parental interest in offspring's reproduction is common. Orcas are known to form strong mother-son bonds, and according to a study published in August in the journal Nature Communications, being born to a high-ranking mom gives male hyenas a reproductive boost later in life.

In primates, mothers have been shown to improve the survival of their daughters' offspring. But mother-son bonds are harder to measure, because most primate males leave their mother's side at puberty. Bonobos, a cousin to chimpanzees, are an exception. Bonobo communities are female-dominated, and males stick with their mothers in adulthood.

Researchers have long known that the status of bonobo males is linked to the status of their mothers, and field observations suggested that moms were taking an active role in facilitating their sons' mating, said Surbeck. To figure out the maternal role, he and his colleagues used DNA information to tease out the relationships between the bonobos in their field area at Salonga National Park in the Congo. Then they observed the bonobos over a 10-month period, watching how often they fought, mated and became fertile.

Maternal matchmakers

They saw that while the primates split into different "parties" during the day, sons stuck with their mothers between 81 percent and 92 percent of the time. When moms weren't around, the dominant male was responsible for about 41 percent of sexual encounters with fertile females. But when the mothers of low-to mid-ranking males were present, that proportion dropped to 25 percent. In other words, moms kept the dominant male from monopolizing the most fertile females, allowing their own sons to mate, too.

Sometimes, the moms interfered, chasing unrelated males away from females or backing up fights involving their sons. Other times, they stood guard while their sons mated, keeping competitors at bay.

But in large part, the mom's role may be more like that of a matchmaker. Since females have lots of social status in bonobo communities, Surbeck said, a mother's presence allows a son to play a more central role in the group. Being in the center of the social group means more interactions with females and more opportunities to mate.

Evolutionary cousins

The study, published this week in the journal Proceedings of the Royal Society B, "confirms largely what we've known for a long time" about the importance of mothers in bonobo communities, said Jo Thompson, the director of the Lukuru Wildlife Research Project in the Democratic Republic of the Congo.

Thompson, who researches bonobos but was not involved in the current study, said the research raises new questions about the influence of a mother's social rank on her son's success, as well about how other family members, like brothers, might influence mating. She also warned that while the current study showed low- and mid-ranking males got to mate more with fertile females when their moms were present, it didn't investigate whether they actually had more offspring.

"This is a good solid study that continues to build on the knowledge we have, and leads to more questions," Thompson said. "The next step is where we really get interesting."

Studying bonobos is important for conservation reasons, as the animals are threatened by habitat loss and poaching, said University of California Los Angeles anthropologist Joan Silk, a primate researcher who was not involved in the study. But because humans share an evolutionary ancestor with bonobos, the studies may also give us hints about our own evolutionary background, Silk said.

"Seeing both chimpanzees and bonobos gives us an idea of the range of possibilities of our ancestors'" behavior and social structure, Silk said. "They help us imagine what early human ancestors might have been like."


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Original Story: For Bonobo Males, Mom Is the Best Wingman
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U.S. Pediatricians Decry Media's Portrayal of Sex

TUESDAY, Aug. 31 (HealthDay News) -- The nation's leading group of pediatricians has issued a strong policy statement directed toward pediatricians, parents and the media on the danger of messages American teens and children are getting about sex from television, the Internet and other media outlets.

The statement, Sexuality, Contraception, and the Media, was published online Aug. 30 and in the September print issue of the journal Pediatrics.

"The media represents arguably the leading sex educator in America today," said Dr. Victor Strasburger, the lead author of the paper. "We do such a poor job of educating kids about sex in sex education classes in school, and parents are notoriously shy about talking to kids about sex. The media picks up the slack."

Seventy percent of teen shows contain sexual content, Strasburger added, "and less than 10 percent of that content involves what anyone would classify as being responsible content. There's no mention of contracting an STD [sexually transmitted disease] or the need to wait to have sex until later."

The United States leads the western world in teen pregnancy rates and American teens have an alarmingly high rate of STDs -- one in four children.

Meanwhile, U.S. children spend seven hours and more a day with various types of often-sexually explicit media, including music, movies, television shows, magazines and the Internet.

"The research shows us that the portrayal of sex in the media is really unrealistic. It's unhealthy. It doesn't consider the consequences of sexual behavior," said Alan Delamater, professor and director of child psychology at the University of Miami Miller School of Medicine. "This is what our kids are growing up thinking. This is what sex is about. To deny its impact is ignorant because there's so much knowledge of it at this point."

