The Market For Human Tissue Katherine M. Sauer University of Southern Indiana [email protected] April 3 rd , 2008 MBAA – ABE Annual Conference Chicago, IL
Dec 28, 2015
The Market For Human Tissue
Katherine M. SauerUniversity of Southern Indiana
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 tobodies- 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 victimsgeneral/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
forvaluable consideration”
- allows for “reasonable payments” associated with the removal
transportation implantation processing preserving quality control
storage of human organs
1987: revised UAGA- prohibited organ sales- streamlined donor registry- medical examiners/coroners can provideorgans 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: PCU621991621991Industry: Blood and organ banksProduct: Blood and organ banksBase Date: 0606
YearJan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Ann.
2006 100.0 101.1 101.0 100.9 100.9 100.9 101.0
2007 102.3 102.3 102.6 102.8 102.7 103.0 103.7 103.8 104.1 104.3104.5(P)
104.3(P)
103.3(P)
2008105.9(P)
105.2(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, ethicstissues – 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
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 0DE 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 46max 44 16 10 5 14 15 42 5min 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
Number of Firms by State and Function (bone)
Source: FDA/CBER HCTER database
state 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 0DE 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 39max 10 8 8 8 11 11 10 4min 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
Number of Firms by State and Function (cornea)
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. SauerUniversity of Southern Indiana
April 3rd , 2008 MBAA – ABE Annual Conference Chicago, IL