Appendix to staff discussion paper, "On the Body and Transplantation: Philosophical and Legal Context," which was prepared for discussion at the February 2007 meeting. (These discussion papers do not represent the official views of the Council or of the U.S. government.)

There is an ambiguity in the meaning of the term "organ" that is not addressed in the text of the staff discussion paper but should be considered by the Council. The federal statute prohibiting the exchange of "organs" for valuable consideration (NOTA) includes the following definition:

The term 'human organ' means the human kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin, and any other human organ specified by the Secretary of Health and Human Services by regulation. (42 USC Sec. 274e)

This list of body parts includes parts that are referred to as "tissues," rather than "organs" in the context of transplantation. In that context, "organs" usually include the kidney, liver, heart, lung, pancreas and intestines - that is, for example, the body parts that UNOS is responsible for allocating. The term "tissue" is used for such therapeutically valuable parts as skin, bones, heart valves, corneas, tendons and veins. This usage of the terms "tissue" and "organ" is arguably not consistent with the application of these terms in other scientific and medical contexts. In spite of this fact - and in spite of the wording of NOTA - there are extensive differences between the way that these groups of body structures are treated in U.S. law and commercial practice.

I. Background

To understand and clarify these differences, and their ethical implications, it is useful to recall certain features and practices that distinguish "organs" and "tissue":

First , "organs" must be taken from the "brain dead" donor or the DCD donor - that is, they must be procured either before or immediately after circulation stops. The same demand for relatively immediate procurement is not characteristic of "tissues," which can be taken from the deceased hours after the cessation of circulation. Sources on federal regulations and industry standards indicate that "tissue" can be taken within 24 hours, if the body has been kept cool during that time. Thus, there are many more deceased individuals who are eligible to be "tissue" donors than organ donors. It is also that case that the deceased does not, in general, have to be as young or in as good health to be a "tissue" donor.

Second , "organs" must be moved from the source to the recipient very rapidly in order to maintain their viability and thus utility. In the staff discussion paper, this feature of an organ was illuminated in terms of an organ's biological need to be at-work in order to stay "alive." "Tissue" also exhibits this property, although not to as great a degree. If handled and stored properly, "tissue" can be "banked" for longer (and variable) amounts of time. The practical upshot of the ability to bank "tissue" is very significant. The realities of handling the tangible item, in the case of "tissue," generates the potential for "middle-men" in the form of tissue banks and, thus, for an industry of tissue banking. This need for tissue processors is further complicated by the consideration we turn to next.

Third , "organs" are transplanted into recipients as unitary things . Tissue - especially skin and bone - may be is used in medical and cosmetic applications after a manufacturing process that yields a distinct, usable product. For example, donated bone is used by one company (Osteotech) to produce " Grafton® Demineralized Bone Matrix (DBM) Gel" for medical applications and skin from donors is used by the company LifeCell to produce "AlloDerm®," a product useful for various kinds of skin graft applications. ¹ Thus, there are organizations that procure tissue (the process is not done by the transplant surgeons who remove "organs"), store it, test it, and utilize it as raw material in manufacturing. Some of these are non-profit organizations and others are for-profit, commercial companies. Media reports have emphasized that the industry is a very lucrative one, referring to the "$1 billion-a-year tissue industry." ²

II. Ethical Concerns

A. Safety

One ethical concern that has been raised with regard to the "tissue" industry has to do with the safe handling of the material. As with any movement of human biological products from one body to another, there is a risk of spreading disease. The FDA is charged with overseeing the safe practices of the tissue industry and there are industry groups that provide accreditation to companies involved at the various stages. ³ At present, no federal regulations require participants in the tissue industry to be accredited. The FDA is permitted to inspect tissue establishments to ensure that safety standards are met. In 2005, the FDA introduced two new sets of rules that "tissue establishments" must follow. The first addresses "donor eligibility," clarifying standards for screening donors and tissue. The second addresses "good tissue practice," clarifying standards for quality control in processing, storage, labeling, packaging, and distributing the material. In 2006, the agency formed a Human Tissue Task Force to assess the effectiveness of the new 2005 regulations.

