Sunteți pe pagina 1din 19

SENIOR THESIS

A LITTLE RED LIE: CHALLENGING THE


GAY BLOOD BAN IN PRACTICE
Quinton K. Meil

ABSTRACT
In this paper I will argue that it is neither illegal nor immoral for gay men to lie
about their sexual orientation in order to donate blood. For nearly 30 years the
FDA and blood donation centers across the U.S. have deferred gay men from
donating blood. Proponents of the deferral policy argue that, because the
prevalence of HIV is disproportionately high within the gay community, their
deferral is an essential step in securing the safety of the blood supply. Critics have
largely dominated the debate by challenging the deferral policy for being
unscientific, unconstitutional, discriminatory, and stigmatizing. Despite the critics
efforts, and a high demand for blood, the FDA continues to defer gay men from
donating based on their sexual orientation. However, many are unaware that the
FDA and blood donation centers hold no legal authority to restrict donations from
gay men. Whats more, the FDAs lack of legal authority over gay blood donors
has not been used to challenge the deferral policy in practice. I wish to continue
the work of the policy critics by offering a novel challenge that posits that gay
men can legally donate blood by lying about their sexual orientation. Not only can
gay men lie about their sexual orientation, they should lie in order to donate blood.
The intent of this challenge is to provide an immediate partial-solution to the high
demand for blood and to help alleviate the discrimination and stigmas endured by
gay men regarding HIV. In Part I. I will provide a general overview of HIV and
current FDA policies surrounding blood donation. In Part II. I show why it is not
illegal for gay men to lie about their sexual identity during blood donation by
analyzing congressional legislation, federal regulations, and donor center policies.
In Part III. I will provide an ethical argument for gay men to lie about their sexual
orientation during blood donation based on utilitarianism, deontology, and
jurisprudence.

B.A. Candidate, 2016, Temple University. Senior thesis submitted in fulfilment of the
requirements for distinction in the study of philosophy. Thank you to Professor Lindsay Craig for
her mentorship on this project and for her guidance throughout my time at Temple University.
Thank you also to Lauren Schumacher for instilling in me the importance of donating blood. This
paper includes information about legal issues and developments. Such materials are for
informational purposes only and should not be taken as legal advice on any particular set of facts
or circumstances.
1

TABLE OF CONTENTS

INTRODUCTION .................................................................................................. 1
I. HIV/AIDS and Blood Donation Policy ....................................................... 4
A. What is HIV/AIDS? .................................................................................. 4
B. Why are HIV and gay men commonly associated? .................................. 6
C. What is the FDA policy regarding gay men who donate blood? ............. 6
II. MSM Deferral and the Law ......................................................................... 8
A. Congressional Legislation ....................................................................... 8
B. Federal Regulations ................................................................................. 9
C. Blood Donation Center Policy ............................................................... 11
D. Civil Liability.......................................................................................... 12
E. Constitutionality ..................................................................................... 13
III. The Ethics of Lying to Avoid MSM Deferral ........................................ 13
A. Utilitarianism ......................................................................................... 13
B. Deontology ............................................................................................. 15
C. Legal Positivism and Natural Law Theory ............................................ 16
CONCLUSION ..................................................................................................... 17

INTRODUCTION

The demand for blood in the United States is constant. At present, the U.S.
transfuses nearly 50,000 pints of blood per day. 1 Loosely classified as a drug,
blood is used in transfusions by surgery centers, emergency rooms, and clinics to
help treat a wide range of conditions and diseases. 2 However, unlike most drugs,
blood cannot be manufactured and must be collected from donors. 3 Whats more,

1
See Blood Facts and Statistics, American Red Cross (last visited April 28, 2016).
Approximately 36,000 units of red blood cells, 7,000 units of platelets, and 10,000 units of
plasma are needed daily in the U.S.. A unit of blood is ~525 mL, or roughly 1 pint. Every 2
seconds a person living in the U.S. requires a blood transfusion and uses on average 3 pints of
blood per transfusion.
2
See Federal Food Drug and Cosmetic Act 21 U.S. Code 321 The term drug
meansarticles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals.
3
See A.I. Alayash, Evaluating the Safety and Efficacy of Hemoglobin-based Blood Substitutes,
U.S. Food and Drug Administration. (last modified Feb. 09, 2016). FDA has not approved any
HBOCs (a synthetic blood substitute) for use in the United States
2

the shelf life of blood is significantly shorter than most drugs at just 42 days. 4
Blood transfusions also pose the unique risk of potentially transferring
communicable diseases from donor to recipient. 5 In an effort to minimize these
risks, blood donations undergo a strict screening process which ranges from the
administration of personal questionnaires regarding a donors risk history, to
laboratory testing which verifies the bloods safety. 6 As a result, the number of
eligible blood donors has been narrowed to a mere 36% of the population, of
which only 10% donate. 7

One way to alleviate the strain of the low supply and high demand for blood
in the U.S. is to increase the amount of donors by relaxing eligibility rules.
Potential blood donors can be deferred for a number of reasons including recent
travel or a history of disease. By and large, the risk history questions used to
determine donor eligibility comport with evidence based risks and are essential to
maintaining the worlds safest blood supply. 8 However, one eligibility question
on the risk history questionnaire has been debated since its inception the
question regarding men who have sex with men (MSM). 9

