From: bigoldberg@igc.apc.org (Billi Goldberg)
Newsgroups: sci.med.aids
Subject: VA Summary 2/14/92
Date: 16 Aug 92 16:44:20 GMT
Organization: unspecifiedNote: Copyright 1992, Dan R. Greening. Non-commercial reproduction allowed.
Archive-Number: 5909

This AIDS Information Newsletter was obtained from the HIV/AIDS Info
BBS (714) 248-2836.  It is the best source of AIDS Info available.
************************************************************************
                   AIDS INFORMATION NEWSLETTER
                   Michael Howe, MSLS, Editor
                     AIDS Information Center
                VA Medical Center, San Francisco
                     (415) 221-4810 ext 3305
                        February 14, 1992 
           Unusual Reactivity Reported on Abbott EIAs 
     Incidents of unusual reactivity in three of Abbott Laboratory's 
blood screening assays have been reported.  Some of the company's blood 
bank customers are reporting a small number of donor specimens that are 
repeatedly reactive with Abbott HIV-1 EIA, Abbott HCV EIA and Abbott 
HTLV-I EIA.  Early reports indicate that a percentage of the donors of 
the multiple reactive units have recently been inoculated with influenza 
vaccine.  None of the multiple reactives appear to be positive on 
supplemental testing (Blood Bank Week, 1991 Dec 13;8(45):1). 
     On December 18, FDA released a press statement regarding reports of 
some persons who have received influenza vaccine who have tested falsely 
positive on three commonly used screening tests for HIV, hepatitis C 
virus, and HTLV-1. This press release and subsequent newspaper articles 
have resulted in numerous calls into CDC.  Flu vaccine does not result 
in infection with HIV, HCV, or  HTLV-1.  In addition, the influenza 
vaccine has not been shown to affect confirmatory tests for these 
illnesses.  (Source:  Centers for Disease Control).  Printed below is 
the press release from FDA. 

           HIV False Positives Caused by Flu Vaccine   
    Blood establishments have reported to the Food and Drug 
Administration and the Centers for Disease Control that some prospective 
donors who recently received influenza vaccine have tested falsely 
positive on three commonly used screening tests -- those for detecting 
antibodies to Human Immunodeficiency Virus type-1 (HIV-1), Hepatitis C 
and Human-T-Lymphotropic Virus-type 1. 
   Additional testing showed the false reactions were not related to 
infection with any of these viruses.  Because additional testing clearly 
showed that the donors were not infected with these viruses, none of 
them were told of the false results. 
    Assistant Secretary for Health James Mason, M.D., who heads the 
Public Health Service, said, "Although these false positive reactions 
may pose some inconvenience to blood donors and blood establishments, 
they represent no risk to the safety of the blood supply. 
    "I also want to assure the public that the flu vaccine is safe.  Flu 
vaccination does not carry risk of these diseases, and it is important 
that people for whom flu vaccine is recommended continue to receive it 
because this is shaping up to be a bad winter for the flu." 
    In the past few weeks, approximately 90 blood donors from more than 
20 blood establishments across the country have been reported to have 
tested repeatedly reactive in antibody tests used to screen for these 
three infections.  Additional testing showed that these reactions were 
false -- that these individuals did not actually have antibodies to 
these viruses. 
    Further analysis has just begun, but early indications are that at 
least 60 percent of these donors had recently been vaccinated against 
the flu. Two percent of the donors with false positive reactions stated 
that they had not received flu vaccines, and vaccination history of the 
remaining donors is not currently known.
    FDA is working with screening kit and flu vaccine manufacturers to 
determine the reason for the false positive reactions and what can be 
done to overcome them.  These false reactions may be due to a kit 
component used in all three antibody test kits manufactured by Abbott 
Laboratories of Abbott Park, Ill. 
    Although the Abbott antibody test kits have been involved in all of 
the reported cases, other manufacturers' antibody kits might be subject 
to the same phenomenon.  Abbott Laboratories has fully cooperated with 
FDA's Center for Biologics Evaluation and Research in examining this 
situation and keeping users informed. 
    No one who receives a flu vaccine is at risk of contracting any 
known infection from the vaccine, and there is no risk of contracting 
HIV, Hepatitis C or HTLV-1 from flu vaccination.  FDA will provide 
appropriate guidance to blood establishments, test kit manufacturers and 
flu vaccine manufacturers as clarifying information becomes available. 
    FDA and the CDC are among the eight Public Health Service agencies 
within HHS.  (Food and Drug Administration Press Release, December 18, 
1991).  
  More Information Sought About Units Reactive to Abbott Tests:
                  Link to Flu Vaccine Suspected 
     Of the 90 cases that have been reported so far the FDA stated that 
at least 60 percent of the donors are known to have recently been 
vaccinated against influenza.  In a letter to Abbott customers, Abbott 
Laboratories stated that "these results do not indicate that influenza 
vaccines are causing an adverse reaction, but may be inducing 
nonspecific reactivity in sera and plasma from vaccine recipients."
     Abbott Laboratories is asking its customers to implement the 
following steps in order to assist the company in gathering information 
about this phenomenon.  1) Contact Abbott's Customer Support Center 
(800-323-9100) if you have observed donor samples that are "multiple 
reactives" in two or three of the following assays:  Abbott HCV EIA 
(List No. 3A53) and Abbott HCV EIA (List  No. 3A53) and Abbott HTLV-I 
EIA (List No. 3077).  2) Note the absorbance values and sample to cutoff 
ratios of test and retest for all three products.  3) Record the sample 
type (anticoagulated or serum sample and type of anticoagulant used) for 
initial test and retest.  4) If possible, save the sample and the unit 
of plasma and forward them to Abbott for further testing (Blood Bank 
Week, 1991 Dec;8(46):3-4). 
        Comment Period on AIDS Definition Extended by CDC 
     On December 9 and 10, 1991, the National Commission on AIDS met to 
consider the policy implications of the Centers for Disease Control's 
(CDC) implementation of its new definition of AIDS.  The CDC had 
targeted January for the release of a final regulation which would 
expand the definition of AIDS to include people who are infected with 
HIV and whose immune systems are weakened (a T cell count below 200, 
with 1,000 being considered "normal") but who may  not yet be seriously 
ill.  On December 12, the National Commission sent a letter to CDC 
Director William roper, M.D., listing nine issues that are among those 
the Commission feels merit further consideration or amplification.  
Among those nine are the likely effects of changed definitions on 
surveillance and reporting processes; the criteria for inclusion of 
specific conditions in the  case definition, particularly as they relate 
to manifestations of HIV in women; the anticipated changes in 
distribution of funds for care under the Ryan White CARE Act resulting 
from new definitions; and the potential psychological impact of a 
changed definition for people living with HIV.  CDC spokesman Kent 
Taylor told the Associated Press that the agency would consider the 
National Commission's request, along with other comments it has received 
on the proposed change (AIDS Reference Guide, 1992 January, Summary 
Bulletin No. 44, pp. 1-2).  As a result, Centers for Disease  Control 
has extended to February 14 the comment period to expand its definition 
of AIDS (AHA News, 6 Jan 1992;28(1):2). 

