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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!

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Saving Lives With Helpful Guys Saving Lives With Helpful Guys Presentation Transcript

  • 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
  • FDABlood DonationRegulation Sub-Agency within Health and Human Services FDA’s Center for BiologicsThe Agency Evaluation and Research (CBER) Regulates U.S. collection of bloodU.S. Foodand Drug and blood productsAdministration Responsible for ensuring the(FDA) safety of the blood supply Regulates blood donation, storage Technical standards, inspections, enforcement, recordkeeping 2
  • The Role of the FDA“While a blood supply with zero risk of transmitting infectiousdisease may not be possible, the blood supply is safer than it hasever been. [B]iological products, blood and blood products arelikely always to carry an inherent risk of infectious agents.Therefore, zero risk may be unattainable. The role of FDA is to drivethat risk to the lowest level reasonably achievable without undulydecreasing the availability of this life saving resource.”– FDA Website March 2011 3
  • Shelf Life – Red Cells at 6ºC for up to 42 daysBlood Facts Platelets at room temperature in up to five days Plasma stored in freezers for up toNeed for Donation one year Need –Blood Banks andthe 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
  • Blood Recommended: 3-Day SupplyShortages Shortages – Shortages of all blood types happen during the summer andNeed for Donation winter holidaysReoccurring Drops Large Percentage of DonationsBelow 2-Day, Even1-Day Supplies from Schools If only one more percent of all Americans would give blood, blood shortages would disappear for the foreseeable future. 5
  • Major Hospitals Forced toBloodShortages Postpone All Elective Surgeries Certain Blood Types Restricted to Emergency Use OnlyCoping with Disasters and Terrorism – BloodShortages Must Be Already “On-Shelf”Emergency Pandemic Fears Reduce Donors –Preparedness, Mad Cow, West Nile, Swine FluFiscal Costs, andPublic Welfare Import Blood from Other States Aging Population More Demand: Changing Youth Behavior and Donor-Drive Marketing Costs 6
  • America’s Blood Centers: 2010-11½ US Volunteer Blood Supply – 1 Day Supply 7
  • America’s Blood Centers: 2010-11½ US Volunteer Blood Supply – 2 Day Supply 8
  • Some Recent Blood Supply Shortages•July 2000 – The majority of American Red Cross (ARC) blood service regionsare operating with less than one days supply of blood. "A blood shortage is adisaster, and we need the same level of public support for this disaster as we do fora hurricane, tornado, flood, or fire"•September 2000 – “This is a critical shortage ... one of the most serious wehave ever seen” ARC•August 2001 – “For the first time, the federal government is starting a day-to-day tracking system to monitor the nations blood supply and sound an alarmwhen shortages loom. It comes none too soon.”•September 2002 – The nations hospitals have insufficient blood reserves torespond to a major national disaster, the countrys largest blood suppliers warned•January 2003 – Hospitals and community blood banks across the nation areexperiencing a blood shortage so severe that some are postponing non-emergencysurgeries 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 twodays, American Blood Centers (ABC) 9
  • Some Recent Blood Supply Shortages•January 2004 – The U.S. Department of Health and Human Services is callingfor blood donations claiming the nation is facing a critical blood shortage. Healthand Human Services Secretary Tommy Thompson says If blood supplies do notimmediately increase, patients, accident victims and those whose lives depend onregular 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 peopleheaded 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 someexperts to question the growing list of safety criteria for blood donors. Sixty sixmillion Americans are excluded from donating blood based on a list that somedoctors call overly restrictive. The figure, recently calculated by researchers at theUniversity of Minnesota, represents more than a third of adult Americans whowould otherwise be eligible.• January and February 2011 – Snowstorms: The Red Cross reported at theend of January that blood levels for this time of year were the lowest in ten years. 10
  • Current Blood Present Ban: 1983, Final V: 1985Donation Response to HIV/AIDS CrisisGuidelines Emergency Measure Transfusion Risks DiscoveredThe 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
