Health Agency

WASHINGTON (AP) -- Scientists have discovered a gene that helps a mother and daughter stay alert on about six hours sleep a night, two hours less than the rest of their family needs.

It's believed to be a very rare mutation, not an excuse for the rest of us who stay up too late. But the finding, published in Friday's edition of the journal Science, offers a new lead to study how sleep affects health.

The National Institutes of Health says adults need seven hours to nine hours of sleep for good health. Regularly getting too little increases the risk of health problems, including memory impairment and a weakened immune system. A major 2006 study estimated that as many as 30 million Americans suffer chronic insomnia, and millions more have other sleep disorders, including sleep apnea.

University of California, San Francisco, researchers have long hunted genes related to how and when people sleep. In 2001, they discovered a mutation that puts its carriers' sleep patterns out of whack: These people regularly go to bed around 7:30 p.m. and wake around 3:30 a.m.

Now the same team has found a gene involved in regulating length of sleep. In one family, the 69-year-old mother and her 44-year-old daughter typically go to bed around 10 p.m., and Mom rises around 4 and her daughter around 4:30, with no apparent ill effects. The rest of the family has typical sleep patterns.

Blood tests showed the women harbored a mutation in a gene named DEC2 that's involved in regulation of circadian rhythms, the body's clock. A check of more than 250 stored DNA samples didn't find another carrier.

Then lead researcher Ying-Hui Fu, a neurology professor, and colleagues bred mice and fruit flies that carried the mutation. Sure enough, the flies' activity and brain-wave measurements on the mice showed those with the mutation slept less - and the mice needed less time to recover from sleep deprivation.

The result: A model that "provides a unique opportunity" to study the effects of different amounts of sleep, Fu concluded.

© 2009 The Associated Press.

LONDON (AP) -- Drugmaker GlaxoSmithKline PLC said Friday it has started testing its swine flu vaccine in humans.

Glaxo said it plans to conduct 16 clinical trials of its swine flu vaccine in more than 9,000 people in Europe and North America. It expects to have early results in September from its first trial in Germany. The data will be shared with drug regulators so they can make an early decision whether to license the vaccine.

Both Europe and the United States have fast-track approval systems for the swine flu vaccine, to ensure that the vaccine is available as soon as possible - and before complete safety tests are finished. The European Medicines Agency has said swine flu vaccines could be approved within five days.

Two other major drugmakers, Novartis AG and Sanofi-Aventis SA, began testing their swine flu vaccines earlier this month. In July, Australian pharmaceutical company CSL started testing their vaccine in Australia.

Glaxo's first trial is being conducted in Germany among 128 people aged 16 to 60, according to spokeswoman Alexandra Harrison.

The company said once it has initial results, these will be submitted to European and American regulatory authorities. Glaxo said it also would provide older data on a bird flu vaccine, on which the swine flu vaccine is based.

Other Glaxo trials will test the vaccine in infants, children and the elderly. The trials are scheduled to last about a year, although Harrison said the vaccine is expected to be on the market much sooner.

"We aim to get the first doses out in September," Harrison said, with major orders fulfilled by the end of the year or early 2010.

In Europe, Glaxo is testing vaccines with an adjuvant, a chemical compound used to stretch a vaccine's active ingredient and boost the body's immune response.

In Canada and the United States, Glaxo is testing vaccines both with and without adjuvants. Neither country has ever licensed any flu medications that contain the compound.

The safety of adjuvant-boosted flu vaccines on pregnant women and children - two of the groups thought to be most at risk from swine flu - has yet to be determined conclusively.

Glaxo has orders from countries worldwide for 291 million doses of swine flu vaccine. The United States has also ordered $250 million worth of vaccine ingredients.

Glaxo says it will donate 50 million doses of swine flu vaccine to the World Health Organization for use in poorer countries. The company also plans to set aside 20 percent of its Canadian production for the same purpose.

Since swine flu emerged in April, it has killed at least 1,462 people worldwide and is estimated to have infected millions.

© 2009 The Associated Press.

LONDON (AP) -- Polio, the dreaded paralyzing disease stamped out in the industrialized world, is spreading in Nigeria. And health officials say in some cases, it's caused by the vaccine used to fight it.

In July, the World Health Organization issued a warning that this vaccine-spread virus might extend beyond Africa. So far, 124 Nigerian children have been paralyzed this year - about twice those afflicted in 2008.

The polio problem is just the latest challenge to global health authorities trying to convince wary citizens that vaccines can save them from dreaded disease. For years, myths have abounded about vaccines - that they were the Western world's plan to sterilize Africans or give them AIDS. The sad polio reality fuels misguided fears and underscores the challenges authorities face using a flawed vaccine.

