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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (950)	10/21/1998 6:37:00 PM
From: Anthony Wong	Respond to of 1722

Lilly, Zeneca Drugs to Be Part of U.S. Cancer Prevention study Washington, Oct. 21 (Bloomberg) -- Drugs sold by Eli Lilly & Co. and Zeneca Group Plc will be part of the largest-ever breast cancer prevention study, U.S. officials said. The 20,000-patient trial, known as the Study of Tamoxifen and Raloxifene, or STAR, is awaiting approval by the U.S. Food and Drug Administration. If the FDA approves plans for the study, it will begin next year and take place in 400 sites around the U.S. First Lady Hillary Clinton announced the study during an event at the White House at which both she and President Bill Clinton lauded recent advancements in breast cancer research and prevention. ''I believe that we are within reach of genuine cures and genuine prevention strategies of stunning impact,'' the president said. Neither Zeneca's tamoxifen nor Lilly's raloxifene is approved for breast cancer prevention. U.K.-based Zeneca, the world's No. 2 cancer drugmaker, is seeking approval of tamoxifen, also known as Nolvadex, for prevention of breast cancer in high-risk women. The drug was shown to lower the incidence of breast cancer in a landmark study

To: Anthony Wong who wrote (950)	10/21/1998 6:41:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

10/21 16:06 U.S. to compare breast cancer prevention drugs By Maggie Fox, Health and Science Correspondent WASHINGTON, Oct 21 (Reuters) - The U.S. government said on Wednesday it is preparing to launch the biggest-ever trial comparing two drugs -- tamoxifen and raloxifene -- to see which one works better to prevent breast cancer. Health and Human Services Secretary (HHS) Donna Shalala made the announcement as part of a report on progress her department and the government have made into fighting cancer, and of a new push to get women over the age of 40 to get regular mammograms. "This will be the single most important legacy of the Clinton Administration." Shalala told reporters. "It will be the largest clinical trial ever into breast cancer." Earlier this year doctors said tamoxifen, marketed as a cancer drug under the name Nolvadex by Zeneca Group Plc <ZEN.L>, reduced the risk of breast cancer by nearly 50 percent in healthy women who took it. They had been testing the drug, long used against breast cancer, to see if it could prevent the disease in women considered at high risk. But rival drug raloxifene, sold under the name Evista by Eli Lilly & Co. <LLY.N>, has also been found to prevent breast cancer, at least in preliminary trials. Evista is prescribed against osteoporosis, a thinning of the bones that affects many older people, especially women. Dr. Leslie Ford of the National Cancer Institute (NCI), who will direct the comparative trial, says it has yet to be approved by the Food and Drug Administration (FDA). But she expects a decision soon. Ford said her team would recruit 20,000 post-menopausal women for the trial. "They also have to be at elevated risk (of breast cancer)," she said. Any woman over the age of 60, or who has a family history of breast cancer or who has had several pre-cancerous lumps removed is considered to have a high risk of breast cancer. "We know tamoxifen works and now the question is, is there another drug, like raloxifene, that works just as well but perhaps without the side-effects," she said. One reason doctors would like to have an alternative to tamoxifen is that it seems to raise the risk of cancer of the uterus, known as endometrial cancer, by two to three times. Endometrial cancer is very rare, and is usually detected early and treatable by hysterectomy, but is nonetheless best avoided. Ford said tamoxifen's effects on endometrial cancer were not known until about 15 years after it was first used, and it may be the same for raloxifene, which has been tested just a few years. The drugs are similar in other risks such as deep vein thrombosis, a blood clot in the leg that can travel to the lungs, and pulmonary embolism, an air bubble that blocks the arteries to the lungs. Ford said Zeneca and Lilly were providing the drugs for free. She said it is still not clear whether tamoxifen prevents cancer altogether, or just delays it. "There is no evidence that once tamoxifen is stopped, that there is a rebound in ... cancers," she said. In the tamoxifen versus raloxifene trial, volunteers wil be taken off the drugs completely after five years. Shalala said the Clinton administration made breast cancer research a priority in part because of lobbying by activist groups. "They didn't say please," she said. But she said it is also a worthy subject of study. Breast cancer is the second-biggest cancer killer of women, after lung cancer. Heart disease is the biggest killer of all Americans, men and women. Shalala said HHS and other government agencies will continue to press for better cancer prevention, detection and treatment. "We are in a golden age of biomedical research," Shalala said. "No longer are we searching for therapies -- we are comparing therapies. The question is which one works better and in what groups." Shalala said Clinton's new budget for 1999 includes $605 million for breast cancer research and education.