HICNet Medical News Digest Mon, 01 May 1995 Volume 08 : Issue 18 Today's Topics: [MMWR] Progress Toward Global Poliomyelitis Eradication, 1985-1994 [MMWR] Increasing Incidence of Gonorrhea -- Minnesota, 1994 [MMWR] Adult Blood Lead Epidemiology and Surveillance -- US 4th Qtr [MMWR] Notifiable Diseases/Deaths in Selected Cities Weekly Information Remarks by David A. Kessler, M.D., Commissioner of Food and Drugs at FDLI Annual Meeting (Dec. 13, 1994) +------------------------------------------------+ ! ! ! 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/ln/MEDNEWS/ Compilation Copyright 1995 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 1994 Progress Toward Global Poliomyelitis Eradication, 1985-1994 =========================================================== SOURCE: MMWR 44(14);273-275,281 DATE: Apr 14, 1995 In 1985, the Pan American Health Organization (PAHO) established as a goal the elimination of poliomyelitis from the Western Hemisphere by 1990; the last confirmed case of paralytic polio caused by wild poliovirus occurred in 1991 in Peru (1). In 1988, the World Health Assembly established the objective of global polio eradication by the year 2000 (2). Substantial progress toward this goal has resulted from the use of four strategies recommended by the World Health Organization (WHO): 1) maintenance of high vaccination coverage levels among children with at least three doses of oral poliovirus vaccine (OPV); 2) development of sensitive systems of epidemiologic and laboratory surveillance, including use of the standard WHO case definition * ; 3) administration of supplementary doses of OPV to all young children (usually those aged less than 5 years) during National Immunization Days (NIDs) to rapidly interrupt poliovirus transmission; and 4) "mopping-up" vaccination campaigns -- localized campaigns targeted at high-risk areas where wild poliovirus transmission is most likely to persist at low levels (3). This report summarizes progress toward global polio eradication from 1985 through 1994 based on data submitted to WHO as of March 20, 1995. Worldwide. From 1985 through 1990, routine vaccination coverage levels increased from 47% to 85% and stabilized at 80%-81% during 1991-1994 (|Figure_1b|). From 1985 through 1994, the number of cases reported annually decreased 84%, from 39,361 to 6241 (|Figure_1b|). The number of countries reporting polio cases decreased steadily, from 1985 (99 {51%} of 196) to 1988 (88 {45%} of 196) and 1994 (51 {24%} of 214) (|Figure_2b|). In addition, the number of countries reporting zero polio cases increased from 1985 (84 {43%}) to 1988 (104 {53%}) and 1994 (145 {68%}) ***. The number of countries with endemic polio that conducted NIDs each year increased from 15 in 1988 to 37 as of April 14, 1995; 24 additional countries have scheduled their first NIDs for later in 1995. A total of 94 countries have implemented surveillance for acute flaccid paralysis (AFP) to detect all cases of polio that meet the standard WHO case definition and to monitor the circulation of wild polioviruses. WHO has certified 12 regional reference laboratories and 60 national laboratories as members of the Global Polio Laboratory Network and has designated six geographic areas as emerging polio-free zones ****: the Western Hemisphere, Western and Central Europe, North Africa, Southern and Eastern Africa, the Middle East, and the Western Pacific. African Region. Polio remains endemic in most countries of West and Central Africa. In 1994, a total of 448 cases were provisionally reported from 20 countries, a decrease of 73% from 1993 (1636 cases) and 98% from 1988 (4564 cases); 12 countries have not yet reported to WHO for 1994; seven countries did not report in 1993. The number of countries reporting zero polio cases increased from eight in 1988 to 16 in 1994; most are island nations or located in southern Africa. Region of the Americas. The last case of indigenous polio in the Americas was reported from Peru in 1991. In September 1994, an international commission convened by PAHO certified that indigenous transmission of wild poliovirus had been interrupted in the Americas (1). Eastern Mediterranean Region. From 1988 through 1994, reported cases of polio decreased 58%, from 2342 to 973. In 1994, the 520 cases reported in Pakistan accounted for 53% of the regional total, although the number of cases within Pakistan declined 71% from 1993 (1803 cases). Pakistan conducted its first NIDs in April and May 1994. Coordinated NIDs are scheduled to be held during March-May 1995 in seven countries (Afghanistan, Iran, Iraq, Jordan, Lebanon, Pakistan, and Syria) and in Gaza, Jericho, and the West Bank (4). These countries reported 669 (69%) of the 973 cases reported in the region during 1994 (4). European Region. The number of reported polio cases in the region has been stable during the 1990s: during 1994, a total of 211 cases were reported, compared with 202 cases in 1993 and 204 cases in 1988. NIDs are scheduled to be held during March-May 1995 in 10 countries (Armenia, Azerbaijan, Bulgaria, Georgia, Kazakhstan, Kyrgyzstan, Tajikistan, Turkey, Turkmenistan, and Uzbekistan) (4). These countries accounted for 200 (95%) of the 211 cases reported in the region during 1994. Southeast Asian Region. From 1988 through 1994, the number of reported cases of polio decreased 84%, from 25,711 to 4184. The number of cases reported in India in 1994 (3867 cases) accounted for 93% of the regional total and 62% of the global total. Western Pacific Region. From 1988 through 1994, the number of reported polio cases decreased 80%, from 2126 to 425. In 1994, polio was reported by five of 35 countries in the region (Cambodia, People's Republic of China, the Lao People's Democratic Republic, Philippines, and Vietnam). The number of cases reported by China (158 cases) was a 71% decrease from 1993 (538 cases) and a 97% decrease from 1990 (5065 cases); WHO-recommended strategies for polio eradication were implemented in China in 1991. Reported by: Expanded Program on Immunization, Global Program for Vaccines and Immunization, World Health Organization, Geneva. International Health Program Office; Div of Viral and Rickettsial Diseases, National Center for Infectious Diseases; Polio Eradication Activity, National Immunization Program, CDC. Editorial Note: Major achievements in the coordinated global campaign to eradicate polio include the substantial reduction in the global incidence of paralytic polio, the complete elimination of polio from the Region of the Americas, and the widespread implementation of NIDs and other WHO-recommended strategies. In