HICNet Medical News Digest Sun, 11 Sep 1994 Volume 07 : Issue 43 Today's Topics: [MMWR] Outbreak Shigella flexneri on a Cruise Ship [MMWR] Uveitis Associated with Rifabutin Therapy [FDA] Panel Recommends Studies for Breast Self-Exam Devices [FDA] The Doxylamine Dilemma [FDA] Electromagnetic Interference with Wheelchairs [FDA] The New Food Label: Scouting for Sodium related to Blood Pressure [FDA] Approves Test for Prostate Cancer [FDA] OTC Options - Help for the Sleepless [FDA] Tricks for the Tired [FDA] Safeguarding Human Tissue Transplants +------------------------------------------------+ ! ! ! Health Info-Com Network ! ! Medical Newsletter ! +------------------------------------------------+ Editor: David Dodell, D.M.D. 10250 North 92nd Street, Suite 210, Scottsdale, Arizona 85258-4599 USA Telephone +1 (602) 860-1121 FAX +1 (602) 451-1165 Internet: mednews@stat.com Bitnet: ATW1H@ASUACAD Mosaic WWW: http://biomed.nus.sg/MEDNEWS/welcome.html Compilation Copyright 1994 by David Dodell, D.M.D. All rights Reserved. License is hereby granted to republish on electronic media for which no fees are charged, so long as the text of this copyright notice and license are attached intact to any and all republished portion or portions. The Health Info-Com Network Newsletter is distributed biweekly. Articles on a medical nature are welcomed. If you have an article, please contact the editor for information on how to submit it. If you are interested in joining the automated distribution system, please contact the editor. Associate Editors: E. Loren Buhle, Jr. Ph.D. Dept. of Radiation Oncology, Univ of Pennsylvania Tom Whalen, M.D., Robert Wood Johnson Medical School at Camden Douglas B. Hanson, Ph.D., Forsyth Dental Center, Boston, MA Lawrence Lee Miller, B.S. Biological Sciences, UCI Dr K C Lun, National University Hospital, Singapore W. Scott Erdley, MS, RN, SUNY@UB School of Nursing Jack E. Cross, B.S Health Care Admin, 882 Medical Trng Grp, USAF Albert Shar, Ph.D. CIO, Associate Prof, Univ of Penn School of Medicine Martin I. Herman, M.D., LeBonheur Children's Medical Center, Memphis TN Stephen Cristol, M.D., Dept of Ophthalmology, Emory Univ, Atlanta, GA Subscription Requests = mednews@stat.com anonymous ftp = vm1.nodak.edu; directory HICNEWS FAX Delivery = Contact Editor for information ---------------------------------------------------------------------- Date: Sun, 11 Sep 94 08:03:40 MST From: mednews (HICNet Medical News) To: hicnews Subject: [MMWR] Outbreak Shigella flexneri on a Cruise Ship Message-ID: Outbreak of Shigella flexneri 2a Infections on a Cruise Ship During August 29-September 1, 1994, an outbreak of gastrointestinal illness occurred on the cruise ship Viking Serenade (Royal Caribbean Cruises, Ltd.) during its roundtrip voyage from San Pedro, California, to Ensenada, Mexico. A total of 586 (37%) of 1589 passengers and 24 (4%) of 594 crew who completed a survey questionnaire reported having diarrhea or vomiting during the cruise. One death occurred in a 78-year-old man who was hospitalized in Mexico with diarrhea. Shigella flexneri 2a has been isolated from fecal specimens from at least 12 ill passengers. Antimicrobial susceptibility testing of representative isolates indicated resistance to tetracycline and susceptibility to ampicillin and trimethoprim-sulfamethoxazole. The subsequent two cruises of the ship were canceled. Investigation of the mode of transmission is under way. Additional information is available from the Vessel Sanitation Program, Special Programs Group, National Center for Environmental Health, telephone (305) 539-6730. Reported by: Communicable Disease Control, Los Angeles County Dept of Health Svcs; Div of Communicable Disease Control, California Dept of Health Svcs. Foodborne and Diarrheal Diseases Br, Div of Bacterial and Mycotic Diseases, National Center for Infectious Diseases; Vessel Sanitation Program, Special Programs Group, National Center for Environmental Health; Div of Field Epidemiology, Epidemiology Program Office, CDC. * This recommendation allows slightly higher doses of prilocaine when body weight is measured in pounds rather than kilograms (8 mg/kg=3.6 mg/lb). ------------------------------ Date: Sun, 11 Sep 94 08:04:39 MST From: mednews (HICNet Medical News) To: hicnews Subject: [MMWR] Uveitis Associated with Rifabutin Therapy Message-ID: Uveitis Associated with Rifabutin Therapy In 1993, the Public Health Service Task Force recommended use of Mycobutin* (rifabutin) at a daily dose of 300 mg for prophylaxis for disseminated Mycobacterium avium complex (MAC) infection in patients with human immunodeficiency virus (HIV) infection and less than 100 CD4+ T-lymphocytes/uL (1). However, uveitis (an inflammatory eye condition characterized by pain, redness, and possible temporary or permanent loss of vision) has been associated with rifabutin therapy. Uveitis has occurred among participants in several trials for treatment and prophylaxis of MAC in which rifabutin was administered at daily doses of 300-900 mg per day in combination with other agents, particularly clarithromycin and/or fluconazole [2-4; C. Benson, Rush-Presbyterian St. Luke's hospital, Chicago, personal communication, 1994). Patients who developed uveitis have had mild to severe symptoms that resolved after treatment with corticosteroid and/or mydriatic eye drops; in some severe cases, however, resolution of symptoms occurred after several weeks. Uveitis occurred an average of 2-4 months after initiation of treatment for MAC (2). Uveitis is rare when rifabutin is used as a single agent at 300 mg/day for prophylaxis of MAC in HIV-infected persons, even with the concomitant use of fluconazole or macrolide antibiotics. However, if higher doses of rifabutin are administered in combination with these agents, clinicians should be alert to the possibility of uveitis. Patients should be instructed to report symptoms of uveitis (i.e., pain, redness, and loss of vision) to their physician. For patients with uveitis, temporary discontinuation of rifabutin and ophthalmologic evaluation are recommended. In most mild cases, using rifabutin again is acceptable; however, if signs or symptoms recur, use of rifabutin should be discontinued. Physicians are encouraged to report cases of uveitis to the Food and Drug Administration's MedWatch Program, telephone (800) 332-1088 ([301] 738-7553). Reported by: Div of Antiviral Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland. Div of HIV/AIDS, National Center for Infectious Diseases, CDC. References 1. CDC. Recommendations on prophylaxis and therapy for disseminated Mycobacterium avium complex for adults and adolescents infected with human immunodeficiency virus. MMWR 1993;42(no. RR-9):14-20. 2. Shafran S, Deschenes J, Miller M, et al. Uveitis and pseudojaundice during a regimen of clarithromycin, rifabutin, and ethambutol. N Engl J Med 1994;330:438-9. 3. Trapnell CB, Narang PK, Li R, et al. Fluconazole increases rifabutin absorption in HIV positive patients on stable zidovudine therapy [Abstract no. PO B31-2212]. Vol 1. IX International Conference on AIDS/HIV STD World Congress, Berlin, 1993. 