  • “Self-Deferral” ProcessCurrent BloodDonation Inform donors about the risk ofGuidelines transmitting infectious diseases. Ask potential donors questions about their health and certainDonation Process behaviors and other factors (likeIntake travel and past transfusions) thatQuestionnaires 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
  • The Intake QuestionQuestion 35: (Male Donors) From 1977 to the present, haveyou had sexual contact with another male, even once?Response: No  Next Question. Yes  Defer Donor Indefinitely. 13
  • Can the patient choose?PROBLEMS No. Patients not informed of viable gay blood donors lack opportunity to decide if they areSelf-Deferral willing to accept the donationGay Blood Ban Ineffective –Actually Filteringout MSM? MSM Lie: outing, personal affront Definitions: “sexual contact” Blood Banks National “Deferral Registry” – No Reason Codes or Statistical Analysis 14
  • Better Testing: Antibody + Virus,PROBLEMS Nucleic Acid Amplification HIV “Window Period” Reduced from Months to Weeks or LessScientific Progress Donor Knowledge: “Rapid” and “At-Home” HIV Testing AvailableGay Blood BanFailing to Add Automated Quarantine Areas forSafety 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
  • 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/YrGay Blood Ban ARC Donations – 80% Mobile BloodCosts Drives (community orgs, companies,MSM Blood schools, colleges, places of worshipUnavailable – or military installations)Shortages ARC Donations – 20% Schools and Colleges Trend: College Anti-Discrimination Policies + Student LGBT Solidarity vs. Donation Drives 16
  • Some Other Permanent Deferrals:PROBLEMS 1) IV Drug Users, 2) Animal Tissue Transplants, 3) Geographic Risk of Malaria orSocial Stigma vCJD/Mad Cow, andDoes FDA Think 4) Sold Sex for Drugs/MoneyGay Blood = DirtyBlood? MSM Ban Not Focused on Unsafe Behavior E.g. Hetero, unsafe sex with sex worker not permanently deferred Vs. Monogamous/Widowed MSM 17
  • March 2006 – FDA WorkshopFDA OfficialResponse Wide Array of Views Solicited FDA Disagreed with Medical MajorityReview of Policy Used 1 Risk Study to JustifyNo 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
  • Obama EraHHS OfficialResponse June 2010 HHS Committee Upheld Ban Voting 9-6 Acknowledge Ban “Suboptimal” – Ban Allows “some potentially highReview of Policy risk donations while preventingNo Change, some potentially low risk donations”AcknowledgeWeaknesses 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
  • Obama Lifted HIV+ Travel andShiftingConstitutional Immigration BansLaw Obama Believes DOMA UnconstitutionalObama and DOMA US DOJ to Stop Defending DOMA in Court, Though StillLGBT ProtectedClass 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
  • Cause of Action Under 14thShiftingConstitutional Amend, Equal Protection ClauseLaw Disparate Impact Gov’t Action + Discriminatory IntentLack of Change Intent may be inferred from, e.g.,Will Cost FDA “irrationality” of classificationCostly Studies vs. Mere Rationality: Legitimate EndCostly Litigation + Rational Means Intermediate : Important Interest + Substantially Related Means Strict: Compelling Interest + Narrowly Tailored Means (i.e. No Less Restrictive Options) 21
  • Costs, Win or Lose EP Suit:Staying Out of Resources Wasted in DefenseCourt P.R. Problems, esp. with younger, target donor demographicResults of EP Suit Grows Divide Between RegulatorNobody 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
  • Proposing Solutions:Short-Term Deferral LOW-RISK OPTIONS, INTERNATIONAL EXPERIENCE, ANDTHE EMERGING MEDICAL CONSENSUS
  • Options: Williams Inst. –5-Yr Deferral 5 Yr Deferral = 89,700 Pints/Yr1-Yr Deferral 1 Yr Deferral = 71,200 Pints/Yr FDA Data –Proposed 5 Yr Deferral = Zero Window PeriodAlternatives and Up to 1.7 Accidental ReleasesArbitrary Period, 1 Yr Deferral = 3 Window Period andBut 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
  • More Effective Behavioral Risk Assessment –Intake Monogamy vs. Unprotected Sex,Questions Numerous Partners Apply Equally to HeterosexualsRisk-Based and HomosexualsDeferral HIV/AIDS No Longer the “GayDropping ArbitraryDeferral Periods, Disease” – esp. African AmericansIncreasing Overall Ask Time of Last HIV/AIDS TestSafety – Window Period of Weeks Wouldn’t Violate Schools’ Anti- Discrimination Language (significant blood source) 25
  • Lifted Ban – RussiaInternationalExperience Intake Questions Target Unsafe Behavior – Spain, Italy, Thai RedProven 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
