'Amazing' therapy wipes out leukemia in study (AP)

NEW YORK � Scientists are reporting the first clear success with a new approach for treating leukemia � turning the patients' own blood cells into assassins that hunt and destroy their cancer cells.

They've only done it in three patients so far, but the results were striking: Two appear cancer-free up to a year after treatment, and the third patient is improved but still has some cancer. Scientists are already preparing to try the same gene therapy technique for other kinds of cancer.

"It worked great. We were surprised it worked as well as it did," said Dr. Carl June, a gene therapy expert at the University of Pennsylvania. "We're just a year out now. We need to find out how long these remissions last."

He led the study, published Wednesday by two journals, New England Journal of Medicine and Science Translational Medicine.

It involved three men with very advanced cases of chronic lymphocytic leukemia, or CLL. The only hope for a cure now is bone marrow or stem cell transplants, which don't always work and carry a high risk of death.

Scientists have been working for years to find ways to boost the immune system's ability to fight cancer. Earlier attempts at genetically modifying bloodstream soldiers called T-cells have had limited success; the modified cells didn't reproduce well and quickly disappeared.

June and his colleagues made changes to the technique, using a novel carrier to deliver the new genes into the T-cells and a signaling mechanism telling the cells to kill and multiply.

That resulted in armies of "serial killer" cells that targeted cancer cells, destroyed them, and went on to kill new cancer as it emerged. It was known that T-cells attack viruses that way, but this is the first time it's been done against cancer, June said.

For the experiment, blood was taken from each patient and T-cells removed. After they were altered in a lab, millions of the cells were returned to the patient in three infusions.

The researchers described the experience of one 64-year-old patient in detail. There was no change for two weeks, but then he became ill with chills, nausea and fever. He and the other two patients were hit with a condition that occurs when a large number of cancer cells die at the same time � a sign that the gene therapy is working.

"It was like the worse flu of their life," June said. "But after that, it's over. They're well."

The main complication seems to be that this technique also destroys some other infection-fighting blood cells; so far the patients have been getting monthly treatments for that.

Penn researchers want to test the gene therapy technique in leukemia-related cancers, as well as pancreatic and ovarian cancer, he said. Other institutions are looking at prostate and brain cancer.

Dr. Walter J. Urba of the Providence Cancer Center in Portland, Ore., called the findings "pretty remarkable" but added a note of caution because of the size of the study.

"It's still just three patients. Three's better than one, but it's not 100," said Urba, one of the authors of an editorial on the research that appears in the New England Journal.

What happens long-term is key, he said: "What's it like a year from now, two years from now, for these patients."

But Dr. Kanti Rai, a blood cancer expert at New York's Long Island Jewish Medical Center, could hardly contain his enthusiasm, saying he usually is more reserved in his comments on such reports.

"It's an amazing, amazing kind of achievement," said Rai, who had no role in the research.

None of the three patients wanted to be identified, but one wrote about his illness, and his statement was provided by the university. The man, himself a scientist, called himself "very luck," although he wrote that he didn't feel that way when he was first diagnosed 15 years ago at age 50.

He was successfully treated over the years with chemotherapy until standard drugs no longer worked.

Now, almost a year since he entered the study, "I'm healthy and still in remission. I know this may not be a permanent condition, but I decided to declare victory and assume that I had won."

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Online:

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

Science journal: http://stm.sciencemag.org

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BULLETIN KILL (AP)

Copyright © 2011 The Associated Press. All rights reserved. The information contained in the AP News report may not be published, broadcast, rewritten or redistributed without the prior written authority of The Associated Press.

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Boy or girl? A simple test raises ethical concerns (AP)

CHICAGO � Boy or girl? A simple blood test in mothers-to-be can answer that question with surprising accuracy at about seven weeks, a research analysis has found.

Though not widely offered by U.S. doctors, gender-detecting blood tests have been sold online to consumers for the past few years. Their promises of early and accurate results prompted genetics researchers to take a closer look.

They analyzed 57 published studies of gender testing done in rigorous research or academic settings � though not necessarily the same methods or conditions used by direct-to-consumer firms.