4. Siegal F, Eilbott D, Burger H, et al. Dose-limiting toxicity of rifabutin in AIDS-related complex: syndrome of arthralgia/arthritis. AIDS 1990;4:433-41. ------------------------------ Date: Sun, 11 Sep 94 08:09:57 MST From: mednews (HICNet Medical News) To: hicnews Subject: [FDA] Panel Recommends Studies for Breast Self-Exam Devices Message-ID: PANEL RECOMMENDS STUDIES FOR BREAST SELF EXAM DEVICES Sept. 1, 1994 We are receiving inquiries about today's advisory committee meeting on devices to aid in breast self examination. The following can be used to answer questions. FDA's Obstetrics and Gynecology Devices Advisory Panel recommended that such devices be tested before they are allowed on the market. The panel, a group of outside experts, recommended that laboratory and clinical studies be performed to address the following questions: * Does the device add benefit to a conventional breast self examination? * After using the device routinely for a long time, will a woman be more likely or less likely to seek help if she finds an abnormality? * Could the device "mask" breast lumps, making them more difficult to detect? If this were the case, it could delay a woman's seeking medical attention. * Could the device lead a woman to believe she has a breast lump when in fact none exists? If this were the case, it could cause needless anxiety and lead to unnecessary testing, including biopsies. The panel also stressed the need for clear labeling of the device to be sure that women understand its proper use and limitations. They also recommended that groups of women be involved in developing the labeling. ------------------------------ Date: Sun, 11 Sep 94 08:11:24 MST From: mednews (HICNet Medical News) To: hicnews Subject: [FDA] The Doxylamine Dilemma Message-ID: The Doxylamine Dilemma In 1978, FDA approved a new drug application providing for OTC marketing of doxylamine succinate for nighttime sleep-aid use. Subsequently, the National Cancer Institute found that methapyrilene, an antihistamine similar to doxylamine, was a potent cancer-causing agent in rats. As a result, methapyrilene was removed from the market in 1979. This prompted FDA's National Center for Toxicological Research to study doxylamine for carcinogenicity and chronic toxicity. The scientists gave mice and rats variable doses of doxylamine in their feed for two years and then examined their tissues. "We got the study results in 1991, and they were inconclusive," says FDA microbiologist Katharine Freeman. "There were no significant differences in survival in the treated or nontreated rats or mice, and it was impossible to say if the changes seen in some animals--like tumors and liver toxicity--were species-specific, or if the findings were relevant to human use. We were left with the problem of how to deal with such nebulous findings." At FDA's request, the Pulmonary-Allergy Drugs Advisory Committee evaluated the data and concluded doxylamine would not likely cause cancer in humans. It recommended OTC status, but suggested the rodent findings be included in the product labeling. Concerned about how to present the information in a way that would be useful to consumers, FDA in 1993 asked its newly formed Nonprescription Drugs Advisory Committee for recommendations about doxylamine and its labeling. This committee agreed with the pulmonary-allergy panel that doxylamine is unlikely to cause cancer in humans and is safe for OTC use. It recommended, however, that there be no statement about tumors in the labeling, but that FDA present the information in an agency talk paper and FDA Consumer article. In January 1994, FDA amended the monograph for OTC antihistamine drug products to include doxylamine succinate. ------------------------------ Date: Sun, 11 Sep 94 08:13:10 MST From: mednews (HICNet Medical News) To: hicnews Subject: [FDA] Electromagnetic Interference with Wheelchairs Message-ID: ELECTROMAGNETIC INTERFERENCE WITH POWERED WHEELCHAIRS August 26, 1994 FDA is receiving inquiries about reports that electromagnetic interference (EMI) can cause some power-driven wheelchairs and scooters to move unexpectedly. The following can be used to answer questions. The agency has investigated this matter and determined that EMI can cause unexpected movement in some power-driven wheelchairs when they are turned on. Not all brands and models of power wheelchairs and scooters have this problem. Some have greater immunity levels than others that may protect against EMI. Common sources of EMI include cellular phones, CB radios, TV and radio stations, amateur (HAM) radios and police, fire and ambulance radios. After receiving reports of problems, FDA tested sample wheelchairs and scooters in its laboratories and obtained information from manufacturers and users about possible EMI-related incidents. As a result of its review, the agency last May asked wheelchair manufacturers to take steps to protect powered wheelchair users from the potential hazards of EMI. FDA required all firms to clearly label wheelchairs and scooters with the immunity level, or else state that the immunity level is not known. It also required them to label wheelchairs and scooters to warn users of the potential hazards of EMI. The agency also asked manufacturers to: * Establish a minimum recommended immunity level of 20 volts per meter for all new motorized wheelchairs and scooters. This would provide a reasonable degree of protection against the more common sources of EMI. * Undertake an educational campaign to inform users and those who care for them about the risks of EMI and ways to avoid it; and * Solicit reports of possible EMI incidents and continue to monitor the full scope of the problem. FDA first learned of a possible problem with motorized wheelchairs from a complaint in June 1992. As a result, the agency began testing sample wheelchairs in its laboratories. Those tests, on several brands of power-driven wheelchairs and scooters, revealed that most -- but not all -- of those sampled were susceptible to interference at various radio frequencies. In some tests, the brakes released. In others, the wheels moved uncontrollably. Sometimes both occurred at once. The extent to which this happens in actual use is not known. In early 1993, FDA began inspecting facilities of all domestic and foreign motorized wheelchair and scooter manufacturers to gather information on the problem. The agency reviewed warranty and complaint files and looked at any manufacturing practices that could contribute to this type of problem. The inspections revealed numerous complaints about erratic, unintentional wheelchair movement, sometimes resulting in injuries. It is unclear, however, exactly what caused the chairs to move in those cases. In addition to EMI, unexpected movement can be caused by failure of an electronic component or by user error. In May 1993, FDA sent letters to all U.S. manufacturers asking