SAFELY AND SENSIBLY REFORMING THE FDA’S

“PERMANENT DEFERRAL” POLICY

http://savingliveswithhelpfulguys.com

KYLE CARLSON CHICAGO-KENT COLLEGE OF LAW

MARCH 2011

Saving Lives with Helpful Guys: Moving Past the Gay

Blood Ban

Blood Donation Regulation

The Agency

U.S. Food and Drug Administration (FDA)

FDASub-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

2

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

Blood Facts

Need for Donation

Blood Banks and the Public Welfare

Shelf Life – Red Cells at 6ºC for up to 42 daysPlatelets at room temperature in

up to five daysPlasma stored in freezers for up

to one yearNeed – Needed every two seconds in U.S.About 1 in 7 people entering a

hospital needs bloodBlood is always needed for

treatment of accident victims, cancer patients, hemophiliacs and surgery patients

Blood cannot be manufactured or harvested

4

Blood Shortages

Need for Donation

Reoccurring Drops Below 2-Day, Even 1-Day Supplies

Recommended: 3-Day SupplyShortages – 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.

5

Blood Shortages

Coping with Shortages

Emergency Preparedness, Fiscal Costs, and Public Welfare

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

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 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

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

Current Blood Donation Guidelines

The Motivation

Pandemic Panic

Present Ban: 1983, Final V: 1985Response to HIV/AIDS CrisisEmergency Measure Transfusion Risks DiscoveredDevastated 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

11

Current Blood Donation Guidelines

Donation Process

Intake Questionnaires

“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.

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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

PROBLEMS

Self-Deferral

Gay Blood Ban Actually Filtering out MSM?

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

14

PROBLEMS

Scientific Progress

Gay Blood Ban Failing to Add Safety Value

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.

15

PROBLEMS

Gay Blood Ban Costs

MSM Blood Unavailable – Shortages

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

16

PROBLEMS

Social Stigma

Does FDA Think Gay Blood = Dirty Blood?

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/MoneyMSM Ban Not Focused on

Unsafe BehaviorE.g. Hetero, unsafe sex with sex

worker not permanently deferred

Vs. Monogamous/Widowed MSM

17

FDA Official Response

Review of Policy

No Change

March 2006 – FDA WorkshopWide Array of Views Solicited FDA Disagreed with Medical

Majority Used 1 Risk Study to JustifyAABB: “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

HHS Official Response

Review of Policy

No Change, Acknowledge Weaknesses

Obama Era June 2010 HHS Committee

Upheld Ban Voting 9-6Acknowledge 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

19

Shifting Constitutional Law

Obama and DOMA

LGBT Protected Class Status Likely

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

Several 2nd Circuit Cases – No Precedent on Level of Constitutional Scrutiny for Sexual Orientation, Likely to Raise Std.

20

Shifting Constitutional Law

Lack of Change Will Cost FDA

Costly Studies vs. Costly Litigation

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)

21

Staying Out of Court

Results of EP Suit

Nobody Wins

Costs, Win or Lose EP Suit: Resources Wasted in DefenseP.R. Problems, esp. with younger,

target donor demographicGrows Divide Between Regulator

and Regulated (blood banks, hospitals, medical professionals)

Additional Cost – FDA Loses: Judicial Control of ReformAdditional Costs – FDA Wins: Fails to Address Blood Shortages

22

LOW-RISK OPTIONS, INTERNATIONAL EXPERIENCE, AND

THE EMERGING MEDICAL CONSENSUS

Proposing Solutions: Short-Term Deferral

Options: 5-Yr Deferral 1-Yr Deferral

Proposed Alternatives

Arbitrary Period, But Safe

Williams Inst. – 5 Yr Deferral = 89,700 Pints/Yr1 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 YrHepatitis B and C “Window

Period” Result in Temporary, 1 Yr Deferrals

24

More Effective Intake Questions

Risk-Based Deferral

Dropping Arbitrary Deferral Periods, Increasing Overall Safety

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)

25

International Experience

Proven Success

Decrease Stigma, Increase Safety

Lifted Ban – Russia

Intake Questions Target Unsafe 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

26

Building Support for Reform

Jump on the Bandwagon

The Blood Banks and the Medical Community

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

27

Building Support for Reform

Jump on the Bandwagon

Local and State Resolutions

August 2009CA Assembly Judiciary

Committee Resolution

2010New York City Council Washington D.C. City Council Chicago City Council San Francisco

28

Building Support for Reform

Jump on the Bandwagon

National Elected Officials

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

29

Building Support for Reform

Jump on the Bandwagon

LGBT Civil Rights Supporters

Gay Men’s Health Crisis – Major Study

National Gay and Lesbian Task Force

Human Rights Campaign Lambda LegalThe Advocate Magazine State and Local Human

Rights Commission Complaints and Settlements

www.SaveALifeMovie.com

30

Building Support for Reform

Jump on the Bandwagon

LGBT Civil Rights Supporters

Some College and University Boycotts and Significant Protests

2007 Iowa State University 2008 Sonoma State University 2008 San Jose State University2010 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

31

Building Support for Reform

Public Education Campaign

What You Can Do

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

http://savingliveswithhelpfulguys.com

Model Petition for School Blood Drives – Do NOT Refuse to Donate!

Model Op-Ed LetterEMAIL 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 practicesBlood 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

ShortageDirty Stigma, Clean Blood: Reforming the Gay Blood

BanReady 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 MisconceptionsAddressing the Wrong Emergency: AIDS Fears vs.

Medical Realities (need for blood) 34

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_report (accessed Feb. 24, 2011).

5. Intake Questionnaire Procedure – “What is Self-Deferral?” http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/QuestionsaboutBlood/ucm108186.htm

6. Intake Question #35, Version.1.3, May 2008 – http://www.fda.gov/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/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

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)

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=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

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; http://www.cob.sjsu.edu/osland_a/Spring2010/Campus-Blood-Drive-Suspension.pdf; www.cbbsweb.org/enf/attachments/fdadeferralmsm_abc_june09.pdf

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 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

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)

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