AP IMPACT: Govt pays millions for unapproved drugs

WASHINGTON – Taxpayers have shelled out at least $200 million since 2004 for medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid, an Associated Press analysis of federal data has found. Millions of private patients are taking such drugs, as well.

The availability of unapproved prescription drugs to the public may create a dangerous false sense of security. Dozens of deaths have been linked to them.

The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s. The FDA says it is trying to squeeze them from the market, but conflicting federal laws allow the Medicaid health program for low-income people to pay for them.

The AP analysis found that Medicaid paid nearly $198 million from 2004 to 2007 for more than 100 unapproved drugs, mostly for common conditions such as colds and pain. Data for 2008 were not available but unapproved drugs still are being sold. The AP checked the medications against FDA databases, using agency guidelines to determine if they were unapproved. The FDA says there may be thousands of such drugs on the market.

Medicaid officials acknowledge the problem, but say they need help from Congress to fix it. The FDA and Medicaid are part of the Health and Human Services Department, but the FDA has yet to compile a master list of unapproved drugs, and Medicaid — which may be the biggest purchaser — keeps paying.

"I think this is something we ought to look at very hard, and we ought to fix it," said Medicaid chief Herb Kuhn. "It raises a whole set of questions, not only in terms of safety, but in the efficiency of the program — to make sure we are getting the right set of services for beneficiaries."

At a time when families, businesses and government are struggling with health care costs and 46 million people are uninsured, payments for questionable medications amount to an unplugged leak in the system.

Sen. Charles Grassley, R-Iowa, has asked the HHS inspector general to investigate.

That unapproved prescription drugs can be sold in the United States surprises even doctors and pharmacists. But the FDA estimates they account for 2 percent of all prescriptions filled by U.S. pharmacies, about 72 million scripts a year. Private insurance plans also cover them.

The roots of the problem go back in time, tangled in layers of legalese.

It wasn't until 1962 that Congress ordered the FDA to review all new medications for effectiveness. Thousands of drugs already on the market were also supposed to be evaluated. But some manufacturers claimed their medications were "grandfathered" under earlier laws, and even under the 1962 bill.

Then, in the early 1980s, a safety scandal erupted over one of those medications. E-Ferol, a high potency vitamin E injection, was linked to serious reactions in some 100 premature babies, 40 of whom died.

In response, the FDA started a program to weed out drugs it had never reviewed scientifically. Yet some medications continued to escape scrutiny.

Sometimes, the medications do not help patients. In other cases, the FDA says, they have made people sicker, maybe even killed them. This year, for example, the FDA banned injectable versions of a gout drug called colchicine after receiving reports of 23 deaths. Investigators found the unapproved drug had a very narrow margin of safety, and patients easily could receive a toxic dose leading to complications such as organ failure.

Critics say the FDA's case-by-case enforcement approach is not working.

"The FDA does not appear to have a systematic mechanism to report these drugs out," said Jon Glaudemans, senior vice president of Avalere Health, a health care industry information company, "and there doesn't seem to be a systematic process by which health insurance programs can validate their status. And everyone is pointing the finger at someone else as to why we can't get there."

In most cases, doctors, pharmacists and patients are not aware the drugs are unapproved.

"Over the years, they have become fully entrenched in the system," said Patti Manolakis, a Charlotte, N.C., pharmacist who has studied the issue. Only a few unapproved drugs are truly essential and should remain on the market, she added.

Tackling the problem is made harder by confusing — and sometimes conflicting — laws, regulations and responsibilities that pertain to different government agencies.

Medicaid officials said their program, which serves the poor and disabled, is allowed to pay for unapproved drugs until the FDA orders a specific medication off the market. But that can take years.

Compare that with Medicare, the health care program for older people.

Medicare's prescription program is not supposed to cover unapproved drugs. Medicare has purged hundreds of such medications from its coverage lists, but continues to find others.

It might be easier to sort things out if the FDA compiled a master list of unapproved drugs, but the agency hasn't. FDA officials say that would be difficult because many manufacturers do not list unapproved products with the agency. Yet, the AP found many that were listed — a possible starting point for a list.

Among the drugs the AP's research identified were Carbofed, for colds and flu; Hylira, a dry skin ointment; Andehist, a decongestant, and ICAR Prenatal, a vitamin tablet. Medicaid data show the program paid $7.3 million for Carbofed products from 2004 to 2007; $146,000 for Hylira; $4.8 million for Andehist products, and $900,000 for ICAR.

Grassley said the system is failing taxpayers and consumers.

"The problem I see is bureaucrats don't want to make a decision," Grassley said. "There is no reason why this should be such a house of mirrors when so much public money is being spent." Grassley is considering introducing legislation to ensure that consumers are told when a medication is unapproved.

FDA officials say they tell Medicaid and Medicare when the agency moves to ban an unapproved drug, so the programs can stop paying.

"The situation is complicated by the fact that Medicaid and Medicare have a different regulatory regime than FDA does," said FDA compliance lawyer Michael Levy. "There are products that we may consider to be illegally marketed that could be legally reimbursed under their law."

The FDA began its latest crackdown on unapproved drugs two years ago and has taken action against nine types of medications and dozens of companies. Typically, the agency orders manufacturers to stop making and shipping drugs, and it also has seized millions of dollars' worth of medications. But federal law does not provide fines for selling unapproved drugs, and criminal prosecutions are rare.

Some manufacturers of unapproved drugs say their products predate FDA regulation and are "grandfathered in."

"These are drugs that don't require an FDA approval," said Bill Peters, chief financial officer of Hi-Tech Pharmacal in Amityville, N.Y. "These are products with active ingredients that have been on the market for a long time." The company is moving away from older products, Peters said, and its new market offerings are FDA-approved.

Levy said the FDA is skeptical that any drugs now being sold are entitled to "grandfather" status. To qualify, they would have to be identical to medications sold decades ago in formulation and other important aspects.

The agency is targeting drugs linked to fraud, ones that do not work and, above all, those with safety risks. While the crackdown has helped, it does not appear to have solved the problem.

The gout drug banned by the FDA this February is not the only recent case involving safety problems.

Last year, the FDA banned unapproved cough medicines containing hydrocodone, a potent narcotic. Some had directions for medicating children as young as age 2, although no hydrocodone cough products have been shown to be safe and effective for children under 6.

