From www.SavingLivesWithHelpfulGuys.com: This presentation attempts to lay out a more comprehensive argument for safely and sensibly reforming the Gay Blood Ban. It was created using the references listed on the final slides and the links and downloads from the parent website. You may copy, edit, or expand on this original presentation for any advocacy purpose. However, please clearly note that the presentation has been edited, point your audience to this website, and leave an acknowledgement to the author, Kyle Carlson. Be sure to Contact us to report any successful presentations!

1. Saving Lives with Helpful Guys:
Moving Past the Gay Blood Ban
SAFELY AND SENSIBLY REFORMING THE
FDA’S
“PERMANENT DEFERRAL” POLICY
http://savingliveswithhelpfulguys.com
KYLE CARLSON
CHICAGO-KENT COLLEGE OF LAW
MARCH 2011

2. FDA
Blood Donation
Regulation Sub-Agency within Health and
Human Services
FDA’s Center for Biologics
The Agency Evaluation and Research (CBER)
Regulates U.S. collection of blood
U.S. Food
and Drug and blood products
Administration Responsible for ensuring the
(FDA)
safety of the blood supply
Regulates blood donation, storage
Technical standards, inspections,
enforcement, recordkeeping
2

3. The Role of the FDA
“While a blood supply with zero risk of transmitting infectious
disease may not be possible, the blood supply is safer than it has
ever been. [B]iological 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.”
– FDA Website March 2011
3

4. Shelf Life –
Red Cells at 6ºC for up to 42 days
Blood Facts
Platelets at room temperature in up
to five days
Plasma stored in freezers for up to
Need for Donation one year
Need –
Blood Banks and
the Public Welfare Needed every two seconds in U.S.
About 1 in 7 people entering a
hospital needs blood
Blood is always needed for treatment
of accident victims, cancer patients,
hemophiliacs and surgery patients
Blood cannot be manufactured or
harvested
4

5. Blood Recommended: 3-Day Supply
Shortages Shortages –
Shortages of all blood types
happen during the summer and
Need for Donation winter holidays
Reoccurring Drops Large Percentage of Donations
Below 2-Day, Even
1-Day Supplies from Schools
If only one more percent of all
Americans would give blood,
blood shortages would disappear
for the foreseeable future.
5

6. Major Hospitals Forced to
Blood
Shortages Postpone All Elective Surgeries
Certain Blood Types Restricted to
Emergency Use Only
Coping with Disasters and Terrorism – Blood
Shortages Must Be Already “On-Shelf”
Emergency Pandemic Fears Reduce Donors –
Preparedness, Mad Cow, West Nile, Swine Flu
Fiscal Costs, and
Public Welfare
Import Blood from Other States
Aging Population More Demand:
Changing Youth Behavior and
Donor-Drive Marketing Costs
6

7. America’s Blood Centers: 2010-11
½ US Volunteer Blood Supply – 1 Day Supply
7

8. America’s Blood Centers: 2010-11
½ US Volunteer Blood Supply – 2 Day Supply
8

9. Some Recent Blood Supply Shortages
•July 2000 – The majority of American Red Cross (ARC) blood service regions
are operating with less than one day's supply of blood. "A blood shortage is a
disaster, and we need the same level of public support for this disaster as we do for
a hurricane, tornado, flood, or fire"
•September 2000 – “This is a critical shortage ... one of the most serious we
have ever seen” ARC
•August 2001 – “For the first time, the federal government is starting a day-to-
day tracking system to monitor the nation's blood supply and sound an alarm
when shortages loom. It comes none too soon.”
•September 2002 – The nation's hospitals have insufficient blood reserves to
respond to a major national disaster, the country's largest blood suppliers warned
•January 2003 – Hospitals and community blood banks across the nation are
experiencing a blood shortage so severe that some are postponing non-emergency
surgeries and thawing frozen blood, a measure that makes it more perishable.
''Some hospitals have only a one-day supply. About 50 percent have less than two
days,'' American Blood Centers (ABC)
9

