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Past News Items - June 2009

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In the News

FDA Failed to Complete State Food Safety Audits

Study: Ginseng Ameliorates Inflammation

Even Simulated Acupuncture More Effective Than Usual Care for Back Pain

Folate Alleviates Allergies, Asthma

Released: 06/01/09

FDA Failed to Complete State Food Safety Audits

The US Food and Drug Administration (FDA) conducted only 50% of the state food safety audits it had promised some 2 years before the high-profile peanut salmonella outbreak that killed 9 people, sickened hundreds more, and led to more than 2000 product recalls—one of the largest recalls in US history. According to documents FDA sent to Congress in May, the agency neglected to do required audits of state-run food inspections in 5 states from 2007 to 2008 and was unable to prove whether any audits at all were conducted in 11 additional states during that time. This included Georgia and Texas, where pervasive salmonella contaminations were found in 2 peanut plants owned by the Lynchburg, Virginia–based Peanut Corporation of America last year.

FDA state audits were created to ensure that food is inspected properly by states that contract with FDA—these state inspections replaced federal inspections through contracts with FDA—but in only 14 states were 100% of the audits completed during 2007-2008. From 2006 to 2007, no audits were conducted in Texas and 7 other states. These statistics came to light when the agency submitted its records on the audits to the US House Energy and Commerce Committee in response to questioning at hearings earlier this year. The agency fully acknowledges that the salmonella outbreak illuminated limitations of FDA's approach and prompted internal discussions about fixing the audit program.

In 2000, a report from the inspector general of the Health and Human Services Department (the agency that oversees FDA) noted the bureau needed better evaluations of the effectiveness of state inspections for food production facilities. FDA itself set a standard that 7% of all state inspections should be audited. According to data collected from regional FDA coordinators for 2007-2008, the total number of contracted state inspections was 10 218, with only 358 audits, or 3.5%, completed by FDA. No audits were performed at all in California, Iowa, Kansas, Nebraska, and Wyoming during that time period. For 2006-2007, the states skipped entirely by auditors were Arkansas, Maryland, South Carolina, Tennessee, Texas, Virginia, West Virginia, and Wyoming. Only 9% of the promised audits were done in California in 2006-2007, during which time an E coli outbreak in spinach caused 3 deaths and more than 200 illnesses.

Because of recent food-borne illness outbreaks and product recalls, Congress has vowed to increase oversight of FDA. Several members of both houses have introduced bills to overhaul the agency, including proposals to separate its food safety from its drug oversight duties and to significantly increase funding for inspections.

Study: Ginseng Ameliorates Inflammation

While Panax ginseng has been used in Chinese and other Asian medicine for centuries to treat hepatitis C, hypertension, menopausal symptoms, and erectile dysfunction, a new study published online in the Journal of Translational Medicine now elucidates its effectiveness in fighting inflammation.

In the study on P ginseng's active components (ginsenosides), researchers from the University of Hong Kong identified 7 ginsenosides extracted from the ginseng root that showed immunosuppressive effects. They used human promonocytic U937 cells to investigate the immunomodulatory effects of ginseng following TNF-alpha treatment. A global gene expression profile was obtained by using genechip analysis, and specific cytokine expression was measured by quantitative RT-PCR and ELISA. HPLC was used to define the composition of ginsenosides in 70% ethanol-water extracts of ginseng. Activation of signaling kinases was examined by Western blot analysis.

The extracts of ginseng significantly inhibited the transcription and secretion of CXCL-10 following TNF-alpha stimulation. Nine ginsenosides—Rb1, Rb2, Rc, Rd, Re, Rf, Rg1, Rg3, and Rh1—were identified by HPLC. When tested individually, 7 of these 9 ginsenosides significantly inhibited TNF-alpha-induced CXCL-10 expression in U937 cells; however, the CXCL-10 suppressive effect of individual ginsenosides was less than that of the crude extract. In other words, individual ginsenosides blocked inflammation pathways, but the most effective antiinflammatory response occurred when constituents of the whole root extract worked together.

