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Ethical Issues in the Allocation of Federal Funds for bio-medical research and in
America’s organ-donor crisis
Dr. Richard Darling, DDS
President & CEO
FAIR Foundation
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Mission Statements
FAIR and equitable bio-medical research funding by the NIH and Congress
The implementation of new organ procurement policies to reverse America’s organ-donor crisis
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• We invite you to meet a few of our 27-member Board of Directors…
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Waldo Concepcion, M.D., F.A.C.S.; Chief of Clinical Transplantation & Pediatric Kidney Transplantation, Stanford
University School of Medicine
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Donald Hillebrand, MD; Medical Director of Liver Transplant Scripps Green Hospital, La Hoya, CA
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Jacqueline Marcell, Advocate: Alzheimer’s, Caregiving, Eldercare Awareness and Reform; Author Elder Rage; Radio Host Coping with Caregiving; Blogs on
Caregiving ThirdAge and Alzheimer’s HealthCentral
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Lorenzo Rossaro, M.D., FACP; Director, Liver Transplant program and Professor and Chief, Division of Gastroenterology and Hepatology, University of California, Davis Medical Center
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Robert Gish, MD, Medical Director of the Liver Disease Management and Transplant Program at California Pacific Medical
Center (CPMC)
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Melba R. Moore, MS, Commissioner of Health, St. Louis City Department of Health, St. Louis, Missouri; Member, Webster University’s Arts and Sciences Advisory Board, St. Louis Connect Care, and the Regional Health Commission; John F.
Kennedy School of Government for State and Local Executives
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Bill Remak, B.Sc.MT, BA PHA; Chairman, California Hepatitis C Task Force; Secretary, National Association of Hepatitis Task
Forces. Patient Advocate: Liver Disease & Stem Cell Research
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Ray Hill, AIDS & HCV Activist, Houston’s gay community: “gay hero 7 years in a row,” ACLU lifetime achievement award for advancing the rights of gay, lesbian and transgender citizens
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• FAIR does not just focus on the disproportionate funding for HIV/AIDS. We also look at other discrepancies, such as….
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1990’s Fears, Exaggerations
• Oprah Winfrey: “Research studies now project that one in every five--listen to me--one in five heterosexuals could be dead from AIDS at the end of the next three years...It is no longer just a gay disease, believe me.“
• Surgeon General C. Everett Koop: "[AIDS is] the biggest threat to health this nation has ever faced....among heterosexuals there are going to be 20 times as many cases.“
• Cover of TIME Magazine: "Now No One is Safe from AIDS."
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Congress & NIH Solution
• 1999: Congress decided to double NIH funding with a 15% increase every year for 5 years
• If you already have a large amount of research funding (HIV/AIDS) and you get 15%, you receive much more than if you have a small amount of research funding
• Unfair to all non-HIV/AIDS patients
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Diabeteskills more Americans than AIDS + breast
cancer combined every year
The increase alone in AIDS funding to 2008 is more than the entire 2009 budget for diabetes, and almost every other disease
$39 per diabetic $3,052 per AIDS patient
Funding Since 1999
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Research Allocations per Disease by the National Institutes of Health
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$3,052 Does Not Include…
Billions spent by the pharmaceutical cos.
Billions raised by non-profits like amfAR, Sharon Stone, Bill Gates Foundation, Warren Buffet
Billions spent by the states >>>>
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Illinois’s Greatest Killer
• Cardiovascular Disease
• Average deaths: 42,540/yr.
• Greater percentage in communities of color than in white community
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Illinois HIV/AIDS Deaths
• From a high of 1,494 in 1995 to 192 in 2007….
• 89% reduction
• Some of those 100 died from non-AIDS causes (car accidents, assault,
suicide, etc.)
