As a practicing clinical oncologist, I treat several men with carcinoma of the breast. I certainly agree with Jaiyesimi and colleagues [1] that they need the same degree and type of aggressive treatment given to women with the condition. The Food and Drug Administration (FDA), as well as the manufacturer of Nolvadex, do not appear to concur. I have one patient who is unable to afford the Nolvadex. Nolvadex has a patient assistance program. Despite qualifying on financial grounds, he has been unable to obtain this medication. The company's rationale is that the FDA has not approved tamoxifen for use in men with breast carcinoma. If this extremely frustrating situation were more widely known, we might be able to remedy it.

Note: Dr. Coffman's letter was forwarded to Dr. Stuart Nightingale at the FDA for comment:

The FDA may not approve a new indication until the manufacturer submits a supplemental application consisting of revised labeling and the safety and efficacy data needed to support the requested change. ICI Pharma requested that tamoxifen be approved for male breast cancer last year. On 16 November 1992, the Oncologic Drugs Advisory Committee, a panel of outside experts, recommended that the agency approve tamoxifen as a treatment for metastatic breast cancer in men. Subsequently, the agency completed its review, and on 12 December 1992 sent the firm a letter indicating that it was prepared to approve the supplemental application on the satisfaction of conditions specified in the letter. These issues were addressed by the firm on 4 February 1993, and final approval for the use of tamoxifen in the treatment of metastatic breast cancer in men issued on 1 April 1993.