Healthy Skepticism Library item: 3496

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Roche Holding Defends Drug Advertisement
Associated Press 2006 Jan 5
http://biz.yahoo.com/ap/060105/switzerland_roche_ad_dispute.html?.v=1

Notes:

Ralph Faggotter’s Comments:

This dispute is one of the side-effects of deregulation, self-regulation and permiting Direct-to-Consumer Advertising.

Full text: AP Roche Holding Defends Drug Advertisement Thursday January 5, 10:52 am ET Swiss Pharmaceutical Company Defends Drug Ad Challenged in U.S. Lawsuit

BASEL, Switzerland (AP) — Swiss pharmaceutical company Roche Holding AG, which is being sued in an advertising dispute in the United States, said Thursday it is confident it is accurately representing its osteoporosis drug Boniva.

“Roche is confident the advertising accurately and appropriately reflects the clinical findings,” said spokeswoman Martina Rupp.

Procter & Gamble Co. and Sanofi-Aventis Group disclosed Wednesday that they were suing Roche and GlaxoSmithKline PLC in U.S. District Court in Manhattan to stop what they allege are unfounded claims about Boniva.

The pharmaceutical wing of Procter & Gamble and Sanofi-Aventis said Roche and Glaxo advertising falsely claimed that the prescription medication had been proven to reduce the risk of nonspinal fractures and that the drug had proven to be more effective than other drugs such as Actonel, which P&G and Sanofi-Aventis co-market.

Roche said it hasn’t been served with the lawsuit, and declined to comment further.

Mary Anne Rhyne, a U.S. spokeswoman for GlaxoSmithKline, said that company also had yet to see the lawsuit.

“We believe that our advertising has been truthful and accurate,” she said.

Sanofi-Aventis shares rose 1.1 percent to 78.10 euros ($92.80) in midday trading in Paris, while in Zurich Roche shares fell 0.4 percent to 197.30 Swiss francs ($150.92).

P&G and Sanofi-Aventis sought in the lawsuit to stop the advertising for Boniva, a once-monthly tablet for treatment and prevention of loss of bone density in postmenopausal women, codeveloped and co-promoted by Roche and Glaxo outside Japan.

Procter & Gamble and Sanofi-Aventis said in a joint statement that both Actonel and Boniva have been proven to reduce the risk of spinal fractures in women with postmenopausal osteoporosis but have not been compared in head-to-head clinical studies.

“However,” the statement said, “Boniva has not been proven to reduce the risk of nonspinal fracture. In its pivotal clinical trial, there were a similar number of nonspinal osteoporotic fractures at three years in women treated with Boniva and placebo.”

At the same time, the companies said, “in pivotal clinical trials, Actonel has been proven to reduce the risk of nonspinal fractures at three years.”