Nigeria and most other poor nations use an oral polio vaccine because it's cheaper, easier, and protects entire communities.

But it is made from a live polio virus - albeit weakened - which carries a small risk of causing polio for every million or so doses given. In even rarer instances, the virus in the vaccine can mutate into a deadlier version that ignites new outbreaks.

The vaccine used in the United States and other Western nations is given in shots, which use a killed virus that cannot cause polio.

So when WHO officials discovered a polio outbreak in Nigeria was sparked by the polio vaccine itself, they assumed it would be easier to stop than a natural "wild" virus.

They were wrong.

In 2007, health experts reported that amid Nigeria's ongoing outbreak of wild polio viruses, 69 children had also been paralyzed in a new outbreak caused by the mutation of a vaccine's virus.

Back then, WHO said the vaccine-linked outbreak would be swiftly overcome - yet two years later, cases continue to mount. They have since identified polio cases linked to the vaccine dating back as far as 2005.

It is a worrying development for officials who hope to end polio epidemics in India and Africa by the end of this year, after missing several earlier deadlines. "It's very disturbing," said Dr. Bruce Aylward, who heads the polio department at the World Health Organization.

This year, the number of polio cases caused by the vaccine has doubled: 124 children have so far been paralyzed, compared to 62 in 2008, out of about 42 million children vaccinated. For every case of paralysis, there are hundreds of other children who don't develop symptoms, but pass on the disease.

When Nigerian leaders suspended polio vaccination in 2003, believing the vaccine would sterilize their children and infect them with HIV, Nigeria exported polio to nearly two dozen countries worldwide, making it as far away as Indonesia.

Nigeria resumed vaccinations in 2004 after tests showed the vaccine was not contaminated with estrogen, anti-fertility agents or HIV.

Experts have long believed epidemics unleashed by a vaccine's mutated virus wouldn't last since the vaccine only contains a weakened virus strain - but that assumption is coming under pressure. Some experts now say that once viruses from vaccines start circulating they can become just as dangerous as wild viruses.

"The only difference is that this virus was originally in a vaccine vial," said Olen Kew, a virologist at the U.S. Centers for Disease Control and Prevention.

The oral polio vaccine used in Nigeria and elsewhere contains a mild version of the live virus. Children who have been vaccinated pass the virus into the water supply through urine or feces. Other children who then play in or drink that water pick up the vaccine's virus, which gives them some protection against polio.

But in rare instances, as the virus passes through unimmunized children, it can mutate into a strain dangerous enough to ignite new outbreaks, particularly if immunization rates in the rest of the population are low.

Kew said genetic analysis proves mutated viruses from the vaccine have caused at least seven separate outbreaks in Nigeria.

Though Nigeria's coverage rates have improved, up to 15 percent of children in the north still haven't been vaccinated against polio. To eradicate the disease, officials need to reach about 95 percent of the population.

Nigeria's vaccine-linked outbreak underlines the need to stop using the oral polio vaccine as soon as possible, since it can create the very epidemics it was designed to stop, experts say. WHO is researching other vaccines that might work better, but none is on the horizon.

Until a better vaccine is ready, WHO and U.S. CDC officials say the oral vaccine is the best available tool to eradicate polio and that when inoculation rates are nearly 100 percent it works fine.

"Nigeria is almost a case study in what happens when you don't follow the recommendations," Kew said.

Since WHO and partners began their attempt to rid the world of polio in 1988, officials have slashed the disease's incidence by more than 99 percent.

But numerous deadlines have been missed and the number of cases has been at a virtual standstill since 2000. Critics have also wondered whether it is time to give up, and donors may be sick of continuing to fund a program with no clear endgame.

"Eradication is a gamble," said Scott Barrett, an economist at Columbia University who has studied polio policies. "It's all or nothing ... and there is a very real risk this whole thing may fall apart."

Aside from Nigeria, polio persists in a handful of other countries, including Afghanistan, Pakistan, India, Chad, Angola and Sudan.

Aylward agreed the Nigeria situation was another unwelcome hurdle, but was confident eradication was possible. "We still have a shot," he said. "We're throwing everything at it including the kitchen sink."

© 2009 The Associated Press.

TRENTON, N.J. (AP) -- Abbott Laboratories Inc. is expanding a study of its top-selling heart stent by more than 2,000 patients, who may also be put in a second, landmark stent study meant to find the best way to prevent potentially fatal blood clots.

The bigger study aims to determine the optimum time people should take blood-thinning medicines after they undergo a common procedure called angioplasty to clear out a blocked artery and implant a stent, a metal-mesh scaffold that props open a blood vessel.