B. Profit

Many critics of the tissue industry - and of the legal environment that enables it - point out the apparent contradiction of the actual practice with NOTA's ban on "valuable consideration." Although it is true that tissue donors are not compensated, it seems clear that, once the "raw material" is out of the family's hands, it is traded like any other tangible commodity. This practice is brought in line with the letter of the law by treating the exchange of money as payment for the services provided by the "middle-men," as is consistent with this clause in NOTA:

42 U.S.C. 274e(c)(2): The term "valuable consideration" does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.

Pointing to the demonstrated profitability of the industry, critics allege that there are no attempts to obey or enforce the stipulation regarding "reasonable payment."

The profits made in the tissue trade are considered particularly objectionable from the perspective families or individuals who agree to tissue donation, without any awareness that this agreement is instrumental to making and sustaining the industry's profits. Some argue that if individuals were aware of just how lucrative the industry is for those who benefit from its profits they would be less inclined to donate.

C. The End-Users of Tissue

Critics also point out that not all end-users of products derived from donated tissue are providers of therapeutic treatments and often target this criticism at the use of products derived from donated skin for elective cosmetic surgery. Again, the concern here is usually expressed in terms of the lack of "informed consent" or "disclosure" provided to the families and individuals who agree to tissue donation.

III. Policy Questions

Several media exposés of the tissue industry have brought public attention to the ethical problems noted above (and perhaps, in some cases, sensationalized the issues). ⁴ Concerns about safety emerged from cases like the death in 2001 of a 23-year old Minnesota man who received allografts of bone and cartilage to reconstruct his knee and the transmission of hepatitis C to five tissue recipients from a single donor in 2002. ⁵ A recent report from the FDA provides an in-depth discussion of the safety concerns and the ensuing regulatory response. ⁶ Still, some call for tighter rules that would require accreditation and mandate regular inspections of the industry and its practices by the FDA.

What the FDA report does not discuss is the issue of incomplete information provided to donors regarding profits for tissue processors and the variety of end-users. A bill that would address both safety issues and these consent questions was introduced in the 109 th congress to both the House and Senate. The title of the bill is the "Safe Tissue Act" (H.R. 5209 and S. 2609). It would require that:

Tissue banks be inspected and audited regularly by the FDA and the inspections would be funded by a user fee established by the Secretary of HHS.

1. The secretary of HHS publish in the Federal Register a "model consent form" for donors that contains that minimum amount of information relevant to donors, including information on the uses that would be made of the tissue.
2. The Secretary of HHS promulgate regulations to accredit all tissue processors.
3. The Secretary promulgate regulations defining "reasonable payments" in 42 U.S.C. 274e(c)(2).

This bill was referred to the U.S. House of Representatives Committee on Energy and Commerce in April 2006, but has not been enacted.

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Footnotes

1. Osteotech website: http://www.osteotech.com/. LifeCell website: http://www.lifecell.com/. Both last accessed 1/18/07.

2. See, for example, Anne Belli, "Families of Donors Rarely Get Full Story," Houston. Chronicle , February. 13, 2005 and Peter Aldhous, "Scandal Grows Over Suspect Body Parts," New Scientist, August 31, 2006.

3. The American Association of Tissue Services (AATS) and the Eye Bank Association of America (EBAA)

4. Most notable among these is a multi-part expose published in The Orange County Register in April 2000. Found online at: http://www.ocregister.com/features/body/ and last accessed Jan 17, 2007.

5. Both of these incidents are mentioned in the FDA Consumer magazine report entitled "Keeping Human Tissue Transplant Safe." Found online at http://www.fda.gov/fdac/features/2005/305_tissue.html and last accessed Jan 17, 2006.

6. Ibid.