In a 2006 case, the agency received 21 reports of children younger than 2 who died after taking unapproved cold and allergy medications containing carbinoxamine, an allergy drug that also acts as a powerful sedative. Regulators banned all products that contained carbinoxamine in combination with other cold medicines.

"We as Americans have a belief that all the prescription drugs that are available to us have been reviewed and approved by the FDA," said Manolakis, the pharmacist. "I think the presence of these drugs shows we have a false sense of security."

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On the Net:

FDA's unapproved drugs page: http://tinyurl.com/4tv2sb

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Pill as good as chemo on lung cancer, but costlier

LONDON – Some advanced lung cancer patients already treated with chemotherapy might be able to skip some of the bad side effects of another series of chemo by taking a pill instead, a study suggests. An international study showed patients on Iressa, an expensive, newer targeted treatment, survived about as long as those on another course of chemotherapy.

"This will provide us with another drug in our armory," said Dr. Michael Seckl, head of Cancer Research UK's Lung Cancer Group at Imperial College in London. Seckl was not connected to the research, which was published Friday in the Lancet medical journal.

Few treatments for lung cancer exist, and most patients die within a few years of diagnosis. Lung cancer kills about 1.4 million people every year.

Iressa, made by AstraZeneca PLC, is one of several new targeted drugs that attack specific growth receptors on cancer cells, doing less harm to patients. But Iressa costs thousands of dollars every month, much more than standard chemotherapy.

It is sold in the United States, but is not licensed in Europe, although it has been available on a limited compassionate use basis.

Two other lung cancer drugs, Tarceva and Avastin, made by Roche Holding AG, are already on the market in the United Kingdom, and Tarceva works similarly to Iressa.

In the study, paid for by AstraZeneca, researchers studied 1,433 advanced lung cancer patients in 24 countries, who had already gone through chemotherapy. Roughly half were given Iressa, or gefitinib, once a day. The other half were on docetaxel, a chemotherapy drug given intravenously every three weeks.

Patients on Iressa survived about 7.6 months while those on chemotherapy survived about 8 months. After one year, 32 percent of patients on Iressa were still alive, versus 34 percent of chemotherapy patients.

The most common side effects in Iressa patients were rash, acne and diarrhea. The patients on chemo most often suffered from fatigue, a higher risk for infections, and hair loss.

In the U.S., Iressa is approved for use in patients who failed chemotherapy. The drug tends to work better in patients who have never smoked, Asians, women and those with a certain genetic profile.

"In the patients that respond, it is very dramatic," said Seckl, who has seen patients live years on the drug. He did not work with AstraZeneca on Iressa, but has consulted with them on other drugs.

"Though the benefits of prolonging life are modest, patients on (Iressa) get a higher quality of life," said Chris Twelves, a professor of clinical cancer oncology at Leeds University. "That should swing the pendulum in its favor."

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Teen lives 4 months with no heart, leaves hospital

MIAMI – D'Zhana Simmons says she felt like a "fake person" for 118 days when she had no heart beating in her chest. "But I know that I really was here," the 14-year-old said, "and I did live without a heart."

As she was being released Wednesday from a Miami hospital, the shy teen seemed in awe of what she's endured. Since July, she's had two heart transplants and survived with artificial heart pumps — but no heart — for four months between the transplants.

Last spring D'Zhana and her parents learned she had an enlarged heart that was too weak to sufficiently pump blood. They traveled from their home in Clinton, S.C. to Holtz Children's Hospital in Miami for a heart transplant.

But her new heart didn't work properly and could have ruptured so surgeons removed it two days later.

And they did something unusual, especially for a young patient: They replaced the heart with a pair of artificial pumping devices that kept blood flowing through her body until she could have a second transplant.

Dr. Peter Wearden, a cardiothoracic surgeon at Children's Hospital of Pittsburgh who works with the kind of pumps used in this case, said what the Miami medical team managed to do "is a big deal."

"For (more than) 100 days, there was no heart in this girl's body? That is pretty amazing," Wearden said.

The pumps, ventricular assist devices, are typically used with a heart still in place to help the chambers circulate blood. With D'Zhana's heart removed, doctors at Holtz Children's Hospital crafted substitute heart chambers using a fabric and connected these to the two pumps.

Although artificial hearts have been approved for adults, none has been federally approved for use in children. In general, there are fewer options for pediatric patients. That's because it's rarer for them to have these life-threatening conditions, so companies don't invest as much into technology that could help them, said Dr. Marco Ricci, director of pediatric cardiac surgery at the University of Miami.

He said this case demonstrates that doctors now have one more option.

"In the past, this situation could have been lethal," Ricci said.

And it nearly was. During the almost four months between her two transplants, D'Zhana wasn't able to breathe on her own half the time. She also had kidney and liver failure and gastrointestinal bleeding.

Taking a short stroll — when she felt up for it — required the help of four people, at least one of whom would steer the photocopier-sized machine that was the external part of the pumping devices.

When D'Zhana was stable enough for another operation, doctors did the second transplant on Oct. 29.

"I truly believe it's a miracle," said her mother, Twolla Anderson.

D'Zhana said now she's grateful for small things: She'll see her five siblings soon, and she can spend time outdoors.

"I'm glad I can walk without the machine," she said, her turquoise princess top covering most of the scars on her chest. After thanking the surgeons for helping her, D'Zhana began weeping.

Doctors say she'll be able to do most things that teens do, like attending school and going out with friends. She will be on lifelong medication to keep her body from rejecting the donated heart, and there's a 50-50 chance she'll need another transplant before she turns 30.

For now, though, D'Zhana is looking forward to celebrating another milestone. On Saturday, she turns 15 and plans to spend the day riding in a boat off Miami's coast

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Doctors transplant windpipe with stem cells

LONDON – Doctors have given a woman a new windpipe with tissue grown from her own stem cells, eliminating the need for anti-rejection drugs. "This technique has great promise," said Dr. Eric Genden, who did a similar transplant in 2005 at Mount Sinai Hospital in New York. That operation used both donor and recipient tissue. Only a handful of windpipe, or trachea, transplants have ever been done.

If successful, the procedure could become a new standard of treatment, said Genden, who was not involved in the research.

