WASHINGTON – When President Barack Obama eased limits on taxpayer-funded embryonic stem cell research, the big question became how far scientists could go. Friday, the government answered: They must use cells culled from fertility clinic embryos that otherwise would be thrown away.

Draft guidelines released by the National Institutes of Health reflect rules with broad congressional support, excluding more controversial sources such as cells derived from embryos created just for experiments.

“We think this will be a huge boost for the science,” said Acting NIH Director Raynard Kington. “This was the right policy for the agency at this point in time.”

The limit will disappoint some researchers who wanted to use a broader variety of cells. But it still means that perhaps hundreds more stem cell lines will be available for government-funded study soon.

“Some groups and scientists have wanted the administration to go further. But we are happy to have this progress after such a long period of limited opportunities to pursue this very important line of research,” said Alan Leshner of the American Association for the Advancement of Science.

The guidelines are “a reasonable compromise based on where the science stands now,” said Dr. Sean Morrison, director of the University of Michigan Center for Stem Cell Biology. “We may need to revisit some of the details down the road depending on how the science develops.”

Scientists are trying to harness embryonic stem cells — master cells that can morph into any cell of the body — to one day create replacement tissues and better treat, possibly even cure, ailments ranging from diabetes to Parkinson’s to spinal cord injury.

Culling those stem cells — which can propagate indefinitely in lab dishes — destroys a days-old embryo, a result strongly opposed by many on moral grounds. So the Bush administration had limited taxpayer-supported research to a small number of embryonic stem cell “lines” or groups already in existence as of August 2001.

Last month, Obama lifted that restriction, widening the field. But he left it to the NIH to set ethics guidelines determining which cell lines now will qualify for government funding.

Federal law forbids using taxpayer money to create or destroy an embryo. At issue here are rules for working with cells that initially were created using private money.

Many scientists had hoped the guidelines would allow use of stem cells derived from embryos created just for science, perhaps even using cloning techniques that could make them genetically customized for a potential recipient.

But the NIH instead proposed limiting new grants to research using stem cells originally derived from fertility-clinic leftovers, the extra embryos that couples wind up not needing and thus often are thrown out.

That’s in line with legislation passed by the last Congress but never signed by President George W. Bush. Besides, Kington noted, no one has yet created a stem cell line using cloning techniques.

“There’s compelling broad support both in the scientific community and the public at large” for the fertility-clinic approach, Kington said. “There is not similar broad support for using other sources at this time.”

The guidelines also demand that the woman or couple who donate the original embryo give proper informed consent. There are other options for such donors, such as donating the embryo to another infertile woman, and all must be explained. Also, the donation must be voluntary, without pressure from scientists.

Those donation practices are standard today, but they weren’t just a few years ago — and Michigan’s Morrison said some of the old Bush-approved lines may not meet the new standards. That poses a grave question, he said: Can work based on those older lines continue?

Friday’s guidelines also clearly forbid some types of research using human embryonic stem cells, such as mixing them with embryos from monkeys and other primates.

Last year, the NIH funded about $88 million in research using embryonic stem cells, Kington said. It’s unclear how much more the agency may spend under the new policy.

The NIH will accept public comments on the guidelines for a month, and issue final rules by early July.

ATLANTA – Toddlers of moms who took the epilepsy drug valproate during pregnancy had lower IQs than the children of women who used other anti-seizure medicines, according to a new study.

The valproate children had IQ scores six to nine points lower by age 3, said the study’s lead author, Dr. Kimford Meador of Emory University. The drug, also sold in the U.S. under the brand name Depakote, had previously been linked to birth defects, particularly spina bifida. Women of childbearing age have long been advised to avoid it.

“We’ve known this drug is a bad actor for a long time,” said Dr. Lewis Holmes, director of the North American Antiepileptic Disease Pregnancy Registry, based at Massachusetts General Hospital in Boston.

The new study is important because it’s the largest to show a connection between valproate and diminished IQ. Its publication in the prestigious New England Journal of Medicine should alert physicians who until now have ignored the drug’s potential dangers to fetuses, added Holmes, who was not involved with the study.

In the United States, about 25,000 children are born each year to women who have epilepsy, a brain disorder that causes people to have recurring seizures. In the study, researchers followed pregnant women in the United States and United Kingdom between 1999 and 2004. The results are based on about 260 of their children.

Toddlers whose mothers had taken valproate had IQs of 92, on average. In contrast, IQ scores were in the range of 98 to 101 for children of women who had taken lamotrigine, phenytoin, and carbamazepine. IQ tests are designed so a child of average intelligence scores 100.

The higher the dosage of valproate a woman had taken, the lower the IQ of the child, the researchers found. For the other drugs, dosage levels made no significant difference.

The number of children in the study is small, and it’s possible that other factors influenced the results. However, the researchers accounted for differences in a child’s birth weight, the age and IQs of their mothers, the type of epilepsy the mothers had, and other factors that could have influenced the results.

A major drawback is that the study did not include children whose epileptic mothers took no medication during pregnancy, Holmes said.

It’s possible that all four epilepsy medications had some effect on mental development, he said. Without such a comparison group, it’s hard to know, said Holmes, who is also a professor of pediatrics at Harvard Medical School.

Valproate, also given for migraine headaches and mood disorders, continues to be used by some epileptics because it’s the only thing that works, said Meador, the study author.

