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· Subject: HICN605 Medical Newsletter Part 1/6 ------------- cut here ----------------- Volume 6, Number 5 March 8, 1993 +------------------------------------------------+ ! ! ! Health Info-Com Network ! ! 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 Compilation Copyright 1993 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. E-Mail Address: Editor: Internet: david@stat.com FidoNet = 1:114/15 Bitnet = ATW1H@ASUACAD @NUMCALLS@@DLBYTES@@INCONF@@NUMTIMESON@@EXPDATE@@HOMEPHONE@@DATAPHONE@LISTSERV = anonymous ftp = vm1.nodak.edu Notification List/ftp = hicn-notify-request@stat.com FAX Delivery = Contact Editor :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: T A B L E O F C O N T E N T S 1. Comments & News from the Editor From the Editor: Scanner/OCR Fund & CDC MMWR Reports (new info) ...... 1 2. Centers for Disease Control - MMWR [5-Mar-93] HIV Testing Services in Acute-Care Hospital Settings ...... 3 Comparison of Early and Late Latent Syphilis ......................... 5 Tetanus Fatality ..................................................... 8 Impact of Legislation on Needle and Syringe Purchase/Possession ...... 11 3. Dental News License Granted to Dental Products that will Remineralize Teeth ...... 15 Dental Researchers Report Novel Approach Treating Arthritis .......... 17 4. AIDS News Summaries AIDS Daily Summary Feb 16, 1993 to March 5, 1993 ..................... 19 5. Clinical Alerts from National Institues of Health Alert: DDI and DDC for HIV infection ................................. 40 6. Announcements of Studies/Research Tamoxifen Breast Cancer Prevention Trial Information ................. 44 7. General Announcments Discussion List for Chronic Fatique Syndrome ......................... 79 Health InfoCom Network News Page i Volume 6, Number 5 March 8, 1993 :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Comments & News from the Editor :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Words from the Editor: Scanner/OCR Fund & CDC MMWR Reports First, I would like to thank everyone who has sent in a donation for the Mednews OCR/Scanner Fund. The total is now at $623. We are more than half way to our goal. For our new subscribers, I am trying to raise enough money to buy a good flatbed scanner to scan in new articles and news releases for the newsletter. Cost for a new scanner is approximately $1000. To prevent boring our old readers, please write to david@stat.com if you have specific questions. I have sent everyone individually thank you notes, but some email has bounced. If you see your name below, but did not receive a thank you note, please drop me a line. If you would like to send in a contribution, mail a check to: David Dodell 10250 North 92nd Street, Suite 210 Scottsdale, Arizona 85258-4599 USA Thank you to the following individuals whose contributions I just received: Chris Spirito Louis Harris William Landry Judy Sproles David Dorward Laura Larsson George Hazzard Jack Cross R.K. Wright Edward Taxin Kriss and Betsy Davis Mark Dixon Franz Piribauer Clark University Robert Robison Health InfoCom Network News Page 1 Volume 6, Number 5 March 8, 1993 My source for the MMWR has finally arrived direct from the Centers for Disease Control. Since I will no longer have to relay on a third-party source, the MMWR should be back to a regular column of the newsletter. Again, thank you for all the contributions sent so far. David Dodell Editor, HICNet Medical Newsletter Health InfoCom Network News Page 2 Volume 6, Number 5 March 8, 1993 :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Centers for Disease Control - MMWR :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: MMWR 42(08) March 05, 1993 Recommendations for HIV Testing Services for Inpatients and Outpatients in Acute-Care Hospital Settings ======================================================= CDC has published revised recommendations for human immunodeficiency virus (HIV) counseling and testing of patients in acute-care hospital settings (1).* These recommendations update previous CDC guidelines published in 1987 (2) and strengthen the recommendation for hospitals to assess the rate of HIV infection among their patient populations and to develop HIV-testing programs that assist infected patients in obtaining HIV-related treatment and prevention services. The revision was prompted by information regarding both the rates of previously unrecognized HIV infection among persons admitted to some acute-care hospitals and the potential medical and public health benefits of recognizing HIV infection in persons who have not developed acquired immunodeficiency syndrome (AIDS). CDC recommends that hospitals and associated clinics encourage health- care providers to routinely ask patients in nonemergency settings about their risks for HIV infection. Patients at risk should be offered HIV counseling and testing services with informed consent obtained in accordance with local laws. In addition, hospitals with an HIV-seroprevalence rate of at least 1% or an AIDS diagnosis rate greater than or equal to 1.0 per 1000 discharges (3) should strongly consider adopting a policy of offering such services routinely to patients aged 15-54 years. These services should be structured to facilitate confidential, voluntary patient participation and should include pretest information about the testing procedures, appropriate posttest counseling for infected patients and those at increased risk, and referral of HIV-infected persons for medical evaluation. Persons who decline HIV testing or who consent to testing and are found to be infected must not be denied needed health care or provided suboptimal care. The recommendations emphasize that HIV counseling and testing programs should not be used as a substitute for universal precautions or other infection-control techniques and underscore the importance of effective and ongoing collaboration between acute-care providers and health departments to improve HIV-related prevention and treatment services. References 1. CDC. Recommendations for HIV testing services for inpatients and outpatients in acute-care hospital settings and technical guidance on HIV counseling. In: Recommendations and reports (January 15). MMWR 1993;42(no. RR- 2):1-6. Health InfoCom Network News Page 3 Volume 6, Number 5 March 8, 1993 2. CDC. Public Health Service guidelines for counseling and antibody testing to prevent HIV infection and AIDS. MMWR 1987;36:509-15. 3. Janssen RS, St. Louis ME, Satten G, et al. HIV infection among patients in U.S. acute-care hospitals: strategies for the counseling and testing of hospital patients. N Engl J Med 1992;327:445-52. * Single copies of the recommendations will be available from the CDC National AIDS Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003; telephone (800) 458-5231. Health InfoCom Network News Page 4 Volume 6, Number 5 March 8, 1993 Comparison of Early and Late Latent Syphilis -- Colorado, 1991 ============================================================== Latent syphilis (i.e., the presence of serological evidence for syphilis without clinical manifestations) is divided into early latent (EL less than 1-year's duration) and late latent (LL more than 1-year's duration) stages (1). LL syphilis, which is often associated with low nontreponemal test (e.g., rapid plasma reagin RPR) titers and is presumed to have been acquired in the distant past, is not routinely included in syphilis surveillance reports and analyses. Although a separate classification of "unknown latent syphilis" has been proposed (1), in practice, duration is unknown for nearly all syphilis cases that are classified as LL. This report compares EL and LL syphilis cases in Colorado during 1991 and demonstrates substantial overlap in their characteristics. Colorado EL and LL syphilis cases reported in 1991 were abstracted for information on age, sex, racial/ethnic group, and serologic test results (RPR). Persons aged greater than or equal to 60 years with RPR titers less than or equal to 16 were not included among LL cases, because these are usually closed administratively without investigation by disease-control staff. Serologic and demographic data were available for 33 (94%) of 35 EL and 92 (91%) of 101 LL cases reported in 1991. Females composed 17 (52%) EL and 35 (38%) LL cases. Blacks composed 13 (39%) EL and 28 (30%) LL cases; whites composed seven (21%) EL and 28 (30%) LL cases; Hispanics composed 30% of both EL and LL cases. Of patients with EL syphilis, 27 (82%) had RPR titers greater than or equal to 8; 40 (43%) patients with LL syphilis also had RPR titers greater than or equal to 8 (Figure 1). The percentage of cases with RPR titers greater than or equal to 32 was 42% for EL and 18% for LL. The median age group was 25-29 years for EL and 30-34 years for LL patients. Of patients with EL syphilis, 28 (85%) were aged less than or equal to 39 years; 70 (76%) patients with LL syphilis were also in this age range (Figure 2). Based on the combination of both RPR titer greater than or equal to 8 and age less than or equal to 39 years, 32 (35%) patients with LL syphilis were similar to the majority of EL patients. Reported by: KA Gershman, MD, HIV/STD Surveillance Program, RE Hoffman, MD, State Epidemiologist, Colorado Dept of Health. Clinical Research Br, and Surveillance and Information Systems Br, Div of Sexually Transmitted Diseases and HIV Prevention, National Center for Prevention Svcs, CDC. Editorial Note: The division of latent syphilis into early and late stages is based on treatment and public health considerations; a previous study of untreated syphilis indicated that most secondary relapses (mucocutaneous lesions) occurred during the first year after infection (2). In the United States, since the 1960s, the early latent stage has been defined as 1 year Health InfoCom Network News Page 5 Volume 6, Number 5 March 8, 1993 from the onset of infection. In practice, latent syphilis is classified as EL with evidence that a person acquired infection during the previous 12 months based on 1) a nonreactive serologic test for syphilis or a fourfold rise in titer from a previous serologic test for syphilis during the previous 12 months; 2) a history of symptoms consistent with primary or secondary syphilis without a history of treatment in the previous 12 months; or 3) a history of sexual exposure to a partner with confirmed or presumptive primary, secondary, or early latent syphilis and no history of treatment during the previous 12 months. If none of these criteria are met, a case of latent syphilis is classified as LL; the duration of infection is usually unknown. Public health surveillance for syphilis is based on reported cases of primary and secondary (P&S) or early (P&S plus EL) syphilis. Because a substantial proportion of persons with infectious P&S syphilis do not seek medical attention despite symptoms (3), reporting that includes EL cases presumably reflects the true incidence of syphilis during the previous 12 months more accurately than does reporting of P&S syphilis alone. The findings in this report that the age and serologic titer patterns of LL and EL syphilis patients are similar suggest that a substantial number of LL case-patients may have acquired infection during the previous 12 months, even though information was inadequate to classify these cases as EL. Based on these findings, the actual number of EL cases in Colorado could be more than twofold greater than what is recognized. Limitations in knowledge about the natural history of nontreponemal test titers in untreated syphilis precludes use of these tests to assess duration of infection. Although peak titers are reached during the first year of untreated infection, data on their rate and variability of subsequent decline are limited (4). For monitoring morbidity trends and evaluating control programs, the category P&S syphilis may be optimal, especially when focusing on patients voluntarily seeking care with signs or symptoms (5). The detection of EL and LL syphilis cases is more dependent on active case-finding conducted by STD programs, including partner notification and serologic screening. Although the division of latent syphilis cases into EL and LL stages has been useful for treatment and partner notification, the findings in this report suggest this classification is problematic for use in surveillance. References 1. CDC. Case definitions for public health surveillance. MMWR 1990;39(no. RR- 13). 2. Sparling PF. Natural history of syphilis. In: Holmes KK, March PA, Sparline PF, Wiesner PJ, eds. Sexually transmitted diseases. New York: McGraw-Hill, 1990:214. Health InfoCom Network News Page 6 Volume 6, Number 5 March 8, 1993 3. Brown WJ, Donohue JF, Axnick NW, Blount JH, Ewen NH, Jones OG. Syphilis and other venereal diseases. Cambridge, Massachusetts: Harvard University Press, 1970:41. 4. Hart G. Syphilis tests in diagnostic and therapeutic decision making. Ann Intern Med 1986;104:368-76. 5. CDC. Epidemic early syphilis -- Montgomery County, Alabama, 1990-1991. MMWR 1992; 41:790-4. Health InfoCom Network News Page 7 Volume 6, Number 5 March 8, 1993 Tetanus Fatality -- Ohio, 1991 ============================== In August 1991, the Ohio Department of Health received a report of a fatal case of tetanus. This report summarizes the investigation of this case. On July 21, 1991, an 80-year-old woman sought treatment in the emergency department of a hospital in central Ohio because of a stiff jaw and dysphagia. On examination, she had slightly slurred speech and difficulty opening her mouth but no difficulty breathing. A wood splinter from a forsythia bush had been lodged in her left shin approximately 1 week; the wound site was erythematous and draining purulent material. The emergency room physician diagnosed tetanus and admitted the woman to the hospital. Treatment included tetanus immune globulin (3000 units) and tetanus toxoid (0.5 cc) and intravenous clindamycin because of a reported history of penicillin allergy. The patient had no history of any previous tetanus vaccinations. She had been treated at an undetermined time in the 1960s for an infected wound associated with a fractured ankle. In addition, she had sought medical care periodically for treatment of hypertension and other medical problems. The patient's clinical status gradually deteriorated, and mechanical ventilation was required because of increasing generalized rigidity. During the ensuing 2-week period, she was treated for tremors, muscle spasms, abdominal rigidity, apnea, pneumonia, and local infection from her leg wound. Despite aggressive treatment, the patient died on August 5. As a result of this case, a public health nurse, serving as part of the Occupational Health Nurses in Agricultural Communities (OHNAC) project *, instituted communitywide educational activities to increase tetanus vaccination coverage among adults. Following these educational efforts, from August 1991 through July 1992, the number of adults receiving tetanus vaccination from the county health department increased 51% ** over the previous 12 months (79 vaccinations compared with 52, respectively). Reported by: M Fleming, Grady Memorial Hospital; A Babcock, Delaware County Health Dept, Delaware; A Migliozzi, MSN, TJ Halpin, MD, State Epidemiologist, Ohio Dept of Health. Div of Surveillance, Hazard Evaluations, and Field Studies, National Institute for Occupational Safety and Health; Div of Immunization, National Center for Prevention Svcs, CDC. Editorial Note: The risk for tetanus is greater in older (aged greater than or equal to 60 years) persons who lack protective levels of antitoxin (1,2). Although tetanus is preventable through adequate vaccination, 117 cases of tetanus were reported to CDC during 1989 and 1990 (3 ). Supplemental information available for 110 of these cases indicates the case-fatality rate was 24%. Of 109 persons for whom age was known, 63 were aged greater than or equal to 60 years. Of the 37 persons in this age group for whom vaccination status was known, 34 (92%) were inadequately vaccinated (CDC, unpublished data, 1992). Health InfoCom Network News Page 8 Volume 6, Number 5 March 8, 1993 Tetanus toxoid is a highly effective vaccine. Protective levels of serum antitoxin are generally maintained for at least 10 years in properly vaccinated persons (4). After completion of the primary vaccination series, booster doses of tetanus toxoid, combined with diphtheria toxoid (as Td) every 10 years are recommended by the Advisory Committee on Immunization Practices, the American College of Physicians, the American Academy of Family Physicians, and the American Academy of Pediatrics. This report and others underscore the consequences of missed opportunities for vaccination (3). Although the patient in this report had numerous prior contacts with the health-care system, she had no history of vaccinations against tetanus. Of the 57 persons with tetanus in 1989 and 1990 for whom vaccination status was known, 45 (79%) reported ever having received less than or equal to 2 doses of tetanus toxoid. In addition, of the 12 who had sought medical care for their injuries and for whom tetanus toxoid was indicated, 11 were not vaccinated (3). Wounds such as that described in the patient in this report are common in persons with tetanus and may not be considered sufficiently severe by the person to warrant a visit to a health-care provider. In 1989 and 1990, only 27 (31%) of 86 persons with tetanus and a clear antecedent acute injury sought medical treatment for their wounds (3). Therefore, internists, family practitioners, occupational physicians and other primary health-care providers who treat adults should use every opportunity to review the vaccination status of their patients and administer Td and other indicated vaccines as appropriate. References 1. CDC. Tetanus--Rutland County, Vermont, 1992. MMWR 1992;41:721-2. 2. CDC. Summary of notifiable diseases, United States, 1991. MMWR 1992;40(no. 53):47. 3. Prevots R, Sutter RW, Strebel PM, Cochi SL, Hadler S. Tetanus surveillance -- United States, 1989-1990. In: CDC surveillance summaries (December 11). MMWR 1992;41(no. SS-8):1-9. 4. ACIP. Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures -- recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40 (no. RR-10). * OHNAC is a national surveillance program conducted by CDC's National Institute for Occupational Safety and Health that has placed public health nurses in rural communities and hospitals in 10 states (California, Georgia, Iowa, Kentucky, Maine, Minnesota, New York, North Carolina, North Dakota, and Ohio) to conduct surveillance of agriculture-related illnesses and injuries Health InfoCom Network News Page 9 Volume 6, Number 5 March 8, 1993 that occur among farmers and farm workers and their family members. These surveillance data are used to reduce the risk for occupational illness and injury in agricultural populations. ** The 51% increase in vaccinations may underestimate the total effect of this intervention because it does not include persons who obtained vaccinations from private physicians or from providers in neighboring counties. Health InfoCom Network News Page 10 Volume 6, Number 5 March 8, 1993 Impact of New Legislation on Needle and Syringe Purchase and Possession -- Connecticut, 1992 =============================================== Human immunodeficiency virus (HIV) and other bloodborne pathogens are transmitted among injecting-drug users (IDUs) through the reuse and sharing of contaminated needles and syringes (NSs) (1). Of the 689 acquired immunodeficiency syndrome (AIDS) cases reported in Connecticut in 1992, 413 (60%) were associated with injecting-drug use. To help reduce IDUs' use of contaminated NSs, Connecticut enacted laws effective July 1, 1992, that allow the purchase without a prescription of up to 10 NSs at one time in pharmacies and the possession of up to 10 clean NSs.