them to provide any information they had about possible problems with radio wave interference, including complaints, reports of injuries and studies on power-driven wheelchairs. In July 1993, the agency alerted consumer groups that represent wheelchair users about the possible problem and requested similar information. An estimated 10,000 motorized wheelchairs and 50,000 motorized scooters are sold annually in this country. ------------------------------ Date: Sun, 11 Sep 94 08:14:08 MST From: mednews (HICNet Medical News) To: hicnews Subject: [FDA] The New Food Label: Scouting for Sodium related to Blood Pressure Message-ID: <0TuHsc14w165w@stat.com> The New Food Label Scouting for Sodium and Other Nutrients Important to Blood Pressure By Paula Kurtzweil (This is the second in a series of articles telling how to use the new food label to meet specific dietary needs.) For years, consumers watching their sodium intake have had to plod through ingredient lists on many food labels like high school students through a Shakespearean play. They had to read a lot of unknown words and then do plenty of guessing. Aiming to get some idea of a food's sodium content, consumers knowledgeable about sodium-restricted diets looked for names like sodium caseinate, monosodium glutamate, trisodium phosphate, sodium ascorbate, sodium bicarbonate, sodium stearoyl lactylate, and other sodium-containing ingredients, including salt (sodium chloride). It wasn't easy, and it wasn't always accurate. Elizabeth Adams of Churchton, Md., can vouch for that. She started to limit her sodium intake 23 years ago. She recalled spending "a long time" in grocery stores reading ingredient lists and looking for nutrition information, which then was voluntary and, until recently, appeared on only about 60 percent of food labels. "I got to the point where I didn't buy a food unless it had only one ingredient or carried nutrition information," she said. "I had no idea otherwise how much sodium the food had in it." Resorting to such measures will no longer be necessary for the nearly 50 million Americans like Adams who suffer from hypertension (high blood pressure) and the many others who want to reduce their risk for it. The food label they depend on to help monitor their sodium intake--and thus control their blood pressure--now must state how much sodium a food contains per serving and how the food fits in with their daily diet. Label Changes These requirements are the result of the Nutrition Labeling and Education Act of 1990 and regulations from the Food and Drug Administration and the U.S. Department of Agriculture. Under these regulations, consumers are seeing: ~ Nutrition information in bigger, more readable type on almost all packaged foods. It appears in the table headed "Nutrition Facts," which is usually on the side or back of the package. Nutrition information also will be available in stores near many fresh foods, like fruits and vegetables. (See "Nutrition Info Available for Raw Fruits, Vegetables, and Fish" in the January- February 1993 FDA Consumer.) ~ "% (percent) Daily Values," which tell consumers at a glance the levels of important nutrients in a food and how those amounts fit into a daily diet. ~ Serving sizes that closely reflect the amount people actually eat. ~ Strictly defined nutrient-content claims, like "low-sodium," "salt-free," and "rich in potassium." This means that when consumers see such claims, they can believe them. (See "A Little 'Lite' Reading" in the June 1993 FDA Consumer.) ~ Strict rules for using health claims, such as one that links low-sodium diets to a reduced risk of high blood pressure. (See "Starting This Month, Look for 'Legit' Health Claims on Foods" in the May 1993 FDA Consumer.) Sodium's Role Some of the information--particularly that pertaining to sodium content--will be of special interest to people with high blood pressure. Sodium has long been a major dietary factor in reducing the risk of, and controlling, high blood pressure. (For more on hypertension, see "High Blood Pressure: Controlling the Silent Killer," in the December 1991 FDA Consumer.) This role was reiterated as recently as January 1993 in the fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The committee noted that numerous studies have shown that reducing sodium intake can reduce blood pressure. What is a reduced sodium intake? According to Camille Brewer, a registered dietitian and nutritionist in FDA's Office of Food Labeling, therapeutic sodium-restricted diets can range from below 1,000 milligrams (mg) to 3,000 mg a day. "American adults, on average, eat too much sodium--between 4 to 6 grams (4,000 mg to 6,000 mg) daily," she said. "Most people would benefit from moderately reducing their sodium intakes." Brewer advises people who are considering a sodium-restricted diet to consult a physician, dietitian or nutritionist first. Under FDA's food labeling rules, the Daily Value for sodium is 2,400 mg. (Daily Values are a new label reference tool. See "'Daily Values' Encourage Healthy Diet" in the May 1993 FDA Consumer.) FDA established this value because it is consistent with recommendations and government reports that encourage reduced sodium intakes. Salt and other sodium compounds used in food processing are the biggest contributors of sodium to most people's diets, Brewer pointed out. (One teaspoon of salt has about 2,000 mg of sodium.) These substances are used in food processing for preserving, flavoring and stabilizing other ingredients, she said. "That's why the ingredient lists of canned, frozen, and other processed foods often contain the names of so many sodium compounds," she said. Also, kosher beef, lamb and chicken have salt added. Sodium also is present naturally in some foods, such as milk, cheese, meat, fish, and some vegetables. Weight Reduction Label information about fat, calories and fiber also will be important for people with high blood pressure who are overweight. These are the nutrients of most concern to those trying to lose weight or control it. (See "Making It Easier to Shed Pounds" in the July~August 1994 FDA Consumer.) Body weight, like sodium intake, often closely correlates with blood pressure: As weight goes up, blood pressure frequently does, too. If weight is reduced, blood pressure often goes down. Other Nutrients Hypertensives also may be interested in label information about potassium, calcium and magnesium. According to the Joint National Committee's report, evidence suggests that these nutrients may play a role in reducing the risk of high blood pressure. For this reason, nutrition experts often encourage people with hypertension to increase their intakes of these nutrients. Information about a food's potassium and magnesium content is required on the Nutrition Facts panel only if the food contains added potassium or magnesium as a nutrient or if claims about those nutrients appear on the label. In all other cases, it is voluntary. When listed, potassium must appear below sodium on the Nutrition Facts