Doctors say it’s often important for epileptic women to keep taking their medications during pregnancy because seizures can lead to injuries.

Women on the drug who want to get pregnant should plan their pregnancies carefully and consult with a doctor, wrote Swedish researcher Dr. Torbjorn Tomson, in an editorial that accompanied the new study.

Switching drugs after a woman realizes she is pregnant is unlikely to reduce the risk of birth defects. And abruptly stopping he medication may endanger the mother and the fetus, he wrote.

“That could be catastrophic,” Meador agreed.

———

ON THE WEB

New England Journal: nejm.org

An experimental treatment that takes an entirely new approach to fighting prostate cancer extended survival in a late-stage study, its maker announced Tuesday.

Seattle-based Dendreon Corp. said that its Provenge cancer vaccine improved overall survival when compared to a dummy treatment in a study of 512 men with advanced disease.

No survival details or information on side effects were given. Full results will be presented at an American Urological Association meeting later this month, and Dendreon said it would seek federal approval of the treatment later this year.

Provenge is not like traditional vaccines that prevent disease. It’s a so-called therapeutic vaccine that treats cancer by training the immune system to fight tumors. If approved, Provenge would be the first such treatment on the market.

This is the second major study in which Provenge has shown a survival benefit, leading some scientists to hope not just for its approval but for a new approach to fighting cancer beyond the surgery, radiation, hormones and chemotherapy used now.

“This is an exciting result, demonstrating that harnessing a patient’s own immune system can successfully attack prostate cancer,” said Dr. Eric Small, cancer specialist at the University of California at San Francisco. “Now we have more confidence that the initial results we saw were real.”

He enrolled some patients in the new study and led the earlier one, but has no financial ties to the company or the vaccine.

In the earlier study of 127 men, those treated with the vaccine lived an average of 4 1/2 months longer than those given dummy treatments. After three years, survival was 34 percent in the vaccine group and only 11 percent in the other.

Those results led advisers to the Food and Drug Administration to recommend Provenge’s approval two years ago. But the FDA delayed action and asked for more data, because extending survival wasn’t the main goal of that study — slowing progression of the cancer was, and the vaccine failed to do that.

The decision sparked protests from men’s groups and cancer advocates because the vaccine did prolong survival, which they considered a more important result.

On Tuesday, results of the new study boosted Dendreon stock by $9.69, closing at $16.99, more than doubling in value as investors bet on improved chances of FDA approval and the potential for a lucrative market.

Provenge is a treatment that is customized for each patient. Doctors collect specialized cells from each patient’s blood. Those cells help the immune system recognize cancer as a threat, much as it would germs that enter the body.

The cells are mixed with a protein found on most prostate cancer cells to help activate the immune system. The resulting “vaccine” is given back to the patient as three infusions two weeks apart.

So far, the vaccine has been tested on men with cancer that has spread beyond the prostate and is no longer responding to hormone treatments to curb its growth.

If Provenge proves safe and wins approval, “it would be an important breakthrough,” said Dr. William Oh, a cancer specialist at Dana-Farber Cancer Center in Boston. Three years ago, he consulted for Dendreon on the vaccine but has had no financial ties to it since then.

“There are so few treatments available” for men whose prostate cancer has spread widely — a situation that affects 40,000 to 60,000 American men, he said.

Prostate cancer is the most common non-skin cancer in American men. An estimated 186,000 new cases and 28,660 deaths from it occurred last year.

Azam Anwar played a lot of competitive tennis in his youth, and trophies aren’t the only thing he has to show for it. An arthritic right knee reminds him of the years spent on the singles court.

“Your body starts talking to you, and you have to start backing off, trying other alternatives,” said Anwar, a Dallas cardiologist. He has had two surgeries on his knee.

Experts say there’s no need for Anwar, 49, and other baby boomers with arthritis to trade their Nikes for a rocking chair on Craigslist.

“People with arthritis might be living under the myth that they can’t be physically active, but now we know there is no doubt that, if you exercise, it keeps you more mobile as you age and builds muscle needed to support your joints,” said rheumatologist Patience White, chief public health officer of the Arthritis Foundation.

White said there are numerous ways to reduce achy joints and stay in the game, including:

• Incorporating stretching and strength training into workouts.

• Playing sports that don’t place a heavy burden on joints.

• Injections for temporary relief.

• Alternative therapies.

“Your most powerful asset may even be your state of mind,” White said.

Arthritis occurs when the cartilage and synovial fluid (the liquid between joints that helps them glide) are inflamed. There are many forms of it. Osteoarthritis, which Anwar has, is the most common and results from chronic wear-and-tear that comes with age. It’s more likely to occur sooner if a joint has been injured or been operated on, said Scott Zashin, clinical assistant professor of rheumatology at the University of Texas Southwestern Medical School in Dallas. “Typically I see it in the knee, but it can affect the spine, hips, hands, feet.”

Ditch the high-risk activities

Anwar knew the solution wasn’t to stop exercising, which could lead to weight gain. So he has modified his fitness routine. “You can’t be a hermit, but there are certain activities that are very high risk. Now I stretch a lot more, weight-lift, golf, walk a lot,” he said. “And if I want to play tennis, I play doubles.”

