Court: No breast cancer details for Evista

That's the message that a southern New York district judge sent to Eli Lilly and its sales reps in a recent court ruling. Judge John Koeltl agreed with the plaintiff, the former Zeneca Pharmaceuticals, that Eli Lilly and Co. was unfairly promoting its anti-osteoporosis drug Evista® (raloxifene) to physicians for the prevention of breast cancer. (Since the lawsuit was filed in February, Zeneca merged with Astra Pharmaceuticals and is now known as AstraZeneca.)

According to present FDA standards, only pharmaceutical companies that receive FDA approval for specific indications can mention those indications to physicians during sales calls. Although a large-scale clinical study has suggested that Eli Lilly's product could be effective in preventing the disease, only tamoxifen - the clinical name of AstraZeneca's Nolvadex® and the primary ingredient of Barr Laboratories' generic equivalent to Nolvadex - has received approval from the FDA for this indication. Therefore, only AstraZeneca and Barr sales reps should mention this benefit when speaking with physicians about tamoxifen.

Consequently, Judge Koeltl ruled that Lilly should stop "stating in its advertising or promotional activities that Evista has been proven, shown or demonstrated to reduce the risk of breast cancer, or that Evista has been proven comparable or superior to tamoxifen in the reduction of the risk of breast cancer."

The judge also ruled that Eli Lilly must implement an internal training program for its sales reps to correct any errant promotional activities they might engage in regarding Evista and its role in breast cancer prevention. The company does not have to change any of its advertisements, however, as Zeneca had originally requested.

In a formal statement, Eli Lilly said that the ruling "will not impact Lilly's ability to detail physicians or affect product performance." The company also stated that it "does disagree with the Court's opinion in several respects" and "is reviewing all legal options," including an appeal. PR