10. Some Recent Blood Supply Shortages
•January 2004 – The U.S. Department of Health and Human Services is calling
for blood donations claiming the nation is facing a critical blood shortage. Health
and Human Services Secretary Tommy Thompson says 'If blood supplies do not
immediately increase, patients, accident victims and those whose lives depend on
regular transfusions are at risk for not getting the blood they need.'
•August 2005 – "If the gasoline supply dropped to one and a half days as people
headed out to enjoy the Labor Day weekend America would consider that a crisis -
we want people to be just as concerned about the blood supply” ARC
•Summer and Fall 2007 – the extreme seasonal drought that is leading some
experts to question the growing list of safety criteria for blood donors. Sixty six
million Americans are excluded from donating blood based on a list that some
doctors call overly restrictive. The figure, recently calculated by researchers at the
University of Minnesota, represents more than a third of adult Americans who
would otherwise be eligible.
• January and February 2011 – Snowstorms: The Red Cross reported at the
end of January that blood levels for this time of year were the lowest in ten years.
10

11. Current Blood Present Ban: 1983, Final V: 1985
Donation Response to HIV/AIDS Crisis
Guidelines
Emergency Measure
Transfusion Risks Discovered
The Motivation
Devastated Sub-Populations:
Pandemic Panic
MSM and Hemophiliacs
MSM = Men Who Have Sex with
Men (behaviorally defined)
FDA: MSM “Permanent Deferral”
Blood Collection Agencies Must
Adhere to FDA Guidelines
11

12. “Self-Deferral” Process
Current Blood
Donation Inform donors about the risk of
Guidelines transmitting infectious diseases.
Ask potential donors questions
about their health and certain
Donation Process behaviors and other factors (like
Intake travel and past transfusions) that
Questionnaires increase their risk of infection.
Help people, even those who feel
well, to identify themselves as
potentially at higher risk for
transmitting infectious diseases.
Reduce unknowing donation of
possibly infected blood.
12

13. The Intake Question
Question 35: (Male Donors) From 1977 to the present, have
you had sexual contact with another male, even once?
Response:
No  Next Question.
Yes  Defer Donor Indefinitely.
13

14. Can the patient choose?
PROBLEMS No. Patients not informed of
viable gay blood donors lack
opportunity to decide if they are
Self-Deferral willing to accept the donation
Gay Blood Ban Ineffective –
Actually Filtering
out MSM?
MSM Lie: outing, personal affront
Definitions: “sexual contact”
Blood Banks National “Deferral
Registry” – No Reason Codes or
Statistical Analysis
14

15. Better Testing: Antibody + Virus,
PROBLEMS Nucleic Acid Amplification
HIV “Window Period” Reduced
from Months to Weeks or Less
Scientific Progress
Donor Knowledge: “Rapid” and
“At-Home” HIV Testing Available
Gay Blood Ban
Failing to Add Automated Quarantine Areas for
Safety Value New Blood – Prevent Mix-Ups
Increased FDA Blood Bank
Inspections (2 yrs or less)
FDA’s Increased Quality Stds. –
Similar to Pharma Mfg.
15

16. HRC’s 2000 Est. U.S. 18+ Gay &
PROBLEMS Lesbian Pop.: 10.5 million of 210
million (limited data)
Williams Inst. – Est. 7.17 Million;
Lifting Ban +219,200 Pints/Yr
Gay Blood Ban ARC Donations – 80% Mobile Blood
Costs
Drives (community orgs, companies,
MSM Blood schools, colleges, places of worship
Unavailable – or military installations)
Shortages ARC Donations – 20% Schools and
Colleges
Trend: College Anti-Discrimination
Policies + Student LGBT Solidarity
vs. Donation Drives
16

