From <@uga.cc.uga.edu:owner-mednews@ASUACAD.BITNET> Mon Mar 6 10:50:22 1995 with BSMTP id 0681; Mon, 06 Mar 95 10:44:35 EST UGA.CC.UGA.EDU (LMail V1.2a/1.8a) with BSMTP id 1978; Mon, 6 Mar 1995 09:16:58 -0500 HICNet Medical News Digest Mon, 06 Mar 1995 Volume 08 : Issue 05 Today's Topics: FDA warning"BAMBA SNAC Fertility Drugs Hepatitis Vaccine Lice Pacemaker Leads Natures Nutrition Form Rules For Spermicides Treatment Pancreatic C FDA Pesticides Program [MMWR] Prevention Program for Reducing Risk for Neural Tube Defects [MMWR] Use of Safety Belts -- Madrid Spain [MMWR] Monthly Immunization Table [MMWR] Vaccination Coverage of 2-year old children [MMWR Feb 27, '95] Serogroup B Meningococcal Disease +------------------------------------------------+ ! ! ! 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 *Asia/Pacific: http://biomed.nus.sg/MEDNEWS/welcome.html *Americas: http://cancer.med.upenn.edu:3000/ *Europe: http:/www.dmu.ac.uk/0/departments/pharmacy/archive/www/MEDNEWS/welcome.h tml 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 Stephen Cristol, M.D. MPH, 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 ---------------------------------------------------------------------- To: hicnews FDA WARNING AGAINST CONSUMING "BAMBA SNACKS WITH PEANUTS" FDA is issuing a national warning against purchasing or consuming "Bamba Snacks with Peanuts" manufactured by OSEM Food Industries Ltd. of Tel Aviv, Israel, because this kosher snack product has been associated with outbreaks of Salmonella agona in Europe. FDA is issuing this warning as a precautionary measure, since it is not known how widely the product is distributed in the U.S., or whether the product in the U.S. is similarly contaminated. Salmonella agona is an organism which can cause serious and sometimes fatal infections in small children, frail or elderly people, and others with weakened immune systems. Healthy individuals may only suffer short-term symptoms such as high fever, severe headache, vomiting, nausea, abdominal pain and diarrhea. Long term complications can include debilitating arthritis. Since December 1, 1994, authorities in England and Wales have reported 27 cases of Salmonella agona infection in children under ten years of age who have consumed this snack product. Authorities in Austria, Germany and Sweden have also reported similar cases. No cases have yet been reported in the U.S. Laboratory examinations of some of the product conducted by health authorities in the United Kingdom have confirmed the the presence of the organism. Efforts to recall the product have been initiated in the United Kingdom and other countries. FDA and the U.S. Centers for Disease Control and Prevention are working to determine whether contaminated product has been distributed in the U.S. and the extent to which it poses a public health threat in this country. In the meantime, consumers who may have this product are urged not to consume it, but to instead contact their local FDA office. ------------------------------ To: hicnews AVAILABILITY OF FERTILITY DRUGS We are receiving inquiries concerning the shortage of two fertility drugs, Pergonal and Metrodin. Both drugs are manufactured by Serono Laboratories Inc. in Switzerland. Recent decisions by Serono on the manufacture of these products have adversely affected worldwide supplies. The following may be used to answer questions about steps being taken by FDA and the manufacturer to increase the supply. Fertility drugs are used to treat certain types of infertility in women, and are often prescribed to correct a woman's hormone imbalance and stimulate ovulation. FDA is discussing with Serono how to expedite the return of these drugs to the United States market. FDA will consider an additional manufacturing facility application so that production of the drugs can be resumed. In letters issued in December l994 to health professionals and distributors, Serono said it will reserve the remaining stocks of the drugs for patients who are currently receiving treatment. If a doctor has a patient who is in midcycle and has run out of her drug supply, the doctor can request an additional supply by contacting Serono's customer service department at 1-800-283-8088. FDA approved the infertility drug Humegon manufactured by Organon Inc., of West Orange, N.J., in September l994. Organon has agreed to FDA's request to make their drug available and will release limited quantities soon. If doctors cannot obtain the necessary drugs from Serono or Organon, FDA will not object if patients working closely with their doctors temporarily import the drugs for personal use from an alternative source. Unless it is medically necessary, however, doctors should wait to begin treating new patients until the supply of approved drugs has increased. Serono's U.S. headquarters are located in Norwell, Mass. ------------------------------ To: hicnews FDA LICENSES HEPATITIS A VACCINE We have been receiving inquiries about FDA's licensure of a hepatitis A vaccine -- the first available to prevent this highly contagious viral disease. The following may be used to answer questions. More than 23,000 cases of hepatitis A were officially reported in the United States in 1992, although 100,000 to 150,000 Americans are estimated to be infected each year. Hepatitis A generally is spread by contaminated food or water and by close personal contact with an infected individual. The disease can also be contracted by consuming raw or undercooked shellfish harvested from contaminated waters. Outbreaks of hepatitis A sometimes occur in institutional settings including day-care centers and facilities that house intellectually impaired children and adults. Military personnel living in field conditions, crowded barracks and high-risk geographic areas also are at higher risk for the disease. Hepatitis A is especially prevalent in developing countries that have poor sanitary systems and standards of hygiene. The new vaccine's effectiveness was demonstrated in a clinical trial conducted in Thailand under the auspices of the U.S. Armed Forces Research Institute for Medical Sciences and the Thai government. In this study, in which more than 19,000 Thai school children were given the vaccine, the effectiveness rate of the product was 84 percent. Adverse reactions were mild and included redness, hardness and swelling at the injection site, fatigue, fever, malaise and nausea. The vaccine is indicated for international travelers, people living in or relocating to areas where the disease is endemic, some military personnel, and certain high-risk individuals such as some hospital and laboratory personnel. On Jan. 28, 1994, FDA's Vaccines and Related Biological Products Advisory Committee reviewed the safety and efficacy of the vaccine and recommended approval for use in selected groups including travelers, the military and laboratory workers. The new vaccine is manufactured by SmithKline Beecham of Philadelphia, Pa., under