Makers of Boniva Accuse P&G of Marketing-Ethics Violations

Allegations From Roche and GSK Heat Up Osteoporosis-Drug War

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A correction has been made in this story. See below for details.

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 makers of osteoporosis drug Boniva are countering claims made by P&G and Sanofi-Aventis, its marketing partner on Actonel.
The makers of osteoporosis drug Boniva are countering claims made by P&G and Sanofi-Aventis, its marketing partner on Actonel.

Boniva vs. Actonel battle
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 yesterday, 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."

Searching for differentiation
The Roche filing said P&G managers first became concerned about Boniva two months before its launch in April 2005 when consumer and physician 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 "They must 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.

November 2005 documents 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 instead of Actonel, 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.")

P&G's expert witness has characterized such statements from P&G as "inaccurate" and "very inappropriate," according to the Roche filing. The company's own "leading opinion leader," Robert Lindsay, acknowledged in a May 2005 talk with analysts that Boniva, Actonel and category leader Fosamax from Merck were "not that far apart in terms of efficacy," the filing said.

The filing 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," but that the company failed to convince thought leaders or its own medical consultants that Actonel worked significantly better than Boniva.

'Alleged consumer survey'
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." P&G's own research showed consumers note Boniva's convenience claims but not the efficacy claims P&G said its ads imply, according to Roche.

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, supporting our complaint of false and misleading advertising of Boniva."

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.

Roche's filing said P&G's drug business is "struggling" after a two-decade effort to join the ranks of major pharmaceutical players. The filing noted that P&G's shortcomings in the sector are due mainly to Boniva's effect on P&G's only billion-dollar drug in Actonel, P&G's failure to get FDA approval for female sex-drive patch Intrinsa and the expiration this month of an exclusivity in marketing AstraZenica's Prilosec over the counter, which opens the door for private-label competition.

Merck, maker of Fosamax, as well as P&G and Sanofi-Aventis, are finding themselves jointly on the defensive in recent lawsuits filed in on behalf of patients claiming that a rare jaw-rotting condition, osteocrenosis, is caused by the osteoporosis-fighting bisphosphonate drugs. None of the lawsuits involve Boniva, which has been on the market since last year. Fosamax launched in the U.S. in 1995 and Actonel in the U.S. in 2001.

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CORRECTION: An earlier version of this story incorrectly reported Roche and GSK were named in recent lawsuits claiming that osteoporosis-fighting bisphosphonate drugs lead to osteocrenosis. Roche and GSK whave not been named in any lawsuit regarding osteocrenosis. We regret that error.
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