particular, the number of reported cases declined dramatically in countries that conducted NIDs in late 1993 or the first half of 1994 (including China, Pakistan, Sudan, and Vietnam). In addition, during March-May 1995, coordinated NIDs targeting 56 million children aged less than 5 years will be conducted in 18 contiguous countries in Europe, Central and South Asia, and the Middle East (4). The implementation of AFP surveillance is a critical element of WHO's eradication strategies. Eradication of disease requires a surveillance system that can detect a single case. Polio-endemic countries have implemented a system in which any AFP case in a person aged less than 15 years is reported as a suspected polio case. Two stool specimens are collected from each suspected case-patient at an interval of 24-48 hours to determine the presence of poliovirus; however, the standard WHO case definition permits an AFP case to be confirmed as polio if it meets any of four criteria, including the isolation of poliovirus from a stool specimen. Accurate and timely surveillance information about wild poliovirus transmission enables the targeting of supplementary vaccination activities toward remaining known reservoirs of poliovirus through intensive, localized vaccination campaigns (i.e., mopping-up vaccination). AFP surveillance also is being used to certify eradication at the national, regional, and global levels. In 1994, the contiguous countries of Bangladesh, India, and Pakistan accounted for 73% of the global total of polio cases. Since 1988, importation of wild poliovirus from these polio-endemic countries of Southeast Asia has accounted for many of the outbreaks or sporadic cases of polio in previously polio-free countries of Europe, the Middle East, and North America. Because Southeast Asia remains a major global reservoir of polioviruses, full implementation of the WHO-recommended polio eradication strategies in these countries is a high priority. The global eradication of polio by the year 2000 will require that all polio-endemic countries implement NIDs and other WHO-recommended strategies by 1997. Implementation of these strategies is especially important in the African Region, which has the largest number of countries not reporting polio surveillance data; the African Regional Office of WHO is assisting countries in strengthening polio surveillance and planning for NIDs. Although global routine vaccination coverage levels remained stable during 1990-1994, reported polio cases declined substantially, largely because of an increase in the number of countries conducting NIDs. Despite substantial progress toward global eradication of polio, several challenges remain, including 1) increasing vaccination levels in unvaccinated subpopulations; 2) preventing the reintroduction of wild poliovirus into polio-free areas by eliminating reservoirs in polio-endemic countries (particularly in the Indian subcontinent); 3) increasing the awareness of donor agencies and governments in industrialized countries of the substantial financial and humanitarian benefits of global eradication of polio, thus engendering support from unaffected countries beyond that already provided by organizations such as Rotary International; 4) encouraging all countries that remain polio-endemic to make polio eradication a priority activity, including the implementation of NIDs and the initiation of AFP surveillance; and 5) providing support to vaccination program managers for training to develop managerial skills for implementing and maintaining effective vaccination and surveillance programs in all countries. The success of the polio eradication initiative will depend on finding solutions to these financial, managerial, political, and technical challenges. References 1. CDC. Certification of poliomyelitis eradication -- the Americas, 1994. MMWR 1994;43:720-2. 2. World Health Assembly. Global eradication of poliomyelitis by the year 2000. Geneva: World Health Organization, January 1995. 3. Hull HF, Ward NA, Milstien JB, de Quadros C. Paralytic poliomyelitis: seasoned strategies, disappearing disease. Lancet 1994;343:1331-7. 4. CDC. Mass vaccination with oral poliovirus vaccine -- Asia and Europe, 1995. MMWR 1995;44:234-6. * A confirmed case of polio is defined as acute flaccid paralysis (AFP) and at least one of the following: 1) laboratory-confirmed wild poliovirus infection, 2) residual paralysis at 60 days, 3) death, or 4) no follow-up investigation at 60 days. Mass campaigns over a short period (days to weeks) in which two doses of OPV are administered to all children in the target age group, regardless of prior vaccination history, with an interval of 4-6 weeks between doses. * The difference between the number of countries reporting polio cases or zero cases and the total number of countries reflects those not submitting reports. ** Geographic areas where wild poliovirus either has disappeared or is at such a low level that eradication could be rapidly achieved. ------------------------------ To: hicnews Increasing Incidence of Gonorrhea -- Minnesota, 1994 ==================================================== SOURCE: MMWR 44(14);282-286 DATE: Apr 14, 1995 In the United States, gonorrhea is an important cause of urethritis in men and cervicitis in women; reproductive complications include infertility and ectopic pregnancy. During 1981-1993, the annual incidence rate of gonorrhea in Minnesota declined; the average annual change in the rate of infection was - 8.5% (|Figure_1c|). However, in 1994, the incidence rate increased 32% (from 56 cases per 100,000 persons in 1993 to 74 cases per 100,000 in 1994). No corresponding increases occurred in rates of other reportable sexually transmitted diseases (STDs), including chlamydial infection and early syphilis. To elucidate possible explanations for the increased rate of gonorrhea in Minnesota in 1994, the Minnesota Department of Health (MDH) analyzed surveillance data for 1994 and compared it with data for 1993. This report presents the findings of the analysis. In 1994, a total of 3346 gonorrhea cases * were reported to MDH, compared with 2543 cases in 1993. From 1993 to 1994, the incidence rate of gonorrhea increased at least 30% in Minneapolis and St. Paul and in the remainder of the seven-county Minneapolis-St. Paul metropolitan area; in rural areas of the state, the rate increased 17% but remained low (i.e., less than 10 cases per 100,000) (|Table_1c|). Six urban zip code areas accounted for 49% of all gonorrhea cases but represented only 5% of the state's population. From 1993 to 1994, the rate of gonorrhea in Minnesota increased 