HEALTH

NARB denies Novartis’ appeal for Excedrin ad claims

BY Michael Johnsen

NEW YORK The National Advertising Review Board last week denied an appeal made by Novartis Consumer Health around the advertising claim that Extra Strength Excedrin relieves pain after 15 minutes.

Following a challenge made by Wyeth Consumer Healthcare, the National Advertising Division of the Council of Better Business Bureaus had advised Novartis to discontinue the 15-minute claim.

The challenged television advertisement showed a woman suffering from a headache sitting at a table at an outdoor cafe. A digital clock rapidly advances below her. When the clock indicates 10 minutes had passed, a voiceover asks: “What’s the only gel tab with a triple-ingredient formula to start relieving your headache in just 15 minutes?”

At the 15-minute mark, the woman’s facial expression dramatically changes and she gets up, smiling, to greet someone. The voiceover answers the question by stating “Extra Strength Excedrin. Go.”

Novartis provided a proprietary clinical study that tested Extra Strength Excedrin to determine its efficacy in relieving pain intensity for episodic tension-type headaches, and argued that the clinical trial was sufficient to support an “onset of action” claim that Extra Strength Excedrin started to work on a pharmacological basis after 15 minutes.

The appeal panel agreed with NAD’s initial finding that the proffered substantiation did not provide support for the reasonably conveyed message that typical consumers can reasonably expect a reduction in headache pain within 15 minutes of taking Extra Strength Excedrin.

Novartis agreed to follow NARB’s recommendation.

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American Dental Association petitions FDA to classify, regulate tooth-whitening products

BY Allison Cerra

CHICAGO The American Dental Association asked the Food and Drug Administration to establish appropriate classifications for tooth-whitening chemicals.

Citing concern about the safety of whitening products that are often administered without the benefit of professional consultation or examination by a dentist, the association said that the application of chemically-based tooth whitening or bleaching agents can harm teeth, gums and other tissues in the mouth.

The ADA pointed out that such concerns have prompted many states to prevent application of tooth whitening products in nondental settings.

“The tremendous expansion of products available directly to consumers and application of products in venues such as shopping malls, cruise ships, and salons is troubling since consumers have little or no assurance regarding the safety of product ingredients, doses or the professional qualifications of individuals employed in these non-dental settings,” said ADA pesident Dr. Ron Tankersley and executive director Dr. Kathleen O’Loughlin, in a letter to the agency.

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CDC reports decrease in flu activity

BY Allison Cerra

ATLANTA Although 43 states have reported widespread influenza activity for the week ended Nov. 14, numbers appear to be dropping, the Centers for Disease Control and Prevention noted Friday.

In its weekly situational update, the CDC reported that the number of states reporting widespread activity of the H1N1 virus dropped to 43 from 46 in the past week. Additionally, influenza-like illnesses nationally decreased again to 5.5%. This is the third consecutive week of national decreases after four consecutive weeks of sharp increases.

On a regional level, the percentage of outpatient visits for influenza-like illnesses ranged from 2.6% to 7.9% during week 45, and decreased in all 10 surveillance regions, compared with the previous week. All 10 regions, however, reported a proportion of outpatient visits for influenza-like illnesses above their region-specific baseline levels (2.3%).

“Influenza is unpredictable, and it is so early in the year to have this much disease. We don’t know if these declines will persist, what the slope will be, whether we’ll have a long decline or it will start to go up again,” said Anne Schuchat, director of the CDC’s Center for Immunization and Respiratory Diseases.

Meanwhile, there have been reports of cases that feature a mutated version of the virus, which apparently is resistant to antiviral Tamiflu, making the disease much more severe. Schuchat, however, said the mutation is no reason for alarm.

“I don’t think it has the public health implications that we would wonder about,” she said, noting that some patients have gotten severely ill, including developing pneumonia, after being infected with strains of the virus without the mutation.

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