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Saving Lives with Helpful Guys Safely and Sensibly Reforming the FDA’s Gay Blood Ban

Saving Lives with Helpful Guys Safely and Sensibly Reforming the FDA’s Gay Blood Ban. www.SavingLivesWithHelpfulGuys.com https://www.facebook.com/SavingLivesWithHelpfulGuys KYLE CARLSON CHICAGO-KENT COLLEGE OF LAW NOVEMBER 2012. FDA Sub-Agency within Health and Human Services

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Saving Lives with Helpful Guys Safely and Sensibly Reforming the FDA’s Gay Blood Ban

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  1. Saving Lives with Helpful Guys Safely and Sensibly Reforming the FDA’s Gay Blood Ban www.SavingLivesWithHelpfulGuys.com https://www.facebook.com/SavingLivesWithHelpfulGuys KYLE CARLSON CHICAGO-KENT COLLEGE OF LAW NOVEMBER 2012

  2. FDA • Sub-Agency within Health and Human Services • FDA’s Center for Biologics Evaluation and Research (CBER) • Regulates U.S. collection of blood and blood products • Responsible for ensuring the safety of the blood supply • Regulates blood donation, storage • Technical standards, inspections, enforcement, recordkeeping Blood Donation Regulation The Agency U.S. Food and Drug Administration (FDA) 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 • Platelets at room temperature in up to five days • Plasma stored in freezers for up to one year • Need – • 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 Blood Facts Need for Donation Blood Banks and the Public Welfare 4

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

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

  7. America’s Blood Centers: Nov 28, 2012½ US Volunteer Blood Supply: % 1 Day Supply 7

  8. America’s Blood Centers: Nov 28, 2012½ 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. Present Ban: 1983, Final V: 1985 • Response to HIV/AIDS Crisis • Emergency Measure • Transfusion Risks Discovered • Devastated Sub-Populations: MSM and Hemophiliacs • MSM = Men Who Have Sex with Men (behaviorally defined) • FDA: MSM “Permanent Deferral” • Blood Collection Agencies Must Adhere to FDA Guidelines Current Blood Donation Guidelines The Motivation Pandemic Panic 11

  12. “Self-Deferral” Process • Inform donors about the risk of transmitting infectious diseases. • Ask potential donors questions about their health and certain behaviors and other factors (like travel and past transfusions) that 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. Current Blood Donation Guidelines Donation Process Intake Questionnaires 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? • No. Patients not informed of viable gay blood donors lack opportunity to decide if they are willing to accept the donation • Ineffective • MSM Lie: outing, personal affront • Definitions: “sexual contact” • Blood Banks National “Deferral Registry” – No Reason Codes or Statistical Analysis PROBLEMS Self-Deferral Gay Blood Ban Actually Filtering out MSM? 14

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

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

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

  18. March 2006 – FDA Workshop • Wide Array of Views Solicited • FDA Disagreed with Medical Majority • Used 1 Risk Study to Justify • 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 FDA Official Response Review of Policy No Change 18

  19. Obama Era • June 2010 HHS Committee Upheld Ban Voting 9-6 • Acknowledge Ban “Suboptimal” – Ban Allows “some potentially high risk donations while preventing some potentially low risk donations” • 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 HHS Official Response Review of Policy No Change, Acknowledge Weaknesses 19

  20. https://federalregister.gov/a/2012-6091 • HHS designing a pilot study • Major Goal: Avoid “Window Period” • Subset of MSM donate blood, probably 1- or 5-yr abstinence • (a) Pre-donation Donor Testing, (b) Post-Donation Testing, (c) Combined Pre-Donation and Post-Donation • Critique: Stigma from Separate Process, Assumes Donor Honesty, Ignores Hetero HIV+ Risk • HHS’s Fear?: Behavioral, Risk-Based Questionnaire Offend Current Donors HHS Official Response Alternatives Examined Public Comment, Focus on Medical Community

  21. Obama Lifted HIV+ Travel and Immigration Bans • Obama Believes DOMA Unconstitutional • US DOJ to Stop Defending DOMA in Court, Though Still Enforced • Argued for Heightened Scrutiny – Something Like Intermediate i.e. Similar to Gender Classifications • Circuit Splits on Appropriate Level of Scrutiny • SCt to announce LGBT case reviews Nov 30, 2012 Shifting Constitutional Law Obama and DOMA LGBT Protected Class Status Likely? 21

  22. Past Cases: No “Right to Donate” • Future: Cause of Action Under 14th Amend, Equal Protection Clause • Disparate Impact Gov’t Action + Discriminatory Intent • Intent may be inferred from, e.g., “irrationality” of classification • Mere Rationality: Legitimate End + Rational Means • Intermediate : Important Interest + Substantially Related Means • Strict: Compelling Interest + Narrowly Tailored Means (i.e. No Less Restrictive Options) Shifting Constitutional Law Lack of Change Will Cost FDA Costly Studies vs. Costly Litigation 22

  23. Costs, Win or Lose EP Suit: • Resources Wasted in Defense • P.R. Problems, esp. with younger, target donor demographic • Grows Divide Between Regulator and Regulated (blood banks, hospitals, medical professionals) • Additional Cost – FDA Loses: Judicial Control of Reform • Additional Costs – FDA Wins: Fails to Address Blood Shortages and Behavioral Risk Factors Staying Out of Court Results of EP Suit Nobody Wins 23

