FDA approves high blood pressure tablets
Mon, 21 Jan 2008 18:14:59 GMTWASHINGTON - Tablets containing a combination of the blood pressure medication aliskiren and water pill hydrochlorothiazide have been approved by the Food and Drug Administration, the product's manufacturer, Novartis AG, said Monday.
Sold under the name Tekturna in the United States, the hypertension compound aliskiren was approved last March. It acts by targeting renin, an enzyme responsible for high blood pressure. The newly approved version also includes hydrochlorothiazide, a compound that inhibits the kidney's ability to retain water. This water pill is commonly used to treat high blood pressure.
Tekturna HCT tablets are intended for patients whose blood pressure has not been controlled by a single drug. They will be available in early February the company said.
Side effects associated with the new combination tablets include dizziness, flu-like symptoms, diarrhea, cough, tiredness and skin rashes.
Attempts to reach FDA officials to confirm the approval were not immediately successful.
Tekturna is known as Rasilez outside of the United States.
The company's U.S. affiliate Novartis Pharmaceuticals Corp. is based in East Hanover, N.J.
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On the Net: http://www.novartis.com or http://www.tekturnahct.com
Study looks at why poor kids are heavy
Mon, 21 Jan 2008 18:20:44 GMTBy AMY LORENTZEN, Associated Press Writer
DES MOINES, Iowa - New research discounts a common theory on why poor children are more likely to be overweight than children from wealthier families.
Iowa State University researchers say their analysis shows that a lack of food isn't necessarily to blame, although they're not sure why so many children from low-income families are overweight.
Previous research has suggested that poor children weren't getting nutritious food and instead ate junk food, such as hot dogs. Or that children may have eaten well when money was available, but would skip meals when cash was short, a cycle that could slow their metabolism and cause them to gain weight.
By challenging those theories, the researchers hope to encourage more research into the issue. Some studies show that nearly one third of American children ages 10-17 are overweight or obese, and that nearly 40 percent of those kids are from low-income households.
Brenda Lohman, a co-author of the study, said the high number of overweight low-income kids is a public health concern.
"Understanding why the rates are so high .... is needed," she said.
Their findings are reported in February's issue of the Journal of Nutrition.
Donna Matheson, of Stanford Medical School's Prevention Research Center, said the study explores some new elements, but disregards others. She noted that the research only looked at children with weight problems, not those who were underweight.
For the study, the researchers analyzed 1999 data about 1,031 children living in low-income households in Boston, Chicago and San Antonio. They assessed whether the children had enough food for a healthy, active lifestyle, which is called food security by researchers. They looked at the individual child, instead of their entire household as previous studies had done.
The researchers asked the children's mothers whether she had reduced the size of a meal due to lack of food or money, if her child skipped a meal because food wasn't available and if her child went hungry because she couldn't afford more food.
They found that about half of the children in the study were overweight or obese, while only about 8 percent weren't getting enough to eat.
Craig Gundersen, lead author of the study, said children who didn't get enough food weren't more likely to be overweight, even though the two factors often coexisted in the low-income population they studied.
He said the study shows that if the government tries to expand food assistance programs to help children, officials can move forward without worrying about an increase in overweight kids living in poverty.
However, Matheson said she thinks much more research is needed before changes in policy are implemented.
"I don't think we are there yet in terms of saying what really works," she said.
Susan Stewart, an Iowa State sociology professor who was involved in the research, said in a statement that most of the research on childhood obesity comes from the medical community, but there should be a closer look at the family and how factors such as stress affect a child's weight.
"Family life has a lot to do with children's lives, particularly when it comes to overeating and obesity," she said.
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On the Net:
Iowa State University: http://www.iastate.edu/
Journal of Nutrition: http://jn.nutrition.org/
Key health issues divide both parties
Sun, 20 Jan 2008 16:12:25 GMTBy KEVIN FREKING, Associated Press Writer
WASHINGTON - The Bush administration's health agenda this year will consist largely of fending off Democratic lawmakers until a new president and Congress take charge.