14%-44% for all racial/ethnic groups; the rate was highest for non-Hispanic blacks (|Table_1c|). Sex-specific rates increased approximately 30% and were similar for men and women. Age-specific rates increased 20%-86% for all age groups except 10- 14-year-olds; rates were highest among adolescents (i.e., 15- 19-year-olds). From 1993 to 1994, the increase in reported cases varied by reporting source. During this period, the number of gonorrhea cases reported by STD clinics increased 28% (from 1120 to 1430, respectively) and by all other sources increased 34% (from 1423 to 1916, respectively). In addition, the related increase in positive cultures for gonorrhea varied by laboratory testing source. At the two STD clinics in Minneapolis and St. Paul that accounted for most (43%) cases during 1993 and 1994, all clients were tested for gonorrhea. These clinics submitted 18,032 culture specimens to the Minnesota Public Health Laboratory (MPHL) in 1994. Although specimen collection, handling procedures, and volume of tests were unchanged at the two clinics, the percentage of cultures in 1994 that were positive for Neisseria gonorrhoeae increased 24% (from 6.7% to 8.3%) and 28% (from 6.0% to 7.7%). Of the five clinics that each submitted greater than or equal to 1500 gonorrhea cultures to the MPHL in 1994, the proportion of positive cultures increased substantially for only one clinic. For 16 private and hospital-based laboratories, the proportion of all tests (i.e., culture and nonculture) that were positive increased from 1.7% (409 of 24,531) during the fourth quarter of 1993 to 1.9% (491 of 26,231) during the fourth quarter of 1994. From 1993 to 1994, the proportion of gonorrhea patients who were interviewed by health department staff (30%) to identify and treat sex partners remained constant. Testing for antimicrobial resistance was performed on every fourth N. gonorrhoeae isolate identified at the MPHL; in 1994, a total of 433 isolates were tested. All were susceptible to ceftriaxone and ciprofloxacin, two of the recommended therapies for gonorrhea (1). Reported by: EA Belongia, MD, J Besser-Wiek, J DeBoer, KL MacDonald, MD, MT Osterholm, PhD, State Epidemiologist, Minnesota Dept of Health; K Henry, MD, St. Paul Public Health, St. Paul; M Simpson, MD, Hennepin County Medical Center, Minneapolis. Epidemiology Research Br, and Surveillance and Information System Br, Div of Sexually Transmitted Diseases and HIV Prevention, National Center for Prevention Svcs, CDC. Editorial Note: Gonorrhea is a major cause of pelvic inflammatory disease and may play a role as a cofactor in human immunodeficiency virus transmission (2,3). During 1975-1993, the rate of reported gonorrhea decreased 65% in the United States, from a peak of 467.7 cases per 100,000 persons to 165.8 per 100,000 (4). Despite the decline, gonorrhea rates in the United States remain the highest úÿ among developed countries (5). The surveillance findings in Minnesota probably reflect a real increase in the incidence of gonorrhea because reported cases increased in all age and race groups without apparent change in program activities, reporting practices, or laboratory procedures. In addition, the proportion of positive cultures increased at the MPHL. Rates remained highest for adolescents, non-Hispanic blacks, and residents of urban areas. National surveillance data also indicate high incidence in these groups (4). Adolescents and young adults are at increased risk for gonorrhea because they are more likely to have multiple sex partners, to have unprotected sex, and to select partners at increased risk (6). In 1993, 81% of the total reported cases of gonorrhea in the United States occurred among blacks (4); although explanations for the high rates among blacks are undetermined, race may be a marker strongly associated with risk factors for STDs, such as low socioeconomic status, access to health care, health-care seeking behavior, illicit drug use, and residence in communities with high prevalences of STDs. In Minnesota, the concentration of gonorrhea cases in some zip code areas suggests the disease is highly focal, and intervention should be targeted geographically. Preliminary national surveillance data suggest that rates of gonorrhea may have increased in other states during 1994. Following the implementation of national gonorrhea screening programs in 1975, the national incidence of gonorrhea had decreased every year except two (1978 and 1985) (4). From 1990 to 1993, the national incidence decreased an average of 14.4% annually. However, during the first three quarters of 1994, the rate decreased only 0.9% compared with the same period in 1993. Of the 35 states reporting greater than or equal to 1000 gonorrhea cases annually, 18 states (including Minnesota) reported an increase during the first three quarters of 1994 (|Figure_2c|); only three states reported increases in 1992 and 1993. The increases in reported cases in many states may reflect stabilization or slowing of the long-term decline in gonorrhea in the United States. Although sporadic cases of fluoroquinolone resistance have been reported, there is no evidence of widespread clinical resistance in the United States to currently recommended gonorrhea therapies (7); therefore, treatment failure probably is not a cause of the slowing decline in rates of gonorrhea. In response to the recent increased incidence of gonorrhea in Minnesota, MDH is collecting standardized information from a sample of patients with STDs to assess demographic, behavioral, and geographic factors contributing to transmission. Other state health departments, especially those in areas with increasing rates in 1994, should assess trends in the occurrence of gonorrhea in local areas and communities with an emphasis on groups that have traditionally been at highest risk for gonorrhea. References 1. CDC. 1993 Sexually transmitted diseases treatment guidelines. MMWR 1993;42(no. RR-14). 2. Laga M, Manoka A, Kivuvu M, et al. Non-ulcerative sexually transmitted diseases as risk factors for HIV-1 transmission in women: results from a cohort study. AIDS 1993;7:95-102. 3. Wasserheit JN. Epidemiological synergy: interrelationships between human immunodeficiency virus infection and other sexually transmitted diseases. Sex Transm Dis 1992; 19:61-77. 4. CDC. Sexually transmitted disease surveillance, 1993. Atlanta: US Department of Health and Human Services, Public Health Service, CDC, December 1994. 5. Piot P, Islam MQ. Sexually transmitted diseases in the 1990s: global epidemiology and challenges for control. Sex Transm Dis 1994;21(suppl 2):S7-S13. 