Pfizer/Bristol drug cuts recurrence of blood clots - study

(Reuters) - A new blood clot preventer from Pfizer Inc and Bristol-Myers Squibb Co reduced the risk of recurrence of clots in veins and lungs and death by 80 percent with no increase in major bleeding in a study testing extended use of the drug.

In the year-long trial of 2,486 patients who had been previously treated for the condition known as venous thromboembolism (VTE) the drug, apixaban, met the combined primary goal by significantly reducing the recurrence of blood clots and death from any cause compared with a placebo, according to data presented at the American Society of Hematology (ASH) meeting in Atlanta, Georgia.

The rate of recurrence or death was 11.6 percent in the placebo group compared with 3.8 percent for those who got 2.5 milligrams of apixaban and 4.2 percent for the 5 mg dose of the drug. The results were also published in the New England Journal of Medicine.

The incidence of major bleeding, always a concern with blood thinners, was extremely low in all three arms of the trial, researchers said - 0.5 percent for placebo, 0.2 percent for the low dose of apixaban and 0.1 percent for the higher dose.

"Usually when you have an effective antithrombotic you have to pay a price in terms of bleeding. This was not the case in this study," Dr. Giancarlo Agnelli, the study's principal investigator, said in a telephone interview.

"There was no evidence at all of increased major bleeding and this is extremely important because you are comparing an active drug with placebo," he said.

There was a slightly higher rate of clinically relevant nonmajor bleeding, such as nose bleeds that required medical attention, observed in patients taking the higher dose of apixaban at 4.2 percent compared with the low dose and placebo, researchers said.

Apixaban belongs to a new class of blood thinners that aim to replace decades old and difficult to use warfarin. The drug, which will be sold under the brand name Eliquis, is widely considered to be one of the most important new medicines for Pfizer and Bristol-Myers, both of which saw their top selling products lose patent protection in the past year.

AWAITING U.S. APPROVAL

It is approved in Europe and awaiting a U.S. approval decision for preventing blood clots and strokes in patients with atrial fibrillation - a type of irregular heart beat - and is also being tested against warfarin as a primary treatment for VTE with data expected next year.

A rival drug from Bayer and Johnson & Johnson called Xarelto is already approved for both conditions, but based on clinical data analysts have said they believe Eliquis is the best class.

An approval for extended use in VTE patients, during which they would take the drug for at least a year after initial treatment, could significantly boost future sales.

"The evidence is for one year. The next step would be to see whether this clinical benefit is extended after one year," Agnelli said.

VTE consists of deep vein thrombosis, typically blood clots in the legs, and pulmonary embolism, which are dangerous clots in the lungs. Clots that begin in the extremities can travel to the heart and lungs and can be fatal. VTE is typically treated with warfarin for three to six months.

After that, "there is quite a remarkable level of uncertainty about whether to extend or not," explained Agnelli, professor of internal medicine at the University of Perugia in Italy, who presented the data at the ASH meeting.

"Extended treatment might be clinically relevant because the recurrence rate after stopping treatment can be 10 percent in the first year," Agnelli said. "Reducing the recurrence of VTE means reduced hospitalization costs and in some cases fewer fatal events."

Physicians have been looking for alternatives to warfarin, which must be closely monitored to keep levels therapeutic but not toxic. The new drugs do not require monitoring or the dietary and lifestyle changes necessary with warfarin. But they still face an uphill battle as warfarin is far less expensive, and doctors have a comfort level using a drug that has been around for more than half a century despite the challenges.

Patients in the study had received treatment with warfarin for six to 12 months before starting the one-year extension trial that aimed to show further treatment could reduce recurrence rates and to see if the lower dose of apixaban was a viable option.

"It is quite clear that the lower dose is as effective as the higher. For the first time we showed that by reducing the dose of an antithrombotic agent in this clinical setting we can have the same efficacy with no major bleeding," Agnelli said.

"This is actually something that could change clinical practice," he added.

Read More..

Civilian Trauma May Contribute To Combat PTSD

War is hell. And for many soldiers, the experience leaves lasting scars. And not just physical ones. A subset of veterans develop posttraumatic stress disorder  or PTSD. But it might not be only the horrors of battle that make them susceptible. According to a study in the journal Psychological Science [link to come] echoes of  childhood abuse may contribute.

Psychologists assessed the mental health of hundreds of Danish soldiers before, during and 8 months after they were shipped to Afghanistan. Turns out the vast majority, some 84%, were resilient, showing no undue signs of stress at any time. A small number, about 4%, developed PTSD, with symptoms that showed up when the troops returned home.