The authors say the results suggest blood tests like those studied could be a breakthrough for women at risk of having babies with certain diseases, who could avoid invasive procedures if they learned their fetus was a gender not affected by those illnesses. But the study raises concerns about couples using such tests for gender selection and abortion.

Couples who buy tests from marketers should be questioned about how they plan to use the results, the study authors said.

The analyzed test can detect fetal DNA in mothers' blood. It's about 95 percent accurate at identifying gender when women are at least seven weeks' pregnant � more than one month before conventional methods. Accuracy of the testing increases as pregnancy advances, the researchers concluded.

Conventional procedures, typically done for medical reasons, can detect gender starting at about 10 weeks.

The new analysis, published in Wednesday's Journal of the American Medical Association, involved more than 6,000 pregnancies. The testing used a lab procedure called PCR that detects genetic material � in this case, the male Y chromosome. If present in the mother's blood, she's carrying a boy, but if absent, it's a girl.

Tests that companies sell directly to consumers were not examined in the analysis. Sex-detection tests using mothers' urine or blood before seven weeks of pregnancy were not accurate, the researchers said.

Senior author Dr. Diana Bianchi, a reproductive geneticist and executive director of the Mother Infant Research Institute at Tufts Medical Center in Boston, called the results impressive. She noted that doctors in Great Britain are already using such testing for couples at risk of having children with hemophilia or other sex-linked diseases, partly to help guide treatment decisions.

The research indicates that many laboratories have had success with the test, but the results can't be generalized to all labs because testing conditions can vary substantially, said Dr. Joe Leigh Simpson, a genetics professor at Florida International University. He was not involved in the study.

Simpson noted that using gender-detection blood testing for medical or other reasons has not been endorsed by guideline-setting medical groups and some experts consider it experimental.

Dr. Lee Shulman, chief of clinical genetics at Northwestern Memorial Hospital in Chicago, said the testing "isn't ready for prime time."

He said his hospital doesn't provide the blood tests, and doesn't offer more conventional techniques, including amniocentesis, to women who have no medical reason for wanting to know their baby's gender.

"I would have a lot of difficulties offering such a test just for gender identification. Gender is not an abnormality," Shulman said. "My concern is this is ultimately going to be available in malls or shopping centers," similar to companies offering "cute" prenatal ultrasound images.

Recent research found that increasing numbers of women in India who already have daughters are having abortions when prenatal tests show another girl, suggesting that an Indian ban on such gender testing has been ineffective. The expense of marrying off girls has contributed to a cultural preference there for boys.

Evidence also suggests that China's limits on one child per couple and traditional preference for male heirs has contributed to abortions and an increasingly large gender imbalance.

There's very little data on reasons for U.S. abortions or whether gender preferences or gender-detection methods play a role, said Susannah Baruch, a policy consultant for the Generations Ahead, an advocacy group that studies genetic techniques and gender issues.

Consumer Genetics Inc. a Santa Clara, Calif.-based company sells an "early gender" blood test called "Pink or Blue" online for $25 plus $265 or more for laboratory testing. It boasts of 95 percent accuracy, using a lab technique its scientists developed from the type of testing evaluated in the new analysis, said Terry Carmichael, the company's executive vice president.

Carmichael said the company sells more than 1,000 kits a year. He said the company won't test blood samples unless women sign a consent form agreeing not to use the results for gender selection.

The company also won't sell kits to customers in China or India because of fears of gender selection, he said.

Medical techniques that can detect gender include amniocentesis, usually done at around 16 weeks, using a needle to withdraw fluid surrounding the fetus to identify abnormalities; chorionic villus sampling, done at around the 10th week to detect abnormalities by examining placenta tissue; and ultrasound, most accurate at around 13 weeks. The first two methods can slightly increase risks for miscarriages.

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Online:

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

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AP Medical Writer Lindsey Tanner can be reached at http://www.twitter.com/Lindsey Tanner

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Pediatricians: Sports in heat OK with precautions (AP)

CHICAGO � Playing sports in hot, steamy weather is safe for healthy children and teen athletes, so long as precautions are taken and the drive to win doesn't trump common sense, the nation's largest pediatricians group says.

