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The Trouble with Tissues

Posted by Jesse Reynolds on November 30th, 2006


Tissue samples collected for research can quickly become valuable - and contested - assets. The development of new technologies can radically alter their potential uses. For example, the derivation of stem cell lines, particularly via "research cloning," heightens a built-in tension between the interests of the patient/subject and those of the physician/researcher, since a stem cell line with the full DNA of the donor could be propagated for years and sent around the world. What's more, although reproductive cloning is prohibited throughout most industrialized nations, it is not in most of the US. It is quite feasible that the first human clone will be created from an unwitting tissue donor.

So it's not surprising that, according to a recent poll, people are concerned that personal tissue samples could be used for cloning, the derivation of stem cell lines, or the development profitable products without the donor sharing in the rewards. Although experts may dismiss the fears as the result of a poorly informed public, such anxiety over the unexpected consequences of biotechnology is warranted.

Two recent examples highlight these tensions and concerns. Carriers of Canavan's disease, a rare genetic condition, provided tissues that led to a test for Canavan's by Miami Children's Hospital. The donors and their families became angry once the hospital not only didn't share the revenues, but did not even offer the test to the donor's families without cost. Donors and their family members sued, but the judge ruled in favor of Miami Children's Hospital.

Similarly, a cancer researcher at Washington University, William Catalona, had collected a vast tissue bank in his twenty years there. Catalona decided to move to Northwestern University after the university asserted control over the tissue bank. With the support of 6000 of the tissue donors, Catalona claimed that their original intent was that he - not the university - manage the samples. As with the Canavan's case, a lawsuit was filed and the judge ruled against the tissue donors and in favor of the research institution.

The convergence of an expanding range of patentable claims, an increasingly commercialized biomedical research field, and rapidly emerging technologies has altered the relationships among research subjects, scientists, and institutions. Too often, a policy vacuum exacerbates an already problematic situation.



Posted in Biotech & Pharma, Jesse Reynolds's Blog Posts, Patents & Other IP, Public Opinion, Reproductive Cloning, Research Cloning, Stem Cell Research


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