Many pediatricians would like to flip the equation and see media outlets introduce more responsible programming.

"Media has an opportunity to continue doing the same old thing, which is to have an adverse effect on child development, or turn it around and shape attitudes and behavior that could have a positive effect on child development," Delamater said.

The statement contains a number of recommendations for parents, physicians and the media.

"We want physicians to ask two media questions at every well-child visit: how much entertainment screen time per day does the child engage in, and is there a TV set or Internet connection in his or her bedroom," said Strasburger, professor of pediatrics at the University of New Mexico School of Medicine. "That takes 20 seconds and may be more important than asking about childproofing or car seats or bicycle helmets."

The authors of the statement ideally would like ads for erectile dysfunction drugs to not be shown on TV until after 10 p.m.

"Half a billion dollars of ads for erectile dysfunction drugs and virtually no ads for birth control pills or condoms or emergency contraception," Strasburger said. "There's not a single shred of evidence that exposing kids to birth control ads or even making birth control available to them makes them sexually active at a younger age. We're doing things completely backwards."

There should also be more attention paid to how kids use social networking sites on the Internet. And parents can use media story lines as teaching tools to discuss sex with their children, instead of having "the big talk," the statement said.

On the more idealistic side, the statement also recommends that advertisers no longer use sex to sell a wide range of products.

"We want parents to realize that kids are spending more time with media than in any other activity but sleeping, and that the media represents a powerful source of information and in this case a powerful sex educator," Strasburger said.

More information

To learn more about children and the media, visit the American Academy of Pediatrics.

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Benefits seen for high-risk women in ovary removal

CHICAGO – Surgery to remove healthy ovaries gives a triple benefit to high-risk women: It lowers their threat of breast and ovarian cancer, and boosts their chances of living longer, new research suggests.

The study is the largest to date to find advantages for preventive surgery for women who carry BRCA gene mutations. Women with the faulty genes have a dramatically higher cancer risk than other women — five times greater for breast cancer and at least 10 times greater for ovarian cancer.

The study, appearing in Wednesday's Journal of the American Medical Association, found benefits for women with two different BRCA gene variants whether they had previously had breast cancer or not.

The results offer more tailored evidence for women considering ovary removal, a surgery that ends fertility, fast-forwards them into early menopause and may contribute to osteoporosis or heart problems later in life.

"It's really critical to have the best information when making such a profound decision," said senior author Timothy Rebbeck of the University of Pennsylvania School of Medicine.

The researchers followed nearly 2,500 women with BRCA mutations in Austria, England, the Netherlands and the United States. All the women were cancer-free at the start. They were watched for an average of four years. Most of the women were younger than 50 at the start of the study.

They got counseling to help them choose between surgery or increased screening to watch for cancers early.

Ten percent of the women chose mastectomy and 40 percent chose to have their ovaries removed; some had both. More than half the women had neither surgery.

The women who chose ovary removal had impressive results:

_1 percent were later diagnosed with ovarian cancer that showed up in cells missed by surgeons, compared to 6 percent of the women who kept their ovaries.

_11 percent were diagnosed with breast cancer, compared to 19 percent of the women who kept their ovaries.

_3 percent of those who had surgery died, compared to 10 percent of the others.

The study also found preventive mastectomy lowered the risk of breast cancer. No breast cancers were seen in the women who had their breasts removed. That may seem unsurprising, but mastectomy can leave behind breast tissue that can turn cancerous.

The study was observational, meaning it can't prove one choice was better than another. Other factors could have caused differences in the women's cancer rates.

But the results will help doctors counsel their patients, said Dr. Virginia Kaklamani of Northwestern University's Feinberg School of Medicine in Chicago, who wrote an accompanying editorial in the journal.

"I'll use it mostly in talking to people considering genetic testing," Kaklamani said. "I can tell them, 'If we know you test positive, there are things to do that will help you live longer.'"

The increased risk for BRCA carriers is frightening. In the general population, about 12 in 100 women will get breast cancer during their lifetimes, compared to about 60 in 100 women who have faulty BRCA genes, according to the National Cancer Institute. For ovarian cancer, the lifetime risk in the general population is a little more than 1 in 100 compared to 15-to-40 in 100 women with BRCA mutations.