In 1983 the FDA issued their first regulation to indefinitely defer MSM
donors due to the disproportionate occurrence of HIV infections in the gay
community. 10 Because little was known about HIV in the early 1980s, a uniform
ban on all high risk groups including homosexuals and intravenous drug users
seemed appropriate at the time. 11 However, as HIV research, testing, and
treatment rapidly advanced, FDA regulations deferring gay men from donating
blood remained unchanged. 12 Men who answered yes on the question have
you engaged in sexual activity of any kind with another man since 1977? were
banned from donating blood for life despite the existence of accurate HIV testing
or monogamous relationships among donors. The issue in contention is the
policys failure to isolate risk factors for HIV infection. Questions linking sexual

4
See Blood Components, American Red Cross. (last visited Apr. 25, 2016). Self-life varies
depending on use, storage method, and blood component. In general, red blood cells can be
stored for up to 42 days.
5
Blood Transfusions, Mayo Clinic. (last visited Apr.03, 2016).
6
Blood Testing, American Red Cross. (last visited Apr. 03, 2016).
7
Id. at 2
8
See Keeping Blood Transfusions Safe, U.S. Food & Drug Admin. (last visited May 1, 2016).
9
See Whitney Larkin, Discriminatory Policy: Denying Gay Men the Opportunity to Donate Blood,
11 Hous. J. Health L. & Poly 121-148 (2011). Because the gay blood deferral policy equates
sexual orientation with a risk of infection, it differs substantially from the other deferral
questions.
10
FOOD & DRUG ADMIN., REVISED RECOMMENDATIONS FOR REDUCING THE RISK OF HUMAN
IMMUNODEFICIENCY VIRUS TRANSMISSION BY BLOOD AND BLOOD PRODUCTS 2-3 (2016).
11
Berner, Boel. The Making of a Risk Object: AIDS, Gay Citizenship, and the Meaning of Blood
Donation in Sweden in the Early 1980's, Sociology of Health & Illness 33, no. 3 (2011): 385-386.
12
Between the years of 1985 2015 the FDAs formal stance on MSM deferral did not change
in spite of annual meetings held to address potential issues. Id. At 9
3

orientation to HIV risk only perpetuate the stigma that being gay is intrinsically
bad and that gay men have dirty blood. The mere act of being gay, or being a
male who sleeps with men, does not predispose a person to the risk of contracting
HIV. Regardless, regulations continue to exclude roughly 219,000 potential blood
donors annually based on their sexual orientation. 13

Many have since challenged the MSM deferral policy for not only
dramatically reducing the number of eligible donors, but for also being
unconstitutional and discriminatory. 14 In response to these criticisms, and to the
growing demand for blood, the FDA revised their MSM deferral policy in 2015.
The new policy allows gay men to donate blood following one year of total
abstinence from sexual contact and for each consecutive year thereafter. 15 Critics
maintain that the revised policy is still discriminatory and that it does not reflect
the current scientific understanding of HIV. The policy again fails to account for
any known HIV risk factors, and instead perpetuates the notion that men who
have sex with men are innately predisposed to disease. Further, the new MSM
deferral policy only increased the donor pool by roughly 62,000 people due to the
seemingly insurmountable barrier of remaining abstinent for one year. 16 The
arbitrary time frame of 12 months since last sexual contact also dehumanizes gay
men because it diminishes the importance of sexuality to human identity. The
FDA maintains that their policy is not discriminatory against gay men because it
targets only men who have sex with men. However, nearly all men who identify
as gay have sex with men because it is through sexual practice that people most
commonly define their sexual identity (with the exception of those who identify
as asexual).

As of now, the revised MSM deferral policy does nothing to isolate HIV risk
factors. Instead, it merely points out a correlation without rooting out the causal
factors. The actual risk factors for HIV infection are known well enough that an
individual could determine their own risk independent of the MSM deferral
question. Regardless of an individuals ability determine their own risk factors,
many questions on the questionnaire already effectively eliminate people with a
high risk of HIV infection including questions about condom use, and/or contact
with people with a known infection. 17 In light of this, a potential challenge to the
MSM deferral policy could be one that allows donors to stand up to the deferral
policy in practice. MSM blood donors should challenge the policy by self-
assessing their actual risk factors for HIV, and answering all but one question
honestly on the risk history questionnaire - the MSM deferral question. With the
help of a little red lie, gay men can avoid deferral and participate in blood
13
Mathew L Morrison, Bad Blood: An Examination of the Constitutional Deficiencies of the
FDAs Gay Blood Ban, 6 Minnesota Law Review. 2379 (2015).
14
Dwayne J. Bensing, Science or Stigma: Potential Challenges to the FDAs Ban on Gay Blood, 14
U. Pa. J. Const. L. 485 (2011). Because the deferral policy explicitly treats gay men differently, it
may violate their right to equal protection under the law.
15
Id. at 10
16
Id. at 13
17
Id. at 10
4

donation. 18 However, before delving into the legal and ethical issues surrounding
this challenge, it is imperative to lay a common groundwork for understanding
HIV, the AIDS epidemic, and FDA policy so that donors may make an informed
choice to lie, or not, based on their individual risk factors.

I. HIV/AIDS and Blood Donation Policy

This section answers the following questions: What is HIV/AIDS? Why are HIV
and gay men commonly associated? What is the FDA policy regarding gay men
who wish to donate blood?

