Monday, September 1, 2008

Another Thing Big In Japan: Measuring Waistlines

In the U.S., there’s an outcry about something as simple as putting calories on restaurant menus as a way to help combat the obesity epidemic. But that’s nothing compared to the Japanese, who now have to face measurements of their waistlines during annual checkups if they’re between 40 and 74 years old, the New York Times reports.



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Japan fights fat with waistline measurements (AP Photo/Jeff Lewis)


Anyone with a weight-related medical concern and whose waist is bigger than the acceptable size �- a rigorous 33.5 inches for men and 35.4 inches for women �- must lose weight, according to a new law. Otherwise, they face compulsory diet advice and follow-up visits for three to six months. For some perspective, the average male waist size in the U.S. is 39 inches, while American women average 36.5 inches.


The idea is to reduce the ranks of the overweight by 10% over the next four years and 25% over the next seven years. If not, the government will start fining companies and local governments, who are the providers of health coverage for the majority of Japanese. Ultimately, Japan hopes this campaign will help curb its health-care costs, which have been increasing, just like waist sizes.


Some people are worried about facing the tape measure. Others have embraced the idea, along with that of reducing the health consequences associated with obesity, such as metabolic syndrome�-or “metabo,” as it’s called in Japan.


But skeptics say there’s no need for such drastic measures. “I don�t think the campaign will have any positive effect,” Yoichi Ogushi, a professor at Tokai University�s School of Medicine told the NYT. “Now if you did this in the United States, there would be benefits, since there are many Americans who weigh more than 100 kilograms,” or about 220 pounds. “But the Japanese are so slender that they can�t afford to lose weight.”





FDA Takes Its Time Reviewing Generic Drugs

fdaThe FDA generally takes longer than the 180-days allowed under federal law to process generic drug applications, a government report released Thursday says, citing, unsurprisingly, the agency’s lack of resources and personnel as a factor.


Reviews are convoluted. For starters, when a drug company submits a generic drug application it gets passed around to three FDA divisions and in some instances a review hasn’t even begun until 180 days after the application hits the agency’s in-box, according to the report by Health and Human Services Inspector General Daniel Levinson.


fdatableLevinson looked at 989 generic drug applications submitted in 2006 and found the median time for review was 217 days. Almost half of applications, or 46%, took longer than the 180 limit, and nearly 96% of applications were rejected.


We suppose the findings might have been more surprising if the agency’s reputation and shortage of resources hadn’t been front and center in a a series of bruising congressional hearings over the last three months. Compared with heparin and problems with food safety, tardy decision on generics applications might not seem so important. But the economic impact of generics is large enough that even small delays can hurt.


For its part, the FDA argues it rejects most original generic drug applications because they don’t meet agency standards. Levinson suggested FDA give the industry more guidance so applicants don’t have to constantly go back to the drafting table.