Hard-on-the-joints sports include football, skiing, basketball, and soccer, said Nicholas DiNubile, an orthopedic surgeon, in Havertown, Pa. DiNubile said walking, swimming, biking, and strength-training are healthier for the joints.

Stretching and core-strengthening activities like yoga and Pilates help stabilize weakened joints, said Nisha Manek, a rheumatologist at the Mayo Clinic. Start with a gentle program, she said. “Honor your limitations.”

Keep the weight off

Eating healthy shouldn’t be overlooked as an arthritis management strategy, said David Karp, chief of the rheumatic diseases at the University of Texas Southwestern Medical Center.

“In this country, obesity is one of the biggest risk factors for arthritis,” Karp said. “Overweight people can obtain joint relief even if they lose 10 pounds.”

In one study, arthritis sufferers who ate a Mediterranean-style diet reported improved well-being. Other research suggests omega-3 fish oil reduces joint inflammation, Manek said.

Medicate with caution

Over-the-counter and prescription drugs can help calm arthritis enough to make exercise comfortable, said Frederick Azar, professor of orthopedics at the University of Tennessee-Memphis. But they carry risks.

Avid basketball player Mark Liszt, 61, of Los Angeles landed in the hospital with an ulcer from prescription anti-inflammatory drugs he took for arthritic knees. “Now, I don’t take anything,” Liszt said.

Cortisone shots can reduce inflammation but also have side effects, Azar said.

“Hyaluronic acid is another weapon in our arsenal,” said Azar about injections of a fluid already present in joints. But Azar said not all patients benefit.

Mayo Clinic rheumatologists April Chang-Miller said Botox injected into specific muscles may ease pain. “Early studies are promising,” she said.

Beyond conventional care

Alternative therapies may help, but not all are clinically proven, Zashin said.

Researchers from Baylor Research Institute say more than half of patients in a 2007 study reported better movement and less pain after taking tart-cherry supplements.

Vitamin D is touted for bone health, but also believed to play a role in inflammation. A study out this month in the Archives of Internal Medicine associated D-deficiency with inflammation in healthy women.

Preliminary data from a Tufts study suggests that tai chi and chi gong exercises help knee osteoarthritis. Mostly, keep a positive attitude, said Theresa Nustvold, 44, of Amery, Wis., who has lupus-related arthritis. Once an avid runner, Nustvold now practices more joint-friendly walking and yoga instead. “You can’t lay down and let it get you. You’ve got to stay moving.”

ARLINGTON, Va. – The federal government is waking up to what has become a growing nightmare in many parts of the country — a bedbug outbreak.

The tiny reddish-brown insects, last seen in great numbers before World War II, are on the rebound. They have infested college dormitories, hospital wings, homeless shelters and swanky hotels from New York City to Chicago to Washington.

They live in the crevices and folds of mattresses, sofas and sheets. Then, most often before dawn, they emerge to feed on human blood.

Faced with rising numbers of complaints to city information lines and increasingly frustrated landlords, hotel chains and housing authorities, the Environmental Protection Agency hosted its first-ever bedbug summit Tuesday.

Put on by an EPA’s federal advisory committee, the two-day conference which drew about 300 participants to the Sheraton Crystal City Hotel in Arlington, Va., will provide the agency with advise and recommendations.

The Sheraton has had no reported bedbug problems, according to a popular online registry, so at least conference participants will be sleeping tight.

“The problem seems to be increasing and it could definitely be worse in densely populated areas like cities, although it can be a problem for anyone,” said Lois Rossi, director of the registration division in the EPA’s Office of Pesticide Programs.

And the EPA is not alone in trying to deal with the problem. An aide to Rep. G.K. Butterfield, D-N.C., says he plans to reintroduce legislation next week to expand grant programs to help public housing authorities deal with infestations

Many of the programs cover cockroaches and rodents, but not bedbugs. The bill will be called the Don’t Let the Bedbugs Bite Act.

“It was clear something needed to be done,” said Saul Hernandez, Butterfield’s legislative assistant.

One of the problems, according to researchers and the pesticide industry, is that there are few chemicals on the market approved for use on mattresses that are effective at reducing bedbug numbers. The appleseed-sized critters have also developed a resistance to some of the chemicals on the market.

The EPA, out of concern for the environment and the effects on public health, has pulled many of the chemicals that were most effective in eradicating the bugs from the U.S. over the last 50 years — such as DDT — off of shelves.

Increasing international travel has also increased the chances for the bugs to hitchhike from developing countries which never eradicated them completely.

“This is a worldwide resurgence,” said Dini Miller, an entomologist and bedbug expert at Virginia Polytechnic Institute and State University, who until 2001 only saw bedbugs on microscope slides dating from the 1950s. Now she gets calls several times a day from people who are often at their wits end dealing with the problem.

“I can’t tell you how many people have spent the night in their bath tubs because they are so freaked out by bedbugs,” Miller said. “I get these people over the phone that have lost their marbles.”

Bedbugs are not known to transmit any diseases. But their bites can cause infections and allergic reactions in some people. The insects release an anticoagulant to get blood flowing, and they also excrete a numbing agent so their bites don’t often stir a victim’s slumber.

Those often hardest hit are the urban poor, Miller said. These are people who cannot afford to throw out all their belongings or take the sanitation measures necessary to rid them of the problem.

