HEALTH

NIH funded study in search of hearing loss supplement

BY Michael Johnsen

ANN ARBOR, Mich. The University of Michigan Kresge Hearing Research Institute on Monday announced they will be testing the use of vitamins and magnesium in the prevention of hearing loss caused by loud noises.

“When we can’t prevent noise-induced hearing loss through screening programs and use of hearing protection, then we really need to come up with some way of protecting people who are still going to have noise exposure,” said Glenn Green, assistant professor of otolaryngology at the U-M Health System and director of the U-M Children’s Hearing Laboratory.

The combination of vitamins A, C and E, plus magnesium, will be given in pill form to patients who are participating in the research. Developed at the U-M Kresge Hearing Research Institute, the combination, called AuraQuell, is designed to be taken before a person is exposed to loud noises. In earlier testing at U-M on guinea pigs, the combination of the four micronutrients blocked about 80 percent of the noise-induced hearing impairment.

Now, AuraQuell is being tested in a set of four multinational human clinical trials: military trials in Sweden and Spain, an industrial trial in Spain, and a trial involving students at the University of Florida who listen to music at high volumes on their iPods and other PDAs, funded by the National Institutes of Health. This is the first NIH-funded clinical trial involving the prevention of noise-induced hearing loss.

“If we can even see 50 percent of the effectiveness in humans that we saw in our animal trials, we will have an effective treatment that will very significantly reduce noise-induced hearing impairment in humans,” remarked Josef Miller, co-lead researcher.

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Glucorell, Anafit settle FTC deceptive advertising claims

BY Michael Johnsen

WASHINGTON Two marketers of dietary supplements that purportedly prevented and treated diabetes have settled Federal Trade Commission charges that they engaged in deceptive advertising practices, FTC reported Thursday.

According to the FTC’s complaint, GlucorelFTCd  and Anafit, both based in Orlando, Fla., made false and unsubstantiated claims that two dietary supplements, Insulow and Glucorell R, were effective for preventing and treating diabetes.

The order contains a judgment of $493,545, which is the total amount the defendants received in sales for Glucorell R and Insulow between January 2005 and May 2008. However, the entire judgment is suspended due to their inability to pay. If it is determined that the financial information given to the FTC was untruthful, then the full amount of the judgment will automatically become due.

Along with statements in their ads such as “Insulow may be the only thing between you … and a needle,” the defendants also made unsubstantiated claims that Insulow prevents or reduces the risk of developing Type 2 diabetes,  is an effective treatment for Type 1 and Type 2 diabetes, lowers high blood sugar levels, prevents or reverses insulin resistence, increases fat loss and decreases insulin-related obesity and enables diabetics to reduce or eliminate the amount of drugs and insulin required to keep blood sugar levels healthy and reduce insulin resistance, according to the complaint. The FTC also alleged that the defendants falsely advertised that all of these claims except the last had been proven by clinical studies.

For Glucorell R, the defendants’ advertisements allegedly claimed that Glucorell R is effective for treating Type 2 diabetes, prevents or reduces the risk of developing Type 2 diabetes and is effective in treating and preventing cancer. According to the complaint, the defendants also falsely advertised that the last two Glucorell R claims were proven by clinical studies.

According to papers filed with the court, Glucorell has been primarily responsible for packaging, distributing and selling Insulow, and has marketed both supplements; while Anafit has been responsible for packaging, distributing, selling and marketing only Glucorell R.

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Prestige Brands Holding posts Q3 1 percent net revenue gain

BY Michael Johnsen

IRVINGTON, N.Y. Prestige Brands Holdings on Thursday posted net revenues of $88.1 million for its second quarter ended Sept. 30, up 1 percent, primarily from increases in Cleary Eyes and Little Remedies brands in the over-the-counter sector, the company reported and the introduction of two products—Chloraseptic Allergen Block and Little Allergies Allergen Block.

Little Remedies grew 37 percent in the quarter, Mark Pettie, Prestige chairman and chief executive officer, told analysts during a conference call. The growth can be attributed the introduction of Little Noses Saline Mist, which delivers nonmedicated pediatric cough-cold relief in a new form, he said. “This product supplements our existing nasal spray business and is providing considerable incremental growth in the expanding pediatrics saline segment.”

Little Remedies also has benefited from dual placement in one of Prestige’s major drug customers. “Early returns on this program indicate strong incrementality for this customer and we expect continued success will make for a compelling selling story with other customers,” Pettie said.

Also helping to drive growth for Little Remedies was last month’s industrywide voluntary label change of children’s medicines marketed for use in children under age 4. “This change has allowed us to get our two voluntarily withdrawn SKUs reinstated in a number of accounts. But it came too late to influence the seasonal cough-cold resets in the majority of our customers. As a result, there will be a modest benefit to Little Remedies in fiscal ’09, but broad reinstatement will not be possible until the fiscal year ’10 cough-cold season,” Pettie said.

Pettie also noted that the company’s wart remover category continues to be down, slightly. “The cryogenic of the wart remover category took a rather steep price reduction as our fiscal year and the summer wart season began,” Pettie explained. “During our fiscal first quarter the Compound W Freeze Off business in particular was significantly depressed by the fact that our new, lower-priced eight application products did not get into certain retailer’s sets until late in the quarter, with some of that transition carrying into Q2. … We [had] projected that in the second quarter, wart care revenues would continue to be down versus one year ago due to the significant cryogenic segment price declines but that we would see meaningfully improved performance relative to Q1. That has proven to be the case, as the pricing came into line and we restored advertising support to Compound W.”

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