Genetically modified human embryo stirs criticism
Mon, 12 May 2008 22:25:28 GMTBy MALCOLM RITTER, AP Science Writer
NEW YORK - News that scientists have for the first time genetically altered a human embryo is drawing fire from some watchdog groups that say it's a step toward creating "designer babies."
But an author of the study says the work was focused on stem cells. He notes that the researchers used an abnormal embryo that could never have developed into a baby anyway.
"None of us wants to make designer babies," said Dr. Zev Rosenwaks, director of the Center for Reproductive Medicine and Infertility at NewYork-Presbyterian/Weill Cornell Medical Center.
The idea of designer babies is that someday, scientists may insert particular genes into embryos to produce babies with desired traits like intelligence or athletic ability. Some people find that notion repugnant, saying it turns children into designed objects, and would create an unequal society where some people are genetically enriched while others would be considered inferior.
The study appears to be the first report of genetically modifying a human embryo. It was presented last fall at a meeting of the American Society for Reproductive Medicine, but didn't draw widespread public attention then. The result was reported over the weekend by The Sunday Times of London, which said British authorities highlighted the work in a recent report.
Rosenwaks and colleagues did the work with an embryo that had extra chromosomes, making it nonviable. Following a standard procedure used in animals, they inserted a gene that acts as a marker that can be easily followed over time. The embryo cells took up the gene, he said.
The goal was to see if a gene introduced into an abnormal embryo could be traced in stem cells that are harvested from the embryo, he said. Such work could help shed light on why abnormal embryos fail to develop, he said.
No stem cells were recovered from the human embryo, said Rosenwaks, noting that abnormal embryos frequently don't develop well enough to produce them.
Marcy Darnovsky, associate executive director of the Center for Genetics and Society, said the Cornell scientists were developing techniques that others might use to make genetically modified people, "and they're doing it without any kind of public debate."
A London-based group called Human Genetics Alert similarly criticized the work.
But Kathy Hudson, director of the Genetics and Public Policy Center in Washington, D.C., said she's not troubled by the work. She said the idea of successfully modifying babies by inserting genes remains a technically daunting challenge.
"We're not even close to having that technology in hand to be able to do it right," she said, and it would be ethically unacceptable to try it when it's unsafe.
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On the Net:
Center for Genetics and Society: http://www.geneticsandsociety.org
Human Genetics Alert: http://www.hgalert.org
Genetics and Public Policy Center: http://www.dnapolicy.org
Nagging via text messages to help teens remember meds
Mon, 12 May 2008 19:25:58 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - 4gt yr meds? Getting kids to remember their medicine may be a text message away. Cincinnati doctors are experimenting with texting to tackle a big problem: Tweens and teens too often do a lousy job of controlling chronic illnesses like asthma, diabetes or kidney disease.
It's a problem long recognized in adults, particularly for illnesses that can simmer without obvious symptoms until it's too late. But only now are doctors realizing how tricky a time adolescence is for skipping meds, too.
Of necessity, parents start turning over more health responsibilities to their children at this age. It's also an age of angst, sometimes rebellion, and when youths may most hate feeling different from their friends because of medication, special diets or other therapy.
"It's a time of so much change in these kids' lives," says Dr. Marva Moxey-Mims, a specialist in pediatric kidney disease at the National Institutes of Health. "It's very difficult when you've got a life-threatening illness to say, 'Let them make their mistakes.'"
There are few good statistics on how many chronically ill kids don't adhere to therapy. But what little data exists is alarming enough that the NIH's National Institute of Diabetes and Digestive and Kidney Diseases will bring specialists together in September to debate next steps:
_Some studies suggest only half of adolescents, on average, properly follow treatment steps, says Dr. Dennis Drotar of Cincinnati Children's Hospital. The more medications required or the more troublesome the side effects — even, for appearance-conscious teens, such things as weight gain from steroid medications — the worse kids adhere.
_Asthma's record is particularly bad, with research suggesting as few as 30 percent of teenagers correctly take medication to prevent asthma attacks.