Because the registration of new pesticides takes so long, one thing the EPA could do is to approve some pesticides for emergency use, Miller said.

The pesticide management industry will be pushing for federal funding for research into alternative solutions, such as heating, freezing or steaming the bugs out of bedrooms.

“We need to have better tools,” said Greg Baumann, a senior scientist at the National Pest Management Association. “We need EPA to consider all the options for us.”

———

ON THE WEB

Harvard School of Public Health: www.hsph.harvard.edu/bedbugs/

University of Kentucky Insect Advice: www.ca.uky.edu/entomology/entfacts/ef636.asp

Fight fat with fat? The newest obesity theory suggests we may one day be able to do just that.

Just like good and bad cholesterol, there apparently are good and bad types of body fat. Scientists until recently believed this good fat, which spurs the body to burn calories to generate body heat, played an important role in keeping infants warm but by adulthood was mostly gone or inactive.

Now three studies — from researchers in Boston, Finland and the Netherlands — show that some good fat remains in adults, affecting metabolism and potentially offering a target to help people shed pounds.

Dr. Francesco Celi, an endocrinology and metabolism researcher at the National Institute of Diabetes and Digestive and Kidney Diseases, said the studies show this fat burns large amounts of energy.

“So it could be used as a target” for a pill that would somehow rev up the fat, he said.

Dr. Louis Aronne, former president of the Obesity Society and a weight control expert at Weill Cornell Medical Center in New York, said the findings are the most conclusive evidence so far of the role of such fat in regulating body temperature and weight.

“I don’t want to use the word ‘exercise-in-a-pill,’ but it’s doing something (that’s) getting rid of calories,” he said, adding that any obesity treatment developed around the fat could be a potential treatment for diabetes as well.

The studies were published in Thursday’s New England Journal of Medicine.

The good fat is actually brownish, while the more predominant bad fat is white or yellow. Brown fat is stored mostly around the neck and under the collarbone. White fat tends to concentrate around the waistline, where it stores excess energy and releases chemicals that control metabolism and the use of insulin.

All three research groups documented the presence and activity of the brown fat by examining tissue samples from some patients and using high-tech imaging that indicated how much sugar, and therefore calories, the fat burned.

One group from Joslin Diabetes Center, Harvard Medical School and three hospitals in Boston looked at scans done on nearly 2,000 patients to diagnose various health problems. The other two groups scanned small numbers of patients, first at room temperature and then after a couple hours in mild cold, about 60 degrees.

Here’s what the scientists learned about brown fat:

— Lean people had far more than overweight and obese people, especially among older folks.

— It burns far more calories and generates more body heat when people are in a cooler environment.

— Women were more likely to have it than men, and their deposits were larger and more active.

Finding a successful treatment for obesity would be a Holy Grail for scientists. Most obese and overweight people are unable to shed pounds and keep them off with dieting and exercise.

And despite plenty of effort, pharmaceutical companies have been unable to develop a medicine that helps people safely lose and keep off a significant amount of weight. Any drug that could do that would be a guaranteed blockbuster.

Aronne said the findings likely would renew interest in the area of brown fat among drugmakers; at least one briefly studied a treatment in lab animals several years ago.

So how could researchers use these basic findings about good fat to eventually come up with a weight-loss medication?

One possibility would be a pill to stimulate a specific protein to release more energy from the fat cells in the form of heat rather than storing it for future energy needs, Aronne and Celi said.

Finding a way to increase the amount of brown fat in a person would be another strategy. Researchers at Dana-Farber Cancer Institute in Boston have been injecting certain genes into mice to try to produce brown fat cells instead of white ones.

Celi said researchers also could try to make a pill that stimulates nerve endings inside brown fat to make it burn more calories.

Or overweight people could simply try turning down the thermostat to see if it makes them burn more energy and lose weight — a strategy that Celi and researchers are testing in a small study that could produce results by the end of the year.

———

On the Web

New England Journal: www.nejm.org

Obesity Society: www.obesity.org

CHICAGO – A striking new study says almost 1 in 5 American 4-year-olds is obese, and the rate is alarmingly higher among American Indian children, with nearly a third of them obese.

Researchers were surprised to see differences by race at so early an age.

Overall, more than half a million 4-year-olds are obese, the study suggests. Obesity is more common in Hispanic and black youngsters, too, but the disparity is most startling in American Indians, whose rate is almost double that of whites.

“The magnitude of these differences was larger than we expected, and it is surprising to see differences by racial groups present so early in childhood,” said Sarah Anderson, an Ohio State University public health researcher. She conducted the research with Temple University’s Dr. Robert Whitaker.

Without interventions, the next generation “will be at very high risk” for heart disease, high blood pressure, cancers, joint diseases and other problems connected with obesity, said Dr. Glenn Flores, a pediatrics and public health professor at University of Texas Southwestern Medical School in Dallas.

The study is an analysis of nationally representative height and weight data on 8,550 preschoolers born in 2001. The results appear in Monday’s Archives of Pediatrics & Adolescent Medicine.

Almost 13 percent of Asian children were obese, 16 percent of whites, almost 21 percent of blacks, 22 percent of Hispanics, and 31 percent of American Indians.

CHICAGO – A striking new study says almost 1 in 5 American 4-year-olds is obese, and the rate is alarmingly higher among American Indian children, with nearly a third of them obese.