the trade name Havrix. The official date of licensure is Feb. 22, 1995. ------------------------------ To: hicnews TELECTRONICS PACEMAKER LEADS The Food and Drug Administration today is advising doctors and their patients with certain pacemakers to check their lead wire for a possible fracture that could result in severe heart injury or death. If the wire is found to be defective, the patients and their doctors need to consult about what medical action is needed. The faulty pacemakers are equipped with Accufix atrial "J" lead wires models 330-801 and 329-701 that were manufactured by Telectronics Pacing Systems in Englewood, Colo., and implanted in patients in the United States from 1988 to 1994. Another model, 330-812, which also has been reported as prone to fracture, was distributed only abroad. FDA is advising the doctors of the estimated 25,000 patients with these models to use fluoroscopy or similar procedures to determine whether the leads have fractured. If a fractured wire is detected, doctors can decide to replace it or leave it in place and monitor it by fluoroscope. Most fractured wires are not medical emergencies. Following reports of the fractures, Telectronics last November told hospitals to stop implanting the devices, recalled the unused products and notified FDA about the problems. Today, the manufacturer is sending a letter to doctors requesting them to contact all patients with the affected leads and advising on their best treatment. In addition, the firm plans to contact directly all users of the recalled devices. The "J" lead wire contains a coiled electric cable and a flat, 3 1/2 inch long wire that helps the lead keep its shape. When the flat wire breaks the conductivity of the lead is not affected and the pacemaker will continue to function. The flat wire, however, can protrude through its polyurethane coating and cut the heart wall or the aorta, thereby causing severe internal hemorrhage. It has not yet been determined how many of the involved wires are likely to break although preliminary estimates, based on the manufacturer's analysis, suggest a 12 percent fracture rate. As of Jan. 14, 1995, 110 confirmed or suspected fractures have been reported, resulting in two deaths and seven serious injuries. There are more than one million pacemaker patients in the United States. The "J" leads are used only with dual chamber pacemakers, although a few patients with single chamber pacemakers may have had an Accufix "J" lead implanted in case it was needed later. ------------------------------ To: hicnews FDA WARNS CONSUMERS AGAINST NATURE'S NUTRITION FORMULA ONE The Food and Drug Administration is warning consumers not to purchase or consume Nature's Nutrition Formula One products labeled as containing Ma huang (ephedrine) and kola nut because the product poses a risk to consumers' health. The products are sold by Alliance U.S.A. of Richardson, Texas. FDA has determined that the products can cause severe injury or death in some people who consume them. Nature's Nutrition Formula One is labeled as a dietary supplement and has been marketed with labeling purporting that it is useful for weight loss and energy enhancement. The potentially dangerous products can be identified by the listing of Ma huang and kola nut as ingredients and the appearance of either of the following usage statements on the label: "Adult Food Supplement Take 1 to 3 capsules at 10:00 AM & 3:00 PM," or "Adult food supplement: one to two capsules mid- morning and mid-afternoon." FDA has received more than 100 reports of injuries and adverse reactions related to the product during the past year. Reported reactions range from serious, life-threatening conditions such as irregular heartbeat, heart attack, stroke, seizures, hepatitis and psychosis, to relatively minor and temporary conditions such as dizziness, headache and gastrointestinal distress. Several deaths have been associated with the product. FDA and outside medical experts have determined that the products represent a threat to health because the combination of Ma huang, a source of ephedrine, and kola nut, a source of caffeine, can cause severe injury to people even under conditions of usual or recommended use. Ephedrine is an amphetamine-like chemical that acts as a stimulant in the body. In November 1994, FDA informed Alliance that Nature's Nutrition Formula One posed a potential health hazard and was in violation of federal laws designed to protect the public health. After inadequate response from Alliance, the agency asked the company to recall the products. Because the company to date has failed to recall its potentially dangerous products, FDA is issuing today's warning as a matter of public health protection. At this time, FDA's warning is limited to versions of Nature's Nutrition Formula One that contain both Ma huang and kola nut. The company has advised FDA that it has reformulated its product to remove the kola nut. This warning does not apply to the reformulated version of the product. The agency is continuing to evaluate the safety of ephedrine-containing products produced or distributed by Alliance U.S.A. and other companies. ------------------------------ To: hicnews RULES PROPOSED FOR SPERMICIDES FDA today published a proposed rule that would ask manufacturers of over-the-counter spermicide products to submit data demonstrating that the final formulations of the products are effective as contraceptives. The agency has already concluded that the active ingredients in marketed spermicides generally are safe, but their effectiveness in final product formulations is highly variable. Therefore, the agency is proposing that manufacturers submit new drug applications for all individual spermicide products. The following can be used to answer questions. Spermicide contraceptives are available in foam, gel, cream, film and suppository formulations. They work by forming a physical and chemical barrier to sperm in the vagina. The active ingredient in most products is nonoxynol-9; some products contain octoxynol-9. There is evidence that some formulations of spermicide products can lose effectiveness during use. For this reason FDA believes that clinical data are needed to ensure that over-the- counter spermicide products remain effective as contraceptives during actual use. Vaginal contraceptives also are sometimes associated with vaginal irritation, which may play a role in transmission of sexually transmitted diseases. Therefore the proposal asks manufacturers to collect information on the occurrence of vaginal irritation during the clinical trials on their products, and to present these data as part of the NDA. Although the proposal is not intended to cover claims for prevention of sexually transmitted diseases (STDs) including HIV, the agency strongly encourages manufacturers to evaluate products for prevention of infectious diseases. While none of these products currently has an approved