US hospitals to ask patients for right to sell their tissue

Several academic hospitals in the United States are forming partnerships with biotechnology companies to provide them with human tissue for research, treatment, and drug development purposes, in a series of arrangements which raise wide legal and ethical issues.

Harvard University's Beth Israel Deaconess Medical Center in Boston and the Duke University Medical Center in North Carolina are among the latest academic hospitals to join such ventures.

Both of these institutions have entered into agreements with Ardais, a genomics startup company, which will bank the tissue, collect data, and sell both the data and the tissue to interested parties.

Patients undergoing surgery at these medical centres will be asked to sign consent forms enabling leftover pathology specimens to be sent to biotechnology companies. The hospitals hope that this will avoid some of the controversies that have occurred in the past, when specimens have been used without consent, the most famous case being that of Henrietta Lacks.

Lacks was a poor, young black woman who died of cervical cancer in 1951. When she was a patient at Johns Hopkins Hospital in the early 1950s a sample of her cervical cells was sent to an in-house researcher who was trying to grow human cells in culture. Though she died nearly 50 years ago, her cells continue to live on as the HeLa cell line. They have contributed to countless biomedical discoveries and can be ordered from tissue culture supply catalogues. Yet neither she nor her family gave permission for these cells to be used, and the family was never compensated for any profits made from them.

Ardais aims to create a massive tissue catalogue, allowing researchers to place internet orders for tissue samples from patients with the specific diseases they are studying.

The company will maintain patients' confidentiality by assigning a numeric code to the donated tissue and clinical information so that medical researchers will not be able to contact the patient.

Although there is a great need for centralised, data linked tissue banks, and surplus tumour tissue is usually discarded anyway, such partnerships raise interesting ethical, financial, and legal questions.

Chief among these concerns are issues of privacy, the treating of body parts as commodities, and whether there is any financial or moral obligation to compensate the tissue donors for contributing the raw material for research and development.

Moreover, the tissue donors themselves, because of the anonymous nature of the donation, may not see any medical or therapeutic benefit from the donation. Additionally, cash strapped hospitals may be tempted to enter into these agreements in order to buttress their financial status.

Tissue banking and joint academic and industrial ventures are not new, but awareness of some of the legal, financial, and ethical implications that they raise is. Many academic hospitals routinely bank frozen tissue of rare and interesting tumours. Usually these tissues are studied in-house to aid diagnosis, and often the tissue is shared with researchers from other departments and hospitals.

However, the biomedical community has a legacy of using such tissues without the patient's the knowledge. Often, these uses begin innocently, such as in an attempt to investigate disease, but even then ethical considerations arise, such as in the Lacks case.

Public policy regarding tissue donation and use is also confused. Trafficking of vital organs for profit is illegal and is specifically proscribed under the National Organ Transplant Act of 1984. When it comes to other tissues, however, the rules are hazy.

Officially sales of other tissues are also illegal, but tissue banking is big business and the law is readily sidestepped by invoking "processing and handling fees" so that the tissue itself is not officially sold.

Profit making tissue banks have been a prime beneficiary of increased organ donations. According to the American Association of Tissue Banks, tissue donation has increased by 172% in the past five years. This is largely because such organisations are informed when a patient dies.

In the United States when a patient dies in a hospital or nursing home, doctors have to ask if the family consents to organ and tissue donation. This is mandated by the National Organ and Tissue Donation initiative of 1999. Whereas vital organs have a finite life span and must be transplanted within hours, tissues such skin, corneas, tendon, bone, and heart valves can be harvested later and cryopreserved. Thus more tissues than organs are donated.

A good proportion of these body parts are processed and sold for profit and become such items as bone putty and collagen. The tissue donor's family is usually not aware of the destination of the body parts and is not financially compensated—nor is it clear that the family should be. Many believe that the transplant and donor pool would shrink if the commercial potential were realised by the public.

The commodification of body parts and the widening of class divides, with the poor selling their tissues, is also a repugnant scenario. Interestingly, donors have long been able to sell their blood, sperm, and eggs in the United States, perhaps because these are seen as self replenishing or surplus body parts.

Clearly, a bank of human tissues is needed to enable further research, diagnosis, and therapeutic development. The ability to relate the molecular findings of the human genome project to clinically relevant material and data is dependent on ventures such as those of Ardais and academic centres.

The bioethical questions and repercussions of these partnerships, however, continue to be problematic.