Researchers were surprised to see differences by race at so early an age.

Overall, more than half a million 4-year-olds are obese, the study suggests. Obesity is more common in Hispanic and black youngsters, too, but the disparity is most startling in American Indians, whose rate is almost double that of whites.

The lead author said that rate is worrisome among children so young, even in a population at higher risk for obesity because of other health problems and economic disadvantages.

“The magnitude of these differences was larger than we expected, and it is surprising to see differences by racial groups present so early in childhood,” said Sarah Anderson, an Ohio State University public health researcher. She conducted the research with Temple University’s Dr. Robert Whitaker.

Dr. Glenn Flores, a pediatrics and public health professor at University of Texas Southwestern Medical School in Dallas, said the research is an important contribution to studies documenting racial and ethnic disparities in children’s weight.

“The cumulative evidence is alarming because within just a few decades, America will become a ‘minority majority’ nation,” he said. Without interventions, the next generation “will be at very high risk” for heart disease, high blood pressure, cancers, joint diseases and other problems connected with obesity, said Flores, who was not involved in the new research.

The study is an analysis of nationally representative height and weight data on 8,550 preschoolers born in 2001. Children were measured in their homes and were part of a study conducted by the government’s National Center on Educational Statistics. The results appear in Monday’s Archives of Pediatrics & Adolescent Medicine.

Almost 13 percent of Asian children were obese, along with 16 percent of whites, almost 21 percent of blacks, 22 percent of Hispanics, and 31 percent of American Indians.

Some previous studies of young children did not distinguish between kids who were merely overweight versus obese, or they examined fewer racial groups.

The current study looked only at obesity and a specific age group. Anderson called it the first analysis of national obesity rates in preschool kids in the five ethnic or racial groups.

The researchers did not examine reasons for the disparities, but others offered several theories.

Flores cited higher rates of diabetes in American Indians, and also Hispanics, which scientists believe may be due to genetic differences.

Also, other factors that can increase obesity risks tend to be more common among minorities, including poverty, less educated parents, and diets high in fat and calories, Flores said.

Jessica Burger, a member of the Little River Ottawa tribe and health director of a tribal clinic in Manistee, Mich., said many children at her clinic are overweight or obese, including preschoolers.

Burger, a nurse, said one culprit is gestational diabetes, which occurs during a mother’s pregnancy. That increases children’s chances of becoming overweight and is almost twice as common in American Indian women, compared with whites.

She also blamed the federal commodity program for low-income people that many American Indian families receive. The offerings include lots of pastas, rice and other high-carbohydrate foods that contribute to what Burger said is often called a “commod bod.”

“When that’s the predominant dietary base in a household without access to fresh fruits and vegetables, that really creates a better chance of a person becoming obese,” she said.

Also, Burger noted that exercise is not a priority in many American Indian families struggling to make ends meet, with parents feeling stressed just to provide basic necessities.

To address the problem, her clinic has created activities for young Indian children, including summer camps and a winter break “outdoor day” that had kids braving 8-degree temperatures to play games including “snowsnake.” That’s a traditional American Indian contest in which players throw long, carved wooden “snakes” along a snow or ice trail to see whose lands the farthest.

The hope is that giving kids used to modern sedentary ways a taste of a more active traditional American Indian lifestyle will help them adopt healthier habits, she said.

———

ON THE WEB

Archives: www.archpediatrics.com

Association of American Indian Physicians: tinyurl.com/c8raox

Researchers at the University of Iowa say they’ve stumbled on a genetic twist that could lead to a birth control pill for men.

The discovery involves an inherited disorder that made sperm unable to swim forcefully. “They could still move, but they need this special, fast motion to actually penetrate the egg, and that would be limited,” said Dr. Michael Hildebrand, a Iowa University researcher who helped lead the study.

Hildebrand believes doctors could induce the disorder in men, making them incapable of impregnating women.

The theory that this discovery could lead to a contraceptive would need to be tested in mice before it could be tried in men. Any treatment for humans would be years away.

The paper was published online Thursday by the American Journal of Human Genetics.

An outside expert who read the paper said it was interesting, but he was skeptical that the discovery could lead to a practical male contraceptive.

Dr. Dale McClure, president of the American Society for Reproductive Medicine, said he doubted the treatment could be reversed. In other words, he said, if men started taking the pills or shots, they could become permanently sterile.

McClure, who is a Seattle urologist, said researchers have worked for years to develop a male birth control pill. They’ve mainly worked with hormones that decrease the function of the testes, which make sperm. However, he said, many of those efforts have interfered with sexual functions.

McClure predicted there would be a market for a successful male birth control treatment. “Say you’re a 27-year-old gentleman and you don’t want to have a child and you don’t want to get married for a few years. It would be nice to have a contraceptive besides the condom,” he said.

McClure said Hildebrand’s proposed treatment theoretically could provide an alternative to vasectomies for men who are sure they don’t ever want to be fathers.

Hildebrand said he believes the treatment could be reversed. It would involve the introduction of antibodies, which he said the body would not continue making on its own. He said several teams have been working to develop such approaches for various treatments, but he acknowledged that they have not been tried in humans.

The new discovery traces back to research that the University of Iowa has done with colleagues in Iran. The researchers focus on hereditary hearing problems. Iranian researchers went to villages in their country where intermarriage is common, making genetic disorders more likely.

