From: Billi Goldberg <bigoldberg@igc.apc.org>
Subject: VA Summary 4/10/92
Note: non-commercial reproduction.
Archive-Number: 5903
Organization: UCLA, Computer Science Department
Date: Sat, 15 Aug 92 08:16:30 PDT

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
                         April 10, 1992 
     SPECIAL TOPIC ISSUE:  HIV AND THE NATION'S BLOOD SUPPLY 
                ARTHUR ASHE ANNOUNCES HE HAS AIDS 
     Arthur Ashe, a well-known professional tennis champion, announced 
on Wednesday that he has AIDS and believes he contracted HIV from a 
blood transfusion he received after surgery in 1983.  Ashe, 48, had 
suffered a heart attack in September 1979 and underwent two heart bypass 
operations, in December 1979 and in June 1983, both of which involved 
blood transfusions.  He said doctors are "one hundred percent sure" he 
contracted HIV from one of those  transfusions, with a 95 percent 
probability it happened in 1983, when he received two units of blood 
several days after the operation.  John E. Hutchinson, who performed the 
1983 surgery, said he had not examined the medical records from Ashe's 
bypass operations and was uncertain whether blood or blood products were 
used in either surgery.  Both operations were conducted before blood 
screening for HIV was standardized.  Ashe told associates of his 
condition in 1988, but decided to publicly disclose it after USA Today 
confronted him.  (UPI) Washington Post (04/09/92), P. A1 (Freeman, 
Mike). Related Stories: New York Times (04/09) P. B9; Los Angeles Times-
-Washington Edition (04/09) P.  A1; Philadelphia Inquirer (04/09) P. A1; 
Baltimore Sun (04/09) P. 1A. 

          IN 1983, HIV BLOOD SCREENING WAS NONEXISTENT 
     When Arthur Ashe contracted HIV in 1983 from blood transfusions 
used during his heart bypass surgery, he faced a much larger risk of 
being infected than people who receive blood transfusions today.  The 
blood screening test to detect HIV was not approved by the Food and Drug 
Administration until April 1985, which was too late for Ashe and 
thousands of other recipients. While 4,408 AIDS cases--about 2 percent 
of the U.S. total--have been a result of blood transfusions, only 20 of 
those cases resulted from screened blood, according to the Centers for 
Disease Control.  Although the screening tests are not 100 percent 
accurate, the American Red Cross estimates the current odds for the 
average transfusion recipient contracting HIV at one in 45,000. The  
screening tests fail most often when a donor is in the window period of 
infection, which can last up to six months and is between the time of 
infection and the body's initial production of antibodies.  The Red 
Cross said about 5 of every 100,000 blood donations is found to be 
tainted.  Washington Post (04/09/92), P. A1  (Herman, Robin). 

                 TRANSFUSIONS AND AIDS STATEMENT 
     As of the end of February 1992, CDC had received reports of 4,770 
AIDS cases (294 of these in children under 13) resulting from receipt of 
blood transfusions, blood components, or tissue.  Most of these cases 
are due to transfusions received before March 1985, when HIV screening 
of blood and blood products began; only 20 cases (out of the total 
4,770) have resulted from screened blood.  It is estimated that the risk 
of becoming infected with HIV from a blood transfusion ranges from 
around one chance in every 61,000 units of transfused blood (San 
Francisco study by the University of California, San Francisco) to 
approximately one chance in every 300,000 units of blood transfused.  A 
study using Red Cross blood donations estimates the odds of contracting 
HIV infection were one chance in every 153,000 units of blood 
transfused. 
     In March 1987 (MMWR 1987;36:137-140), CDC recommended that 
physicians should consider offering HIV antibody testing to patients who 
received transfusions between 1978 and late spring of 1985  (U.S. 
Department of Health and Human Services, Public Health Service, Centers 
for Disease Control, April 1992). 