The results were published online Wednesday in the medical journal, The Lancet.

The transplant was given to Claudia Castillo, a 30-year-old Colombian mother of two living in Barcelona, suffered from tuberculosis for years. After a severe collapse of her left lung in March, Castillo needed regular hospital visits to clear her airways and was unable to take care of her children.

Doctors initially thought the only solution was to remove the entire left lung. But Dr. Paolo Macchiarini, head of thoracic surgery at Barcelona's Hospital Clinic, proposed a windpipe transplant instead.

Once doctors had a donor windpipe, scientists at Italy's University of Padua stripped off all its cells, leaving only a tube of connective tissue.

Meanwhile, doctors at the University of Bristol took a sample of Castillo's bone marrow from her hip. They used the bone marrow's stem cells to create millions of cartilage and tissue cells to cover and line the windpipe.

Experts at the University of Milan then used a device to put the new cartilage and tissue onto the windpipe. The new windpipe was transplanted into Castillo in June.

"They have created a functional, biological structure that can't be rejected," said Dr. Allan Kirk of the American Society of Transplantation. "It's an important advance, but constructing an entire organ is still a long way off."

So far, Castillo has shown no signs of rejection and is not taking any immune-suppressing drugs, which can cause side effects like high blood pressure, kidney failure and cancer.

"I was scared at the beginning," Castillo said in a press statement. "I am now enjoying life and am very happy that my illness has been cured."

Her doctors say she is now able to take care of her children, and can walk reasonable distances without becoming out of breath. Castillo even reported dancing all night at a club in Barcelona recently.

Genden said that Castillo's progress needed to be closely monitored. "Time will tell if this lasts," he said. Genden added that it can take up to three years to know if the windpipe's cartilage structure is solid and won't fall apart.

People who might benefit include children born with defective airways, people with scars or tumours in their windpipes, and those with collapsed windpipes.

Martin Birchall, who grew Castillo's cells at the University of Bristol, said that the technique might even be adapted to other organs.

"Patients engineering their own tissues is the key way forward," said Dr. Patrick Warnke, a surgeon at the University of Kiel in Germany. Warnke is also growing patients' tissues from stem cells for transplants.

Warnke predicted that doctors might one day be able to produce organs in the laboratory from patients' own stem cells. "That is still years away, but we need pioneering approaches like this to solve the problem," he said.

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On the Net:

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Tiny, long-lost primate rediscovered in Indonesia

WASHINGTON (Reuters) – On a misty mountaintop on the Indonesian island of Sulawesi, scientists for the first time in more than eight decades have observed a living pygmy tarsier, one of the planet's smallest and rarest primates.

Over a two-month period, the scientists used nets to trap three furry, mouse-sized pygmy tarsiers -- two males and one female -- on Mt. Rore Katimbo in Lore Lindu National Park in central Sulawesi, the researchers said on Tuesday.

They spotted a fourth one that got away.

The tarsiers, which some scientists believed were extinct, may not have been overly thrilled to be found. One of them chomped Sharon Gursky-Doyen, a Texas A&M University professor of anthropology who took part in the expedition.

"I'm the only person in the world to ever be bitten by a pygmy tarsier," Gursky-Doyen said in a telephone interview.

"My assistant was trying to hold him still while I was attaching a radio collar around its neck. It's very hard to hold them because they can turn their heads around 180 degrees. As I'm trying to close the radio collar, he turned his head and nipped my finger. And I yanked it and I was bleeding."

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Family history can trump breast cancer gene test

WASHINGTON – If breast cancer runs in the family, women can be at high risk even if they test free of the disease's most common gene mutations, sobering new research shows. The genes BRCA1 and BRCA2 are linked with particularly aggressive hereditary breast cancer, and an increased risk of ovarian cancer, too.

When a breast cancer patient is found to carry one of those gene mutations, her relatives tend to breathe a sigh of relief if they test gene-free.

But those headline-grabbing genes account for only about 15 percent of all breast cancer cases. Even in families riddled with breast cancer, a BRCA gene is the culprit only in roughly one family of every five that gets tested, said University of Toronto cancer specialist Dr. Steven Narod.

So clearly members of those families remain at risk from other yet-to-be-found genes, but how much risk?

Narod tracked nearly 1,500 women from 365 breast cancer-prone families, who tested negative for BRCA1 and BRCA2 mutations.

After five years, those women had a fourfold higher risk than average women of developing breast cancer, Narod reported Monday at a meeting of the American Association for Cancer Research.

This is crucial information for women considering gene testing, said Georgetown University genetics counselor Beth Peshkin, who wasn't part of the study.

"This is contrary to what I think the common perception is," Peshkin said. "Unless a mutation is identified in the family, a negative test result doesn't provide reassurance."

The good news: Narod's study showed these women didn't have an increased risk of ovarian cancer, like BRCA1- and BRCA2-carriers do.

While the $3,000 BRCA tests are well-accepted, newer tests for other genes linked to breast cancer are coming on the market.

But "the family history is a much stronger predictor," stressed Narod. He recommends that such women take the anti-cancer drug tamoxifen and undergo MRI cancer checkups instead of easier mammograms "regardless of what other gene tests showed."

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Doctors hoping for new era of artificial ankles

WASHINGTON – What was left of Dan Sivia's ankle simply didn't work. He limped through his 30s by sheer force of will, one foot almost completely immobile from repeated broken bones and surgeries. Then a doctor offered his last hope: An ankle replacement. A what? Sivia knew about hip, knee, even shoulder replacements. But ankles?

His confusion is understandable: The first ankle replacements of the 1970s were abandoned when they couldn't withstand the pounding of daily life. A second generation in the '90s lasted longer but never became really popular.

Now the nation is embarking on a new generation of artificial ankles designed to work more like the joint you're born with, a move specialists hope finally will offer less pain and more function to thousands who hobble — although it's too soon to be sure.

"These third-generation prostheses really mimic a natural ankle, which is really what makes them different," says ankle specialist Dr. Steven L. Haddad of the Illinois Bone and Joint Institute and an orthopedic surgery professor at Northwestern University.

If the newer implants pan out, it's a market ripe for growth. More than 200,000 people seek care for ankle pain annually, with few options for the severely damaged. More than 8,000 a year get their ankle bones fused, a last-ditch treatment after years of suffering, while surgeons perform between 2,000 and 2,500 ankle replacements.