A. What is HIV/AIDS?

The human immunodeficiency virus, more commonly referred to as HIV,


has infected more than 1.2 million people living in the United States. 19 It is
estimated that there are currently more than 36.9 million people worldwide living
with HIV infection with roughly 70% of all cases presenting in Sub-Saharan
Africa. 20 In 2001, the United Nations General Assembly classified the prevalence
and spread of HIV as a global emergency and outlined a comprehensive set of
measures governments can take to combat the virus. 21 Despite this, HIV
infections continue to plague minority groups, gay men, and injection drug users
at disproportionate rates. 22

HIV infections largely attack the immune system by targeting a specific


type of white blood cell known as a T cell. 23 Once the virus binds with a CD4
glycoprotein coating on the surface of an individual T cell, it is able to
commandeer the cells nucleus in order to make copies of its genetic
information. 24 During this process, the virus remains incognito and the immune
system is not inclined to respond. Once the virus is copied, it leaves the infected T
cell and repeats the process indefinitely. Because T cells play an important role in
activating the bodys immune response, the uncontrolled replication of HIV can
have a tremendous impact on the hosts ability to fight of other infections. When
left untreated, HIV will progress into Acquired Immune Deficiency Syndrome,
18
Little white lies are traditionally seen as harmless, lacking malicious intent, and are often told
as a way to accomplish a greater good. The type of lying I suggest in this paper is equivalent to a
white lie, but is referred to as a red lie to symbolize the color of blood.
19
HIV in the United States: At a Glance Centers for Disease Control and Prevention (last
updated September 2015).
20
Global Health Observatory (GHO) Data, World Health Organization (last visited on Apr. 17,
2016).
21
See UNITED NATIONS, DECLARATION OF COMMITMENT ON HIV/AIDS (2001). The global HIV/AIDS
epidemic, through its devastating scale and impact, constitutes a global emergency and one of
the most formidable challenges to human life and dignity, as well as to the effective enjoyment
of human rights, which undermines social and economic development throughout the world and
affects all levels of society national, community, family and individual.
22
HIV by Group, Centers for Disease Control and Prevention (last updated June 21, 2015)
23
HIV Lifecycle, AIDS.gov (last updated Apr. 20, 2016).
24
Id.
5

more commonly referred to as AIDS. This is the result of an advanced HIV


infection within the body and it occurs when the level of CD4 cells an individual
has drops below 200 cells per microliter. 25 AIDS is a serious medical condition
which causes pneumonia, extreme muscle wasting, chronic infections, and various
cancers.

The first known case of HIV / AIDS occurred in 1982, in what would later
become known as the AIDS epidemic. 26 Cases of a rare and difficult disease
began puzzling doctors in California and within a few months, gay men and
injection drug users across the U.S. were succumbing to the disease at alarming
rates. 27 Fear crippled the gay and straight communities alike, for little was known
about how it spread. Because of the disproportionate occurrence of HIV in the gay
population, it was quickly referred to as a gay disease and harsh stigmas
associated with HIV quickly branded the gay community at large. 28 Within a year,
AIDS was named, and by 1984 researchers isolated HTLV-III as the culprit. 29
The first HIV test was soon after developed which could accurately detect HIV in
blood 25 days after exposure by measuring the level of antibodies produced by
the body to fight the virus. 30

By 1986, nearly 30,000 people living in the United States had HIV. Three
years later, the first medication was released to treat the virus, but despite
advancing tests, nearly 30 million people worldwide had contracted the virus. At
present day, there is no known cure for HIV. However, modern tests can detect an
HIV infection within 9 days of exposure. 31 Additionally, medications have
advanced to the point of achieving total viral suppression or undetectable status.
This means that once the virus is blocked from replicating, it declines in number
so greatly that no blood test can detect it. 32 For these reasons, most people in the
United States living with HIV infection do not face the threat of acquiring
AIDS. 33 The development of anti-retroviral medications which prevent the virus
from replicating, allows individuals to maintain a healthy immune system.
Additionally, these medications have been shown to reduce the risk of
transmission from an HIV positive individual to a negative person substantially. 34

25
Stages of HIV Infection, AIDS (last visited on Apr. 17, 2016).
26
Id. at 9
27
Morrison, Bad Blood, 6 Minnesota Law Review. 2366 (2015)
28
The still-unknown disease affecting men mostly in NY and CA became so associated with
homosexuals that it was initially called the Gay-related immune disease. Id.
29
History of HIV and AIDS, Avert (last updated on Jan. 26, 2016)
30
Larkin, Discriminatory Policy, 11 Hous. J. Health L. & Poly 136 (2011). The test on average
can identify the presence of HIV antibodies twenty-five days after someone has been exposed to
them.
31
HIV Test Types, AIDS (last visited on Apr. 17, 2016).
32
Melissa Dahl, What Does It Mean to Have Undetectable HIV?, NY Mag.
33
HIV treatment is still inaccessible to some groups, and as such, AIDS is still a relevant issue in
the U.S. however, it is not usual.
34
Id. 14
6

B. Why are HIV and gay men commonly associated?

With a basic understanding of what HIV is and how it progressed, it is


important to understand why it disproportionately affects the gay community. It is
no secret that HIV and homosexuality have become synonymous. In fact, 81% of
all HIV infections occur in gay or bisexual men. 35 Particularly for gay men ages
18-25, HIV prevention and treatment is a familiar conversation due to their high
rate of infection. In the past, some have argued that HIV is the wrath of God
cast upon gay men for their immoral lifestyle. 36 Others have argued that male
sexual behaviors combined with biology facilitate the disproportionate figures.
Surprisingly, God has more to do with it than one might image. For centuries,
religion has denied the existence of homosexuality and proclaimed it as sin.
Further, monogamous relationships between gays were not legally recognized
until 2015 when the Supreme Court ruled in favor of marriage equality. 37 As such,
gay men were often forced to live their lives in secrecy, increasing the riskiness of
their sexual encounters. 38

Another reason why HIV disproportionately plagues gay men has to do


with biology. While it is true that biology in general plays a role in the
transmission of HIV, it is wrong to label gay men as being biologically
predisposed to contracting the virus. The most common way HIV spreads during
intercourse is through anal sex. 39 Individuals engaging in anal sex with an HIV
positive partner have a 1.4% chance of contracting HIV. This is because
microscopic tears form in the lining of the rectum during penetration and allow a
direct route for semen to come in contact with the blood stream. 40 To argue that
gay men are biologically predisposed is misleading because both men and women
are capable of, and participate in, anal intercourse. Additionally, homosexual
couples employ various methods of sexual contact just as heterosexual couples do.
While anal sex is risky, it is equally as risky in both men and women.