They wound up finding two families in which many men were sterile. The scientists looked into the cause and found two similar genetic disorders causing problems with the sperm’s ability to penetrate eggs.

NEW YORK – One in five Medicare patients ends up back in the hospital within a month of discharge, a large study found, and that practice costs billions of dollars a year.

The findings suggest patients aren’t told enough about how to take care of themselves and stay healthy before they go home, the researchers said. A few simple things – like making a doctor’s appointment for departing patients – can help, they said.

The study found that a surprising half of the nonsurgery patients who returned within a month hadn’t even seen a doctor between hospital stays.

“Hospitals put more effort into the admission process than they do into the discharge process,” said Dr. Eric Coleman, one of the study’s authors from the University of Colorado in Denver.

Coleman, who runs a program to improve “hand-offs” between health care systems, said patients often have a honeymoon notion about how things will be once they’re home. Then when they become confused about how to take their medicine or run into other problems, they head back to the hospital because they don’t know where to turn, he said.

The issue of hospital readmissions and their cost has come under scrutiny in recent years. And it’s getting attention now because President Obama’s budget calls for reducing spending on Medicare readmissions to pay for health care reform.

For their study, reported in Thursday’s New England Journal of Medicine, the researchers looked at Medicare records from late 2003 through 2004. They found that about 20 percent of 11.9 million patients were readmitted to the hospital within a month of discharge; about a third were back in the hospital within three months.

About half of the patients hospitalized for ailments didn’t see a doctor before they landed back in the hospital within a month.

Patients with heart failure and pneumonia had the most readmissions overall; among surgical procedures, heart stents and major hip and knee surgery had the highest returns.

About 10 percent of all readmissions were probably planned, such as putting in a stent, the researchers said. They estimated that unplanned return visits accounted for $17.4 billion of the $102.6 billion that Medicare paid hospitals in 2004.

“It’s a big hunk of money and it’s a big hunk of misery,” said another study author, Dr. Stephen Jencks, an independent consultant who worked for the Centers for Medicare and Medicaid Services.

Besides making follow-up doctor appointments, Jencks said hospitals should give patients a list of all their medications, explain what to do at home and where to call if they run into problems. He said the hospitals should also call the patient within two days and make sure that the patient’s doctor knows they were in the hospital.

He said the goal is to keep patients from getting really sick again, not to keep them out of the hospital if they do.

———

ON THE WEB

• New England Journal: http://www.nejm.org

• Care Transitions: http://www.caretransitions.org/

• Project Red: http://www.bu.edu/fammed/projectred

WASHINGTON – The federal government would for the first time have regulatory powers over the tobacco industry under a bill the House approved Thursday after years of campaigning by anti-smoking forces.

The measure, passed 298-112, gives the Food and Drug Administration authority to regulate — but not ban — cigarettes and other tobacco products.

The Senate could take up its version of the bill later this month, and supporters have expressed confidence they can overcome expected resistance from tobacco-state senators. The White House supports the legislation, a shift from the Bush administration which threatened to veto a House-passed measure last year.

President Barack Obama has spoken publicly about his own struggles to kick a smoking habit.

“This vote brings us closer to putting a deceitful and dangerous industry under the watchful eyes of government regulators,” American Heart Association CEO Nancy Brown said in a statement.

The bill was sponsored by Energy and Commerce Committee Chairman Henry Waxman, D-Calif., who in 1994 summoned the heads of big tobacco to a memorable hearing where they testified that nicotine was not addictive.

Waxman and his Senate counterpart, Sen. Edward Kennedy, D-Mass., have promoted legislation giving the FDA regulatory powers over tobacco products since the Supreme Court in 2000 ruled that the agency did not have that authority.

“We have come to what I hope will be an historic occasion, and that is finally doing something about the harm that tobacco does to thousands and thousands of Americans who die each year,” Waxman said Wednesday as lawmakers debated his Family Smoking Prevention and Tobacco Control Act.

His bill wouldn’t let the FDA ban nicotine or tobacco outright, but the agency would be able to regulate the contents of tobacco products, make public their ingredients, prohibit flavoring, require much larger warning labels and strictly control or prohibit marketing campaigns, especially those geared toward children.

Opponents from tobacco-growing states such as top-producing North Carolina argued that the FDA had proven through food safety failures that it’s not up to the job. They also said that instead of unrealistically trying to get smokers to quit or prevent them from starting, lawmakers should ensure they have other options, like smokeless tobacco.

That was the aim of an alternate bill offered by Rep. Steve Buyer, R-Ind., who would leave the FDA out and create a different agency within the Health and Human Services Department. His proposal failed on a 284-142 vote.

“Effectively giving FDA stamp of approval on cigarettes will improperly lead people to believe that these products are safe, and they really aren’t,” Buyer said. “We want to move people from smoking down the continuum of risk to eventually quitting.”

Major public health groups, including the American Lung Association and the American Medical Association, wrote to lawmakers asking them to oppose Buyer’s bill, contending it would leave tobacco companies without meaningful regulation and able to make untested claims about the health effects of their products.

Rep. Mike Rogers, R-Mich., also was unsuccessful in changing a provision that allows the FDA to tap its general fund for about six months to get the new program started. He argued that money would be diverted from the agency’s already overstretched food inspection and disease research budgets. Waxman countered that the user fees from the tobacco industry would pay for the new FDA office and that any money borrowed from the general fund would be paid back without affecting other programs.