17. Some Other Permanent Deferrals:
PROBLEMS 1) IV Drug Users,
2) Animal Tissue Transplants,
3) Geographic Risk of Malaria or
Social Stigma
vCJD/Mad Cow, and
Does FDA Think
4) Sold Sex for Drugs/Money
Gay Blood = Dirty
Blood? MSM Ban Not Focused on Unsafe
Behavior
E.g. Hetero, unsafe sex with sex
worker not permanently deferred
Vs. Monogamous/Widowed MSM
17

18. March 2006 – FDA Workshop
FDA Official
Response Wide Array of Views Solicited
FDA Disagreed with Medical
Majority
Review of Policy Used 1 Risk Study to Justify
No Change AABB: “Much of the [FDA’s
MSM] data comes from STD
clinics, so they come from people
who have the most promiscuous
MSM behavior”
FDA Risk Model Based on
Inaccurate 1990s Data Before
Blood Bank Safety Reforms
18

19. Obama Era
HHS Official
Response June 2010 HHS Committee Upheld
Ban Voting 9-6
Acknowledge Ban “Suboptimal” –
Ban Allows “some potentially high
Review of Policy risk donations while preventing
No Change, some potentially low risk donations”
Acknowledge
Weaknesses Supported Ban: Hemophiliacs,
American Plasma Users Coalition,
Family Research Council, etc…
14-0 Vote to Move Towards
Behavior-Based Q/A
But Recommend Further Study and
Set No Timeline
19

20. Obama Lifted HIV+ Travel and
Shifting
Constitutional Immigration Bans
Law Obama Believes DOMA
Unconstitutional
Obama and DOMA
US DOJ to Stop Defending
DOMA in Court, Though Still
LGBT Protected
Class Status Likely
Enforced
Argued for Heightened Scrutiny –
Something Like Intermediate i.e.
Similar to Gender Classifications
Several 2nd Circuit Cases – No
Precedent on Level of
Constitutional Scrutiny for Sexual
Orientation, Likely to Raise Std.
20

21. Cause of Action Under 14th
Shifting
Constitutional Amend, Equal Protection Clause
Law Disparate Impact Gov’t Action +
Discriminatory Intent
Lack of Change
Intent may be inferred from, e.g.,
Will Cost FDA “irrationality” of classification
Costly Studies vs. Mere Rationality: Legitimate End
Costly Litigation + Rational Means
Intermediate : Important Interest
+ Substantially Related Means
Strict: Compelling Interest +
Narrowly Tailored Means (i.e. No
Less Restrictive Options)
21

22. Costs, Win or Lose EP Suit:
Staying Out of Resources Wasted in Defense
Court
P.R. Problems, esp. with younger,
target donor demographic
Results of EP Suit
Grows Divide Between Regulator
Nobody Wins and Regulated (blood banks,
hospitals, medical professionals)
Additional Cost – FDA Loses:
Judicial Control of Reform
Additional Costs – FDA Wins:
Fails to Address Blood Shortages
22

23. Proposing Solutions:
Short-Term Deferral
LOW-RISK OPTIONS,
INTERNATIONAL EXPERIENCE, AND
THE EMERGING MEDICAL CONSENSUS

24. Options: Williams Inst. –
5-Yr Deferral 5 Yr Deferral = 89,700 Pints/Yr
1-Yr Deferral 1 Yr Deferral = 71,200 Pints/Yr
FDA Data –
Proposed 5 Yr Deferral = Zero Window Period
Alternatives
and Up to 1.7 Accidental Releases
Arbitrary Period, 1 Yr Deferral = 3 Window Period and
But Safe
3 Accidental Releases
Similar Risk Scenarios –
MSM Tissue Donation = 5 Yr
Hepatitis B and C “Window Period”
Result in Temporary, 1 Yr Deferrals
24