panel, and magnesium must be shown in the list of vitamins and minerals. The Daily Value for potassium is 3,500 mg. For magnesium, it's 400 mg. Information about calcium is mandatory. It, too, appears in the list of vitamins and minerals. The Daily Value for calcium is 1 gram (g), or 1,000 mg. %Daily Values The place to begin is the "%Daily Value" column under Nutrition Facts. This column contains numbers that show whether a food is high or low in the nutrients listed. For people with high blood pressure, the %Daily Value for sodium is especially important. If the %Daily Value for sodium is 5 or less, the food is considered low in that nutrient. So, the goal should be to select, as much as possible, foods that have a %Daily Value for sodium of 5 or less. The goal for the full day's diet should be to select foods that together add up to no more than 100 percent of the Daily Value for sodium. People with high blood pressure also may want to check the %Daily Values for fat, fiber, calcium, and, if listed, potassium and magnesium. The goal for the full day's diet should be to select foods that together add up to no more than 100 percent of the Daily Value for fat and at least 100 percent for fiber and calcium. Serving Size Serving size information is important, too. It tells the amount of the food, stated in both common household and metric measures, to which all other numbers apply. Under the new regulations, serving sizes are designed to reflect the actual amounts that most people eat, although they are not necessarily the amounts recommended by various health groups. Also, the serving size must be about the same for like products--for example, different brands of potato chips--and for similar products within a category of foods--for example, potato chips, pretzels, and popcorn within the category "snacks." This makes it easier to compare the nutritional qualities of related foods. Other Information The Nutrition Facts panel also gives the amount in milligrams of a food's sodium content. This information can help consumers who monitor the milligrams of sodium they consume. The %Daily Values for other nutrients are helpful, too, because they can help consumers determine how nutritious a food is overall. Whether the %Daily Values are for nutrients most people should limit--for example, saturated fat and cholesterol--or eat more of--for example, total carbohydrate, fiber, vitamin A, and calcium--the %Daily Values tell at a glance how the food compares nutritionally to others. Food Label Claims On some food packages, claims describing the food's nutritional benefits may appear. Often, they will show up on the front of the package where shoppers can readily see them. Nutrient claims--like "sodium-free," "salt-free," and "very low sodium"--describe desirable levels of nutrients in the food. (See "Nutrient Claim Guide.") Relative nutrient claims compare a product to the "regular" version of the food or to a similar food. For example, a "reduced- sodium" claim on the label of canned spaghetti sauce means the food has at least 25 percent less sodium than regular canned spaghetti sauce. A claim of "light in sodium" on canned spaghetti sauce means the sodium has been reduced by at least 50 percent. Other claims simply show that a food is high or low in a nutrient, without any particular comparisons to other products. For example, "low-sodium" means the food has 140 mg or less per serving. "Very low sodium" means it has 35 mg or less per serving. Also, health claims may be made about the relationship between a nutrient or food and a disease or health-related condition. Only those health claims authorized by FDA may appear because they're the only ones supported by substantial scientific evidence. The claim that diets low in sodium may reduce the risk of high blood pressure is an authorized claim. This claim can appear only on products that meet the definition of "low-sodium" and that provide 20 percent or less of the Daily Value for fat, saturated fat and cholesterol per serving. FDA incorporated this requirement so that low-sodium foods would not be counterproductive by being high in other components that contribute to heart disease. Whatever the source--health claims, nutrient claims, or the Nutrition Facts panel--consumers, especially those restricting their sodium intake, will find that the new food label puts an end to the guessing games they may have played before. Instead, they'll see that the label gives them more complete, accurate information to help them make more healthful food choices. n Paula Kurtzweil is a member of FDA's public affairs staff. Special Report In-depth but easy-to-understand information about the new food label is provided in an FDA Consumer special report, Focus on Food Labeling. Copies cost $5 each. To order, write to: Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Ask for stock number S/N 017-012-00360-5. Nutrient Claim Guide Sodium Sodium-free: less than 5 milligrams (mg) per serving Very low sodium: 35 mg or less per serving or, if the serving is 30 grams (g) or less or 2 tablespoons or less, 35 mg or less per 50 g of the food Low-sodium: 140 mg or less per serving or, if the serving is 30 g or less or 2 tablespoons or less, 140 mg or less per 50 g of the food Light in sodium: at least 50 percent less sodium per serving than average reference amount for same food with no sodium reduction Lightly salted: at least 50 percent less sodium per serving than reference amount. (If the food is not "low in sodium," the statement "not a low-sodium food" must appear on the same panel as the "Nutrition Facts" panel.) Reduced or less sodium: at least 25 percent less per serving than reference food. Salt (Sodium Chloride) Salt-free: sodium-free (see above definition) Unsalted, without added salt, no salt added: ~ no salt added during processing, and ~ the food it resembles and for which it substitutes is normally processed with salt (If the food is not "sodium free," the statement "not a sodium-free food" or "not for control of sodium in the diet" must appear on the same panel as the Nutrition Facts panel.) Potassium High-potassium: 700 mg or more per serving Good source of potassium: 350 mg to 665 mg per serving More or added potassium: at least 350 mg more per serving than reference food Calcium High-calcium: 200 mg or more per serving Good source of calcium: 100 mg to 190 mg per serving More or added calcium: at least 100 mg more per serving than reference food (For weight-reduction claims, see "Making It Easier to Shed Pounds" in the July-August 1994 FDA Consumer.) Alternatives to High-Sodium Foods If you find yourself continually eating more than 100 percent of the Daily Value for sodium each day, consider these lower sodium alternatives. For labeled items, check the %Daily Value for sodium; try to select foods that provide 5 percent or less per serving. Instead of: Eat: smoked, cured, salted, and canned unsalted fresh or frozen beef, meat, fish and poultry lamb, pork, fish, and poultry regular hard and