blood>press release

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HHS FACT SHEET

October 8, 1998

Contact: HHS Press Office (202)690-6343

HHS MOVES TO IMPROVE THE SAFETY OF THE U.S. BLOOD

SUPPLY

Background: In July 1993, HHS Secretary Donna E. Shalala asked that

the Institute of Medicine of the National Academy of

Sciences conduct a thorough study of events during the early 1980s

surrounding the use of blood and blood products for

transfusion and for treatment of person with hemophilia. The study was

ordered to examine decision-making regarding the

nation's blood supply during a period of scientific uncertainty.

Issued July 13, 1995, it looked especially at the period before

the cause of AIDS or its manner of transmission were established, and

before HIV blood tests were available.

During the early 1980s, HIV was transmitted through blood products to

more than half of the 16,000 hemophiliacs in the U.S.

Since approval of the HIV blood test in 1985, the risk of transmission

through blood has been greatly diminished. For blood

transfusion, the per-unit risk of HIV infection has decreased from 1

in 2,500 in 1985 to a current estimate of 1 in 680,000

today. For plasma derivatives in particular, including anti-hemophilic

products, no known cases of HIV transmission have

occurred since 1987.

The purpose of the IOM study was to provide guidance on policy

development in future efforts to protect the blood supply,

especially in the face of significant gaps in medical knowledge and

during times of a high degree of public concern about the

blood supply. The study found that the nation's public health system

failed to perform as well as it could have during this

period. Government and non-government organizations missed

opportunities to limit the spread of AIDS, the IOM found. The

report concluded that " no person or agency was able to coordinate all

of the organizations sharing the public health

responsibility for achieving a safe blood supply. "

The report made 14 recommendations. For federal agencies, the findings

touched on four general areas: leadership across the

blood safety system, the public health advisory process, the need for

independent sources of key data, and the need to plan as

much as possible for dealing with unknowns in protecting the blood

supply. On Oct. 12, 1995, Secretary Shalala outlined

further steps that HHS will take to protect blood safety. The steps

are responsive to recommendations made in the Institute of

Medicine study. They include designation of the Assistant Secretary

for Health to serve as Blood Safety Director for HHS,

and creation of a Blood Safety Committee in the Department.

Blood Safety Committee. The Department's Blood Safety Committee brings

together agencies of the Public Health Service

with blood safety responsibilities. Chaired by the Assistant Secretary

for Health, the committee's membership includes the

FDA Commissioner, CDC Director and NIH Director.

The Advisory Committee on Blood Safety and Availability. While the

FDA's Blood Products Advisory Committee continues

to advise on technical blood safety issues, the advisory council

provides a forum in which to examine broad public health and

societal implications of blood safety issues. These include cost,

availability, informed consent and other issues. Industry and

consumer representatives, scientific experts and ethicists currently

serve on the committee.

HEPATITIS C LOOK BACK

One of the Advisory Committee on Blood Safety's first activities was

to examine transmission of the Hepatitis C virus (HCV)

through the blood supply. The Centers for Disease Control and

Prevention estimates there are about 4 million Americans

chronically infected with HCV, including roughly 300,000 who were

infected by blood transfusions prior to 1992. Many

Americans with Hepatitis C are unaware they have the disease because

it does not cause symptoms until it is far advanced.

On January 28, 1998, Secretary Shalala announced a " look back, " a plan

to notify people who received blood from a

potentially infected donor of their risk.

Look back, however, will not reach everyone at risk. For example, it

will not reach the 20 percent of recipients whose donors

never return to give blood and therefore are never discovered to have

Hepatitis C. It also cannot reach those who contracted

HCV from something other than blood. To help reach those individuals,

CDC has developed educational programs for health

care professionals and the public at large to support recognition,

diagnosis, counseling and testing for those at risk for

Hepatitis C.