While Medicare pays for ankle replacements, which Haddad says can reach $50,000 including a three- to five-day hospital stay, many other insurers don't. And a review in September's Journal of the American Academy of Orthopedic Surgeons cautions that so far, there is little research to tell how long newer versions will last — and that few hospitals have much practice in implanting them.

But for Sivia, the surgery restored an ability to walk that the 39-year-old thought he'd forever lost. His leg was crooked from a series of breaks that began in childhood and included a crushing ankle fracture at 28. A decade of pain later, he sought out Haddad. Then he spent 17 months on crutches, with external pins holding bones in place, as Haddad rebuilt his leg. The last surgery, the ankle implant, came in July.

"When I got to rake my own lawn — I've done it three times just because I can," the Waukegan, Ill., man said with a laugh. "I'm riding my bike, I'm doing all the things everybody else is doing."

Haddad says ankle sufferers tend to move like a sidewinder snake, one foot gingerly turned out to the side while the other foot does the heavy pushing to walk. They might have standard arthritis. But usually, fractures from years earlier — sometimes broken ankles, but often broken legs that left the entire lower limb out of alignment — simply made the ankle and its cushioning cartilage wear out.

Fusion — eliminating the pain-causing friction by permanently connecting ankle bones so they won't move — is usually an easy operation, with about 5 percent who fail to heal. The disadvantage is a stiff ankle that limits the foot's range of motion and eventually causes a domino effect, wearing out smaller joints in the foot to cause more pain until they, too, are fused.

Hence the quest for artificial ankles that would allow a fully flexible foot and normal gait.

That's not an easy task. The ankle joint is smaller than the hip and knee and must absorb more force than its sister joints, Dr. Keith Wapner of the University of Pennsylvania told a recent American Academy of Orthopedic Surgeons meeting.

The Food and Drug Administration began clearing so-called third-generation ankle implants in 2005, versions that Wapner expects to last longer. Each model is slightly different but consists of two attached parts. Surgeons drill a tunnel into the lower leg bone and slide in the stem of the artificial joint. A bottom piece connects to the top of the foot. Thin plastic hooked to one side functions as cartilage. Bone then grows into the implant, holding it in place.

In Europe, doctors also can use a similar but three-piece artificial ankle, where the plastic cushion is free-floating. Amid questions about whether that approach is better or worse, the FDA is evaluating whether to allow it here.

So which is better, fusion or replacement?

It all depends on age and activity. Even if these new ankles last more than a decade as Haddad expects, someone who jogs or mountain climbs will wear theirs out faster than someone who is sedentary. Also, different patients have different risks of wound infections.

"If you're someone that does not mind having additional surgeries on your ankle in the future as a trade-off to get better function, then a replacement is a better option," Haddad tells patients. "If you want to take care of it once, you have to opt for a fusion."

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W. Virginia town shrugs at poorest health ranking

HUNTINGTON, W.Va. – As a portly woman plodded ahead of him on the sidewalk, the obese mayor of America's fattest and unhealthiest city explained why health is not a big local issue.

"It doesn't come up," said David Felinton, 5-foot-9 and 233 pounds, as he walked toward City Hall one recent morning. "We've got a lot of economic challenges here in Huntington. That's usually the focus."

Huntington's economy has withered, its poverty rate is worse than the national average, and vagrants haunt a downtown riverfront park. But this city's financial woes are not nearly as bad as its health.

Nearly half the adults in Huntington's five-county metropolitan area are obese — an astounding percentage, far bigger than the national average in a country with a well-known weight problem.

Huntington leads in a half-dozen other illness measures, too, including heart disease and diabetes. It's even tops in the percentage of elderly people who have lost all their teeth (half of them have).

It's a sad situation, and a potential harbinger of what will happen to other U.S. communities, said Ken Thorpe, an Emory University health policy professor who is working with West Virginia officials on health reform legislation.

"They may be at the very top, but obesity and diabetes trends are very similar" in many other communities, particularly in the South, Thorpe said.

The Huntington area's health problems, cited in a U.S. health report, are a terrible distinction for the city, but the locals barely talk about it. Many don't even know how poorly the city ranks.

Culture and history are at least part of the problem, health officials say.

This city on the Ohio River is surrounded by Appalachia's thinly populated hills. It has long been a blue-collar, white-skinned community — overwhelmingly people of English, Irish and German ancestry.

For decades, Huntington thrived with the coal mines to its south, as barges, trucks and trains loaded with the black fuel continually chugged into and past the city. There were plenty of manufacturing jobs in the chemical industry and in glassworks, steel and locomotive parts. Nearly 90,000 people lived in the city in 1950.

The traditional diet was heavy with fried foods, salt, gravy, sauces, and fattier meats — dense with calories burnt off through manual labor. Obesity was not a worry then. Workplace injuries were.

But as the coal industry modernized and the economy changed, manufacturing jobs left. The city's population is now fewer than 50,000, and chronic diseases — many of them connected to obesity — seem much more common.

Shari Wiley is a nurse at St. Mary's Regional Heart Institute in Huntington. She runs a program that identifies heavy school children and tries to teach them better eating and exercise habits. The effort began because of an alarming trend.

"A lot of the patients we were seeing were getting heart attacks in their 30s. They were requiring open heart surgery in their 30s. And we were concerned because it used to be you wouldn't see heart patients come in until they were in their 50s," Wiley said.

The Huntington area is essentially tied with a few other metro areas for proportion of people who don't exercise (31 percent), have heart disease (22 percent) and diabetes (13 percent). The smoking rate is pretty high, too, although not the worst.

However, the region is a clear-cut leader in dental problems, with nearly half the people age 65 and older saying they have lost all their natural teeth. And no other metro area comes close to Huntington's adult obesity rate, according to the report by the U.S. Centers for Disease Control and Prevention, based on data from 2006.

Perhaps fittingly, hospitals are now Huntington's largest employers. Another is Marshall University, home of the "Thundering Herd" football team depicted in the 2006 film "We Are Marshall" which dominates local sports conversations.