C. What is the FDA policy regarding gay men who donate blood?

Irrespective of why HIV impacts the gay community more often than
others, the AIDS epidemic sparked unilateral fear and legitimate concern about
the safety of the national blood supply. Once news broke that HIV was a disease
largely spread through blood, the FDA immediately implemented an indefinite

35
HIV Among Gay and Bisexual Men, Centers for Disease Control and Prevention (last updated
Sept. 29, 2015)
36
Godwin Haruna, No! HIV/Aids is Not Punishment From God, Africa News Service(Sept. 5, 2007)
37
Obergefell v. Hodges, 576 U.S. (2015)
38
A comparable example is the association between violent crimes and drug use. Because drug
use is heavily criminalized in the U.S., buying and selling drugs has become a dangerous business
relegated to underground networks. As such, men wishing to have sex with men were often
forced to do so in circumstances riskier than heterosexuals.
39
James Wilton, Putting a number on it: The risk from an exposure to HIV, CATIE (Fall 2012).
40
Unprotected sex and HIV, AVERT (last updated May 1, 2015) Vaginal sex has a rate of
infection of .08%, roughly half the risk of anal sex.
7

deferral of gay men from donating blood. 41 The only observable characteristic
available to the FDA at this time was that gay men were getting sick, and the
virus was blood borne. However, as testing became available and the virus was
identified, LGTBQ organizations began increasing their opposition to the ban
citing stigma and failure to isolate actual risk. 42 Thirty years went by before any
policy revisions were made. During that time, the invention of advanced testing,
treatment, and prevention had all become relevant. In 2015, the deferral policy
was finally amended to allow men who have abstained from sexual contact with
another male for 12 months to donate blood.

Initially this policy change was lauded for its progressive stance on HIV
risk isolation and for its positive impact on gay identity. However, soon after its
enactment, the new MSM policy has become in many respects worse than the
original. First, the 12 month abstinence period is arbitrary. Even the least sensitive
HIV tests can theoretically guarantee detection of an infection 6 months after
exposure. More advanced tests are considered to be 100% effective at detecting
infections within 9 days of exposure. 43 A 12 month deferral does not take into
consideration the current scientific understanding of HIV. The new policy also
dehumanizes gay men in a way the old policy did not. This is because it separates
gay men from their sexual identity by suggesting such a long period of sexual
abstinence. Gay men are men who have sex with men, so it is harmful to suggest
that gay men can donate blood, so long as the abstain from sex for one year.
Additionally, the new policy is even more discriminatory because it specifically
targets gay men unlike the old one. Having sexual contact with a man since 1977
disqualifies many men who experimented once or twice with homosexuality as
well as gay men who regularly have sex with other men. However, Gay men are
now the specific target of the new policy because they are more likely to have sex
with another man within a one year period than men who do not identify as gay
but have experimented in the past.

With a background on what FDA policy says about gay blood donors and
insights on the rationale used for their deferral, it is possible to provide challenges
or avenues of recourse. Prior to the policy revision in 2015, the MSM deferral
policy was challenged in large part on constitutional grounds. Many academics
provided a framework for arguing discrimination in the nations highest courts.
Others have relied on science to show that the policy is outdated. Few, if any,
have provided a framework to show how an individual donor can challenge the
MSM deferral policy by lying to the donation center.
41
Shawn Carroll Casey, Illicit Regulation: A Framework for Challenging the Procedural Validity of
the Gay Blood Ban, 66 FOOD & DRUG L.J. 553-554 (2011)
42
Berner, The Making of a Risk Object, Sociology of Health & Illness 385-386 (2011) Gay
organizations from England, Denmark, France, the U.S., condemned the gay blood ban citing its
discriminatory effects.
43
Bensing, Science or Stigma, 14 U. Pa. J. Const. L. 493 (2011)
8

II. MSM Deferral and the Law

This section will answer the following question: Is it illegal to lie on the MSM
deferral question in order to donate blood donation?

A. Congressional Legislation

According to the U.S. Constitution, the authority to enact new laws and
change existing ones lies with the legislative branch. 44 In order for proposed
legislation to become a statute backed by the full force of law, both the House of
Representatives and the Senate within Congress must pass identical versions of
the legislation. 45 To date, the Federal government has passed several pieces of
legislation regarding HIV / AIDS and blood donation safety. One such law is a
provision in Title 18 of the United States Code which prohibits the donation of
blood and other organs from an individual who is knowingly HIV positive. 46
Under this statute, an individual may be held criminally liable for donating blood
after receiving a positive test result for HIV. 47 To the extent of federal law, it is
illegal for an individual to donate blood with a known HIV infection. Whats
more, the mere act of lying about a known HIV infection to a blood donation
center is illegal because transmission of the HIV virus is not required under this
statue. 48 Therefore, even if infected blood is detected and discarded during the
blood screening process, an individual may be held criminally liable for lying
about their HIV status during a blood donation.