processed low-sodium cheese, low-sodium cheese, regular peanut butter peanut butter crackers with salted tops unsalted crackers regular canned and dehydrated low-sodium canned soups, soups, broths and bouillons broths and bouillons regular canned vegetables fresh and frozen vegetables and low-sodium canned vegetables salted snack foods unsalted tortilla chips, pretzels, potato chips, and popcorn ------------------------------ Date: Sun, 11 Sep 94 08:15:16 MST From: mednews (HICNet Medical News) To: hicnews Subject: [FDA] Approves Test for Prostate Cancer Message-ID: <6VuHsc15w165w@stat.com> FDA APPROVES TEST FOR PROSTATE CANCER Aug. 29, 1994 The Food and Drug Administration today approved the first blood test to help detect prostate cancer in men 50 and older. The test, a prostate specific-antigen (PSA) blood test, was approved for use in conjunction with a digital rectal exam. The PSA test was initially approved by FDA in 1986 to aid in the care of patients who already had been diagnosed with prostate cancer. Today's approval expands the use to include helping to diagnose the disease. The PSA test by itself cannot be relied on to determine whether a man has prostate cancer. It must be used in conjunction with other diagnostic procedures, including the digital rectal exam. The final diagnosis requires a biopsy. "This test--used with other procedures--can help detect those men at risk for prostate cancer early on when more treatment options are available," said FDA Commissioner David A. Kessler, M.D. "But for the test to help, men must be aware of the importance of early check ups and get them on a regular basis." FDA's approval of the test--the Tandem PSA Assay made by Hybritech Corp. of San Diego--is based on a review of clinical studies on safety and effectiveness submitted by the manufacturer and on the recommendation of FDA's Immunology Devices Panel. The tests were done in conjunction with a digital rectal exam. The firm's studies of more than 6,300 men showed that PSA testing when combined with a rectal exam was more effective in detecting prostate cancer than either a rectal test or PSA test alone. While high levels of PSA may signal prostate cancer, they may also signal other common, non-cancerous prostate disorders. Conversely, low PSA levels do not necessarily indicate an absence of prostate cancer. Therefore, it is important that the PSA test be interpreted with results from other established procedures such as a digital rectal exam. If either test is positive, confirmatory testing with transrectal ultrasound and biopsy is needed to diagnose prostate cancer. Prostate cancer is the second most common cancer in men in the United States, after skin cancer. The prostate gland, which produces seminal fluid, is about the size of a walnut and is located below the bladder and in front of the rectum. Most cases of prostate cancer occur in men 65 or older, with the risk increasing with age. Approximately 13 percent of American men will be diagnosed with the disease during their lifetimes, but most cases never become life threatening. Many questions still remain in the medical community about how best to treat prostate cancer. To help answer these and other questions, the National Cancer Institute is currently sponsoring a long-term screening study of 37,000 men, ages 60 to 74. ------------------------------ Date: Sun, 11 Sep 94 08:16:04 MST From: mednews (HICNet Medical News) To: hicnews Subject: [FDA] OTC Options - Help for the Sleepless Message-ID: OTC Options - Help for the Sleepless By Marian Segal When your head hits the pillow but your body refuses to sleep, lying in the dark counting sheep just might induce tossing and turning instead of heavy eyelids. Often, simple remedies can solve the problem of an occasional restless night. For some people, just a few minutes' reading or television gazing will lull the mind to sleep. Others coax slumber by taking a warm bath or light snack just before bedtime. Over-the- counter (OTC) nighttime sleep-aids, regulated by the Food and Drug Administration, are another option. According to a 1993 report to Congress by the National Commission on Sleep Disorders Research, "frequent or chronic insomnia, estimated to affect more than 60 million Americans--about one of every three adults--is a severe problem for approximately half of those individuals." Insomnia lasting just a few days--what the American Sleep Disorders Association (ASDA) calls "transient insomnia"--is a common aftermath of stress or excitement. It's not unusual to lose one or two days' sleep worrying about a spat with a spouse or a report due at work. Good things sometimes keep people awake, too, like an exciting sports event or anticipation of the start of a vacation. "Short-term insomnia"--lasting two or three weeks--may result from ongoing stress. A job setback, illness, or death of a loved one can upset normal sleep habits for a while. If unresolved, "chronic insomnia"--defined by the ASDA as "poor sleep every night, most nights, or several nights a month"--may ensue. There are a lot of questions about sleep that scientists can't answer--why it's necessary, what its purpose is, how it's regulated, or what the brain does during sleep. But you don't have to be a scientist to recognize the effects of going without sleep. Anyone who has slept poorly for a few nights running knows that's the reason they are tired and irritable, and have trouble concentrating and staying alert. Chronic insomnia can have more serious consequences. In a March 24, 1993, commentary in the Journal of the American Medical Association, sleep expert William C. Dement, M.D., Ph.D., notes that drowsiness is blamed for some 200,000 to 400,000 automobile accidents a year, accounting for almost half of all accident- related deaths in the United States. The commission's report to Congress links sleep deprivation to increased psychosocial problems and illness and death, and to diminished productivity and performance. It names fatigue and drowsiness as contributors to accidents in hospitals, military operations, and the nuclear industry, and to major air, rail, road, and sea transportation disasters. The Challenger space shuttle explosion, the Exxon Valdez grounding, and the collision of two Conrail freight trains resulting in four deaths and $6 million dollars in damages are among several catastrophes cited. So, while researchers want to learn more about sleep for many reasons, we plain folk who lie awake nights simply want to know how we can get more of it. Professional or Self-Help? People with chronic insomnia should see a doctor for treatment, which may include short-term use of prescription sleeping pills. Poor sleep for extended periods may be a symptom of an underlying disorder, such as depression, sleep apnea (repeated interruptions of breathing during sleep), pain from arthritis or other illness, or a neurological disease. But if all that's needed is a little help to overcome a restless night or two, a do-it-yourself approach is sensible. Experts