Immune Globulin Products

The Advisory Committee on Blood Safety and Availability has been

considering ways to resolve severe shortages in immune

globulin products. These products are one of several classes of

proteins derived from human plasma, the fluid (non-cellular)

portion of circulating blood. Other important plasma-derived proteins

of medical value include albumin used to treat burn

victims and clotting factors used to treat hemophiliacs. There are two

types of immune globulin preparations used to prevent

and treat infectious and inflammatory diseases. They are immune

globulin intravenous (IGIV) and immune globulin

intramuscular (IGIM).

IGIM is primarily indicated for post-exposure prophylaxis against

Hepatitis A. (It has also been used for travelers requiring

Hepatitis A prophylaxis, although the hepatitis A vaccine, approved

for use in 1995, is now recommended instead of IGIM).

IGIM is routinely needed by every local health department when dealing

with a sporadic case of hepatitis A and is particularly

critical in the setting of an outbreak, such as in 1997, when

individuals in Michigan developed hepatitis A after eating

contaminated frozen strawberries. It also is used in children with

primary immune deficiency, but IGIV is usually preferred to

avoid administration of large volumes intramuscularly.

CDC was first alerted to shortages of IGIM in October 1994, when a

State health department was having difficulty locating

sufficient quantities of the product for a large number of people who

had been exposed to a food handler with hepatitis A.

CDC assisted the State in meeting its IGIM demand. Upon contacting

Armour Pharmaceutical Company, now Centeon,

CDC learned that most of the company's production was going to the

Department of Defense, which was routinely using

IGIM as a prophylaxis for soldiers stationed around the world. The

first hepatitis A vaccine was approved by FDA in

February 1995.

Throughout much of 1997, HHS received sporadic reports about shortages

of clotting factors, immune globulins and albumin.

CDC and FDA worked with industry to facilitate IGIM availability. In

October 1997, the Department recognized the

potential for another IGIM shortage and requested all IGIM

manufacturers to increase production. In addition, FDA worked

with one manufacturer to perform testing on tetanus immune globulin so

the product could be used as a substitute for IGIM.

FDA also worked with two companies to file applications to produce

additional product. These applications were reviewed

expeditiously -- both in approximately one month -- to facilitate

increased production. Presently, the amount of IGIM being

produced is enough to meet routine public health needs, but because

inventories remain low, HHS is concerned that IGIM

reserves would not be sufficient to meet the demands of unanticipated

public health crises.

IGIV. The current IGIV shortage is the result of many factors,

including increased demand for product, decreased production

by the manufacturers, as well as increased quarantines, withdrawals

and recalls due to manufacturing problems. Overall, HHS

estimates that supply of IGIV fell short of demand by about 20 percent

in 1997. The demand for IGIV has been increasing by

about 10 percent per year since 1994. This increased demand results

from both new approved indications and an increase in

off-label uses of IGIV.

Concerns over the potential threat of transfusion-transmissible CJD

has been another contributing factor to the shortage of

IGIV. Multiple IGIV lots have been quarantined or withdrawn because of

donors who, after donation, were identified as

being at risk of, or as having developed, CJD. However, intensive

surveillance has failed to document a single case of

transfusion-transmissible CJD in the U.S. or anywhere else in the

world, and animal experiments have recently shown that the

manufacturing process used to prepare clotting factors reduce the

potential risk of transmitting a spongiform eucephalopathy

by a factor of 10 billion. For these reasons, the FDA recently revised

its policy on plasma from donors who subsequently are

found to have developed classical (but not new variant) CJD. This

action could improve the availability of scarce plasma

derivatives without compromising blood safety.

ONGOING HHS EFFORTS TO IMPROVE THE SAFETY OF THE BLOOD SUPPLY

Food and Drug Administration Initiatives. FDA has strengthened its

internal management of blood issues. FDA's Center for

Biologics Evaluation and Research was reorganized in 1992, partly to

reflect the increased visibility and importance of blood

safety and product approval issues. CBER and FDA's field force have

strengthened their ability to collaborate effectively on

enforcement and compliance. In addition, CBER and the CDC, working

with the National Hemophilia Association, jointly

carry out a surveillance program to detect HIV and hepatitis among

patients receiving coagulation products.