At the state level, similar congressional legislation regarding HIV


transmission has been passed in 33 states. 49 Although a majority of state
legislation does not address blood donation specifically, much of it draws upon
the concept of HIV status disclosure during high risk events. One example is Title
5 of the Arkansas Code which requires individuals with a known HIV infection to
disclose their status to sexual partners and medical professionals. Failure to
comply with this statute may result in criminal prosecution and conviction of a
felony. 50 In some cases, HIV positive individuals who have transmitted the virus

44
U.S. Const. art. I. sec. 1. All legislative powers herein granted shall be vested in a Congress of
the United States, which shall consist of a Senate and House of Representatives.
45
U.S. Const. art. I. sec 7. Every bill which shall have passed the House of Representatives and
the Senate, shall, before it become a law
46
18 U.S.C. 1122 (2013)
47
Id. According to this statute, elements for prosecution under it require the defendant to have
received actual notice of HIV infection prior to donating and for the defendant to have
knowingly donated their blood or other organs. If convicted, individuals may be required to pay
a fine of up to $10,000.00 and/or serve up to 10 years of imprisonment.
48
Id. at16.
49
See Stan J. Lehman, Et al., Prevalence and Public Health Implications of State Laws that
Criminalize Potential HIV Exposure in the United States, 18 AIDS and Behavior. 997-1006 (2014).
50
Ark. Code Ann. 5-14-123
9

or placed others at risk for infection have been charged with assault. 51 For that
reason, depending on the state in which an individual donates blood, it is likely
illegal to lie about a known HIV infection. These state and federal statues address
the disclosure of an individuals known HIV, not the disclosure of sexual
orientation or preference. With the exception of a few vestigial sodomy laws at
the state level, there are currently no federal or state statutes requiring the
disclosure of an individuals sexual orientation to anyone at any time. Because
the question in contention on the risk history questionnaire pertains solely to
sexual activity and not HIV disclosure, it falls beyond the scope of state and
federal statutes. Meaning, as a matter of congressional legislation, lying on the
MSM question alone is not illegal.

B. Federal Regulations

While the MSM question on the blood donation form is not backed by the
force of law under congressional legislation, it was placed there in part by a
Federal regulation. 52 Distinct from laws enacted by Congress, Federal
Regulations are the rules and regulations of specific departments and agencies
within the government 53. In the U.S., blood donation is licensed and regulated by
the Food and Drug Administration (FDA). 54 The FDA garners its authority to
regulate blood donation from two statutes enacted by congress, the Public Health
Act (PHA) and the Food Drug Cosmetic Act (FDCA). Within the FDA, the
specific entity charged with regulating the donation of blood and blood products
for transfusion is the Center for Biologics Evaluation and Research (CBER).
Before enacting new or revised regulations, CBER consults with the Blood
Products Advisory Committee (BPAC) which is comprised of academics,
professionals, and experts in a variety of fields relevant to transfusion safety. 55
The decisions made by CBER regarding blood donation are entered into the
Federal Code of Regulations and become binding rules upon the entries in which
they regulate. In order to obtain licensing, blood donation centers must comply
with the regulations set forth by the FDA which are backed by the full force of
law similar to those of laws enacted by congressional legislation. Therefore,
blood donation centers are legally required to test donated blood for infectious
diseases, defer high risk donors, and operate under a specific set of guidelines.

In order for Federal Regulations to acquire the full force of law and bind
blood donation centers, they must adhere to the requirements set forth by the

51
Rashida Richardson, Et al., State and Federal Laws and Prosecutions, 1 Positive Justice Project.
14-26 (2015). In California, HIV positive individuals charged with sexual assault can be charged
with aggravated assault if no protection was used.
52
FOOD & DRUG ADMIN., REVISED RECOMMENDATIONS (2016).
53
42 U.S.C 262(a) (2006)
54
See Registration of producers of drugs or devices 21 U.S. Code 360
55
Blood Products Advisory Committee, U.S. Food and Drug Administration (April, 15 2015)
10

Administrative Procedures Act (APA). Passed by Congress in 1946 the APA


requires that regulations proposed by government agencies undergo promulgation
(a public comment period) before they may become a statement of policy backed
by the force of law. While many practices such as blood testing, and high risk
donor referral have become legally enforceable Federal Regulations, to the
surprise of many, the MSM policy is not a binding federal regulation. Meaning,
the classification of men who have sex with men as high risk blood donors is not a
regulation set forth by the FDA. This is because the FDA did not follow APA
guidelines when enacting the MSM deferral policy. Instead, the MSM deferral
policy is merely a recommendation to blood centers to classify men who have sex
with men as high risk and suggests their deferral. 56 The official MSM deferral
policy states This guidance represents the current thinking of the FDA on this
topic. It does not establish any rights for any person and is not binding on FDA or
the public. 57 Whats more, FDA guidance documents, including this document,
do not establish legally enforceable responsibilities. 58 In light of this, a blood
center has no legal obligation to defer gay blood donors, and while all do, no legal
recourse against them for choosing not to defer MSM donors existents. Therefore,
as a matter of federal regulation, it is not illegal for blood donation centers to
accept MSM blood donors. As mentioned most, if not all blood centers choose to
defer men who have sex with men as high risk. This is in part due to precedent for
blood donation centers to refer to the FDAs current thinking irrespective of legal
authority. 59

If the MSM deferral policy were compliant with the APA and was
considered a legally enforceable regulation, blood donation centers would be
required to defer MSM blood donors. In this scenario, nothing would change for
individual blood donors because the FDA deferral policy, law or not, applies only
to blood donation centers. This is because the FDA garners its Authority over
blood supply from the PHSA and FBCA, which constrict the actions of blood
donation centers not individuals. That means, if the MSM question on the risk
history questionnaire were a regulation instead of the current recommendation, it
would only be a violation of law for a donation centers not to defer MSM donors
not for donors to lie on the MSM question. In this scenario, it would also be a
violation of law for a donation center to not administer an MSM deferral
questionnaire. Despite this hypothetical requirement for donation centers to
administer MSM deferral questions, authority would not extend to the content of a

