Notes from Calgary: Stem cell hype and medical tourism

CIRM's Senior Officer to the Standards Working Group, Geoff Lomax, is blogging this week from Calgary where his attending the Canadian Stem Cell Network's meeting "Stem Cell Controversies".  

The Stem Cell Network meeting Understanding Stem Cell Controversies is refreshing for its focus on clinical trials and efforts to get basic stem cell research to patients. There is no controversy over the need to develop these treatments, but the process of getting there and how those treatments are understood by the public have raised troubling issues.

Brian Kwon from the University of British Columbia provided a very nice treatment of the issues that emerge in trying to move stem cell-based therapies to the clinic. Areas he emphasized were the types of evidence required before engaging in clinical trials and the challenge of evaluating how effective the therapies were over time. Although these issues are relevant in the development of any new therapy, stem cell therapies have some additional features that need to be taken into account before they can be tested in people. One example is the need to prove absolutely that the cells are safe before trials begin.

One recurring theme among the presenters has been concerns over “stem cell hype” and “medical tourism.” It was noted that patients will frequently inquire about stem cell treatments for a range of illness and injury. Speakers suggested this “hype” may be attributed, in part, to the many products incorporating stem cells (or at least suggesting on the label). Data indicate there is a growing promotion of direct-to-consumer stem cell treatments, and the claims in these promotions are not supported by scientific evidence. Tim Caulfield reported on his research indicating the average cost of an unverified, direct-to-consumer “stem cell treatment” is $24,350.

There was recognition among the speakers of the need to provide the public with more complete information about:

• The status of cell/stem cell treatments for specific diseases
• The risks of certain interventions
• Points to consider when evaluating treatments

Independent resources like CIRM's stem cell tourism page and the International Society for Stem Cell Research website A Closer Look At Stem Cell Treatments were viewed as important counter weights to the numerous web sites promoting miracle cures to our ailments.

Here's a video CIRM produced about stem cell tourism, featuring Jeanne Loring of the Scripps Research Institute:



- Geoff Lomax

Understanding Stem Cell Controversies -- Texas Hold’em Anyone?

CIRM's Senior Officer to the Standards Working Group, Geoff Lomax, will be blogging this week from Calgary where his attending the Canadian Stem Cell Network's meeting "Stem Cell Controversies". 

Today kicks off the Canadian Stem Cell Network’s intensive three-day course titled Understanding Stem Cell Controversies. The focus is on emerging ethical and policy issues as the science moves towards clinical application. The course will include a conversation about the process CIRM employs to develop policies to govern the institute. But, more on that later.

First, as we were leaving sunny San Francisco, the captain mentioned it was negative 24C in Calgary. Well at least it is not humid. After a full sprint from the terminal to the taxi, the driver and I engaged in the obligatory Canadian ritual of catching up on the latest developments in the hockey world. Fortunately the Calgary Flames “walloped em” – everything was right in the universe.

The NHL was followed by the “what brings you to Calgary line.” I was immediately thrust into my “stem cell basics rap” (always good to practice before a big training). My driver was particularly interested in knowing what was so unique about stem cells. He could easily learn from CIRM's Stem Cell Basics online, but since driving a web browsing is frowned on I gave him the verbal run down. Fortunately, he showed his hand by expressing his fascination about cell division, so we quickly covered progenitor and differentiated cell types. He was also curious about genes and how they relate to the splitting process. We discussed how the splitting process relates to disease.

Then came the utterly brilliant moment. My driver is a BIG poker player (loves to go the Vegas) and believes in cosmic connections. He then spent the remainder of the journey relating cell division to the odds of where the aces would fall in a game of Texas hold em. It was actually a brilliant metaphor for stochastic events in biology. It was an extraordinarily coherent explanation of how the probability of “aces showing” changes over time as players drop out. In his view, there could be some connection to stem cell division. Yes, the probability of a disease-causing mutation may change in relation to cellular changes or environmental events.