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State Deaths
• Connecticut– 91 percent decrease in deaths to 75 from its
1995 high
• New York State– 85 percent decrease from 8,301 to 1,209
• Pennsylvania– 95 percent decrease to 97
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• And in the following chart, black columns represent deaths and gray columns represent survivors…
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California
98% decline in AIDS deaths in “newly-infected” patients from just under 10,000 in 1992 to 218 as of 9/30/07
89% decrease in all HIV/AIDS deaths to 867 as of 12/31/07
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50 States and District of Columbia
• CDC estimates for 1999-2007 have remained at 16,000 to 17,500 despite plummeting death rates.
• We complained to CDC Director—they now report 14,000
• FAIR’s total as reported by all fifty states: 10,050
• Conclusion: $3,052 is an understatement
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The FAIR Foundation recommends..
In allocating bio-medical research dollars, the NIH shall place selective emphasis on a disease’s mortality
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Secondary Allocation Factors.. the degree of disability and suffering
produced by a disease the morbidity (rate of incidence) a disease’s cost to society need to act quickly to stop a disease cause of death, but is not reflected on the
death certificate Orphan (rare) disease
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Benefits of FAIR’s Factors
FAIR & Equitable for all diseases… Easy to understand and implement… Hollywood favoritism is eliminated… Political Correctness is eliminated… No more need for disease advocates to run
to Congress and complain, “My disease is not getting its fair share!”
A portion of disproportionate HIV/AIDS funding redistributed to other diseases
Solution to frozen NIH budget
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Henry J. Kaiser Foundation
2009 US AIDS Funding…$24.1 Billion 8.3% increase: only 4% prevention
Care, housing & cash…….. $12.3 Billion Commitment for global….. $6 Billion
over 5 yrs, Bush & Obama want $50 billion for HIV/AIDS
Total since 1981-2009 …… $250 billion
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In the USA (2006) AIDS killed …
13 under the age of 13 49 from age 13 to 19 162 from age 20-24 405 from 25-29 629 under 30
Every AIDS deaths is a tragedy, be it child or adult as with every disease, but research allocations
must be independent of emotional rhetoric
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What is needed in Africa?
• The same solutions effective in the USA: Prevention programs (stated by Dr. Fauci) Providing existing medicines (HAART) Harm Reduction education Setting up health infrastructures to get the
above remedies to the citizens President Bush proposes raising global AIDS
budget from $15 Bil to $50 Bil WHO states global HIV/AIDS infection rate is
<1percent in every country except two
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What does Dr. Fauci say?
The Director of the NIAID (National Institute of Allergy and Infectious Diseases) is our top AIDS researcher overseeing all AIDS funding
So powerful that the NIH Director cannot take funds from Dr. Fauci to redistribute
Dr. Fauci speaks
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Hepatitis C…
• …is also a communicable disease Average HCV deaths every year: 10-12,000 Estimated HIVAIDS deaths….....10,500-14,000
•NIH Allocation for HCV……… $ 107 millionNIH Allocation for HIV/AIDS… $ 2.9 Billion
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The Flu…
• …is also a communicable disease Average flu deaths every year: 36,000
Estimated AIDS deaths…....... 11,020-16,000
NIH Allocation for the flu…… $ 199 millionNIH Allocation for HIVAIDS.. $ 2.8 Billion
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Clinical Trials
HIV/AIDS: 3,351 HCV 527 COPD 525 Parkinson’s 420 Alzheimer’s 443
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Please..
Let us not use emotional phrases to sway public opinion….
AIDS is a crisis (CNN’s Gupta at AIDS Summit, the media, Foundations)
We all have AIDS Communicable Epidemic, Pandemic Killing the young Global Affecting us all
….instead, let us use the facts.
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Summarizing….
• Is it ethical for the NIH and Congress to show such favoritism for certain diseases like HIV/AIDS?
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Organ Donation
The “Gift of Life”
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How many lives can you save..
by being an organ donor after you die?
1 3 6 8
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8
2 kidneys 2 Lungs The liver can be split, 1/3 to child, 2/3 to
an adult = 2 Pancreas or small intestine = 1 + Heart = 8
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How many patients can you help…
..with tissues such as your corneas?