When the researchers compared those two groups, they discovered that the cohort with PTSD had not been exposed to more battlefield trauma—but they were more likely to have experienced violence or abuse in civilian life, particularly as a child.

For the remaining soldiers, being deployed actually helped: something about being part of the team quelled the anxiety they started out with. That finding suggests that PTSD is not uniform, even for those in uniform. And that one man’s poison may be another man’s cure.

Read More..

USDA to allow more meat, grains in school lunches

WASHINGTON (AP) — The Agriculture Department is responding to criticism over new school lunch rules by allowing more grains and meat in kids' meals.

Agriculture Secretary Tom Vilsack told members of Congress in a letter Friday that the department will do away with daily and weekly limits of meats and grains. Several lawmakers wrote the department after the new rules went into effect in September saying kids aren't getting enough to eat.

School administrators also complained, saying set maximums on grains and meats are too limiting as they try to plan daily meals.

"This flexibility is being provided to allow more time for the development of products that fit within the new standards while granting schools additional weekly menu planning options to help ensure that children receive a wholesome, nutritious meal every day of the week," Vilsack said in a letter to Sen. John Hoeven, R-N.D.

The new guidelines were intended to address increasing childhood obesity levels. They set limits on calories and salt, and phase in more whole grains. Schools must offer at least one vegetable or fruit per meal. The department also dictated how much of certain food groups could be served.

While nutritionists and some parents have praised the new school lunch standards, others, including many conservative lawmakers, refer to them as government overreach. Yet many of those same lawmakers also have complained about hearing from constituents who say their kids are hungry at school.

Though broader calorie limits are still in place, the rules tweak will allow school lunch planners to use as many grains and as much meat as they want. In comments to USDA, many had said grains shouldn't be limited because they are a part of so many meals, and that it was difficult to always find the right size of meat.

The new tweak doesn't upset nutritionists who fought for the school lunch overhaul.

Margo Wootan, a nutrition lobbyist for the Center for Science in the Public Interest, says the change is minor and the new guidance shows that USDA will work with school nutrition officials and others who have concerns.

"It takes time to work out the kinks," Wootan said. "This should show Congress that they don't need to interfere legislatively."

Congress has already interfered with the rules. Last year, after USDA first proposed the new guidelines, Congress prohibited USDA from limiting potatoes and French fries and allowed school lunchrooms to continue counting tomato paste on pizza as a vegetable.

The school lunch rules apply to federally subsidized lunches served to low-income children. Those meals have always been subject to nutritional guidelines because they are partially paid for by the federal government, but the new rules put broader restrictions on what could be served as childhood obesity rates have skyrocketed.

School kids can still buy additional foods in other parts of the lunchroom and the school. Congress two years ago directed USDA to regulate those foods as well, but the department has yet to issue those rules.

Sen. Hoeven, who had written Vilsack to express concern about the rules, said he will be supportive of the meals overhaul if the USDA continues to be flexible when problems arise.

"This is an important step," he said. "They are responding and that's what they need to do."

Read More..

Venezuela's Chavez says cancer back, operation in days

CARACAS (Reuters) - Venezuela's Hugo Chavez said on Saturday that his cancer  had returned and he would undergo another operation in the coming days, and for the first time the president named a successor if anything happened to him.

The news was a big blow for supporters of the 58-year-old socialist leader, who elected him in October to a new six-year term in office. Twice since mid-2011 Chavez has said he was cured, and then had to have more surgery.

In an emotional television broadcast from the Miraflores presidential palace, Chavez was flanked by ministers and looked resolute. He even sang, briefly. And in his first comments on a possible successor, he said supporters should vote for Vice President Nicolas Maduro.

Speculation about Chavez's health had grown during a three-week absence from public view that culminated in his latest trip for medical tests in Cuba - where he has undergone three cancer operations since June 2011. He returned to Venezuela on Friday.

"Unfortunately, during these exhaustive exams they found some malignant cells in the same (pelvic) area ... . It is absolutely necessary, absolutely essential, that I undergo a new surgical intervention," the president said.

"With God's will, like on the previous occasions, we will come out of this victorious. I have complete faith in that."

Chavez, who has dominated Venezuelan politics since taking power 14 years ago, said he would return to Cuba on Sunday, and that the operation would take place there in next few days.

