Boniva Makers Slam P&G for Unethical Marketing

GSK, Roche Say Marketer Told Doctors They Could Be Sued for Prescribing It

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CINCINNATI ( -- Marketers of the osteoporosis drug Boniva are accusing Procter & Gamble Co. of falsely telling doctors they could be sued for malpractice if they prescribed the drug; making efficacy claims not supported by P&G experts; and submitting consumer research with forged signatures to the court in documents unsealed late yesterday by the U.S. District Court for the Southern District of New York.

The charges come in counterclaims to a lawsuit P&G and Sanofi-Aventis, its marketing partner on osteoporosis drug Actonel, filed earlier this year against Boniva marketers Hoffman-La Roche and GlaxoSmithKline. In its suit, P&G said Boniva ads by Publicis Groupe's Saatchi & Saatchi, New York, falsely claim or imply that the once-monthly drug is as effective as weekly doses of Actonel in preventing nonspinal bone fractures, though the Food and Drug Administration hasn't approved Boniva for preventing such fractures.

The court concluded hearings last week on an injunction sought by P&G but has yet to issue a ruling. The counterclaims, contained in an amended answer filed originally April 25 but kept under seal until last week, allege P&G's lawsuit is part of a broader marketing defense against Boniva -- one that appears to have slowed Boniva's advance against Actonel.

Roche and GSK are seeking an injunction to stop P&G from falsely disparaging Boniva, reimbursement for legal costs from the litigation, and treble damages.

"We stand by our complaint against Roche and GSK," said a spokesman for P&G. "We believe their counterclaims are simply an attempt to draw attention away from their false and misleading advertising of Boniva."

The Roche filing said P&G managers first became concerned about Boniva two months before its launch in April 2005 when research found the once-monthly product would have significant appeal. At that point, the defendants said P&G shifted its marketing emphasis for Actonel from speed to efficacy and that internal documents show its sales reps were told to "show how Actonel 'differentiates' itself from other products, even when it doesn't."

When that approach didn't work, Roche said P&G shifted its focus to having sales reps tell doctors that Boniva doesn't work on nonspinal fractures, though Roche contends both drugs work in similar ways to strengthen bones throughout the body.

Documents from 2005 show P&G felt Actonel was "under significant competitive pressure unlike anything we've ever seen," according to the filing. At that point, call notes show P&G sales reps began telling doctors that Boniva "actually caused fractures" and that the doctors could be sued for malpractice for prescribing it, Roche said.

The P&G spokesman said sales reps get very clear training consistent with the company's "Purpose, Values and Principles" statement, that they were told not to make unauthorized sales messages. He said P&G "specifically directed them not to make claims or statements the defendants are alleging were made."

The filing also cited an e-mail from a P&G VP that stated "we've got to find SOME way to get our 'friends' to differentiate [osteoporosis drugs] publicly."

Roche said P&G submitted to the court "an alleged consumer survey" regarding perceptions of Boniva's marketing that "contains numerous examples of forged signatures and other irregularities," but P&G hadn't withdrawn the filing "despite being confronted with the fact of those improprieties."

The consumer perception research challenged by the defendants "were surveys conducted on our behalf by a company dedicated to this type of research and used by many other companies for various market research and litigation purposes," the P&G spokesman said. "In response to Roche/GSK's argument that the survey is tainted because of errors or fraud in the collection of some of the survey data, we responded by pulling those responses alleged as fraudulent or in error. After filtering out those responses, the survey results were the same."

Since launching its "defense plan" against Boniva, a P&G internal presentation from Feb. 8 showed that Actonel share trends have improved while Boniva's have declined, the countersuit said.
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