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Eliminate Deferrals of MSM Donors

Jordan Luty

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Contents:

Introduction:

Problem and Solution

Objectives

Background:

Reasons Why the Deferral is Ineffective Today

Scope and Limitations

Methods:

Overcoming the Current Deferrals Issues

Chart with Information on HIV Diagnosis

Safety Precautions List

Post-Approval of the Deferral Elimination/Expected Project Results:

Feasibility

Method Timeline

Budget

Conclusion:

Honesty vs Ethics

Work Cited:

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Jordan Luty
Composition 2 - 2B
1 Mar. 2015
Proposal
Eliminate Deferrals of MSM Donors
Introduction:
Problem and Solution:
Problem: Every two seconds someone in the United States needs blood. This statement opens
the Blood Facts and Statistics section of the Red Cross website. In fact, the website states,
More than 41,000 blood donations are needed every day. With more than 90,000 people in
America affected by Sickle Cell Disease (SCD), the Red Cross continually searches for donors
(Sickle Cell Disease). Why, then, is a significant group of the countrys population deferred? By
removing Men who have Sex with Men (MSM) from the list of available donors, the
organization bans millions of willing gay men from giving blood. When the deferral was
instigated in 1983, it was an effective and appropriate solution to the HIV/AIDS epidemic. As
time and technology progress, however, our nations safety precautions and AIDS awareness
movements should cause the organization to rethink its decision. The ban on MSM only
perpetuates the stigma that gay men engage in illicit and sexually devious acts, while many are in
committed and completely healthy relationships.
Solution: Eliminate the ban incurred on MSM in order to promote blood donations. As the New
York Times cites, the [12 month-deferral] rules change could add about 317,000 pints of blood
to the nations supply annually, and completely removing the ban could double the potential
new supply, which would significantly decrease the nations demand for new donors.
Objectives:
Work with HIV/AIDS testing facilities to organize an effective way to detect the disease such
as the fourth generation or Western blot tests.
Construct a concise way to transfer information from facilities to the Red Cross in order to
establish a legitimate and reliable relationship between the two organizations so that blood
contamination is more easily recognized.
Devise a method for men who are in committed, homosexual, monogamous relationships to
donate blood.
Eliminate the deferral on MSM, but strengthen the process so that safety is still priority
number one.
Encourage Dual Testing in positive HIV results
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Background:
The original deferral, which was instigated in 1983, was an effective and appropriate solution in
that century. Any man that has undergone homosexual intercourse since 1977 has, up until this
point, been permanently deferred from donating blood with the Red Cross. To ensure blood
safety, this was an acceptable solution to the issue. Statistics have shown that, while gay men
only make up roughly two percent of the United Statess population, it is the demographic most
prominently effected by HIV. In the 1980s, tens of thousands contracted the infectious disease
through blood transfusions, and this resulted in a lack of trust in the blood donation process
(Kumanan). The Center for Biologics Evaluation and Research (CBER), a branch of the FDA
that evaluates the safety of blood products distributed in America, recommended the
implementation of the deferral in response to the contamination of blood transfusions from MSM
(Diaz). Many were skeptical; they didnt even believe the disease existed (UCLA Students). As
Acquired ImmunoDeficiency Syndrome (AIDS) became even more affiliated with homosexuals,
the Red Cross instigated the deferral. At this time, it proved to be the organizations only option
since there was no way to detect the AIDS-causing agent (Kumanan). Therefore, on March 4th,
1983, the Office of Biologics issued the first non-mandatory guidelines which dissuaded gay
men away from donating who were, as Vianca Diaza student of University of Maryland Law
states, currently sexually active with multiple partners, had overt symptoms of immune
deficiency, or had previously engaged in sexual relations with people who now exhibited such
symptoms (Diaz). As the years progressed, however, so did the laws, and thusin 1992the
lifetime deferral was enacted.
While the ban was once a legitimate solution originally for the American Red Cross, modern
medicine and technology has deemed it unnecessary and inappropriate. Many have already
looked at this issue and deemed it necessary for change. For instance, multiple organizations,
blood establishments, and political leaders called on the FDA, CDC, and Red Cross, culminating
in 2010 with a reevaluation of the current deferral (Diaz). The Advisory Committee on Blood
and Tissue Safety (ACBTSA), the main federal agency in charge of the MSM ban, met to
deliberate on whether or not the current indefinite deferral for men who have had sex with
another man even one time since 1977 [should] be changed at the present time in light of the
societal factors surrounding these issues as well as the science (Caption Notes). In the span
of the 2-day long meeting, perhaps the most notable influence was made as a joint statement
from American Association of Blood Banks, Americas Blood Centers, and the American Red
Cross with, the current lifetime deferral for men who have had sex with other men is medically