indication for prevention of STDs, FDA is aware of literature reports and other data suggesting they may play a role. Separate clinical trials need to be conducted before such claims could be made for the products. Manufacturers have been asked to consult with the agency on the data requirements. Marketing status of over-the-counter spermicide products would not be immediately affected by the proposed rule. To assure continued availability of affected products after a final rule is published, FDA is encouraging manufacturers to contact the agency as soon as possible so that clinical studies can be conducted and applications approved as quickly as feasible. Products that fail to meet the requirements of the final rule would be considered unapproved new drugs and subject to regulatory action. Comments on the proposal may be sent within 120 days to Dockets Management Branch (HFA-305), Food and Drug Administration, Rm. 1-23, 12420 Parklawn Drive, Rockville, Md. 20857. ------------------------------ To: hicnews FDA AUTHORIZES TREATMENT IND FOR ADVANCED PANCREATIC CANCER úÿ úÿ(Continued from last message) FDA has authorized a treatment IND (investigational new drug) for gemcitabine HCL for patients with advanced pancreatic cancer who are not candidates for surgery. The following can be used to answer questions. FDA's treatment IND regulations offer a mechanism that allows drug developers to provide earlier and wider access to investigational therapies for patients with immediately life- threatening or otherwise serious diseases for which there is no satisfactory alternative treatment, while review of the new drug application for the same indication is completed. About 27,000 people in the United States were diagnosed with pancreatic cancer in l994. Pancreatic cancer is generally asymptomatic until late in the course of the disease. It is among the most difficult cancers to treat and is rarely curable. FDA authorized the treatment IND for gemcitabine to provide a promising treatment of locally advanced or metastatic pancreatic cancer. Patients may have had either one prior chemotherapy regimen or none. No therapies have been approved specifically for this disease. A preliminary review by FDA of two clinical trials of gemcitabine suggests that it may have some effectiveness in the treatment of this disease. The sponsor, Eli Lilly and Co. of Indianapolis, Ind., carried out two trials in patients with pancreatic cancer, one a comparison with 5 fluorouracil (5-FU) in previously untreated patients; the other a study in 5-FU failures. The studies measured tumor shrinkage, survival and an overall estimate of clinical benefit (pain and ability to function). Both studies showed a small rate of tumor shrinkage (about 7 percent); there was a small (about one and a half months) improvement in median survival in the study comparing gemcitabine with 5-FU. In both studies gemcitabine treated patients experienced an approximately 25 percent rate of clinical response. The 1 year survival rates in the comparative trial were 18 percent and 2 percent for gemcitabine and 5-FU respectively. A second phase II trial included patients who had not responded to 5-FU treatment. Symptoms improved in 27 percent of patients, with a median survival time of 3.85 months and a one year survival rate of 4 percent. A partial response rate (50 percent or greater decrease in tumor size) was observed in 7.9 percent with disease stabilization reported in 31.7 percent. The major side effects of gemcitabine included neutropenia, a decrease in white blood cells, which increases susceptibility to infection; thrombocytopenia, a decrease in blood platelets, which can cause excessive bleeding; and elevation of liver enzymes. Nausea, vomiting, rash, flu-like symptoms, breathing difficulties and traces of blood and protein in the urine have been reported. Rarely, hemolytic-uremic syndrome (anemia associated with kidney failure) was reported. The drug is manufactured under the trade name Gemzar. ------------------------------ To: hicnews FDA PESTICIDES PROGRAM FDA has been receiving inquiries about its pesticide residue monitoring program in light of a recently released report prepared by the Environmental Working Group, a public advocacy group based in Washington, D.C. The following may be used to answer questions. The FDA is committed to reducing the risks associated with pesticides for all Americans, and especially to ensuring appropriate protection for children. After reviewing portions of the report in draft and a draft executive summary, FDA believes that the draft materials reviewed include constructive recommendations for increasing public health protection against potentially harmful pesticide residues on food. Specific examples include: o controlling residue through a Hazard Analysis Critical Control Points (HACCP) approach. HACCP principles have been successfully adopted by the U.S. seafood industry, and FDA is seeking comments about extending HACCP principles to other segments of the food industry o improving record keeping o reducing use of pesticides o enhancing computer availability of EPA tolerance information. Nevertheless, other recommendations in the report -- such as the suggestion that all food shipments be sampled and tested for pesticides -- are impractical and are likely to prove unworkable. Unfortunately, the report itself exhibits two fundamental shortcomings: it overstates the incidence of illegal pesticide residues in domestic and imported foods, and it fails to represent accurately the effectiveness of the FDA's residue monitoring program. The EWG's report seems to misinterpret the complex data FDA gathers on pesticide residues. In reviewing FDA's data, the EWG has apparently interpreted every finding of both "trace" and very low level pesticide residues as intentional violations of U.S. pesticide tolerances -- the allowable levels established by the Environmental Protection Agency and enforced by FDA. This approach skews the data, inflating purported violation rates and suggesting adverse public health consequences when in fact the potential risk is extremely low or even nil. Findings of "trace" levels arise when FDA analysis of fresh or processed food shows a slight "blip" on the chromatogram, a finding that could simply represent a so-called false positive. In such cases, FDA cannot state with certainty what pesticide may be present, or even whether any pesticide is present. These trace levels are not violations of the law. If the FDA were to contemplate any regulatory action in such cases, it would have to confirm the possible trace residue with a "check analysis" -- another, separate, test performed by a different analyst. In other cases, if an extremely low level of illegal pesticide residue can be measured, FDA considers that produce sample positive and an apparent violation of the law. In affording "trace" or "apparent violation" figures the same regulatory and public