6. CDC. Premarital sexual experience among adolescent women -- United States, 1970-1988. MMWR 1991;39:929-32. 7. CDC. Decreased susceptibility of Neisseria gonorrhoeae to fluoroquinolones -- Ohio and Hawaii, 1992-1994. MMWR 1994;43:325-7. * A written report of gonorrhea submitted by a physician and confirmed by a positive laboratory test for Neisseria gonorrhoeae. ------------------------------ To: hicnews Qtr Adult Blood Lead Epidemiology and Surveillance -- United States, Fourth Quarter 1994 ================================================================ SOURCE: MMWR 44(14);286-287 DATE: Apr 14, 1995 CDC's National Institute for Occupational Safety and Health (NIOSH) Adult Blood Lead Epidemiology and Surveillance (ABLES) program monitors elevated blood lead levels (BLLs) in adults in the United States. Blood lead data from laboratory reports are transmitted to state-based lead surveillance programs and are compiled by NIOSH for quarterly reporting (1). The total number of elevated blood lead reports for 1994 increased 4% over 1993; this increase is attributed to the participation of two additional states (North Carolina and Oklahoma) (|Table_1d|). The number of reports in 1994 increased 5% at lower BLLs (25-39 ug/dL and 40-49 ug/dL) and decreased 18% at higher BLLs (50-59 ug/dL and greater than or equal to 60 ug/dL), compared with the number of reports in 1993. Since 1988, the number of states with legislation requiring laboratories and physicians to report elevated BLLs in adults to state health departments has increased from four to 32. As of this report, 22 of these 32 states contribute to quarterly national reporting; 10 others are developing their capacity to report. Aggregation of state-specific data began in 1992 with 12 states providing quarterly data (4). ABLES data have improved understanding of the magnitude of this public health problem; identified workplace-specific clusters of overexposures to lead; and resulted in follow-up investigations leading to either remedial activities by employers (5), identification of new sources of exposures (6-8), or enforcement actions by the Oc-cupational Safety and Health Administration (9). Reported by: JP Lofgren, MD, Alabama Dept of Public Health. C Fowler, MS, Arizona Dept of Health Svcs. S Payne, MA, Occupational Lead Poisoning Prevention Program, California Dept of Health Svcs. BC Jung, MPH, Connecticut Dept of Public Health and Addiction Svcs. M Lehnherr, Occupational Disease Registry, Div of Epidemiologic Studies, Illinois Dept of Public Health. R Gergely, Iowa Dept of Public Health. E Keyvan-Larijani, MD, Lead Poisoning Prevention Program, Maryland Dept of the Environment. R Rabin, MSPH, Div of Occupational Hygiene, Massachusetts Dept of Labor and Industries. A Carr, MBA, Bur of Child and Family Svcs, Michigan Dept of Public Health. L Thistle-Elliott, MEd, Div of Public Health Svcs, New Hampshire State Dept of Health and Human Svcs. B Gerwel, MD, Occupational Disease Prevention Project, New Jersey State Dept of Health. R Stone, PhD, New York State Dept of Health. S Randolph, MSN, North Carolina Dept of Environment, Health, and Natural Resources. E Rhoades, MD, Oklahoma State Dept of Health. M Barnett, MS, State Health Div, Oregon Dept of Human Resources. J Gostin, MS, Occupational Health Program, Div of Environmental Health, Pennsylvania Dept of Health. R Marino, MD, Div of Health Hazard Evaluations, South Carolina Dept of Health and Environmental Control. D Perrotta, PhD, Bur of Epidemiology, Texas Dept of Health. D Beaudoin, MD, Bur of Epidemiology, Utah Dept of Health. L Toof, Div of Epidemiology and Health Promotion, Vermont Dept of Health. J Kaufman, MD, Washington State Dept of Labor and Industries. V Ingram-Stewart, MPH, Wisconsin Dept of Health and Social Svcs. Div of Surveillance, Hazard Evaluations, and Field Studies, National Institute for Occupational Safety and Health, CDC. References 1. CDC. Surveillance of elevated blood lead levels among adults -- United States, 1992. MMWR 1992;41:285-8. 2. CDC. Adult blood lead epidemiology and surveillance -- United States, fourth quarter, 1993. MMWR 1994;43:246-7. 3. CDC. Adult blood lead epidemiology and surveillance -- United States, 1992-1994. MMWR 1994;43:483-5. 4. CDC. Elevated blood lead levels in adults -- United States, second quarter, 1992. MMWR 1992;41:715-6. 5. CDC. Control of excessive lead exposure in radiator repair workers. MMWR 1991;40:139-41. 6. CDC. Lead intoxication associated with chewing plastic wire coating -- Ohio. MMWR 1993; 42:465-7. 7. CDC. Lead poisoning among sandblasting workers -- Galveston, Texas, March 1994. MMWR 1995;44:44-5. 8. CDC. Controlling lead toxicity in bridge workers -- Connecticut, 1991-1994. MMWR 1995;44: 76-9. 9. CDC. Lead poisoning among battery reclamation workers -- Alabama, 1991. MMWR 1992; 41:301-4. ------------------------------ To: hicnews Information Notifiable Diseases/Deaths in Selected Cities Weekly Information ================================================================ SOURCE: MMWR 44(14);276-280 DATE: Apr 14, 1995 (|Figure_Ie|) Notifiable Disease Reports, Comparison of 4-week Totals Ending April 8, 1995, with Historical Data -- United States (|Table_Ie|) Summary -- Cases of Selected Notifiable Diseases, United States, for the Weeks Ending April 8, 1995 and April 9, 1994 (|Table_IIe|) Notifiable Diseases of Low Frequency, Cumulatives for the Year 1995 (|Table_IIIe|) Cases of Selected Notifiable Diseases, United States, by Reporting Area, for the Weeks Ending April 8, 1995 and April 9, 1994 (|Table_IVe|) Deaths in 121 U.S. Cities, Week Ending April 8, 1995 (14th Week) ------------------------------ To: hicnews Drugs at FDLI Annual Meeting (Dec. 13, 1994) 0100000@conciliator.acsu.buffalo.edu> Remarks by David A. Kessler, M.D., Commissioner of Food and Drugs FDLI Annual Meeting Washington, D.C. December 13, 1994 NOTE: THIS TEXT IS THE BASIS FOR COMMISSIONER KESSLER'S ORAL REMARKS. IT SHOULD BE READ WITH THE UNDERSTANDING THAT SOME MATERIAL MAY HAVE BEEN ADDED OR OMITTED DURING THE PRESENTATION. Editor's note: To preserve the flow of the speech, text indicators of slides used during the presentation were saved (ie: Slide 1). Good morning. I'm here today to focus on the workings of FDA. I'm going to focus on things that I believe are vital to the Agency's future but which, for the most part, often haven't received widespread visibility. I am going to give you a lot of details, show you a lot of numbers, a lot of slides. At the risk of being a little long, I hope the information I convey this morning leads to a better understanding of this vitally important Agency. Five FDLI speeches ago I