* Before this date, purchase and possession of NSs without a prescription had been illegal in Connecticut. This report presents preliminary information from the first 5 months of an ongoing evaluation to determine whether the new laws affected pharmacy-based NS sales, IDUs' reported knowledge of the laws and places to obtain NSs, and law enforcement officers' risk for needlestick injuries. Investigation of Pharmacy-Based NS Sales In June 1992, eight pharmacies in Hartford, a city of 139,739 (1990 U.S. Census), were enrolled in a sentinel surveillance system to monitor pharmacy- based NS sales. For 1992, the annual incidence of AIDS in Hartford was 86 cases per 100,000 residents. All sentinel pharmacies were located in neighborhoods where injecting-drug use was reported to be prevalent. Monthly prescription and nonprescription NS sales for each participating pharmacy were monitored beginning July 1992. By November 1992, six (75%) of the eight pharmacies were selling nonprescription NSs. The number of nonprescription NSs sold by these pharmacies increased steadily each month through October 1992 (480 in July; 856, August; 1143, September; and 1560, October). In the two pharmacies not selling nonprescription NSs in November, pharmacists reported they had sold nonprescription NSs when the law went into effect, but cited IDU-related incidents (i.e., a used syringe was found on a shelf and an IDU disrupted business) in their pharmacy as the reason for now refusing to sell. IDUs' Knowledge of Laws and Places to Obtain NSs During August-November 1992, staff members at three HIV counseling and testing sites, two correctional facilities, and two drug-treatment centers in Connecticut interviewed active IDUs using a standard questionnaire. Active IDUs were defined as persons who reported using a needle or syringe to inject drugs into their veins, into their muscles, or under their skin during June 1992 and who reported using injected drugs during the 30 days preceding the interview. IDUs were asked about their knowledge of the new laws and NS- purchasing practices during the 30 days preceding the interview and during the 30 days before the laws became effective. Of 124 active IDUs, 68 (55%) reported they were aware they could both Health InfoCom Network News Page 11 Volume 6, Number 5 March 8, 1993 purchase and possess clean NSs. An additional 26 (21%) IDUs were aware they could legally purchase NSs but did not know they could legally possess them. Thirteen (59%) of the 22 IDUs who were not aware of either law were men interviewed in correctional facilities. More IDUs reported purchasing NSs from a pharmacy during August-October (51 41%) than during June (23 19%). This change included 27 IDUs who began purchasing from a pharmacy and two IDUs who reported not purchasing from a pharmacy after the new laws went into effect (p<0.001, sign test, matched-pair analysis). Those purchasing NSs during June may have been IDUs with diabetes, made illegal pharmacy purchases, or recalled inaccurately their purchasing during that time. Fewer IDUs reported purchasing NSs on the street during August-October (73 59%) than during June (92 74%); four IDUs reported they began purchasing and 24 reported they did not purchase on the street (p<0.001, sign test). However, of all methods to obtain NSs, purchases on the street (59%) were reported more often than purchases from pharmacies (41%). The prevalence of NS sharing was unchanged -- during both periods, approximately 36% of IDUs reported at least one episode of NS sharing. In November 1992, four focus groups were held in Hartford with a total of 34 active IDUs to address issues regarding NS use and purchasing practices. Participants reported that many IDUs changed their NS-purchasing practices in July and began purchasing from pharmacies. Approximately two thirds of the IDUs attending the meetings were aware that clean NS possession was legal and reported they were now more likely to carry NSs with them on the street. Focus group participants reported that NS-sharing episodes were less frequent after the new laws went into effect. Law Enforcement Officers' Risk for Needlestick Injuries To determine whether Hartford police officers were at greater risk for needlestick injuries after the new laws went into effect --because IDUs reported that they were more likely to carry NSs on the street -- Occupational Safety and Health Administration-mandated reports of occupational injuries and illnesses were reviewed for reports of needlestick injury among police officers. Needlestick injury rates among officers were similar during the 3 months before and after July 1 (two needlestick injuries in 423 arrests for opium, cocaine, or NS possession versus one in 478 arrests, respectively). Reported by: Hartford Dispensary; Regional Network of Programs; Chemical Dependency Unit, Community Health Svcs; Hartford Police Dept; AIDS Program, Hartford Health Dept. AIDS Program, Bridgeport Health Dept. AIDS Program, Waterbury Health Dept. Health Svcs Div, Connecticut Dept of Correction. B Weinstein, MPH, AIDS Section, JL Hadler, MD, State Epidemiologist, Connecticut Dept of Health Svcs. Div of Field Epidemiology, Epidemiology Program Office; Clinical Research Br, and Behavioral and Prevention Research Br, Div of Sexually Transmitted Diseases and HIV Prevention, National Center for Health InfoCom Network News Page 12 Volume 6, Number 5 March 8, 1993 Prevention Svcs; Office of HIV/AIDS, Office of the Director, CDC. Editorial Note: In July 1991, the National Commission on AIDS recommended removing legal barriers to the purchase and possession of NSs as part of a strategy for reducing the spread of HIV among IDUs unable or unwilling to enter drug treatment (2 ). Statutes in 44 states and the District of Columbia place criminal penalties on the possession and distribution of NSs (drug paraphernalia laws), and the sale of NSs without a medical prescription are prohibited in 10 states and the District of Columbia (needle prescription laws) (3). Although IDUs in some localities have begun to clean their NSs and to decrease NS sharing in response to the AIDS epidemic (4,5), NS sharing continues, reflecting the limited availability of NSs and the established practices of injecting-drug use (5-7). Because the number and proportion of HIV infections related to injecting- drug use in Connecticut are high, efforts to prevent HIV infection among IDUs and their sex partners have been broad and include street outreach and drug- treatment-based education to encourage safer sex and injection practices, comprehensive drug treatment, HIV counseling and testing, and legalizing the availability of sterile NSs. In July 1990, the Connecticut legislature legalized needle exchange in New Haven, and in May 1992, the legislature approved and funded additional needle-exchange programs in Hartford and Bridgeport. Connecticut legislators also amended the state's needle prescription and drug paraphernalia statutes. Legalizing over-the-counter purchase of up to 10 NSs potentially expanded IDUs' access to sterile needles to include pharmacies in Connecticut that might choose to sell nonprescription NSs. Allowing possession of up to 10 clean NSs might encourage IDUs to carry their own NSs, thereby decreasing the likelihood of unsafe NS sharing. A follow-up questionnaire survey of active IDUs is being conducted to determine whether the behaviors reported in these preliminary findings have changed and to better characterize NS-purchasing practices, NS ownership, and patterns of NS usage as IDUs' knowledge of the new laws becomes more widespread. One issue being explored is the discrepancy between questionnaire results indicating that no change occurred in NS-sharing practices while focus groups indicated that NS-sharing episodes decreased. The increase in the number of nonprescription NSs sold by sentinel pharmacies in Hartford probably reflects NS purchasing by IDUs but might also represent a shift from prescription to nonprescription sales to persons with diabetes or those who use NSs for medical purposes. To better define pharmacists' knowledge, attitudes, and practices regarding nonprescription NS sales, pharmacists will be interviewed in person and be surveyed by mail during 1993. References --------- end of part 1 ------------ · Subject: HICN605 Medical Newsletter Part 2/6 1. Schoenbaum EE, Hartel D, Selwyn PA, et al. Risk factors for human immunodeficiency virus infection in intravenous drug users. N Engl J Med Health InfoCom Network News Page 13 Volume 6, Number 5 March 8, 1993 1989;321:874-9. 2. National Commission on Acquired Immune Deficiency Syndrome. The twin epidemics of substance use and HIV. Washington, DC: National Commission on Acquired Immune Deficiency Syndrome, July 1991:10-1. 3. Gostin L. The needle-borne epidemic: causes and public health responses. Behavioral Sciences and the Law 1991;9:287-304. 4. CDC. Coordinated community programs for HIV prevention among intravenous- drug users -- California, Massachusetts. MMWR 1989;38: 369-74. 5. Selwyn PA, Feiner C, Cox CP, Lipshutz C, Cohen RL. Knowledge about AIDS and high-risk behavior among intravenous drug users in New York City. AIDS 1987;1:247-54. 6. DesJarlais DC, Friedman SR, Sotheran JL, Stoneburner R. The sharing of drug injection equipment and the AIDS epidemic in New York City: the first decade. In: Battjes RJ, Pickens RW, eds. Needle sharing among intravenous drug abusers: national and international perspectives. Washington, DC: US Department of Health and Human Services, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, 1988. (NIDA research monograph no. 80). 7. Grund JPC, Kaplan CD, Adriaans NFP. Needle sharing in the Netherlands: an ethnographic analysis. Am J Public Health 1991;81:1602-7. * Connecticut General Statutes, Sections 21a-65, 21a-240, 21a-267, 1992. Under the new laws, pharmacies are permitted, but not required, to sell NSs without a prescription. Health InfoCom Network News Page 14 Volume 6, Number 5 March 8, 1993 :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Dental News :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: First License Granted to Produce Dental Products that will Remineralize Teeth ----- NIDR Research Digest by Roger Rensberger The National Institute of Standards and Technology has granted a patent license to a U.S. dental materials manufacturer to produce dentifrice products using a new method to remineralize teeth. The method was developed by a NIST researcher with support from the National Institute of Dental Research. The manufacturer plans to use the remineralization method to develop toothpastes, chewing gum, and other dental products that can help repair early cavities, restore decalcified areas, and make teeth less sensitive to hot and cold. The exclusive license to produce products with the patented remineralization process was granted to Enamelon Inc., of Yonkers, N.Y., by the American Dental Association Health Foundation (ADAHF) at the National Institute of Standards and Technology The remineralization method was invented by research chemist Dr. Ming S. Tung of the Paffenbarger Research Center at NIST. The remineralization patent is held by the American Dental Association Health Foundation, sponsor of the 64- year-old Paffenbarger Research Center. Use of Amorphous Calcium Phosphate Dr. Tung's remineralization method uses amorphous calcium compounds, or a carbonate solution, that crystallize to form hydroxyapatite, the primary mineral in teeth and bone. The aim of remineralization is to disperse hydroxyapatite into the tooth structure to prevent further tooth decay and restore the tooth to its original form. Enamelon's products will contain the amorphous calcium phosphate that causes the remineralization process to take place. In the past, commercialization of a solution for remineralization has been prevented by problems such as instability, slow diffusion and reaction time, and surface precipitation. The process patented by the ADAHF contains calcium Phosphate that overcomes these problems and remineralizes the tooth rapidly. FDA Approval Needed The initial period of the exclusive license agreement with Enamelon will be Health InfoCom Network News Page 15 Volume 6, Number 5 March 8, 1993 extended to a date three years after the manufacturer has demonstrated that the remineralizing material has been physically and chemically stabilized for storage and marketing, similar to other dentifrices or chewing gums. Some of the materials will require clinical testing to receive Food and Drug Administration approval for marketing the products to dental professionals and the public. The remineralization method developed by Dr. Tung is a prime example of how dental materials research conducted at NIST supports the safe, efficient, and economical use of materials for the benefit of consumers and practicing dentists," said John A. Tesk, leader of the NIST Dental and Medical Materials Group. The NIST dental materials program is a cooperative activity involving researchers from the institute's Polymers Division, research associates from the ADAHF, NIDR, and industry, and guest scientists from leading dental schools. Health InfoCom Network News Page 16 Volume 6, Number 5 March 8, 1993 NEWS FROM NIDR - 03/07/93 ----------------------------------------------------------------- 03/03/93 DENTAL RESEARCHERS REPORT NOVEL APPROACH FOR TREATING ARTHRITIS Scientists have successfully treated arthritic rats by blocking the action of molecule that regulates the body's response to infection or tissue injury. The molecule is called transforming growth factor-beta (TGF-beta). When an antibody that inhibits TGF-beta (anti-TGF-beta) was injected directly into the animals' joints, arthritis symptoms were greatly reduced. This finding could have applications for treating arthritis, periodontal diseases, and other chronic inflammatory disorders, said Dr. Sharon Wahl of the National Institute of Dental Research, who led the study. She cautioned, however, that the use of antibodies for therapy has inherent problems, but added that these studies serve as a prototype for local administration of other TGF-beta antagonists currently under development. TGF-beta is a multifunctional molecule that plays a pivotal role in switching the immune system on and off. In the early stages of an infection, TGF-beta is secreted by white blood cells and acts as a signal that attracts other white cells and stimulates them to fight the infection. As the infection subsides, TGF-beta reverses its role and suppresses the activity and recruitment of white cells. However, in chronic disease situations such as arthritis, the normal cycle of events does not occur and TGF-beta continues to attract white cells. It is the excessive accumulation of white cells that produces red, swollen joints and eventually leads to tissue and bone destruction. Scientists examined rats with experimentally induced arthritis to determine the therapeutic effect of anti-TGF-beta, which specifically binds to TGF-beta and blocks its activity. Rats were first injected with a bacterial cell preparation that produces symptoms that mimic human rheumatoid arthritic. Without additional treatment, the rats experience an acute form of arthritic that appears within 24 hours and is characterized by swelling of the joints and feet and redness of the overlying skin. The acute phase subsides within several days, and after a period of two to three weeks, the disease enters the chronic stage. This phase is identified by joint deformity brought on by the gradual destruction of cartilage and bone replacement with connective tissue containing large numbers of white bloods cells. Rats receiving a single injection of anti-TGF-beta into a hind ankle just Health InfoCom Network News Page 17 Volume 6, Number 5 March 8, 1993 prior to injection with the bacterial cell preparation experienced a significant reduction in both acute and chronic forms of arthritis. Acute symptoms were reduced by over 75 percent and chronic symptoms by over 60 percent. Moreover, when anti-TGF-beta was administered only after the chronic disease phase had begun, arthritis symptoms were still reduced by almost 70 percent. According to Dr. Wahl and her associates, anti-TGF-beta works by interrupting the cycle of white cell migration into the joints. The researchers feel that this antibody and other TGF-beta inhibitors may provide a mechanism for treating arthritis and other chronic inflammatory diseases. The study was conducted by Drs. Sharon Wahl, Janice Allen, Gina Costa, and Henry Wong of the National Institute of Dental Research in Bethesda, Maryland, and Dr. James Dasch of Celtrix Pharmaceuticals, Inc. in Santa Clara, California. The results were reported in the January 1993 issue of the Journal of Experimental Medicine. Health InfoCom Network News Page 18 Volume 6, Number 5 March 8, 1993 :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: AIDS News Summaries :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: AIDS Daily Summary Feb 16, 1993 to March 5, 1993 AIDS Daily Summary The Centers for Disease Control and Prevention (CDC) National AIDS Clearinghouse makes available the following information as a public service only. Providing this information does not constitute endorsement by the CDC, the CDC Clearinghouse, or any other organization. Reproduction of this text is encouraged; however, copies may not be sold. Copyright 1992, Information, Inc., Bethesda, MD ===================================================================== February 16, 1993 ===================================================================== "U.S. Starts Initial Human Tests on New Type of AIDS Vaccine" Los Angeles Times (02/14/93), P. A7 On Friday, the federal government began preliminary human trials of an AIDS vaccine, which researchers hope will protect against several strains of HIV. The National Institute of Allergy and Infectious Diseases (NIAID) said researchers would first give the vaccine to 36 healthy volunteers to test its safety and the immune system response of the participants. The vaccine is manufactured by United Biomedical Inc. of Hauppauge, N.Y. It is a so-called "peptide vaccine," based on a laboratory-synthesized protein fragment, or peptide. An agency AIDS researcher, Margaret Johnston, said, "Peptide vaccines have two particular strengths: They are inexpensive and relatively easy to modify, to include new mixtures of peptides and those from different HIV strains." There are at least five genetically distinguishable strains of HIV, according to research. The NIAID said United Biomedical eventually wants to develop a vaccine involving a mix of peptides that would provide protection against all strains of the AIDS virus. ===================================================================== "New