For women with a family history of breast or ovarian cancer, the decision to get tested can be agonizing. The $3,300 blood test, while often covered by insurance, can disrupt families, force decisions on childbearing and leave a woman feeling stigmatized. Surgery costs thousands of dollars, not including lost time at work. Without preventive surgery, a woman faces a regimen of mammograms, MRIs and blood tests to look for cancer.

But several signs point to "the beginning of a new era" for high-risk women, said Joanna Rudnick, a 36-year-old Los Angeles filmmaker. She has known for nine years that she carries a breast cancer gene mutation. Engaged and planning to have children, she's also planning to have her breasts and ovaries removed when she's 40. Her documentary "In the Family" tells about her choices and those faced by other "BRCA-positive" women.

With testing more than a decade old, researchers are just beginning to have better data to understand the benefits of risk-reducing surgery. For high-risk women, equally important are the breakthroughs in cosmetic breast reconstruction, laws to prevent genetic discrimination and evolving attitudes toward removing body parts to avoid cancer, Rudnick said. A federal judge recently struck down patents on the two genes held by Myriad Genetics Inc., which may widen research possibilities and testing options.

Rudnick's glad to hear ovary removal may reduce her risk of breast cancer as well as ovarian cancer.

"This is one of the rare silver linings that has been learned from these prospective studies," Rudnick said.

___

Online:

JAMA: http://jama.ama-assn.org

BRCA genes: http://www.cancer.gov/cancertopics/factsheet/risk/brca

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Aging vets' costs concern Obama's deficit co-chair

RALEIGH, N.C. – The system that automatically awards disability benefits to some veterans because of concerns about Agent Orange seems contrary to efforts to control federal spending, the Republican co-chairman of President Barack Obama's deficit commission said Tuesday.

Former Wyoming Sen. Alan Simpson's comments came a day after The Associated Press reported that diabetes has become the most frequently compensated ailment among Vietnam veterans, even though decades of research has failed to find more than a possible link between the defoliant Agent Orange and diabetes.

"The irony (is) that the veterans who saved this country are now, in a way, not helping us to save the country in this fiscal mess," said Simpson, an Army veteran who was once chairman of the Senate Veterans' Affairs Committee.

The Department of Veterans Affairs has also allowed Vietnam veterans to get money for ailments such as lung cancer and prostate cancer, and the agency finalized a proposal Tuesday to grant payments for heart disease — the nation's leading cause of death.

Simpson declined to say whether the issue would become part of his work on Obama's panel examining the nation's debt. He looked to Congress to make a change.

Sen. Daniel Akaka, a Hawaii Democrat who currently chairs the VA committee, said Tuesday he will address the broader issue of so-called presumptive conditions at a hearing previously set for Sept. 23. The committee will look to "see what changes Congress and VA may need to make to existing law and policy," Akaka said in an e-mail.

"It is our solemn responsibility to help veterans with disabilities suffered in their service to our country," said Akaka, who served in the Army Corps of Engineers during World War II. "That responsibility also requires us to make sure limited resources are available for those who truly need and are entitled to them."

Virginia Sen. Jim Webb, a Democrat and Vietnam combat veteran, has also raised questions about the spending. The leading Republican on the committee, North Carolina Sen. Richard Burr, has not responded to several requests for comment on the topic in recent months.

Because of concerns about Agent Orange, Congress set up a system in 1991 to grant automatic benefits to veterans who served in Vietnam at any point during a 13-year period and later got an ailment linked to the defoliant. The VA has done that with a series of ailments with strong indications of an association to Agent Orange, including Hodgkin's disease, soft-tissue cancers and non-Hodgkin's lymphoma.

Other ailments have been added even though and Institute of Medicine review has found they only have a potential association and that they could not rule out other factors. Those maladies include prostate cancer, lung cancer and diabetes. The committee has said that, for diabetes, more powerful influences include family history, physical inactivity and obesity.

The AP found in reviewing millions of VA compensation records that diabetes is now the most frequently compensated ailment, ahead of post-traumatic stress disorder, hearing loss or general wounds. VA officials use a complex formula when awarding benefits and do not track how much is spent for a specific ailment, but AP calculations based on the records suggest that Vietnam veterans with diabetes should receive at least $850 million each year.

Paul Sullivan, executive director for the advocacy group Veterans for Common Sense, said it would be unreasonable for veterans to have to prove on a case-by-case basis that their illness came from Agent Orange. He believes the science supports the decision by VA to grant presumptive benefits.