stood before you and set forth my initial agenda for the Food and Drug Administration. On that cold December morning, I acknowledged that my first priority was the most difficult to discuss. It was difficult because I knew then, as I know now, that the commitment of FDA employees to their Agency is unmatched anywhere. My first priority upon arriving at the FDA in December 1990 was to rebuild the Agency's credibility after the generic drug scandal. This is what I said: "The most important thing we can do to rebuild the credibility of the Agency is to ensure the integrity of its processes." Today I want to take a moment to tell you something about the integrity of this Agency and its employees. Over the past two years, six FDA field staff have been offered bribes for special treatment. The products involved ranged from spices and seafood to surgical instruments and foodstuffs. Six attempted bribes. Six different FDA field employees. One attempt on the West coast, five on the East coast. In every case, the FDA people did what our bribery awareness training had taught them: They reported the criminal activity to the appropriate authorities and cooperated with the Inspector General's Office. In subsequent meetings with those who offered the bribes, each employee pretended to accept the bribe. As a result, I can tell you today that seven arrests have been made. Three of those arrested have pleaded guilty, the other four cases are still pending. The exemplary performance of these six employees speaks for itself. Make no mistake, these individuals, who put their own safety at risk, are heroes in the eyes of this Agency. Let me move on to the focus of my remarks today: some of the work we have done over the last year, and some of what we plan to do in 1995. And I need to underscore that I am going to be talking about only some, not all. A good place to begin is the Prescription Drug User Fee Act of 1992 -- what has come to be known as PDUFA. As many of you know, the Act authorizes the Agency to use fees collected from the pharmaceutical industry to expedite review of applications for new drugs and biologics. There has been a tremendous push at FDA to get this program up and running. Today I want to show you some of the progress we have seen so far. Perhaps the most important early goal of PDUFA is elimination of the user-fee defined backlog. (slide 1) The Agency committed to clearing a backlog of 696 overdue drug and biologic submissions by July 2, 1995 -- about six and a half months from today. As of November 30, 1994, only 9 of those 696 remain. We are way ahead of schedule. We will meet this goal. When it comes to new applications for NDAs, PLAs and ELAs, or applications for manufacturing supplements, the performance goals are set for twelve months or six months respectively after the submissions are received and filed by FDA. As a result, we cannot yet accurately measure our review performance for applications received in fiscal year 1994. However, we now have performance figures for new applications and manufacturing supplements filed in fiscal year 1993. (slide 2) A second PDUFA goal is to have 55% of NDAs, PLAs, and ELAs received in fiscal year 1994 reviewed in 12 months. We won't be able to analyze how we've done on the FY 94 cohort until 12 months after the last application is submitted -- probably Fall 1995. So the FY 1994 cohort is still work in progress. But as you can see on this slide, if you look at the applications that came in during fiscal year 1993, we exceeded our 55% goal set for the fiscal year 1994 cohort with the 1993 cohort. So that, too, is good news. This slide also shows the improvement in on-time actions over 1990-91 when no user fee program was in place. (Slide 3) As the next graph shows, our performance in reviewing the 1,252 manufacturing supplements received in fiscal year '93 also represents substantial improvement over previous years. Our goal for manufacturing supplements that is set for applications received during fiscal year 1994 is to have 55% reviewed within six months. Final analysis is going to have to wait until six months after the last supplement in that cohort is submitted. Yet I can announce today, that as of November 30, 1994, -- two weeks ago -- we already reached the 55% goal for the fiscal year 1994 cohort. The final percentage of supplements completed within six months in the 1994 cohort can only be higher, and in all likelihood will be somewhere between 55 and 70%. (Slide 4) The final PDUFA graph illustrates another important achievement: substantial improvement in approval times. In the FY '93 cohort, 20 NDAs and PLAs were approved within 14 months compared to only 12 in the years preceding PDUFA. Six of these faster approvals followed the second review cycle, and the sponsor turnaround time between review cycles averaged less than 60 days. FDA review time on these second cycles averaged less than three months. This confirms a basic assumption of the user fee program; cutting review times means quicker approval times for approvable applications. These improvements in the drug approval process are very important and very heartening and I am enormously proud of the FDA staff who have worked so hard to make them happen. Safe and effective products are getting to market sooner. But a lot of hard work remains to fully realize the goals of the program. We aren't fooling ourselves. We aren't resting on our laurels. It will take an enormous, sustained effort to reach performance levels mandated in upcoming fiscal years. I want to move on to medical devices where an efficient review process is also a high priority. And today I want to show you some significant progress in the area of medical devices, too. (Slide 5) This slide shows that we have reduced the backlog of 510(k) applications by 75% percent from its peak of 2,000 just one year ago. We are also concentrating our resources on 510(k) devices requiring the most intensive review. (Slide 6) Last week -- on December 7 -- we published a final rule exempting an additional 148 generic types of class I "low risk" devices from 510(k) premarket notification requirements. This makes a total of 441 or 65% of all class I devices that are now exempt from review. We expect this to decrease the number of 510(k) applications by about 600 a year. In the coming year, we plan to propose additional low-risk products for exemption. This enables industry to market devices more quickly and FDA to use its resources more efficiently. With the reduction of our 510(k) backlog, we are now intensifying our efforts to improve review times on PMAs. We have also been