25. More Effective Behavioral Risk Assessment –
Intake Monogamy vs. Unprotected Sex,
Questions Numerous Partners
Apply Equally to Heterosexuals
Risk-Based and Homosexuals
Deferral
HIV/AIDS No Longer the “Gay
Dropping Arbitrary
Deferral Periods,
Disease” – esp. African Americans
Increasing Overall Ask Time of Last HIV/AIDS Test
Safety
– Window Period of Weeks
Wouldn’t Violate Schools’ Anti-
Discrimination Language
(significant blood source)
25

26. Lifted Ban – Russia
International
Experience
Intake Questions Target Unsafe
Behavior – Spain, Italy, Thai Red
Proven Success Cross
Spain’s HIV Transfusions Drop!
Decrease Stigma,
Increase Safety
6 Month Deferral – South Africa
1 Year Deferral – Sweden, Brazil,
Argentina, Australia, Japan, and
Hungary
5 Yr Deferral – New Zealand
26

27. Building 2006 ARC, AABB, and ABC –
Support for “scientifically and medically
Reform unwarranted”
2010 ARC: “We strongly support the
Jump on the use of rational, scientifically-based
Bandwagon deferral periods that are applied
fairly and consistently among donors
The Blood Banks
and the Medical who engage in similar risk
Community activities.”
2010 AABB: “You wonder, if this
wasn’t about gay men, would the
rules be applied in the same way?”
2010 AMA – 5 Yr Deferral Policy
27

28. Building August 2009
Support for CA Assembly Judiciary
Reform
Committee Resolution
Jump on the
2010
Bandwagon
New York City Council
Local and State
Resolutions Washington D.C. City Council
Chicago City Council
San Francisco
28

29.  FDA and HHS Letters – Partial Listing
Building
 2010 Senate: John Kerry, Kirstin
Support for
Reform Gillibrand, Dick Durbin, Daniel Akaka,
Sheldon Whitehouse, Sherrod Brown,
Frank Lautenberg, Bob Casey, Bernie
Jump on the
Sanders, Russ Feingold, Mark Udall, Al
Bandwagon
Franken, Maria Cantwell, Carl Levin,
Tom Harkin, Mark Begich, Rolland
National Elected Burris, Michael Bennet
Officials  2010 House: Mike Quigley, Diane
Watson, Tammy Baldwin, Jared
Polis, Barney Frank, Anthony Weiner,
Jerrold Nadler, Sam Farr, Michael
Honda, Debbie Wasserman Schultz,
Raul M. Grijalva
29

30. Building Gay Men’s Health Crisis – Major
Support for Study
Reform National Gay and Lesbian Task
Force
Jump on the Human Rights Campaign
Bandwagon
Lambda Legal
LGBT Civil Rights
Supporters The Advocate Magazine
State and Local Human Rights
Commission Complaints and
Settlements
www.SaveALifeMovie.com
30

31.  Some College and University Boycotts
Building and Significant Protests
Support for
Reform  2007 Iowa State University
 2008 Sonoma State University
 2008 San Jose State University
Jump on the
 2010 Keene State College
Bandwagon
LGBT Civil Rights  Ohio LGBT-Affirming Churches
Supporters
 http://www.gaypeopleschronicle.com/s
tories05/august/0826053.htm
 Lost Donations = LGBT + Allies
 PR Disaster, Young Demographic
Target Donors
31

32.  Petitions: www.Change.org - ID
Building Medical Community Signatories and
Support for Public Officials
Reform  Targets: HHS, FDA, HHS/FDA
Congressional Oversight Committees,
Previous Elected Signatories,
Public Education  Links to Advocacy Websites/LGBT
Campaign Group Studies,
 Ask Eric Holder/DOJ to Clarify Position
What You Can Do on FDA’s Guidelines
 http://savingliveswithhelpfulguys.com
 Model Petition for School Blood Drives
– Do NOT Refuse to Donate!
 Model Op-Ed Letter
 EMAIL MY SITE TO REPORT
SUCCESSES! – Emphasize Blood Bank
Worker Support
32