_Among kidney transplant recipients, adolescents have the worst long-term outcomes of any age group, says Moxey-Mims.
Even when parents try to keep close tabs, "kids are cunning," Drotar notes. "Parents are in a bind because there's pushback."
Drotar once used a monitor to detect whether cystic fibrosis patients performed a chest-thumping therapy to clear their lungs. One teen's monitor showed weird readings: He'd strapped it onto his dog.
Kabrina Moton, 16, of Cincinnati knows she'll start wheezing and need her inhaler when she plays basketball if she hasn't taken her daily asthma pill.
Still, "one time I went a whole month without taking it," she confesses. "It's just work and school and being in and out of the house all the time. ... When I would think about it, I wasn't around it or I was out and I wouldn't remember later on."
Enter text messages.
Dr. Maria Britto, an asthma specialist at Cincinnati Children's, noticed that even when she's talking to adolescent patients perched on the clinic exam table, they'll keep texting on their cell phones.
"You have to get in their face a little," she says with a laugh.
But it sparked the idea for a study to see if a daily medication reminder via text message would improve kids' asthma control — preventing full-blown attacks, improving school attendance and decreasing doctor and emergency-room visits. After all, Britto says kids as young as 12 carry the phones into her clinic, poor and middle class alike.
Pilot testing recently began, with a full study set for later this year. Participants say what time they want the reminder, and a clinic volunteer types out the messages — words spelled out, no mimicking of kids' text lingo.
Moton says she texts a lot, so it's easy to spot her reminder at 7 each evening — and so far, she hasn't missed a dose.
"It always says, 'Have a nice day,'" she says. "It makes me feel good about it."
If the simple reminders work for asthma, they may for other diseases, too.
"We have the science" backing treatments, Britto notes. "We just can't figure out how to get the right drugs into the right kids' bodies."
But remembering medication doses is only one part of a very complex problem. First, families must understand the importance of following treatment even when children feel fine. Then, parent-adolescent relationships play a huge role.
"Kids are thinking short-term and not long-term complications. If they're feeling better for the moment, there's a tendency to keep testing the limit," says Drotar.
He tracked teens whose leukemia was in remission, and found a shocking 30 percent had no evidence in their blood of the follow-up medicines designed to help keep them in remission.
Now Drotar's team is testing problem-solving techniques with those leukemia survivors, bringing in parents and teens to discuss treatment barriers and brainstorm solutions without nagging or teen-parent head-butting.
Peer pressure is another approach, talks from older teens who can empathize with the rigors of dialysis, for example, or who tell how they got sick from skipping treatment.
And in an NIH-funded study, researchers in Cincinnati, the University of Miami and the Nemours Clinic in Wilmington, Del., are tracking 9- to 11-year-olds and their families for three years, to pinpoint what predicts a drop-off in control of Type 1 diabetes during adolescence.
Not surprisingly, Drotar says, kids with stable families and positive parent relationships fare better.
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EDITOR's NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
Study Older brains dont benefit from painkillers
Mon, 12 May 2008 20:30:12 GMTBy CARLA K. JOHNSON, Associated Press Writer
CHICAGO - Results from a large government experiment are dimming hopes that two common painkillers can prevent Alzheimer's disease or slow mental decline in older people.
The arthritis drug Celebrex and the over-the-counter painkiller Aleve showed no benefit on thinking skills, new findings show. Earlier results from the same research showed the two drugs didn't prevent Alzheimer's, at least in the short term.
The experiment was halted several years early in 2004 when heart risks turned up in a separate study on Celebrex. Researchers also had noticed more heart attacks and strokes in the people taking Aleve in the Alzheimer's prevention study.
Despite the study's early end, there was still enough data to hint at how the drugs act on thinking and memory. The findings were posted online Monday and will appear in July's Archives of Neurology.
"These were not the results we were hoping for," said co-author Barbara Martin of the Johns Hopkins Bloomberg School of Public Health. "We designed this study hoping we would see a protective effect of these drugs."