successful in cutting our time to process certificates for exports and export permits, as these next slides show. (slide 7) In calendar year 1993 the average time required for a permit to export unapproved devices was 65 days. In 1994, it was only 16 days. (Slide 8) We have made similar gains with export certificates for approved products -- a drop from an average of 52 days in 1993 to only 10 days in 1994. And most importantly, the improvements that you've seen in drugs, biologics and medical devices have been accomplished without lowering the high standards that the American people have come to expect. This is welcome news, but I would be remiss if I didn't also add a note of caution. The progress I have shown you results from management improvements and shifts in resources. However, these internal improvements can take us only so far. The number of applications and their complexity continue to increase at a phenomenal rate, pushing our resources beyond their limits. To achieve the kind of expedient, effective review process that all of us want, I continue to believe that we need a user fee program for medical devices. Another very important initiative out of the Center for Devices and Radiological Health is, of course, implementation of the Mammography Quality Standards Act -- MQSA. This is one very important part of the Agency's commitment to improving women's health. High quality mammography can save lives from breast cancer. But high quality mammography is technically demanding. Two years ago Congress passed the MQSA to ensure that every mammogram in this country is of the highest quality. We have been working very hard over the past year to make that a reality. (Slide 9) We met our October 1 deadline, announcing on that day that more úÿ 95% of the approximately 10,000 mammography facilities have been certified. Today, I can report that about 99% of the facilities have been certified. Some have full accreditation and others have been provisionally certified, meaning their staff and equipment meet quality standards and they have six months to meet other requirements. Mammography, I want to add, is a user fee program. Another important area where we have taken steps may be less familiar to many of you. It concerns the regulation of imported products. (Slide 10) The volume of imports into this country has been growing exponentially. Currently, FDA-regulated products account for one out of every three products offered for entry into this country--a robust 3 million entries a year and growing. We simply cannot cope effectively with this kind of volume without an automated system, and that is what FDA, together with the U.S. Customs Office and the import industry, have been putting in place over the past two years. We now have 55 ports of entry on this automated system, accounting for 80% of the FDA-regulated products coming into the country. By the end of next year, every port will be on the system. This system has transformed turnaround time from days to minutes...days to minutes. At the same time, the system enables us to do a better job of screening for volatile products -- we are seeing higher detention rates in participating ports -- and it also generates data that help us analyze long-term trends. On the international front, I also want to note the accomplishments over the course of the past year on international harmonization of drug regulations and development of international standards for devices, foods, and veterinary medicine products. FDA has been a very active participant in the International Conference on Harmonization (ICH), the International Organization for Standardization, Codex Alimentarius Commission, and other efforts that are helping to create a unity and order where once a cacophony of differing standards and requirements was the order of the day. These cooperative ventures will mean that manufacturers do not have to comply with a host of different and sometimes incompatible standards and regulations depending on where on the map they want to market their products. In an increasing number of areas, we are all reading off the same page. (Slide 11) In 1994 in the drug area, for example, FDA published four final ICH guidelines covering reproductive toxicity, stability testing, geriatric testing and dose response studies. (Slide 12) We will be publishing another seven guidelines developed in 1994 in early 1995. In the device area, international standards were developed covering biocompatibility of implants, ethylene oxide and moist heat sterilization, and heart valves to name but a few. I've spent the last few minutes reviewing some of our activities over the past year. Let me now turn to the present and two announcements. First, I want to announce a new policy on pediatric drug labeling. I have had a strong personal interest in this initiative because, as a pediatrician, I know just what a difference it can make in the medical care of children. When I first came to the FDA I began to ask why it is that drug labels have so little to say about the proper use of drugs in children. The fact is, drug companies usually don't test drugs for safety and efficacy in pediatric populations. They collect data on adults. Pediatricians are left to extrapolate, guess a little, prescribe based on experience, what is in the pediatric literature, or what is known about the drug's effects in adults. But children are not just miniature adults. You can't simply calculate the pediatric dose based on the dose that is safe and effective in adults. Relying only on information about adults is simply not good enough. I'm pleased to announce that today we are publishing in the Federal Register a final rule to make it easier for drug companies to include information about pediatric use in the labeling. (Slide 13) This slide shows the various ways a company should now convey information -- or a lack of information -- about pediatric use. Notice especially the second one here. If the course of a disease is similar in adults and children, and the sponsor provides supporting pediatric information, such as pharmacokinetic or safety studies, FDA now will consider approving the product for pediatric use. Let me repeat: If the disease behaves the same in adults and children, adequate and well-controlled trials to show efficacy may not need to be repeated in children. All that may be necessary under the new rule is information on the appropriate dose and perhaps additional safety information for children. We hope this provides an incentive for manufacturers to submit pediatric information to us. (Slide 14) This rule is part of a broader FDA initiative to