have come up with many useful tips to help people fall asleep and develop and maintain good sleeping habits (see "Tricks for the Tired"). Used appropriately, OTC and prescription sleep-aids also can help provide sounder sleep, the ASDA advises. The association cautions, however, that for some types of insomnia, such as that caused by breathing disorders, the products may be dangerous. "Before taking any OTC drug product, you should read the label for directions on how and when to use it, and whether you should check with a doctor before taking it," says FDA regulatory review pharmacist Michael Benson. "Antihistamines are the ingredients in OTC nighttime sleep-aids that make you nod off, and some contain other ingredients, like an analgesic for pain," he says. FDA allows three antihistamines--diphenhydramine hydrochloride (HCl), diphenhydramine citrate, and doxylamine succinate--to be used as the active ingredient in OTC nighttime sleep-aids. In the early 1970s, FDA began a review of OTC drug products. Manufacturers were requested to submit data on the safety and effectiveness of the active ingredients for their intended uses. Expert panels on various classes of drug products were convened to review the data and make recommendations to the agency. In 1978, FDA approved a new drug application providing for OTC marketing of doxylamine succinate for nighttime sleep-aid use. In 1982, the agency authorized the initial marketing of diphenhydramine HCl and diphenhydramine citrate for this use. These two drugs were the only ones included in the agency's final monograph on OTC nighttime sleep-aids, issued in 1989. After the monograph's publication, products containing active ingredients other than doxylamine succinate, diphenhydramine HCl, or diphenhydramine citrate had to be reformulated or taken off the market. Read the Label Consumers can find out what ingredients are in an OTC drug product by reading the label. Unisom contains doxylamine succinate, for example, while Nytol contains diphenhydramine HCl. Some products, such as Sominex Pain Relief Formula and Bufferin AF Nite Time contain an analgesic for pain relief as well as an antihistamine. You may find that one works better for you than another. Because of the different product ingredients, the label warnings and directions for use vary. Most OTC sleep-aid product labels caution patients with certain conditions to check with a doctor before taking the product. Such conditions include shortness of breath, asthma, emphysema, chronic pulmonary disease, glaucoma, and difficulty urinating due to enlarged prostate gland. The labels also warn against taking the product along with alcohol or other central nervous system depressants, such as sedatives or tranquilizers, because they heighten the depressant effect. (Recently approved revisions in wording will appear on all labels by April 11, 1995: The words "breathing problems" will be used to describe shortness of breath and difficulty breathing related to obstructive pulmonary disease; "chronic bronchitis" will replace "chronic pulmonary disease"; and the word "asthma" will be removed. These changes will help consumers recognize respiratory distress symptoms more readily.) Sleep-aids that contain aspirin must carry a warning to consult a doctor about Reye syndrome before giving the product to children and teenagers who have chickenpox or flu symptoms. Reye syndrome is a rare but serious disease that has been associated with use of aspirin in children with these conditions. This warning may also appear on products containing other salicylates. These drugs should not be given to children under 12, and they should not be used for more than two weeks unless under a doctor's direction. Pregnant and nursing women should check with a doctor before taking these products. OTC nighttime sleep-aids can provide welcome relief from a night of wide-eyed wakefulness. OTC status does not, however, guarantee the product is hazard-free. Just like prescription drugs, OTC drug products must be used with care. "The bottom line for all OTC drug products," says FDA's Benson, "is to read the label and follow the instructions." (For more on insomnia, see "Why Aren't You Asleep Yet? A Bedtime Story" in the October 1989 FDA Consumer. Also, write to the American Sleep Disorders Association, 1610 14th St., N.W., Rochester, MN 55901.) ------------------------------ Date: Sun, 11 Sep 94 08:17:10 MST From: mednews (HICNet Medical News) To: hicnews Subject: [FDA] Tricks for the Tired Message-ID: Tricks for the Tired If you're having trouble sleeping, you may want to try modifying some behaviors that might be keeping you awake. The American Sleep Disorders Association suggests one or more of the following practices might help: ~ Get up about the same time every day, regardless of when you go to bed. ~ Go to bed only when sleepy. ~ Establish relaxing pre-sleep rituals, such as a warm bath, light bedtime snack, reading, or watching television. ~ Exercise regularly. Get vigorous exercise--such as jogging or squash--in the late afternoon, and mild exercise--such as simple stretching or walking--two or three hours before bedtime. ~ Don't eat or drink caffeine-containing products within six hours of bedtime. It's better not to smoke at all, but if you do, avoid smoking at bedtime. Caffeine and nicotine are both stimulants. Even if they don't interfere with falling asleep, they may trigger awakenings later. ~ Don't drink alcoholic beverages at bedtime. A nightcap may induce sleep, but it can interfere with sound sleep through the night. ~ Don't nap, unless you find that naps don't interfere with sleep later on. ~ If you often worry at bedtime, reserve another time of day for working on problems. ~ If you can't sleep, get out of bed and go to another room to read or watch television. You may want to try sleep restriction. This strategy is based on the finding that many insomniacs spend excessive time in bed, hoping to make up for lost sleep. Go to bed later than usual, and get up at the same time each morning. Stay in bed only as long as you actually sleep, even if it's only a few hours. When you sleep at least 90 percent of your allotted time in bed for five days in a row, go to bed 15 minutes earlier. After a week or two you should be sleeping better and, after a few months, as long as you want. While you can try this on a do-it-yourself basis, ASDA says, it is generally more easily done under the supervision of a sleep specialist. ------------------------------ Date: Sun, 11 Sep 94 08:18:05 MST From: mednews (HICNet Medical News) To: hicnews Subject: [FDA] Safeguarding Human Tissue Transplants Message-ID: Safeguarding Human Tissue Transplants by John Henkel For millions of Americans, human tissue transplants represent a modern miracle. These bits of donated eye, skeleton, skin, muscle, sperm, and other reusable body tissues can restore sight or repair injured knees and ankles. They can help mend a burn victim or renew a cancer patient's lost bone. They can even