That study, announced last November, includes more than 25,000 patients and academic researchers, federal regulators and eight major prescription drug and medical device makers. The first patients are scheduled to be in world this fall.

Abbott, of North Chicago, Ill., said Thursday it is expanding a study of its already-approved Xience V stent. Those patients will be followed for five years to see how many develop a blood clot near the site of the stent and will be eligible to also enroll in the larger study.

That study was requested by the Food and Drug Administration to help doctors figure out the best treatment for their patients. It was designed and is being overseen by the Harvard Clinical Research Institute.

Because of its huge size and cost, it involves and is partly supported by the four big U.S. stent makers - Johnson & Johnson, Boston Scientific Corp., Abbott and Medtronic Inc. - plus four large drugmakers that sell anticlotting medicines - Bristol-Myers Squibb Co., Sanofi Aventis SA, Eli Lilly & Co. and Daiichi Sankyo.

Some patients will get bare-metal stents, but most will get newer ones coated with a drug to prevent re-clogging of the artery around the stent. Everyone will get at least 81 milligrams of aspirin a day and an anticlotting drug. After a year, those who haven't had complications will be split in two groups, with one continuing on the blood-thinning therapy for 18 months and the rest stopping it.

About 800,000 to 1 million American patients a year have one or more stents implanted after angioplasty. Less than 1 percent have a clot form near the stent, according to FDA officials, but that still leads to many strokes, heart attacks and deaths.

In afternoon trading, shares of Abbott rose 3 cents to $44.04.

(This version CORRECTS the name of the institute overseeing the study to Harvard.)

© 2009 The Associated Press.

CHICAGO (AP) -- Score another win for the humble aspirin. A study suggests colon cancer patients who took the dirt-cheap wonder drug reduced their risk of death from the disease by nearly 30 percent.

Aspirin already is recommended for preventing heart attacks and strokes, along with its traditional use for relief of minor aches and pains. Its merit in colon cancer prevention has been tempered by its side effects, bleeding from irritation of the stomach or intestines.

The new study suggests patients who already have colon cancer may benefit from taking aspirin along with surgery and chemotherapy. In a separate analysis of a subgroup of patients, only those with the most common type of tumor, those that overproduce the Cox-2 enzyme, saw a benefit.

"The paper is absolutely incredible, and I don't gush normally," said Dr. Alfred Neugut of Columbia University Medical Center in New York who has done similar research but was not involved in the new study. In an accompanying editorial, Neugut wrote that the study "comes as close as it can to offering patients a way to help themselves."

"This is certainly something patients would want to discuss with their doctors," said Dr. Andrew Chan of Harvard Medical School in Boston, who led the study, which appears in Wednesday's Journal of the American Medical Association.

It's too early for an across-the-board recommendation however, both Chan and Neugut said. The results should be confirmed in an experiment where patients would be randomly assigned to take aspirin or a dummy pill. A study based in Singapore that's now recruiting patients may verify aspirin's benefit.

Chan's study was observational, meaning researchers merely observed what patients were already doing, such as taking aspirin regularly for headaches. It's possible that factors other than aspirin accounted for the difference in cancer deaths.

Colorectal cancer is the second leading cause of cancer death in the United States after lung cancer. The National Cancer Institute estimates that nearly 50,000 Americans will die from it this year.

The researchers analyzed data from two large ongoing studies, the Nurses' Health Study and the Health Professionals Follow-up Study.

They looked at nearly 1,300 people with colorectal cancer who'd been followed for an average of 12 years. All the patients in the study had surgery for colon cancer and many also had chemotherapy.

Among the 549 participants who used aspirin regularly after their diagnosis, 81 died from colorectal cancer (about 15 percent). In contrast, among the 730 people who didn't use aspirin, 141 died of the disease (about 19 percent).

Taking into account other cancer risk factors, such as family history, the researchers calculated aspirin's overall benefit: a 29 percent reduction in risk of cancer death.

"It's exciting that an inexpensive, commonly used medication may be of benefit among this group of patients who are worried about having their cancer recur," Chan said.

About one-third of the tumors could be tested for Cox-2. Aspirin helped only those patients whose tumors tested positive for the enzyme. That makes sense, Chan said, because aspirin blocks the enzyme, which is thought to play a role in cancer's spread.

If aspirin becomes the standard of care in colon cancer, testing for Cox-2 may become routine, Neugut said. That wouldn't add much to costs, he said, because tumor tissue already is tested and a Cox-2 test could be easily added.

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On the Net:

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

© 2009 The Associated Press.