health significance as clearly intentional pesticide residue violations, the EWG report does not advance the important public policy discussion of pesticide residues in food. The FDA's extensive monitoring program for pesticide residues in foods, both domestic and imported, has repeatedly demonstrated that the overall incidence of illegal pesticides in food is low: about one percent for domestically produced foods, approximately three to five percent for imported foods. These violation rates have remained consistently low for the last decade or so. FDA's pesticide monitoring shows that foods do contain low levels of pesticide residues, generally in the parts-per-billion range. These residues are nearly always well below the EPA tolerances, which are based on conservative estimates of risk. Moreover, FDA's violation rate estimates are quite consistent with those of the U.S. Department of Agriculture's Pesticide Data Program, and with those of other states. Finally, the FDA measures pesticide residues in another way besides direct sampling of food. The FDA's Total Diet Study measures the actual dietary intake of food as U.S. consumers actually eat it -- ready for the table. FDA buys "market baskets" of food around the U.S. and ships the food to one location, where it is prepared according to home recipes and then analyzed for pesticide residues. The Total Diet Study, which includes restaurant food, has consistently shown that the actual dietary intake of pesticide residues by Americans is less than one percent of the levels deemed safe by the World Health Organization. To further reduce risks from pesticides, the EPA, the USDA, and the FDA are working on the recommendations of the 1993 National Academy of Sciences report on pesticides in the diets of infants and children. By 1997, a National Pesticide Residue Database, designed to consolidate the extensive pesticide residue monitoring data from industry and government, is expected to be in place. FDA and USDA are also cooperating to organize the National Laboratory Accreditation Program, which will enhance the quality of residue data from laboratories around the country. The FDA welcomes independent review of findings from its pesticide residue monitoring program. Reports summarizing FDA's pesticide residue program are available from FDA Public Affairs (202-205-4144). The residue data on which these summaries are based are available for a fee from the National Technical Information Service (703-487-4650). ------------------------------ To: hicnews Defects Prevention Program for Reducing Risk for Neural Tube Defects -- South Carolina, 1992-1994 Neural tube defects (NTDs) are common and serious malformations that originate early in pregnancy. In the United States, approximately 4000 pregnancies each year are affected by the two most common NTDs (spina bifida and anencephaly), and an estimated 2500 infants are born with NTDs. Based on a Public Health Service (PHS) recommendation published in September 1992, at least one half of NTDs could be prevented if all women capable of becoming pregnant consumed 0.4 mg of folic acid daily during the periconceptional period (1). Women who have previously had an NTD- affected pregnancy would especially benefit from folic acid supplements (2). In 1992, with support from a CDC cooperative agreement, the South Carolina Department of Disabilities and Special Needs implemented a prevention program to reduce the incidence of folic acid-preventable NTDs in the pregnancies of women with prior NTD-affected pregnancies. This report describes surveillance findings resulting from this program during 1992- 1994. In October 1992, the NTD prevention program initiated a pilot surveillance system to monitor the occurrence of NTDs in the Piedmont Region of the state (1990 population: 1.1 million). Data about NTD cases were collected from hospital medical records, vital records, and prenatal diagnoses procedure records. In October 1993, the surveillance system was expanded statewide (1990 population: 3.5 million). During October 1992- September 1994, the surveillance system identified 105 NTD cases and 72,493 live-born infants, representing a rate of 14.5 cases per 10,000 resident live-born infants. Of the 105 women identified as having had NTD-affected pregnancies, 71 participated in a personal interview about use of folic acid- containing supplements during the periconceptional period (i.e., 1 month before conception through the third month of pregnancy). Overall, six (8%) of the 71 women reported using a folic acid-containing multivitamin supplement during the periconceptional period, including four (7%) of the 54 women who had a last menstrual period after the PHS recommendation was issued, and two (12%) of the 17 women who had a last menstrual period before the PHS recommendation was issued. Reported by: RE Stevenson, MD, JH Dean, WP Allen, MD, Greenwood Genetic Center, Greenwood; M Kelly, South Carolina Dept of Disabilities and Special Needs, Columbia. Birth Defects and Genetic Diseases Br, Div of Birth Defects and Developmental Disabilities, National Center for Environmental Health, CDC. Editorial Note: During 1980-1990, an estimated 18,000 infants were born in the United States with spina bifida; by 1990, approximately 5000 (28%) of these children had died. Annual medical and surgical costs in the United States for all persons with spina bifida exceed $200 million. For each person with typical severe spina bifida, the estimated lifetime direct and indirect costs are $250,000 (3). In 1992, PHS estimated that, if all women capable of becoming pregnant adhered to the recommendation to consume 0.4 mg of folic acid per day, the number of cases of spina bifida and anencephaly would be reduced by 50%. Consumption of a vitamin supplement containing the prescribed amount of folic acid is one method to ensure receipt of the proper dosage of folic acid. In 1992, an estimated 20% of all U.S. women were consuming a multivitamin containing 0.4 mg of folic acid (4). However, the findings in this report indicate that, among women with NTD-affected pregnancies in South Carolina who had conceived after issuance of the PHS recommendation, only 7% had consumed 0.4 mg of folic acid during the periconceptional period. In addition, among a sample of 60 women in South Carolina who had given birth to infants without NTDs during October 1992-September 1994, seven (12%) reported using folic acid-containing vitamin supplements during the periconceptional period (Greenwood Genetic Center, Greenwood, South Carolina, unpublished data, 1994). These findings suggest that overall use of folic acid-containing supplements in South Carolina is lower than the 1992 PHS estimate of use among the total population of U.S. women (4). The findings in this report underscore the need for increased efforts in South Carolina to 1) publicize the benefits and promote the use of increased folic acid consumption during the periconceptional period, 2) encourage women of childbearing age to increase their folic acid consumption, and 3) ensure that all women have the opportunity to increase their consumption of folic acid. Since promulgation of the 1992 PHS recommendation, public and private health-care and advocacy organizations in South Carolina have initiated information and education campaigns to promote consumption of folic acid among women of childbearing age. In addition, educational programs have been designed and implemented to communicate information about the protective benefits of folic acid to health professionals, public school educators, and the public. References 1. CDC. Recommendations for the use of folic acid to reduce the number of cases of spina bifida and other neural tube defects. MMWR 1992;41(no. RR-14). 