Faculty Bibliography

An advisory committee of the Food and Drug Administration recommended today approval of the first drug specifically for Crohn's disease, an often debilitating bowel ailment that afflicts some 100,000 Americans. The drug, infliximab, is manufactured from mouse and human cells by Centocor Inc. of Malvern, Pa. Researchers are also testing it against another disease, rheumatoid arthritis. But the F.D.A. limited the committee's deliberations on infliximab today to Crohn's disease, although information on the drug's safety included the results of testing in rheumatoid arthritis patients. Infliximab, administered by injection, is not a cure for Crohn's disease. It was recommended today as a therapy to relieve the symptoms and improve the condition of people with moderate to severe cases in which standard therapy is inadequate. The panel also found that it helped heal a complication called draining fistula -- tracks that drain pus from the bowel through the skin, bladder, vagina and rectum

BETHESDA, Md. -- An advisory committee of the Food and Drug Administration on Tuesday recommended approval of the first vaccine against Lyme disease but expressed concerns about its safety and effectiveness. The 23-member panel said the vaccine, which must be taken in three doses over a year, met federal standards for marketing. But it called on the manufacturer, SmithKline Beecham, to continue testing the vaccine. The panel recommended that the vaccine be approved for use only for people 18 to 70. The committee's unanimous recommendations are not binding, but the FDA usually follows the advice of its expert panels. Until the agency acts, the vaccine, Lymerix, will not be available to the public. FDA officials said they considered the vaccine a priority but would not say how soon it might be available

An advisory committee of the Food and Drug Administration recommended approval of the first vaccine against Lyme disease tonight, but expressed serious concerns about its safety and effectiveness. The 23-member panel said the vaccine met Federal standards for marketing. But it called on the manufacturer, SmithKline Beecham, to continue testing the vaccine. The panel recommended that the vaccine be approved for use just for people 18 to 70. Lyme disease, which is spread by ticks, is a cause of great concern each summer for parents and those who spend a lot of time outdoors. Over 16,000 cases of Lyme disease were reported to the Federal Centers for Disease Control and Prevention in 1996, the most recent date for which figures were available

For weeks, a barrage of good news about cancer in people has come from scientists and public health officials. The number of new cancer cases has dropped for the first time since the 1930s, and there is a continued decline in cancer deaths. Additionally, new drugs have shown promise for reducing the risk of or treating cancer. Taken together, these findings provide important guideposts for the next skirmishes in the decades-old war on cancer

The problem has increased significantly in recent years following wider use of drugs for common cancers. A partial list includes tamoxifen and taxol for breast cancer, adriamycin for cancer of the lymph system, and 5-fluorouracil for colon cancer. But with expanding use, there has been scarce discussion of the safety and effectiveness of such drugs in patients older than 65, who account for more than half the total number of cancer cases in this country each year, said Dr. Frank Haluska, a cancer expert at the Massachusetts General Hospital in Boston. He moderated a news conference at the annual meeting of the American Society of Clinical Oncology that ended here Tuesday. Now, oncologists are belatedly recognizing that they have included too few older cancer patients in the clinical trials that they conduct to determine the most effective therapies for all cancer patients

The problem has increased significantly in recent years following wider use of drugs for common cancers. A partial list includes tamoxifen and Taxol for breast cancer, Adriamycin for cancer of the lymph system, and 5-fluorouracil for colon cancer. But with expanding use, there has been scarce discussion of the safety and effectiveness of such drugs in patients older than 65, who account for more than half the total number of cancer cases in this country each year, said Dr. Frank Haluska, a cancer expert at the Massachusetts General Hospital in Boston. He moderated a news conference at the annual meeting of the American Society of Clinical Oncology that ended in Los Angeles Tuesday. Now oncologists are belatedly recognizing that they have included too few older cancer patients in the clinical trials that they conduct to determine the most effective therapies for all cancer patients

The problem has increased significantly in recent years following wider use of drugs for common cancers. A partial list includes tamoxifen and taxol for breast cancer, adriamycin for cancer of the lymph system and 5-fluorouracil for colon cancer. But with expanding use, there has been scarce discussion of the safety and effectiveness of such drugs in patients older than 65, who account for more than half the total number of cancer cases in this country each year, said Dr. Frank Haluska, a cancer expert at Massachusetts General Hospital in Boston. He moderated a news conference at the annual meeting of the American Society of Clinical Oncology, which ended here today. Now oncologists are belatedly recognizing that they have included too few older cancer patients in the clinical trials that they conduct to determine the most effective therapies for all cancer patients

LOS ANGELES - Tens of thousands of American women with breast cancer are losing a breast unnecessarily each year because their doctors do not follow national guidelines in treating the breast cancer, the first comprehensive study of current practices shows. About 65 percent, or 117,000, of the 180,000 breast cancers diagnosed among American women each year are classified as early stage (1 and 2). Of these, three-fourths are eligible for breast- conserving therapy, which involves removing the cancer in a procedure known as a lumpectomy, followed by radiation therapy

Tens of thousands of American women with breast cancer are losing a breast unnecessarily each year because their doctors do not follow national guidelines in treating the breast cancer, the first comprehensive study of current practices shows. About 65 percent, or 117,000, of the 180,000 breast cancers diagnosed among American women each year, are classified as early stage (1 and 2). Of these, three-fourths are eligible for breast conserving therapy, which involves removing the cancer in a surgical procedure known as a lumpectomy, followed by radiation therapy. Also, national guidelines published in 1992 state that doctors should not use age, prognosis and tumor type as criteria in choosing mastectomy over breast conservation therapy. The guidelines also list four absolute reasons not to perform such conservation therapy. They are multiple tumors in the same breast, a history of prior irradiation therapy to the breast region, first or second trimester pregnancy and diffuse areas of calcifications on X-rays