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The bacteria are not a result of pollution, so although oysters should always be obtained from reputable sources, such sources, clean waters, and high turnover of oysters in restaurants do not provide protection against the bacteria.
Certain health conditions put people at high risk for infection. These conditions are:
* liver disease
* hemochromatosis, an iron disorder
* diabetes
* stomach problems
* cancer
* immune disorders, including infection with HIV
* long-term steroid use (as for asthma or arthritis).
People who drink moderate to heavy amounts of alcoholic drinks also may be at increased risk. According to the 1993 Special Report to Congress on Alcohol and Health, and the National Institute on Alcohol Abuse and Alcoholism, drinking two to three alcoholic beverages each day can cause liver disease, which often has no signs or symptoms. People with liver disease are almost 200 times more likely to die from Vibrio vulnificus infection than those without liver disease.
Check with a doctor if you're unsure of your risk, and, if you're at increased risk, do not eat raw oysters. Fully cooking oysters kills the bacteria.
For more information, call the FDA Seafood Hotline, (1-800) FDA-4010.
In January, FDA sent warning letters to 44 companies stating that it is unlawful to market their quinine sulfate products for night leg cramp relief because FDA has not approved the drug for this use. By the end of March, all major manufacturers and distributors had stopped labeling their products for this use, including Marion Merrell Dow, the manufacturer of the original and best-known quinine drug, Quinamm.
From 1969 through June 1992, FDA received 157 reports of health problems related to quinine use, including 23 that resulted in death. Nonserious problems included temporary sight and hearing disturbances, dizziness, fever, nausea, vomiting, and diarrhea. Serious problems included thrombocytopenia, a destruction of blood platelets that can lead to massive bleeding and sometimes death.
After weighing the benefits and risks of OTC quinine sulfate for night leg cramps, FDA concluded that quinine is not safe and effective for this use because:
* No studies demonstrate that quinine is effective against night leg cramps.
* Night leg cramps are not a threat to life or health.
* Health risks outweigh any small potential benefits.
Based on this finding, the agency published a rule in the Aug. 22, 1994, Federal Register prohibiting OTC marketing of the drug for leg cramps.
FDA also proposed to stop OTC marketing of quinine for another use--to prevent or treat malaria. The public has until July 3 to comment on the proposal, published in the April 19, 1995, Federal Register. The agency based the proposal on its conclusion that physician monitoring is essential to the safe and effective treatment of this serious, potentially life-threatening disease. Written comments may be sent to: FDA Dockets Management Branch (HFA-305), Rockville, MD 20857.
The pilot will help FDA determine if the approach, called Hazard Analysis Critical Control Point, or HACCP, is practical for wider application in the food industry.
Under the HACCP plan, companies analyze their manufacturing processes to identify where problems are most likely to occur and where preventive measures need to be focused. The idea behind HACCP is to build safety into the manufacturing process, rather than rely on inspections and sampling to identify unsafe products after they've been made.
Companies participating in the voluntary pilot program and their products are:
* Alto Dairy, Wapun, Wis.--hard cheese
* Campbell Soup Company, Camden, N.J.--refrigerated salad dressing
* Campbell-Taggart, Inc., St. Louis, Mo.--pan breads
* Con Agra, Omaha, Neb.--flour
* Ocean Spray Cranberries, Lakeville-Middleboro, Mass.--pasteurized juice
* Pillsbury, Minneapolis, Minn.--bakery products
* Hans Kissle Foods, Wilmington, Mass. (in cooperation with the Massachusetts Department of Health)--quiche
FDA's suspension on April 20 of the establishment and product licenses of Midland County Hospital District, also known as Permian Basin Regional Blood Center, prevents the center from shipping blood or blood components interstate.
An FDA inspection of the center from March 14 through April 11, 1995, found violations such as improper and unsterile blood collection and processing, inadequate follow-up of donor adverse reactions, inaccurate record-keeping, and inadequate staff training.
The license suspension does not stop the center from procuring U.S.-licensed blood and blood components from another acceptable source, provided that appropriate measures are taken to ensure proper storage and distribution.
If the center develops a plan to correct the violations, FDA will review the plan and decide what further action should be taken.
The vaccine was developed and patented by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health.
An effective vaccine would annually prevent more than 1 million cases of severe rotaviral diarrhea in U.S. children under 5, including 65,000 hospitalizations. In developing nations each year, moderate to severe rotaviral diarrhea affects 18 million youngsters, killing more than 870,000.