Research Shows HIV and Cancer Genes May Be Blocked" United Press International (02/15/93) Cleveland--A new drug may inhibit cancer and viral infections, including HIV, according to recent research conducted by the Cleveland Clinic and the National Institutes of Health, and published in the Monday issue of the Proceedings of the National Academy of Sciences. The drug, 2-5A-antisense, Health InfoCom Network News Page 19 Volume 6, Number 5 March 8, 1993 causes the breakdown of unwanted messenger RNA. Messenger RNA determines which protein will be made in the cell. Therefore, when the unwanted RNA is broken down, the gene cannot function. Dr. Robert Silverman of the Cleveland Clinic's Cancer Biology Department said, "The research is in its very early stages. But our results are exciting. This method takes a much more targeted approach to treating viral infections and cancer." The approach reported uses a modified "antisense," which is a piece of DNA that seeks out and binds with messenger RNA. Attached to the antisense is an enzyme activator, known as 2-5A. The antisense binds to the unwanted messenger RNA, which is then killed by the activated enzyme. The report states, "In any virus, the genes have a sequence unique in nature. In theory, we can make an antisense that will bind only to the virus RNA without binding to human RNA, thereby destroying the virus without harming the person." Silverman warns that the findings have been in cell extracts, not within animals or people. But he said the researchers still consider the results quite promising. ===================================================================== "Unexplained Opportunistic Infections and CD4+ T-Lymphocytopenia Without HIV Infection" New England Journal of Medicine (02/11/93) Vol. 328, No. 6, P. 373 (Smith, Dawn K., et al.) The mysterious AIDS-like condition without evidence of HIV infection that has recently been reported appears to be rare and not transmissible, write Dr. Dawn K. Smith and colleagues of the Centers for Disease Control in Atlanta, Ga. Researchers conducted investigations to determine the demographic, clinical, and immunologic features of patients with idiopathic CD4+ T-lymphocytopenia (ICL); whether the syndrome is epidemic or transmissible; and its possible causes. The researchers reviewed 230,179 cases in the CDC AIDS Reporting System and performed interviews, medical reviews, and laboratory analyses of blood specimens from adults and adolescents who met the CDC definition of ICL. The patients' sexual contacts, household contacts, and persons who had donated blood to them were also tested. The researchers interviewed 31 of the 47 patients identified with ICL, as well as 23 of their contacts. A total of 18 patients had one or more risk factors for HIV infection: seven had hemophilia, six had engaged in homosexual sex, six had received blood transfusions, and two had had heterosexual sex partners who were at risk for HIV infection. The other 29 patients had no risk factors for HIV infection. When blood from 28 patients was tested, eight were found to have T-cell counts of less than 300 cells per cubic millimeter, and 6 had fewer than 250 T-cells per cubic millimeter. The researchers determined that 10 sex partners, three household contacts, and four children of the ICL patients, as well as six persons who had donated blood to the patients, were immunologically and clinically normal. Health InfoCom Network News Page 20 Volume 6, Number 5 March 8, 1993 ==================================================================== February 17, 1993 ==================================================================== "Effort to Manufacture Artificial Blood is Thwarted" Los Angeles Times-- Washington Edition (02/17/93), P. B7 (Maugh, Thomas H.) The production of an artificial blood product has encountered an unexpected hindrance that may seriously postpone its commercialization, said a University of California--San Diego physician at a meeting of the American Association for the Advancement of Science. While researchers from the four companies conducting clinical trials on the artificial bloods have not disclosed the preliminary findings from their trials, enough information has been released to allow observers to figure out the cause of the difficulties, said Dr. Robert M. Winslow, a professor of medicine at UC-San Diego who was formerly in charge of the U.S. Army's efforts to develop an artificial blood. Participants in the clinical trials of the artificial bloods have reported various unexpected side effects, including chest pains, back pains, nausea, and hypertension. What seems to be the cause is nitric oxide (NO), which interacts with artificial blood, Winslow said. The hemoglobin in the artificial blood is leaking out of blood vessels and into the surrounding tissues, where it binds NO tightly, inhibiting its vasorelaxant properties, said Winslow. Consequently, the blood vessels constrict, causing the unusual symptoms. The problem could be very hard to solve because NO binds with the hemoglobin at the same molecular location that oxygen does. Any efforts to prevent the binding will most likely restrict hemoglobin's oxygen- carrying capacity. ==================================================================== "Idiopathic CD4+ T-Lymphocytopenia--Immunodeficiency Without Evidence of HIV Infection" New England Journal of Medicine (02/16/93) Vol. 328, No. 6, P. 380 (Ho, David D. et al.) It remains undetermined whether idiopathic CD4 T-lymphocytopenia (ICL) is new, transmissible, or acquired, write David D. Ho et al. of the Aaron Diamond AIDS Research Center in New York, N.Y. Patients recently diagnosed with severe CD4 T-lymphocytopenia but without evidence of HIV infection have spurred a national surveillance network to investigate such cases. The researchers examined 12 patients with CD4 T-lymphocytopenia who were referred by three U.S. cities. The patients (10 men and 2 women) ranged in age from 30 to 69 years. A total of eight had risk factors for HIV infection. The clinical conditions were heterogeneous: five patients had opportunistic infections, five had syndromes of unknown cause, and two had no symptoms. Two patients died from severe complications of their immunodeficiency. The Health InfoCom Network News Page 21 Volume 6, Number 5 March 8, 1993 patients' lowest CD4 T-lymphocyte counts ranged from three to 308 per cubic millimeter. Three patients had complete or partial spontaneous reversal of the CD4 T-lymphocytopenia. Concomitant CD8 T-lymphocytopenia was found in three patientsJand abnormal immunoglobulin levels were found in five. Multiple virologic studies by serologic testing, culture, and polymerase chain reaction were completely negative for HIV in all patients. The researchers found that the 12 patients with ICL appear to be epidemiologically, clinically, and immunologically heterogeneous. Although the conditions experienced in the ICL patients resemble AIDS, HIV infection was not detected. The cause of ICL is unknown, the researchers conclude. ==================================================================== "Projections of the Number of Persons Diagnosed With AIDS and the Number of Immunosuppressed HIV-Infected Persons--United States, 1992-1994" Journal of the American Medical Association (02/10/93) Vol. 269, No. 6, P. 733 The Centers for Disease Control recently released new estimates of the number of persons in the United States who will initially be diagnosed with an illness included in the 1987 AIDS surveillance case definition during 1992-1994. About 58,000 Americans had AIDS during 1991 as defined by the 1987 AIDS definition. Between 1992-1994, the number of persons who have illnesses meeting these criteria is expected to rise by only a few percent annually, with about 85 percent of those persons being reported to the CDC with cases of AIDS. The rate of increase in reported AIDS cases in persons who contracted HIV via heterosexual contact is expected to be higher than that in persons who contracted the virus through homosexual/bisexual contact or IV-drug use. The CDC predicts that, as of January 1993, an additional 120,000 to 190,000 Americans had HIV-related severe immunosuppression. Not all of these persons were aware of their HIV infection, however, and of those who know their HIV infection status, not all have had a T-cell count. If the AIDS definition went unchanged, about 50,000 to 60,000 reported AIDS cases would have been expected in 1993. The new definition of AIDS that includes HIV-related severe immunosuppression should increase reported cases by about 75 percent. The effect of this expansion on the number of reported cases is estimated to be smaller in later years because in 1993 many prevalent as well as incident cases of immunosuppression will be reported as the expanded surveillance case definition is used. Reported AIDS cases may decrease from 1993 through 1994, according to the CDC. ==================================================================== "Multicenter Clinical Trials of AIDS Vaccines Scheduled to Get Under Way in Coming Months" Journal of the American Medical Association (02/10/93) Vol. 269, No. 6, P. 725 (Marwick, Charles) Health InfoCom Network News Page 22 Volume 6, Number 5 March 8, 1993 HIV-negative volunteers at high risk of infection areJbeing recruited for nationwide clinical trials of two AIDS vaccines. A total of about 320 male and female volunteers aged 18-60 years old will be involved. However, some officials from the National Institutes of Health project that it will be at least two more years before full-scale vaccine trials are conducted. The two vaccines will be tested in five American centers: Johns Hopkins University Center for Immunization, Baltimore, Md.; St. Louis (Mo.) University School of Medicine; University of Rochester (N.Y.) Medical Center; Vanderbilt University Medical Center, Nashville, Tenn.; and the University of Washington School of Medicine in Seattle. The two vaccines have already undergone safety testing, and do not appear to produce unwanted side effects. The trials will test the ability of two recombinant proteins made from the HIV envelope protein gp160 to boost protective antibodies and possibly cytotoxic T-lymphocyte responses, says Daniel Hoth, MD, director of the AIDS division at the National Institute of Allergy and Infectious Diseases. Volunteers will be counseled to avoid high-risk behaviors linked with HIV transmission. They will be assigned randomly to receive one of the vaccines or a placebo. Three intramuscular injections will be given--an initial injection and then two boosters at one and six months. One vaccine, genetically engineered by Genentech Inc., uses the HIV-1 MN strain. The other, made by Biocine, uses the closely related HIV-1 SF-2 strain. The two vaccines are equipped with adjuvants to further potentiate an immune response. ==================================================================== "TB Control Guidelines Cause Coast-to-Coast Confusion" American Medical News (02/08/93) Vol. 36, No. 6, P. 1 (Voelker, Rebecca) Due to the lack of a national plan to prevent tuberculosis transmission, federal, state, and regional health officials have developed conflicting respiratory-protection guidelines. The suggested measures range from protective surgical masks to the cumbersome powered air respirators proposed last year by the National Institute for Occupational Safety and Health. But in its current draft guidelines, the Centers for Disease Control backs away from the NIOSH-recommended respirators because of opposition from both health professionals and hospital administrators. Despite the tighter facial fit of the respirators, the CDC says, "There is not sufficient scientific evidence to support" their routine use. The agency instead suggests that protective surgical masks and valveless dust and mist respirators are sufficient for minimum protection. CDC spokeswoman Kay Golan said, "NIOSH was required by law to assess the risk and make recommendations so that no worker suffers. They were prohibited from considering cost or feasibility when they made their recommendations." But if the NIOSH recommendations are adopted in a federal OSHA standard, they could become legally enforceable. Dr. Michael Health InfoCom Network News Page 23 Volume 6, Number 5 March 8, 1993 Tapper, chairman of the AIDS/TB committee of the Society for the Hospital Epidemiologists of America, attended a meeting at the CDC in Atlanta concerning its first round of revisions to the 1990 guidelines for TB control in health-care settings. He said that consensus based on science is desperately needed to dispel the confusion. ====================================================================== February 18, 1993 ====================================================================== "Drug Combination Stops AIDS Virus Reproduction" Washington Post (02/18/93), P. A3 A drug strategy has been developed that inhibits HIV from reproducing in a test tube, according to a report published in Thursday's issue of Nature by researchers from the Massachusetts General Hospital and the Harvard Medical School in Boston. The technique involves a combination of three drugs: AZT, ddI, and a third compound called pyridinone. All three drugs attack a single enzyme, called reverse transcriptase, which HIV needs to reproduce. If the approach is found to also block the spread of HIV in people, a patient's immune system might be able "to at least keep the virus in control for long periods of time, and perhaps forever," said Martin Hirsh, one of the researchers in the study. However, he and other researchers warn that it will take experiments in humans to determine if the technique is actually effective. HIV can mutate to produce subtle alterations in the enzyme that yield resistance to individual drugs. Yung-Kang Chow, one of the researchers, said the concept behind the "convergent combination therapy" was that the virus would be unable to resist a triple attack. In addition, thwarting the spread of the enzyme might prevent the virus from developing drug-resistant strains, said Chow. The researchers infected blood cells with HIV, then waited a week until HIV reproduction was at its peak. At this point, they added the three-drug combination. After 35 days, the infection was no longer detectable. After 49 days of treatment the drugs were discontinued, and no HIV reproduction was evident for the next 45 days. The three-drug combination will be tested in a study of people with advanced- stage HIV infection beginning this spring. Related Stories: New York Times (02/18) P. A1: Philadelphia Inquirer (02/18) P. A3 ====================================================================== "TB Drugs" Associated Press (02/16/93) (Johnson, Linda A.) Trenton, N.J.--Responding to a resurgence of tuberculosis cases that resist therapy, federal health officials are reintroducing three drugs that pharmaceutical firms stopped marketing. Bristol-Myers Squibb will introduce the first anti-microbial drug, its injectable form of isoniazid, which should be on the market within 10 days. The FDA asked the pharmaceutical Health InfoCom Network News Page 24 Volume 6, Number 5 March 8, 1993 manufacturers to resume production of the three tuberculosis drugs because of the public health threat that tuberculosis now poses. The companies stopped selling the drugs in 1990, because they were not producing profits. ====================================================================== February 22, 1993 ====================================================================== "Bill Seeks to Coordinate NIH Research on AIDS" Washington Post (02/22/93), P. A4 (Brown, David) The question of whether or not a more centralized AIDS research effort would help put an end to the AIDS epidemic is currently being raised by researchers. Last week, the Senate passed a bill that would give more power to the National Institutes of Health's Office of AIDS Research (OAR) and make its director, if not a "czar," then at the very least an official with unprecedented authority over how the government spends money studying the disease and searching for a cure. The bill requires the office to develop an overall budget for AIDS research and eventually acquire major influence in the decisions of what scientific questions will be most researched--and funded. But many scientists are skeptical that central planning will lead to better science and are fearful that a new AIDS coordinating office will add another layer to the NIH bureaucracy and possibly slow the pace of research. The proposal was written into the Senate version of the NIH Revitalization Bill by Sen. Edward M. Kennedy (D-Mass.). A House subcommittee will consider a similar bill on Tuesday. The Senate bill calls for the OAR to have a full-time director with no other responsibilities at NIH and an advisory council of scientists and lay people. The director would decide what is the best balance of basic and applied research and how much should be done inside and outside the NIH. The OAR director would have full authority over the AIDS budget, which could not be altered by the head of NIH or the secretary of Health and Human Services. ====================================================================== "Engineered Blood Factor for Clotting Passes Tests" Journal of Commerce (02/22/93), P. 9A A genetically engineered form of a blood clotting factor has been found to be safe and effective in a long-term test of children with the most severe type of hemophilia, according to a report published in Thursday's New England Journal of Medicine. People who suffer from hemophilia A lack what is known as factor VIII. Approximately 1 in 10,000 males are born with hemophilia A, but females rarely suffer from the condition. Factor VIII has previously been extracted from donated blood. But filtering out deadly viruses, including HIV, has been difficult even though significant progress has been made in attempts to distinguish blood-borne illnesses. The study shows that genetically engineered factor VIII made by Miles Inc. was safe among infant test subjects, a group selected because they had never received any treatment Health InfoCom Network News Page 25 Volume 6, Number 5 March 8, 1993 for hemophilia. The safety and efficacy of the engineered factor VIII among patients previously treated for hemophilia have been proven in earlier studies. An additional 75 patients have now been treated and the entire group has been followed for a longer period. The researchers examined 95 hemophiliacs given the genetically engineered factor VIII between Jan. 1 1989, and July 1, 1992. The median age of the subjects at the time of first treatment was about nine months. The treatment demonstrated its effectiveness in every case with only three reports of minor side effects in the 3,315 times it was administered. ====================================================================== February 23, 1993 ====================================================================== "Tortuous Route to an AIDS Vaccine" USA Today (02/23/93), P. 4D (Painter, Kim) Although there are several AIDS vaccines currently in clinical trials, it could be 10 to 15 years before one could be used in large numbers of people. Dr. Bernadine Healy, director of the National Institutes of Health, said at a recent New York Symposium on AIDS vaccines, "I think it's