FDA review process – The Health Care Blog

Where’s the Outrage? Government Proposes (Food) Rationing!!!

Jun 28, 2012• 2

By Merrill Goozner

The U.S. Preventive Services Task Force is at it again. This time, the government-appointed panel is on fat patrol. Its review of the medical literature found that diet and exercise combined with group counseling beat popping a pill when it comes to controlling weight.

For those with short memories, USPSTF is the government panel that in the midst of the health care reform debate had the temerity to suggest the evidence was iffy on the wisdom of mammography for women under 50. Check with your doctor before deciding if an early start to routine breast cancer screening was right for you, they said.

Conservatives had a field day. “We don’t know how far government will go in this bureaucracy,” cried Rep. Michele Bachmann, R-Minn., who a few months later launched her presidential campaign. “This is how rationing begins,” intoned Rep. Marsha Blackburn, R-Tenn.

When it comes to obesity, though, a little food rationing is just what the doctor ordered, according to the latest from the USPSTF. How one rations matters, however.

“With drugs, when people stop, they gain the weight back,” said David Grossman, a senior investigator at Group Health Research Institute in Seattle and chairman of the 16-member panel that issued the updated guidelines on obesity prevention on Tuesday. “This is a lifestyle problem. If you don’t change your lifestyle, drugs are not likely to provide a long-term solution.”

Michelle Obama wasn’t taking the easy path when she chose the obesity epidemic and childhood obesity in particular as her main cause. Since the late 1970s, the number of people considered obese grew by half and now totals 32 percent of men and 36 percent of women. One in 20 Americans are now considered morbidly obese. By 2030, if nothing is done, those numbers are expected to grow to over 40 percent obese with over 10 percent morbidly so.
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Wrong Rx for the FDA

Mar 6, 2012• 3

By Henry Miller

The congressional legislators who oversee the Food and Drug Administration and control the nation’s coffers have shown again that they neither understand drug development nor the regulatory problems that plague it.

In February, Sen. Barbara A. Mikulski(D-Md.) unveiled a bipartisan bill intended to spur innovation in research and drug development for chronic, costly health conditions such as Alzheimer’s disease, cancer, diabetes and heart disease.

According to the press release, the bill will invest “in public-private partnerships to ensure scientists and researchers are able to develop new safe and effective drugs,” shrink product development timelines, increase the number of drugs in the development pipeline and expedite the FDA review process.

However, there is currently plenty in the development pipeline. The federal government is boosting funding for research and development on Alzheimer’s disease; the Department of Health and Human Services alone will allot more than $500 million to it in fiscal year 2013. Moreover, drug companies spend more than $65 billion annually on R&D.

For example, there are now nearly 100 drugs in development for Alzheimer’s disease, dementias and other cognitive disorders, and almost 900 medicines being tested for cancer.