         Extension of Public Comment Period for Revision
             of HIV Infection Classification System
       and Expansion of AIDS Surveillance Case Definition 
     As previously announced (CDC. Review of draft for revision of HIV 
infection classification system and expansion of AIDS surveillance case 
definition. MMWR 1991;40:787), CDC is revising the classification system 
for human immunodeficiency virus infection and is expanding the 
surveillance case definition for acquired immunodeficiency syndrome 
(AIDS) among adolescents and  adults. The public comment period for this 
draft document has been extended for 60 days. The document is available 
for review from the National AIDS Clearinghouse, P.O. Box 6003, 
Rockville, MD 20849- 6003; telephone (800) 458-5231. Written comments on 
this document should be received at the same address by February 14, 
1992. Reprinted from MMWR 1992;40(891). 
 Controlling Diarrhea:  Octerotide (Sandostatin) Studies Recruiting  
Dangerous weight loss (cachexia) in people with AIDS can result from 
malabsorption and chronic diarrhea as well as loss of appetite 
(anorexia). Some of the choices for countering diarrhea include 
diphenoxylate (Lomotil), loperamide (Imodium),  cholestyramine 
(Qestran), and tincture of opium (Paregoric).  
A newer, somewhat experimental option is somatostatin, a naturally-
occurring peptide-inhibitor associated with the regulatory activities of 
the digestive system. Somatostatin can be given intravenously to treat 
the processes that contribute to diarrhea, but unfortunately the half 
life of this substance is  short.  
Octreotide is a synthetic agent given sub-cutaneously that approximates 
somatostatin's activity, only with a much extended half life. Octreotide 
is now approved for certain non-AIDS-specific indications, and is 
marketed by Sandoz under the label Sandostatin. 
Sandoz has designed a protocol to study Sandostatin in people with HIV-
related diarrhea which has not responded to other treatments. There are 
19 local sites for this study; their locations and the details of 
exclusion and inclusion criteria can be obtained by calling AIDS 
Clinical Trials Information Service at (800) 874- 2572.  (1991 Dec 20, 
AIDS Treatment News Issue #141, p. 7). 
 Controlling Weight Loss:  Dronabinol (Marinol) Trials Recruiting  
Dronabinol is a manufactured version of THC, the principal active agent 
in marijuana. Dronabinol and marijuana have both been reported to 
control nausea and stimulate appetite in people with AIDS or cancer (for 
background information see issues #131 and #139 of AIDS TREATMENT NEWS).  
Developed jointly by UNIMED and Roxane Laboratories under the trade name 
Marinol, dronabinol is approved by the FDA to treat nausea. The makers 
would like the labeling expanded to include treatment for loss of 
appetite, which is a serious problem for many people fighting cancer or 
opportunistic infections. Robert Gorter, M.D., an Assistant Professor of 
Medicine at the University of California San Francisco who has studied 
dronabinol in patients with HIV  infection, discusses it in "Management 
of Anorexia-Cachexia Associated With Cancer and HIV Infection," 
published in the September 1991 supplement of the journal Oncology.  
There are 25 sites recruiting for the current Marinol protocol that is 
hoped to demonstrate appetite improvement. To locate the closest local 
study, interested persons may call AIDS Clinical Trials Information 
Service at (800) 874-2572. (1991 Dec 20, AIDS Treatment News Issue #141, 
p. 7). 

