BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: AJR 13
A
AUTHOR: Ammiano
J
AMENDED: August 25, 2009
R
HEARING DATE: June 9, 2010
CONSULTANT:
1
Orr/
3
SUBJECT
Blood donation
SUMMARY
Requests the President of the United States to encourage,
and the Secretary of the United States Department of Health
and Human Services to adopt, policies that repeal the
current donor suitability and deferral policies of the FDA
regarding blood donation by men who
have had sex with other men and, instead, direct the FDA to
develop science-based policies.
CHANGES TO EXISTING LAW
Existing federal law:
Establishes the Food and Drug Administration (FDA) which
regulates the collection of blood and blood components used
for transfusion or for the manufacture of pharmaceuticals
derived from blood and blood components.
Pursuant to federal guidelines regarding blood donation,
the FDA:
Requires potential donors to be asked screening
questions about their health status, health behaviors,
and other factors associated with an increased risk of
being infected with transmissible disease, in order to
Continued---
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Page 2
help persons identify themselves as potentially at
higher risk for transmitting infectious diseases and
defer from donating on their own accord, rather than
unknowingly donating blood that may be infected.
Requires that the minimum information presented to
potential donors at every visit indicate clearly that
persons meeting certain criteria should not donate
blood, including, but not limited to, men who have had
sex with other men even one time since 1977.
Prohibits blood donation establishments from allowing
men who have had sex with other men even one time since
1977 to donate blood, even when such a donor does not
wish to self-defer.
Existing state law:
Prohibits blood or blood components from being used for
humans in this state, unless the blood or blood components
have been tested and found nonreactive for HIV, with
specified exceptions.
Requires that blood banks and plasma centers make
laboratory tests of all human whole blood and blood
components received to detect the presence of viral
hepatitis and HIV in the manner specified. If the blood
bank or plasma center finds the presence of viral
hepatitis, or an antigen thereof, in the blood or blood
components tested, it shall report that finding to the
local health officer.
Pursuant to the Unruh Civil Rights Act, provides that all
persons within the jurisdiction of this state are free and
equal, and specifically prohibits discrimination based on
sex, race, color, religion, ancestry, national origin,
disability, medical condition, marital status, or sexual
orientation with respect to accommodations, advantages,
facilities, privileges, or services in all business
establishments of every kind.
This resolution:
Requests the President and the Department of Health and
Human Services to adopt science-based policies that repeal
current Food and Drug Administration policies that prohibit
men who have had sex with men from donating blood.
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Page 3
FISCAL IMPACT
This resolution is keyed non-fiscal.
BACKGROUND AND DISCUSSION
Under an existing FDA policy, men who have had sex with
other men (MSM), at any time since 1977, are banned from
donating blood for their entire lives. The FDA has argued
this rule is necessary because men who have sex with men
are at higher risk of contracting and transmitting HIV and
hepatitis. Yet, heterosexual groups at similar high risk
for HIV and other sexually transmitted infections do not
face a lifetime ban on blood donation. This resolution
urges the repeal of the U.S. FDA's rule prohibiting MSM
from donating blood.
The author believes that the FDA's policy prevents
innumerable gay and bisexual men, who are otherwise
healthy, from contributing to the nation's blood supply at
a time when we are facing chronic shortfalls due to a lack
of donations. In 2007, the Red Cross reported that Southern
California's blood supply had reached critical levels,
resulting in a record low four-hour supply of type-O
negative blood. More recently, in January, the New York
Blood Center began rationing its supply to hospitals in and
around New York City because of a shortfall there.
FDA guidelines
In the U.S., there are over twenty million transfusions of
blood, red cell concentrates, plasma or platelets every
year. The FDA is responsible for ensuring and enhancing
blood safety and to protect blood recipients. As biological
products, blood and blood products are likely always to
carry an inherent risk of infectious agents. Therefore,
zero risk may be unattainable. The role of FDA is to drive
that risk to the lowest level reasonably achievable without
unduly decreasing the availability of this life saving
resource.
Over a period of years, the FDA has attempted to strengthen
safeguards to protect patients from unsuitable blood and
blood products. Blood donations are tested for seven
different infectious agents. Blood donors are now asked
STAFF ANALYSIS OF ASSEMBLY JOINT RESOLUTION 13 (Ammiano)
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specific and direct questions about risk factors that could
indicate possible infection with a transmissible disease.
This "up-front" screening eliminates approximately 90
percent of unsuitable donors. FDA also requires blood
centers to maintain lists of unsuitable donors to prevent
the use of collections from them.
Men who have had sex with other men (MSM), at any time
since 1977 (the beginning of the AIDS epidemic in the
United States) are currently deferred as blood donors. This
is because the FDA believes that MSM are, as a group, at
increased risk for HIV, hepatitis B and certain other
infections that can be transmitted by transfusion. The
FDA's policy regarding men who have had sex with men was
first imposed in 1983 in response to the AIDS crisis, when
little was known about the disease or how it is spread.