5 10 29 50
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50!! 50 people can benefit from your tissues
after you die!
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The Facts..2.3 million people died last year, how many
do you think were organ donors?
101,267
54,000
19,200
7,000
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Only 7,000 Not all 2.3 million died under
circumstances whereby there could be an organ donor—brain dead—but still, 7,000 is a very small number vs. the waiting list
Brain dead means the heart is still pumping oxygen to the organs, but the brain is dead and will never recover
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How many are waiting for a life-saving organ?
6,400
22,700
67,000
99,000
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99,000+ and rising every day One of them will die every 82 minutes
because no organ is available Every 17 minutes another person is added
to the waiting list We have an ORGAN-DONOR CRISIS! Solutions??
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1) Altruism unselfish concern for, or devotion to, the
welfare of others (opposed to egotism) What grade (A, B, C, D, E, F) for UNOS
and its OPO’s as to their effectiveness in reversing the organ donor crisis with altruism?
F
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• You’re the M.D. in charge of an emergency room….if 99,000 people were in the waiting room and one was dying every 82 minutes, would you say, “I don’t think we need to try new policies?”
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2) Presumed Consent Extensive, lengthy media campaign asking “Do you want
to be an organ donor.. If “No” you will be kept in an opt-out registry If you do not answer, donation will be presumed Utilized in over 20 countries-France, Dr. Mendler A form of it exists in California: DMV + alcohol Donate Life Registry—from 25 years to sign up all
residents to 0 immediately upon signed legislation YOU Make the decision! Not a relative after In Delaware and Nevada legislatures now If you opt out, you are not eligible as recipient until
waiting list is zero
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3) Donation Benefits When family members are asked if their brain-dead
loved one in the emergency room is an organ donor, >50% say, “I don’t know and don’t want to do it.”
$10,000 or more benefit if they say “Yes” Whose to pay for this?? All insurers, including the
government. Why? It costs $300,000 to keep one person on kidney dialysis—the $10,000 would be cost effective
Everyone gets paid $$, why not the donor or his family? Ethics in withholding such $ ??
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4) Government reimbursement to living donors
Imagine you are dying of kidney failure, on dialysis 3X per week, waiting list 6 years:The government or/and insurers say, “We’ll
give a qualified living donor a combination of $50,000 and/or lifetime medical insurance (Medicare) if they agree to donate a kidney.”
Expectation: incentivizing kidney donation would eliminate the kidney waiting list (75,000+400,000 more on dialysis) within 5-10 years
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Cost Effective to insurers?
• Yes, very much so.
• $400,000 to keep one person on kidney dialysis
• Millions more dollars in ER and ICU costs
• All such future expenses are eliminated with the transplant
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But… NOTA = National Organ Transplant Act prevents
the purchase of any organ Act passed by Congress in 1984 when there
were NO WAITING LIST DATA The waiting list wasn’t started until 1989 and
then it was only 19,000 Now it’s 99,000 No more time for moralizing, people are dying! Everyone gets paid $$, why shouldn’t the person
who saves your life and ceases your misery?
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Organ Donation & Ethics
• Is it ethical to continue present OD policies without pilot projects
of new OD policies?
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How to become an organ donor…
Put the pink dot on your drivers license or school ID card
Fill out the top of the card and put it in your purse or wallet
Join at www.donatelifecalifornia.org MOST IMPORTANT!! TELL YOUR
FAMILY, “If I die, I want to save 8 lives and help as many as 50 others with tissues like my cornea.”
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What is a hero?
A hero is an ordinary person who does an extraordinary thing
My organ donors are my heroes!
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FAIR makes it easy to be proactive
• ..and to contact the President and your Congresspersons and ask for fair research funding and new organ-donor policies
• ..you giving presentations in Congressional buildings is not necessary
• Easy to be an advocate with FAIR’s welcoming email
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