and scientifically unwarranted [and should be] modified and made comparable with criteria for
other groups at increased risk for sexual transmission of transfusion-transmitted infections.
They even recommended that the current lifetime deferral be amended to a twelve-month
deferral (Joint Statement Before the Advisory Committee). Through the entire process,
however, the ACBTSA still advised that the policy and deferral not be changed. Later, in 2014,
the FDA decided to review the current policy (The New York Times Editorial Board). FDA
Commissioner Margaret Hamburg stated, The FDA has carefully examined and considered the
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available scientific evidence relevant to its blood donor deferral policy for men who have sex
with men, including the results of several recently completed scientific studies and recent
epidemiologic data. Following this review the agency will take the necessary steps to
recommend a change to the blood donor deferral period for men who have sex with men from
indefinite deferral to one year since the last sexual contact. As Barry Zingman, M.D., medical
director of the AIDS Center at Montefiore Medical Center and a professor at Albert Einstein
College of Medicine., states, The policy stigmatizes gay men. It limits the donation pool, its not
medically justified, and its not right (Darling).
Reasons the Deferral is Ineffective Today:
We, as a nation, understand HIV more holistically now and have better methods of preventing
it and testing for the virus.
All blood samples are tested for AIDS, no matter who donates (Blood Donations; Burton).
Although there is a 1 in 2 million chance of the result being incorrect, the Red Cross could
partner with HIV testing facilities to minimize this (Blood Donations).
As Sickle Cell Disease continues to be an issue, the desire for blood donors will continue to
rise.
The deferral perpetuates the stigma that being in a committed, monogamous, homosexual
relationship is somehow dirtier than having heterosexual intercourse with a prostitute
(Darling).
The current ban encourages dishonesty with its donors and prompts them to question their
value of ethics over honesty (Brennan; Darling).
Scope and Limitations:
All individuals who have been deferred by the previous 1983/1992 version must be contacted for
reevaluation; all individuals who identify as MSM must be targeted. To maximize the healthy
blood donation, the FDA must undergo a series of processes to determine the effectiveness of
eliminating the lifetime ban.
Methods:
Overcoming the Current Deferrals Issues:
Our worlds understanding of the Human Immunodeficiency Virus (HIV) has grown
exponentially, therefore calling for a reevaluation of the existing deferral. When the current ban
was established in 1983 and further strengthened in 1992, the viral agent behind AIDS still
required research to be fully understood. As technology develops, so does our understanding of
AIDS pathology. Today, humans are regularly making new discoveries and fighting against HIV/
AIDS. While it may be a while until humanity fully cures the disease, it is certainly less potent
than it was 20 years ago. As CBS states, The rate of HIV infections diagnosed in the United
States each year fell by one-third over the past decade (HIV Diagnosis Rate). While this is
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positive and encouraging news, it does not mean that blood drives are completely safe from HIV
contamination. It should, however, represent a positive change in Americas viral health.
Someday, the disease will be vaccinated and eradicated, and until then, the FDA should not
ascertain or stigmatize the disease with an entire group of people.
Another complication with the current ban is that every blood sample is tested for HIV, so the
deferral should, in theory, be completely unnecessary for everyone who has not tested positive
for the disease. While there is a 1 in 2 million chance for error in the readings, the FDA should
consider partnering with HIV/AIDS testing facilities to obtain more accurate results. Though this
could present a challenge, working with facilities such as the Lafene Health Center at Kansas
State University would be one way to bolster the HIV testing process. If an individuals results
were consistent with both an AIDS testing facility and the Red Cross, there would be a 1 in 4
trillion (4,000,000,000,000) chance of a mistake appearing. Currently, the Red Cross uses an
Enzyme Immunoassay test to detect HIV 1 and 2 (Blood Testing; Conklin; Hale). The
organizations site states that 1 in 2 million tests produce errors, which would lead to an incorrect
deferral (Blood Testing). Considering 15.7 million donation occur each yearas reported by
the Red Cross sitenearly 8 individuals are improperly banned from donating blood annually.
To refine the blood donation process, each positive HIV result should undergo a second test to
confirm the original answer. If the test is done 15.7 million times, what justification can be used
against 8 (plus however many more actually correctly result positive for HIV) more? Using this
information, all donors who identify as MSM should undergo two HIV tests to ensure safety.
That should be common protocol if the deferral were to be fully eradicated. As Rachel Conklin,
customer safety officer for the FDA, alluded to, Safety is the FDAs number one priority. All
measures must be enacted to ensure blood donation is as smooth and uncontaminated as
possible. To do so, dual testing should become more normalized.
Different Examples of Blood Testing and Cost (as reported by Lafene Medical Center at Kansas
State University, the FDA itself, WebMD, CDC, and the Red Cross; conglomerate of all results):
Turnaround Time

