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Health Highlights: Jan. 16, 2009

FDA Lax in Review of High-Risk Medical Devices: Report Health Care Reform Near Top of Public's Wish List for 2009 Pneumonia Vaccine for Young Children Works: CDC

Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

FDA Lax in Review of High-Risk Medical Devices: Report

From 2003 to 2007, the U.S. Food and Drug Administration approved some 228 medical devices -- some of them for sensitive uses -- without a full scale review, a Government Accountability Office (GAO) report said Thursday.

The report found that two dozen distinct types of devices -- such as metal hip joints, external defibrillators to assist heart attack victims, and electrodes for pacemakers -- were approved without close scrutiny, the Associated Press said.

Some devices approved have been recalled because of malfunctions and other problems, according to the consumer group Public Citizen. "It all adds up to less-than-rigorous device review, and it's placing tens of thousands of Americans at risk," Peter Lurie, deputy director of Public Citizen's health research group, told the news service.

While the report did not look into whether any patients were harmed as a result of the approvals, it does highlight calls for closer scrutiny of the FDA's medical device approval process, which has been subject to charges that scientists were pressured to OK some medical machinery against their professional judgment, the AP said.

In 1976, Congress established a three-tiered classification system for these devices, which include everything from tongue depressors to silicone breast implants to pacemakers, the AP said. Low-risk devices such as bandages could be cleared by notifying the FDA before going to market, while high-risk devices such as pacemakers would face tighter scrutiny. Manufacturers were required to provide evidence of safety and effectiveness, but subsequent gains in technology have increased not only the number of devices coming to market but also the number of upgraded products coming up for review, the news service said.

"In general, we agree with the conclusions and recommendations," FDA spokeswoman Karen Riley said. "We are considering legal and procedural options to accomplish this objective."


Health Care Reform Near Top of Public's Wish List for 2009

When it comes to what the American public wants its political leaders to attack first in the coming year, health care reform is near the top of the list, a new survey shows.

As President-elect Barack Obama prepares to take office next Tuesday, researchers from the Kaiser Foundation and the Harvard School of Public Health report that finding ways to help the newly unemployed afford basic health insurance was outranked only by efforts to help businesses generate new jobs while preserving old ones as the most pressing political mandates for the future.

While improving the economy is overwhelmingly the top priority -- three-quarters of those surveyed said that should be the first business for the new Administration -- 43 percent view health care as a top concern, ranking it third just behind fighting terrorism, at 48 percent. Health care was of greater concern than reducing the federal budget deficit (39 percent), improving public schools (37 percent), working to create more clean energy sources (36 percent) and dealing with Iraq (35 percent). More than 60 percent of Americans believe that in light of the overwhelming economic problems facing the country, "it is more important than ever to take on health reform now."

"The economic crisis has created an unprecedented window of opportunity for health reform. But we are in the early happy talk stage on health reform, and the window could close if policymakers cannot move fairly quickly to take advantage of the opportunity they have," Kaiser President and CEO Drew Altman said in a news release.

A key health reform idea that draws support from both liberals and conservatives is more regulation of health insurance companies and more consumer protections.

That's not to say that members of each political party hold the same opinion on how to do that.

"We can see the framework of a winning package of health reform proposals from the public's perspective," said Robert J. Blendon, a professor of health policy and political analysis at the Harvard School of Public Health. But there are some distinct differences among partisans that will pose a challenge to policymakers, he added, "with the key split being how to pay for health care reform."

Conducted last December among a nationally representative random sample of 1,628 adults aged 18 and over, the survey involved phone interviews that were done in both English and Spanish.


Pneumonia Vaccine for Young Children Works: CDC

A pediatric pneumonia vaccine introduced in 2000 has led to a significant drop in hospitalizations for young children with the respiratory disease, U.S. health officials reported Thursday.

In 2006, the rate of hospitalizations for pneumonia among children 2 years old or younger was 8.1 per 1,000 children -- 35 percent lower than the rate before the vaccine was introduced. This reduction means there were an estimated 36,300 fewer pneumonia hospitalizations in 2006, compared to pre-vaccine levels, according to the U.S. Centers for Disease Control and Prevention.

The bacteria streptococcus pneumoniae (pneumococcus) is a leading bacterial cause of childhood pneumonia, which accounts for an estimated 8 percent of all childhood hospital admissions, the CDC said.

Routine childhood immunization with the PCV7 vaccine began in 2000 and substantial declines in hospital admissions for pneumonia in young children were previously reported through 2004, the CDC said in its Morbidity and Mortality Weekly Report.

The updated results confirm that pneumococcus is a leading cause of pneumonia in children, and they show the need for continued monitoring of the immunization program's effects on pneumonia hospitalizations among children, the CDC said.

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