56
Shawn Carroll Casey, Illicit Regulation: A Framework for Challenging the Procedural Validity of
the Gay Blood Ban, 66 FOOD & DRUG L.J. 551 (2011)
57
FOOD & DRUG ADMIN., REVISED RECOMMENDATIONS, 1 (2016).
58
Id.
59
Id. at 41 If a blood bank disregarded FDA recommendations, however, FDA would penalize
that agency under its authority to regulate the blood supply. Essentially, blood donation centers
are strong-armed into MSM deferral.
11

donors response. Meaning, even if the MSM deferral policy were backed by law
(which it currently is not), lying on this question would not be illegal.

At this point, I have shown why the MSM deferral question has no force of
law with regards to congressional legislation or federal regulations. I have also
shown that even with a legally binding regulation in place, lying on the MSM
deferral question would not be a violation of the law.

C. Blood Donation Center Policy

Donors are often asked to verify the accuracy of their answers provided on the
risk history questionnaire. The donor questionnaire administered by the
American Red Cross has a Declaration section requiring which donors are
required to endorse. Before signing the declaration, donors read a list of
conditions pertinent to the responses they provide in the risk history
questionnaire. On such condition in the declaration states that willful
misrepresentations may be punishable by law. At first thought, this condition
appears to contradict a majority, if not all of my main argument. A closer look at
this declaration section of the risk history questionnaire will show that it highly
misleading and has no legal value. 60

First, it is essential to understand that the risk history questionnaires are not
legally binding oaths. That is, by providing false information on the questionnaire,
individuals cannot be held legally liable for the sole act of lying on the
questionnaire itself. For example, imagine that two roommates sign a sheet of
paper upon which they agreed to split their monthly electric bills. Then, at the
time payment is due, one roommate refuses to pay their share of the bill. The
roommate who lied cannot be held responsible for lying because their original
agreement was not a legally binding oath. That said, the roommates are still
responsible for repercussions outside of their agreement due to a past due electric
bill. In the case of blood donation, the declaration section has no legal authority.
Rather, it is seen as a promise to the blood center. Like the roommate example,
blood donors are still responsible for the repercussions of their actions if they lied.
For instance, because donating blood with a known infection is illegal, you may
be held criminally liable as the declaration suggests. But because the declaration
is signed as a promise and not a legally binding oath, the act of lying on it is not
illegal.

Instead, blood donation centers have policies in place to deal with the
occasional donor who provides misleading information. Donors caught lying are
simply placed on the deferral list and can no longer donate blood. Because gay
men face certain deferral for being honest about their sexual orientation, lying

60
The information used in this section was obtained by calling 1-800-RedCross.
12

with the slight risk of deferral is favored. Looking forward, 21 CFR 630.10(b),
effective May 23, 2016, will require that donor educational material be presented
to donors in a manner they will understand, which may include oral, written, or
multimedia formats, and must instruct the donor not to donate when a risk factor
for HIV infection is present. 61 This is a legally binding regulation which means
blood centers must instruct individuals when a risk factor is present. This is a rule
constricting blood centers, meaning if they do not provide instruction, they will be
in violation. It is the donors choice whether to heed the instructions given.

D. Civil Liability

Civil liability or a lawsuit more generally, is a common but unfounded


concern for donors who lie. If for example, an individual with an HIV infection
unknown to them, lied on the MSM question and donated blood, it is highly
unlikely that the donor could be held liable in civil court. It is important to note
that a court would not be able to consider congressional legislation regarding HIV
transmission because those involve known infections. Technically, a blood
donation center or blood recipient could initiate a lawsuit against an individual for
fraud. They would need to prove that the individual misled them, intentionally
misled them, and received damages as a result of being misled. 62 First, it is
unlikely a blood center would discover that you misled them on the MSM
question. Further it would be even more unlikely they could prove it was your
intent to mislead them. Because the new policy creates an arbitrary time frame of
12 months, sexual contact becomes difficult to pinpoint and intention becomes
more ambiguous. It is reasonable that a donor would not be able to recall if their
sexual contact with a man had occurred 350 days ago, or if it occurred 365 days
ago.

Second, the party filing the lawsuit would have to prove that they were
damaged as a result of the misrepresentation. This would be incredibly difficult
for someone who received infected blood to prove that the damages were a result
of a lie on MSM question specifically. The MSM question is technically not
designed to catch an HIV risk factor, therefore lying on it could not be the cause
of a recipients infection. Infected individuals would more than likely sue a blood
donation center than a donor because they have a legal duty to protect the blood
supply, and in most cases, have more money to pay out in damages. Additionally,
blood centers are not likely to initiate a law suit against a blood donor in fear of
setting a dangerous precedent. If each time a person donated, they feared the
repercussions of civil liability; donations may decrease because the potential cost
to an individual would greatly outweigh the benefit.

