TAMOXIFEN: FDA Approval Brings Hard Decision For Women
Yesterday's decision by the Food and Drug Administration to approve tamoxifen as the first drug to help prevent breast cancer will mean tough choices for some women. Women at high risk for breast cancer now must decide whether to take a drug that has been shown to cut the incidence of the disease by 44% but carries a heightened risk of endometrial cancer and blood clots (Pear, New York Times, 10/30). Acting FDA Commissioner Michael Friedman said, "We know that tamoxifen has real serious side effects and that not all women who take it get benefits from it. But we do know that some women at high risk have a very meaningful reduction in that risk." Women at high risk for breast cancer previously had only two choices: "They could opt for a mastectomy while sill cancer-free ... or practice 'watchful waiting' with the hope of catching the cancer if it did develop in its earliest stages" (Cimons, Los Angeles Times, 10/30). Tamoxifen's manufacturer, Zeneca Pharmaceuticals, will "distribute computer disks, developed with the National Cancer Institute, to doctors to help them assign precise scores on a risk table to individual women," which will help physicians decide whether the drug should be prescribed (New York Times, 10/30).
The community of breast cancer advocates was divided in its reaction to the FDA's action. Susan Braun, president of the Susan Komen Breast Cancer Foundation, said the approval "brings us such extraordinary optimism. While there are still unanswered questions, there is a huge potential in this when you compare it to other measures of progress in the fight against breast cancer." However, Cynthia Pearson, executive director of the National Women's Health Network, called the FDA's approval "premature," adding that "it is based on the results of only one study and warning that there is insufficient information about the drug's long-term effects" (Los Angeles Times, 10/30). She also warned that "heavy advertising could lead to overuse of the drug" (New York Times, 10/30). The New York Post reports that a "coalition of women's advocacy groups ... yesterday urged healthy women not to take tamoxifen to prevent breast cancer because of the serious side effects" (Delfiner, 10/30). Consumer advocacy group Public Citizen issued a release saying, "Tamoxifen can induce tumors by altering a woman's DNA and may cause other types of cancers years later." The group criticized the sole National Cancer Institute study for failing to derive any survival benefit from the drug, distorting the risk-reduction actually conferred by taking tamoxifen and failing to state the side-effects among women taking the drug. Larry Sasich of Public Citizen's Health Research Group said, "I have great concern that otherwise healthy women may be injured or killed from tamoxifen, thinking that it was going to prevent them from dying from breast cancer" (Public Citizen release, 10/29). Zeneca spokesperson Mary Carver "downplayed" the dangers, saying that "the normal risk of uterine [endometrial] cancer is about one case in 1,000 women; using tamoxifen raises that risk to between two and three cases per 1,000 (Larson, Washington Times, 10/30).
The Business Angle
The Wall Street Journal reports that Zeneca sells $300 million worth of tamoxifen -- marketed as Nolvadex -- a year as a cancer treatment. The company co-markets the drug in an agreement with Roche Laboratories, and saw its shares rise $1.625 to $38.50 in NYSE trading yesterday (Sharpe, 10/30). Sergio Traversa of Mehta Partners "estimated that sales would increase 20% to 30%" in the wake of the FDA approval. However, Traversa noted that the "safety profile is not perfect for a product that would be used on a large patient base or for a long time" (New York Times, 10/30). The Wall Street Journal reports that the NCI is planning "the U.S.'s largest breast-cancer clinical trial early next year, comparing the risks and benefits of tamoxifen" to Eli Lilly's osteoporosis-prevention drug raloxifene, which has shown fewer side effects than tamoxifen (10/30). Click here for previous AHL coverage of tamoxifen.