focus sponsors and FDA on obtaining more information on pediatric data throughout the drug development period and in labeling. One personal note: Much of the credit for this rule goes to a number of folks within FDA. But credit also goes to a brave and courageous woman who died earlier this month -- Elizabeth Glaser, the co-founder of the Pediatric AIDS Foundation. Several years ago, she and I met and discussed the need for more information about the proper use of drugs in children. During that conversation, I promised her that we would move forward. This rule is only a first step. We have launched discussions with members of the pharmaceutical industry, as well as the pediatric community on next steps. (Slide 15) The new food label is here. It is on literally billions of food packages across this country. The food industry has done a remarkable job. It is enormously satisfying to see those new food labels and we are gratified by the overwhelmingly positive response to them from consumers and health professionals. A recent survey of dietitians, for example, found that almost 70 percent of their clients and nearly two-thirds of the dietitians changed what food they buy as a direct result of the new label. The second announcement that I would like to make today has to do with compliance with the new food labeling requirements. Since last August, FDA inspectors have been in food stores and in factories. And today I want to share with you what we have found. (Slide 16) We have examined more than 5,000 products. Less than 1% did not have the new label when they should have had it. We have had to issue only 28 warning letters for failure to display the new label. Scoring better than 99% is an A+ in any grading system. (Slide 17) Today I am also releasing the results of a survey of 300 food products off store shelves. The Agency received the final report last week, and the news here is also good. Ninety four percent of the analyses done on fat content found the numbers on the label indeed accurately reflected what was in the package. For calories, it was 93%. Overall, 87 percent of the analyses done on a dozen nutrients found the numbers on the label were accurate. These results show that consumers can trust what it says on the new food label. In addition to labels consumers can trust, we also want to make sure they are easy to read. (Slide 18) This is what the new food label should look like on the vast majority of food products. We have been meeting cooperatively with companies to make sure that it does. Next, I want to move on to the future and the Agency's plans and priorities for the next year. The starting point for any talk about the future has to be the announcement just a few days ago of FDA's future home. The Montgomery County site selected is Clarksburg. (Slide 19) If all goes as planned, by the year 2003 the Centers for drugs, biologics, medical devices and radiological health as well as the office of regulatory affairs and office of the commissioner will be together at the Clarksburg site. This site was chosen by a panel of five experts -- three from GSA and two from FDA -- who worked for nine months exploring every aspect of the three sites that were under consideration. The panel weighed the suitability of each site according to a carefully defined point system, considered the results of a detailed environmental impact study, and discussed each potential choice in public meetings with the residents who would be affected by the construction. Some have questioned why GSA has proposed that we move out so far. While many factors came into play, there are not many parcels of land in Montgomery County that can accommodate 350 buildable acres. This site stood out because the land is continguous and it is the only one of the sites where FDA's buildings would not have to be needlessly broken up by existing or proposed roads. This site will allow us to be housed so that we can encourage cross-center collaboration in a way that none of the others would. The process of choosing a new site was independent and rigorous, and confidentiality about the selection was maintained until the end. I received word of the choice in an official phone call Friday morning at 8 a.m., just before the public announcement. I want to express my personal thanks and the gratitude of the Agency for the truly outstanding work of those involved in making this decision. The new consolidated site is still several years away. Our immediate focus needs to be on our program priorities for the coming year. Let me set out the top program priorities for 1995, center by center. One caveat: The list is not meant to be all-inclusive. These are programmatic priorities. In a moment, I will some back to some more specific policy initiatives for the coming year. (Slide 20) Our Center for Veterinary Medicine will be instituting changes to strengthen its product approval system--making it more flexible and decreasing the time and cost required without sacrificing standards of safety, efficacy, and quality. It will also be removing from the market unapproved animal health products that compete with FDA-approved products. A third priority for CVM is to improve the safety of animal-derived foods through increased enforcement. (Slide 21) HACCP -- the Hazard Analysis Critical Control Points program- -will be a top priority for CFSAN next year. So will implementation of the dietary supplement regulations. You will also see management improvements in 1995, consistent with the National Performance Review and recommendations of the Food Advisory Committee. (Slide 22) CDER has listed four priorities: meet or exceed PDUFA goals, make progress in information technology initiatives, implement Good Review Practice Initiatives, and continue the Agency's efforts on international harmonization of drug regulations. Let me say a few words about what to expect in the area of international harmonization in 1995. I mentioned earlier that we will be publishing seven additional ICH guidelines. In addition, work will continue on another 14 documents that are at various stages of drafting. Many of these will be completed by the ICH III meeting in Japan in November 1995. Additional topics will also be launched in 1995, on biotechnology, clinical trials, medical terminology, and electronic standards for the transfer of regulatory information. In 1995 we will also be reaching more Mutual Recognition Agreements with other countries to ensure that their standards for safety are equivalent to ours, with the promise of both freer trade for American food and drug manufacturers and safer products for American