2. MRC Vitamin Study Research Group. Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. Lancet 1991;338:131- 7. 3. CDC. Economic burden of spina bifida--United States, 1980-1990. MMWR 1989;38:264-7. 4. Moss AJ, Levy AS, Kim I, et al. Use of vitamin and mineral supplements in the United States: current users, types of products, and nutrients. Hyattsville, Maryland: US Department of Health and Human Services, Public Health Service, CDC, NCHS, 1989. (Advance data no. 174). ------------------------------ To: hicnews Use of Safety Belts -- Madrid, Spain, 1994 An estimated 300,000 persons die and 10-15 million persons are injured each year in traffic crashes throughout the world (1). In Spain, during 1993, motor-vehicle crashes accounted for 6378 deaths (16 per 100,000 population) and were the leading cause of death for persons aged 1-44 years and the leading cause of years of potential life lost (2). Safety belts are 40%-70% effective in preventing severe injuries and deaths associated with motor-vehicle crashes (3). In April 1975, the Traffic Safety Administration of Spain implemented a mandatory safety-belt-use law for persons who were front-seat passengers traveling outside city limits (i.e., interurban traffic). On June 15, 1992, the law was expanded to include all front- seat passengers traveling in vehicles in the city limits and passengers in the back seats of vehicles with manufacturer-installed safety belts (4). In September 1994, the Ministry of Health of Spain, in collaboration with the Traffic Safety Administration, conducted surveys to assess the impact of the expanded law. This report summarizes findings of this assessment in Madrid, including the first direct observation survey of safety-belt use by front-seat occupants and a telephone sample survey of knowledge, attitudes, and behaviors related to motor-vehicle use. Observational Survey The observational survey was conducted at five city intersections and five intersections at principal gates leading out of the city. At each site, two persons began observations by selecting the second vehicle in a stopped position and observing three consecutive vehicles per traffic light cycle. At each site, approximately 400 vehicles were observed, including approximately 100 observations (50 in each direction) during each of four time periods (weekday 8-10 a.m., weekday 7-9 p.m., weekend 8-10 a.m., and weekend 7-9 p.m.). Each front-seat occupant was counted separately. Vehicles exempted from the law (taxis and public service vehicles) were excluded. Of the 4069 total observations, 2381 (58.5% [95% confidence interval (CI)=57.0%-60.1%) of front-seat occupants were using safety belts (Table 1). The overall prevalence of use at the interurban city gates was 67.2% (range: 58.2%-80.0%) while the prevalence within the city was 50.1% (range: 43.5%-59.1%) (prevalence ratio [PR]=1.3; p less than 0.05). The prevalence of safety-belt use was greater among women than men (61.9% and 56.7% [PR=1.1; p less than 0.05]) but similar when compared by intersection, day of week, hour of day, and seat position of vehicle occupant (5,6). Telephone Survey The Madrid city residential telephone directory was used to obtain a random sample of eligible potential respondents. Interviewers obtained information from respondents aged greater than or equal to 18 years about the number of persons aged greater than or equal to 18 years at home. Of 1063 phone numbers called to identify eligible households, 294 (27.7%) could not be contacted (no one answered or the line was busy), and 185 were excluded (because either the phone number was commercial [37], or no one aged greater than or equal to 18 years was in the home at the time of the call, or respondents never traveled by vehicle [185]). Categories of safety-belt use included always, almost always, sometimes, seldom, and never. Those who reported always wearing safety belts were considered users for the analysis (7). Of the 584 eligible persons, 433 (74.1%) completed the interview (respondents); 232 (53.6%) were women. Follow-up calls were made to the 151 nonrespondents to obtain demographic information; of these, 91 (60.3%) agreed to an interview. The distribution by sex was similar among respondents and nonrespondents; however, a higher proportion of nonrespondents than respondents were aged greater than or equal to 60 years (37% compared with 21%, p less than 0.05). The prevalence of self-reported safety-belt use in interurban areas was 94.0% (95% CI=91.8%-96.2%); the prevalence in the city was 64.0% (95% CI=59.5%-68.5%) (Table 2). Age and sex were not associated with safety- belt use during interurban or city travel. Characteristics associated with increased city safety-belt use included history of motor-vehicle collision (PR=1.2 [95% CI=1.0-1.5]) and positive opinions of effectiveness. Risk factors associated with safety-belt nonuse in the city included history of previous motor-vehicle fine (e.g., speeding or running stop signals) (PR=3.7 [95% CI=1.3-10.5]) and negative opinion of the effectiveness of safety belts (PR=1.8 [95% CI=1.4-2.3]). The prevalence of safety-belt use in interurban areas was higher among respondents who reported no history of fines, who denied driving under the influence of alcohol at least once during the preceding month, and who had a positive opinion of the effectiveness of safety belts. úÿ úÿ(Continued from last message) Reported by: P Godoy, J Castell, EF Peiro, D Herrera, J Rullan, Field Epidemiology Training Program, National Center for Epidemiology, Carlos III Institute of Health, Ministry of Health and Consumer Affairs, Madrid; A Patricia, C Ibanez, M Marin, A Molejon, C Plitt, L Relano, C Ruiz, C Sanz, J Torcal, O Vazquez, F Yanez, autonomous community health depts, Spain. Field Epidemiology Training Program, Div of Field Svcs, Epidemiology Program Office; Div of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC. Editorial Note: The findings from both the direct observational and the telephone surveys described in this report suggest that persons in Madrid are less likely to use safety belts while in vehicles traveling within the city and more