Buyer pointed out that Waxman’s bill is supported by the nation’s largest tobacco company, Marlboro maker Philip Morris USA. Officials at rival tobacco companies contend the Waxman bill could lock in Philip Morris’ market share.

Kennedy plans to introduce his version of the legislation after Congress returns from a recess later this month. Sen. Richard Burr, R-N.C., is expected to lead the opposition, but supporters are confident they can clear the 60-vote threshold needed to break a filibuster.

NEW YORK – BASF, the world’s largest chemical maker, says it has found a way to prevent cavity-causing bacteria from attacking teeth, a development that could be seen in toothpaste, mouthwash and even candy as early as next year.

Using a microorganism related to those used in yogurt cultures, the Germany-based company said it has engineered a process that clusters harmful bacteria in the mouth before they can bind with sugar and form plaque.

The organism and plaque-causing bacteria are then swallowed as part of the mouth’s natural cleaning process.

It’s safe to swallow the bacteria, known by the scientific name Streptococcus mutans, because it’s regularly found in the mouth and humans already digest it constantly, the company said.

“There is a complex dynamic of bacteria that grow on the teeth,” said University of Connecticut Health Center’s Jason Tanzer, who studied BASF’s results and is presenting his findings at an industry conference Thursday. “They can stick to those surfaces and form a film or they can be swallowed.”

As part of his study, Tanzer fed two groups of rats a diet high in sugar, but put BASF’s product, known as pro-t-action, in only one group’s food.

Tooth decay in the group of rats using pro-t-action was far less pronounced than in the group not using the product, a development that Tanzer said was promising.

“I would be rather optimistic about this product,” he said.

The active organism in pro-t-action is effectively dead, meaning it doesn’t need to be kept cool — like yogurt — and can be used in a wide array of products like sugar-free candy, gum, toothpaste, and possibly beverages like smoothies. To be effective, the product needs to be in the mouth for about 10 to 15 seconds.

“This is not a replacement” for brushing, said Markus Pompejus, a BASF scientist who helped develop the product. “But it clearly helps to improve your daily oral hygiene.”

BASF developed pro-t-action with OrganoBalance, a Berlin-based microbiology company.

The companies are mum on human testing — a necessary precursor before any commercial distribution. Still, BASF hopes to have pro-t-action on store shelves by 2010 or 2011.

The company’s stock is traded on exchanges in London and Frankfurt, Germany.

TERRA BELLA, Calif. – It could take weeks before health officials know exactly which pistachio products may be tainted with salmonella, but they’ve already issued a sweeping warning to avoid eating the nuts or foods containing them.

The move appears to indicate a shift in how the government handles food safety issues — from waiting until contaminated foods surface one-by-one and risking that more people fall ill to jumping on the problem right away, even if the message is vague.

Officials wouldn’t say if the approach was in response to any perceived mishandling of the massive peanut recall that started last year, only that they’re trying to keep people from getting sick as new details surface about the California plant at the center of the pistachio scare.

“What’s different here is that we are being very proactive and are putting out a broad message with the goal of trying to minimize the likelihood of consumer exposure,” said Dr. David Acheson, FDA’s assistant commissioner for food safety. “The only logical advice to consumers is to say ‘OK consumers, put pistachios on hold while we work this out. We don’t want you exposed, we don’t want you getting salmonella.”‘

Dr. Joshua Sharfstein, the president’s new acting commissioner who started Monday, made it clear staff needed to move quickly, Acheson said.

The agency announced Monday that Setton Pistachio of Terra Bella Inc., the second-largest pistachio processor in the nation, recalled more than 2 million pounds of its roasted pistachios.

Suspect nuts were shipped as far away as Norway and Mexico, Acheson said Tuesday. One week after authorities first learned of the problem, they still had little idea what products were at risk, he said.

As federal health inspectors take swabs inside the plant to try to identify a salmonella source, a whole range of products from nut bars to ice cream and cake mixes remain in limbo on grocery shelves.

Company officials said Tuesday they suspected their roasted pistachios may have been contaminated by salmonella-tainted raw nuts they were processed with at the hulking facility.

Roasting is supposed to kill the bacteria in nuts. But problems can occur if the roasting is not done correctly or if roasted nuts are re-exposed to bacteria.

The firm sells its California-grown pistachios to giants of the food industry such as Kraft Foods Inc., as well as 36 wholesalers across the country.

“We care about our business and our customers greatly,” said Lee Cohen, the production manager for Setton International Foods Inc., a sister company to Setton Pistachios. “We’ve never had an illness complaint before but obviously this affects the whole industry. It’s not good.”

California supplies 99.99 percent of the U.S. pistachio market, according to the California Pistachio Board.

“What’s scary is that it’s after the nuts have been processed that this stuff is getting into it, so it really makes you wonder,” said Marcia Rowland, an avid pistachio eater in Apopka, Fla.

The FDA learned about the problem March 24, when Kraft notified the agency that routine product testing had detected salmonella in roasted pistachios. Kraft and the Georgia Nut Co. recalled their Back to Nature Nantucket Blend trail mix the next day and expanded the recall to include any Planters and Back to Nature products that contain pistachios Tuesday.

