Monday, October 31, 2011

FDA backs Vytorin for kidney disease patients (AP)

WASHINGTON � The Food and Drug Administration says Merck's cholesterol drug Vytorin helps reduce heart attack, stroke and related problems in patients with kidney disease, a potential new use for the blockbuster drug.

The agency's online review also found no new safety concerns with Vytorin, which came under scrutiny for potential cancer risks in 2008.

Merck has asked the FDA to approve the drug for a new use in reducing heart-related problems chronic kidney disease patients. The combination pill is already cleared to reduce bad cholesterol.

FDA says that Vytorin lowered kidney disease patients' heart-related problems by 16 percent compared with placebo. However results varied depending on whether patients were receiving dialysis, standard treatment for patients with late-stage kidney disease who can no longer remove waste from their blood. Patients on dialysis only saw a six percent drop in heart problems, compared with a 22 percent reduction for healthier patients not on dialysis.

On Wednesday, the FDA will ask non-government advisers to comment on the disparity and to vote on the overall safety and efficacy of the drug for kidney disease patients.

Vytorin, a $2 billion-a-year drug for Merck, combines two brand-name cholesterol pills Zocor and Zetia.

In July 2008, preliminary results from a four-year study indicated a possible increased risk of cancer in patients getting Vytorin. But FDA's latest review found no evidence of a link between Vytorin and cancer.

"We believe these data should help lay to rest investor concerns about Vytorin and Zetia's safety," Leerink Swann analyst Seamus Fernandez wrote in a research note Monday.

Shares of Merck & Co. Inc. fell 23 cents to $34.88 in morning trading Monday.



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Violence more common among kids of combat veterans (AP)

ATLANTA � A new study suggests that when parents are deployed in the military, their children are more than twice as likely to carry a weapon, join a gang or be involved in fights.

And that includes the daughters.

"This study raises serious concerns about an under-recognized consequence of war," said Sarah Reed, who led the research of military families in Washington state.

Last year, nearly 2 million U.S. children had at least one parent serving in the military. Deployment can hurt a family in a variety of ways. There's stress while that parent is overseas and in danger, as the remaining parent has to shoulder all responsibilities and family roles shift. There can also be challenges after deployed parents' return, especially if they were physically or psychologically damaged.

The effect of military deployment on kids is an emerging field of research. The new study is considered the first of its kind to focus on those affected by deployments to Afghanistan and Iraq. It's unique in that it looked at a statewide swath of the population in comparing the behavior of kids in military families to children in non-military families.

The study, to be presented Monday at a public health conference in Washington, D.C., was based on a 2008 questionnaire survey of about 10,000 students in the 8th, 10th and 12th grades in Washington. That state has the sixth largest active duty population in the country.

About 550 of surveyed children said they had a parent deployed to a combat zone in the previous six years.

The study tried to account for potential differences in educational background and other issues between military families and the general population that might skew the results.

Even after taking steps to account for such differences, the researchers found that high school-age daughters of deployed parents were nearly three times more likely than civilian girls to be in a gang or get into a fight. They were more than twice as likely to carry a weapon to school. There were similar increases among boys of deployed families when compared to civilians.

To be sure, such behavior in boys is more common � the rate of boys from deployed families involved in such violent behaviors was twice as high as for girls in deployed families. For example, 14 percent of girls from these military families said they had been in fights, compared to 28 percent of boys.

Nevertheless, experts say the findings contradict the traditional view that girls under stress exhibit "internalizing" behaviors, like becoming depressed or thinking about suicide, while boys are the ones who "externalize" through violent behavior

The new research may be something of a wake-up call for health professionals who deal with military families, one expert suggested.

"Maybe if we make assumptions about children, we may overlook other ways they may be suffering," said Dr. Gregory Gorman, an assistant professor of pediatrics at the Uniformed Services University of the Health Sciences in Bethesda, Md.

Additional research is needed to confirm the findings, said Reed, who has since left the University of Washington and is now a social worker with the Dana-Farber Cancer Institute in Boston. For example, the survey found that 10 to 20 percent of the adolescents in deployed families said they were in gangs. That's surprisingly high � more like something seen in New York City in the 1950s. Perhaps a larger, more national study would produce a lower number.

But it's not surprising that kids in deployed families would seek out other kids to help them deal with stress, said Gregory Leskin, a UCLA psychologist who is director of a military family program at the National Child Traumatic Stress Network.

"Adolescents may be able to get lost in social networks," he said.

___

Online:

American Public Health Association meeting:

http://www.apha.org/meetings/AnnualMeeting/



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