          Special Reports on Awareness of AIDS and HIV
             Among Racial and Ethnic Minority Groups 
      CDC's National Center for Health Statistics (NCHS) has released 
two special reports examining the awareness of acquired immunodeficiency 
syndrome (AIDS) and human immunodeficiency virus  (HIV) among blacks and 
Hispanics in the United States. The reports, based on data collected in 
1990, describe various aspects of AIDS-related knowledge and HIV-
antibody testing experience. Differentials by age, sex, and education 
are compared with those from the non-Hispanic white population.   
     Copies of the reports, AIDS Knowledge and Attitudes of Black  
Americans: United States, 1990 (1) and AIDS Knowledge and  Attitudes of 
Hispanic Americans: United States, 1990 (2), are   available free of 
charge from the Scientific and Technical  Information Branch, NCHS, CDC, 
Room 1064, 6525 Belcrest Road,   Hyattsville, MD 20782; telephone (301) 
436-8500.  (MMWR, 17 Jan 1992;41(2):30). 
REFERENCES  1. NCHS. AIDS knowledge and attitudes of black Americans: 
United  States, 1990. Hyattsville, Maryland: US Department of Health and 
Human Services, Public Health Service, CDC, 1991. (Advance data  no. 
206).   2. NCHS. AIDS knowledge and attitudes of Hispanic Americans:   
United States, 1990. Hyattsville, Maryland: US Department of  Health and 
Human Services, Public Health Service, CDC, 1991.  (Advance data no. 
207). 

                  CDC National AIDS Clearinghouse 
                          Announcement  
Beginning February 14, 1992, a nominal prepayment will be required for 
postage and handling costs when you order bulk quantities of materials 
from the CDC National AIDS Clearinghouse.  Single copies of up to five 
different items (brochures and posters) will still be free.  By 
recovering these costs, the Clearinghouse will be able to meet the ever-
increasing demand for HIV information without eliminating essential 
services.  
Methods of payment include check or money order, credit card, government 
purchase order, or deposit account.  You may call a reference specialist 
at 1-800-458-5231 to obtain further information about the cost recovery 
program.  

            Fifth National Forum on AIDS, Hepatitis,
                  and Other Bloodborne Diseases 
     The National Foundation for Infectious Diseases, in collaboration 
with Centers for Disease Control and the National Institute of Allergy 
and Infectious Diseases, will cosponsor the Fifth National Forum on 
AIDS, Hepatitis, and Other Bloodborne Diseases March 29-April 1,1992, in 
Atlanta. The forum will emphasize the integration of scientific 
knowledge with public and health-care policy in three majors areas: 1) 
epidemiology of blood borne diseases and their agents; 2) occupational 
and patient safety-risk assessment and prevention of bloodborne 
infections; and 3) diagnostic, therapeutic, and preventive approaches to 
blood borne diseases.
     Additional information is available from the forum secretariat:  
SYMEDCO, Two Research Way, Princeton, NJ 08540.  Telephone: (609) 452-
7100 (MMWR, 17 Jan 1992;41(2):31). 

      Frontline Health-Care Workers: A National Conference
            on Device-Mediated Bloodborne Infections 
     CDC, the Food and Drug Administration, and the Occupational Safety 
and Health Administration will cosponsor "Frontline Health- Care 
Workers: A National Conference on Device-Mediated Bloodborne Infections" 
in Washington, D.C., August 17-19, 1992.  The meeting will 1) focus 
attention on sharp-instrument injuries and performance safety of medical 
devices and instruments; 2) bring together device manufacturers and 
user/purchaser(s) to facilitate understanding of needs and interventions 
pertaining to device- mediated infections; and 3) facilitate private-
sector initiatives for technology advancement, including the development 
of infection- prevention devices and strategies.
     Additional information is available from Laura Timperio, PACE 
Enterprises, Inc., 17 Executive Park Drive, Suite 200, Atlanta, GA 
30329.  Telephone: (404) 633-8610 (MMWR, 17 Jan 1992;41(2):30). 
Newsgroups: sci.med.aids