33. Marketing and Messaging – Tactics
Growing shortage crises due to demographics
Reduced donations outside of directly affected MSM
Disaster/Terrorism preparedness: “on-the-shelf”
Emphasize safety advances, science, oversight and
operating practices
Blood Bank & Medical Community Consensus
Behavioral Risk Assessment Questionnaire –
Internationally Proven Strategy
Ban Costs: PR (esp. w/ target donor demographic),
Discrimination Settlements, Future Litigation w/
Protected Class Status = Judicial Control of Reform
33

34. Marketing and Messaging – Slogans/Themes
Saving Lives with Helpful Guys
It’s Time: Ending the Gay Blood Ban
Not Dirty: Gay Blood and the National Blood Shortage
Dirty Stigma, Clean Blood: Reforming the Gay Blood Ban
Ready to Serve: Reforming Gay Blood Donations
Moving Forward to Save Lives – Reforming the Gay
Blood Ban
Who’s Afraid of Saving Lives? Challenging the FDA’s Gay
Blood Ban
Inertia and Misconceptions
Addressing the Wrong Emergency: AIDS Fears vs.
Medical Realities (need for blood)
34

35. References
1. The Role of the FDA –
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/default.htm
2. Blood Product Shelf Life - http://www.redcrossblood.org/learn-about-
blood/what-happens-donated-blood
3. Blood Need – http://www.americasblood.org/go.cfm?do=Page.View&pid=5
4. ABC Supply Charts –
http://stoplight.americasblood.org/plsql/ecat/supply_monitor_pkg.web_repo
rt (accessed Feb. 24, 2011).
5. Intake Questionnaire Procedure – “What is Self-Deferral?”
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/Questionsa
boutBlood/ucm108186.htm
6. Intake Question #35, Version.1.3, May 2008 –
http://www.fda.gov/biologicsbloodvaccines/bloodbloodproducts/approvedpro
ducts/licensedproductsblas/blooddonorscreening/ucm164185.htm
7. History of Gay Blood Ban – Gay Mens Health Crisis Report, A Drive for
Change: Reforming U.S. Blood Donation Policies (2010)
8. 80% ARC Collection - http://www.givelife2.org/sponsor/quickfacts.asp
9. Deferred Donor Registry - http://www.pptaglobal.org/program/deferral.aspx

36. References
1. FDA Blood Safety –
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/default.htm
2. Advocate – FDA’s MSM Data Wrong + Spain’s Transmission Reduction After
Reform: http://www.advocate.com/printArticle.aspx?id=98974
3. FDA Risk Models Faulty – June 9, 2010 Representative Quigley Letter to FDA;
See Anderson et al. in Transfusion (2009; 49: 1102-1114)

37. References – Blood Supply Shortages
1. Shortages – http://www.americasblood.org/go.cfm?do=page.view&pid=12
2. Shortages – news articles list of the various years elective surgery has been
postponed
3. Shortages – Terrorism/Major Disaster
http://pqasb.pqarchiver.com/latimes/access/171352671.html?
dids=171352671:171352671&FMT=ABS&FMTS=ABS:FT&type=current&date=S
ep+11%2C+2002&author=EDDY+RAMIREZ&pub=Los+Angeles+Times&desc
=A+YEAR+AFTER%3B+Blood+Shortage+Seen+for+National+Disaster
%3B+Health%3A+Red+Cross
%2C+other+suppliers+urge+Congress+to+help+build+up+reserves.&pqatl=go
ogle
4. Shortages – Aging Demographics Change Behavior and Marketing Costs
http://www.pbs.org/nbr/site/onair/transcripts/070927c/ AND
http://www.usatoday.com/news/health/2004-09-23-blood-usat_x.htm
5. Amount of Gay Blood Available – Naomi Goldberg and Gary Gates, Effects of
Lifting Blood Donation Bans on Men Who Have Sex with Men, The Williams
Institute UCLA School of Law (June 2010)
6. Schools Rebuffing Discriminatory Blood Drives:
http://www.sgn.org/sgnnews38_20/page1.cfm;

