WASHINGTONA US federal court has granted a preliminary
injunction barring Eli Lilly and Company and its sales
representatives from promoting its drug Evista (raloxifene ) as
effective in reducing the risk of breast cancer.
The injunction was sought by AstraZeneca, a unit of Zeneca, Inc.,
whose drug Nolvadex (tamoxifen) is approved both for treating breast
cancer and for reducing the risk of breast cancer in high-risk women.
Evista is approved for use in preventing osteoporosis, and some
research has suggested that it may be helpful in preventing breast
The two drugs are currently being tested for effectiveness in
preventing breast cancer in STAR, the Study of Tamoxifen and
Raloxifene, which began enrolling the first of 22,000 patients in
AstraZeneca filed for an injunction on Feb. 25, under the Lanham Act,
a federal statute dealing with false advertising. The company alleged
that Lillys sales force had falsely promoted Evista to
physicians as having been shown to reduce the risk of breast cancer.
In a 106-page decision rendered on July 16, Judge John Koeltl, of the
US District Court of the Southern District of New York, granted the
injunction. He ordered Lilly to cease any claims that Evista has been
shown, proven, demonstrated, or established to reduce the risk of
breast cancer and to institute a training program for its sales force
to ensure that its representatives conform with the courts ruling.
However, Judge Koeltl denied Astra-Zenecas request that the
court require Lilly to distribute corrective advertising.
In a statement, Lilly said it was pleased that the court found
no evidence to support Zenecas claim that Lilly is promoting
Evista as a drug that is approved or indicated by the FDA for the
prevention of breast cancer. The company said that although it
disagreed with several aspects of the courts decision, it would
institute the ordered training program.
The ruling addresses a very narrow issue, said Angela
Sekston, a spokeswoman for Lilly at its Indianapolis headquarters.
She added that an internal review of material provided to physicians
showed that they specifically state that Evista has not been
demonstrated to reduce the risk of breast cancer. It appears
that our materials are in line with the courts ruling,
Ms. Sekston said.