Ethical Issues in the Allocation of Federal Funds for biomedical research and in Americas organdonor

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• Ethical Issues in the Allocation of Federal Funds
  for bio-medical research and in Americas
  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 Americas 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 Alzheimers,
Caregiving, Eldercare Awareness and Reform
Author Elder Rage Radio Host Coping with
Caregiving Blogs on Caregiving ThirdAge and
Alzheimers 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 Universitys 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, Houstons 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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1990s 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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Funding Since 1999

• 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

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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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Illinoiss 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 Directorthey now report
  14,000
• FAIRs 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 diseases
  mortality

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Secondary Allocation Factors..

• the degree of disability and suffering produced
  by a disease
• the morbidity (rate of incidence)
• a diseases 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 FAIRs 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 Funding24.1 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
  

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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
• Parkinsons 420
• Alzheimers 443

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Please..

• Let us not use emotional phrases to sway public
  opinion.
• AIDS is a crisis (CNNs 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
• s6s

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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 donorbrain
  deadbut 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
  OPOs as to their effectiveness in reversing the
  organ donor crisis with altruism?
• F

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• Youre 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 dont 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 Registryfrom 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 dont know and dont 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 dialysisthe 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, Well 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 (75,000400,000
  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 wasnt started until 1989 and
  then it was only 19,000
• Now its 99,000
• No more time for moralizing, people are dying!
• Everyone gets paid , why shouldnt 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 FAIRs welcoming email

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