The river runs along the edge of town, but it's not a focal point. Marshall and one of the city's remaining factories sit to the east with several blocks of hotels and office buildings farther west. A new complex called Pullman Square — which includes a movie theater and a Starbucks — is trying to become a retail and dining center and illustrates a transition to a service economy.

The area's unemployment rate was about 5 percent in September, actually a bit better than the 6.1 percent national average that month. But often the jobs are not high-paying. Many workers lack health insurance, and corporate wellness programs — common at large national companies — are rare.

Poverty hovers, with the area rate at 19 percent, much higher than the national average. In the hilly coal fields to the South, people still live in houses or trailers with drooping, battered roofs. They stare hard at any stranger in a new car. In Huntington and its outskirts, many people think of exercise and healthy eating as luxuries.

The economy needs to pick up "so people can afford to get healthy," said Ronnie Adkins, 67, a retired policeman, as he sat one recent morning on the smoking porch of the Jolly Pirate Donuts shop on U.S. 60.

Doughnut shops don't help either, of course. But breakfast pastry shops aren't the most common outlets for fatty food. Pizza joints are. They are seemingly on every block in some parts of the city. The online Yellow Pages lists more pizza places (nearly 200) for the Huntington area than the entire state of West Virginia has gyms and health clubs (149).

Hot dog places also abound, with the city hosting an annual hot dog festival every summer. "I've never seen so many places that are hot dog oriented. I guess it's a cultural thing. Appalachian," said Mayor Felinton, who grew up in Maryland and moved to Huntington to attend Marshall University and stayed put.

Fast food has become a staple, with many residents convinced they can't afford to buy healthier foods, said Keri Kennedy, manager of the state health department's Office of Healthy Lifestyles.

Kennedy said she had just seen a commercial that presented "The KFC $10 Challenge." The fried-chicken chain placed a family in a grocery store and challenged them to put together a dinner for $10 or less that was comparable to KFC's seven-piece, $9.99 value meal.

"This is what we're up against," said Kennedy, noting it's an extremely persuasive ad for a low-income family that is accustomed to fried foods. "I don't know what you do to counter that."

Lack of exercise is another concern. During a warm and sunny autumn week in Huntington — the kind of weather that would bring out small armies of joggers in some cities — it was unusual to see a runner or bicyclist. The exercise that does occur is mostly confined to a local YMCA, at campus recreation facilities at Marshall, or at Ritter Park in a tony neighborhood south of downtown.

Some attribute the problem to crumbling sidewalks in the city and a lack of walkways along busy rural roads. Others blame it on lack of motivation, as well as a cultural attitude that never included exercise for health.

There's a connection between education and lack of exercise, too, said Dr. Thomas Dannals, a Huntington family physician.

"The undereducated don't know the value of it. They don't have the drive for it. There's a reason you're successful, you've got drive. The same is true for exercise," said Dannals.

Dannals has been trying to change cultural attitudes. The local newspaper has called him "an exercise evangelist" for founding the city's triathlon, marathon and other projects designed to make exercise popular and fun. He's also spearheading a riverfront exercise trail project, called the Paul Ambrose Trail for Health (PATH).

Ambrose was a Huntington physician who died in the Sept. 11, 2001, jet that crashed into the Pentagon. Just before he died, he had been working on a U.S. Surgeon General report on obesity, and was on the plane that morning to attend an adolescent obesity conference in Los Angeles.

But the PATH project, first proposed more than a year ago, has yet to win the necessary funding. The lack of support is not surprising: Dannals can't even get a company to sponsor the Huntington marathon.

Local politicians tend to be equally tepid about improving health, said Dr. Harry Tweel, director of the Cabell-Huntington Health Department.

Smoking — a common sin in West Virginia — has been hard to control, Tweel said. When the health department tried to restrict smoking in local bars and restaurants, a group of local businesses fought it all the way to the state Supreme Court. (The restrictions were upheld in 2003.) Even hospitals have fought smoking restrictions in the past, Tweel said.

Other communities have taken more ambitious steps to control the amount of fat in local restaurant food. In July, the Los Angeles City Council placed a moratorium on new fast food restaurants in an impoverished area of the city with above-average rates of obesity. In 2006, New York City became the first U.S. city to ban artificial trans fats in restaurant foods. Other cities are considering similar measures.

Forget it, Tweel said. Not in Huntington.

"You're mentioning areas (of the country) that are well beyond this local region in accepting that kind of change," said Tweel.

"People here have an attitude of 'You're not going to tell me what I can eat.' The cultural attitude is 'My parents ate that and my grandparents ate that,'" he said.

Mayor Felinton echoed Tweel. Felinton had stomach surgery last year to help him lose weight and has been walking to work about three days a week. He has shed nearly 80 pounds and became sort of a local poster boy for weight loss. But in the midst of a re-election campaign last month, he said he had no plans to plunge into a fight over fat in restaurants.

"We want as much business as we can have here," said Felinton, who lost his recent re-election bid and leaves office in January. "As many restaurants as you have, it kind of enhances the livability. Maybe not the health."

To be fair, most people in Huntington don't seem to be aware of how poorly their city looks in national health statistics.

The latest numbers came from the CDC report, released in August, but little-publicized. It was based on survey data from 2006, comparing about 150 metropolitan areas. The Huntington area includes five counties — two in West Virginia, two in Kentucky and one in Ohio.

Of the 40 Huntington-area residents interviewed for this story, many had heard something about West Virginia being one of the unhealthiest states. But only one — Tweel — knew about the latest report showing how bad Huntington compared with other metro areas.

Some doctors, on hearing the statistics, noted the Huntington area is not in such bad shape by West Virginia standards. A recent state study found that health problems are significantly worse in the more rural coal counties to the south. But those places didn't show up in the CDC report, because they were too small.

Still, Huntington is an unusually obese place, said Dr. John Walden, chairman of the family and community health department at Marshall University's medical school.

Walden is a third generation physician in the area, but he's also traveled extensively around the world. He says it's always a little jolting coming home and realizing how obese his hometown is compared to the rest of the world.

"I don't know that I've ever been in a place where I've seen so many overweight people," he said.

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Doctors say marrow transplant may have cured AIDS

BERLIN – An American man who suffered from AIDS appears to have been cured of the disease 20 months after receiving a targeted bone marrow transplant normally used to fight leukemia, his doctors said Wednesday.