Reliability

Cost

Cited from

30-40 Minutes

99.8%

$30.00

Lafene Medical Center

Venous Blood Specimen 20-30 Minutes

99.9%

$29.00

Lafene Medical Center

Alere Determine HIV 1/2


Ag/Ab Combo

30 Minutes

99.7%

$30.00

Lafene Medical Center

Rapid HIV Test

20 Minutes

99.6%

$8.00

CDC

ELISA Test

Several Days

99%

$150

CDC

Oral Specimen

One major issue with the current deferral is that MSM in committed, monogamous, homosexual
relationships are turned away even though neither partner has the virus. The New York Times
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states, the [proposed plan of the FDA to change to a one year deferral] could add about 317,000
pints of blood to the nations supply annually, an increase of 2 percent to 4 percent. The new
policy will exclude the 3.8 percent of American men who report having had a male sexual
partner in the past year, a group that could double the potential new supply, the institute
said (The New York Times Editorial Board). Obviously, obtaining the highest quantity of
healthy blood is the FDA and Red Crosss main goal. A significant amount of donors are MSM
who are in committed relationships, and they are being denied the right to give blood. As Alan
Cumming, advocate for the GLAAD (Gay and Lesbian Alliance Against Defamation)
organization, states, [the FDA policy should be changed so that] donors are screened based on
their exposure to risk and not their sexual orientation so no matter who you are, you can save
lives (Heigl). While this is a good idea in essence, the FDA and other safety organizations argue
of its authenticity and feasibility. There is no way to guarantee that a MSM who identifies as
being a member of a committed relationship actually is; furthermore, our definitions of what a
committed relationship is often differ, andjust because one individual identifies as
committedit doesnt mean the partner is as well alluded Conklin. Agreeably, donor honesty
will always be an issue as long as potential donors are deferred. It is, however, important to
recognize the buffers that the FDA and Red Cross already have instigated to protect individuals
who receive blood. As Diaz states, There are five overlapping layers of safety precautions in
place to ensure the safety of blood products distributed in our country.
Safety Precautions List:
Initial questioning prior to the donation about personal life may lead to a deferral of the donor
(Diaz; Full-Length).
Initial questioning prior to the donation about sexual health and safety may lead to a deferral of
the donor (Full-Length).
All blood establishments maintain a list of ineligible donors in order to defer any that appear at
a donation site (Diaz).
Once the donation occurs, all blood is subjected to numerous tests for HIV, Hepatitis, and other
diseases and are kept in quarantine until said tests are completed (Blood Testing; Burton;
Diaz).
Lastly, investigations are required if there are any reports or suspicions that blood
establishments [or donations] breach the above steps (Diaz).
Furthermore, the current pre-donation questionnaire is designed to target individuals with life
styles that would place them in high-risk situations (Full-Length). Questions should be adopted
to screen for homosexual intercourse that would produce a high-risk for HIV/AIDS
contamination.
While the ban was designed to protect blood donors and receivers alike, it perpetuates the stigma
that gay men are more disease-ridden than other groups. Regarding the change to a one-year
deferral, the AABB made this statement: AABB, Americas Blood Centers and the American
Red Cross believe all potential blood donors should be treated with fairness, equality and respect,
and that accurate donor histories and scientifically supported donor deferral criteria are critical to
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the continued safety of blood transfusion (Joint Statement on FDA recommendation). Of
course, the ban is in place to encourage the safety of donors. Thankfully, the donor is being
switched to a one-year deferral (Burton). To have a lifetime ban was absolutely ridiculous in lieu
of recent technological developments. Zingman states, Lots of heterosexual people pose a high
risk and dont face a lifetime ban. This is about behavior; its not about being gay. The policy
stigmatizes gay men. It limits the donation pool, its not medically justified, and its not
right (Darling). Considering that men who have sex with prostitutes are deferred for one year,
and intravenous drug abusers faced the same deferral as a man who had homosexual intercourse
in 1977, the FDA will be reviewing the current policy and changing it to a one-year deferral; the
proposed change will be submitted to public comment in spring of 2015 (Blood Donations;
Conklin; Hamburg).
Post-Approval of the Deferral Elimination/Expected Project Results:
Once the proposal is submitted, the FDA must undergo rigorous testing to determine whether
eliminating the deferral would have serious negative effects on blood contamination. Because of
the reasons outlined above, this would come back conclusive. Afterwards, the FDA, AABB, Red
Cross, and other organizations must work together to create a MSM-deferred list conglomerate to
determine who was incorrectly banned. These individuals must be notified of the change in
deferral so that they can reevaluate their donor eligibility. Once they are aware of the nonexistent
ban, donations will begin for MSM.
Feasibility:
Working with other HIV/AIDS testing facilities presents a challenge, considering most blood
establishments already test their samples for the disease. The necessity, however, has been
outlined. After speaking with Lafene Medical Center at Kansas State University, they would
happily arrange an authentic way of transmitting diagnoses to blood donation sites. Whether it be
through email or postal services, a clear and effective way needs to be established to reiterate
MSM blood safety.
Dual testing positive samples for HIV should not present any issues. While cost might come up
as concern, so many HIV tests are done that a few more would not substantially impact the cost
as a whole. As stated earlier, If the test is done 15.7 million times, what justification can be used
against 8 (plus however many more actually correctly result positive for HIV) more? The
reasoning behind doing this of course is not only to protect MSM, but it would also provide for
any false-positive tests that occur with general donors. For instance, Molly Burton-head of
many drives within Abilene High School-stated, I tested false positive for a disease years ago.
I got tested again at a different facility, and my results came back negative. Afterwards, I
reapplied for donor eligibility with the Red Cross, but they would not allow it. To protect
donors and maximize healthy blood donations, it is feasible to dual test all positive results and
MSM donors.

