Tuesday, December 04, 2007

Carb Management Good for Everyone, FDA Budget & Organization Issues

First, people with diabetes are regularly told that they should try to manage their consumption of carbohydrates, particularly highly-refined carbs like sugar, refined white flour, potatoes, rice and other foods that cause a rapid rise in blood glucose levels. The reasons differ, depending on what type of diabetes a person has. In the case of type 1, the non-physiological manner in which insulin is administered means that insulin is delayed in getting into the bloodstream and therefore cannot adequately match the body's needs. Although insulin analogs are supposed to better address this issue, they are not without their flaws. People with type 2 who use supplemental insulins have similar issues to people with type 1. They, along with those on other treatments also try to manage their carb intake to avoid spikes so the insulin already present in their bodies can work effectively with any other treatments they are using. Based on decades of experience, I certainly would never dispute the recommendation to manage carb consumption, because it has proven its value repeatedly.

However, I always have a sense of irritation when people without diabetes feel free to consume entire bagels (which are carb bombs, for a lack of a better term), and then wash it down with a sugary carton of orange (or grapefruit, apple, etc.) or a mocha frappucino and believe they don't have to worry about it because they don't have diabetes. It turns out that managing carb consumption applies to everyone, not just people with diabetes.

Whenever simple carbs are consumed, the body is forced to respond by releasing a surge of insulin to counteract the rapid rise in blood glucose caused by those foods. As a wise person once wrote (and I paraphrase here because I cannot find the original work), rapidly forcing glucose into the cells goes against the body's natural order of things, and this applies whether or not a person has diabetes. Many people without diabetes have reactive hypoglycemia caused by the insulin surge that the carb consumption causes. This may create a temporary sense of discomfort, but should also be a warning sign that what they're doing is not the best thing for their body or health.

Now, Researchers led by Chung-Jung Chiu and Allen Taylor, both at the Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA) in Boston, MA analyzed dietary intake and other data from more than 4,000 men and women aged 55 to 80 participating in the Age-Related Eye Disease Study, or AREDS. They found that consuming higher-than-average amounts of carbohydrates that cause blood sugar levels to spike and fall rapidly may be a risk factor for central vision loss with aging, which has nothing to do with diabetes, but does have to do with vision loss in the elderly. Although the findings are preliminary, they do suggest that the modern diet simply doesn't work as well as more traditional diets based largely on unprocessed foods.

See here for a summary of those findings: http://www.sciencedaily.com/releases/2007/11/071126153729.htm

Advisers Say F.D.A.'s Flaws Put Lives at Risk

Second, and perhaps more important, as the major news media reported, the U.S. Food and Drug Administration (FDA) is desperately short of money and poorly organized, which is putting people's lives at risk. The report was written by three members of the F.D.A. Science Board, an advisory panel that reports directly to the agency's commissioner, Dr. Andrew C. von Eschenbach. The three authors in turn had 30 scientific advisers.

Among the problems cited in the report were inadequate staffing, poor retention, out-of-date technology and a lack of resources, all of which have impaired the FDA's abilities. The report was a result of a year-long review by a distinguished panel of experts, the Subcommittee's report concludes that the state of FDA's scientific and regulatory programs could not be separated from the lack of resources available to support the agency's scientific base, hire and train a broadly-capable scientific workforce, and build a sophisticated and modern information technology infrastructure.

The full report, entitled "FDA Science and Mission at Risk", can be found at the Food and Drug Administration's website.

"Over the last decade, complex scientific advances, globalization and challenging new safety issues have combined to multiply the responsibilities of the FDA. As this new report makes clear: our expectations cannot exceed the resources we give FDA to accomplish its mission. In this regard, more is definitely better," commented Mark McClellan, MD, former FDA commissioner and chairman of the new Reagan-Udall Institute designed to enhance FDA's readiness for future scientific challenges.

But while Congress passed more than 100 laws expanding the FDA's authority since 1988, it has not increased the funding appropriately, the report found. As The New York Times reported, "the report concludes that over the last two decades, the agency's public health responsibilities have soared while its appropriations have barely budged. The result is that the FDA is falling farther and farther behind in carrying out its responsibilities and understanding the science it needs to do its many jobs." In fact, during the same 20-year period, while faced with 123 new statutes, FDA gained through appropriation only 646 employees - an increase of 9% - and lost more than $300 million to inflation.

To give just one example of how the agency's computer system has failed the public health, the report notes that "most recently during an E. coli food contamination investigation" the agency's aging computer system was prone to breakdowns.

"Reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still handwritten and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with customs and other government systems," the report stated.

In addition, the FDA often misses significant product arrivals because its computers are so poor that they cannot distinguish between shipments of road salt and those of table salt, the report said.

Don Kennedy, PhD, former FDA commissioner and editor-in-chief of the scientific journal Science said that the "FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources. Congress is negotiating FDA's FY 2008 (current year) budget right now and can start to fix this critical problem."

The current problem is caused, in part, by the major funding mechanism for the FDA at the present time. As the Boston Globe reported:

In 1992, Congress put the fox in the chicken coop. It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay "user fees" to the FDA for each brand-name drug considered for approval. Nearly all of the money generated by these fees has been earmarked to speed up the approval process.

In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster.

But while it's a small investment for drug companies, it's a lot of money for the agency, and it has drastically changed the way it operates -- creating a disproportionate emphasis on approving brand-name drugs in a hurry. Consequently, the part of the agency that reviews new drugs gets more than half its money from user fees, and it has grown rapidly. Meanwhile, the parts that monitor safety, ensure manufacturing standards, and check ads for accuracy have languished or even shrunk.

Obviously, the President and Congress shares the blame for this situation, but it remains to be seen as to how they address it. The user fee system has enabled the U.S. Government to largely avoid paying for the agency which is responsible for the safety of the U.S. food and drug supply. With their focus fixated on a failed policy in Iraq and a desire to cut taxes (for certain groups, anyway), Congress had planned to simply re-authorize the user-fee system and the President promised to rubber-stamp approve it as long as restrictions on the Pentagon's budget were not included.

But the moral to the story is that if we want the food and drug supply to be safe, then taxpayers need to pay for it, otherwise we have no one to blame but ourselves. Perhaps this report will help change some minds among lawmakers.


Anonymous said...

I guess this exsplains the FDA's sub par performance as of late. Ecoli problems, asbestas in toys, and not to mention allowing dangerous prescription medications on the market. This is definetly a subject that the American public cannot afford to see pushed to the back burner.

BetterCell said...

The disarray in the the FDA sounds like a job for Bruce Wayne (Funding/Investment/Better Management) and Batman(closing down counterfeit drugs/contamination of chemicals via China and India that go into the production of Generic Pharmaceuticals).
I cannot think of anyone else who would be more appropriate in-order to fix the existing mess both at the FDA and from countries exporting contaminant and toxic chemicals that go into the manufacture of Drugs for the American Market.