In a preview of what is ahead, Health and Human Services Secretary Mike Leavitt says the administration will work to limit the government's role in the delivery of health care. That goal is at odds with several Democratic proposals, such as giving the health chief the power to negotiate drug prices and greatly increasing enrollment in federally sponsored health insurance for children.
Leavitt sees the philosophical divide playing out in numerous ways before the November elections. The year, he predicted, "will be replete with the kind of conflict this town is famous for."
Most policy analysts see little chance for compromise on almost all the major health issues before Congress — a view shared by the top Republican on the House Energy and Commerce Committee, which oversees most health issues.
Based on last year's experience in the first year of Democratic control, "I'm not expecting too much cooperation or bipartisanship," Texas Rep. Joe Barton said. "I would assume that all that gets done will be the things that absolutely have to get done."
Democrats will try to keep attention on a proposed expansion of the State Children's Health Insurance Program. The party sees this program as the most practical way to increase coverage to 4 million children, said Democratic Rep. Frank Pallone of New Jersey, who heads the health subcommittee.
Under the program, the government and states subsidize insurance for children in low-income families that do not qualify for Medicaid. Leavitt often refers to the children's insurance program as government-run health care. Pallone, however, notes that private insurers routinely contract with states to administer the benefit.
The administration is "into this ideological labeling of everything, even when there's no basis for it," Pallone said. "That makes it difficult. But look, we're going to be practical and we're going to see if we can come to an agreement with them."
Democrats, with some Republican support, will try on Wednesday to override President Bush's veto of a bill that would basically double spending on the program, to $12 billion annually. A similar vote last year fell 13 votes shy.
Democrats also are focused on trimming payments to private health insurers that serve older people and the disabled. Democratic Sen. Max Baucus of Montana, who heads the Senate Finance Committee, has said a hard look at the payments and the marketing practices of insurers is long overdue.
The insurance companies provide coverage to about 9 million people through a program known as Medicare Advantage. The government, on average, spends about 12 percent more for beneficiaries treated through Medicare Advantage than it does for those in traditional Medicare. Under regular Medicare, the government simply reimburses a provider a set rate for a particular service.
But Leavitt said the administration will not support cutting money for Medicare Advantage.
"We want to protect it, enhance it and expand it as a tactical approach to entitlements in general," Leavitt said.
Agreement could come on a separate health-related issue, food safety. Barton said Rep. John Dingell, chairman of the House Energy and Commerce Committee, has told him he would like to work with Republicans on the issue.
"I think we would support more inspectors," Barton said. "I think we would support foreign inspections where we go into processing plants overseas like the FDA has the right to do here."
Democrats will try to allow more poor people with Medicare coverage to qualify for extra financial help, and they are promising continued reviews of insurers' marketing practices.
About the only legislation that both Democrats and Republicans view as having to pass would eliminate a pay cut for doctors who treat the elderly and disabled. The doctors were scheduled to take a 10-percent rate cut beginning Jan. 1 until Congress granted a six-month reprieve.
As part of that expected bill, the administration wants to require that doctors adopt electronic record keeping. Those who do not buy such technology would get paid less than the doctors who do.
Such records can help coordinate patient care, potentially reducing health costs. The widespread adoption of electronic records furthers the administration's priority of creating a marketplace that gives people more information about the quality and price of the care they receive, Leavitt said.
Pallone said Democrats back the idea of electronic records, but he will not support requiring doctors to go along with the technology as a basis for their Medicare payments.
"It just becomes an excuse to reduce their rates," Pallone said.
Leavitt hinted that Bush will continue to recommend a slowdown in Medicare and Medicaid spending, but he declined to get specific.
Also at issue is an anticipated Democratic effort to allow the FDA to regulate tobacco. Leavitt said he opposes giving the agency that responsibility because some people could get a false sense of security about the safety of tobacco products.
