HEALTH

Severe sleep apnea increases risk of death

BY Alaric DeArment

WASHINGTON Sleep apnea can do more than interfere with a sound sleep—it can also increase risk of death, according to a report.

The report, published in the journal Sleep, was the result of an 18-year study that found sleep apnea increased the risk of death from any cause by causing the person’s health to deteriorate over time.

The research team that conducted the study examined 1,522 men and women aged 30 to 60. Among the control group, the death rate was 2.85 per 1,000 people each year. Among those with mild to moderate sleep apnea, it was 5.54 and 5.42 per thousand, while the rate was 14.6 per thousand among those with severe sleep apnea. More than 40 percent of deaths among those with severe sleep apnea resulted from cardiovascular disease.

The National Heart, Lung and Blood Institute estimates that sleep apnea affects 12 million to 18 million Americans.

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FDA siezes more than $24 million in unapproved drugs

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Wednesday executed its second product seizure in a week, having confiscated $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. after United States Attorney Catherine Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

The seizure followed an inspection of several of the company’s plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

“The FDA is committed to taking enforcement action against firms that circumvent the drug approval process,” stated Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace.”

Earlier this year, FDA had found KV Pharmaceutical was violating a May 29, 2007 edict that required companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs.

Wednesday’s seizure falls only one week after the FDA confiscated $74,000 in Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals of Miami, Fla.

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NAD recommends changes to Cinnergen claims

BY Michael Johnsen

NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Wednesday recommended that eFoodSafety.com discontinue or modify several advertising claims for the company’s Cinnergen product.

At the outset of NAD’s review, eFoodSafety.com explained that it had substantially reformulated Cinnergen, resulting in a significant increase in certain ingredients, meaning that the clinical studies that would have been applicable to support some of those claims were no longer sufficient.

• “Clinically proven to control blood sugar”• “Over half the patients in our clinical study were able to stop taking prescribed medication.”• “70 percent of people in our study had a decrease in A-1c levels!!!”

The advertiser also agreed to modify those claims that may lead consumers to believe that Cinnergen is a replacement for their normal insulin regimen, specifically that Cinnergen “Helps Insulin work more effectively” and “Cinnergen is a Natural Part of the Diabetics Diet!!”

The remaining claims, the eFoodSafety.com asserted, are supported by clinical trials on comparable doses of key ingredients in Cinnergen.

Following its review of the advertiser’s evidence, NAD noted that while the studies, taken together, reveal that there is emerging evidence that cinnamon supplementation can be beneficial in reducing blood glucose levels and improving insulin sensitivity, NAD determined, among other things, the evidence in the record is not conclusive as to whether daily cinnamon supplementation should be recommended for type 2 diabetics or individuals who are insulin resistant. Accordingly, NAD recommended that the claims “Keeps blood sugar levels in normal range!” be discontinued, as well as the references to “nurtures vital cell generation” and “Guaranteed to Control Blood Sugar Levels” as well as the quantified performance claims which were based on testing of a prior formulation of Cinnergen.

NAD also recommended that the advertiser modify the claims that the product “promotes healthy glucose metabolism” and “[h]elps insulin work more efficiently!” to state that emerging science indicates that cinnamon supplementation may be beneficial in reducing blood glucose levels in type 2 diabetics and avoid conveying the unsupported message that there is conclusive or scientific consensus regarding cinnamon supplementation or Cinnergen’s efficacy. Further, NAD recommended the advertiser modify claims related to diabetes to avoid conveying the unsupported message that Cinnergen is a substitute for insulin or other medications prescribed for diabetics.

As for the antioxidant claims, NAD recommended that the claim “[p]rovides vital nutrients to turn sugar into energy!” be discontinued and that the claim “offers antioxidant benefits!” be modified to communicate that certain ingredients in the product – rather than the product itself –may provide antioxidant benefits.

NAD recommended that the advertiser discontinue the claim “Doctor Recommended Formula. Guaranteed To Work!” Finally, NAD recommended the advertiser modify the claim “Natural, Safe & Effective,” to remove the references to “effective” and “safe” and to make clear that the “natural” reference in the claim refers solely to the ingredients.

In its advertiser’s statement, eFoodSafety.com said it is “disappointed … that NAD did not give greater weight to the clinical studies on ingredients in Cinnergen” but that “eFoodSafety.com appreciates the opportunity to participate in the self-regulatory process [and] will modify its advertising consistent with NAD’s decision.”

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