New guidelines from the American Academy of Pediatrics arrive just as school sports ramp up in sultry August temperatures. The advice, released Monday, comes a week after two Georgia high school football players died following practices in 90-plus degree heat. Authorities were investigating if the weather contributed.

The guidelines replace a more restrictive policy based on old thinking that kids were more vulnerable to heat stress than adults. New research shows that's not true, the academy says. With adequate training, water intake, time-outs and emergency treatment available on the sidelines, healthy young athletes can play even in high heat and humidity � within reason, the guidelines say.

"The more educated parents, athletes and staff are about risks associated with heat illness, the more likely they will think twice before allowing a competitive culture to overtake sound sensibilities," said Dr. Cynthia Devore, co-author of the policy and a physician for schools in the Rochester, NY area..

Government data released last week showed that more than 3,000 U.S. children and teens younger than 20 received emergency-room treatment for nonfatal heat illness from sports or exercise between 2001 and 2009.

A few young athletes die annually from heat-related illness. Over a 13 year period, 29 high school football players died from heat stroke, data from the American Football Coaches Association and others show. Football is a special concern, because players often begin intense practice during late-summer heat, wearing uniforms and padding that can be stifling.

Dr. Michael Bergeron, a University of South Dakota sports medicine specialist, said the academy's old policy was often ignored because it recommended limiting or avoiding sports even in common hot weather conditions. The new policy is more detailed and nuanced, recommending that athletes be evaluated individually for play in hot weather.

Still, Bergeron warned that overzealousness can be dangerous even for healthy kids, and even in relatively tame summer weather.

"You can take somebody in 80-degree heat and you can kill them if you work them hard enough," he said.

The guidelines don't list temperature or humidity cutoffs, but say safety should be the top priority.

Other academy advice includes:

_Teams should have emergency plans with trained personnel and treatment available and policies for avoiding heat illness.

_Give kids about two weeks to adapt to preseason sessions, gradually increasing intensity and duration. Closely monitor more vulnerable kids, including those who are overweight or have diabetes.

_Make sure athletes are well-hydrated before practice or games. During activity, kids aged 9-12 should drink about half a cup to a cup of water every 20 minutes; for teens, 5 or 6 cups an hour. Sports drinks containing electrolytes and sodium should be offered during extra strenuous activity.

_Educate everyone about signs of heat stress, including dizziness, muscle cramps, headaches and nausea. Kids with symptoms should be sidelined and treated immediately; athletes should be encouraged to report if teammates seem to be struggling.

___

Online:

American Academy of Pediatrics: http://www.aap.org

National Institute for Athletic Health & Performance: http://bit.ly/aelUn3

___

Lindsey Tanner can be reached at http://www.twitter.com/LindseyTanner

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Japan team produces sperm from mice stem cells (AP)

TOKYO � A team of scientists has produced viable sperm from the stem cells of mice in an experiment that could be a breakthrough toward treating infertile humans, according a newly released study.

The Kyoto University researchers managed to induce mice stem cells into creating sperm precursors, which were transplanted into infertile male mice. The mice then produced sperm that was successfully used to fertilize eggs in vitro.

The offspring were healthy and fertile, according to a paper published online Thursday in the Cell, an academic journal.

The research team, led by Mitinori Saitou, said they believe their success may help in the development of infertility treatments in humans, although they said many hurdles remain.

"We have high hopes, but it's not that easy," Saitou told the Associated Press by telephone Friday from Kyoto, in western Japan. "There are many difficult issues ahead in applying this to humans. But it is a first step."

Experts outside the group say it's an important first step toward infertility treatment although there would be a long way.

"This is a very good experiment for thinking about treatment of infertile man but a very very long way," said Toshio Suda, developmental biology professor at Keio University.

He said the Kyoto team's findings were great work but it is not easy to prepare the mature sperm cells at present. If some hurdles are cleared, it could successfully identify "which gene is very important to prepare the sperm."

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Windfall for Massachusetts hospitals is questioned (AP)

WASHINGTON � An obscure provision tucked into the federal health care law has turned into a jackpot for Massachusetts hospitals, but officials in other states are upset because the money will come from their hospitals.