While researchers — and the doctors themselves — caution that the case might be no more than a fluke, others say it may inspire a greater interest in gene therapy to fight the disease that claims 2 million lives each year. The virus has infected 33 million people worldwide.

Dr. Gero Huetter said his 42-year-old patient, an American living in Berlin who was not identified, had been infected with the AIDS virus for more than a decade. But 20 months after undergoing a transplant of genetically selected bone marrow, he no longer shows signs of carrying the virus.

"We waited every day for a bad reading," Huetter said.

It has not come. Researchers at Berlin's Charite hospital and medical school say tests on his bone marrow, blood and other organ tissues have all been clean.

However, Dr. Andrew Badley, director of the HIV and immunology research lab at the Mayo Clinic in Rochester, Minn., said those tests have probably not been extensive enough.

"A lot more scrutiny from a lot of different biological samples would be required to say it's not present," Badley said.

This isn't the first time marrow transplants have been attempted for treating AIDS or HIV infection. In 1999, an article in the journal Medical Hypotheses reviewed the results of 32 attempts reported between 1982 and 1996. In two cases, HIV was apparently eradicated, the review reported.

Huetter's patient was under treatment at Charite for both AIDS and leukemia, which developed unrelated to HIV.

As Huetter — who is a hematologist, not an HIV specialist — prepared to treat the patient's leukemia with a bone marrow transplant, he recalled that some people carry a genetic mutation that seems to make them resistant to HIV infection. If the mutation, called Delta 32, is inherited from both parents, it prevents HIV from attaching itself to cells by blocking CCR5, a receptor that acts as a kind of gateway.

"I read it in 1996, coincidentally," Huetter told reporters at the medical school. "I remembered it and thought it might work."

Roughly one in 1,000 Europeans and Americans have inherited the mutation from both parents, and Huetter set out to find one such person among donors that matched the patient's marrow type. Out of a pool of 80 suitable donors, the 61st person tested carried the proper mutation.

Before the transplant, the patient endured powerful drugs and radiation to kill off his own infected bone marrow cells and disable his immune system — a treatment fatal to between 20 and 30 percent of recipients.

He was also taken off the potent drugs used to treat his AIDS. Huetter's team feared that the drugs might interfere with the new marrow cells' survival. They risked lowering his defenses in the hopes that the new, mutated cells would reject the virus on their own.

Anthony Fauci, director of the National Institute of Allergy and Infections Diseases in the U.S., said the procedure was too costly and too dangerous to employ as a firstline cure. But he said it could inspire researchers to pursue gene therapy as a means to block or suppress HIV.

"It helps prove the concept that if somehow you can block the expression of CCR5, maybe by gene therapy, you might be able to inhibit the ability of the virus to replicate," Fauci said.

David Roth, a professor of epidemiology and international public health at the London School of Hygiene and Tropical Medicine, said gene therapy as cheap and effective as current drug treatments is in very early stages of development.

"That's a long way down the line because there may be other negative things that go with that mutation that we don't know about."

Even for the patient in Berlin, the lack of a clear understanding of exactly why his AIDS has disappeared means his future is far from certain.

"The virus is wily," Huetter said. "There could always be a resurgence."

(This version CORRECTS spelling of doctor's name to Huetter throughout.)

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Dinosaur experts bust up prehistoric party theory

SALT LAKE CITY – So maybe there was no dinosaur dancing after all.

Paleontologists say there are no signs of dinosaur tracks at a remote spot along the Utah-Arizona border that was previously described by University of Utah geologists as a "dinosaur dance floor" for its density of tracks.

"We didn't observe a single footprint," said Andrew Milner, paleontologist at the St. George Dinosaur Discovery Site at Johnson Farm in southwestern Utah.

He was one of four paleontologists who hiked into the area last week after a heavily publicized study claiming there were more than 1,000 previously unknown dinosaur tracks crammed onto less than an acre in the Arizona portion of Vermillion Cliffs National Monument.

"We went up there optimistic, really hoping we were going to find footprints," Milner said Friday.

They quickly determined there were none. Instead, it was a dense collection of potholes caused by erosion in the sandstone, they said.

And the supposed tail-drag marks in the rock? Probably another result of erosion, the paleontologists said.

Marjorie Chan, a University of Utah researcher who co-authored the "dinosaur dance floor" study, said she's open to the paleontologists' views and says she'll team up with other researchers for another examination of the site.

"I'm interested in the truth, no matter what the outcome is," Chan said.

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Cold front could thwart Friday's shuttle launch

CAPE CANAVERAL, Fla. – An approaching cold front could thwart NASA's plans to launch space shuttle Endeavour on Friday on a flight to the international space station.

But the seven astronauts arrived Tuesday ahead of the countdown start and hopeful for an on-time liftoff.

"This mission is all about home improvement, home improvement both inside and outside," shuttle commander Christopher Ferguson said after arriving from Houston with his crew.

During the 15-day mission, the astronauts will deliver a new bathroom, kitchenette, two bedrooms and exercise machine, as well as a water recycling system — and a new resident for the space station. A new astronaut will replace one of the three space station residents.

The plan is to expand the living quarters of the space station so the crew can be doubled to six by next June.

"On the inside of the space station, the walls are largely up," Ferguson said. "... Well, it's moving day. It's time to fill them up."

Ferguson also noted the never-before-attempted repairs that are planned for outside the space station. Three of the crew will take turns going outside to clean and lubricate a clogged joint that is preventing one set of solar wings from turning automatically toward the sun, and they'll replace its bearings.

This will be NASA's first shuttle launch since the end of May.

"We haven't had a launch for a while, so we're really excited to be back in the saddle again," said test director Jeff Spaulding.

The threatening cold front was moving across the central part of the nation Tuesday and was expected to bring rain and thick clouds to the launch site by week's end.

Shuttle weather officer Kathy Winters said there was a 60 percent chance of acceptable conditions at the 7:55 p.m. Friday liftoff time and only a 40 percent chance on Saturday.

"The timing of the front will be critical," she said.

NASA has a shuttle launch window until Nov. 25.

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Fat kids found to have arteries of 45-year-olds

NEW ORLEANS – Obese children as young as 10 had the arteries of 45-year-olds and other heart abnormalities that greatly raise their risk of heart disease, say doctors who used ultrasound tests to take a peek inside.