consumers. (Slide 23) CBER is working with CDER on the same list of priorities. CBER also is looking to implement tissue regulations and establish a gene therapy registry. (Slide 24) Our Center for Devices will continue to improve the review and approval process. One priority is to be able to approve most IDE's by 30 days. CDRH will also exempt and down classify products where 510(k)s don't add significant consumer protection. It will implement the mammography standards under MQSA, as I mentioned earlier, and also move forward on design controls as the cornerstone of good manufacturing practices. (Slide 25) The National Center for Toxicological Research provides a critical scientific base for our efforts and in the coming year it will be focusing on scientific issues that bear on food safety and drug toxicity. NCTR plans to develop better analytical methods to identify microbial and chemical contamination of foods and other products, expand knowledge on the relationship between dietary modulation and susceptibility and expression of chemical/drug- induced toxicity, and continue to develop new test models to improve our ability to predict and identify toxicity. Those are some, and I underline the word "some," of our program priorities for 1995. Let me next set out some of the policies that we expect to be working on in the upcoming year. (Slide 26) Perhaps our most important initiative in foods is applying the Hazard Analysis Critical Control Points to food safety. Our final HACCP regulations for seafood will be out early next year, and we'll be working closely with the food industry on extending HACCP, as appropriate, to other commodities. HACCP not only gives American consumers greater assurance of food safety; adoption of HACCP as the standard for assuring quality will also help American food producers market their products overseas. We will continue to fine-tune our food labeling initiative in 1995. We particularly want to address concerns we've heard about how the regulations might inhibit the use of valid health claims on foods. And, of course, Congress has made changes in the way we regulate dietary supplements. We'll be preparing the regulations to implement that new legislation as well, I hope in a way that improves a relationship that has often been too adversarial. Related rulemaking--to protect children from toxic doses of iron-containing supplements--has received widespread support in its proposal form, from the industry and the public, and will be finalized next year. We're continuing to promulgate the many medical device regulations required by Congress in recent years. One of the most difficult, user facility reporting of adverse events, is almost ready, and a proposal on the new requirements for mammography facilities and practices will be announced in the Spring. In the drug and biologics areas, we are working with pharmaceutical, pharmacy and consumer groups on how to get drug information to patients. We averted a problem last year when we uncovered attempts to import into this country potentially infectious tissue for transplantation. The regulations we published then will be followed this year with a more thorough proposal on human tissue handling, processing, and storage. And finally, this year Congress made a needed change in the law governing animal drugs by giving veterinarians greater authority to use such drugs outside their labeled indications. We'll be doing the implementing regulations during 1995. As you can tell, there will be no shortage of activity. We have a very full plate. The Prescription Drug User Fee Program has made it possible for us to do our job better. But for the most part in the coming year we are going to have to do our job in an environment of limited resources. Budget constraints are very real. We have to find ways to do more with less. One way we are trying to make that possible is by streamlining and automating our administrative and support functions throughout the Agency. A very important focus over the past year and in the upcoming year will be on developing appropriate information systems for the Agency. (Slide 27) The most ambitious undertaking is the development of what we call the SMART information system, which will in a standardized way allow us to receive and review applications for new drugs and biologics. This system will allow us to support and better manage the entire review process. Four modules of this SMART system will be piloted in the upcoming year. A full plate. A limited budget. But in the end what gives me confidence about the future is the leadership we have in place at this Agency. Today, I am pleased to announce a new appointment: Sharon Smith Holston as our new Deputy Commissioner for External Affairs. Sharon has served this Agency for 22 years, most recently as Associate Commissioner for Management. Her knowledge of FDA is invaluable. She brings to her task an outstanding record as a manager. Sharon has earned the respect and admiration of her colleagues and we all welcome her to this new position. In a moment, she will say a few words to you. I can also report today that we have selected a new Deputy Commissioner for Policy. I expect to be able to announce that appointment soon. These two deputy commissioners join a leadership team that I depend on in everything I do. Make no mistake: We have in place at FDA a new generation of Center Directors. Over the last several years, there has been new leadership for Biologics, Devices, Veterinary Medicine, NCTR and Drugs. The real future of this Agency lies less in any particular policy, less in any particular system than it does in these Center Directors. For in the end, they are the ones who make the decisions. They are the ones with the final say in their areas. They are this Agency's future. They are smart, tough, creative and committed leaders who know who to get things done. Three new Center Directors have been appointed since I last spoke here, one year ago. It is important that you get a sense of them and of our new Deputy Commissioner for Policy first hand and so I have asked each of them to make a few brief comments. Ms. Holston will begin, followed by Dr. Bernard Schwetz, Director of the National Center for Toxicological Research and Associate Commissioner for Science, Dr. Steve Sundloff, the Director of the Center for Veterinary Medicine, and Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research. ------------------------------ End of HICNet Medical News Digest V08 Issue #18 ********************************************* --- Editor, HICNet Medical Newsletter Internet: david@stat.com FAX: +1 (602) 451-6135