The agency claims its MSM deferral policy is intended to
protect all people who receive blood transfusions from an
increased risk of exposure to blood potentially infected
with certain disease-causing agents, including HIV. The FDA
has stated it would change its MSM deferral policy "only if
supported by scientific data showing that a change in
policy would not present a significant and preventable risk
to blood recipients."
The deferral for men who have had sex with men is based on
several considerations regarding risk of HIV. Data from the
Centers for Disease Control and Prevention (CDC) show that
HIV and other blood-borne pathogens are not randomly
distributed in the population, but are concentrated within
specific subgroups. Surveillance data from the CDC indicate
that men who have sex with men and would be likely to
donate have a HIV prevalence that is over 15 fold higher
than the general population, and over 2,000 fold higher
than current repeat blood donors (i.e., those who have been
negatively screened and tested) in the U.S. Male-to-Male
sexual contact continues to account for the highest amount
of new HIV cases (53 percent) followed by high-risk
heterosexual contact (31 percent).
Blood Testing
A better understanding of the disease and significant
innovations in blood screening technology make the fear of
HIV/AIDS spreading through the blood supply highly
STAFF ANALYSIS OF ASSEMBLY JOINT RESOLUTION 13 (Ammiano)
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unlikely, but not completely nonexistent. There are several
types of tests to detect HIV. Blood donation centers test
for HIV antibodies and HIV antigen, among others.
HIV antibody tests are the most appropriate test for
routine diagnosis of HIV among adults. When a person is
infected with HIV, their body responds by producing special
proteins that fight infection, called antibodies. An HIV
antibody test looks for these antibodies in blood, saliva
or urine. If antibodies to HIV are detected, it means a
person has been infected with HIV. Most people develop
detectable HIV antibodies within 6 to 12 weeks of
infection. In very rare cases, it can take up to 6 months.
It is exceedingly unlikely that someone would take longer
than 6 months to develop antibodies.
Antigens are the substances found on a foreign body or germ
that trigger the production of antibodies in the body. The
antigen on HIV that most commonly provokes an antibody
response is the protein P24. Early in HIV infection, P24 is
produced in excess and can be detected in the blood serum
(although as HIV becomes fully established in the body it
will fade to undetectable levels). P24 antigen tests only
work before antibodies are produced in the period
immediately after HIV infection.
Some of the most modern HIV tests combine P24 antigen tests
with standard antibody tests to reduce the window period.
The 'window period' is a term used to describe the period
of time between HIV infection and the detection of
antibodies. During this time, an antibody test may give a
'false negative' result, which means the test will be
negative, even though a person is infected with HIV.
Testing for antibodies and P24 antigen simultaneously has
the advantage of enabling earlier and more accurate HIV
detection. When two tests are combined, the chance of
getting an inaccurate result is less than 0.1 percent.
Since 2001, donated blood has also been screened with
nucleic-acid-based tests (NAT), which can detect the
genetic material of HIV rather than the antibodies to the
virus. NAT systems can identify HIV in the blood within two
or three weeks of infection. For HIV-1, the average window
period with antibody tests is 22 days. The use of antigen
testing shrinks the window period to 16 days, and testing
using the NAT systems reduces it to approximately 12 days.
STAFF ANALYSIS OF ASSEMBLY JOINT RESOLUTION 13 (Ammiano)
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Screening tests may be followed up with more specific tests
called confirmatory tests. Confirmatory tests help
determine whether a donor is truly infected. If the test
result from a donated unit of blood is abnormal for any
disease markers, the unit is discarded and the donor is
notified. The donor's name is then added to a donor
deferral list and is prohibited from donating blood
indefinitely.
Blood donor testing using current advanced technologies has
greatly reduced the risk of HIV transmission, but cannot
yet detect all infected donors or prevent all transmission
by transfusions. Today's highly sensitive tests fail to
detect less than one in a million HIV infected donors.
Blood collection agencies
In 2006, three major blood collection agencies, the
American Red Cross (ARC), the American Association for
Blood Banks (AABB), and America's Blood Centers (ABC),
testified before the FDA's Blood Products Advisory
Committee that FDA's lifetime deferral policy for MSMs is
medically and scientifically unwarranted. These
organizations recommended that the deferral period for MSM
be changed to 12 months since last sexual contact, which
would make this consistent with the deferral periods for
potentially high risk sexual exposures.
New evidence shows that the vast majority of donors with
HIV infection will test positive for infection by both
serologic testing and NAT methods between 10 and 21 days
after exposure. As a result, according to the blood
collection agencies, the risk to recipients of blood
products posed by false negative screening in the
laboratory is very minimal. Given that this window period
is very narrow, the blood collection agencies stated that
there is no valid scientific reason to differentiate
between individuals infected a few months or many years
previously.