fair to say no one of these vaccines in early testing ... appears to stand out." However, she says she is optimistic about the prospects for therapeutic vaccines, which help people who are already HIV-positive. Most vaccines being studied--for both preventative and therapeutic uses--are made with pieces of HIV that cannot cause illness. These vaccines appear to be safe and boost immune responses in volunteers. Yet no one knows whether these responses can protect humans from actual HIV infection. Moreover, scientists don't know what an effective response is. One promising method was tested in a recent monkey study. Harvard Medical School researcher Ronald Desrosiers gave healthy monkeys live simian immunodeficiency virus, the monkey form of HIV, weakened by the removal of one gene. The monkeys contracted HIV but did not become ill. Subsequently, they received massive doses of real SIV and stayed healthy--indicating that the altered virus allowed their immune systems to resist infection. While the finding may be promising, no other approach is so risky. The worst-case scenario is that a live weakened virus could quickly switch to a deadly form. Desrosiers is more concerned that weakened viruses might cause cancer or a delayed form of AIDS several years after vaccination. He said the first human trial would have to be small and might take many years. ====================================================================== "AIDS and the Changing Face of Pneumonia" Washington Post (Health) 02/23/93), P. 12 (Colburn, Don) The AIDS epidemic has had a dramatic impact on the pattern of pneumonia cases in hospital intensive care units. Pneumocystis carinii pneumonia (PCP), once one of the rarest types of pneumonia, is currently the most Health InfoCom Network News Page 26 Volume 6, Number 5 March 8, 1993 common AIDS-related condition. Frederick L. Ruben, a lung specialist at the University of Pittsburgh School of Medicine and University Montefiore Hospital in Pittsburgh, said, "Before, the only time it was seen was in severely malnourished children or kidney transplant patients. Even infectious disease specialists wouldn't see a case in five years. Now you can't go a week without seeing a case." According to a recent study at a community hospital in San Francisco, the AIDS epidemic "has profoundly affected the spectrum of pneumonia in intensive care units." Of the 1,854 patients treated in the hospital's ICU over a three-year period, one out of seven had pneumonia. Of those, 29 percent were HIV-positive. PCP accounted for more cases--28 percent--than any other type of pneumonia in the San Francisco ICU study, which was published in the Western Journal of Medicine last December. In all 74 cases of PCP, the patient was also infected with HIV. But four previous studies of pneumonia in ICUs during the 1980s had no reported cases of PCP. The study demonstrated a sharp contrast in the age pattern, also. Before the AIDS epidemic, fatal pneumonia struck mainly the elderly or very young children. But in the San Francisco study, older pneumonia patients had a much higher survival rate. The difference is the direct impact of the AIDS epidemic, which affects mostly young and middle- aged people. ====================================================================== "Two Firms Collaborate on Hemophilia Project" Baltimore Sun (02/23/93), P. 11D (Bowie, Liz) Genetic Therapy Inc. and CytoTherapeutics Inc. have signed an agreement to collaborate on research to discover a new way to deliver a treatment for hemophilia B. CytoTherapeutics has made a semipermeable polymer membrane that could be implanted in a patient's body to deliver a drug. Genetic Therapy has genetically modified cells that produce a protein called Factor IX to treat hemophilia. The two companies seek to combine the technologies, which will allow Genetic Therapy's protein to be slowly released through CytoTherapeutics' membrane. ====================================================================== "In the Nation: 10 Sites Tentatively Set for New AIDS Therapy" Baltimore Sun (02/23/93), P. 9A Federal health officials announced yesterday that 10 research sites were tentatively named to host human trials of the AIDS therapy which uses a combination of three drugs to inhibit the spread of HIV. Research has demonstrated that the therapy can block a key enzyme in the development of HIV, although the treatment's safety and efficacy in humans is undetermined. The sites being considered for the trials are Albert Einstein University in Bronx, N.Y.; Cornell University in New York; the Harvard University consortium of Boston, Mass.; Northwestern University in Chicago, Ill.; the University of Alabama in Birmingham; the University of California--San Diego; Health InfoCom Network News Page 27 Volume 6, Number 5 March 8, 1993 the University of Colorado in Denver; Florida's University of Miami; the University of Minnesota in Minneapolis; and the University of Southern California in Los Angeles. The National Institutes of Allergy and Infectious Diseases said the trials are expected to begin in the spring. ====================================================================== February 24, 1993 --------- end of part 2 ------------ · Subject: HICN605 Medical Newsletter Part 5/6 Colorado Cancer Research Program Denver, Colorado Aurora Presbyterian Hospital . . . . . . . . . .303-360-3028 Presbyterian/St. Luke's Medical Center . . . . .303-869-2037 Porter Memorial Hospital . . . . . . . . . . . .303-777-6877 Rose Medical Center. . . . . . . . . . . . . . .303-320-7142 Saint Joseph Hospital. . . . . . . . . . . . . .303-866-8600 Swedish Medical Center . . . . . . . . . . . . .303-788-4636 CONNECTICUT University of Connecticut Hartford, Connecticut Health InfoCom Network News Page 55 Volume 6, Number 5 March 8, 1993 Hartford Hospital Hartford, Connecticut. . . . . . . . . . . . . .203-524-2193 Mount Sinai Hospital Hartford, Connecticut. . . . . . . . . . . . . .203-286-4699 St. Francis Hospital and Medical Center Hartford, Connecticut. . . . . . . . . . . . . .203-548-5323 Middlesex Memorial Hospital Middletown, Connecticut. . . . . . . . . . . . .1-800-548-2394 New Britian General Hospital New Britian, Connecticut . . . . . . . . . . . .203-224-5660 University of Connecticut Health Center Farmington, Connecticut. . . . . . . . . . . . .203-679-4900 DISTRICT OF COLUMBIA Georgetown University V.T. Lombardi Cancer Research Center Washington, D.C. . . . . . . . . . . . . . . . . .202-342-2400 DELAWARE Medical Center of Delaware CMC Research Office Newark, Delaware . . . . . . . . . . . . . . . .302-731-8116 Beebe Hospital Lewes, Delaware. . . . . . . . . . . . . . . . .302-645-8487 Nanticoke Hospital Seaford, Delaware. . . . . . . . . . . . . . . .302-629-0260 St. Francis Hospital Wilmington, Delaware . . . . . . . . . . . . . .302-421-4300 (press 1) FLORIDA Health InfoCom Network News Page 56 Volume 6, Number 5 March 8, 1993 Baptist Regional Cancer Center Jacksonville, Florida. . . . . . . . . . . . . . .904-348-7073 South Florida Breast Cancer Prevention Trial Miami Beach, Florida . . . . . . . . . . . . . . .305-674-2868 Florida Hospital Orlando, Florida (See Duke University, North Carolina). . . . . . .407-897-5763 GEORGIA Atlanta Breast Cancer Prevention Program at Northside Hospital Atlanta, Georgia . . . . . . . . . . . . . . . . .404-303-3355 Atlanta Community Women's Health Project Atlanta, Georgia Atlanta Regional CCOP Cobb Hospital and Medical Center. . . . . . .404-732-4640 Kennestone Hospital . . . . . . . . . . . . .404-429-7518 South Fulton Medical Center . . . . . . . . .404-669-4594 St. Joseph's Hospital . . . . . . . . . . . .404-851-7116 Emory University . . . . . . . . . . . . . . . .404-248-4617 Grady Hospital CCOP. . . . . . . . . . . . . . .404-616-6166 University of Kentucky Consortium/ Lexington Clinic Morehouse School of Medicine Atlanta, Georgia . . . . . . . . . . . . . . . . .404-752-1567 ---------------------------------------------------------------------------- TELEPHONE NUMBERS IN THE UNITED STATES - BY STATE HAWAII - MICHIGAN Health InfoCom Network News Page 57 Volume 6, Number 5 March 8, 1993 HAWAII Cancer Research in Hawaii Honolulu, Hawaii . . . . . . . . . . . . . . . . .808-586-2979 ILLINOIS Carle Cancer Center BCPT Champaign-Urbana, Illinois . . . . . . . . . . . .1-800-446-5532 Or 217-355-6817 Oncology/Hematology Associates of Central Illinois Peoria, Illinois . . . . . . . . . . . . . . . .1-800-793-2262 Central Illinois CCOP Memorial Medical Center Springfield, Illinois. . . . . . . . . . . . . .217-788-4444 Decatur Memorial Hospital Decatur, Illinois. . . . . . . . . . . . . . . .217-875-3228 Illinois Cancer Center Chicago, Illinois. . . . . . . . . . . . . . . . .312-986-7047 Evanston Hospital Evanston, Illinois . . . . . . . . . . . . . . .708-570-2100 Hinsdale Hematology Oncology Associates Hinsdale, Illinois . . . . . . . . . . . . . . .708-654-1790 Lutheran General Hospital Park Ridge, Illinois . . . . . . . . . . . . . .708-696-8650 McNeal Cancer Center Berwyn, Illinois . . . . . . . . . . . . . . . .708-795-3195 Michael Reese-Humana Hospital Chicago, Illinois. . . . . . . . . . . . . . . .312-791-3341 Health InfoCom Network News Page 58 Volume 6, Number 5 March 8, 1993 Northwestern University Cancer Center Chicago, Illinois. . . . . . . . . . . . . . . .312-908-9068 Oncology Care Center Belleville, Illinois . . . . . . . . . . . . . .618-236-1000 ext. 139 Rockford Clinic Rockford, Illinois . . . . . . . . . . . . . . .815-968-0051 ext. 2345 St. John's Cancer Institute Springfield, Illinois. . . . . . . . . . . . . .217-544-6464 ext. 5385 Swedish American Hospital Rockford, Illinois . . . . . . . . . . . . . . .815-968-2500 University of Illinois at Chicago Chicago, Illinois. . . . . . . . . . . . . . . .312-996-5949 Illinois Masonic Cancer Center Chicago, Illinois. . . . . . . . . . . . . . . . .312-296-5338 Or 312-296-7236 Mercy Hospital and Medical Center Chicago, IL. . . . . . . . . . . . . . . . . . .312-567-2600 St. Francis Hospital Evanston, IL . . . . . . . . . . . . . . . . . .708-492-7115 Illinois Masonic Community Health Center Chicago, IL. . . . . . . . . . . . . . . . . . .312-296-7454 Hispano Care, Inc. Chicago, IL. . . . . . . . . . . . . . . . . . .312-296-7678 Masonicare, Inc. Chicago, IL. . . . . . . . . . . . . . . . . . .312-296-7166 IMMC/Dept. of OB/GYN Chicago, IL. . . . . . . . . . . . . . . . . . .312-296-7041 Health InfoCom Network News Page 59 Volume 6, Number 5 March 8, 1993 IMMC/Dept. of Ambulatory Care Chicago, IL. . . . . . . . . . . . . . . . . . .312-296-7062 Piel BCPT Chicago, IL. . . . . . . . . . . . . . . . . . .312-549-5400 Currie BCPT Chicago, IL. . . . . . . . . . . . . . . . . . .312-288-3310 St. Elizabeth Hospital Chicago, IL. . . . . . . . . . . . . . . . . . .312-278-2000 . . . . . . . . . . . . . . . . . . . . . . . . .ext. 5907 Loyola Medical Center Maywood, IL. . . . . . . . . . . . . . . . . . .708-216-4762 University of Illinois Chicago, IL. . . . . . . . . . . . . . . . . . .312-996-5162 Progressive Care Chicago, IL. . . . . . . . . . . . . . . . . . .312-774-0042 Rush Medical College Chicago, Illinois. . . . . . . . . . . . . . . . .312-563-2057 University of Chicago Chicago, Illinois. . . . . . . . . . . . . . . . .312-702-3183 Or 312-702-0921 SEE INDIANA: Galesburg Clinic SEE IOWA: United Medical Center INDIANA Hoosier Oncology Group Indianapolis, Indiana. . . . . . . . . . . . . . .1-800-227-2345 Galesburg Clinic Galesburg, Illinois. . . . . . . . . . . . . . .1-800-428-4963 WUMC - Barnard Cancer Center St. Louis, Missouri. . . . . . . . . . . . . . .314-362-5252 Health InfoCom Network News Page 60 Volume 6, Number 5 March 8, 1993 IOWA Cedar Rapids Oncology Project CCOP Cedar Rapids, Iowa . . . . . . . . . . . . . . . .319-365-5241 United Medical Center Moline, Illinois . . . . . . . . . . . . . . . .309-757-2000 University of Iowa Iowa City, Iowa. . . . . . . . . . . . . . . . . .319-356-2778 SEE SOUTH DAKOTA: Sioux-Land Hematology Oncology KANSAS University of Kansas Medical Center Kansas City, Kansas. . . . . . . . . . . . . . . .913-588-4092 Wichita CCOP Wichita, Kansas. . . . . . . . . . . . . . . . . .316-268-8222 Or 316-268-5784 KENTUCKY University of Kentucky Consortium/ Lexington Clinic Lexington, Kentucky. . . . . . . . . . . . . . . .606-255-6841 ext. 4994 University of Kentucky Medical Center Clinical Research Program Markey Cancer Center Lexington, Kentucky. . . . . . . . . . . . . . . .606-257-5207 University of Kentucky Consortium/ Lexington Clinic King's Daughter Hospital Ashland, Kentucky. . . . . . . . . . . . . . . . .606-327-4535 Or 606-327-4630 Health InfoCom Network News Page 61 Volume 6, Number 5 March 8, 1993 University of Kentucky Consortium/ Lexington Clinic Graves Gilbert Clinic Bowling Green, Kentucky. . . . . . . . . . . . . .502-781-5111 ext. 127 University of Kentucky Consortium/ Lexington Clinic, Cancer Care Center St. Elizabeth's Medical Center Edgewood, Kentucky . . . . . . . . . . . . . . . .606-344-5550 University of Louisville Louisville, Kentucky . . . . . . . . . . . . . . .502-588-5245 Oncology Associates Knoxville, Tennessee . . . . . . . . . . . . . .615-523-2024 The Tennessee Breast Center Maryville, Tennessee . . . . . . . . . . . . . .615-984-9282 LOUISIANA CCOP, Alton Ochsner New Orleans, Louisiana . . . . . . . . . . . . . .504-838-3708 (Also has sites in Mississippi) MAINE East Maine Medical Center Clinic for Cancer & Blood Disorders Bangor, Maine. . . . . . . . . . . . . . . . . . .207-945-7481 MARYLAND University of Maryland Medical Center Baltimore, Maryland. . . . . . . . . . . . . . . .1-800-492-5538 Or Health InfoCom Network News Page 62 Volume 6, Number 5 March 8, 1993 410-328-5224 Greater Baltimore Oncology Center Baltimore, Maryland. . . . . . . . . . . . . . .410-828-3706 Johns Hopkins Hospital Baltimore, Maryland. . . . . . . . . . . . . . .410-955-4765 Sacred Heart Oncology Clinic Cumberland, Maryland . . . . . . . . . . . . . .301-759-5075 MASSACHUSETTS Boston University Medical Center Boston, Massachusetts. . . . . . . . . . . . . . .617-638-8260 Or 617-638-8261 Brockton Hospital Boston, Massachusetts. . . . . . . . . . . . . .508-941-7979 Lahey Clinic Burlington, Massachusetts. . . . . . . . . . . .617-273-8989 St. Ann's Hospital Fall River, Massachusetts. . . . . . . . . . . .508-675-5688 University of Massachusetts Medical Center Worcester, Massachusetts . . . . . . . . . . . .508-856-2424 or 508-856-3902 Dana-Farber Cancer Institute Boston, Massachusetts. . . . . . . . . . . . . . .617-732-2177 Harvard Community Health Plan Boston, Massachusetts. . . . . . . . . . . . . .617-421-1375 Faulkner Breast Center Boston, Massachusetts. . . . . . . . . . . . . .617-732-2177 Miriam Hospital Providence, Rhode Island . . . . . . . . . . . .617-732-2177 Health InfoCom Network News Page 63 Volume 6, Number 5 March 8, 1993 The Breast Health Center New England Medical Center Hospital Boston, Massachusetts. . . . . . . . . . . . . . .617-350-8159 Lawrence Memorial Hospital of Medford Medford, Massachusetts . . . . . . . . . . . . .617-396-9250 ext. 1820 Southwood Community Hospital/Norwood Hospital Norfolk & Norwood, Massachusetts . . . . . . . .1-800-458-0228 MICHIGAN Michigan State University East Lansing and Bay City, Michigan. . . . . . . .517-336-2616 CCOP Kalamazoo Kalamazoo, Michigan. . . . . . . . . . . . . . .616-383-4823 University of Michigan Ann Arbor, Michigan. . . . . . . . . . . . . . . .313-936-9943 Henry Ford Hospital Detroit, Michigan. . . . . . . . . . . . . . . .313-876-1046 Saginaw Cooperative Hospitals Saginaw & Bay City, Michigan . . . . . . . . . .1-800-541-3939 Grand Rapids Clinical Oncology Program Grand Rapids, Michigan Holland, Michigan Battlecreek, Michigan Traverse City, Michigan Big Rapids, Michigan . . . . . . . . . . . . . .616-732-8889 Wayne State University Detroit, Michigan. . . . . . . . . . . . . . . . .313-745-9590 ---------------------------------------------------------------------------- TELEPHONE NUMBERS IN THE UNITED STATES - BY STATE MINNESOTA - NORTH CAROLINA Health InfoCom Network News Page 64 Volume 6, Number 5 March 8, 1993 MINNESOTA Hennepin County Medical Center Minneapolis, Minnesota . . . . . . . . . . . . . .612-347-4262 Metro-Minnesota BCPT Center St. Louis Park, Minnesota. . . . . . . . . . . . .1-800-227-2345 Abbott-Northwestern Hospital Minneapolis, Minnesota . . . . . . . . . . . . .612-874-4444 Fairview Riverside Medical Center Minneapolis, Minnesota . . . . . . . . . . . . .612-371-6200 Fairview Southdale Hospital Edina, Minnesota . . . . . . . . . . . . . . . .612-371-6200 Health One Mercy Hospital Coon Rapids, Minnesota . . . . . . . . . . . . .612-336-6100 Health One Unity Hospital Fridley, Minnesota . . . . . . . . . . . . . . .612-336-6100 Methodist Hospital St. Louis Park, Minnesota. . . . . . . . . . . .612-932-5700 Health East Midway Hospital St. Paul, Minnesota. . . . . . . . . . . . . . .612-221-2273 Health East St. Joseph's Hospital St. Paul, Minnesota. . . . . . . . . . . . . . .612-221-2273 United Hospital St. Paul, Minnesota. . . . . . . . . . . . . . .612-336-6100 Health East St. John's Hospital Maplewood, Minnesota . . . . . . . . . . . . . .612-221-2273 North Memorial Medical Center Robbinsdale, Minnesota . . . . . . . . . . . . .612-520-5155 Rice Memorial Hospital Willmar, Minnesota . . . . . . . . . . . . . . .612-231-4570 The Duluth Clinic, Ltd. Health InfoCom Network News Page 65 Volume 6, Number 5 March 8, 1993 Duluth, Minnesota. . . . . . . . . . . . . . . . .218-725-3456 Midelfort Clinic, Ltd. Eau Claire, Wisconsin. . . . . . . . . . . . . .715-839-5296 Thunder Bay Regional Cancer Centre Thunder Bay, Ontario . . . . . . . . . . . . . .807-343-1610 ext. 1675 MISSISSIPPI See Louisiana, Ochsner Clinic MISSOURI Ellis Fishel Cancer Center Columbia, Missouri . . . . . . . . . . . . . . . .314-882-8545 Midwest Cooperative Group Outreach Program Kansas City, Missouri. . . . . . . . . . . . . . .816-932-3590 St. Luke's Hospital Kansas City, Missouri. . . . . . . . . . . . . .816-932-2085 Kansas City Clinical Oncology Program Baptist Medical Center Kansas City, Missouri. . . . . . . . . . . . . .816-276-7834 Ozarks Regional CCOP Springfield, Missouri. . . . . . . . . . . . . .417-885-6444 St. Louis/Cape Girardeau CCOP Christian Hospital Northeast/Northwest St. Louis, Missouri. . . . . . . . . . . . . . .314-355-2300 ext. 5733 Or 314-355-2500 ext. 5733 Depaul Health Center St. Louis, Missouri. . . . . . . . . . . . . . .314-344-7995 St. John's Mercy Medical Center St. Louis, Missouri. . . . . . . . . . . . . . .314-569-6540 Health InfoCom Network News Page 66 Volume 6, Number 5 March 8, 1993 St. Joseph's Hospital St. Louis, Missouri. . . . . . . . . . . . . . .314-966-1659 Southeast Missouri Hospital Cape Girardeau, Missouri . . . . . . . . . . . .1-800-455-4636 St. Francis Medical Center Cape Girardeau, Missouri . . . . . . . . . . . .314-339-6886 SEE INDIANA: WUMC - Barnard Cancer Center MONTANA Montana Breast Cancer Prevention Group Billings, Montana. . . . . . . . . . . . . . . . .406-259-2245 NEBRASKA Creighton Cancer Center Omaha, Nebraska. . . . . . . . . . . . . . . . . .1-800-858-7475 (RISK) NEVADA Southern Nevada Cancer Research Foundation Las Vegas, Nevada. . . . . . . . . . . . . . . . .702-384-5608 NEW HAMPSHIRE Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire . . . . . . . . . . . . . .603-650-5284 NEW JERSEY SEE PENNSYLVANIA: Memorial Hospital of Burlington County and Saint Francis Medical Center NEW MEXICO University of New Mexico Cancer Center Health InfoCom Network News Page 67 Volume 6, Number 5 March 8, 1993 Albuquerque, New Mexico. . . . . . . . . . . . . .505-277-3839 NEW YORK Central New York Breast Cancer Prevention Group Syracuse, New York . . . . . . . . . . . . . . . .315-446-8205 Glens Falls Hospital Glens Falls, New York. . . . . . . . . . . . . . .1-800-724-4425 Mary Imogene Bassett Hospital Cooperstown, New York. . . . . . . . . . . . . . .607-547-3800 North Shore University Hospital Manhasset, New York. . . . . . . . . . . . . . . .516-562-8255 Roswell Park Cancer Institute Buffalo, New York. . . . . . . . . . . . . . . . .716-845-7667 or 1-800-767-9355 (ROSWELL) Special Surveillance Breast Program Memorial Sloan Kettering Cancer Center New York, New York . . . . . . . . . . . . . . . .212-639-5877 Strang Cancer Center New York, New York . . . . . . . . . . . . . . . .212-734-5625 St. Vincent's Hospital/Guttman New York, New York . . . . . . . . . . . . . . . .212-229-9355 NORTH CAROLINA Duke University Medical Center Durham, North Carolina . . . . . . . . . . . . . .919-684-2995 Florida Hospital Orlando, Florida . . . . . . . . . . . . . . . .407-897-5763 East Carolina University Greenville, North Carolina . . . . . . . . . . . .1-800-722-3281 ext. 2391 Health InfoCom Network News Page 68 Volume 6, Number 5 March 8, 1993 Southeast Cancer Control Consortium, Inc. Goldsboro, North Carolina. . . . . . . . . . . . .919-580-0000 Southeast Cancer Control Consortium, Inc. Hickory, North Carolina. . . . . . . . . . . . . .704-324-9550 Southeast Cancer Control Consortium, Inc. Greensboro, North Carolina . . . . . . . . . . . .919-379-4183 Southeast Cancer Control Consortium, Inc. Asheville, North Carolina. . . . . . . . . . . . .704-253-0969 Southeast Cancer Control Consortium, Inc. Raleigh, North Carolina. . . . . . . . . . . . . .919-783-3105 Southeast Cancer Control Consortium, Inc. Winston-Salem, North Carolina. . . . . . . . . . .919-760-0122 Southeast Cancer Control Consortium, Inc. Presbyterian Hospital Charlotte, North Carolina. . . . . . . . . . . . .1-800-755-7563 Or 704-384-4111 Southeast Cancer Control Consortium, Inc. (SCCC) Carolinas Medical Center Charlotte, North Carolina. . . . . . . . . . . . .704-355-3789 University of North Carolina Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina. . . . . . . . . . . .1-800-862-8660 Cape Fear Valley Medical Center Fayetteville, North Carolina . . . . . . . . . .919-323-6910 --------- end of part 5 ------------ · Subject: HICN605 Medical Newsletter Part 4/6 patients had used ZDV an average of 14 months, whereas those failing ZDV had used it an average of 23 months. Approximately 66% of patients had a prior AIDS diagnosis. The median CD4+ cell count of the enrolled patients was very low, 37 cells per cubic millimeter. The use of concomitant medications at baseline was similar in the two groups. Results Main Endpoint Disease progression, including death, occurred in 156 ddI patients and 150 ddC patients (rate per 100 person years: 92.3 for ddI vs 86.4 for ddC; relative risk = 0.93, p-value = 0.56). Thus, there is no statistically significant difference between the two treatments based on this endpoint. The ddI group reported 100 deaths while the ddC group had 87 and the difference between the groups is approaching, but does not reach, a statistically significant level (relative risk 0.76, p-value = 0.072). There were small, not statistically significant differences in several characteristics with known prognostic value for progression of HIV disease and survival: number of CD4+ cells, AIDS diagnosis and Karnofsky score. These small baseline imbalances in important prognostic factors between the two groups, especially for Karnofsky score, indicate that the ddC group may have been, by chance, slightly more ill than the ddI group. It may be difficult to distinguish the effect of the treatments under study from any inherent differences in those baseline characteristics. Adjusted analysis is done in order to make sure that any differences in outcome have not been influenced by those random baseline differences. When analysis of these results was performed adjusting for these prognostic characteristics, the risk of progression of disease including death is in the direction of favoring ddC, although still not statistically significant (p = 0.11). The adjusted risk of death alone, however, does indicate an advantage for ddC (p = 0.002). Health InfoCom Network News Page 41 Volume 6, Number 5 March 8, 1993 Disseminated Mycobacterium avium infection (MAI) infection was the most common non-fatal first event in both treatment groups (ddI=24 vs ddC=27), with Pneumocystis carinii pneumonia (PCP) and candidiasis following. Longitudinal analysis of data on CD4+ cells show that the average change after 2 months for those receiving ddI was significantly greater than for those receiving ddC. Between months 2 and 18, CD4+ cell counts declined in both groups. Toxicity While on initial study drug, at least one adverse experience was reported by 67% of patients on ddI and 66% on ddC. Many patients had multiple adverse experiences. Although the number and rates for patients with at least one adverse experience were similar in the two groups, the nature of these experiences were different. Peripheral neuropathy was seen significantly more frequently in patients receiving ddC (32 on ddI vs 69 on ddC, p<0.001), while stomatitis occurred only in ddC (8 patients). Pancreatitis was seen only in patients on ddI (4 patients). Diarrhea (48 vs 9, p<0.001) and abdominal pain (16 vs 7, p=0.030) occurred significantly more often in patients receiving ddI than in those receiving ddC. Conclusions The findings of the ddI/ddC study may offer a new therapeutic option to clinicians treating patients with advanced HIV disease. For patients in this study, those who have failed or are intolerant of ZDV, ddC was found to be at least as efficacious as ddI in delaying disease progression and death. The results of this study suggest that ddC is an acceptable alternative monotherapy to ddI in patients intolerant of or failing on ZDV; ddC monotherapy delays clinical progression at least as long as ddI, and may provide a survival advantage. Since the majority of patients (66 percent overall) experienced disease progression with either treatment and the differences in outcome are not large, the toxicity profiles of these two drugs will be important to consider when choosing antiretroviral treatment for an individual patient. The results of this study, along with other recently released studies, provide additional information on the choice of antiretroviral agents for treatment of persons with HIV infection. The results of the CPCRA ddI/ddC study are not intended to answer questions about the use of these therapies in previously untreated patients, the relative benefit of nucleoside therapy versus no nucleoside therapy in patients who have failed or are intolerant of ZDV, or the use of either ddI or ddC in patients who tolerate or derive benefit from ZDV. Other ongoing or recently completed studies address those questions. In order to guide clinicians in the integration of the results of these studies Health InfoCom Network News Page 42 Volume 6, Number 5 March 8, 1993 into their clinical practice, the Division of AIDS of NIAID will sponsor a conference on the state-of-the art of antiretroviral therapy in HIV infection. This conference is planned for summer 1993. For more information about the CPCRA ddI/ddC study, please call 1-800-TRIALS-A. Health InfoCom Network News Page 43 Volume 6, Number 5 March 8, 1993 :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Announcements of Studies/Research :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Tamoxifen Breast Cancer Prevention Trial Information ============================================================================ Q and A About the Breast Cancer Prevention Trial (1/93) Questions and Answers About the BCPT Trial (1/93) 1. What is the Breast Cancer Prevention Trial? The Breast Cancer Prevention Trial or BCPT is a clinical trial designed to see whether taking the drug tamoxifen (trade name Nolvadex) can prevent breast cancer in women who are at an increased risk of developing the disease. The BCPT will also determine whether taking tamoxifen decreases the number of heart attacks and reduces the number of bone fractures in these women. Researchers with the National Surgical Adjuvant Breast and Bowel Project (NSABP) are conducting the study in centers across the United States and Canada. The study is funded by the National Cancer Institute, the U.S. government's lead agency for cancer research. 2. What is a clinical trial? A clinical trial is a research study conducted with people. There are many types of clinical trials. They range from studies to prevent, detect, diagnose, and treat a disease to studies of the psychological impact of the disease and ways to improve a patient's comfort and quality of life. 3. Who is eligible to participate in the BCPT? Two groups of women are eligible to participate in the study: women 60 years of age and older are eligible based on their age alone, while women between the ages of 35 and 59 will be eligible if they are at sufficiently increased risk for developing breast cancer. Health InfoCom Network News Page 44 Volume 6, Number 5 March 8, 1993 4. Why are women 60 years of age or older eligible for the BCPT based on age alone? Many diseases, including breast cancer, occur more often in older persons. The risk of developing breast cancer increases with age, so it is more common to find breast cancer in women over 60 years of age. The risk of heart disease also increases with age, and tamoxifen may be of benefit in reducing risk for developing this disease. 5. What determines increased risk of breast cancer for women aged 35 to 59? To participate in the trial, women 35 to 59 years of age must have a risk of developing breast cancer within the next five years that is equal to or greater than the average risk of a 60-year-old woman. This increased risk is determined in one of two ways: A woman must have other risk factors, in addition to her age, that combine to place her at increased risk for breast cancer. This risk is determined by a computer calculation based on the following factors: - number of first-degree relatives (mother, daughters, or sisters) who have been diagnosed with breast cancer; - whether a woman has any children and her age at the first delivery; - the number of times a woman has had breast lumps biopsied, especially if the tissue was shown to have a condition known as atypical hyperplasia; and - the woman's age at her first menstrual period. OR A woman must have been diagnosed with the noninvasive breast cancer, lobular carcinoma in situ, a condition that greatly increases her chance of developing invasive breast cancer. Health InfoCom Network News Page 45 Volume 6, Number 5 March 8, 1993 6. Are there other factors that affect eligibility for the trial? Certain existing health conditions may affect a woman's eligibility for the trial. For example, women at increased risk for blood clots are not able to participate. Also, women who are taking hormone replacements for menopausal symptoms and women using oral contraceptives cannot take part in the trial unless they stop taking these medications. Those who stop taking these hormones are eligible for the trial three months after they discontinue the drugs. 7. Are pregnant women allowed to participate in this trial? Women who are currently pregnant or who plan to become pregnant are not eligible to participate. Premenopausal women partici- pating in the BCPT must use some method of birth control other than oral contraceptives ("the pill") while taking tamoxifen. Oral contraceptives may change the effects of tamoxifen and may also affect the risk of breast cancer. 8. Will every woman in the trial receive tamoxifen? The 16,000 women who will participate in the BCPT will be randomized (selected by chance) to receive either tamoxifen or a placebo (an inactive pill that looks like tamoxifen). In a process known as "double-blinding," neither the participant nor her physician will know which pill she is receiving. Setting up a trial in this way allows researchers to clearly see what the true benefits and side effects of tamoxifen may be without the influence of other factors. 9. What is the dose of tamoxifen and how long will it be given? All women in the trial will take two pills a day for five years, either a 20-milligram dose of tamoxifen (two 10 mg pills) or a placebo. 10. How much will the tamoxifen cost? Health InfoCom Network News Page 46 Volume 6, Number 5 March 8, 1993 There is no charge to participants for the tamoxifen or placebo. The company that manufactures tamoxifen, ICI Americas, Inc., Wilmington, Del., is providing both the tamoxifen and the placebo without charge. 11. Are women required to have any medical exams? Participants are required to have blood tests, a pelvic exam, mammogram, and physical exam before they are accepted into the study. Women 55 years of age and older will need to have an electrocardiogram, or ECG (a test to measure the heart's muscular activity), in addition to the other tests. These tests will be repeated at intervals during the study. 12. Who will pay for these medical exams? Physician or medical test costs will be charged to the partici- pant in the same fashion as if she were not part of the trial; however, the costs for these tests may be covered by a number of insurance companies. For women over 55, the required electrocardiograms will be done at no cost. Every effort will be made to contain the costs specifically associated with participation in this trial. 13. What are the responsibilities of a woman participating in this trial? Women entering the Breast Cancer Prevention Trial need to be committed to it for at least five years. Throughout the course of the study, participants will have several responsibilities. Daily for five years, women need to take two pills. Partici- pants must also report any side effects they experience to the investigators, and must obtain periodic followup examinations. At the time of these exams, participants also will be required to complete some forms and questionnaires. Every effort will be made to make followup appointments convenient and to ensure that all the women who participate in the trial feel comfort- able with their involvement. 14. How can women enroll in the trial? Health InfoCom Network News Page 47 Volume 6, Number 5 March 8, 1993 Women who are interested in participating in the trial should contact the center nearest to them. To locate the nearest center in the United States, a woman can call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) or the American Cancer Society's Cancer Response System at 1-800-ACS- 2345. In Canada, participating centers can be located by calling: in British Columbia and the Yukon, 1-604-879-2323; in Ontario, 1- 800-263-6750; in Quebec, 1-800-361-4212; and in other areas, 1- 416-387-1153. --------------------------------------------------------------------------- Questions and Answers About Tamoxifen (1/93) 1. What is tamoxifen? Tamoxifen is a drug, taken by mouth as a pill, that has been used for almost 20 years to treat patients with advanced breast cancer. Since 1985 it has also been recommended in the United States for "adjuvant," or additional, therapy following radiation and/or surgery for early stage breast cancer. 2. How does tamoxifen work in treating breast cancer? One way that tamoxifen works in breast cancer is to interfere with the activity of estrogen, a female hormone that promotes the growth of cancer cells in the breast. Because tamoxifen works against the effects of estrogen on breast cancer cells, it is often called an "anti-estrogen." As a treatment, the drug slows or stops the growth of these cancer cells. As adjuvant therapy, tamoxifen has been shown to help prevent the original breast cancer from returning. 3. Why is tamoxifen now being tested to prevent breast cancer? Research has shown that taking tamoxifen as adjuvant therapy for breast cancer may also prevent the development of new cancers in the opposite breast. Evidence from these and other Health InfoCom Network News Page 48 Volume 6, Number 5 March 8, 1993 studies suggests that tamoxifen may have beneficial prevention qualities in healthy women who do not yet have breast cancer. 4. Does tamoxifen affect other parts of the body besides breast tissues? While tamoxifen acts against the effects of estrogen in breast tissues, it acts like estrogen in other body systems. For example, because it acts like estrogen, women who take tamoxifen may have many of the beneficial effects of estrogen replacement therapy, such as a lowering of blood cholesterol and a slowing of bone loss that may lead to osteoporosis. 5. Can tamoxifen cause side effects? Like most medications, whether over-the-counter medications, prescription drugs, or drugs in clinical trials, tamoxifen may cause side effects. For example, in a recent NSABP breast cancer study where women with breast cancer took either tamoxifen or a placebo, the side effects experienced more often by women taking tamoxifen were hot flashes and vaginal discharge. Women in both groups reported sometimes having side effects--even though the placebo itself would not cause any symptoms. The side effects that some women in both groups reported included: vaginal dryness, itching, or bleeding; menstrual irregularities; depression; loss of appetite; nausea and/or vomiting; dizziness; headaches; and fatigue. Participants in the BCPT will have all their side effects monitored and will receive periodic physical exams. Treatments that may minimize or eliminate most side effects will be avail- able. 6. Does tamoxifen cause a woman to begin menopause? Tamoxifen does not cause a woman to begin menopause. In most women taking the drug, the ovaries continue to function normally and produce female hormones (estrogens) in the same or slightly increased amounts. Because tamoxifen does not cause a woman to begin menopause, there is a chance that pregnancy Health InfoCom Network News Page 49 Volume 6, Number 5 March 8, 1993 could occur. This is why all premenopausal women participating in this trial must use some method of birth control other than oral contraceptives while taking tamoxifen. 7. Does tamoxifen cause blood clots? Data from large clinical trials suggest that there is a small increase in the number of blood clots in breast cancer patients taking tamoxifen, particularly if they are also receiving other anticancer drugs (chemotherapy). The total number of women who have experienced blood clots while taking tamoxifen is small. Women who have had blood clots in the past may not be eligible to participate in this trial. 