likely to use safety belts in interurban areas. Potential explanations for this difference are 1) the first law enacted in 1975 applied only to travel in areas outside of the city, and the intent of the expanded law of 1992 has neither been understood nor accepted by many persons; 2) a substantial proportion of persons are unaware of the risks for collision associated with the shorter distances traveled within the city; and 3) efforts to enforce the expanded law have been more vigorous in interurban areas. Direct observational surveys, such as that described in this report, provide valid estimates of safety-belt use. The telephone survey supplemented the observational survey by assessing knowledge, attitudes, and behaviors regarding safety-belt use. However, previous reports indicate that telephone surveys overestimate the use of safety belts, compared with estimates by observational surveys (5,6). In the United States, the National Highway Traffic Safety Administration has recommended the periodic use of observational probability sample surveys at the same intersections to assess changes in safety-belt use.* In 1992, the motor-vehicle collision fatality rate in Spain (4.8 motor-vehicle deaths per 100 million kilometers [62.5 million miles] traveled) ranked second in Europe after Portugal (9.0), and was substantially higher than that in other countries, including the United Kingdom (1.1), Holland (1.3), Germany (1.9), France (2.0), and the United States (1.1) (8). Factors associated with the higher rate in Spain may include the quadrupling in the estimated number of motor vehicles operating since 1970; road conditions--which are being rapidly improved but lag in comparison to some other industrialized countries in Europe; and the condition of currently operating vehicles (i.e., 38% of vehicles in use are greater than 10 years old). Findings in this study indicated that a positive attitude toward safety-belt effectiveness was most strongly associated with safety-belt use, both for city and interurban travel. In other countries, safety- belt use has increased following intense periodic campaigns combining public education about the benefits of safety-belt use and enforcement of safety-belt-use laws (9). In Spain, the Ministry of Health in collaboration with the Traffic Safety Administration will use these results in planning education programs to improve traffic safety and other projects to increase safety-belt use. References 1. Ross A, Baguley C, Hills B, McDonald M, Silcock D. Towards safer roads in developing countries: a guide for planners and engineers. Crowthorne, England: Transport and Road Research Laboratory, 1991. 2. Traffic Safety Administration. Accidents 1993 [Spanish]. In: Annual Bulletin of the Traffic Safety Administration. Madrid, Spain: Ministry of Justice and Interior, 1993. 3. Chorba TL. Assessing technologies for preventing injuries in motor vehicle crashes. Int J Technol Assess Health Care 1991;7:296-314. 4. Royal Decree 13, January 17, 1992. General regulations on vehicle traffic. State official bulletin. January 31, 1992 (no. 27). 5. CDC. Use of seat belts--DeKalb County, Georgia, 1986. MMWR 1987;36:433- 7. 6. CDC. Driver safety-belt use--Budapest, Hungary, 1993. MMWR 1993;42;939- 41. 7. Streff FM, Wagenaar AC. Are there really shortcuts? Estimating seat belt use with self-report measures. Accid Anal Prev 1989;21:509-16. 8. International Road Federation. International Road Statistics, 1989- 1993. Geneva, Switzerland: International Road Federation, 1994. 9. Dessault C. Seat belt use: the Quebec experience. In: Proceedings of the National Leadership Conference on Increasing Safety Belt Use in the United States. Washington, DC: American Coalition for Traffic Safety, National Highway Traffic Safety Administration, 1991. * 57 FR 28899-904. ------------------------------ To: hicnews Monthly Immunization Table To track progress toward achieving the goals of the Childhood Immunization Initiative (CII), CDC publishes monthly a tabular summary of the number of cases of all diseases preventable by routine childhood vaccination reported during the previous month and year-to-date (provisional data). In addition, the table compares provisional data with final data for the previous year and highlights the number of reported cases among children aged less than 5 years, who are the primary focus of CII. Data in the table are derived from CDC's National Notifiable Diseases Surveillance System. ------------------------------ To: hicnews Vaccination Coverage of 2-Year-Old Children -- United States, January-March, 1994 The Childhood Immunization Initiative (CII)* was initiated to increase vaccination coverage among 2-year-old children. The 1996 objective is to have at least 90% coverage for four of the five critical vaccines routinely recommended for children (i.e., one dose of measles-mumps-rubella vaccine [MMR] and at least three doses each of diphtheria and tetanus toxoids and pertussis vaccine [DTP], oral poliovirus vaccine, and Haemophilus influenzae type b vaccine [Hib]), and at least 70% coverage for three doses of hepatitis B vaccine (Hep B) (1). These objectives are an interim step toward the year 2000 goal of at least 90% coverage for the recommended series of vaccinations and are being monitored on an ongoing basis. This report presents national estimates of vaccination coverage among 2-year- old children derived from provisional data from the National Health Interview Survey (NHIS) for the first quarter of 1994 and compares these with the last two quarters of 1993. The NHIS, a probability sample of the civilian, noninstitutionalized U.S. population, provides quarterly data that enables calculation of national coverage estimates (2). Quarterly estimates for children aged 19- 35 months were based on sample sizes of 483 (third quarter 1993), 490 (fourth quarter 1993), and 608 (first quarter 1994). Children included in the survey during the first quarter of 1994 were born during February 1991- August 1992; their median age was 27 months. For the last two quarters in 1993, 37% of NHIS respondents used a vaccination record for reporting vaccination information; for the first quarter of 1994, the use of vaccination records increased to 52%. For the other respondents, such records were unavailable, and information was based on parental recall. Overall, 12%-16% of respondents were excluded because they either reported not knowing whether a child had received a particular vaccination or did not know the number of doses the child had received. Confidence intervals were calculated using SUDAAN. During the first quarter of 1994, vaccination coverage levels for children aged 19-35 months ranged from 89.6% for measles-containing vaccine (MCV) to 25.5% for Hep B vaccine (Table 1). Coverage for the most critical doses for the 1996 objective ranged from 70.6% ( greater than or equal to 3 doses Hib) to 89.6% (MCV). Coverage for the year 2000 goal for the