He said he had rejected the advice of his doctors to have the surgery sooner, on Friday or this weekend, telling them he needed to fly back to Venezuela to seek the permission of lawmakers to return for the operation.

"I decided to come, making an additional effort, in truth, because the pain is not insignificant," Chavez said. "But with treatment and painkillers, we are in the pre-operation phase."

MADURO GETS THE NOD

Chavez has been receiving treatment at the tightly guarded Cimeq hospital in Havana as a guest of his friend and political mentor, former Cuban leader Fidel Castro.

The normally garrulous president had sharply cut back his public appearances since winning the October 7 election, saying the campaign and radiation therapy had left him exhausted.

Under Venezuela's constitution, an election would have to be held within 30 days if Chavez were to leave office in the first four years of his next term, which is due to begin on January 10.

For the first time, in a rare admission that he might not be able to govern for as long as he hopes, he singled out Maduro - a 50-year-old former bus driver and union leader - as his chosen candidate.

"He is a complete revolutionary, a man of great experience despite his youth, with great dedication and capacity for work," Chavez said. "In a scenario where they were obliged to hold a new presidential election, you should choose Nicolas Maduro."

In addition to putting his own future in doubt, the news that Chavez's cancer has returned is also a blow to ruling Socialist Party candidates who wanted him to campaign alongside them before elections for state governors on December 16.

Another prolonged absence recuperating in Cuba could also postpone important policy decisions, such as a widely expected devaluation of the bolivar currency.

Read More..

Study could spur wider use of prenatal gene tests

A new study sets the stage for wider use of gene testing in early pregnancy. Scanning the genes of a fetus reveals far more about potential health risks than current prenatal testing does, say researchers who compared both methods in thousands of pregnancies nationwide.

A surprisingly high number — 6 percent — of certain fetuses declared normal by conventional testing were found to have genetic abnormalities by gene scans, the study found. The gene flaws can cause anything from minor defects such as a club foot to more serious ones such as mental retardation, heart problems and fatal diseases.

"This isn't done just so people can terminate pregnancies," because many choose to continue them even if a problem is found, said Dr. Ronald Wapner, reproductive genetics chief at Columbia University Medical Center in New York. "We're better able to give lots and lots of women more information about what's causing the problem and what the prognosis is and what special care their child might need."

He led the federally funded study, published in Thursday's New England Journal of Medicine.

A second study in the journal found that gene testing could reveal the cause of most stillbirths, many of which remain a mystery now. That gives key information to couples agonizing over whether to try again.

The prenatal study of 4,400 women has long been awaited in the field, and could make gene testing a standard of care in cases where initial screening with an ultrasound exam suggests a structural defect in how the baby is developing, said Dr. Susan Klugman, director of reproductive genetics at New York's Montefiore Medical Center, which enrolled 300 women into the study.

"We can never guarantee the perfect baby but if they want everything done, this is a test that can tell a lot more," she said.

Many pregnant women are offered screening with an ultrasound exam or a blood test that can flag some common abnormalities such as Down syndrome, but these are not conclusive.

The next step is diagnostic testing on cells from the fetus obtained through amniocentesis, which is like a needle biopsy through the belly, or chorionic villus sampling, which snips a bit of the placenta. Doctors look at the sample under a microscope for breaks or extra copies of chromosomes that cause a dozen or so abnormalities.

The new study compared this eyeball method to scanning with gene chips that can spot hundreds of abnormalities and far smaller defects than what can be seen with a microscope. This costs $1,200 to $1,800 versus $600 to $1,000 for the visual exam.

In the study, both methods were used on fetal samples from 4,400 women around the country. Half of the moms were at higher risk because they were over 35. One-fifth had screening tests suggesting Down syndrome. One-fourth had ultrasounds suggesting structural abnormalities. Others sought screening for other reasons.

"Some did it for anxiety — they just wanted more information about their child," Wapner said.
Of women whose ultrasounds showed a possible structural defect but whose fetuses were called normal by the visual chromosome exam, gene testing found problems in 6 percent — one out of 17.
"That's a lot. That's huge," Klugman said.
Gene tests also found abnormalities in nearly 2 percent of cases where the mom was older or ultrasounds suggested a problem other than a structural defect.

Dr. Lorraine Dugoff, a University of Pennsylvania high-risk pregnancy specialist, wrote in an editorial in the journal that gene testing should become the standard of care when a structural problem is suggested by ultrasound. But its value may be incremental in other cases and offset by the 1.5 percent of cases where a gene abnormality of unknown significance is found.