                HOW FDA PROTECTS THE BLOOD SUPPLY
                     by Bradford Wind Stone  
Widespread concerns have developed about the safety of the blood supply 
since the advent of the AIDS epidemic. But a close look reveals that 
enormous progress has been made in preventing the transmission of 
infectious agents though blood products. In fact, FDA and the blood 
industry have implemented safeguards in recent years that have made the 
blood supply much safer than ever before.  
Blood is vital to the American health-care system, and FDA plays a 
crucial role in ensuring the safety of the nation's supply. Every year, 
more than 11 million units of blood are drawn from volunteer donors for 
use in more than 3.5 million Americans. Much of this blood is further 
processed to manufacture specialized therapeutic agents such as immune 
globulin to prevent infections and clotting  factors used to treat 
hemophilia.  
The Public Health Service, of which FDA is a part, has been responsible 
for regulating the blood supply ever since the modern blood-banking 
industry was developed in the 1940s. Under the Public Health Service Act 
and other laws, FDA's Center for Biologics Evaluation and Research has 
the authority to license all blood establishments that participate in 
interstate commerce and to inspect the more than 2,500 registered blood 
establishments throughout the United States that process blood. FDA 
establishes regulations and guidelines designed to protect the blood 
supply from dangerous contaminants and unsafe practices and uses its 
ongoing inspection program to insure the blood industry's full  
compliance with good manufacturing practices.  
Safety Starts with Donation  
Blood safety begins with the donation. Only healthy individuals are 
allowed to give blood. All potential donors undergo extensive screening 
designed to reveal any medical condition or behavioral pattern that may 
put them at greater risk of carrying a blood-borne infectious agent. If 
information from the screening procedures indicates that a donor has a 
high risk of having been exposed to the AIDS virus or to other dangerous 
viruses or bacteria (such as those that cause hepatitis or syphilis), 
that person is not permitted to donate blood.  
Blood banks must inform all potential donors about risk factors for 
these diseases in writing and through direct questioning. Potential 
donors who are concerned that they may be at risk for infectious 
conditions but are reluctant to acknowledge their risk status to blood 
bank personnel are also given opportunities to indicate, anonymously, 
that their blood should not be used for transfusion. This confidential 
exclusion is accomplished a number of different  ways, including the use 
of cards with bar codes that correspond to an individual's donated unit.  
Contrary to popular belief, the practice of paying people to donate 
blood for transfusion rarely, if ever, occurs in the United States. This 
practice virtually ended nearly 20 years ago. Today blood collection for 
transfusion use is voluntary, and donors have no financial incentive to 
give their blood.  
The situation with the collection of plasma for use in manufacture is 
somewhat different. Plasma--the clear, yellowish, fluid portion of 
blood--can be collected more often than whole blood because the 
remaining elements of the blood, such as the red cells and platelets, 
can be reinfused into the donor at the time of donation. To encourage 
the greater rate of donation needed to keep pace with the demand for 
plasma-derived products, plasma centers usually pay  their donors. 
However, plasma collection facilities must follow many of the screening 
and testing procedures required by FDA, including thorough physical 
examinations of all donors on a regular basis.  
Moreover, unlike blood for transfusion, plasma products must be 
processed to refine them for therapeutic use. This processing includes 
treatments that kill or eliminate viruses.  
As Gerald V. Quinnan, M.D., acting director of the Center for Biologics 
Evaluation and Research notes, "The manufacturing processes for plasma 
derivatives are varied. Most of these products, such as immune globulin 
and anti-hemophilic clotting factors [known as factor VIII], are free of 
infectious agents. A small number of products--such as clotting factor 
IX--that are used  for rare conditions can also be treated to eliminate 
risk of AIDS virus transmission, but they still carry some risk of being 
infectious for hepatitis virus despite the effects of the manufacturing 
treatments."  Once a potential donor has passed the screening process, a 
pint of blood is drawn by a trained nurse or medical technician. The 
`sterile needle and plastic container used to collect the blood is 
discarded after a single use. This makes it virtually impossible to get 
any disease from donating blood. Quinnan observes that, "If you are a 
healthy individual, donating blood is a very safe procedure."  
Testing Blood  
Through a vigorous battery of tests, lab technicians analyze all blood 
collected for transfusion for signs of contamination with serious blood-
borne agents. These tests include:  
* Hepatitis B Surface Antigen Test--for evidence of infection with the 
hepatitis B virus. Hepatitis B can become chronic and cause severe liver 
damage, cancer and death.  
* Hepatitis B Core Antibody Test--additional screening test for 
hepatitis B  
* Hepatitis C Antibody Test--for evidence of infection with hepatitis C 
(the form of the disease most frequently transmitted through blood), 
which can cause chronic hepatitis  
* Human Immunodeficiency Virus Type-1 (HIV-1) Antibody Tests--for 
evidence of infection with the AIDS virus  
* HTLV-I--for evidence of a rare, leukemia virus found mainly outside 
the United States  
* Syphilis--for evidence of this sexually transmitted disease, which, if 
left untreated, can cause severe neurological damage.  
In addition, many blood centers test for antibody to HIV-2, another form 
of the AIDS virus, which is extraordinarily rare in the United States.  
Although no test is perfect, these tests are very sensitive. Tests for 
antibodies to the HIV type-1 virus, for example, can detect more than 
99.9 percent of infected blood units that contain the antibody. The 
tests are particularly effective when used with the pre-donation 