AABB, ABC, and ARC acknowledge that there is a concern that
relaxation of deferral criteria may increase the number of
donors who are positive for an infectious disease, and
thereby increase risk to recipients because of false
negative laboratory screening or inadvertent release of
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infectious units. They claim that this impact has not been
measured directly, and that it may be based on incomplete
assumptions. Therefore, they claim it is not rational to
broadly differentiate sexual transmission via male-to-male-
sexual activity from that via heterosexual activity on
scientific grounds.
Advisory Committee on Blood Safety and Availability
The Department of Health and Human Services (HHS) Advisory
Committee on Blood Safety and Availability (ACBSA) will
hold a public meeting on the policy on deferral of donors
with high-risk exposure to HIV on June 10, 2010. The ACBSA
provides advice to the Secretary and Assistant Secretary
for Health on a range of policy issues on the blood supply
and blood products related to transfusion and
transplantation safety. At the June 10-11, 2010 meeting,
the HHS ACBSA will hear presentations and engage in
deliberations on the current MSM deferral policy.
Specifically, the ACBSA will be asked to discuss the
following: what are the most important factors (e.g.
societal, scientific, and economic) to consider in making a
policy change; is the currently available scientific
information, including risk assessments, sufficient to
support a policy change at this time; what studies, if any,
are needed before implementing a policy change; what
monitoring tools or surveillance activities would need to
be in place before implementing a policy change; what
additional safety measures, if any, are needed to assure
blood safety under a revised deferral policy?
Related bills
SJR 9 (Kehoe) 2010 urges the Congress and the President of
the United States to adopt the Military Readiness
Enhancement Act of 2009 (H.R. 1283) and the Military
Readiness Enhancement Act of 2010 (S. 3065) that
institutes a policy of nondiscrimination based on sexual
orientation, and to repeal the "Don't Ask, Don't Tell"
policy. Currently pending in the Assembly.
Prior legislation
ACR 157 (Yee) Chapter 5, Statutes of 2004, recognized
January 2004, as "California Volunteer Blood Donor Month"
and would declare it as the official start of a public
effort to increase the number and diversity of blood donors
in California. The measure would declare that the citizens
STAFF ANALYSIS OF ASSEMBLY JOINT RESOLUTION 13 (Ammiano)
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of California pay tribute to those who donate blood for
others in need, especially to those who donate blood on a
regular basis.
Arguments in support
The City of West Hollywood supports this measure because
they believe the FDA's policy prevents innumerable gay and
bisexual men who are otherwise healthy from contributing to
the nation's blood supply. They claim that several colleges
and universities around the country no longer sponsor
on-campus blood drives, claiming that the FDA's policy runs
counter to their anti-discrimination rules. Given that a
significant number of HIV cases are via heterosexual
contact, the rationale for this 1983 ban is irrational and
highly biased.
Blood Centers of California supports the policy of the AAB,
ABC, and ARC, which advocate that the deferral period for
male-to-male sex be changed to 12 months. BCC's primary
concern is maintaining an adequate and safe blood supply
for California based on volunteer donors. With the aging of
the established blood donor population, BCC believes that
we must continuously encourage and recruit a younger
generation to fulfill this vital role of volunteering.
Arguments in opposition
Concerned Women of California claims that this resolution
would create an unnecessary threat to the health and safety
of our nation. They quote the FDA, citing that "scientific
models show there would be a small but definite increased
risk to people who receive blood transfusions if the FDA's
MSM policy were changed and that preventable transfusion
transmission of HIV could occur as a result. They claim
that less than three percent of the population accounts for
nearly half of the HIV cases, and that statistic should
cause the greatest possible caution in protecting the blood
supply and the public health.
Capitol Resource Family Impact claims that the FDA's
policies are not discriminatory, and that they also prevent
donations from those who use intravenous drugs or have been
paid for sexual intercourse. They claim the FDA has
admitted that although testing has improved, it cannot
detect 100 percent of HIV-infected blood. These measures
protect innocent recipients who could survive a
STAFF ANALYSIS OF ASSEMBLY JOINT RESOLUTION 13 (Ammiano)
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life-threatening accident only to face life with an
incurable disease.
PRIOR ACTIONS
Assembly Floor: 46-29
Assembly Judiciary Committee: 7-3
POSITIONS
Support: Equality California (sponsor)
AIDS Legal Referral Panel (ALRP)
Center for AIDS Research, Education and Services
(CARES)
City of West Hollywood
National Center for Lesbian Rights (NCLR)
Santa Clara County Board of Supervisors
Southern California HIV Advocacy Coalition (SCHAC)
Oppose: Capitol Resource Family Impact
Concerned Women for America
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