Novartis to Alter Ad Claims for Its Motion-Sickness Drug

Novartis Corp. agreed Monday to modify questionable advertising claims for its prescription motion-sickness drug, Transderm Scop.

But the Swiss pharmaceutical giant said it won’t remove the claims from its package insert, which the government approved when the drug was introduced more than 20 years ago.

Advertising watchdogs said similarly confusing situations are likely to arise as prescription drug advertising becomes more prevalent. Pharmaceutical firms spent $1.9 billion to pitch prescription medications in 2000.

At issue is Novartis’ claim that Transderm Scop is “more effective” than Pharmacia Corp.’s Dramamine, an over-the-counter remedy.

Novartis said the advertising claim is based on its package insert, which states Transderm Scop provides “significantly greater protection” than dimenhydrinate, the chemical name for Dramamine. The Food & Drug Administration signed off on the package insert when Transderm Scop was approved in 1979.

But the National Advertising Review Board, a unit of the Better Business Bureau, said Novartis based its claim on flawed studies. The NARB said it was “troubled” that 183 of the 195 participants in three studies of Transderm Scop worked for Alza Corp., which developed the motion-sickness patch.

The NARB said none of the studies showed a “statistically significant superior performance” for Transderm Scop.

The Better Business Bureau unit reviewed the ad at the request of Pharmacia. NARB manager Bruce Hopewell said there was no indication that the FDA meant for package insert data, which is directed at doctors, to be used in consumer ads.

“Novartis and the FDA continue to believe our data and clinical studies support our claim,” said Henna Inam, marketing vice president for Novartis’ gastrointestinal products business. “We’re letting it go because we agreed to participate in the self-regulatory process.”