In those cases, "a lot of couples might not be happy that they ordered that test" because it can't give a clear answer, she said.

Ana Zeletz, a former pediatric nurse from Hoboken, N.J., had one of those results during the study. An ultrasound suggested possible Down syndrome; gene testing ruled that out but showed an abnormality that could indicate kidney problems — or nothing.

"They give you this list of all the things that could possibly be wrong," Zeletz said. Her daughter, Jillian, now 2, had some urinary and kidney abnormalities that seem to have resolved, and has low muscle tone that caused her to start walking later than usual.
"I am very glad about it," she said of the testing, because she knows to watch her daughter for possible complications like gout. Without the testing, "we wouldn't know anything, we wouldn't know to watch for things that might come up," she said.
The other study involved 532 stillbirths — deaths of a fetus in the womb before delivery. Gene testing revealed the cause in 87 percent of cases versus 70 percent of cases analyzed by the visual chromosome inspection method. It also gave more information on specific genetic abnormalities that couples could use to estimate the odds that future pregnancies would bring those risks.

The study was led by Dr. Uma Reddy of the National Institute of Child Health and Human Development.

Read More..

Twins have simultaneous and free hip replacements

BENSALEM, Pa. (AP) — To make the high school cheerleading team 40 years ago, twins Deborah and Sandra Fanelli performed an acrobatic move called "the flying splits."

The memory recently drew a rueful laugh from the once-active sisters, who in recent years have had trouble simply walking.

Severe arthritis has nearly crippled Sandra, known as Sam, who uses a walker. Deb has relied on a cane.

But on Friday, the 56-year-old twins, who have lived their entire lives together, were wheeled into side-by-side operating rooms at Rothman Orthopaedic Specialty Hospital in the Philadelphia suburb of Bensalem.

Deb received a right hip replacement and Sam had surgery on both hips as part of Operation Walk USA, a program that offers free knee and hip replacements to uninsured patients like the Fanellis.

"I'm just incredibly grateful and in awe of this procedure," Sam said, just hours after surgery as she took her first steps down a hospital corridor to visit her sister.

Doctors, hospitals and implant manufacturers donate time and equipment for the procedures. A hip replacement would normally cost about $16,000, plus hospitalization, according to Rothman officials.

The program started in the mid-1990s to serve patients in developing countries but has been offered in the U.S. for only the past two years. The Fanelli twins were among five patients at Rothman, and among 200 people nationwide, receiving free new joints on Friday.

The sisters had become increasingly debilitated with arthritis after dancing and singing professionally for 20 years, including eight years at a casino in Atlantic City, N.J.

They have been living in their childhood home in Clementon, N.J., with their spry and doting 81-year-old mother, Blanche, who has watched with alarm as her daughters' conditions have deteriorated.

"Because I'm not a young person," Blanche said in an interview Thursday. "And I thought, 'Oh, my gosh, who's going to take care of them?'"

Over the past few years, Sam has run a small gourmet cookie business out of the house and Deb has sold cosmetics. But their outings have been minimal, limited mainly to the grocery store and their parish church.

"It's hard to even get up some days," Deb said. "The hip pain and the limitations have robbed us of our freedom and robbed us of our, just, mental joy, to get up and live."

Sam's problems started about 10 years ago. One hip became so painful that their father paid for an experimental replacement procedure in 2003, but Sam saw little improvement. Deb's leg gave out a couple of years later and has gotten progressively worse. The twins have never had health insurance.

Then earlier this year, a friend told them about Operation Walk USA. The family was overcome with joy when they found out both sisters qualified for free surgery.

Dr. Bill Hozack, who gave Sam a new left hip and fixed the old replacement on her right hip, said the operations went well.

"Assuming everything heals properly, no complications — which is usually the case — they should be able to go out and do everything they want to do and not have any problems with the hips," Hozack said.

For now, the sisters must recover and begin re-learning to walk on their new joints. After a tearful reunion in Deb's hospital room Friday afternoon, they said they looked forward to this new phase in their lives.

"I'm flabbergasted. I'm overwhelmed," Deb said. "The worst is behind us. We're going to be great."

A day earlier, the twins had said one of their first goals is to participate this spring in a fundraising walk for ovarian cancer, in memory of a dear friend.

"The first year we went to participate, we had to sit on the sidelines and just kind of watch everybody," Deb said. "So this year, we want to get out there and walk."

"Definitely," added Sam. "I can't wait."

Read More..