screening measures, which also help to eliminate units donated by 
recently infected individuals who may not have developed antibodies to 
the virus that would be detected by laboratory tests. 
Blood units that test positive for evidence of any of these agents are 
not used for transfusion. Donors whose blood tests positive for evidence 
of infection with any of these agents are not eligible to donate for 
transfusion unless it can be definitively shown that the donor is not 
infected. Blood banks must keep careful records to insure that they do 
not accept donations from these ineligible donors.  
FDA Monitoring  
FDA carefully monitors the record-keeping and other essential elements 
of safe blood preparation, such as screening, testing, labeling, 
storage, and handling. Each year the agency inspects all blood 
establishments and examines significant aspects of their performance. If 
FDA finds any problems or deficiencies, it requires the firm to take 
prompt corrective action. The agency checks to make sure that these 
difficulties are fully and quickly resolved. If the blood establishment 
does not take corrective action, or if FDA finds dangerous violations, 
FDA can suspend or revoke the firm's license, seize its products, and 
take other legal actions that can result in civil or criminal penalties 
against the blood establishment and its officials. For example, in June 
1990, FDA took action to revoke the license of an Albany, N.Y., blood 
establishment after it repeatedly failed to comply with good standards 
of practice. As a result of this action, the center was closed and its 
major functions were transferred to another center.  
Additional safeguards and monitoring programs developed by blood 
establishments themselves often supplement FDA's regulatory program. 
Many blood establishments are affiliated with national blood 
organizations (such as the American Association of Blood Banks, the 
Council of Community Blood Centers, the American Red Cross, and the 
American Blood Resources Association), which have  also implemented 
safety and quality initiatives for their member  establishments.  
FDA Commissioner David A. Kessler, M.D., has observed that, "All of 
these efforts have had a tremendous effect in improving the safety of 
the American blood supply. This effect is evidenced by the tremendous 
decline in the overall rate of infections of various types stemming from 
blood transfusions in the past few years."  
Fewer Infections Transmitted  
As a result of these cooperative efforts to improve the safety of the 
blood supply, the rate of transfusion-related cases of hepatitis has 
dropped significantly. Less than 30 years ago, nearly 1 in 3 patients 
receiving blood transfusions contracted some form of hepatitis. Reforms 
in the collection process, as well as modern donor screening and testing 
methods, have lowered the risk of contracting hepatitis through 
transfusion to less than 3 in 100  patients. This represents a greater 
than 90 percent decrease in the rate of blood transfusion-related 
hepatitis infections.  
Great progress has also been made in stemming the spread of HIV 
infection through the blood supply. As knowledge grew about the threat 
the AIDS virus posed to the blood supply, FDA immediately began steps to 
decrease this risk. The agency established screening procedures in the 
early 1980s specifically designed to prevent donations from those at 
higher risk of infection. Within months after the HIV type-1 virus was 
identified as the cause of the disease, a screening test was developed 
at the National Institutes of Health in Bethesda, Md., and use of the 
technology was licensed to several private companies. The first of these 
tests was licensed quickly by FDA in March 1985, and blood 
establishments put these tests into use shortly thereafter.  
As a result of these and subsequent actions, the risk of contracting 
AIDS from a blood transfusion is estimated to have dropped by more than 
99 percent from 1983 to 1991. In fact, the chances of contracting the 
AIDS virus from a blood transfusion are now estimated to be rarer than 
dying from an adverse reaction to penicillin.  
Dr. Quinnan notes the overall effects that FDA's safety measures have 
had on the blood supply. "Thanks to the successes in reducing the rate 
of blood-borne infections, as well as technological advances in the art 
of storing units, labeling blood to match the recipient with a 
compatible blood type, and transfusing blood safely, the blood supply is 
now better suited to the health needs of Americans than ever before."  
Increasing Safety  
Nevertheless, FDA continues to look at new approaches and technologies 
to make the blood supply even safer. The agency regularly updates 
guidelines for donor screening to keep them current with the latest 
information about risk factors and improved methods for questioning 
potential donors about these factors.  Similarly, FDA is working with 
others in government and with industry representatives to develop a new 
generation of screening tests that will be even more sensitive in 
detecting infectious units.  
FDA sponsors workshops and meetings with other government agencies, 
health-care organizations, consumer groups, and blood industry 
associations to discuss state-of-the-art information on blood safety. 
FDA's Blood Product Advisory Committee, composed of leading outside 
experts in the fields of hematology and transfusion medicine, also meets 
regularly to review crucial issues affecting  the blood supply and to 
advise the agency on these matters. FDA communicates the latest 
information through letters to all blood establishments, as well as 
through press releases and other announcements designed to inform the 
media and general public.  
FDA will continue to work closely with health professionals, the blood 
industry, and others to identify and implement better, faster ways to 
communicate information about existing or potential problems in the 
blood supply to blood banks, other government regulators, health 
professionals, and the American public.  
Through these and other efforts, FDA is working to further improve the 
safety of the nation's blood supply and the benefits it provides to the 
American people (From FDA's Consumer Magazine, June 1991; Bradford Wind 
Stone is an FDA press officer). 

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