8. Does tamoxifen cause any other serious side effects? Before a woman agrees to participate in the Breast Cancer Prevention Trial, a health professional will fully discuss the potential benefits and risks from the drug and medical procedures that will be used. The potential benefits and side effects of tamoxifen are frequently due to its estrogen-like effects. Estrogens are known to increase the risk of endometrial cancer, and there are reports from several large clinical trials showing that breast cancer patients taking tamoxifen have an increased risk of endometrial cancer. Endometrial cancer frequently causes bleeding and is usually diagnosed in its early stages--when treatment by surgery alone is effective. The endometrial cancers that have occurred during studies of women taking tamoxifen have all been found in very early stages. Because of some association between estrogens (particularly oral contraceptives) and liver cancer, there has also been some concern that tamoxifen may cause liver cancer. No liver cancers have been reported in trials in which women took a 20 mg/day dose of the drug (the dose given in the BCPT). In studies in which women took 40 mg of tamoxifen daily, there have been two reports of liver cancer as well as a few reports of liver complications. Based on the current available information, tamoxifen has not been shown to be the cause of the liver complications or the liver cancer. However, to ensure the safety of the women who participate in the BCPT, blood tests to check liver functions will be done at regular Health InfoCom Network News Page 50 Volume 6, Number 5 March 8, 1993 intervals. --------------------------------------------------------------------------- Other Important Questions About the BCPT (1/93) 1. Why is the Breast Cancer Prevention Trial so important? This year, over 180,000 women in the United States alone will be diagnosed with breast cancer, and more than 46,000 will die of the disease. For many years, women at increased risk for developing breast cancer have had no way to reduce their risk. Women have to rely on examinations such as monthly breast self- examinations, frequent checkups, and periodic mammograms to detect breast cancer in its earliest stages. Doctors sometimes suggest that certain women at very high risk have a preventive (prophylactic) mastectomy, which is surgery to remove breast tissue before cancer develops. The operation does not always guarantee that breast cancer will be avoided, because it is almost impossible to remove all the breast tissue. If tamoxifen is successful in preventing breast cancer, women at increased risk for developing the disease will have a choice other than more frequent exams or major surgery. Tamoxifen may be able to reduce by one-third or more the number of breast cancers that occur in women at increased risk. In addition, tamoxifen may decrease the risk of heart attacks by lowering blood cholesterol. However, in order to give women this choice, tamoxifen must be tested in a large clinical trial to determine if the benefits outweigh any risk. 2. How could a healthy woman benefit from participating in the BCPT? The decision to take part in any clinical trial is an individu- al one. Researchers hope that tamoxifen will prevent breast cancer from occurring in those women receiving it in the trial. Women will also benefit from regular mammograms and checkups, which can help detect breast cancer in its earliest stages. They will also benefit from the state-of-the-art medical care they receive from the health professionals involved in the Health InfoCom Network News Page 51 Volume 6, Number 5 March 8, 1993 trial. At each clinical center where women can be enrolled, nurses and physicians will explain important information about the trial and will discuss any questions a potential partici- pant may have. 3. What is the National Surgical Adjuvant Breast and Bowel Project? The National Surgical Adjuvant Breast and Bowel Project is a large group of cancer researchers who receive funding and support from the U.S. National Cancer Institute. The more than 6,000 physicians, nurses, and other medical professionals in the NSABP are located in over 250 medical centers throughout the United States and Canada. NSABP was founded in 1958 and has been a leader in breast cancer research. The results of clinical trials conducted by NSABP researchers have been the dominant force in altering the standard surgical treatment of breast cancer from mastectomy to lumpectomy plus radiation. This group was also the first to demonstrate that adjuvant therapy could alter the natural history of breast cancer, thus increasing survival rates. To date, more than 30,000 women who have had breast cancer have participated in treatment clinical trials conducted by NSABP investigators. A clinical trial to prevent breast cancer is a logical next step for this research group. ============================================================================ Tamoxifen Breast Cancer Prevention Trial Information 2. Breast Cancer Prevention Trial Referral Information (7/92) The Breast Cancer Prevention Trial is being conducted at over 270 sites across the United States and Canada. Referral information has been arranged alphabetically by state so that the closest participating organization can be located. Breast Cancer Prevention Trial (BCPT) with Tamoxifen Telephone Contact List Health InfoCom Network News Page 52 Volume 6, Number 5 March 8, 1993 MAIN TELEPHONE NUMBERS United States. . . . . . . . . . . . . . . . . . .1-800-4-CANCER Or 1-800-ACS-2345 Canada British Columbia/The Yukon . . . . . . . . . . .604-879-2323 Ontario. . . . . . . . . . . . . . . . . . . . .1-800-263-6750 Quebec . . . . . . . . . . . . . . . . . . . . .1-800-361-4212 Other Regions. . . . . . . . . . . . . . . . . .416-387-1153 TELEPHONE NUMBERS IN THE UNITED STATES - BY STATE ALABAMA - GEORGIA ALABAMA Baptist Medical Center Birmingham, Alabama. . . . . . . . . . . . . . . .1-800-421-2065 Or 205-581-9800 University of Alabama at Birmingham Cancer Center Birmingham, Alabama. . . . . . . . . . . . . . . .205-934-1338 University of South Alabama Mobile, Alabama. . . . . . . . . . . . . . . . . .205-460-6474 ARIZONA Arizona Cancer Center Tucson, Arizona. . . . . . . . . . . . . . . . . .602-626-4100 Tucson Breast Center Tucson, Arizona. . . . . . . . . . . . . . . . .602-326-6267 Greater Phoenix CCOP Health InfoCom Network News Page 53 Volume 6, Number 5 March 8, 1993 Phoenix, Arizona . . . . . . . . . . . . . . . .602-239-6797 Maricopa Medical Center Phoenix, Arizona . . . . . . . . . . . . . . . .602-267-5508 CALIFORNIA Bay Area Cancer Control Consortium CCOP San Francisco, California. . . . . . . . . . . . .1-800-283-9765 City of Hope National Medical Center Duarte, California . . . . . . . . . . . . . . . .1-800-934-5555 Harbor-UCLA Medical Center Research and Education Institute Torrance, California . . . . . . . . . . . . . . .310-533-2217 Kaiser Permanente CCOP San Diego, California. . . . . . . . . . . . . . .619-528-6325 Long Beach Memorial Breast Center Long Beach, California . . . . . . . . . . . . . .1-800-638-1900 Saddleback Breast Cancer Center Saddleback Memorial Medical Center Orange County, California. . . . . . . . . . . .714-859-2660 Los Angeles Oncologic Institute at St. Vincent Medical Center Los Angeles, California Other Sites: Los Angeles Intake Center San Gabriel Valley Intake Center Inland Empire Intake Center. . . . .1-800-499-5264 Or 213-484-7086 Norris Cancer Hospital Los Angeles, California. . . . . . . . . . . . . .1-800-498-6666 Or 213-224-6929 San Joaquin Valley CCOP Fresno, California . . . . . . . . . . . . . . . .209-221-5614 Health InfoCom Network News Page 54 Volume 6, Number 5 March 8, 1993 St. Mary Medical Center/Long Beach Community Hospital Long Beach Community Hospital Long Beach, California . . . . . . . . . . . . .1-800-554-2844 St. Mary Medical Center Los Angeles County and Orange County, California1-800-377-7040 Stanford University Breast Cancer Prevention Center Palo Alto, California. . . . . . . . . . . . . . .415-723-8686 Sutter Breast Cancer Center Sacramento, California . . . . . . . . . . . . . .1-800-524-7475 (RISK) University of California, LA Los Angeles, California. . . . . . . . . . . . . .310-825-9502 U.C. Davis Cancer Center Sacramento, California . . . . . . . . . . . . . .1-800-547-2278 (BCPT) COLORADO --------- end of part 4 ------------ --- Internet: david@stat.com FAX: +1 (602) 451-1165 Bitnet: ATW1H@ASUACAD FidoNet=> 1:114/15 Amateur Packet ax25: wb7tpy@wb7tpy.az.usa.na --- * PCB/UseNet Gateway from Sparkware #3 ∙HEADER:USENET Path: channel1!uupsi!psinntp!rpi!gatech!asuvax!ennews!stat!david From: david@stat.com (David Dodell) Newsgroups: sci.med Subject: HICN605 Medical Newsletter Part 4/6 Message-ID: <qHq5ZB12w165w@stat.com> Date: Mon, 08 Mar 93 22:30:37 MST Reply-To: david@stat.com (David Dodell) Distribution: world Organization: Stat Gateway Service, WB7TPY Lines: 708 ============================================================================== Date: 03-10-93 (14:29) Number: 20974 Channel 1(R) Communica To: ALL Refer#: NONE From: DAVID DODELL Read: YES Subj: HICN605 MEDICAL NEWSLETTE Conf: (1659) med ------------------------------------------------------------------------ · Newsgroup: sci.med · Message-ID: <0iq5ZB14w165w@stat.com> · Subject: HICN605 Medical Newsletter Part 6/6 ------------- cut here ----------------- --------------------------------------------------------------------------- TELEPHONE NUMBERS IN THE UNITED STATES - BY STATE NORTH DAKOTA - TEXAS Health InfoCom Network News Page 69 Volume 6, Number 5 March 8, 1993 NORTH DAKOTA St. Luke's Hospital CCOP Roger Maris Cancer Center Fargo, North Dakota. . . . . . . . . . . . . . . .701-234-5842 OHIO Columbus CCOP Columbus and Springfield, Ohio Community Hospital of Springfield Doctors Hospitals Grant Medical Center Medical Center of Chillicothe Mercy Medical Center of Springfield Mount Carmel Hospitals Park Medical Center. . . . . . . . . . . . . . .614-443-2267 Ohio State James Cancer Hospital Columbus, Ohio . . . . . . . . . . . . . . . . . .614-293-8892 Riverside Regional Cancer Institute Columbus, Ohio . . . . . . . . . . . . . . . . .614-566-4321 Northeast Ohio Breast Cancer Prevention Trial Group Cleveland, Ohio. . . . . . . . . . . . . . . . . .1-800-686-2278 (BCPT) The Dayton Clinical Oncology Program Kettering, Ohio. . . . . . . . . . . . . . . . . .513-296-7278 Toledo Community Hospital Oncology Program Toldeo, Ohio . . . . . . . . . . . . . . . . . . .419-255-5433 University of Cincinnati Cincinnati, Ohio . . . . . . . . . . . . . . . . .513-558-2278 (BCPT) University of Kentucky Consortium/ Lexington Clinic The Christ Hospital Cancer Center Cincinnati, Ohio . . . . . . . . . . . . . . . . .513-369-2859 Health InfoCom Network News Page 70 Volume 6, Number 5 March 8, 1993 OKLAHOMA Cancer Center of the Southwest Baptist Medical Center of Oklahoma Oklahoma City, Oklahoma. . . . . . . . . . . . . .1-800-327-2273 Or 405-946-2273 Saint Francis Hospital Natalie Warren Bryant Cancer Center Tulsa, Oklahoma. . . . . . . . . . . . . . . . . .1-800-695-9501 Or 918-494-4500 OREGON Columbia River Oncology Program Portland, Oregon . . . . . . . . . . . . . . . . .503-230-6853 SEE WASHINGTON: Kaiser Permanente PENNSYLVANIA Albert Einstein Cancer Center Philadelphia, Pennsylvania . . . . . . . . . . . .1-800-355-8269 Or 215-456-3500 Bryn Mawr Cancer Center Bryn Mawr, Pennsylvania. . . . . . . . . . . . . .215-526-3800 Fox Chase Network/Affiliates Fox Chase Cancer Center Philadelphia, Pennsylvania . . . . . . . . . . . .215-728-2792 Delaware County Memorial Hospital Drexel Hill, Pennsylvania. . . . . . . . . . . .215-284-8448 Memorial Hospital of Burlington County Mount Holly, New Jersey. . . . . . . . . . . . .609-265-7555 Montgomery Hospital Health InfoCom Network News Page 71 Volume 6, Number 5 March 8, 1993 Norristown, Pennsylvania . . . . . . . . . . . .215-270-2700 North Penn Hospital Lansdale, Pennsylvania . . . . . . . . . . . . .215-361-4950 Paoli Memorial Hospital Paoli, Pennsylvania. . . . . . . . . . . . . . .215-648-1636 Polyclinic Medical Center Harrisburg, Pennsylvania . . . . . . . . . . . .717-782-6678 Saint Francis Medical Center Trenton, New Jersey. . . . . . . . . . . . . . .609-599-5790 Saint Mary Hospital Langhorne, Pennsylvania. . . . . . . . . . . . .215-750-5300 The Reading Hospital and Medical Center Reading, Pennsylvania. . . . . . . . . . . . . .215-378-6512 Geisinger Medical Center - Breast Clinic Danville, Pennsylvania . . . . . . . . . . . . . .1-800-622-2515 Lehigh Valley Hospital Allentown, Pennsylvania. . . . . . . . . . . . . .215-778-2290 Grand View Hospital Sellersville, Pennsylvania . . . . . . . . . . .215-453-4690 Norristown Regional Cancer Center Norristown, Pennsylvania . . . . . . . . . . . .215-278-2500 Pottstown Memorial Medical Center Pottstown, Pennsylvania. . . . . . . . . . . . .215-327-7480 Mercy Hospital Scranton, Pennsylvania . . . . . . . . . . . . . .717-348-7673 Or 717-348-7940 University of Pennsylvania Cancer Center Philadelphia, Pennsylvania . . . . . . . . . . . .1-800-777-8176 Western Pennsylvania BCPT Project NSABP Adjuvant Therapy Center Health InfoCom Network News Page 72 Volume 6, Number 5 March 8, 1993 Pittsburgh, Pennsylvania . . . . . . . . . . . .412-624-6221 Allegheny CCOP Pittsburgh, Pennsylvania . . . . . . . . . . . .412-359-6190 RHODE ISLAND SEE MASSACHUSETTS: Miriam Hospital SOUTH CAROLINA Greenville Memorial Hospital Greenville, South Carolina . . . . . . . . . . . .1-800-998-9080 Or 803-455-3315 Southeast Cancer Control Consortium, Inc. (SCCC) Greenwood, South Carolina. . . . . . . . . . . . .803-227-4457 Southeast Cancer Control Consortium, Inc. (SCCC) Columbia, South Carolina . . . . . . . . . . . . .1-800-775-2287 Southeast Cancer Control Consortium, Inc. (SCCC) Florence, South Carolina . . . . . . . . . . . . .803-667-2376 Or 803-678-5101 Southeast Cancer Control Consortium, Inc. (SCCC) Charleston, South Carolina . . . . . . . . . . . .803-577-2276 Spartanburg CCOP Spartanburg, South Carolina. . . . . . . . . . . .803-560-6810 SOUTH DAKOTA Sioux Community Cancer Consortium Dakota Midwest Cancer Institute Sioux Falls, South Dakota. . . . . . . . . . . . .605-331-3257 Sioux-Land Hematology Oncology Sioux City, Iowa . . . . . . . . . . . . . . . .712-252-3403 Health InfoCom Network News Page 73 Volume 6, Number 5 March 8, 1993 TENNESSEE Southeast Cancer Control Consortium, Inc. (SCCC) Kingsport, Tennessee . . . . . . . . . . . . . . .615-224-5592 Thompson Cancer Center Knoxville, Tennessee . . . . . . . . . . . . . . .1-800-388-3313 Or 615-541-4966 Centennial Medical Center Nashville, Tennessee . . . . . . . . . . . . . .615-342-3760 SEE KENTUCKY: Oncology Associates and The Tennessee Breast Center TEXAS Baylor-Charles A. Sammons Cancer Center Dallas, Texas. . . . . . . . . . . . . . . . . . .1-800-422-9567 M.D. Anderson Houston, Texas . . . . . . . . . . . . . . . . . .713-792-8515 Scott & White Hospital and Clinic/ Texas A&M University School of Medicine Temple, Texas. . . . . . . . . . . . . . . . . . .1-800-551-8858 Or 817-774-5888 University of Texas Health Science Center San Antonio, Texas . . . . . . . . . . . . . . . .512-567-5750 --------------------------------------------------------------------------- TELEPHONE NUMBERS IN THE UNITED STATES - BY STATE UTAH - WISCONSIN UTAH Utah Cancer Center Salt Lake City, Utah . . . . . . . . . . . . . . .801-581-4048 Health InfoCom Network News Page 74 Volume 6, Number 5 March 8, 1993 Or 801-581-5052 VERMONT Vermont Cancer Center Burlington, Vermont. . . . . . . . . . . . . . . .802-656-4414 VIRGINIA Massey Cancer Center Medical College of Virginia Hospitals Richmond, Virginia . . . . . . . . . . . . . . . .1-800-925-8821 James River Clinic Newport News, Virginia . . . . . . . . . . . . .804-766-1905 Southeast Cancer Control Consortium, Inc. Danville, Virginia . . . . . . . . . . . . . . . .804-793-0047 Southeast Cancer Control Consortium, Inc. Martinsville, Virginia . . . . . . . . . . . . . .703-666-7827 WASHINGTON Northwest CCOP/Virginia Mason CCOP Northwest CCOP/Tacoma General Hospital Tacoma, Washington . . . . . . . . . . . . . . . .206-594-1461 St. Joseph Hospital Tacoma, Washington . . . . . . . . . . . . . . .206-627-4101 ext. 5524 St. Peter Hospital Olympia, Washington. . . . . . . . . . . . . . .206-493-7281 Capital Medical Center Olympia, Washington. . . . . . . . . . . . . . .206-754-5858 ext. 2433 Virginia Mason Medical Center CCOP Seattle, Washington. . . . . . . . . . . . . . .206-223-6742 Health InfoCom Network News Page 75 Volume 6, Number 5 March 8, 1993 Kaiser Permanente Portland, Oregon . . . . . . . . . . . . . . . .503-282-8421 Or 503-249-3315 Puget Sound Oncology Consortium Fred Hutchinson Cancer Research Center Seattle, Washington. . . . . . . . . . . . . . . .206-667-6544 WEST VIRGINIA BCPT in West Virginia: Charleston and Morgantown Charleston Area Medical Center Charleston, West Virginia. . . . . . . . . . . .304-348-9523 Or 304-348-9541 West Virginia University Morgantown, West Virginia. . . . . . . . . . . .304-293-3515 Or 304-293-4500 WISCONSIN CCOP Marshfield Clinic Marshfield, Wisconsin. . . . . . . . . . . . . . .1-800-358-3844 Or 715-389-3844 Milwaukee Breast Cancer Prevention Trial Milwaukee, Wisconsin . . . . . . . . . . . . . . .414-283-6814 Wisconsin Comprehensive Cancer Center Madison, Wisconsin . . . . . . . . . . . . . . . .1-800-622-8922 Or 608-262-5223 SEE MINNESOTA: Midelfort Clinic, Ltd. TELEPHONE NUMBERS FOR CANADA Health InfoCom Network News Page 76 Volume 6, Number 5 March 8, 1993 B.C. Cancer Agency Vancouver, British Columbia. . . . . . . . . . . .604-822-7997 Cross Cancer Institute Alberta, Canada. . . . . . . . . . . . . . . . . .403-492-8784 Tom Baker Cancer Centre Calgary, Alberta . . . . . . . . . . . . . . . . .403-670-2492 Credit Valley Hospital Mississauga, Ontario . . . . . . . . . . . . . . .416-820-4040 Hamilton Regional Cancer Center Hamilton, Ontario. . . . . . . . . . . . . . . . .416-575-6348 Toronto Hospital Toronto, Ontario . . . . . . . . . . . . . . . . .416-340-3196 Women's College Hospital Toronto, Ontario . . . . . . . . . . . . . . . . .416-961-3433 Jewish General Hospital/St. Mary's Hospital Montreal, Quebec . . . . . . . . . . . . . . . . .514-340-7562 St. Mary's Hospital Montreal, Quebec . . . . . . . . . . . . . . . .514-342-5630 Royal Victoria Hospital Montreal, Quebec . . . . . . . . . . . . . . . . .514-843-1572 Montreal General Hospital Montreal, Quebec . . . . . . . . . . . . . . . .514-937-7813 Queen Elizabeth Hospital Montreal, Quebec . . . . . . . . . . . . . . . .514-485-5134 University of Montreal Hotel Dieu de Montreal Montreal, Quebec . . . . . . . . . . . . . . . . .514-849-7346 (SEIN) Or 514-843-2611 ext. 4951 Quebec BCPT Center Health InfoCom Network News Page 77 Volume 6, Number 5 March 8, 1993 Quebec City, Quebec. . . . . . . . . . . . . . . .418-682-7394 Manitoba Cancer Treatment and Research Foundation Winnipeg, Manitoba . . . . . . . . . . . . . . . .204-787-4148 Or 204-787-4160 SEE MINNESOTA: Thunder Bay Regional Cancer Center Health InfoCom Network News Page 78 Volume 6, Number 5 March 8, 1993 :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: General Announcments :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Discussion List for Chronic Fatique Syndrome From: "Roger Burns, CFS-MED Moderator" <BFU@CU.NIH.GOV> Announcement An Internet discussion list (CFS-MED) has been created to enable physicians to discuss medical research and clinical issues regarding chronic fatigue syndrome (CFS), usually known outside of the USA as myalgic encephalomyelitis (ME). CFS/ME can be difficult to diagnose, and available treatments are not widely