"The presumptive law is absolutely essential," he said. "Money should not be an issue."

Sullivan also said many veterans file claims not for the compensation but for access to free health care.

The VA also acknowledged in its heart disease rule Tuesday that it could cost billions more than initially anticipated. The initial projection was that the new ailments, mostly heart disease but also Parkinson's disease and certain types of leukemia, would total $42.2 billion over 10 years. But that was based on disease prevalence rates for the general population, not representative of the aging class of Vietnam veterans.

VA used an age-adjusted formula in its latest proposal and estimated that it could cost some $67 billion in the next decade.

"It's the kind of thing that's just driving us to this $1 trillion, $400 billion deficit this year," Simpson said. "It's not that I'm an uncaring person, but common sense is the most uncommon thing in Washington."

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Scientists expect C-section rate to keep rising

WASHINGTON – More women will be giving birth by C-section for the foreseeable future, government scientists said Monday, releasing a study into the causes of a trend that troubles maternal health experts.

Overall, cesarean deliveries account for about a third of births in the U.S. While much attention has recently focused on women having repeat C-sections, researchers with the National Institutes of Health found that nearly one third of first-time moms delivered by cesarean.

That is "somewhat surprising," said Dr. Jun Zhang, lead author of a study that looked at nearly 230,000 deliveries in 19 hospitals around the country. "It has consequences for future pregnancies."

Many doctors and hospitals follow a policy of "once a cesarean, always a cesarean."

The study also suggested a link between chemically induced labor and higher likelihood of a C-section. Women whose labor was induced were twice as likely to have a cesarean. The authors said more research is needed to clarify if there's a cause-and-effect relationship.

Many medical experts consider cesarean deliveries to be a major component of "overtreatment" in the U.S. — procedures and tests that provide little or no benefit while subjecting patients to additional risks. Indeed, new clinical recommendations say vaginal birth is safe for most women who've had a first C-section.

But the trend does not appear likely to reverse. Since the mid-1990s, the C-section rate in the U.S. has increased by more than 50 percent.

How low should it be? In Scandinavian countries it hovers in the 20 percent range, with no evidence of ill-effects for mothers or babies, Zhang said. How high can it go? In some countries 60 percent to 70 percent of babies are now delivered surgically.

"I hope that we won't get there," said Zhang. "The upward trajectory seems likely to continue in the near future."

Explaining the increase in C-sections is no simple matter. The study found a variety of reasons, some related, including heavier moms and babies, women giving birth later in life, an increase the number of twins and multiple births, and evidence that doctors may be opting for a cesarean if women encounter difficulties in the early stages of labor.

One factor that made no difference was whether the mother had private health insurance or was covered through a government program like Medicaid.

The study was published in the American Journal of Obstetrics & Gynecology.

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Prostate biopsy can cause urinary, erectile problems

NEW YORK (Reuters Health) – Biopsies taken to diagnose prostate cancer commonly cause temporary erectile dysfunction and, in some cases, lingering urinary problems, according to a new study.

The findings, reported in the Journal of Urology, highlight the fact that even the tests for diagnosing prostate cancer can have side effects.

And men who are undergoing prostate biopsies -- as well as those considering prostate cancer screening -- should be aware of those risks, experts say.

This is especially important for men facing the prospect of multiple biopsies, since the risk of side effects appears to be related to the number of needle sticks used.

For the study, German researchers followed 198 men who had been randomly assigned to undergo one of three forms of biopsy to check for suspected prostate cancer: a standard biopsy, where a needle was used to take no more than 10 tissue samples; a 10-sample biopsy along with the use of a periprostatic nerve block to lessen any pain from the procedure; or a "saturation" biopsy, where 20 tissue samples were taken.

Saturation biopsies may be done in some cases where the doctor suspects a man has a particularly elevated risk of having cancer -- such as a man who has had a negative biopsy in the past yet has persistently suspicious findings on PSA screening tests. Taking more tissue samples during the biopsy should increase the chances of finding any tumor.

But all those needle sticks may come at a cost, the study found.

Men who underwent saturation biopsies had the highest risk of developing lingering problems with urination, such as straining to pass urine and frequent nighttime trips to the bathroom.

Of that group, 10 percent reported severe symptoms before the biopsy; that figure increased to 18 percent one week after the test, and to 29 percent 12 weeks afterward.