replace a failing heart valve or allow an infertile couple to have children. But like blood and other body fluids, these living materials also can transmit disease--including HIV (the virus that causes AIDS) and two types of viral hepatitis. Concern over this potential is fueling increased FDA oversight of the human tissue industry, which provides products for an estimated 300,000 transplants a year in the United States. FDA and industry experts say the chance of actually passing disease through transplants appears small. They emphasize that patients should not decline a needed transplant for fear of acquiring a disease. Industry organizations, they say, have made notable efforts to oversee tissue bank products. Industry Checks Itself For years, without extensive federal controls, large segments of the domestic human-tissue industry have self-regulated the quality and commerce of products through voluntary compliance with industry standards. For example, trade groups such as the American Association of Tissue Banks (AATB) and the Eye Bank Association of America (EBAA) sponsor voluntary accreditation programs requiring periodic inspections and adherence to standards. FDA estimates that more than 100 of the 150 to 200 U.S. tissue banks are accredited by AATB or are undergoing accreditation. Of EBAA's member banks, which are responsible for providing tens of thousands of corneas annually, 95 percent are accredited. The American Fertility Society accredits some reproductive tissue banks. The American Red Cross, a major supplier of human tissue, uses AATB guidelines. In addition, five states--California, Florida, Georgia, Maryland, and New York--require licensing of tissue bank facilities. In May, the national Centers for Disease Control and Prevention published new guidelines for preventing HIV transmission in tissue and organ transplants. CDC~s guidance now includes detailed instructions concerning issues such as donor screening and testing, donor exclusion criteria, inactivation of infectious organisms, and recall of tissues found to be contaminated. Since 1985, U.S. doctors have performed 1 million tissue transplant operations, according to CDC estimates. In all these cases, only two tissue donors are known to have transmitted AIDS to recipients. (Other diseases, such as hepatitis and rabies, have been transmitted through transplants, though the incidence is extremely low.) Both AIDS transmission cases occurred in the mid-1980s, during the early days of the AIDS epidemic, when tests for the virus were less sophisticated. One incident involved transfer of a small amount of bone tissue from an HIV-positive donor, which infected a recipient. The other episode came to light three years ago. A reputable Virginia tissue bank, LifeNet Transplant Services, had stored 61 organs and tissue grafts taken from a man in 1985 after he died of gunshot wounds. Before removing organs and tissue, the bank twice analyzed the donor's blood for infectious disease. In both instances the blood tested negative. But in 1991, through retrospective analysis using more refined methods, the tissue bank discovered that the donor's blood tested positive for HIV. The bank immediately set out to find and test recipients. Due to poor record keeping by hospitals and practitioners, LifeNet could locate only 34 of more than 40 patients who received the infected organs or tissue. Seven of these persons are known to have contracted the AIDS virus, and three have died. FDA Tightens Controls Concerns that disease transmission, though rare, can occur, coupled with new information gleaned from an FDA investigation into imported human tissue, have prompted FDA to impose controls on tissue banking and has set the stage for possible congressional action. In December 1993, FDA imposed interim rules that make most banked human tissue--including bone, ligaments, tendons, fascia (muscle-enclosure tissue), cartilage, corneas, and skin--subject to some of the same kinds of scrutiny for infectious agents now applied to the nation's blood supply. The rules do not cover transplants of organs such as the heart and liver, which are managed under separate programs in the federal Health Care Financing Administration and Health Resources and Services Administration. Other tissue products fall under existing regulations and are exempt from the new rules. For example, bone marrow transplants are managed by the National Institutes of Health. Dura mater (brain membrane material), heart valve allografts, and corneal lenticules are regulated by FDA under the Medical Device Amendments of 1976. Sperm and Ova Reproductive tissues, primarily sperm and ova, are presently not regulated by the federal government and are exempt from FDA's interim rules. Though this industry has some degree of self regulation and state monitoring, it is not without its problems. Last October, Congress heard testimony from New York state officials explaining that until the state tightened standards in 1989, many of New York's sperm banks had been based in physician's offices and often used fresh semen from untested donors. The officials identified other problems, such as employees' lack of technical expertise in infectious disease testing and inadequate screening of donors who designate a semen recipient. The state had also found a case in which two semen bank operators were using only themselves as donors but leading recipients to believe that the bank had stored semen from more than a dozen donors. While emphasizing the potential of passing infectious disease through reproductive tissue, FDA officials also point out the possibility of transmitting inherited diseases. Based on these concerns, Congress is now considering legislation that would give FDA regulatory oversight of sperm and ova banks and make these facilities accountable to rigid standards. Meanwhile, FDA cautions persons who intend to use donated reproductive tissue to discuss with their doctors the screening and testing standards under which the tissue was collected and insist on documentation. Tissue Brokers FDA put its new regulatory controls (see accompanying article) into action last February when it ordered an El Paso, Texas, tissue-processing firm to retain or destroy stored tissue and recall previously distributed tissue from about 180 donors. The agency determined that the firm, AlloTech, which imported tissue from Eastern Europe, lacked adequate documentation of medical history screening and disease testing for the tissue. There was no evidence that AlloTech's donors carried any of the target diseases, but FDA saw the firm's shortcomings as a potential hazard. AlloTech had dealt with "tissue brokers" marketing donor cadavers from former Soviet bloc countries. FDA's concern was that certain brokers could not produce original records of donor screening or donor consent. In a 1993 investigation of imported tissue brokers, FDA found no proof of disease transmission from any of these products. Further, the agency points out that some tissue banks