The Market For Human Tissue

Katherine M. Sauer
University of Southern Indiana
kmsauer1@usi.edu

April 3rd , 2008 MBAA – ABE Annual Conference Chicago, IL

 In the news…

On March 19, 2008, Michael Mastromarino

plead guilty to stealing human body parts,
enterprise corruption, and reckless
endangerment.
- Biomedical Tissue Services (BTS)
$4.6m
- pay funeral directors for access to
bodies
- resell the tissue to biotech firms
- falsify records
 Body Part Price Range

Brain $500-$600

Torso $1,200-$3,000

Hand $350 - $850 (each)

Knee $450 - $650 (each)

Cervical Spine $835 - $1,825

Whole Cadaver $4,000 - $5,000

Source: Body Brokers: Inside America’s Underground Trade in Human

Remains By Annie Cheney 2006
Background

What is human tissue?

- bone, skin, corneas, ligaments, tendons,

dura mater, heart valves, ova, semen,
cells from biopsies, etc…

- not vascularized organs (e.g. kidney, heart,

liver)
 Human Tissue Uses

1.allografts (over 1million in US per year)

transplanted tissues are used extensively for:

orthopedics neurosurgery burn victims
general/plastic surgery dental procedures

Cornea transplants can restore an individual’s sight.

reproductive medicine
2. research

 basic research
 pharmaceutical testing (liver toxicity)
 diagnostic tests

In 2000, there were an estimated 300 million

samples of human tissue being stored with an
additional 20 million being added each year.
- military facilities, forensic DNA banks,
government labs, diagnostic pathology,
commercial, hospitals, universities
 Tissue Transfers

donate (25,000 per year)

- living (research, reproductive)
- cadaveric (legit donation or stolen)

medical waste
- diagnostic purposes
- commercial purposes
 Regulations

Human cell, tissue, and cellular and tissue-

based products (HCT/Ps) are regulated by the
FDA’s Center for Biologics Evaluation and
Research (CBER).
Code of Federal Regulations 21–1270,1

- establishment registration
- screen and test donors
- procedures and records
1947 – 1968: statutes in 40 states allowing
anatomical donations from cadavers for
transplantation or scientific research

1968: Uniform Anatomical Gifts Act

- all 50 states and DC adopted
- two witnesses required
- right to donate organs, eyes, tissues
1984: National Organ Transplantation Act
- outlaws transfer of “any human organ
for
valuable consideration”

- allows for “reasonable payments”

associated with the removal
transportation
implantation
processing
preserving
quality control
storage
1987: revised UAGA
- prohibited organ sales
- streamlined donor registry
- medical examiners/coroners can provide
organs from autopsies
- 26 states adopted

2006: revised UAGA

- facilitates donation
- modernizes the Act
- 20 states enacted in 2007
 To What Extent is there a Market?

In the United States

allografts: $1billion industry

research: $700 million market

Human tissue is valued at $5000/gram.

 Producer Price Index
Series Id:  PCU621991621991
Industry:   Blood and organ banks
Product:    Blood and organ banks
Base Date:  0606
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Ann.
Year

2006           100.0 101.1 101.0 100.9 100.9 100.9 101.0  

104.5 104.3 103.3
2007 102.3 102.3 102.6 102.8 102.7 103.0 103.7 103.8 104.1 104.3
(P) (P) (P)
105.9 105.2
2008                      
(P) (P)
P : Preliminary. All indexes are subject to revision four months after original publication.
With the exception of ova and sperm, donors do
not receive compensation.

Donors are encouraged to conceptualize their

donation as a “gift” to the recipient.

Non profit tissue banks are heavily involved.

- LifeNet … LifeCell ($190.5m revenue)
- Musculoskeletal Transplant Foundation
 Previous Work

solid organs – efficiency of markets, ethics

tissues – property rights, ethics (medicine, law)

Charo (2002) “Skin and Bones: Post Mortem Markets”

Nova Law Review

Mahoney (2000) “The Market for Human Tissue”

Virginia Law Review

Harrison (2002) “Neither Moore nor the Market”

American Journal of Law and Medicine
What’s missing?

- treatment in the economic literature

Research Question:

What determines the number of

HCT/P establishments?
FDA/CBER registration data:
- name
- location
- function
screen, recover, process, distribute, etc
- product
bone, ligament, heart valve, etc

2001 to present
 Number of Firms by State and Function (bone)
state distribute label package process recover screen store test
AL 8 1 1 0 3 2 6 0
AK 2 0 0 0 1 1 2 0
AZ 13 3 3 3 3 2 13 1
AR 4 2 2 0 2 2 4 1
CA 44 9 8 5 10 10 42 2
CO 9 3 3 2 2 3 10 1
CT 5 2 2 1 3 3 4 0
DE 0 0 0 0 0 0 0 0
FL 19 16 10 4 14 12 26 5
GA 17 5 3 4 6 6 17 3
                 
Total 368 103 88 50 135 127 372 46
max 44 16 10 5 14 15 42 5
min 0 0 0 0 0 0 0 0
mean 7.2 2.0 1.7 1.0 2.6 2.5 7.3 0.9
Source: FDA/CBER HCTER
database
 Number of Firms by State and Function
state(cornea)
distribute label package process recover screen store test
AL 1 1 4 1 4 1 4 1
AK 1  0 0 0  1 1 1 0 
AZ 2 2 2 2 4 3 2 1
AR 2 2 2 1 2 2 2 1
CA 10 5 5 6 7 9 9 1
CO 2 2 2 3 1 2 2 1
CT 1 1 1 1 1 1 1  0
DE  0  0 0 0  0  0  0  0
FL 3 2 3 2 9 5 3 2
GA 6 3 2 3 3 3 5 2
                 
Total 100 92 92 90 123 113 111 39
max 10 8 8 8 11 11 10 4
min  0  0 0 0  0  0  0  0
mean 2.6 2.4 2.4 2.4 3.1 2.8 2.8 1.6
Source: FDA/CBER HCTER
database
 Potential determinants:

- population (density, death rates, age)

- registered organ donors
- research institutions, medical facilities
- industry profits
- presumed consent laws (corneas)
- income (reproductive medicine, cosmetic
surgery)
- religion
 Comments? Questions?

Katherine M. Sauer
University of Southern Indiana
kmsauer1@usi.edu

April 3rd , 2008 MBAA – ABE Annual Conference Chicago, IL