61
FOOD & DRUG ADMIN., REVISED RECOMMENDATIONS, 12 (2016).
62
John J. Tollefsen, Defining Fraud, Tollefsen Law (2008).
13

E. Constitutionality

If still unconvinced that the ban on gay blood is nothing more than a
suggestion lacking legal force, I offer one last challenge. It has been previously
argued that the ban on gay blood is unconstitutional. This argument rests largely
on the grounds that the deferral policy violates the rights of gay men to equal
protection under the law. As discussed, the current policy specifically targets gay
men, even if the policys artful prose suggest otherwise. Further, the policy places
a stigma on gay men that is unnecessary and irrational both of which are
burdens the Supreme Court has used in the past in equal protection cases. 63
Because the FDAs intention is to isolate risk factors and not gay men, the
deferral recommendations should and could be phrased as such. While the
Supreme Court does not view homosexuality in an elevated level of scrutiny as it
does with race and gender, The Court would likely rule that the ban were
unconstitutional due to the reasoning applied in Lawrence v. Texas which found
that laws banning sexual practices common to gay men were a violation of the 5th
amendment equal protection clause. 64 In order for a case to reach the Supreme
Court, a law in question must be broken. A donor wishing to assert that the policy
were unconstitutional and therefore that lying is not illegal would need to practice
civil disobedience. That is, a donor would break the law in question and with the
view that their actions were not illegal and challenge their case until it reached the
Supreme Court. However, because I have shown why lying on the MSM deferral
question is not illegal on multiple levels, a constitution challenge is not necessary
for the goals of this project. What is necessary is to show why donors should lie
once they know they legally can.

III. The Ethics of Lying to Avoid Deferral

This section will address the following question: Is it ethical to lie on the MSM
deferral question in order to donate blood?

A. Utilitarianism

While it is legal to lie on the MSM deferral question, many argue that it is
unethical to do so. Often citing increased rick of blood supply contamination,
people tend to perceive the idea of lying on the blood donor risk history
questionnaire as morally reprehensible.

When asking this question within the scope of multiple ethical theories, it
becomes clear that lying on the MSM deferral question is not only legal; it is the
moral thing to do. First, I will address the question at hand with reference to
utilitarianism. In general terms, utilitarianism is an ethical theory that assigns

63
Bensing, Science or Stigma, 14 U. Pa. J. Const. L. (2011)
64
Lawrence v. Texas (02-102) 539 U.S. 558 (2003)
14

moral weight based on the outcome of an action. Under this theory of ethics,
people should choose between actions based on the amount of utility produced.
Moral actions are therefore seen as actions that create the greatest amount of
value over disvalue. 65 John Stewart Mill, a 19th century political philosopher,
argued that happiness is the utility people should seek to maximize. Unlike many
classical utilitarian theorists, Mill argued that actions could create harm or pain
and still be moral, so long as the action created a good or pleasure that
outweighed the bad. 66

In utilitarian theory, personal interests often clash with the interests of


society as a whole. What produces the greatest amount of pleasure for an
individual may harm a group more broadly. In contrast, a less self-interested
conception of utilitarianism states that moral actions are those which increase the
good of the whole. With reference to blood donation, people often choose to
donate for a combination of self-interested and group welfare reasons. In a survey
conducted, people responded that they donated most often blood it made them
feel good. This is clearly self-interested utilitarianism. Others however felt it was
their duty to society. In either case, the pleasure experienced is derived from the
perception of doing something good. If the benefits outweigh the risks, lying in
order to donate blood should have a similar positive impact.

There are potential negative consequences of lying on the risk history


questionnaire that must be taken into account. First, lying on the risk history
questionnaire decreases its validity and authority over donors. When donors
decide which policies to follow and which to disregard, all of the questions
become seemingly arbitrary. However, in this specific instance, there is an
abundance of scientific evidence which singles out the MSM question from the
rest as invalid. The ability to isolate an individual question in this manner protects
the validity of the questionnaire at large. Because many of the other questions on
the questionnaire address specific HIV risk factors, donors can rely on those
questions to isolate their risk, while comfortably excluding the one question
which does not fit. Whats more, evidence suggests that some donors have lied
on the risk history questionnaire in the past. Researchers found that a small but
growing number of people already do not comply with the MSM deferral
question. 67 At a minimum, because some people already lie, the issue of trying to
maintain the questionnaires validity becomes in part, irrelevant as a practical
matter.

65
The History of Utilitarianism, Stanford Encyclopedia of Philosophy. (2014)
66
Id.
67
Blood Donor Deferral for men Who Have Sex With Men: The Blood Donation Rules Opinion
Study, Transfusion 55 (Dec. 2015).
15

The most common argument against lying on the risk history


questionnaire is that it puts people in need of blood transfusions at an increased
risk for contracting a communicable disease. Individuals in need of blood
transfusions are often suffering from a chronic illness or a traumatic event, and as
such, society has a special duty to care for these individuals. Many fear that by
allowing men who have sex with men to donate blood, the risk of HIV infected
blood being transfused would increase due to the high occurrence of HIV in the
gay community. However, with proper screening, the current risk of 1 in 1.5
million, would only increase to 1.5 in 1.5 million. 68

All drugs and medical treatments carry risks. Blood transfusions are
actually less risky than many equivalent procedures. Regardless, doctors treat
blood transfusion as a last resort, meaning those who are exposed to the risks of
blood transfusion are already running low on options. Society should be willing to
accept that small burden of risk based on the tremendous good that can be done. It
is estimated that 219,000 additional pints of blood could be added to the blood
supply, potentially saving 657,600 more lives annually. 69 Therefore, from a
utilitarian perspective I argue that it is ethical to lie on the MSM deferral
questionnaire.

In this particular case, the outcome of a persons action clearly matters because it
pertains to public health and matters of life and death. That said, the intention of
the individual who is donating blood is still highly relevant to a discussion of
ethics.

