Scientific and commercial development of human cell lines: issues of property, ethics, and conflict of interest

Article Abstract:

A discussion is presented of selected legal, ethical, and social aspects surrounding the use of human tissue for scientific and commercial purposes. A recent decision by the Supreme Court of California in the case of Moore v. Regents of the University of California is explained. The case concerned a leukemia patient, Moore, whose spleen had been removed for therapeutic purposes; other tissues (sperm, bone marrow, blood) had also been studied. Moore's physician, David Golde, was said to have used these tissues for his own scientific and commercial purposes; Moore, however, claimed a property interest in the tissue. A research colleague, two private corporations, and the University of California (which patented the spleen cell line), were also involved. A lower California court that Moore had a ''continuing property interest'' in his own tissue, and stated that the patient was entitled to a share in profits from the cell line. The California Supreme Court, however, felt the potential for disruption of the cell line industry was great, and determined that the vast numbers of human tissues used in biomedical research gave the case considerable importance. The Court rejected any property interest by Moore; however, it left open to him the option of suing for monetary damages if he could prove that Golde had had a commercial interest in the cells when he obtained consent for their removal. In such a case, though, no substantial sums could be awarded, because the spleen had been removed for therapeutic purposes. Thus, there is an inherent conflict between the roles of the physician and the biomedical scientist: in the first case, they are ethically bound to tell the patient the truth and provide optimal care; in the second, they face a dilemma when they propose a therapeutically necessary procedure that could also bring financial rewards. Solutions to this dilemma could include informed consent that includes permission to use cells or tissue, or withdrawal from the case by clinicians who face such conflicts of interest. In any event, patients should not be bargained with or paid fees for their tissues, an approach analogous to that taken with respect to organ donation. (Consumer Summary produced by Reliance Medical Information, Inc.)

Economic aspects, Physician and patient, Physician-patient relations, Ethical aspects, Human cell culture

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Beyond the best interests of a child: bone marrow transplantation among half-siblings

Article Abstract:

A legal case decision is reviewed concerning a 12-year-old boy who developed a rare form of leukemia (a malignancy of blood cells), for which immediate bone marrow transplantation was the only possible treatment. The only potential physiologically compatible donors were twins, aged three and one half, who were half-siblings of the affected boy. The boy's father, who had previously acknowledged paternity of the twins, sought to compel their mother (with whom he had previously lived) to have them tested as potential donors and to allow bone marrow transplantation, if appropriate. The Supreme Court of Illinois, which eventually heard the case, declined the father's request, even though it recognized that the boy was likely to die as a result of its decision. This case was important because of the limitations it placed on the extent to which courts can interfere with a parent or guardian decision concerning a child's welfare. The concepts of substituted-judgement and ascertaining a child's best interests, were both considered by the Court. Substituted judgement was rejected when presented as an argument by the boy's father, because the twins were not considered to be able to make a reasonable judgement of their own. It was determined that the mother, who had consulted with informed people about possible dangers to the twins and the odd of the success of the transplantation, had not acted arbitrarily, and was empowered to act as the sole guardian of her children's best interests. Potential benefits to the twins from saving the life of a close relative were also evaluated, but it was deemed that this half-sibling relationship did not constitute 'family'; hence, the twins could not be expected to suffer from a sense of loss if the boy died. While the outcome of the case may be disturbing, the Court's opinion is well-constructed, informative, and worth reading. (Consumer Summary produced by Reliance Medical Information, Inc.)

Health aspects, Social policy, Transplantation of organs, tissues, etc., Organ transplantation, Tissue transplantation, Transplantation, Parent and child (Law), Donation of organs, tissues, etc., Tissue donation, Parental consent, editorial

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Legal immunity for medical peer-review programs: new policies explored

Article Abstract:

Peer-review programs are set up for physicians to monitor their own medical competence and conduct. This process has not been popular among some physicians because of the legal issues involved; ruined professional reputations provoked the initiation of law suits. This reaction led to an impairment of the ability of peer review programs to take disciplinary action. The recent removal of 'learned professions,' including medicine, from being affected by antitrust laws led to additional litigation and the possibility of large damage awards in court. Discussion is presented encouraging the peer review system to develop better legal protection so that it can continue to monitor the quality of care provided by physicians.

Analysis, Cases, Antitrust law, Privileges and immunities, Professional standards review organizations (Medicine), column

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