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RU 486 CANADIAN BREAST CANCER PHASE II TRIAL WILL BEGIN NEXT SPRING

Executive Summary

RU 486 CANADIAN BREAST CANCER PHASE II TRIAL WILL BEGIN NEXT SPRING with 15 to 30 post-menopausal women and finish about one year later, Elizabeth Eisenhauer, MD, director of the Investigational New Drug Program at Canada's National Cancer Institute, told a Dec. 5 hearing of the House Small Business/Regulation Subcommittee. The hearing was held by Chairman Wyden (D-Ore.) to discuss the effects on U.S. research on RU 486 from FDA's 1989 import alert. Eisenhauer said the Phase II study is still undergoing approval clearance by the Health Protection Branch, Canada's FDA equivalent. The study, which Eisenhauer said was initiated by Canada's NCI, will include women with hormone receptor-positive tumors, a history of recurrent breast cancer and no prior hormonal therapy. The study's dosing regimen for RU 486 has not yet been finalized. Rep. Weiss (D-N.Y.) will examine RU 486 and other breast cancer therapies at a House Government Operations/Intergovernmental Relations Subcommittee hearing scheduled for Dec. 11. Weiss also will release a General Accounting Office report on the "progress and failures" of current breast cancer treatments. Witnesses scheduled to appear include: National Institutes of Health Director Bernadine Healy, MD; Faulkner Breast Center (Boston) Director and breast cancer treatment activist Susan Love, MD; Ruth Spear, co-founder of the National Association of Breast Cancer Organizations; and Eleanor Chelimsky, MD, the GAO's assistant comptroller general. The hearing will "examine new developments in breast cancer research, as well as possible strategies for translating federally-funded research on breast cancer into improved survival for breast cancer patients," a Dec. 6 subcommittee press release states. Weiss is expected to question why breast cancer research with RU 486 is not being vigorously pursued in the U.S. Wyden used the Dec. 5 hearing to reiterate his charges that FDA's import ban on RU 486 has hindered U.S. research of the drug and is motivated by political pressure because RU 486 is an effective abortifacient. In his opening statement, Wyden charged that as of Dec. 4, FDA records show that there have been "no new [INDs] for basic research with RU 486 in at least three years. And the FDA informs us that the dozen pre-existing IND research projects in this country are, for the most part, moribund." Wyden last February introduced a bill (HR 875) that would lift the FDA alert. Wyden also criticized RU 486's manufacturer, Roussel-Uclaf. The company "sees too many political, legal and commercial obstacles in its path," Wyden said in his opening statement. He argued that Roussel-Uclaf should make a greater effort to conduct research with RU 486 in the U.S. The company "must put its money where its mouth is," he stated. "It must substantiate its statements that America hasn't been frozen out of strategic planning for this drug, including abortifacient and contraceptive testing, by commencing trials, immediately." A Wyden subcommittee memo on the status of development for RU 486 says interviews with Roussel-Uclaf indicate that the company "probably will pursue future, important contraceptive therapy research in Europe rather than in the United States due to concerns about criticism from U.S. anti-abortion groups." However, Etienne Emile Baulieu, the French researcher whose lab first isolated RU 486, said that he hopes to start a joint U.S.-French- Swiss study on contraception with RU 486 by next year. On Dec. 3, a 30-member coalition of U.S. mayors, headed by New York's David Dinkins, proclaimed strong support for bringing the drug to the U.S. as soon as possible. On behalf of the coalition, Dinkins sent a Dec. 3 letter to President Bush stating: "All of the medical evidence so far suggests that RU 486 is a safe and effective alternative to early surgical abortion. . . . The drug also shows promise in testing breast cancer . . . brain cancer, Cushing's disease, and endometriosis, a leading cause of infertility in women. But this potentially lifesaving research is being blocked as long as the drug cannot find its way into the country."

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