combined series of four doses of DTP, three doses of polio vaccine, and one dose of MCV was 66.0%. During the last two quarters of 1993 and the first quarter of 1994, vaccination levels have remained statistically unchanged for the combined series and individual antigens with the exception of Hib and Hep B. For the first quarter of 1994, coverage with three doses of Hib vaccine increased significantly from the third quarter of 1993 to a record high of 70.6%, and Hep B coverage increased from 15.7% in the third quarter of 1993 to 25.5% during the first quarter of 1994. Reported by: Assessment Br, Div of Data Management, National Immunization Program, CDC. Editorial Note: The findings in this report document recent statistically significant increases in the national vaccination levels for Hib and Hep B. In addition, vaccination levels are near the highest ever recorded for three doses of DTP, three doses of polio vaccine, and one dose of MCV and for the combined series. Despite these improved levels of coverage, however, the findings in this report indicate that coverage levels are 3- 19 percentage points below the interim objectives for DTP, polio, and Hib. Coverage levels for Hep B vaccine are the furthest from the 1996 goal. However, because recommendations for universal Hep B vaccination of infants became effective in November 1991, only approximately half of the children in the survey were eligible for Hep B vaccine. An estimated 2 million children aged 19-35 months still need one or more doses of DTP, polio, or MMR vaccine to be completely vaccinated with the combined series of four doses of DTP, three doses of polio vaccine, and one dose of MCV. The levels for three doses of DTP, three doses of polio vaccine, one dose of MCV, and for the combined series have been constant for three quarters, suggesting that coverage levels may have plateaued. However, such data should be interpreted with caution; the larger number of children in the annual samples provides greater precision for those estimates than the quarterly samples. To achieve the interim objective for 1996, efforts to implement CII must be accelerated. In particular, as emphasized by the Standards for Pediatric Immunization Practices (3), providers should use all opportunities to vaccinate children, regardless of the reason for the visit (e.g., sick- or well-child visit)--taking advantage of missed opportunities potentially may increase coverage by 8-22 percentage points (4,5). Because health-care providers may believe coverage levels within their practices are higher than actual levels (6), CDC recommends that providers conduct coverage level assessments; information obtained from such assessments will assist providers in recognizing undervaccination in their practices and in instituting measures to increase coverage. In addition, providers should inform parents about the specific number of vaccine doses needed before age two years (11-15 doses), and parents should be encouraged to review their child's vaccination status at each visit to a health-care provider. References 1. CDC. Reported vaccine-preventable diseases--United States, 1993, and the Childhood Immunization Initiative. MMWR 1994;43:57-60. 2. Massey JT, Moore TF, Parsons VL, et al. Design and estimation for the National Health Interview Survey, 1985-94. Hyattsville, Maryland: US Department of Health and Human Services, Public Health Service, CDC, 1989. (Vital and health statistics; series 2, no. 110) 3. Ad Hoc Working Group for the Development of Standards for Immunization Practices. Standards for immunization practice. JAMA 1993;269:1817-22. 4. Dietz VJ, Stevenson J, Zell ER, Cochi S, Hadler S, Eddins D. Potential impact on vaccination coverage levels by administering vaccines simultaneously and reducing dropout rates. Archives of Pediatrics and Adolescent Medicine 1994;148:943-9. 5. CDC. Impact of missed opportunities to vaccinate preschool-aged children on vaccination coverage levels--selected U.S. sites, 1991-1992. MMWR 1994;43:709-11,717-8. 6. Bushnell C, Link DA. Private provider assessment. In: 28th National Immunization Conference proceedings. Atlanta: US Department of Health and Human Services, Public Health Service, CDC. (in press). * The purposes of CII are to 1) improve delivery of vaccines to children; 2) reduce the cost of vaccines for parents; 3) enhance awareness, partnerships, and community participation to improve vaccination coverage; 4) monitor vaccination coverage and occurrence of disease; and 5) improve vaccines and their use. ------------------------------ To: hicnews Serogroup B Meningococcal Disease -- Oregon, 1994 In Oregon, the incidence of meningococcal disease has increased substantially, more than doubling from 2.2 cases per 100,000 persons in 1992 to 4.6 per 100,000 in 1994--the highest incidence in Oregon since 1943. This incidence was almost fivefold higher than recent estimates for the United States during 1989-1991 (approximately one case per 100,000 persons annually) (1). This report describes meningococcal disease surveillance data from 1994 and summarizes epidemiologic and laboratory data on serogroup B meningococcal disease in Oregon during 1987-1994. During 1994, a total of 143 cases of meningococcal disease was reported to the State Health Division. In 124 cases, Neisseria meningitidis was isolated from a normally sterile site (confirmed cases); in four cases, gram-negative diplococci were detected in specimens obtained from a normally sterile site or in persons who had classic symptoms after contact with a confirmed case (presumed cases). Characteristic symptoms (including petechial rash and hypotension) occurred in 14 cases; however, these cases were not culture confirmed (suspected cases). Of 115 isolates for which serogroup was known, 70 (61%) were serogroup B, 40 (35%) were serogroup C, four were serogroup Y, and one was serogroup W-135. When compared with 1992 and 1993, the serogroup-specific incidence in 1994 was higher for both serogroups B and C. Of the 70 culture-confirmed cases of serogroup B infection, 34 (49%) occurred in females. Seven (10%) cases were fatal; of these, one occurred in a child aged 2 years, and four deaths occurred in persons aged 55-88 years. During 1987-1992, 63% (84 of 133) of cases of serogroup B occurred in children aged less than 5 years; in comparison, in 1994, 27% (19 of 70) occurred in this age group. When compared with 1987-1992, the incidence of reported serogroup B disease in 1994 increased modestly among those aged less than 5 years (from 6.9 to 8.4), approximately 14-fold among those aged 15-19 years (from 0.4 to 5.4), and approximately fourfold among those aged greater than or equal to 60 years (from 0.3 to 1.1) (Figure 1). In 1994, serogroup B cases occurred in 17 of the 36 counties in Oregon; these counties account for 83% of the total population of Oregon. The risk for disease was highest in counties in the Willamette Valley in the