FDA has broadened the composition of its Blood Products Advisory

Committee (BPAC) and has improved its use of the

committee as an independent source of expertise. FDA has reconfigured

the BPAC to include broader representation from

consumer advocates, care givers, ethicists and those who frequently

use blood and blood products. In addition, FDA now

brings emerging blood safety issues to the BPAC sooner and more

frequently.

FDA has strengthened the overlapping safeguards that protect patients

from unsuitable blood and blood products, building on

improvements made prior to 1986. Since 1990, blood collection centers

have been required to ask specific and very direct

questions about risk factors, to keep blood from unsuitable donors

from entering the system. This more " up-front " screening

eliminates approximately 90 percent of unsuitable donors. Blood

donations are also now screened for seven different

infectious agents. As a preventive measure, FDA instituted screening

for HIV-2 in 1992. In March 1996, FDA approved a

new test to screen donors for HIV-1 antigen, to be used in addition to

antibody tests to improve blood safety. FDA was also

proactive in implementing screening for HTLV-I (the leukemia virus) in

1988.

FDA has significantly increased its oversight of the blood industry.

The agency now inspects all blood facilities at least every

two years, and problem facilities are inspected more often. FDA has

repeatedly provided the blood industry with detailed and

specific guidance about how to ensure that blood and blood products

are as safe as possible. FDA routinely holds workshops

for the blood industry, the academic community and health providers.

Centers for Disease Control and Prevention. CDC has improved

surveillance systems to identify blood or blood

product-related diseases. CDC investigates AIDS cases who have

previously received blood or blood products, in order to

" look back " for HIV transmission from a possible blood source. It also

has established surveillance systems and other

mechanisms to identify a variety of other potential blood-borne

diseases, including newly-identified problems. In particular,

CDC has also developed surveillance systems for monitoring disease in

hemophiliac populations.

CDC has worked with blood collection centers to monitor the rate of

HIV infection in prospective blood donors. The studies

have resulted in improvements in the donor deferral process and a

reduction in the rate of HIV infection in the donor

population.

National Institutes of Health. NIH has been active in developing and

disseminating guidelines for physicians on the appropriate

therapeutic use of blood components. Through its Office of Medical

Applications Research, the National Heart, Lung, and

Blood Institute, and several other NIH and PHS entities, NIH has

convened four meetings of transfusion medicine and other

experts to examine controversies related to testing of blood products

and appropriate use of blood components.

The National Heart, Lung, and Blood Institute (NHLBI) supports

research to improve blood banking operations and blood

safety. A grant was recently funded to study human error in blood

banking, adapting some of the principles and techniques

used in the aviation and nuclear energy industries to achieve near

zero error. NHLBI also is supporting work on methods to

inactivate infectious agents in cellular blood components, and

studying the toxicity of hemoglobin-based oxygen carriers

(blood substitutes).

NHLBI has continued to identify and investigate other viral agents

that may contaminate the blood supply. Its contracts for

evaluating current tests to screen out HIV infected blood donors have

also provided invaluable information on the transmission

of HTLV-I/II from blood transfusions and on the efficacy of both

surrogate and specific antibody tests for Hepatitis C. Other

contracts were aimed at developing new and better tests for these

viruses, and one of these contractors continues to work on

direct virus tests (as opposed to antibody tests) that would be

suitable for screening large numbers of blood or organ donors.

NHLBI's REDS Study (Retrovirus Epidemiology in Donors Study) has

resulted in a serum and a cell repository that can be

used to investigate new threats to blood donation. This study is

designed to look for evidence of new potential threats to

transfusion safety and find better ways to avoid old threats, such as

continued donation by individuals with at-risk behavior for

HIV infection.

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