known. Discussions on CFS-MED will hopefully increase knowledge within the medical community about this important illness. The list is moderated. CFS/ME is an illness characterized by debilitating fatigue and a variety of flu-like symptoms. The illness is also known as chronic fatigue immune dysfunction syndrome (CFIDS), and in the past it has been known as chronic Epstein-Barr virus (CEBV). To subscribe to CFS-MED, send the following command to LISTSERV@NIHLIST or to LISTSERV@LIST.NIH.GOV: SUB CFS-MED your_full_name where "your_full_name" is your name. For example: SUB CFS-MED William Harvey M.D. Please remember that CFS-MED is a LISTSERV list, so that administrative commands (such as SUBSCRIBE, etc.) must be sent to LISTSERV@nodename, whereas messages for posting to the list must be sent to CFS-MED@nodename. Note that the CFS-NEWS Electronic Newsletter is also available for subscription at the same LISTSERV. CFS-NEWS emphasizes medical news about CFS, and is issued between 1 and 4 times each month. Additionally, there is a CFS-L general discussion list where patients and others exchange information, also at the same LISTSERV. @NUMCALLS@@DLBYTES@@INCONF@@NUMTIMESON@@EXPDATE@@HOMEPHONE@@DATAPHONE@Roger Burn Moderator, CFS-MED medical list Editor, CFS-NEWS Chronic Fatigue Syndrome Electronic Newsletter List-owner, CFS-L discussion Health InfoCom Network News Page 79 · Subject: HICN605 Medical Newsletter Part 3/6 "Idiopathic CD4+ T-Lymphocytopenia--Four Patients With Opportunistic Infections and No Evidence of HIV Infection" New England Journal of Medicine (02/11/93) Vol. 328, No. 6, P. 393 (Duncan, Robert A. et al.) Although lifelong suppressive therapy is recommended for many AIDS- related conditions, it is unclear whether similar principles apply to patients with idiopathic CD4+ T-lymphocytopenia (ICL), write Robert A. Duncan et al. of Boston City Hospital and University Hospital Boston University School of Medicine in Boston, Mass. Four patients without major risk factors for HIV infection were examined, each of whom was presented with severe opportunistic infections and was found to have ICL. The opportunistic infections experienced by the ICL patients included Pneumocystis carinii pneumonia (PCP), cryptococcal meningitis, and histoplasma-induced brain abscess. During 10 to 68 months of observation, none of the four patients had evidence of infection with HIV type 1 or 2 or human T-cell lymphotropic virus type I or II on the basis of epidemiologic, serologic, or polymerase-chain-reaction studies or culture, nor was there any detectable reverse transcriptase activity. While all of the patients had severe persistent CD4 T-lymphocytopenia (range 12 to 293 cells per cubic millimeter), the CD4 cell count progressively declined in only one and was accompanied by multiple opportunistic infections. All four patients had substantially reduced numbers of circulating CD8+ T cells, natural killer cells, or B cells. These four patients had ICL with opportunistic infections but no sign of HIV infection. Instead of the progressive, selective depletion of CD4 T cells characteristic of HIV infection, some patients with ICL have stable CD4 T cell counts accompanied by decreases in the levels of several other lymphocyte subgroups, the researchers conclude. ===================================================================== February 25, 1993 ===================================================================== "Questions Raised About AIDS Case" Los Angeles Times--Washington Edition (02/25/93), P. A6 (Cimons, Marlene) A report published yesterday in the British journal Nature raised questions about whether a Florida dentist who died of AIDS--accused in a highly publicized case of infecting five patients with HIV--actually was the source of transmission. Ronald W. DeBry, an evolutionary biologist in Florida State University's department of biological science and one of the Health InfoCom Network News Page 28 Volume 6, Number 5 March 8, 1993 researchers in the report, said, "We are not saying that the dentist did not infect the patients--we're saying you really can't prove it one way or the other." The case of Dr. David Acer was the only reported instance of HIV transmission from an infected health professional to a patient since the AIDS epidemic began in 1981. Officials from the Centers for Disease Control, who conducted the first investigation and have concluded that Acer was the source, criticized the Nature report, saying that it ignores significant additional proof that points to the dentist. The CDC investigation indicated that none of the five infected patients had any known high risk behaviors that would have made them more vulnerable to infection. DeBry and his colleagues used molecular sequencing techniques in the study and analyzed viral samples obtained from all of Acer's infected patients. They also compared these samples to known information about the strain that infected Acer, even though they did not have an actual sample from the dentist. The strains of HIV were then compared to "control" samples obtained from HIV- positive individuals in Florida who had no known connection to Acer. They discovered that "there is not enough difference between the dental group sequences and the control sequences to prove that these [dental] sequences are a separate set," said DeBry. Related Story: Baltimore Sun (02/25) P. 17A ===================================================================== "Vestar Files for Approval of AIDS-Related Kaposi's Sarcoma Treatment" United Press International (02/24/93) San Dimas, Calif.--Vestar Inc. announced Wednesday that it has submitted a new-drug application to the Food and Drug Administration for DaunoXome, its drug that treats AIDS-related Kaposi's sarcoma. DaunoXome has been distributed in Europe to individual patients by Vestar, but the company has not yet received approval to market the drug. Among all of the cancers that are associated with AIDS, Kaposi's sarcoma is the most common. The disease causes lesions of the skin, mucous membranes, and lymph nodes, and often progresses to internal organs, including the lungs and gastrointestinal tract. Kaposi's sarcoma is experienced in approximately 15 percent or more of AIDS patients. ===================================================================== "Expanded European AIDS Case Definition" Lancet (02/13/93) Vol. 341, No. 8842, P. 441 (Ancelle-Park, Rosemary et al.) Because of the importance of having a common AIDS case definition in Europe, all European countries should implement the new expanded AIDS case definition, write Rosemary Ancelle-Park et al. of the Hopital National de Saint-Maurice in Saint Maurice, France. The European Center for the Epidemiological Monitoring of AIDS gathered experts in public health and epidemiology participating in the AIDS Prevention and Control Research Program of the European Community in Jan. 1993. The attendees discussed the case definition of AIDS for surveillance purposes in Europe, following the Health InfoCom Network News Page 29 Volume 6, Number 5 March 8, 1993 introduction of an expanded surveillance case definition in the United States. The 1993 U.S. revised definition adds pulmonary tuberculosis, recurrent pneumonia and invasive cervical cancer to its list of 23 conditions defining AIDS. Also, it added HIV-positive people who have a CD4+ count under 200 to the list. In 1991, European countries decided that HIV-positive people should not be defined as having AIDS based on CD4 counts alone because of concerns over the accurateness of AIDS surveillance based solely on the degree of immunosuppression, biases that would be introduced in comparing AIDS exposure categories, and possible negative psychological effects on asymptomatic HIV-positive patients. Also, access to medical care in Europe is not based on a person meeting an AIDS definition. After meeting with AIDS surveillance representatives in 38 European countries, this position was reconfirmed by the expert group. The possible inclusion of the three opportunistic infections that the U.S. added to its AIDS definition were examined. It was decided that the addition of these illnesses was valuable for epidemiologic purposes. ===================================================================== "Orogenital Sex and Risk of Transmission of HIV" Lancet (02/13/93) Vol. 341, No. 8842, P. 441 (Spencer, Brenda) Recommending to the public that orogenital sex is unsafe is without a question theoretically correct, but the use/efficacy of a method depends not only on its biological efficiency but also on its acceptability to the user, writes Brenda Spencer of the Hopital de Bicetre in Le Kremlin-Bicetre, France. In the Dec. 12 issue of the Lancet, correspondents report that HIV-1 has been detected in the pre-ejaculatory fluid, and conclude that this fluid is therefore a potential vector for sexual transmission of HIV. But these findings bring into question what the chance is that the presence of HIV-1 in the mouth will result in infection of the receptive partner. One of the most difficult things in health education is how to manage uncertainty about risk- -as suggested by the confusion as to what defines safe sex. There have been both extremes to the risk of oral HIV transmission. At the 1990 AIDS conference in Montreal, one stand displayed a poster recommending to gay men that they engage in oral rather than anal sex, whereas another ran a video for adolescents advising that deep kissing may present a risk of infection. The latter position neglects to consider the possibility that, faced with a multitude of differing recommendations, the individual may fail to comply with any. Some people have asked whether the belief that orogenital sex carries a high risk of transmission yields an increase in unprotected anal sex. The formulation of safer sex guidelines should consider psychological factors along with any new laboratory discoveries, concludes Spencer. ===================================================================== February 26, 1993 ====================================================================== "As Their Life Expectancy Grows, So Do Needs of AIDS Patients" Washington Health InfoCom Network News Page 30 Volume 6, Number 5 March 8, 1993 Times (02/26/93), P. A1 (Goldberg, Karen) As a result of the longer life expectancy among AIDS patients, more treatment, both physical and mental, is also required. Bob Howard, spokesman for the Centers for Disease Control, said the life expectancy for HIV- positive people has increased as a record number of HIV cases have developed into full-blown AIDS. Many of the opportunistic infections that accompany AIDS would have killed a patient much more quickly five years ago, according to Dr. Robert Thomas, a Washington, D.C., physician specializing in HIV. "When I was a resident [in 1987] people were looking at 18 months to live after an AIDS diagnosis. Now I tell them three to five years." Aside from medical services, longer-living AIDS patients need social, legal, and psychological assistance. The District's Whitman Walker Clinic, the city's main provider of services for AIDS patients, is having a difficult time keeping its food bank stocked. Barbara Chinn, Whitman-Walker's deputy chief program officer, said the food bank "is serving 600 clients a month now. This time last year, it was 300. I'd say in another year it will be 900." Approximately 2,000 volunteers work for Whitman-Walker--an all-time high. The clinic has 30 support groups, nine housing facilities, and three satellite offices, including the new Max Robinson Center. The CDC's Howard said, "What we are seeing now is the maturing of the epidemic. More people are presenting with AIDS, and that is a reflection of what went on eight years ago. We have already seen a leveling off in that category [homosexuals], but it is other areas like heterosexuals and IV-drug users, we are still concerned about." ====================================================================== "Three Centers Plan Human Test of New AIDS Therapy" Reuters (02/24/93) (Zengerle, Patricia) Pittsburgh--Researchers from the University of Pittsburgh Medical Center announced on Wednesday they were preparing to launch human trials of an encouraging new three-drug AIDS therapy recently shown to inhibit HIV in a test tube. The human trials will be funded by Merck & Co, which makes one of the drugs being tested. The research sites include the University of Pittsburgh, the University of Pennsylvania in Philadelphia, and Brown Miriam Hospital in Providence, R.I. This trial will apparently precede by at least several weeks the beginning of government-supported human testing of a similar treatment this spring. The 24-week study in Pittsburgh will involve 30 to 40 individuals infected with HIV, who will be separated into two groups. The first group will receive AZT initially. The other group will receive AZT and a Merck drug called L-661. After two months of therapy, both groups will also begin to receive the AIDS drug ddI. L-661 is part of a new class of experimental drugs known as non-nucleosides, which have shown promise in blocking the replication of HIV in test tubes when used in combination with AZT and ddI. The University of Pittsburgh researchers said Health InfoCom Network News Page 31 Volume 6, Number 5 March 8, 1993 their trial would start as soon as 30 to 40 volunteers, who must meet several criteria, are enrolled. ====================================================================== "Cardiac Structure and Function in HIV-Infected Children" New England Journal Of Medicine (02/18/93) Vol. 328, No. 7, P. 513 (Lewis, William and Dorn, Gerald W.) Toxicity from AZT may be related to the development of cardiomyopathy, write William Lewis and Gerald W. Dorn of the University of Cincinnati Medical Center in Cincinnati, Ohio. In the Oct. 29 issue of the New England Journal of Medicine, Lipshultz et al. reported on cardiac dimensions and function in HIV-positive children and concluded that progressive left ventricular dilation occurred independently of any effect of AZT. However, Lewis and Dorn disagree with that conclusion. Ejection performance was normal in Lipshultz's patients at the start of AZT therapy but was depressed after therapy. Ejection performance declined, but contractility was unchanged. The causative factor appeared to be an increase in afterload despite increased posterior-wall thickness and left ventricular mass. End- systolic wall stress is related directly to end-systolic left ventricular pressure and dimension and is related inversely to wall thickness. Because end-systolic blood pressure was reported to be normal throughout the study, end-systolic dimension must have increased. Since ejection performance, not intrinsic myocardial contractility, is the primary determinant of clinical status, the data suggest that AZT can worsen the development of dilated cardiomyopathy in HIV-positive children. But no data from endomyocardial biopsies were included. The lack of characteristic endomyocardial morphologic changes would support the authors' thesis that AZT had no cardiac toxicity, but no pertinent information was provided, conclude Lewis and Dorn. ====================================================================== "India: Zidovudine Production" Lancet (02/20/93) Vol. 341, No. 8843, P. 485 (Mangla, Bhupesh) Indian pharmaceutical company Cipla Laboratories has begun manufacturing and marketing a lower-cost AZT in 100 mg capsules with the brand name Zidovir-100. The company is challenging Burroughs Wellcome's Retrovir because its price is significantly cheaper. This is good news for developing countries which can't afford the $3 per 100 mg capsule of Retrovir. A study by the United Nations Development Program (UNDP) shows that the cost of drugs will be a large determinant affecting the economic impact of AIDS in developing countries. India may have to spend $1.6 billion on AIDS by the year 2000. Cipla was able to make its drug cheaper with the help of the Indian Institute of Chemical Technology (IICT) in Hyderabad. IICT, a government-funded laboratory, has made the most of India's patent laws, according to which pharmaceutical products can be granted only process patents. Therefore, a drug enjoying a product patent outside India can be Health InfoCom Network News Page 32 Volume 6, Number 5 March 8, 1993 manufactured in the country made by a process different from that used by the original patent holder. Dr. A.V. Rama Rao, ICCT director, said, "Our aim is to make the drug available at a low price to all the needy countries, whose populace cannot afford the Burroughs Wellcome product. Quality wise there is no difference between Burroughs and us. In the international markets, we all have to meet the same standards." Drug companies in the United States have been enraged by the fact that India can get hold of U.S. patents. But AZT falls into a gray area--it was discovered originally, not by Burroughs Wellcome, but by the U.S. National Cancer Institute as an anti-cancer treatment. ====================================================================== "Rapid HIV Tests" Lancet (02/20/93) Vol. 341, No. 8843, P. 502 (Wannan, Gary J. and Cutting, William A.M.) Multiple uses of the HIV-CHEK test gave results as accurate as single use of the test, write Gary J. Wannan and William A.M. Cutting of the University of Edinburgh in Edinburgh, U.K. With the HIV-CHEK method, antigen from HIV-1 and HIV-2 are incorporated in the membrane on the top of a small block. Buffer is passed through the membrane followed by a serum or plasma sample from the person to be tested, then by gold conjugate and a wash solution. In positive cases a red-spot color reaction develops on the membrane within 10 minutes. The researchers discovered that they could put samples from at least 6 patients through the membrane before adding the gold conjugate and wash solutions and still get a positive result if any subject was infected. The researchers tested samples from 491 pregnant women and revealed that multiple use was just as accurate as single use of the test. In areas where the rate of HIV is low, it is possible to screen between 4 and 10 blood donors, pregnant women, or individuals in a population screening program with a single HIV-CHEK. Because the HIV-CHEK tests cost about 3 pounds sterling per test, in an area where the rate of HIV infection is less than 4 percent, the multiple sample screening method can save about 2,400 pounds sterling for every 1000 individuals tested. Even though the findings are encouraging, there still is a great need for an accurate and inexpensive test to detect HIV antibodies, conclude Wannan and Cutting. ====================================================================== March 2, 1993 ====================================================================== "Shalala Backs Reorganization" Science (02/12/93) Vol. 259, No. 5097, P. 889 (Cohen, Jon) Secretary of Health and Human Services Donna Shalala recently expressed support for a Senate bill addressing the reorganization of the National Institutes of Health's Office of AIDS Research (OAR). The proposal has incited opposition from some scientists and NIH officials who argue that it Health InfoCom Network News Page 33 Volume 6, Number 5 March 8, 1993 would add another layer of bureaucracy to AIDS research. The Senate proposal is designed to improve