Christopher Thomas Scott

Stem Cell Tourism and the Power of Hope

This paper explores the notions of hope and how individual patient autonomy can trump carefully reasoned ethical concerns and policies intended to regulate stem cell transplants. We argue that the same limits of knowledge that inform arguments to restrain and regulate unproven treatments might also undermine our ability to comprehensively dismiss or condemn them. Incautiously or indiscriminately reasoned policies and attitudes may drive critical information and data underground, impel patients away from working with clinical researchers, and tread needlessly on hope, the essential motivator of patients, advocates and researchers alike. We offer recommendations to clinicians and health care providers to help balance the discourse with individuals seeking treatment while guarding against fraud, misconception, and patient harm.

Personal medicine—the new banking crisis

As the healthcare industry moves from a twentieth century approach of providing treatments of last resort to a future of individualized medicine, biobanks will play a pivotal role in this transition. Yet at the cutting edge of biobanking research are new ethical, social and policy challenges beyond those familiar to basic biomedical research.

iPS Cells: Mapping the Policy Issues

Given the explosion of research on induced pluripotent stem (iPS) cells, it is timely to consider the various ethical, legal, and social issues engaged by this fast-moving field. Here, we review issues associated with the procurement, basic research, and clinical translation of iPS cells.

And then there were two: use of hESC lines.

volume 27 number 8 AuGuST 2009 nature biotechnology Using data on cell line shipments obtained from HSCI and WiCell—which curates the NSCB—we see that lines have been neither uniformly available nor uniformly used, indicating far less diversity of materials than most believe8. Our most recent data set tracks WiCell’s distribution of five of its own lines (derived by James Thomson) beginning in 1999, those available from the NSCB after its inception in 2005 and those distributed by HSCI since April 2004. No more than 18 approved cell lines have ever been available through the NSCB and that number is only accurate for the first months of 2009. Importantly, we find that just two NSCB lines—H1 and H9—are commonly used. The story is slightly better for HSCI, where all 28 bench has as much to do with past policies and the field’s history as it does with the variety of lines available in the banks. We enter this discussion with systematic data on the patterns of use of cell lines from the largest US repositories, the NSCB and the Harvard Stem Cell Institute (HSCI; Cambridge, MA, USA). In prior work, we examined the geographical patterns of distribution of hESC lines from these two sources. We showed that despite federal funding restrictions, hESC research is vigorous and growing in the United States. We see that states with high levels of research activity can blunt local laws and policies that would seek to restrict or chill hESC research7. To the Editor: Last month, the US National Institutes of Health (NIH) issued its final guidelines defining the types of human embryonic cell (hESC) lines that would be eligible for public funding. The number of NIHapproved hESC lines available for federal funding was a bellwether issue for scientists during the Bush era prohibition. Originally, the agency announced 78 lines could be used. This was later revised downward to 64, then downward again to 21, the number most often cited in the literature1,2. Among the criticisms of the remaining lines in the National Stem Cell Bank (NSCB) is that they have a limited range of genetic diversity3. Now that the NIH has announced its intention to set up a national registry of hESC lines, the biggest issue facing the agency will be how to rebuild the bank into a robust and valuable research resource. Getting many different stem cell lines— the fundamental tool of regenerative medicine—into numerous laboratories with varied scientific and clinical foci is a worthy goal. We caution, however, that social and institutional factors such as intellectual property rights, access fees, use restrictions and competition shape the choices scientists make about research materials4,5. Federal policies and institutional guidelines, established and well-understood protocols, assays, reagents and the prominence of some lines in the published literature also have an impact. State-level policies can be even more restrictive than federal rules, and the possibility of legal challenges makes transfer of materials to some locales more difficult than others. Indeed, initial social differences (in accessibility, ease of use or availability of technical complements such as known reagents and laboratory procedures) can lead to increasing returns for the selection of particular materials and eventually to lock-in on a dominant but often sub-par technological standard for a field6. In short, the diversity of lines actually in use at the And then there were two: use of hESC lines

A review of the key issues associated with the commercialization of biobanks

A review of the key issues associated with the commercialization of biobanks Timothy Caulfield∗, Sarah Burningham, Yann Joly, ZubinMaster, Mahsa Shabani, Pascal Borry, Allan Becker, Michael Burgess, Kathryn Calder, Christine Critchley, Kelly Edwards, Stephanie M. Fullerton, Herbert Gottweis, Robyn Hyde-Lay, Judy Illes, Rosario Isasi, Kazuto Kato, Jane Kaye, Bartha Knoppers, John Lynch, AmyMcGuire, Eric Meslin, Dianne Nicol, Kieran O’Doherty, Ubaka Ogbogu, Margaret Otlowski, Daryl Pullman, Nola Ries, Chris Scott, Malcolm Sears, HelenWallace andMa’n H. Zawati†

The zinc finger nuclease monopoly

A decade of sound science and aggressive deal making has given Sangamo Biosciences a stranglehold on zinc finger technologies. Now, academic labs that helped build Sangamos empire want in on the action. Are the ingredients ripe for a revolt that could break the companys monopoly? Christopher Thomas Scott investigates.

Democracy derived? new trajectories in pluripotent stem cell research

How has the development of human induced pluripotent stem cells (hiPSCs) modified the trajectory of stem cell research? Here, coauthorship networks of stem cell research articles and analysis of cell lines used in stem cell research indicate that hiPSCs are not replacing human embryonic stem cells, but instead, the two cell types are complementary, interdependent research tools. Thus, we conclude that a ban on funding for embryonic stem cell research could have unexpected negative ramifications on the nascent field of hiPSCs.

Challenges to Human Embryonic Stem Cell Patents

The patenting of human embryonic stem (hES) cells has produced one of the most unusual and fraught situations in the history of science, ethics, and law. This Commentary examines legal and moral challenges to three foundational patents held by the Wisconsin Alumni Research Foundation (WARF). We conclude that, in the United States, technical challenges may, paradoxically, produce a stronger patent position for WARF. In the European Union, moral challenges mean confusion for member states. We demonstrate that hES cell intellectual property will be guided and bound by a welter of moral, technical, and legal inputs, with discrete national and jurisdictional dimensions.

Distribution of Human Embryonic Stem Cell Lines: Who, When, and Where

Document S1. Supplemental Findings, Supplemental Methods, Supplemental References, and One TablexDownload (.06 MB ) Document S1. Supplemental Findings, Supplemental Methods, Supplemental References, and One Table

Patenting pluripotence: the next battle for stem cell intellectual property

What will be the impact of induced pluripotent stem cell discoveries on the current stem cell patent landscape?