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

  25. Williams Inst. – • 5 Yr Deferral = 89,700 Pints/Yr • 1 Yr Deferral = 71,200 Pints/Yr • FDA Data – • 5 Yr Deferral = Zero Window Period and Up to 1.7 Accidental Releases • 1 Yr Deferral = 3 Window Period and 3 Accidental Releases • Similar Risk Scenarios – • MSM Tissue Donation = 5 Yr • Hepatitis B and C “Window Period” Result in Temporary, 1 Yr Deferrals Options: 5-Yr Deferral 1-Yr Deferral Proposed Alternatives Arbitrary Period, But Safe 25

  26. Behavioral Risk Assessment – Monogamy vs. Unprotected Sex, Numerous Partners • Apply Equally to Heterosexuals and Homosexuals • HIV/AIDS No Longer the “Gay Disease” – esp. African Americans • Ask Time of Last HIV/AIDS Test – Window Period of Weeks • Wouldn’t Violate Schools’ Anti-Discrimination Language (significant blood source) More Effective Intake Questions Risk-Based Deferral Dropping Arbitrary Deferral Periods, Increasing Overall Safety 26

  27. Lifted Ban – Russia • Intake Questions Target Risky Behavior – Spain, Italy, Thai Red Cross • Spain’s HIV Transfusions Drop! • 6 Month Deferral – South Africa • 1 Year Deferral – Sweden, Brazil, Argentina, Australia, Japan, and Hungary • 5 Yr Deferral – New Zealand International Experience Proven Success Decrease Stigma, Increase Safety Considerations Demographics of HIV Vary 27

  28. 2006 ARC, AABB, and ABC – “scientifically and medically unwarranted” • 2010 ARC: “We strongly support the use of rational, scientifically-based deferral periods that are applied fairly and consistently among donors who engage in similar risk 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 Building Support for Reform Jump on the Bandwagon The Blood Banks and the Medical Community 28

  29. August 2009 • CA Assembly Judiciary Committee Resolution • 2010 • New York City Council • Washington D.C. City Council • Chicago City Council • San Francisco Building Support for Reform Jump on the Bandwagon Local and State Resolutions 29

  30. FDA and HHS Letters – Partial Listing • 2010 Senate: John Kerry, Kirstin Gillibrand, Dick Durbin, Daniel Akaka, Sheldon Whitehouse, Sherrod Brown, Frank Lautenberg, Bob Casey, Bernie Sanders, Russ Feingold, Mark Udall, Al Franken, Maria Cantwell, Carl Levin, Tom Harkin, Mark Begich, Rolland Burris, Michael Bennet • 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 Building Support for Reform Jump on the Bandwagon National Elected Officials 30

  31. Gay Men’s Health Crisis – Major Study • National Gay and Lesbian Task Force • Human Rights Campaign • Lambda Legal • The Advocate Magazine • State and Local Human Rights Commission Complaints and Settlements • www.SaveALifeMovie.com Building Support for Reform Jump on the Bandwagon LGBT Civil Rights Supporters 31

  32. Some College and University Boycotts and Significant Protests • 2007 Iowa State University • 2008 Sonoma State University • 2008 San Jose State University • 2010 Keene State College • Ohio LGBT-Affirming Churches • http://www.gaypeopleschronicle.com/stories05/august/0826053.htm • Lost Donations = LGBT + Allies • PR Disaster, Young Demographic Target Donors Building Support for Reform Jump on the Bandwagon LGBT Civil Rights Supporters 32

  33. Petitions: www.Change.org - ID Medical Community Signatories and Public Officials • Targets: HHS, FDA, HHS/FDA Congressional Oversight Committees, Previous Elected Signatories, • Links to Advocacy Websites/LGBT Group Studies, • Ask Eric Holder/DOJ to Clarify Position on FDA’s Guidelines • Emphasize Blood Bank Worker Support • http://savingliveswithhelpfulguys.com • Model Petition for School Blood Drives – Do NOT Refuse to Donate! • Model Op-Ed Letter • REPORT SUCCESSES! – Email Me! Building Support for Reform Public Education Campaign What You Can Do 33

  34. 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 34

  35. 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) 35

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

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

  38. References – Blood Supply Shortages • Shortages – http://www.americasblood.org/go.cfm?do=page.view&pid=12 • Shortages – news articles list of the various years elective surgery has been postponed • Shortages – Terrorism/Major Disaster 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 • 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 • 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) • Schools Rebuffing Discriminatory Blood Drives: http://www.sgn.org/sgnnews38_20/page1.cfm; http://www.cob.sjsu.edu/osland_a/Spring2010/Campus-Blood-Drive-Suspension.pdf; www.cbbsweb.org/enf/attachments/fdadeferralmsm_abc_june09.pdf

  39. 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

  40. 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

  41. References – Constitutionality & Legal Views • D.C. Human Rights Commission Settlement: http://www.thebody.com/content/art13321.html?ts=pf • 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). • Adam Pulver, Gay Blood Revisionism: A Critical Analysis of Advocacy and The “Gay Blood Ban”, 17 Law & Sexuality 107 (2008). • 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). • Michael Belli, The Constitutionality of the “Men Who Have Sex with Men” Blood Donor Exclusion Policy, 4 J. L. Society 315 (2003). • Daniel J. Penofsky, Transfusion-Associated AIDS Litigation, 58 Am. Jur. Trials 1 (Originally published in 1996; Updated April 2010)

  42. References – 2006 and 2010 Reviews • 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

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