"As the old saying goes, you're as old as your arteries are," said Dr. Geetha Raghuveer of Children's Hospital in Kansas City, who led one of the studies. "This is a wake-up call."

The studies were reported Tuesday at an American Heart Association conference.

About a third of American children are overweight and one-fifth are obese. Many parents think that "baby fat" will melt away as kids get older. But research increasingly shows that fat kids become fat adults, with higher risks for many health problems.

"Obesity is not benign in children and adolescents," said Dr. Robert Eckel, a former heart association president and cardiologist at the University of Colorado-Denver. It is why the American Academy of Pediatrics recently recommended cholesterol-lowering drugs for some kids, he noted.

Raghuveer wanted to see if early signs of damage could be documented. She and colleagues used painless ultrasound tests to measure the thickness of the wall of a major neck artery in 70 children, ages 10 to 16. Almost all had abnormal cholesterol and many were obese.

No one knows how thick a 10-year-old's artery should be, since they're not regularly checked for signs of heart disease, so researchers used tables for 45-year-olds, who often do get such exams.

The kids' "vascular age" was about 30 years older than their actual age, she found.

A separate study tied childhood obesity to abnormal enlargement of the left atrium, one of the chambers of the heart. Enlargement is a known risk factor for heart disease, stroke and heart rhythm problems.

Julian Ayer, a researcher at Royal Prince Alfred Hospital Sydney Australia, did ultrasound exams on 991 seemingly healthy children ages 5 to 15. He saw a clear link between rising weight and size of the left atrium.

A third study by Dr. Walter Abhayaratna of Australian National University in Canberra, Australia, also used ultrasound tests and found impairment in the heart's ability to relax between beats in children who were overweight or obese.

The study involved the first 150 children participating in a larger community-based study.

Earlier research he helped conduct found more rigid arteries in such children — a possible sign of plaque deposits starting to form.

"Even at this young age of 10, you can have children who have got arterial stiffness who are comparable to 30- and 40-year-olds," he said.

Dr. Michael Schloss, a New York University heart disease prevention specialist, said the evidence shows obesity is more than a cosmetic issue for children.

"If you've seen what's on the menu for most school lunches, these findings are no surprise," he said. "The time has come to seriously deal with the issue of childhood obesity and physical inactivity on a governmental and parental level."

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Studies: Vitamin pills don't prevent heart disease

NEW ORLEANS – Vitamins C and E — pills taken by millions of Americans — do nothing to prevent heart disease in men, one of the largest and longest studies of these supplements has found.

Vitamin E even appeared to raise the risk of bleeding strokes, a danger seen in at least one earlier study.

Besides questioning whether vitamins help, "we have to worry about potential harm," said Barbara Howard, a nutrition scientist at MedStar Research Institute of Hyattsville, Md.

She has no role in the research but reviewed and discussed it Sunday at an American Heart Association conference. Results also were published online by the Journal of the American Medical Association.

About 12 percent of Americans take supplements of C and E despite growing evidence that these antioxidants do not prevent heart disease and may even be harmful.

Male smokers taking vitamin E had a higher rate of bleeding strokes in a previous study, and several others found no benefit for heart health.

As for vitamin C, some research suggests it may aid cancer, not fight it. A previous study in women at high risk of heart problems found it did not prevent heart attacks.

Few long-term studies have been done. The new one is the Physicians Health Study, led by Drs. Howard Sesso and J. Michael Gaziano of Harvard-affiliated Brigham and Women's Hospital in Boston.

It involved 14,641 male doctors, 50 or older, including 5 percent who had heart disease at the time the study started in 1997. They were put into four groups and given either vitamin E, vitamin C, both, or dummy pills. The dose of E was 400 international units every other day; C was 500 milligrams daily.

After an average of eight years, no difference was seen in the rates of heart attack, stroke or heart-related deaths among the groups.

However, 39 men taking E suffered bleeding strokes versus only 23 of the others, which works out to a 74 percent greater risk for vitamin-takers.

The study was funded by the National Institutes of Health and several vitamin makers. Results were so clear that they would be unlikely to change if the study were done in women, minorities, or with different formulations of the vitamins, Howard said.

"In these hard economic times, maybe we can save some money by not buying these supplements," she said.

A second study found that vitamins B-12 and B-9 (folic acid) did not prevent heart disease either, supporting the results of previous trials. That study involved more than 12,000 heart attack survivors and was led by Dr. Jane Armitage of the University of Oxford in England.

___

On the Net:

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

Heart meeting: http://www.americanheart.org/

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Study: Wider cholesterol drug use may save lives

NEW ORLEANS – People with low cholesterol and no big risk for heart disease had dramatically lower rates of heart attacks, death and stroke if they took the cholesterol pill Crestor, a large study found.

The results, reported Sunday at an American Heart Association conference, were hailed as a watershed event in heart disease prevention. Doctors said the study might lead as many as 7 million more Americans to consider taking cholesterol-lowering statin drugs, sold as Crestor, Lipitor, Zocor or in generic form.

"This takes prevention to a whole new level, because it applies to patients who we now wouldn't have any evidence to treat," said Dr. W. Douglas Weaver, a Detroit cardiologist and president of the American College of Cardiology.

The study also gives the best evidence yet for using a new test to identify people who may need treatment, according to a statement from Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute. The new research will be considered by experts reviewing current guidelines.

However, some doctors urged caution. Crestor gave clear benefit in the study, but so few heart attacks and deaths occurred among these low-risk people that treating everyone like them in the United States could cost up to $9 billion a year — "a difficult sell," one expert said.

About 120 people would have to take Crestor for two years to prevent a single heart attack, stroke or death, said Stanford University cardiologist Dr. Mark Hlatky. He wrote an editorial accompanying the study published online by the New England Journal of Medicine.

"Everybody likes the idea of prevention. We need to slow down and ask how many people are we going to be treating with drugs for the rest of their lives to prevent heart disease, versus a lot of other things we're not doing" to improve health, Hlatky said.

Statins are the world's top-selling drugs. Until this study, all but Crestor have already been shown to cut the risk of heart attacks and death in people with high LDL, or bad cholesterol.