northwestern part of the state. Based on investigation of serogroup B cases, six (9%) were linked to other cases. Two co-primary cases (disease in a close contact within 24 hours of disease onset in a primary case) were linked to a single primary case. Four secondary cases (disease in a close contact greater than 24 hours after disease onset in a primary case) were identified; at least two occurred in patients for whom appropriate chemoprophylaxis had been prescribed but who were noncompliant with therapy. Of the 114 N. meningitidis serogroup B strains isolated in Oregon during 1993-1994, a total of 64 (56%) has been characterized at CDC by multilocus enzyme electrophoresis. Of these, 55 (86%) belong to the enzyme type-5 (ET-5) complex, a group of genetically related serogroup B meningococcal strains associated with epidemic meningococcal disease in other countries (2). Twelve of these isolates also have been serotyped, serosubtyped, and immunotyped; all are serotype 4 or 15, serosubtype P1.7,16, and immunotype L3,7,9,8,10. Reported by: K Hedberg, MD, F Hoesly, MD, D Fleming, MD, State Epidemiologist, State Health Div, Oregon Dept of Human Resources. K Steingart, MD, Southwest Washington Health District; M Goldoft, MD, P Stehr-Green, DrPH, State Epidemiologist, Washington Dept of Health. Div of Field Epidemiology, Epidemiology Program Office; Childhood and Respiratory Diseases Br, Div of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, CDC. Editorial Note: The recent increased occurrence of serogroup B meningococcal disease in Oregon has been associated with a group of closely related strains belonging to the ET-5 clonal complex. These strains were first identified as the cause of a serogroup B meningococcal epidemic in Norway that began in 1974 and persisted through 1991 (3). After its identification in 1974, serogroup B meningococci belonging to the ET-5 complex subsequently caused epidemics in Europe, Cuba, and South America (2). Endemic meningococcal disease typically is caused by a heterogeneous mix of strains. In comparison, the predominance of closely related strains, or clones, in Oregon is characteristic of epidemic disease, as is the disproportionate increase in age-specific incidence among young adults. The latter pattern has been suggested as a reliable predictor of the transition from endemic to epidemic meningococcal disease (4,5). Although serogroup C meningococcal outbreaks have occurred with increasing frequency nationwide since 1991 (6), Oregon is the only state to report substantially increased rates of serogroup B meningococcal disease. While Washington state had only a slight increase in the overall rate of meningococcal disease in 1994, rates of serogroup B meningococcal disease in Clark County, Washington (1994 population: 280,800) (across the Columbia River from metropolitan Portland, Oregon), have increased almost fivefold (from 1.5 per 100,000 in 1987 to 7.1 per 100,000 in 1994). These increasing rates underscore the need for determining the serogroup of all isolates to assist in assessing trends in the occurrence of meningococcal disease and serogroup distribution of invasive N. meningitidis in other states. The primary means for the control and prevention of serogroup B meningococcal disease is chemoprophylaxis of close contacts. The meningococcal vaccine licensed in the United States provides protection against serogroups A, C, Y, and W-135 but does not provide protection against serogroup B meningococcal disease. Meningococcal capsular polysaccharides determine serogroup and are used in purified form to produce the A/C/Y/W-135 vaccine. Unlike the other major meningococcal serogroups, however, serogroup B capsular polysaccharide is poorly immunogenic in humans. Alternate approaches to the development of a serogroup B meningococcal vaccine have focused on use of outer-membrane proteins from specific epidemic serogroup B meningococcal strains. Three outer-membrane protein-based serogroup B meningococcal vaccines employing two-dose regimens have been effective among older children and young adults in large clinical trials outside the United States (7-9); estimated efficacies ranged from 57% to 83%. The only vaccine available commercially is not licensed for use in the United States but has been used in some South American countries to control serogroup B meningococcal epidemics. In Sao Paulo, Brazil, approximately 2.4 million children aged úÿ úÿ(Continued from last message) 3 months to 6 years were vaccinated during 1989 and 1990, and the vaccine was estimated to be 74% effective in children aged 4-6 years (10). Efforts to initiate studies in the United States to evaluate available vaccines under an investigational new drug application are in progress. Oregon and three other states (California, Connecticut, and Minnesota) are participating in a cooperative agreement with CDC to study emerging infectious diseases. One focus of this program in Oregon is disease caused by N. meningitidis serogroup B; a study of potentially modifiable risk factors for meningococcal disease is under way. References 1. Jackson LA, Wenger JD, Meningococcal Disease Study Group. Laboratory-based surveillance for meningococcal disease in selected areas, United States--1989-1991. In: CDC surveillance summaries (June). MMWR 1993;42(no. SS-2):21-30. 2. Caugant DA, Froholm LO, Bovre K, et al. Intercontinental spread of a genetically distinctive complex of clones of Neisseria meningitidis causing epidemic disease. Proc Natl Acad Sci U S A 1986;83:4927-31. 3. Lystad A, Aasen S. The epidemiology of meningococcal disease in Norway, 1975-91. NIPH Ann 1991;14:57-66. 4. Peltola H, Kataja JM, Makela PH. Shift in the age-distribution of meningococcal disease as predictor of an epidemic? Lancet 1982;2:595-7. 5. Jones DM, Mallard RH. Age incidence of meningococcal infection England and Wales, 1984-1991. J Infect 1993;27:83-8. 6. Jackson LA, Schuchat A, Reeves MW, Wenger JD. Serogroup C meningococcal outbreaks in the United States: an emerging threat. JAMA 1995;273:383- 94. 7. Sierra GVG, Campa HC, Varcacel NM, et al. Vaccine against group B Neisseria meningitidis: protection trial and mass vaccination results in Cuba. NIPH Ann 1991;14:195-207. 8. Bjune G, Hoiby EA, Gronnesby JK, et al. Effect of outer membrane vesicle vaccine against group B meningococcal disease in Norway. Lancet 1991;338:1093-6. 9. Boslego JB, Garcia J, Cruz C, et al. Efficacy, safety, and immunogenicity of a meningococcal group B (15:P1.3) outer membrane protein vaccine in Iquique, Chile. Vaccine 1995 (in press). 10. de Moraes JC, Perkins BA, Camargo MCC, et al. Protective efficacy of a serogroup B meningococcal vaccine in Sao Paulo, Brazil. Lancet 1992;340:1074-8. ------------------------------ End of HICNet Medical News Digest V08 Issue #05 *********************************************** --- Editor, HICNet Medical Newsletter Internet: david@stat.com FAX: +1 (602) 451-1165 Bitnet : ATW1H@ASUACAD