Affiliations of authors: J. Norsigian, Boston Women's Health Book Collective, Boston, MA; M. Napoli, Center for Medical Consumers, New York, NY; B. A. Brenner, Breast Cancer Action, San Francisco, CA; N. Cody, DES Action, Oakland, CA; S. Batt, Breast Cancer Action Montreal, Canada; C. A. Pearson, National Women's Health Network, Washington, DC; L. Potovsky-Beachell, Breast Cancer Action Manitoba, Rosser, Manitoba, Canada; V. S. Cohen, Women's Community Cancer Project, Cambridge, MA.
Correspondence to: Maryann Napoli, Center for Medical Consumers, 237 Thompson St., New York, NY 10012-1090 (e-mail: mnapolia{at}lx. netcom.com).
In April 1998, the Breast Cancer Prevention Trial (P-1) was halted 14 months early because of a 45% reduction in breast cancer among those patients receiving tamoxifen. At that time, all of the major networks and newspapers made a lead story out of the National Cancer Institute's announcement of this finding. Many of the media reports repeated the investigators' contention that the trial's entry criteria identified women who are potentially eligible for tamoxifen therapy, e.g., all women over the age of 60 years (1).
Now, 1 years later, the Journal has published a special article entitled "Weighing the Risks and Benefits of Tamoxifen Treatment for Preventing Breast Cancer" (2). Its authors assessed the data from the Breast Cancer Prevention Trial P-1 (3) and estimate that the benefits of taking tamoxifen substantially outweigh the risks only for younger high-risk women; conversely, the risks might outweigh the benefits for most black women older than 60 years of age and most white women older than 60 years with a uterus. In other words, tamoxifen therapy is an appropriate consideration for a much smaller subset of high-risk women than was originally thought.
The Journal special article (2) states that the risk/benefit assessment grew out of a National Cancer Institute-sponsored workshop held in July 1998. Why did it take so long to get this assessment into print? By contrast, results of the P-1 trial were published by the Journal less than 6 months after the trial ended. Until this assessment was published, it was not known which women are at enough of a high risk to make tamoxifen's potentially fatal side effects worth its potential benefits. Yet as early as October 1998, tamoxifen received U.S. Food and Drug Administration (FDA) approval for risk reduction which, in turn, allowed its producer, AstraZeneca (Wilmington, DE), to mount an immediate and extensive direct-to-consumer advertising campaign. At the time, we believed that the FDA approval was premature; this assessment only confirms our conviction.
For the first time, an anticancer drug is being marketed to healthy people; more care should have been taken beforehand to estimate who can safely benefit from tamoxifen.
REFERENCES
1 Grady D. Breast cancer drug dilemma: who should take it, and when? The New York Times 1998 Apr 14;Sect. Science:1 (col. 4)
2
Gail MH, Costantino JP, Bryant J, Croyle R, Freedman L, Helzlsouer K, et al. Weighing the risks and benefits of tamoxifen treatment for preventing breast cancer. J Natl Cancer Inst 1999;91:182946.
3
Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Natl Cancer Inst 1998;90:137188.
![]() |
||||
|
Oxford University Press Privacy Policy and Legal Statement |