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To the Editor: Mr Vastag's Medical News & Perspectives article¹ failed to present a balanced view regarding recruitment challenges for the Study of Tamoxifen and Raloxifene (STAR) trial and contained inaccurate and misleading information about raloxifene hydrochloride and Eli Lilly and Company.

Vastag correctly states that enrollment for STAR is nearly on target. Nevertheless, he reports study sites have faced challenges in meeting enrollment goals because physicians "have already decided that raloxifene is a better choice [than tamoxifen]." This claim is unsubstantiated and oversimplifies the complex dynamics of enrolling postmenopausal women in breast cancer trials.

Raloxifene is a nonsteroidal selective estrogen receptor modulator (SERM), not a "synthetic estrogen" as stated in the article, and received approval for treatment of osteoporosis in postmenopausal women in 1999, not 1998. More importantly, Lilly never asked the US Food and Drug Administration (FDA) to approve raloxifene for breast cancer risk reduction.

Lilly stands behind . . . [Full Text of this Article]

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