Men who'd had a standard biopsy showed an increase in urinary symptoms only in the first week. The percentage reporting moderate symptoms increased from roughly 32 percent to 39 percent, and the proportion with severe symptoms rose from 18 percent to 20.5 percent.

Among men who'd had a biopsy with nerve block, just 0.6 percent reported severe urinary symptoms before the test. That rose to 8 percent one week afterward, and to almost 17 percent by week 12 -- though that latter finding was not statistically significant, which means it could have been due to chance.

When it came to erectile function, men in all three biopsy groups had more problems one week after the test. The side effect did, however, gradually decrease over time.

Among men in both the standard biopsy and saturation-biopsy groups, just over half reported severe erectile dysfunction one week after the test -- up from around one-quarter before. In the nerve-block group, that rate rose from 11 percent to 39 percent.

By week 12, the men's rates of erectile problems had declined to close to their baseline levels.

The findings are "not unexpected," said Dr. Paul Schellhammer, a urologist at Sentara Health System/Eastern Virginia Medical School in Norfolk who was not involved in the research.

However, he noted in an interview, there has been little study into the urinary and erectile side effects of prostate biopsies.

"This study begins to define the risks," said Schellhammer, who has studied the effects of prostate cancer treatment on men's sexual and urinary function.

Men facing repeat biopsies over time -- whatever the type of biopsy -- should be particularly aware of the chances for side effects, Schellhammer told Reuters Health, since it appears that the greater the number of needle-sticks into the prostate, the greater the odds of lingering urinary problems.

It is not clear from this study exactly why men undergoing saturation biopsy had a greater risk of longer term urinary symptoms, according to lead researcher Dr. Tobias Klein of Marienhospital Herne in Germany.

But it is possible, he told Reuters Health in an email, that damage to the "neurovascular bundle" -- a complex of nerves and blood vessels close to the prostate -- plays a role.

The fact that prostate biopsies carry some risks -- which, besides the ones seen in this study, include more-immediate problems like bleeding and infection -- also has implications for men considering prostate cancer screening, according to Schellhammer.

Routine screening with PSA testing is controversial. The tests measure concentrations of prostate-specific antigen, a protein produced by the prostate gland whose blood levels generally rise when a prostate tumor is present; however, a relatively high PSA does not necessarily mean cancer, and a biopsy must be done to confirm. And those biopsies often turn out to be negative.

In the current study, 40 percent of the men were found to have cancer after their prostate biopsy.

Much of the concern about PSA testing revolves around the fact that prostate tumors are often slow-growing, and screening may result in many men being treated for cancers that would never have caused them problems. So those treatments -- with their risks of side effects like erectile dysfunction and urinary incontinence -- can do more harm than good for some men.

But men should also be aware, Schellhammer said, that prostate biopsies can have side effects as well, and that can be considered when they are making decisions on PSA screening.

He added that the findings are also relevant to men diagnosed with prostate cancer who choose "active surveillance" -- where the doctor does not immediately treat the cancer, but instead monitors its progression. That surveillance, Schellhammer noted, might include yearly biopsies.

SOURCE: http://link.reuters.com/wew28n Journal of Urology, online August 19, 2010.


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Clinical Trials Update: Aug. 30, 2010

(HealthDay News) -- Here are the latest clinical trials, courtesy of ClinicalConnection.com:

Migraine

This study is for females who have at least two migraine attacks per month just before or during the menstrual cycle. If you qualify, the investigational medication and study exams will be provided at no cost.

The research site is in Plano, Texas.

More information

Please see http://www.clinicalconnection.com/clinical_trials/condition/migraine.aspx.

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Irritable Bowel Syndrome

This study will evaluate an investigational irritable bowel syndrome drug. You may qualify if you are aged 18 to 79, have at least 28 stools over a seven-day period, and have moderate-to-severe pain in the abdomen.

The research site is in Burbank, Calif.

More information

Please see http://www.clinicalconnection.com/clinical_trials/condition/ibs.aspx.

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Attention Deficit Hyperactivity Disorder (ADHD)

This study is for people who have attention deficit hyperactivity disorder. You may qualify if you have trouble getting organized, paying attention, finishing tasks and often feel distracted.

The research site is in Seattle, Wash.

More information

Please see http://www.clinicalconnection.com/clinical_trials/condition/adhd.aspx.

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Copyright 2010 ClinicalConnection.com. All rights reserved.

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