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Method Timeline:
March-April:
One-Year Deferral proposal submitted for public comment
Proposal initiated
Submitted for review with FDA
May-August:
Testing by FDA about feasibility and authenticity
Cost evaluated for proposal
September:
Deferral elimination approval
Contact of all previously-deferred donors
October:
Begin screening/testing for initial MSM donations
Instigate fully accessible MSM donor eligibility
Budget:
The only necessary budget requirements would be as stated:
the previously-provided chart of different HIV tests, two per individual
the salaries of FDA screeners over the time of deferral testing and pre-screen questionnaire
rewriting
postage for any MSM donor incorrectly deferred by the 1983/1992 version to inform them of
the change
financial compensation to MSM donors who donate plasma, which is approximately $20 an
individual (Burton)
Conclusion:
Because of the necessity for healthy blood donations, a reevaluation of the FDAs current ban of
MSM donors is justified. Obviously, the agency is open to change with the one-year deferral
being submitted for public comment later in 2015. As outlined in this proposal, however, a
complete elimination of the ban is the most beneficial solution. Through the six provided reasons
of why the deferral is ineffective, it remains clear that this countrys blood donation tactics need
a revamp, and screening individuals on risk and dual testing MSM does that.
Honesty vs Ethics:
My name is Jordan Luty, and Im an 18 year old student in Abilene, Kansas. I am a homosexual,
but I have not participated in intercourse at this point. Someday, however, I hope to share that
bond with someone, and its hard for me to think Id have to consider which is more important:
intercourse with someone I love or saving lives. Ive donated blood 5 times and have participated
in every school drive offered; I absolutely love donating. Nothing gives me more hope than
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feeling like Ive made a positive contribution to someones life, and I want to keep doing that for
as long as I can. This ban disheartens me and the rest of the gay community. While I cannot
speak for the minority as a whole, I dont plan to infect anybody through a transfusion; thats not
my goal. I understand that people often have the disease while not knowing it because of the
stalled appearance of the antibodies, but I think its important to realize that there are individuals
in the gay community who are in committed, healthy relationships that want to donate blood. I
know the risks of having homosexual sex, but I dont want to have to lie about who I am to be
able to donate blood to an individual. I know how much its needed, and I know how I can help;
please consider letting me.