B. Deontology

Deontological ethical theories are often those which require adherence to specific
rules based on a persons duty. Immanuel Kant is known for his deontological
theory which creates universal rules when addressing questions related to ethics
and morality. 70 While applying a universal rule to the notion of lying during a
blood donation has many challenges, part of Kants theory is still salvageable. In
Kants theory intention plays a large role in determining an actions moral worth
not outcome. 71 Therefore, assessing the intentions of the MSM deferral policy
as well as of the individual donors themselves may shed light on the ethical
implications of lying.
The FDA has clear and explicit goals for regulating the blood supply. That is, they
aim to keep the blood supply safe while collecting as much blood as possible.
Their intention in keeping the blood supply safe is to ensure that the recipients of

68
Morrison, Bad Blood, 6 Minnesota Law Review. (2015)
69
Id.
70
Deontological Ethics, Stanford Encyclopedia of Philosophy. (2012)
71
Id.
16

blood transfusions are at the lowest possible risk for contracting an infection. As
discussed, in order to achieve this goal the FDA has both recommended and
required certain questions regarding their risk be asked to potential donors. Many
of these questions align with the FDAs specific intent to secure the blood supply.
However, the specific MSM question has been shown to isolate nothing more
than an individuals sexual orientation and fails to align with the FDAs intent to
screen for risk factors.
If a lie is morally reprehensible based on malicious or deceptive intention,
lying on the MSM deferral question would not be considered immoral. Because
donors are aware that it is the FDAs intention to keep the blood supply safe when
asking risk history questions, lying on a question that has been blatantly shown
to fail in isolating risk over multiple decades is not immoral. This is because
individuals who lie on the MSM deferral question do so not with the intent to
deceive the FDA. Lying on the MSM deferral question should not be perceived as
malicious because the question itself so clearly does not comport with the FDAs
intent in asking the question. In fact by lying, MSM blood donors are helping to
safely increase the nations blood supply without genuinely deceiving the FDA.
C. Legal Positivism and Natural Law Theory

Despite showing why the MSM deferral has no legal authority, Jurisprudence
theory is still an important consideration when discussing the ethics of lying in
this circumstance. While the issue at hand is not a matter of law directly, the
MSM deferral policy is often perceived as an extension of government authority.
Further, the policies enacted by individual donation centers have been a result of
the governments recommendation. As such, the policies of individual donation
centers often function as law in a sense because they are explicitly laid out and
enforceable meaning donation centers may legally defer a donor who is caught
lying indefinitely.

With that in mind, it is possible to address this issue from a jurisprudence


perspective. Legal positivism is the notion that law and morality are two separate
entities, and as such laws need not be moral in order to command respect and
validity. 72 Simply by virtue of being a law, legal positivists argue that people have
a duty to follow law because they were enacted by a more or less just society
and have authority as such independent of their merit. While the MSM policy is
not technically a law, a legal positivist would argue that it is immoral for donor to
lie on the MSM question because the act of breaking a law or policy is wrong
in and of itself.

Despite this critique, gay blood donors have natural law theory on their side
which helps to further the idea that it is ethical to lie on the MSM deferral

72
Legal Positivism, Stanford Encyclopedia of Philosophy. (2003)
17

question. Natural law theorists think that law ought to be moral to be considered a
law. That is, if a law lacks merit, it fails as a law and therefore breaking it would
be both legal and ethically warranted. 73 Again, while the MSM policy is not a law,
it could be argued the from the perspective of natural law theorist that breaking
the MSM policy is ethical. Because the MSM deferral policy lacks merit in
isolating HIV risk factors and discriminates against an entire group of people,
natural law theorist would posit the MSM deferral policy is in fact not a policy at
all.

CONCLUSION

In the United States there is a great deal of need for people to donate blood.
Unfortunately, thousands of pints of life saving blood remain uncollected every
day because of outdated policies rooted in homophobia. In 1983 gay men were
banned from donating blood out of concern for the safety of the blood supply.
Due to the high correlation of HIV and homosexuality, and no known treatment,
test, or cure, I believe the broad deferral policy may have been just at the time.
After 30 years of research, HIV has become easily detectable and treatable,
turning the MSM deferral policy into a homophophic scar that causes more harm
than good. By allowing gay men to donate blood without qualification of their
sexual orientation, over half a million more lives could be saved each year. Not
only would abolishing the MSM deferral policy be lifesaving, it would be life
changing. Gay men face discrimination and stigma daily at both a legal and social
level. And while abolishing the MSM deferral policy will not solve these issues, it
is a necessary step in the right direction in improving the quality of life of gay
men.
By and large, adherence to the MSM deferral policy has been relatively
followed despite its unjust effect. Many donors question the MSM policy based
on its normative merits, but few question its authority in practice. Many MSM
donors are unaware that the deferral policy is merely a recommendation. Whats
more, those who are aware of its status as a recommendation do not understand
what that means. The truth of the matter is that gay men where never legally
barred from donating blood. The FDA has no authority to ban gay men from
donating blood mainly because the policy was not properly implemented through
the guidelines imposed on government agencies by congress.
In this paper I have shown how men can legally lie about their sexual
orientation to donate blood. This method of challenging the deferral policy allows
for an immediate solution to the issued created by the MSM deferral policy.
Many donors do not consider whether or not the policy is legal because ethics
play a large role in the policys adherence. I argue that it is not just legal but also
ethical to lie on the MSM donor question. From a utilitarian perspective, the costs
73
The Natural Law Tradition in Ethics, The Stanford Encyclopedia of Philosophy
18

of lying are greatly overshadowed by the benefits. The intent behind lying on the
MSM deferral question also lacks intent to deceive the FDA because the
underlying purpose of the deferral is to reduce risk something the deferral does
accomplish. In the future I hope the FDA will revise its deferral policy to reflect
scientific evidence, but there is no need to wait for them to do so. Donate.

S-ar putea să vă placă și