News in brief - Aug. 8, 2011

Certain health risk factors could lead to brain damage later in life - FDA regulation of medical devices "fundamentally flawed," IOM says

Certain health risk factors could lead to brain damage later in life

Middle-aged patients who smoke, are overweight or have hypertension or diabetes may be prone to cognitive problems 10 years later, says an Aug. 2 study in Neurology (neurology.org/content/77/5/461.abstract).

Researchers studied brain structure changes in 1,352 participants of the Framingham Heart Study Offspring Cohort. Those with hypertension at middle age later developed small areas of vascular brain damage at a faster rate than those with normal blood pressure. Smokers and diabetes patients had more rapid loss of volume in the brain's temporal horn.

Midlife smoking also was linked to a significant decrease in total brain volume. Obese patients had increased risk of changes in executive function.

"Our findings provide evidence that identifying these risk factors early in people of middle age could be useful in screening people for at-risk dementia and encouraging people to make changes to their lifestyle before it's too late," said Charles DeCarli, MD, study co-author and professor at the University of California Davis School of Medicine in Sacramento.

FDA regulation of medical devices "fundamentally flawed," IOM says

The process the Food and Drug Administration uses to approve new medical devices is "fundamentally flawed" because safety and efficacy data are not examined, according to an Institute of Medicine report released July 29.

The FDA review, known as the 510(k) process, requires the agency to approve medical devices that are "substantially equivalent" to devices already on the market. But that process leads to allowing the marketing of medical devices that may be dangerous or ineffective, and the FDA ought to come up with a way of testing new devices before approval, said the IOM's report (www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx).

In a statement, the FDA said it does not want to eliminate the 510(k) process but is considering ways to strengthen its review procedures. A trade group representing devicemakers said tougher approval criteria would do little to improve safety and would impede innovation.