10:22 AM Mar 12, 1997
A TRADE WITHOUT ORIGIN OR LABELLING RULES
Geneva Mar (TWN/RAFI) -- The market for human tissue trade is estimated to be now an annual $427 million, and within a generation the market could be as high as $80 billion. In general it is difficult to trace the precise origin of tissues being traded internationally. This is because of the sporadic nature of collections, the highly variable purposes for and circumstances under which tissues are initially collected, and the ease - through multiple transfers - with which they become separated from their original collectors. For instance, cells from the Pima indigenous people (US) are stocked and distributed by tissue banks and labs in the US and Europe; but since the Pima have donated tissue samples in many different disease research project, involving several public and private institutions, it is difficult to ascertain the precise origin of any given sample of the Pima's cells. One IHW participant, Dr. Peter Parham of Stanford University (US), who is working on genetic means of determining historical relationships between peoples, donated to the IHW cell panel 41 cell lines from populations from at least five continents. It seems quite unlikely that Parham collected all the cell lines himself, and in many cases his lab was almost certainly acting as a secondary distributor of the materials. These cell lines have subsequently been replicated and distributed (and are still available) through the ECACC to interested laboratories worldwide. While promises may have been made regarding commercialization and reproduction of the tissue, the link between the original donor's understanding of uses for the cells and their actual use and disposition becomes more tenuous at each step along the route. In September 1996, in the course of other research, RAFI accidentally discovered a database from the International Histocompatibility Workshop Anthropology Component (IHWAC). This database was placed in the public directory of an internet-connected computer at the Anthropology Department of the University of Geneva (Switzerland). It reveals interesting new information about how tissue samples and related genomic data enter international circulation. The IHWAC database provides detailed information on about 130 populations submitted by 83 laboratories. Entries identify institutions submitting cell lines and usually provide climatic details of the region in which they reside, historical information about the populations, about the languages they speak, annotation of high mortality rates for particular diseases, and an eclectic inconsistent hodge-podge of other information. It does not include documentation of informed consent, as this was not part of the databases's purpose. IHWAC says that its collections are "conducted under the strictest conditions of informed consent at every stage for the collection, use and care of the samples." The database does reveal - regardless of the consent circumstances of collection - how, where and what kind of cells are of interest and being tested by the largest survey currently underway of human genetic diversity. Information regarding location and method of sample collection is not provided in all cases, due to a variety of reasons.... those that do document details most often list blood banks and hospitals as the source... Many populations in the database are from remote rural areas worldwide.... Many populations in the database were originally collected for non-IHW purposes, including samples originating from legal disputes and women receiving obstetrical care... The wildly varying kinds of anthropological details submitted suggest collecting samples and genetic information was a considerably higher priority for the IHWAC than learning anything about study populations.... In cases in Spain (involving persons born in Guinea Bissau) and UK, labs submitted populations and noted they were looking for an anthropologist or 'local contact' with knowledge of the sampled people, after collecting the tissue from them. In Europe, many labs were interested in confirming peoples' family background, with emphasis on the populations being 'genuine' ('one lab says both parents genuine Inuits'). An Italian lab looked for samples in part based on surnames, "three generations residence in area" and "closeness of archaeological sites". Spanish researchers confirmed that a population only included persons with "three past generations being of Spanish origin." Other kinds of descriptions are inconsistent and/or unexplained. Mental health factors are not mentioned in the database except in the case of a single group of Austrians described as "parents of schizophrenics" .... A group of Mexicans was partially described as "middle and low socio-economic cultural class"... Several Chinese populations were described by a Japanese lab in terms of their ancestors, including one which "dominated China during the Yukan Dynasty". Despite the near disavowal of race as a valid scientific concept, laboratories often noted 'inbreeding' in study populations and provided racial descriptions of study groups. One Indian population was described as an "important example of historical racial admixture", while a Russian group was said to "belong to the large Caucasian race... the weak Mongoloid mixture is noticed" .... (Though) the IHW cell panel list and the Geneva data base implies broad international exchanges, it does not include materials not transferred through third countries as part of the cell panel collection process, the distribution of tissues through the cell panel, which is an ongoing process managed by ECAAC or direct tissue exchanges between individual labs, which may be more numerous than those