  • Building 2006 ARC, AABB, and ABC –Support for “scientifically and medicallyReform unwarranted” 2010 ARC: “We strongly support theJump on the use of rational, scientifically-basedBandwagon deferral periods that are applied fairly and consistently among donorsThe Blood Banksand the Medical who engage in similar riskCommunity 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
  • Building August 2009Support for CA Assembly JudiciaryReform Committee ResolutionJump on the 2010Bandwagon New York City CouncilLocal and StateResolutions Washington D.C. City Council Chicago City Council San Francisco 28
  •  FDA and HHS Letters – Partial ListingBuilding  2010 Senate: John Kerry, KirstinSupport forReform Gillibrand, Dick Durbin, Daniel Akaka, Sheldon Whitehouse, Sherrod Brown, Frank Lautenberg, Bob Casey, BernieJump on the Sanders, Russ Feingold, Mark Udall, AlBandwagon Franken, Maria Cantwell, Carl Levin, Tom Harkin, Mark Begich, RollandNational Elected Burris, Michael BennetOfficials  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
  • Building Gay Men’s Health Crisis – MajorSupport for StudyReform National Gay and Lesbian Task ForceJump on the Human Rights CampaignBandwagon Lambda LegalLGBT Civil RightsSupporters The Advocate Magazine State and Local Human Rights Commission Complaints and Settlements www.SaveALifeMovie.com 30
  •  Some College and University BoycottsBuilding and Significant ProtestsSupport forReform  2007 Iowa State University  2008 Sonoma State University  2008 San Jose State UniversityJump on the  2010 Keene State CollegeBandwagonLGBT Civil Rights  Ohio LGBT-Affirming ChurchesSupporters  http://www.gaypeopleschronicle.com/s tories05/august/0826053.htm  Lost Donations = LGBT + Allies  PR Disaster, Young Demographic Target Donors 31
  •  Petitions: www.Change.org - IDBuilding Medical Community Signatories andSupport for Public OfficialsReform  Targets: HHS, FDA, HHS/FDA Congressional Oversight Committees, Previous Elected Signatories,Public Education  Links to Advocacy Websites/LGBTCampaign Group Studies,  Ask Eric Holder/DOJ to Clarify PositionWhat 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
  • 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
  • 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
  • References1. The Role of the FDA – http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/default.htm2. Blood Product Shelf Life - http://www.redcrossblood.org/learn-about- blood/what-happens-donated-blood3. Blood Need – http://www.americasblood.org/go.cfm?do=Page.View&pid=54. 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.htm6. Intake Question #35, Version.1.3, May 2008 – http://www.fda.gov/biologicsbloodvaccines/bloodbloodproducts/approvedpro ducts/licensedproductsblas/blooddonorscreening/ucm164185.htm7. 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.asp9. Deferred Donor Registry - http://www.pptaglobal.org/program/deferral.aspx
  • References1. FDA Blood Safety – http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/default.htm2. Advocate – FDA’s MSM Data Wrong + Spain’s Transmission Reduction After Reform: http://www.advocate.com/printArticle.aspx?id=989743. FDA Risk Models Faulty – June 9, 2010 Representative Quigley Letter to FDA; See Anderson et al. in Transfusion (2009; 49: 1102-1114)
  • References – Blood Supply Shortages1. Shortages – http://www.americasblood.org/go.cfm?do=page.view&pid=122. Shortages – news articles list of the various years elective surgery has been postponed3. 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 ogle4. 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.htm5. 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;
  • 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=search&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+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=google
  • 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 Weatherhttp://www.accuweather.com/blogs/news/story/45539/winter-weather-leads-to-nation.asp?partner=accuweather ANDhttp://www.redcrossblood.org/news/missouri-illinois/winter-storm-causes-blood-supply-shortages-many-states
  • References – Constitutionality & Legal Views1. D.C. Human Rights Commission Settlement: http://www.thebody.com/content/art13321.html?ts=pf2. 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 Donees 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)
  • References – 2006 and 2010 Reviews1. 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