Stem Cell Ethics: An Overview from UC Davis Event

Alison Sorkin -- Knoepfler photo

California scientist Paul Knoepfler yesterday posted a synopsis of the recent stem cell ethics session at UC Davis that touched on topics ranging from Right to Try laws to hype about hype in stem cell research. 

Writing on his blog, Knoepfler estimated the attendance at 70 to 80 persons including patient advocates as well as scientists, attorneys and institutional compliance officers.

One presenter was Alison Sorkin, deputy general counsel for University of Colorado Health, who dealt with her state’s Right to Try law. Knoepfler wrote that she said that the law is actually quite limited. Knoepfler wrote,

“She also discussed problematic issues with the specifics of the law such as that patients would be responsible for paying for all of their own healthcare for 6 months after treatment under Right To Try as insurers would be exempt from having to provide ANY coverage. There seems to be a growing sense that Right To Try in Colorado may not actually lead to any patients getting non-FDA approved drugs.” 

Tim Caulfield, a professor, Faculty of Law and School of Public Health at the University of Alberta, dealt with hype. Knoepfler wrote,

“Tim focused on hype in the stem cell field and in particular hype involving scientific publications. He even talked about hype about hype. In the current environment there are strong pressures for scientists to hype their work, including in particular in abstracts. What is the relationship between hype in science articles and in the media?” 

The session was the second annual such event for UC Davis, which will presumably stage another next year.

Ethics and Stem Cell Research Symposium Feb. 12: Gordie Howe to Right to Try

The public and other interested parties are invited to a UC Davis bioethics symposium Feb. 12 that is likely to deal with some high profile issues involving stem cell research.

Davis researcher Paul Knoepfler is helping to organize the event which he said will include stem cell tourism (think former hockey great Gordie Howe), Right to Try laws and much more. The panelists include Timothy Caulfield of the University of Alberta and Leigh Turner of the University of Minnesota.

A blogger by the name of HappyAnise wrote on the StemcellPromise blog,

“What it makes this so exciting is that they’re apparently going to be talking about some REAL, GENUINE ethical issues. To wit… what on earth are we going to do about all of those stem cell clinics popping up in various and assorted countries? You know, the ones with the weird, dubious, expensive treatments that the FDA would never approve in a gazillion years? And while we’re on the subject, when is the FDA going to do anything about regulating, say, $10,000 stem cell creams? And what about those “Right to Try” laws? They passed in four states in November, but what is the federal government going to do, if anything? What should they do?”

You can register with at 916-734-6181 or julie.bechtel@ucdmc.ucdavis.edu.

'Immortal' Stem Cells and Informed Consent in California

The California stem cell agency is looking for some help in connection with a $32 million stem cell banking program to be sure that people who donate tissue understand that their cells will be transformed and made “immortal.”

The agency has issued a $150,000 request for proposals (RFP) for a 12-month study dealing with informed consent matters in the banking effort. The agency's RFP said it is “a unique program because it involves the creation of 9,000 iPS cell lines, from 3,000 individuals” that could increase to 5,000.

The RFP requests a report that will provide “in-depth analysis of donors' current understanding with respect to the informed consent process” and “recommendations for education materials that may improve program performance over time.”

Issues dealing with informed consent and research were highlighted a few years ago in a book, "The Immortal Life of Henrietta Lacks," that was on the New York Times hardcover bestseller list for more than 40 weeks. 

The California stem cell agency's RFP said,

“Unique aspects of the tissue collection for disease modeling awards that is critical for donors to understand include that researchers intend to:
“• Test donors blood and skin samples for infectious disease
“• Transform donor cells and make them into immortal iPSC lines
“• Record the genetic sequence of donor their cells
“• Distribute donor cells and associated medical and genetic information widely
“• Use cells and associated information to develop commercial medical products with no financial compensation to donors.
“In addition, minors and/or individuals with cognitive impairments will be recruited for this research and consent may be obtained from their legal guardian."

The proposed California study is linked to a $4 million segment of its $32 million stem cell banking effort approved in March of 2013. Former CIRM President Alan Trounson said at the time,

“This initiative will provide scientists with access to multiple cell lines that should have much of the genetic variations that represent the variety within any human disease such as Alzheimer’s, heart disease, lung fibrosis and autism.”

The deadline for applications is June 1. Here is a link to a 2010 CIRM report on issues involved in the stem cell banking program, which was only a proposal at the time.