But half of all heart attacks occur in people with normal or low cholesterol, so doctors have been testing other ways to predict who is at risk.

One is high-sensitivity C-reactive protein, or CRP for short. It is a measure of inflammation, which can mean clogged arteries as well as less serious problems, such as an infection or injury. Doctors check CRP with a blood test that costs about $80 to have done.

A co-inventor on a patent of the test, Dr. Paul Ridker of Harvard-affiliated Brigham and Women's Hospital in Boston, led the new study. It involved 17,802 people with high CRP and low LDL cholesterol (below 130) in the U.S. and 25 other countries.

One-fourth were black or Hispanic, and 40 percent were women — important because previous statin studies have included few women. Men had to be 50 or older; women, 60 or older. None had a history of heart problems or diabetes.

They were randomly assigned to take dummy pills or Crestor, the strongest statin on the market, made by British-based AstraZeneca PLC. Neither participants nor their doctors knew who was taking what.

The study was supposed to last five years but was stopped in March, after about two years, when independent monitors saw that those taking Crestor were faring better than the others.

Full results were announced Sunday. Crestor reduced a combined measure — heart attacks, strokes, heart-related deaths or hospitalizations, or the need for an artery-opening procedure — by 44 percent.

"We reduced the risk of a heart attack by 54 percent, the risk of a stroke by 48 percent and the chance of needing bypass surgery or angioplasty by 46 percent," Ridker said.

Looked at another way, there were 136 heart-related problems per year for every 10,000 people taking dummy pills versus 77 for those on Crestor.

Remarkably, every single subgroup benefited from the drug.

"If you're skinny it worked, if you're heavy it worked. If you lived here or there, if you smoked, it worked," Ridker said.

AstraZeneca paid for the study, and Ridker and other authors have consulted for the company and other statin makers.

One concern: More people in the Crestor group saw blood-sugar levels rise or were newly diagnosed with diabetes.

Crestor also has the highest rate among statins of a rare but serious muscle problem, so there are probably safer and cheaper ways to get the same benefits, said Dr. Sidney Wolfe of the consumer group Public Citizen.

"It is highly unlikely that (the benefits are) specific to Crestor," said Wolfe, who has campaigned against the drug in the past.

Crestor costs $3.45 a day versus less than a dollar for generic drugs.

Drs. James Stein and Jon Keevil of the University of Wisconsin-Madison used federal health statistics to project that 7.4 million Americans, or more than 4 percent of the adult population, are like the people in this study.

Treating them all with Crestor would cost $9 billion a year and prevent about 30,000 heart attacks, strokes or deaths, they calculate.

"That's pretty costly. This would be a very difficult sell" unless a person also had family history or other heart disease risk factors, said Dr. Thomas Pearson of the University of Rochester School of Medicine and Dentistry.

Pearson was co-chairman of a joint government-heart association panel that wrote current guidelines for using CRP tests to guide treatment.

Researchers do not know whether the benefits seen in the study were due to reducing CRP or cholesterol, since Crestor did both.

This study and two other government-sponsored ones reported on Sunday "provide the strongest evidence to date" for testing C-reactive protein, and adding it to traditional risk measures could identify millions more people who would benefit from treatment, Nabel's statement says.

U.S. Crestor prescriptions totaled $420 million in the third quarter of this year, up 23 percent from a year earlier. In the rest of the world, third quarter sales were $520 million, up 33 percent.

Sales have been rising even though two statins — Zocor and Pravachol — are now available in generic form.

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On the Net:

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

Heart conference: http://www.americanheart.org

Government: http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhatIs.html

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The aircraft mission

The agencies involved in this exciting project are the United States National Science Foundation, the British Antarctic Survey, the German Federal Institute for Geosciences and Natural Resources (BGR), Australian Antarctic Division, Chinese Arctic and Antarctic Administration and the Japanese National Institute of Polar Research. Nine aircraft are involved in this ambitious project. In addition to the two specially equipped science aircraft from UK and US, seven others will support the project by transporting people, fuel, equipment and supplies to both field camps.

Fuel to AGAP South will be moved by air and by overland traverse from where it is currently stockpiled. An overland traverse will head out of South Pole arriving at AGAP South on 10th December. Air drops using a C17 are planned for four dates in November to bring additional fuel to AGAP North.
2-3 December 2008: GAMBIT. The BAS twin otter survey aircraft will move to AGAP-North. The survey team will also move to AGAP-North in a BAS support Twin Otter (VPF AZ). The BAS Twin Otter survey aircraft will remain at AGAP-North for 37 days maximum. The goal is to complete 43 survey flights. If weather and field conditions are good flights could take as little as 29 days.

11 December: The USAP aircraft will transfer to AGAP-South to be in place when the early GAMBIT science team arrives.

17 December 2008: The USAP utility twin otter aircraft begins its deployment of 25 seismic stations for the GAMSEIS project. Of the 25 sites to be visited, 15 stations are to be new installations; 10 existing stations are to be serviced (~ 3 hrs per station to be serviced). The stations to be serviced actually take more ground time than the “to be installed” stations. This process includes removing the battery data logger box from the ice, brought back for service at AGAP-South and put into another box install at another site. Sixteen flight days with a double crew are targeted for this effort.







17 December 2008 – 10 January 2009: GAMBIT- USAP Twin Otter aircraft begins flying at AGAP-South. Fifty-four flights are necessary to complete the science program. Assuming a production rate of 1.85 flights per day from the Lake Vostok survey, 39 flights are likely to be completed in the 21 day planned flight operation window. Any option to begin survey flights sooner will facilitate the completion of the science program. The USAP Survey aircraft will conduct flights that require refuelling at a location know as AGO-1 and AGAP-North.

5-10 January 2009: The BAS Survey Twin Otter and team will work from AGAP-South. If fuel is available at AGO-3 the BAS Survey Otter will acquire the geophysical lines over the northern Recovery Lakes at the end of the season. The airframe will transfer back to McMurdo via AGO-1.

10 January 2009: the USAP Survey aircraft will transfer back to McMurdo where the geophysical equipment will be removed. The aircraft will be released to other projects on 16 January.

16 January 2009: The BAS aircraft will depart McMurdo via Pole for Patriot Hills and Rothera on. The survey team will depart with NSF through New Zealand.















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