The Medicare windfall for Massachusetts � $275 million a year � adds up quickly, about $1.4 billion over five years.

"If I could think of a better word than outrageous, I would come up with it," said Steve Brenton, president of the Wisconsin Hospital Association.

The news was buried in a Medicare regulation issued Monday and comes at a time when hospitals face more cuts under the newly signed federal debt deal.

Even Medicare says it is concerned about "manipulation" of its inpatient payment rules to create big rewards for one state at the expense of others.

Hospitals in 41 states will lose money as a result of the change. The biggest loser: New York, which is out $47.5 million.

Seven states come out ahead, though none do as well as Massachusetts. Runner-up New Jersey stands to gain $54 million, a fraction of what Massachusetts will get.

President Barack Obama's health care overhaul was supposed to lead to reforms in Medicare's byzantine payment system. Critics say this latest twist will encourage the big players to game the system in a scramble for increasingly scarce taxpayer dollars.

The health care law "was to usher in a new era, based on innovations that focused on quality improvement and more efficient health care," said Herb Kuhn, president of the Missouri Hospital Association. "What we are seeing is innovation in the area of how to manipulate the payment system."

"It subverts any notion of fairness and equity in developing the rates," said Laurens Sartoris, president of the Virginia Hospital & Healthcare Association. "It's someone going through the backdoor to get special treatment in what amounts to an earmark."

No backdoor maneuvers were involved, said the head of the Massachusetts Hospital Association, defending the change.

"We do not see this as a manipulation of the rules," said Lynn Nicholas. She said the higher payments will help compensate Massachusetts hospitals for a Medicare policy change a few years ago that cost them hundreds of millions of dollars.

Massachusetts Democratic Sen. John Kerry, a co-sponsor of the provision in the health care law that benefited his state's hospitals, was also steadfast.

"When (Medicare) changed the rules five years ago, the rest of the country gained at our expense and Massachusetts took a big hit," Kerry said in a statement. "These new rules just provide some correction."

The American Hospital Association supported the change when the law was being debated. An official there now says hospitals didn't understand what they were getting with the obscure provision.

The saga of how Massachusetts scored big could come straight from a lobbyist's playbook.

It goes back a few years and twists and turns through Medicare's mind-boggling payment rules.

Those rules include a factor that's used to adjust payments to hospitals for the difference in labor costs around the country. The adjustments cannot lead to any increase in overall Medicare spending, automatically setting up potential winners and losers.

On top of that, another rule says that the labor cost factor for a hospital in an urban area of a state cannot be less than for that state's rural areas.

That's where two small hospitals on Nantucket and Martha's Vineyard, islands off the Massachusetts coast popular with vacationers, come into the picture.

Those hospitals had been operating as "critical access hospitals," reimbursed by Medicare at special rates that usually work out to be top tier.

Then, according to Kuhn, some mainland hospitals persuaded them to reclassify themselves as "rural" hospitals. That put them back under the same payment rules as the mainland hospitals. What followed was a sort of domino effect.

Since labor costs are relatively high on the islands, it raised rural costs in the entire state. In turn, that led to higher payments for urban hospitals. A group of mainland hospitals affiliated with the island hospitals also agreed to reimburse them for any financial losses as a result of the change.

Changing from "critical access" to "rural" hospitals was totally legitimate, Nicholas said.

"They were fully qualified to do that," she said. "That hurt them individually financially, but because of their relationship with the overall system they were able to subsidize those losses."

Medicare put up roadblocks to the change, and in 2008 it looked like the feds would win out. Then the health care overhaul law turned the tables.

Medicare officials declined to comment. But in another regulation issued this year, the agency expressed concern with what it termed the "manipulation" of its rules to win an 8 percent increase for one state at the expense of others.

The new payment rates take effect Oct. 1.

In addition to Massachusetts and New Jersey, other states that come out ahead � for a variety of reasons � are Alaska, California, Colorado, Connecticut and New Hampshire. Hospitals in Wyoming break even. And Maryland hospitals have long been paid under a different system.

Every other state loses.

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