HEALTH

NAD to Novartis: Modify or discontinue advertising claims for Extra-Strength Excedrin

BY Michael Johnsen

NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Wednesday recommended that Novartis modify or discontinue certain advertising claims for Extra-Strength Excedrin.

NAD examined claims that Novartis’ Extra-Strength Excedrin provided pain relief in as quickly as 15 minutes, based on a challenge from Wyeth. NAD examined evidence that included a study provided by Novartis on subjects who took either Extra Strength Excedrin or a placebo. NAD determined that the evidence demonstrated that while some consumers may feel some relief in fifteen minutes, most consumers will not experience perceptible relief in that short of a time period.

NAD recommended that the advertiser either discontinue the claim or substantially modify it to reflect the results of its study — that some people, not most, will experience some relief in as little as 15 minutes.

“Novartis respectfully disagrees with the NAD’s decision as to how consumers interpret its express claim ‘Start[s] relieving your headache in just fifteen minutes,’” the company stated in its response to NAD.

Novartis has reported it will appeal certain NAD findings to the National Advertising Review Board.

NAD, the advertising industry’s self-regulatory forum, examined broadcast advertising for the product following a challenge by Wyeth, a manufacturer of competing pain relief products.

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Bayer Consumer Care praises USPSTF’s recommendation of broader use of aspirin

BY Michael Johnsen

MORRISTOWN, N.J. Bayer Consumer Care on Tuesday commended the U.S. Preventive Services Task Force’s recent support of broader use of aspirin in the prevention of heart attack and stroke.

“[Tuesday’s] recommendations add support for broader appropriate uses of aspirin and do not affect the already [Food and Drug Administration]-approved indications for prevention of recurrent heart attack and stroke, as well as reduction of the risk of death when taken during a suspected heart attack,” Bayer stated. “Further, it’s important that those on doctor-recommended aspirin treatment regimens do not stop taking aspirin without consulting with their doctor as research shows that aspirin withdrawal actually puts patients at higher risk for a cardiovascular event.”

The new recommendations provide more specific guidance on aspirin use, providing clarity on maximizing benefits and minimizing risk, Bayer suggested. To help increase awareness around appropriate use of aspirin as a prophylactic to heart disease, Bayer is introducing “Is Aspirin Right For Me?” — a downloadable discussion guide available at http://www.wonderdrug.com/ to help consumers have meaningful conversations with their healthcare providers to together determine if aspirin is right for them.

“Bayer applauds the USPSTF for today’s important announcement,” stated Wes Cetnarowski, SVP global research and development at Bayer Healthcare. “These recommendations are consistent with our ongoing commitment to advancing appropriate aspirin use to reduce the personal and public health impact of cardiovascular disease.”

The USPSTF granted its highest level of evidence rating encouraging the use of low-dose aspirin in men over 45 and women over 55 to prevent first heart attack and ischemic stroke respectively, when the benefits outweigh the risks. The guidance specific to women is based on results from the Women’s Health Study.

As stated in the Annals of Internal Medicine accompanying editorial, Aspirin for Prevention and Treatment of Cardiovascular Disease, “in women older than 65 years, the WHS did demonstrate a clear 26% reduction in [myocardial infarction]: the same risk reduction as occurred in primary prevention trials of aspirin in men.”

In addition, the new recommendations advise caution with respect to aspirin use in men and women 80 and above.

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LifeScan, Apple demonstrate prototype diabetes management software

BY Michael Johnsen

MILPITAS, Calif. Johnson & Johnson’s LifeScan on Tuesday demonstrated a prototype diabetes management software application, integrating the company’s OneTouch blood glucose meters with the Apple iPhone and iPod touch products. LifeScan was one of a handful of companies invited by Apple to develop and preview innovative new applications at Apple’s iPhone OS 3.0 software event, the company stated.

Using a modified OneTouch Meter, the prototype application demonstrated transmission of a blood glucose test result to the Apple iPhone. Once on the iPhone, test results were available for integration with other information in a series of user-friendly graphics, including the user’s level of glucose control over time relative to targets established with his or her healthcare professional.

The application also will include a customizable food database to help users determine the amount of carbohydrates consumed during meals. Future applications also may include the capability for users to calculate a bolus insulin dose based on the last glucose result and the number of carbohydrates that will be consumed.

A demo of the new product functionalities is available at  www.apple.com/iphone/preview-iphone-os. The LifeScan demo begins at approximately the 43 minute, 32 seconds mark.

The new OneTouch/iPhone application is in the early stages of development, the company noted.

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