may import human tissue legitimately with the proper documentation. In its investigation, FDA collected revealing evidence about the credibility of some tissue brokers. FDA investigators placed an order for cadavers after contacting two brokers representing interests in former Soviet bloc countries. One broker, claiming the bodies tested disease-free, gave investigators four vials of blood taken from the cadavers. FDA analyzed the samples and found that one tested positive for the hepatitis B virus. At the time, no federal regulatory provisions existed that would allow FDA to take direct action. Now, under the agency's interim rules, FDA can crack down on noncompliant brokers. An "import alert," put in place last December, requires any tissue importer to notify FDA before bringing foreign tissue into the country. Acknowledging that importing potentially tainted tissue is "something that has happened," Jim Weixel, spokesman for the AATB, says, "it's not really a big problem in this country. The amount of tissue that comes in from overseas, as far as we know, is very small compared with that recovered domestically." He adds, however, that because reporting was never required, "nobody really has accurate statistics" on tissue importation. Legislation Introduced Over the last several years, Sen. Paul Simon (D-Ill.) and Rep. Ron Wyden (D-Ore.) have examined safe and effective use of human tissue transplants. Wyden, key sponsor of a tissue-regulation bill in the House of Representatives, has spoken out about other problems with tissue banking besides disease transfer and imported products. In congressional testimony last October, he called for a halt to "practices that damage tissue and render it useless." For example, he cited "over-freezing for preservation" and "zapping them with too many gamma rays to irradiate disease" as tissue-banking "practices that must be stopped." Also, he said, "there must be further scrutiny of sterilization methods currently in use which leave cancer-causing residues." Further, he pointed out disparities in training levels of persons who collect, process and store tissues. He called for uniform training standards that would be required of all banks. On Nov. 19, 1993, both Wyden and Simon introduced similar tissue- banking legislation. At press time, both bills still were pending. FDA's interim rules are designed as a "temporary measure" until FDA "can complete its evaluation of whether additional regulations are necessary," says Steven Falter, director of FDA's division of bioresearch monitoring and regulation. FDA has provided technical advice to congressional officials on bills introduced by Wyden and Simon. Among other things, Falter says, legislation would require tissue banks to register with FDA. This would put to rest lingering questions about just how many U.S. tissue banks exist. With no previous federal oversight of tissue facilities and only sporadic state supervision of tissue banks, such numbers have been impossible to produce accurately. Other provisions in the bills involve labeling all banked tissue and requiring that strict written procedures be followed in tissue recovery, processing, storage, and distribution. A law regulating tissue products has widespread support in the tissue- banking industry. AATB assisted Wyden and Simon in formulating their bills, each of which contained elements already part of AATB's standards and accreditation program. Likewise, EBAA advocates "well-drafted legislation." In congressional testimony, Ellen Heck of the eye-bank trade group said, "The legislation must take care to seek out and not delay in applying regulation to those [tissue banks] most likely to linger undetected and, therefore, unregulated and noncompliant." The American Red Cross agreed that enforceable federal standards are needed. Who Will Pay the Bills? FDA, Congress and industry agree on one critical aspect about pending legislation: Regulating human tissues requires resources. As Kathryn Zoon, Ph.D., director of FDA's Center for Biologics Evaluation and Research, says, "It will do little good to enact a statute or launch a [tissue-regulation] program without the resources to establish the program and sustain the program over time." Where will these funds come from? Key players in the legislation are brainstorming possibilities. One is to levy user fees on the tissue-banking industry. Such a program, says Zoon, "would provide real value to the tissue-banking community in terms of public credibility and a level playing field, and it is fair to ask that community to bear the cost." But she warns that user-fee costs would likely be passed on to consumers. Legislation, she says, should be "thoroughly examined" for its impact on health-care reform. Industry sources express mixed feelings about user fees. The AATB, says spokesman Weixel, would likely support such fees, provided they were fair and "dedicated to accomplishing regulation, not to underwriting budget difficulties." He says user fees probably could not fund an entire regulation program, only parts such as tissue-bank registration and some inspections. Other resources, such as federal seed money or a value-added tax on transplants, might be needed to finance compliance, research, and other critical elements, Weixel adds. Though officials are wrestling with how to fund legislation, many express confidence that the issue will be resolved. "As a society," says FDA's Zoon, "we must balance the benefits that would clearly accrue from allocating resources to tissue regulation against using the resources to address other issues." Until further measures take shape, FDA is relying on the interim rule to safeguard tissue transplants. For the moment, says FDA Commissioner David A. Kessler, M.D., the rule "will ensure that the public is protected, and protected well." n John Henkel is a staff writer for FDA Consumer. FDA's Interim Rules Tissue banks covered under FDA's interim rules now must test blood specimens from all donors using laboratories regulated under the Clinical Laboratories Improvement Act of 1988. Blood samples must test negative for antibodies to HIV (types 1 and 2), hepatitis B surface antigen, and antibodies to hepatitis C virus. Some of the other interim rule conditions provide for: ~ Screening--Tissue banks are required to obtain a medical history for each donor to help rule out risk factors. ~ Record keeping--Banks must keep written or electronic records for 10 years that document donor testing and screening. All banked tissue must be either quarantined or accompanied by proper records. ~ Inspections--FDA can inspect tissue-banking facilities to ensure compliance with the new rules. ~ Recall--FDA may order the recall or destruction of any tissue not meeting interim-rule requirements. ------------------------------ End of HICNet Medical News Digest V07 Issue #43 *********************************************** --- Editor, HICNet Medical Newsletter Internet: david@stat.com FAX: +1 (602) 451-1165 Bitnet : ATW1H@ASUACAD