The vaccine, RRV-TV, was developed in 1986 by Robert Chanock, M.D., Albert Kapikian, M.D., and others at NIAID's Laboratory of Infectious Diseases. Chanock is chief of the laboratory, and Kapikian is assistant chief. NIAID patented the vaccine in 1988.
In the study, reported in the April 19 Journal of the American Medical Association, researchers at 23 U.S. medical centers compared a placebo to the RRV-TV vaccine, which uses four important human rotavirus strains, and to another investigational vaccine, the RRV-S1, which uses only one of the strains, serotype 1. Chanock and colleagues developed the RRV-S1 in 1985, and NIAID patented it in 1987.
During the testing, both vaccines protected against serotype 1 disease, but only the RRV-TV protected against disease caused by the other strains during the second year after immunization, according to the report's authors, led by David Bernstein, M.D., of the J.N. Gamble Institute of Medical Research, in Cincinnati.
Specifically, the two vaccines provided the following protection:
* all cases of rotaviral diarrhea--RRV-TV, 57 percent; RRV-S1, 40 percent
* less serious cases--RRV-TV, 49 percent; RRV-S1, 31 percent
* most severe cases--RRV-TV, 82 percent; RRV-S1, 73 percent
* episodes longer than three days--RRV-TV, 92 percent; RRV-S1, 36 percent
* cases requiring medical visits--RRV-TV, 78 percent reduction; RRV-S1, 67 percent reduction.
The researchers enrolled 1,006 healthy infants, ages 4 to 26 weeks, between August 1989 and February 1990. Of those enrolled, 898 received three oral doses of one of the vaccines or the placebo at least two weeks apart, with the final dose by age 30 weeks. The researchers followed the 898 children for one year and 864 for two years, until June 1991. Neither researchers nor parents knew which product a child received until the study ended.
Through a cooperative research agreement with NIAID, Wyeth-Ayerst Laboratories, of Philadelphia, produced both vaccines for the study. The firm had requested to meet with FDA and, after that meeting, chose not to pursue developing the RRV-S1 vaccine product.
American children have beneficial attitudes and behaviors about food, nutrition, and physical activity, according to a nationwide survey of children aged 9 to 15.
The telephone poll, conducted by the Gallup Organization last November and December, queried 410 children about topics such as eating habits, parents' influence on diet, and the school's role in food and fitness.
According to the poll:
* Ninety-seven percent agreed that a balanced diet is "very important" for good health, and 98 percent said the same about physical activity.
* Sixty-six percent said they like eating "many different kinds of foods," while 74 percent agreed that eating "a lot of bread, cereal, and other grains is good for you."
* Sixty-four percent rated their own eating habits "good to excellent," and 76 percent said the same about their parents' eating habits.
* Forty-nine percent said they eat meals with their families every day, while 13 percent said they eat with their families only once a week or less.
* Sixty-four percent agreed that foods good for them "don't taste good," a 14 percent rise from a 1991 survey.
* Eighty percent want to do more physical activity this year.
Children reported getting nutrition information from schools and teachers (90 percent), parents (77 percent), television (64 percent), books (60 percent), and health professionals (59 percent).
Survey results are encouraging, says Doris Derelian, Ph.D., president of the American Dietetic Association, a survey sponsor. "Children understand that they can enjoy a wide variety of foods eaten in moderation," she says.
"Children need encouragement from their family, friends and teachers to ... participate regularly in moderate-to-vigorous physical activity," says Sylvia Rowe, president of the International Food Information Council, another survey sponsor.
The third survey sponsor, the President's Council on Physical Fitness and Sports, will mail a free brochure to help children plan a healthy lifestyle. For a copy, send a self-addressed, stamped business-sized envelope to:
10 Tips for You
P.O. Box 1144
Rockville, MD 20850
They are two FDA Consumer reprints--one on prostate cancer, the other on the new food label; a poster on iron poisoning; a backgrounder on the new food label; and a brochure on mammography published by the Agency for Health Care Policy and Research.
The publications and their FDA publication numbers are:
* Prostate Cancer: New Tests Create Treatment Dilemmas (FDA) 95-1220
* The New Food Label: Better Information for Special Diets (FDA) 95-2291
* Protect Your Child from Iron Poisoning (FDA) 95-1221P
* The New Food Label (BG 95-12)
* A Woman's Guide: Things to Know About Quality Mammograms (FDA) 95-8286
For single copies, write to FDA, Rockville, MD 20857. For two to 100 copies, write to FDA, HFI-40, at the same address, or fax your order to (301) 827-5308. Include the publication number.