The research team reasoned that the antiinflammatory properties of ginseng might be due to the combined effect of all of the ginsenosides because each may target a different level of immunological activity. They also noted that further studies are necessary to explore the potential of ginsenosides in the management of acute and chronic inflammatory diseases. At present, ginseng is manufactured from the root and/or leaves as a liquid extract or dried and dispensed in tablets, capsules, and teas. Topical creams are also made from either method.

Even Simulated Acupuncture More Effective Than Usual Care for Back Pain

Back pain costs Americans at least $37 billion annually, and many patients with this chronic condition, unsatisfied with allopathic medical care, seek help from acupuncturists. According to a report in the May 11 issue of Archives of Internal Medicine, these patients may be ahead of the curve. Researchers found that 3 kinds of acupuncture therapy—an individually-structured program, standard therapy, and a simulation involving toothpicks at key acupuncture points—appear more effective than usual care for chronic low back pain.

Expanding on numerous recent studies suggesting that sham or simulated acupuncture (ranging from needles inserted at points for treating another condition, needles inserted at points that are not acupuncture points, and use of special needle-like devices that do not pierce the skin) appears as effective as real acupuncture, a research team from the Group Health Center for Health Studies, Seattle, compared 4 different treatment models in a randomized clinical trial involving 638 adults with chronic low-back pain.

During 7 weeks of treatment conducted at Group Health in Seattle and Kaiser Permanente Northern California in Oakland, 157 participants received 10 acupuncture treatments prescribed by a diagnostic acupuncturist; 158 underwent a standardized course of acupuncture; 162 received 10 sessions of simulated acupuncture, in which practitioners used a toothpick inside of an acupuncture needle guide tube to imitate the action of needling; and 161 received usual care.

At the 8-week follow-up, 60% of the participants receiving any type of acupuncture (individualized, standardized, or simulated) experienced improvement in their levels of functioning, compared with 39% of those receiving usual care. At the 1-year follow-up, 59% to 65% of those in the acupuncture groups experienced an improvement in function compared with 50% the usual care group.

Several possible explanations exist for the effectiveness of simulated acupuncture, the authors note. Superficial stimulation of acupuncture points may provoke physiological processes that result in reduced pain and improved function. Alternatively, the improvement may be due to interaction with the therapist or a belief that acupuncture will be helpful: the classic placebo effect.

Even if the mechanism of action remains unclear, various methods of acupuncture point stimulation appear to be reasonable options for back pain without the side effects of conventional medications.

Folate Alleviates Allergies, Asthma

Folate, or vitamin B9, may alleviate allergic reactions and allergy symptoms by shutting down inflammation, according to a study published in a recent issue of the Journal of Allergy and Clinical Immunology.

Although previous studies have noted a potential connection between folate and inflammatory conditions like heart disease, this study, conducted at the Johns Hopkins Children's Center in Baltimore, discovered actual links between higher levels of folate and relief from asthma, atopy, and respiratory symptoms. Funded by the National Institutes of Health, the study involved a review of medical data from 8083 patients aged 2 to 85 who participated in the 2005-2006 National Health and Nutrition Examination Survey (NHANES), utilizing data from NHANES to analyze serum folate and total immunoglobulin E (IgE) levels. IgE is a class of antibodies that mediates allergic reactions; higher levels indicate a higher incidence of allergic reaction.

According to review results, higher folate levels were linked to lower IgE levels, fewer reported allergies, decreased wheezing, and a lower likelihood of the patient developing asthma. People with the lowest folate levels (less than 8 ng per mL of blood) had a 40% increased risk of wheezing, 30% increased risk elevated IgE levels, 31% increased risk of allergic symptoms, and a 16% higher risk of asthma compared to those with the highest levels of folate (above 18 ng per mL of blood). The authors also noted asthma and respiratory symptoms in patients who participated in the NHANES.

However, additional research is needed to confirm these early findings and to determine exactly how folate works on inflammatory responses. The research team now plans to an in vivo study compare the effects of folate to placebo in people with allergies and asthma.

Folate occurs naturally in food like leafy vegetables, asparagus, fruits, legumes, yeast, mushrooms, and organ meat. Folic acid is the synthetic form of folate used primarily in baked goods and ready-to-eat cereals.

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