|A P&G spokespeson said that Boniva ads are 'misleading consumers and physicians.'
The suit, filed yesterday in U.S. District Court in New York, charges that Boniva's ads, marketing materials and sales pitches falsely claim or imply that the once-a-month drug is as effective as weekly doses of Actonel in preventing non-vertebral bone fractures -- such as hip, wrist and clavicle breaks, which are more common and costly than spinal fractures. According to the lawsuit, Boniva was approved by the U.S. Food and Drug Administration only for the treatment of vertebral bone fractures. Clinical trials by Roche and GSK indicated Boniva, even at daily dosage, was no more effective than placebos at preventing non-vertebral fractures, according to the complaint.
Spokespeople for Roche and GSK did not immediately return calls for comment.
Departure for P&G
The lawsuit is a departure from recent practice by P&G, which was itself the target of several false-advertising lawsuits more than two years ago. The spate of lawsuits, at least three of which P&G lost either in final verdicts or at the injunction stage, prompted P&G Chairman-CEO A.G. Lafley to call on competitors to direct ad disputes to the National Advertising Division of the Council of Better Business Bureaus, “where advertising claims ought to be handled,” he said.
The NAD wasn’t an option in this case, said a P&G spokeswoman, because it involves pharmaceutical advertising regulated by the FDA’s Division of Drug Marketing Advertising and Communication.
P&G has filed three letters with the division about Boniva ads since the drug’s May 2005 launch, according to the complaint. “DDMAC has acknowledged the initial correspondence, has indicated that P&G’s claims have merit and that DDMAC is investigating further, but it has not yet taken enforcement action,” the complaint said.
'Misleading consumers and physicians'
Another reason P&G decided to file suit is because of the risk of harm to patients, the spokeswoman said. “We feel that because their ads imply that they have a class effect [similar to Actonel and Merck & Co.’s Fosamax] that they are misleading consumers and physicians into believing that women are going to be getting all the protection they need by taking the once-a-month over the once-a-week,” she said.
Publicis Groupe’s Saatchi & Saatchi Consumer Healthcare Group, New York, handles Boniva ads. WPP Group’s Grey Worldwide, New York, handles Actonel.
Though Boniva’s label and disclaimers disclose that it isn’t approved for prevention of non-vertebral fractures, P&G’s complaint said ads and other marketing materials imply otherwise. One TV ad shows a hand sweeping away four weekly doses of an unnamed drug in favor of a single monthly dose of Boniva, implying Boniva is simply a more convenient substitute for other weekly osteoporosis drugs.
Actonel and Merck’s Fosamax, the leading osteoporosis drug, both have clinical trials showing they reduce risk of non-vertebral fractures, such as those of the hip and wrist, according to the complaint. But Actonel claims superiority to Fosamax, too, based on clinical trials showing it’s the only drug proven to reduce risk of fractures at the endpoint of six commonly fractured bones, the complaint said.
The lawsuit also points to Boniva.com, where a section states: “Hip fractures can be especially traumatic and osteoporosis is responsible for approximated 300,000 of these fractures annually. ... Fortunately, there are medicines like once-monthly Boniva available today.”
“The literal meaning and necessary implication” of this Web page ... is that Boniva has been proven to lessen the risk of all fractures, including of the hip, according to the complaint.
The stakes for P&G’s fledgling prescription-drug business in the lawsuit appear considerable. Actonel is by far P&G’s biggest Rx brand and the company’s only billion-dollar global blockbuster. Its success, along with that of the Prilosec OTC conversion in 2003, has been one of the key factors in P&G’s decision to keep the drug business, which Mr. Lafley acknowledged in 2001 he had considered divesting.
Another potential P&G blockbuster drug, Intrinsa, a testosterone patch for post-menopausal women with low sexual desire, failed to get FDA clearance when P&G originally hoped it would in 2004. P&G has continued clinical trials in hopes of demonstrating long-term safety in hopes of winning approval. Several Publicis agencies, including the Medicus unit of Publicis Worldwide, handle Intrinsa.
Taking a toll on Actonel sales
Now, it appears a fast start for Boniva is taking a toll on Actonel. The brand has U.S. sales of $838 million and a market share of more than 25%, according to the complaint, but immediately after the Boniva launch, “prescription and sales of Actonel declined and have continued to decline ever since.” That’s no surprise, P&G said in its complaint, because market research shows women prefer monthly to weekly doses all things being equal -- unless they’re informed the monthly doses don’t protect against fracture outside the spine -– in which case 87.5% prefer the weekly dose.
P&G and Sanofi-Aventis are seeking a preliminary injunction to prohibit ads that imply Boniva is equivalent to Actonel as well as retractions and corrections of past ads; profits from Boniva sales to date; treble damages in compensation for lost Actonel sales and punitive damages.
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Rich Thomaselli contributed to this report.