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Work Cited:
"Blood Donations from Men Who Have Sex with Other Men Questions and Answers." U.S.
Food and Drug Administration. U.S. Department of Health and Human Services, 23 Dec.
2014. Web. 23 Feb. 2015.
"Blood Facts and Statistics." The American Red Cross. The American National Red Cross, 2015.
Web. 9 Feb. 2015.
Blood Testing. The American Red Cross. The American National Red Cross, 2015. Web. 27
Feb. 2015.
Brennan, Nina. Rejected: Gay Blood and the FDA. Equality Insight. Wordpress, 12 Dec. 2014.
Web. 27 Feb. 2015.
Burton, Molly. Personal interview. 26 Feb. 2015.
Caption Notes for Advisory Committee on Blood Safety and Availability Day 1. The Advisory
Committee on Blood and Tissue Safety. The National Institute of Health, 10 Jun. 2010.
Web. 23 Feb. 2015.
Conklin, Rachel. Personal Interview. 26 Feb. 2015.
Darling, Mike. Banned for Life. Mens Health. Rodale Inc., 2013. Web. 23 Feb. 2015.
Diaz, Vianca. A Time for Change: Why the MSM Lifetime Deferral Policy Should Be
Amended. University of Maryland Law Journal of Race, Religion, Gender and Class.
Digital Commons, 2014. Web. 23 Feb. 2015.
Full-Length Donor History Questionnaire. FDA.gov. U.S. Food & Drug Administration, June.
2005. Web. 28 Feb. 2015.
Hale, Jan. Re: Red Cross. Message to Jordan Luty. 27 Feb. 2015.

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Hamburg, Margaret. FDA Commissioner Margaret A. Hamburg's Statement on FDAs Blood
Donor Deferral Policy for Men Who Have Sex with Men. 23 Dec. 2014. U.S. Food and
Drug Administration. Web. 9 Jan. 2015.
Heigl, Alex. Watch Alan Cumming's Entertaining New 'Pro-Abstinence' PSA (VIDEO). People
Magazine. Time Inc., 19 Feb. 2015. Web. 28 Feb. 2015.
Heintz, Shannon. Personal interview. 25 Feb. 2015.
HIV Diagnosis Rate in U.S. Declines Significantly. CBS News. CBS, 21 July. 2014. Web. 27
Feb. 2015.
Joint Statement Before the Advisory Committee on Blood Safety and Availability. American
Association of Blood Banks, Americas Blood Centers, and the American Red Cross. The
United States Department of Health and Human Services, 11 Jun. 2010. Web. 23 Feb.
2015.
Joint Statement on FDA Recommendation to Change MSM Deferral Policy. The American
Association of Blood Banks. AABB, Dec. 2014. Web. 28 Feb. 2015.
Kumanan, Wilson, Katherine Atkinson, and Jennifer Keelan. Three decades of MSM donor
deferral policies. What have we learned?. International Journal of Infectious Diseases.
Elsevier, Jan. 2014. Web. 23 Feb. 2015.
"Screening Tests for HIV Diagnosis and Treatment." WebMD. WebMD LLC, 2015. Web. 9 Feb.
2015.
Scripps Florida Scientists Announce Anti-HIV Agent So Powerful It Can Work in a Vaccine.
Scripps.edu. The Scripps Research Institute, 18 Feb. 2015.
Sickle Cell Disease (SCD). Centers for Disease Control and Prevention. USA.gov, 16 Sep.

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2011. Web. 23 Feb. 2015
The New York Times Editorial Board. "Gay Men Should Be Allowed to Give Blood." The New
York Times. The New York Times Company, 27 Nov. 2014. Web. 23 Feb. 2015.
UCLA Students. FDA. The Institute for Society and Genetics. Controversies in Biology and
Society, 6 Jun. 2013. Web. 23 Feb. 2015.

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