It was a wonderful example of how probabilistic events in cell biology can be related to everyday activities. For myself, it is a useful metaphor to use the next time I find myself needing to explain stem cells to non-biologists.

The moral of the story: Try your stem cell rap on your next taxi driver, it’s good practice and you may learn something. And you may dispel a few popular stem cell myths while you are at it.

- Geoff Lomax

From Sputnik to Stem Cells

Guest blogger Geoff Lomax
Senior Officer to the Standards Working Group

I was chatting, over a nice bottle of wine, with some long-time friends of mine at the Breakthrough Institute. They advocate federal funding to advance clean energy technology in the U.S. They were curious about the ongoing litigation over NIH funding for human embryonic stem cell research. It was interesting to hear their view that the decision was a blow to human capital and strategic investment. They drew an analogy to the space race when they wrote:

The U.S. simply could not have won the space race without major federal investments in targeted education programs. Spurred on by the Soviet launch of Sputnik, Congress passed the National Defense Education Act in 1958, committing billions of dollars to equip a generation to confront the Soviet challenge. These investments developed the human capital necessary to put a man on the moon and invent the technologies that catapulted our world into the Information Age, from microchips and telecommunications to personal computing and the Internet.

The point was that almost all major advances in engineering, medicine and telecommunications track back to public investment. The policy question was not a narrow one of whether the Federal policy should fund human embryonic stem cell research, but, rather, does the U.S. want to maintain its leadership position in biomedicine. As is the case with clean energy technology, China and India are making massive public investments in human and physical capital to support innovation in biomedicine.

Their concerns appear to be supported by recent research (account required for this link). Aaron Levine at Georgia Tech published survey results suggesting the legal challenge to the NIH hESC research policy has negative economic impacts and undermines the development of human capital for all aspects stem cell research. Specific impacts include:

• Delaying hESC research or new projects
• mpeding existing research projects
• Adopting suboptimal research designs

Levine concludes:

More surprisingly, these results also suggest that the ruling and ongoing policy uncertainty have negatively affected non-hESC stem cell research.

Levine’s findings are consistent with research conducted by CIRM. CIRM surveyed researchers with NIH grants to perform hESC research. 38% believed the funding freeze would have signification impacts. Loss of postdoctoral researchers was a major potential impact. Consistent with Levine’s findings, respondents to the CIRM survey indicated all forms of stem cell research would be hurt by the freeze.

Like my friends postulated, the loss of this critical human capital constitutes a blow to medical research broadly. As Levine suggests, to develop or maintain leadership in the field policies are needed that provide a clear legal and policy basis for ongoing research and innovation.

Stem cell banking workshop explores ethical and policy issues

At the 2010 Stem Cell Banking Workshop on May 26, CIRM president Alan Trounson discussed the potential value of a cell bank designed to support the needs of researchers and industry. Many of the participants believe there would be great scientific value in a bank that could provide a common approach to cell collection and distribution.

The workshop was designed to give special attention to ethical concerns related to the collection, creation, use and sharing of stem cells. Foremost, were ethical concerns about how to tell potential donors about how there cells will be used.  This process refereed to as “informed consent” is the cornerstone of research ethics. Participants agreed donors need to understand to the following:

•    What type of experiments there cell may be used in
•    How there privacy will be protected
•    Whether or not they would get any medical benefit from donating
•    Whether they can discontinue participation in the future (e.g. withdraw from the bank)

The workshop was not designed to answer these questions, but rather explore how these issues are being addressed already and consider how CIRM may adopt best practices. CIRM staff were asked to provide a report in the future. Workshop panelists included leading researchers and cell banking organizations. They provided cogent recommendations and offered concise insights for how these issues can be addressed.

In addition, they provided estimates of the costs and organizational capacity needed to run a cell bank. Overall, the workshop achieved its primary goal and served to stimulate discussion on a range of ethical and policy issues. A complete transcript will be available in June 2010.

- Geoff Lomax
Senior Officer to the CIRM Standards Working Group