made for the cell panel. The confidentiality of personal medical information is critical in any circumstances where research is being conducted or care provided. In the case of international biomedical research, maintenance of confidentiality is complicated by new technologies that facilitate the rapid international transfer of research data, including patient histories and genetic information specific to individuals. The rapidly escalating capability of laboratories to create or recreate human biomaterials on the basis of electronically-transmitted sequence information presents a further challenge. While this capability is currently limited to relatively small genes and gene segments, this may not be the case for long. In the information age, confidentiality systems that could previously be enforced by simple lock-and-key mechanisms become an anachronism for labs in much of the world. Public confidence in biomedical research is and will continue to be directly linked to laboratories' fulfilment of their commitments to confidentiality, no matter what technologies and collaborations are employed in the course of research. The 12th IHW's management of such information plainly demonstrates severe shortfalls in the protection of research subjects. IHW researchers left detailed patient information on public data servers at the IHW central data collection and analysis centre in Toulouse (France). For a period of atleast eight months, anyone in the world with access to the internet could obtain thousands of IHW records containing confidential medical information. Major confidential portions of the IHW's database on over 26,000 human cells (over 11500 of which are part of the Anthropology component) were compromised. The data sets are sufficiently detailed so as to identify individual persons who donated tissues and, in at least one case, even includes patients' names. The data sets include information on several IHWAC populations and groups from other IHW studies. Examples include: * Full name, medical history, and HLA profile of juvenile arthritis patients of a participating US lab; * HLA profiles, medical information, sex, date, and place of birth for rural Russian persons whose cells are included in the IHWAC study. Similar information was also included on persons born in Guinea-Bissau. Prior to publishing this Communique, RAFI contacted the IHW and requested removal of this confidential medical material from public areas of internet. For some laboratories, research interest in human genetic diversity isn't just about science and advancement of knowledge; it is also about patents and profits. Thousands of human genes are claimed in pending patent applications. In many cases, the research leading to these gene patents heavily depends upon diverse human tissue samples that the patenting researchers pick up from the global human tissue market. For instance, potentially highly-profitable US patents and patent applications on genes linked to Alzheimer's disease, asthma, and diabetes have depended upon tissue samples from rural populations and indigenous people. The US government has patented the cells of an indigenous person (and later abandoned the claim), and tried to patent two more indigenous peoples' cell lines. In none of these cases is it likely that the donors of the material that contributed to the patent will see any of the financial or medical benefits that their tissue donations have made possible. The blurred lines between medical research and commercial interests extend to laboratories participating in the IHWAC. Several IHWAC participants have filed for and received patents on human cells, cell products, and other HLA-related processes or techniques.... Making money from the use of human tissues is not strictly limited to the culture of the tissue itself. Bioinformatics uses computer technologies to aid clinical and industrial use of genetic information. Bioinformatics companies develop new computer systems capable of rapidly sequencing and characterizing DNA, and information retrieval and analysis systems that collect and provide information from public and private databases. It is a burgeoning technology on which gene boutique companies depend when sequencing genes. One of the newest bioinformatics companies is Genomica Corporation - a US company founded in 1996 with investments from two venture capital firms. The founder of Genomica is Dr. Thomas Marr, who also holds posts at Cold Spring Harbor Laboratory (a US non-profit research center heavily funded by the US government) and the US National Cancer Institute. Marr specializes in developing software to access and analyze genetic information held in databases. He is also the chair of the informatics committee of the Human Genome Diversity Project (HGDP). Genomica is trying to distinguish itself from other bioinformatics startup companies through a "high-powered" scientific advisory board of geneticists and bioinformatic specialists. The board includes Dr. Aravinda Chakravarti, a well-known US geneticist and member of the National Academy of Sciences (NAS) which is advising the US government on funding for the HGDP. It is unclear if Marr intends to put knowledge gained through the HGDP into Genomica or if the NAS or the US government will consider Chakravarti's dual roles a potential conflict of interest. [This is part II of a three-part article, which has been excerpted from the RAFI Communique of January/February 1997, in view of its topicality. The first part was in SUNS #3941. The final part will deal with genetic research for military weapons, and the range of multilateral actions needed. RAFI is a Canada-based public interest international NGO. Fax 613-567-6884 and email: rafican@rafi.ca]