38. References – List of Blood Shortages Slide
•July 2000 –
http://findarticles.com/p/articles/mi_m0FSL/is_3_72/ai_65539092/
•September 2000 – http://articles.cnn.com/2000-09-
19/health/blood.shortage.02_1_elective-surgeries-blood-shortage-america-s-
blood-centers?_s=PM:HEALTH
•August 2001 – http://nl.newsbank.com/nl-search/we/Archives?
p_product=CS&s_site=thestate&p_multi=CS&p_theme=realcities&p_action=sea
rch&p_maxdocs=200&p_topdoc=1&p_text_direct-
0=0EE338AA797144EF&p_field_direct-
0=document_id&p_perpage=10&p_sort=YMD_date:D&s_trackval=GooglePM
•September 2002 –
http://pqasb.pqarchiver.com/latimes/access/171352671.html?
dids=171352671:171352671&FMT=ABS&FMTS=ABS:FT&type=current&date=Sep
+11%2C+2002&author=EDDY+RAMIREZ&pub=Los+Angeles+Times&desc=A+Y
EAR+AFTER%3B+Blood+Shortage+Seen+for+National+Disaster%3B+Health
%3A+Red+Cross
%2C+other+suppliers+urge+Congress+to+help+build+up+reserves.&pqatl=googl
e

39. References – List of Blood Shortages Slide
•January 2003 – http://nl.newsbank.com/nl-search/we/Archives?
p_product=SJ&s_site=mercurynews&p_multi=SJ&p_theme=realcities&p_action
=search&p_maxdocs=200&p_topdoc=1&p_text_direct-
0=0F899F7A01352EA3&p_field_direct-
0=document_id&p_perpage=10&p_sort=YMD_date:D&s_trackval=GooglePM
•January 2004 – http://www.life.com/image/2873838
•August 2005 –
http://www.naturalnews.com/011315_blood_Red_Cross_college.html
•Summer and Fall 2007 –
http://www.reuters.com/article/2007/09/10/idUSN06426222
• January and February 2011 – Nationwide Bad Weather
http://www.accuweather.com/blogs/news/story/45539/winter-weather-leads-to-
nation.asp?partner=accuweather AND
http://www.redcrossblood.org/news/missouri-illinois/winter-storm-causes-
blood-supply-shortages-many-states

40. References – Constitutionality & Legal Views
1. D.C. Human Rights Commission Settlement:
http://www.thebody.com/content/art13321.html?ts=pf
2. Law Review Articles – John Culhane, Bad Science, Worse Policy: The
Exclusion of Gay Males from Donor Pools, 24 St. Louis U. Pub. L. Rev. 129
(2005).
3. Adam Pulver, Gay Blood Revisionism: A Critical Analysis of Advocacy and
The “Gay Blood Ban”, 17 Law & Sexuality 107 (2008).
4. Jay Zitter, Liability for Donee's Contraction of Acquired Immune Deficiency
Syndrome (AIDS) from Blood Transfusion, 64 A.L.R.5th 333 (Originally
published in 1998).
5. Michael Belli, The Constitutionality of the “Men Who Have Sex with Men”
Blood Donor Exclusion Policy, 4 J. L. Society 315 (2003).
6. Daniel J. Penofsky, Transfusion-Associated AIDS Litigation, 58 Am. Jur.
Trials 1 (Originally published in 1996; Updated April 2010)

41. References – 2006 and 2010 Reviews
1. HHS 2010 Review – http://lubbockonline.com/life/2010-06-10/committee-
could-change-ban-gay-men; http://www.365gay.com/news/gay-blood-ban-
remains/; http://perezhilton.com/2010-06-14-gay-men-ban-from-donating-
blood-upheld; http://www.metroweekly.com/news/?ak=5334;
http://www.nytimes.com/2010/08/03/health/03blood.html?
_r=1&pagewanted=print