Researchers hope to continue monitoring the participants to see if they find any delayed benefit.
Scientists have speculated that nonsteroidal anti-inflammatories, such as Aleve and Celebrex, might prevent Alzheimer's by reducing inflammation in the brain or by other means.
"The drugs have several effects in the brain and the different effects could be important at different stages in the illness," said study co-author Dr. John Breitner of the University of Washington in Seattle.
Previous studies had found that people who took the drugs ran a lower risk of developing Alzheimer's. But those were observational studies, meaning they observed people's behavior and health. The people who took the pills may have had other healthy habits that lowered their risk.
The halted study included more than 2,000 people ages 70 and older with a family history of Alzheimer's but no thinking problems themselves. People were randomly assigned to take standard daily doses of either Celebrex, Aleve, also known as naproxen, or a dummy pill.
At the start and annually for up to three years, they took a battery of tests. In one, they named as many grocery items as they could in one minute.
All three groups scored about the same at the start. But over time, the Aleve takers scored on average slightly lower than the people who took placebos. The Celebrex takers scored slightly lower than the placebo takers on most, but not all, of the tests.
"There's no evidence that people should be on these drugs to prevent Alzheimer's disease," said Dr. David Bennett of Chicago's Rush University Medical Center, who was not involved in the study but does similar research. "With the side effects of these drugs, people shouldn't be taking them for this reason."
Both products now carry warnings about heart risks. Anti-inflammatory drugs also can cause serious gastrointestinal bleeding. Experts advise patients to ask their doctors about how long to take the drugs for pain.
The study was funded by the National Institute on Aging. Pfizer Inc. and Bayer Healthcare provided the drugs and matching dummy pills for the study, but did not participate in the research. Some of the authors reported receiving speaking or consulting fees from drug companies, including Pfizer.
"Unfortunately, as this paper demonstrates, research doesn't always translate into successful new treatments," said Dr. Gail Cawkwell of Pfizer in an e-mail. Cawkwell pointed out that the study did not find increased heart risks for Celebrex.
Bayer spokeswoman Tricia McKernan said the early end to the experiment reduces the relevance of the data. She said the findings don't apply to the intended use of Aleve as a short-term pain reliever.
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On the Net:
Archives of Neurology: http://archneur.ama-assn.org
All poultry in Seoul killed after bird flu outbreak
Tue, 13 May 2008 02:14:17 GMTBy HYUNG-JIN KIM, Associated Press Writer
SEOUL, South Korea - South Korean officials said Monday they have killed all poultry in Seoul, the capital, to curb the spread of bird flu following a new outbreak of the disease in the city.
Quarantine officials destroyed 15,000 chickens, ducks, pheasants and turkeys raised in farms, restaurants, schools and homes in the capital, said Kim Yoon-kyu, a Seoul Metropolitan Government official.
The Seoul government said the slaughter was necessary to contain the disease. It said it will now focus on preventing live poultry from being brought into the capital.
The slaughter began Sunday night, hours after authorities confirmed Seoul's second outbreak of bird flu in less than a week.
The slaughter did not affect parrots, parakeets and canaries because they have little chance of spreading the disease, Kim said.
Government tests were under way to determine whether the outbreak was caused by the virulent H5N1 virus, said Kim Chang-seop, an official at the Agriculture Ministry. He said test results would be available as early as Monday night.
On Monday night, government tests confirmed the latest outbreak in Seoul was caused by the deadly H5N1 virus, said Yoon Young-ku, a spokesman at the Agriculture Ministry.
The tests also confirmed two additional outbreaks of the virus in Busan, brining to 31 the total number of outbreaks in South Korea, he said.
Bird flu began sweeping southern parts of the country last month for the first time in more than a year, forcing the slaughter of about 6.8 million birds.
The virus remains hard for people to catch, but scientists worry it could mutate into a form that spreads more easily between humans, with the potential to kill millions worldwide.