Kraft spokeswoman Laurie Guzzinati said her company’s auditors visited the plant early last week, and “observed employee practices where raw and roasted nuts were not adequately segregated and that could explain the sporadic contamination.”

She said she didn’t know specifically what they saw.

Federal inspectors last visited the plant in 2003, and the California Department of Public Health was there last year, Acheson said. Federal officials made note of several problems — an open door into one of the nut rooms, and an employee wearing street clothes that weren’t adequately covered — but nothing that posed a food safety threat, he said.

Acheson said management corrected the problems that day, and said he did not have access to California inspectors’ records.

Cohen said the plant had never had an illness complaint, followed industry health guidelines and had its huge metal silos and warehouse inspected regularly, but refused to provide additional details or records. Several plaques on the firm’s office walls showed the firm won industry awards for food safety excellence.

No illness have been tied to contaminated pistachios. Two people called the FDA complaining of gastrointestinal illness that could be associated with the nuts, but the link hasn’t been confirmed, Acheson said.

While consumer advocates praised the government’s swift action, they said the pistachio recall illustrated that more oversight was needed.

“It is encouraging that this response was so quick, but we need to move to a system that focuses on prevention through the entire food production process,” said Jeff Levi, executive director of Trust for America’s Health.

Two California legislators introduced a bill Tuesday that would require periodic testing of food at food processing facilities and mandate processors to report to state authorities within 24 hours any positive test result for a dangerous contaminant.

“We shouldn’t be reacting to the next crisis, we should be preventing the next crisis,” said Assemblyman Mike Feuer, D-Los Angeles.

———

ON THE WEB

www.settonfarms.com

www.fda.gov

Josh Kowalczyk, an intern with the West Michigan Whitecaps, in Comstock Park, Mich., tries the $20 burger that features a sesame-seed bun made from a pound of dough, five 1/3-pound beef patties, five slices of cheese, nearly a cup of chili and liberal doses of salsa and corn chips.

GRAND RAPIDS, Mich. – The staff dietitian at a doctors group says a minor-league baseball team in Grand Rapids, Mich., should warn fans that a 4,800-calorie burger it plans to sell is bad for them.

Susan Levin of the Washington-based Physicians Committee for Responsible Medicine sent a letter to the West Michigan Whitecaps on Tuesday. She wants the enormous burger to be labeled a “dietary disaster” that increases the risk of cancer and heart disease.

The 4-pound, $20 burger features five beef patties, five slices of cheese, nearly a cup of chili and liberal doses of salsa and corn chips – all on an 8-inch bun.

Whitecaps spokesman Mickey Graham says the team hasn’t considered labeling the burger, which he says is a gimmick being promoted as a very unhealthy menu item.

The recession has given the marketing world a twist: ads that boast about helping the newly unemployed.

Some of the nation’s savviest marketers also have figured out that the best way to get folks who fear job loss to spend money is to promise them a rebate, refund or special deal if they are laid off shortly after the purchase.

“Altruism marketing is a powerful way to say, “We care,’ ” says Michael Silverstein, senior vice president at Boston Consulting Group. “I expect to see a lot more of it over the next 90 days.”

Today, Walgreens will unveil an offer that promises customers of the drug chain’s in-store health care clinics free family services for the rest of 2009 if they lose their jobs. It’s limited to stuff such as colds, earaches and allergies, not major health issues. “We’re doing it because it’s the right thing to do,” says Hal Rosenbluth, president of Walgreens Health and Wellness division.

Walgreens is just the latest retailer to offer special deals to the jobless. The national unemployment rate hit 8.1 percent in February.

Who’s doing it now:

• Health care. The Walgreens plan is offered at its 342 Take Care Clinics located inside a limited number of Walgreens stores. The service is available to the unemployed and their dependents who are uninsured and had used the service prior to their job loss. (Details: takecarerecoveryplan.com.)

Besides helping the jobless and their families, the move also will build “greater awareness” of the rapidly expanding health clinic chain, Rosenbluth says.

• Cars. Under Hyundai Assurance Plus, the carmaker will make up to three car payments for new Hyundai buyers who lose their jobs, and let them give the car back without penalty if they still haven’t found work. Hyundai’s Internet traffic is up 22 percent this year, says Joel Ewanick, marketing chief.

AutoNation, the giant car retailer, just rolled out a program that will make car payments for up to six months for car buyers who lose their jobs.

• Airlines. JetBlue is waving flight-cancellation fees – up to $100 per ticket – for customers who lose their jobs. The deal was expanded this month to vacation packages booked via JetBlue.

• Retailers. Jos. A. Bank Clothiers, the men’s clothing chain, recently took job-loss aid to the next step. Customers who buy its $199 suits and lose their jobs will have their money refunded and can keep the suits. “Like all retailers, we find motivating customers to purchase is challenging,” CEO Neal Black says. “We expect to make some long-term customers out of this promotion.”

• Business services. FedEx Office this month had 24,000 people take it up on its one-day offer to print 25 free rÈsumÈs for folks who had lost their jobs. About 890,000 were printed, says CEO Brian Philips, who received hundreds of thank-you notes and e-mails. One Ohio pastor used a church bus to take congregants to the store for the free rÈsumÈs.

———

WALGREENS PLAN

takecarerecoveryplan.com