planning and coordination of AIDS research at the 21 NIH institutes by giving the OAR more authority over NIH's AIDS budget and establishing a discretionary fund for the OAR director to use at his or her discretion. Those who oppose the Senate bill include NIH directors, who on Jan. 22 sent a memo to NIH Director Bernadine Healy addressing their fears that the budget process would be "severely disrupted" by the proposed changes which "may inadvertently be detrimental" to AIDS and non-AIDS research. Healy sent the memo to Shalala, who subsequently showed it to members of the House subcommittee on health and the environment. She told the subcommittee that although she doesn't think "a reorganization alone will yield improvements in science necessarily," HHS backs the bill because it hopes that a strengthened OAR will elicit "a clearer view of where we're going." She added that if the plan backfires and hampers AIDS research, "we will be the first ones back here at this table to tell you that we have a structure that doesn't work." ====================================================================== "Use of Evolutionary Limitations of HIV-1 Multidrug Resistance to Optimize Therapy" Nature (02/18/93) Vol. 361, No. 6413, P. 650 (Chow, Yung-Kang et al.) Convergent combination therapy may be beneficial to the treatment of HIV- 1 infections and in post-exposure prophylaxis, write Yung-Kang Chow et al. of the Massachusetts General Hospital and Harvard Medical School in Boston, Mass. Certain drug combinations may prevent the co-existence of adequate reverse transcription function and multi-drug resistance (MDR). Retroviral drug resistance is conferred only by mutations in its own genome and is limited by genome size. Therefore, combination drugs directed against the same essential viral protein may thus prevent HIV-1 MDR, whereas the conventional approach of targeting different HIV-1 proteins for combination therapy may not. This is because genomes with resistance mutations in different HIV-1 genes might recombine to develop MDR. The researchers tested whether combinations of mutations giving rise to single-agent resistance might further compromise or even abolish viral replication, and if multidrug- resistant virus could be constructed. Certain combinations of mutations conferring resistance to AZT, ddI, and pyridinone are incompatible with viral replication. These findings suggest that evolutionary limitations exist to restrict development of MDR. Furthermore, elimination of reverse transcription by convergent combination therapy may also limit MDR, the researchers conclude. ====================================================================== March 3, 1993 ====================================================================== "Johnson and Johnson Belgian Unit in HIV Drug Trials" Reuters (03/02/93) Health InfoCom Network News Page 34 Volume 6, Number 5 March 8, 1993 Brussels--American pharmaceutical firm Johnson and Johnson's Belgian subsidiary Janssen Pharmaceutica, announced yesterday it had tested an AIDS drug that stopped the replication of one strain of HIV in the test tube. However, HIV developed resistance to the drug, alpha-APA, when used by itself. Janssen said it began tests on HIV-positive patients and had discovered that alpha-APA was well absorbed by the body and had few adverse side effects. Other tests are being conducted to determine whether the drug blocks the spread of HIV in the body. The alpha-APA compound inhibits the action of reverse transcriptase, which can lead to the development of full- blown AIDS. The drug company said that like similar agents, alpha-APA was effective against the strain of HIV called HIV-1, but not against HIV-2. Janssen is planning clinical trials to test the efficacy of combinations of alpha-APA and other drugs. "These studies will indicate whether such combinations of drugs will inhibit the multiplication of the virus for a longer period and prevent resistance," said the company. Other companies conducting similar studies have found that the virus developed resistance when used with reverse transcriptase inhibitors. They subsequently used combinations of inhibitor drugs and AZT to overcome the problem. ====================================================================== "HIV Vaccine Enters Clinical Trial Stage" American Medical News (03/01/93) Vol. 36, No. 9, P. 25 The first large-scale clinical trial of an AIDS vaccine has been launched in Sweden and will last six years. The trial will be testing VaxSyn made by MicroGeneSys Inc. The therapeutic vaccine has exhibited its ability to stabilize or reduce the amount of virus in an HIV-positive person, incite an immune response, and stop the loss of CD4 cells. The trial in Sweden is the last test MicroGeneSys must undergo before it can begin commercial production of the vaccine. ====================================================================== "Cheaper Way to Make AZT" American Medical News (03/01/93) Vol. 36, No. 9, P. 25 A less expensive process for making AZT has been developed by a Japanese company. The pharmaceutical company Kobayashi Koryo makes thymidine, a key ingredient of AZT, using heat evaporation, a process that is up to 50 percent cheaper than the current fermentation method, said company officials. The trading concern Kanematsu Corp. expects to start selling thymidine to drug companies in India and Brazil by the end of the year. ====================================================================== "HIV Clue Announced" American Medical News (03/01/93) Vol. 36, No. 9, P. 25 A chemical transformation in cells that helps explain how HIV spreads has been discovered by researchers at the Webb-Warring Institute in Denver, Colo. According to the scientists, HIV quells production of a vital enzyme Health InfoCom Network News Page 35 Volume 6, Number 5 March 8, 1993 called superoxide dismutase. The researchers are testing human cell cultures to elucidate if a drug can inhibit HIV's ability to suppress the enzyme. If they are able to safeguard the enzyme's levels in cells, the time HIV stays inactive could be prolonged. ==================================================================== March 5, 1993 ==================================================================== "Hospitals Told to Test for HIV" Washington Post (03/05/93), P. A3 Hospitals with significant numbers of AIDS cases should offer HIV testing to all persons admitted or treated in emergency rooms, federal health officials announced yesterday. The Centers for Disease Control issued guidelines that require voluntary testing for HIV to be routine in about 600 hospitals--11 percent of the nation's total--mostly in urban areas. The results of the tests would be kept confidential and people could not be denied care because they objected to being tested for HIV. Secretary of Health and Human Services Donna Shalala said, "These recommendations will help people learn of their HIV status and get early treatment. They will also be able to take precautions to protect loved ones." A toll-free hotline for physicians and other health care physicians will also be provided by the HHS to answer questions about treating patients with HIV/AIDS. The new CDC guidelines advise hospitals to offer voluntary testing to everyone between the ages of 15 to 54 admitted to the hospital or treated in the emergency room, clinics, or other outpatient departments. The agency encourages testing in hospitals with rates of infection of at least 1 percent or in the event that one in 1,000 discharged patients has AIDS. The tests would reveal more than two-thirds of HIV-positive persons in those age groups hospitalized for conditions other than HIV/AIDS, according to the CDC. ==================================================================== "Six More Sites Named for AIDS Therapy Test" Journal of Commerce (03/05/93), P. 5A Six additional locations where human trials of a new AIDS treatment will be conducted were tentatively named yesterday by the National Institutes of Health. The new sites are Indiana University in Indianapolis, Mount Sinai Hospital in New York, the University of California--San Diego, the University of Cincinnati, the University of North Carolina--Chapel Hill, and the University of Pennsylvania in Philadelphia. ==================================================================== "A Shot in the Arm for TB Research" Science (02/12/93) Vol. 259, No. 5097, P. 886 (Watson, Traci) Nearly a decade since tuberculosis began making its resurgence, the government has started giving research into the disease a higher priority. Health InfoCom Network News Page 36 Volume 6, Number 5 March 8, 1993 NIH Director Bernadine Healy intends to improve funding for TB research by reallocating money among the NIH institutes. Healy told the Clinton administration that this year, she will provide $12.5 million more than planned for research on mycobacterium, including new diagnostic techniques and treatments. About $9.2 million of the funding will come from cutting other NIH programs. Although the increase will make the funding for TB research $37 million in 1993, Healy also seeks to obtain emergency money from Congress through lobbying efforts. She hopes increased congressional spending on TB research will attract more scientists to study the disease. However, congressional members said getting more money from Congress will prove difficult with President Bill Clinton's pressure to cut governmental spending. Healy claims additional funding is imperative because the number of TB cases increased 18 percent between 1985 to 1991, and many of the new cases are resistant to existing drugs. ==================================================================== "Triple Teaming the Deadly AIDS Virus" U.S. News & World Report (03/01/93) Vol. 114, No. 8, P. 60 (Brink, Susan) The recent finding that three drugs used in combination were effective in attacking HIV in the test tube is encouraging for future research, even if this method is not effective in humans. Yung-Kang Chow, a little-known AIDS researcher, developed the three-drug approach, which is intended to force the virus to profusely mutate until it destroys itself. Chow and colleagues at Massachusetts General Hospital combined AZT and ddI with either pyridinone or nevirapine. The chemical mix either overwhelmed the virus or forced it to mutate so fast and furiously it couldn't replicate itself. By adding a third agent--either pyridinone or nevirapine--to the AZT/ddI combination, Chow et al. managed to compel HIV to mutate three times simultaneously in an attempt to survive. Three quick mutations are more than the virus can tolerate in the test tube. The new approach, called "convergent combination therapy," is an extreme departure from the traditional method of treating HIV infection, in which researchers have attempted to disable the virus at various stages in the disease's development. But the researchers are cautious about the new strategy's clinical potential, warning that any practical benefit from this research could be years away. The National Institutes of Health is currently forming clinical trials of the drug combination expected to begin no later than July. Although the research is preliminary, it helps reinforce the idea that AIDS might someday be controlled by a combination of drugs. ==================================================================== "Playing Chess With Reverse Transcriptase" Nature (02/18/93) Vol. 361, No. 6413, P. 588 (Richman, Douglas D.) Scientists are researching the possibility of making the human immunodeficiency virus (HIV) inviable by introducing mutations for drug- resistance. Chemotherapy for HIV patients prolongs their disease-free Health InfoCom Network News Page 37 Volume 6, Number 5 March 8, 1993 interval. However, this nucleoside treatment, using AZT, ddC, and ddI, only reduces the virus replication but doesn't completely suppress it. These drugs work by inhibiting the viral enzyme. The disease continues to progress, which may result from emergence of viral mutants with less susceptibility to the treatment drugs. A second class of possible inhibitors of HIV-1 replication also stops reverse transcriptase (RT). Several chemically distinct non-nucleoside compounds share properties, including low toxicity, high potency, synergy with nucleoside agents, and excellent pharmacokinetic properties. However, the resistant mutants of HIV indicate that the non-nucleoside reverse transcriptase inhibitors may possess a weak element when used as drugs. Although reducing the amounts of virus replication and increasing CD4 lymphocyte counts, the drugs dissipated after one month, which is about the same time as the appearance of the mutants. ====================================================================== March 4, 1993 ====================================================================== "The Emergence of Drug-Resistant Tuberculosis in New York City" New England Journal of Medicine (02/25/93) Vol. 328, No. 8, P. 521 (Frieden, Thomas R. et al.) AIDS patients are more likely to be infected with drug-resistant tuberculosis and are more likely to die if infected with these organisms, write Thomas R. Frieden et al. of the Centers for Disease Control in Atlanta, Ga. The researchers gathered information on every patient in New York City with a positive culture for Mycobacterium tuberculosis during April 1991. Among the 518 patients with positive cultures, 466 (90 percent) had isolates available for testing. A total of 33 percent of these patients had isolates resistant to one or more antituberculosis drugs, 26 percent had isolates resistant to at least isoniazid, and 19 percent had isolates resistant to both isoniazid and rifampin. Among the 239 patients who had received antituberculosis therapy, 44 percent had isolates resistant to one or more drugs and 30 percent had isolates resistant to both isoniazid and rifampin. Of the patients who had never been treated, the proportion with resistance to one or more drugs increased from 10 percent in 1982-1984 to 23 percent in 1991. Patients who had never been treated and who were HIV-positive or reported IV-drug use were more inclined to have resistant isolates. Among AIDS patients, those with resistant isolates were more likely to die during follow-up through January 1992. A history of antituberculosis treatment was the strongest indicator for the presence of resistant organisms. Improvements in TB-control programs and in social and economic conditions are greatly needed and can promote the control of both TB and the emergence of drug- resistant organisms, conclude the researchers. ====================================================================== "Dental HIV Transmission?" Nature (02/25/93) Vol. 361, No. 6414, P. 691 (DeBry, Ronald W. et al.) Health InfoCom Network News Page 38 Volume 6, Number 5 March 8, 1993 The case of the Florida dentist who allegedly infected five of his patients needs to be examined more closely with another dataset from some other region of the HIV genome, write Ronald W. DeBry et al. of the Florida State University in Tallahassee, Fla. Ou et al. recently reported that the dentist did indeed transmit the virus to his five patients. Population genetics indicate that a rapidly evolving marker can develop strong geographical substructure. Therefore, an appropriate null hypothesis is that the patients independently acquired similar variants within the local community. The dental transmission hypothesis entails that a branch on the viral phylogenetic tree lead to the dental group alone and not include any controls. But in phylogenetic terms, the dental group must be monophyletic. The null hypothesis would be rejected if a tree with a monophyletic dental group is significantly better supported than any tree with controls intermixed within the dental group. The researchers tested the hypotheses using new sequences from the dental patients and a new set of regional controls. This selection is justified: the dental group should be monophyletic compared to any controls. In addition, the test is biased in favor of accepting the dental transmission hypothesis because the controls in both studies were obtained at clinics about 90 miles from the dentist's practice area. The researchers conclude that the available data are consistent with both the dental transmission hypothesis and the null hypothesis and do not yet distinguish between the two. Volume 6, Number 5 March 8, 1993 :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Clinical Alerts from National Institues of Health :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: CLINICAL ALERT IMPORTANT THERAPEUTIC INFORMATION ON TREATMENT OF HIV INFECTION Health InfoCom Network News Page 39 IN HIV-INFECTED PATIENTS WHO ARE INTOLERANT OF OR HAVE FAILED ZIDOVUDINE THERAPY Released February 1, 1993 Purpose of this Document This document provides information on the results of a recently completed clinical trial that compared ddI and ddC in HIV-infected patients who were intolerant of or who had failed zidovudine therapy. Application of these results beyond this specific patient population can not be supported by this study. The study was conducted by the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA), which is part of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. This information is provided to you, as a health care practitioner, to serve as preliminary information while a manuscript is being readied for submission to a peer-reviewed medical journal. Introduction and Background The CPCRA was established in 1989 to involve community physicians and their patients in studies of treatments for HIV. A unique feature of this program is its community-based focus for evaluating the effectiveness of a broad spectrum of therapies and treatment regimens. The CPCRA is comprised of 17 research units, consisting of consortiums of primary care physicians and nurses, located in 13 U.S. cities. These research units represent a significant geographic, racial and risk group diversity. Through this diversity, the CPCRA extends greater opportunity for participation in clinical research to those persons underrepresented in traditional, university-based HIV studies. Study Design The CPCRA ddI/ddC study was designed to answer the important clinical question of which one of the currently available nucleoside analogues should be given to a patient who can no longer tolerate or has failed ZDV therapy. The study was an open-label comparison of ddI and ddC with progression of disease, including death, and tolerance of the study drugs as the main endpoints. The CPCRA ddI/ddC study opened in December 1990 and enrolled 467 patients by Health InfoCom Network News Page 40 Volume 6, Number 5 March 8, 1993 September 20, 1991, exceeding target accrual three months earlier than projected. All patients were followed for at least one year after the last patient was enrolled. The protocol ended follow-up on September 20, 1992. Study Population Study Population: 230 patients were randomized to receive ddI and 237 to receive ddC. Ten percent of the patients were women and two-thirds were white. Nearly a quarter of the patients enrolled had a history of injection drug use. The average age was 38 years. Approximately 63% of patients were ZDV intolerant, 48% of them because of hematologic intolerance. Intolerant --------- end of part 3 ------------