Worldwide, at least 241 people have died from bird flu since 2003, according to the World Health Organization. Most human cases have been linked to contact with infected poultry.
Chinese drugs seen driving down generic prices
Tue, 13 May 2008 08:19:52 GMTBy Ben Hirschler
LONDON - A coming wave of Chinese pills is set to push down the price of generic drugs, as more low-cost finished medicines from the country win approval in major markets, according to a report on Tuesday.
Pharmaceutical information group IMS Health Inc said last year's first okay from the U.S. Food and Drug Administration for a Chinese generic -- a copy of AIDS drug nevirapine -- was a sign of things to come.
China is already the world's biggest producer of active pharmaceutical ingredients , the chemical raw materials needed to manufacture medicines, but to date it has not been a significant supplier of finished generic pills.
Now that is about to change.
Zhejiang Huahai Pharmaceutical Co Ltd won a U.S. green light last July to sell generic nevirapine, once the patent held by Germany's Boehringer Ingelheim expires in 2012.
At least 10 other Chinese companies are set to follow suit with other generic products, according to IMS. Some could be available as early as this year.
The result will be increased competition in a generic drugs industry that is already struggling with tumbling prices.
"In order to ensure their success in the market, the Chinese manufacturers are likely to undercut all others on price," IMS said in its annual Intelligence.360 report.
"Chinese policy will drive generic prices down still further, with far-reaching consequences for both R&D players and international generic companies."
The rise of Chinese generic drugmakers is expected to mirror that of Indian firms like Ranbaxy Laboratories Ltd, which also started out as an API supplier but moved into finished generic medicines a decade ago.
IMS believes China will seek to erode India's strong position in manufacturing by targeting the United States, Europe and key emerging markets.
One potential obstacle for China's emerging generics industry, however, may be its reputation for quality.
IMS said recent safety issues involving tainted heparin made with ingredients from China had put the country "on the back foot."
"India has had less publicity than China for manufacturing inadequacies ... and it is here where the competitive battle may be won or lost," IMS said.
Contaminated supplies of various brands of the blood thinner heparin have been linked to 81 U.S. deaths since January 2007.
Celebrex Naproxen Won39t Prevent Mental Decline
Tue, 13 May 2008 03:47:11 GMTBy Amanda Gardner
HealthDay Reporter
MONDAY, May 12 -- Contrary to prior studies, a new trial shows that daily use of two popular pain-relieving drugs, Celebrex and naproxen, does not prevent cognitive decline in people with a family history of Alzheimer's disease.
In fact, naproxen, which goes under the brand names Aleve and Naprosyn, may even have a deleterious effect on cognitive function, the study found.
"The drugs we studied did not seem to improve cognitive function and, if anything, there was some weak evidence for a detrimental effect," said Barbara Martin, an investigator on the trial and assistant professor of epidemiology at the Johns Hopkins School of Public Health in Baltimore. "So we don't at this time recommend taking NSAIDs for the purpose of preventing Alzheimer's or cognitive decline."
Added Dr. John Morris, director of the Alzheimer's Disease Research Center at Washington University School of Medicine in St. Louis and a member of the medical and scientific advisory council for the Alzheimer's Association: "My strong recommendation is I would not take any drug for a hoped-for effect until it has been demonstrated to have such an effect. Drugs potentially have side effects and unless there's a documented benefit, just because it's popular, I wouldn't rush to do that."
Both Celebrex and naproxen belong to the class of pain-killing drugs known as non-steroidal anti-inflammatory drugs .
The study, to be published in the July issue of Archives of Neurology, was funded by the U.S. National Institute on Aging. The drug maker Pfizer provided the supply of Celebrex used in the study, plus a matching placebo, while Bayer Healthcare provided naproxen and a matching placebo.
Inflammatory processes may play a role in Alzheimer's disease and in cognitive decline in general.
"In addition to the plaques and tangles which are pathological hallmarks of Alzheimer's, there also seem to be signs of inflammation in the brains of people with the disease," Martin said.
That observation has led scientists to speculate that anti-inflammatory drugs may have an effect on the disease and, in fact, some previous observational studies have shown an association between NSAID use and a reduced risk of developing Alzheimer's.
In May 2007, the same group of researchers published findings that Celebrex and naproxen did not prevent Alzheimer's disease.
For the new study, 2,117 men and women over the age of 70 with a family history of Alzheimer's disease were randomly assigned to receive 200 milligrams of Celebrex twice a day, 220 milligrams of naproxen twice a day, or a placebo. Participants did not have a diagnosis of Alzheimer's, other dementias or mild cognitive impairment at the March 2001, start of the trial.
The participants' cognitive function was tested annually, but therapy was stopped in December 2004 because another study had reported an increased risk of cardiovascular problems in people taking Celebrex.
Analysis of this trial found that people taking naproxen had lower overall scores on measures of cognitive function than did men and women taking the placebo. Individuals taking naproxen or Celebrex had lower scores on a specific mental exam than did those taking a placebo.
The differences in results between this trial and previous research may have to do with the design of the study, or the results here may apply only to Celebrex and naproxen and not to other anti-inflammatory drugs such as ibuprofen, the researchers said. Or NSAIDs may only confer protection when given much earlier.
"This is speculative but there is increasing evidence that it may be a matter of timing, so by the time older adults take these drugs, if there is a protective effect, it may be past that time," Morris explained.
At this point, however, experts don't know what the best time would be to start the drugs.
"Increasingly we see that if we're going to want to understand how the process of Alzheimer's disease begins in the brain, we cannot limit our studies simply to older adults," Morris said. "We have to begin to study people even in middle age because the disease process may have its origins decades before people actually develop it."
Dr. Gary Kennedy is director of geriatric psychiatry at Montefiore Medical Center in New York City. Regarding this particular area of anti-inflammatory research as it pertains to cognitive problems, he said, "It's not strike three, but it's strike two for sure. The inflammatory model was a reasonable shot to begin with, but it was a long shot. [Inflammation] may be a side effect."
More information
There's more on cognitive decline at the Alzheimer's Association.
Being breastfed may lower breast cancer risk
Mon, 12 May 2008 18:19:40 GMTBy Joene Hendry
NEW YORK - Adult women who were breast-fed as infants may have a lower risk of developing breast cancer than those who were not breast-fed, unless they were first-born, study findings suggest.
"As a general group, women who reported they had been breast-fed in infancy had a 17 percent decrease in breast cancer risk," Hazel B. Nichols, who was involved in the study, told Reuters Health.
"However, we did not observe this reduction when we looked specifically among first-born women," said Nichols, of the University of Wisconsin, in Madison.
A woman's age at childbirth helps predict the levels of environmental contaminants in her breast milk, and studies have suggested a possible link between increased breast cancer risk and the accumulation of these contaminants, Nichols and colleagues note in the medical journal Epidemiology.
To analyze whether an adult woman's birth order, mother's age at the time of her birth, and whether or not she was breast-fed alters her risk for breast cancer, the investigators interviewed 2,016 women, aged 20 to 69 years, with breast cancer, and 1,960 women of similar age without breast cancer.
As noted, women breast-fed during infancy generally had reduced breast cancer risk.
However, in analyses restricted to breast-fed women, those with 3 or more older siblings had a lesser risk for breast cancer than first born women, the researchers found. But breast-fed women showed no altered breast cancer risk according to their mothers' age at childbirth.
Among women who were not breast-fed, reduced adult breast cancer risk was linked with their mothers' older age at childbirth, but the investigators identified no association between breast cancer risk and birth order in this group.
While the current results hint that breast cancer risk may differ according to whether or not women were breast-fed during infancy, additional studies are needed to determine if these associations vary with duration of breast-feeding or according to measured levels of environmental contaminants present in breast milk, Nichols said.
SOURCE: Epidemiology, May 2008
