Ask, Ask, Ask: The views of patients and the public should inform stem cell treatments and research

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

The afternoon session on Day 2 at the Understanding Stem Cell Controversies workshop began picking apart the complex relationship between research and the public, specifically where they intersect in clinical trials and experimental therapies.

Two case studies illustrate the gap in expectations vs. reality that exist in this context.

First, Dr. Harry Atkins spoke about his ongoing trial at the Ottawa Hospital Research Institute, in which MS patients are being treated with transplants of their own harvested blood-forming stem cells. This is transplant can have considerable side effects and some risk of death for the patient. A recent publication on the trial spurred a flurry of media attention in Canada, after which, understandably, Dr. Atkins received a number of emails from patients and patient caregivers seeking to get involved in the trial.

Looking broadly at these requests, as well as comments emerging from the media coverage, Dr. Atkins identified the following challenges and perceptions that require thought and an approach from the scientific and medical community:

• The medical message has not been transmitted or received – there is a lack of understanding on method, biology, medicine
• Patient decisions (on wanting to take part in a trial, for example) are often made based on sound bytes and there is a lack of desire to learn more about the risks and benefits of participation
• There are misperceptions on the part of patients about the severity of their health issues
• A sense of desperation on the part of patiets – they will go to all lengths even if there is no visible impact of disease. This is coupled with a feeling there is a need to do something at all costs – it’s never too late for a “hail mary”
• There is anger on behalf of patients/public at the regulatory environment for holding things back
• Conflicts of interest are not understood or are twisted for self-interest (i.e. conspiracy theories to explain barriers to treatment)

Of course, the gulf of understanding is not generated by the public alone. Researchers and medical professionals bring their own perceptions and biases to the table and these were highlighted by Judy Illes of the University of British Columbia. Using the Geron trial and spinal cord injury as a case study, Illes identified the position of the scientific field:

• There is a focus on cause, methodology, statistics and data, adverse effects
• Lack of emotion; delivery of the information is dispassionate
• Decisions are often made without input from patients – in the spinal cord example, there was a significant mismatch between when a patient was informed and willing to engage in risk (~18 months post-injury) vs. the timeline of therapy identified by researchers (7-14 days post injury)

One of the key points to be made about the two examples, MS and spinal cord injury, is the nature of the illness itself. On one hand, there is an injury that is has an immediate impact on a patient (spinal cord injury), from which a patient has a reasonable expectation of possible improvement or, at the very least, no significant further deterioration post injury. On the other hand, MS patients may begin with very minimal impact to quality of life, but the disease progressively gets worse. These two realities will greatly shape the decisions and perceptions of patients and should therefor shape the method of communication from the research community.

This topic continued in this morning’s sessions. Debra Matthews from the Johns Hopkins Berman Institute of Bioethics discussed the influence of public opinion on policy. She emphasized the importance of science “being informed by public opinion.” She used the example of embryo donation for research. She cited surveys showing that individual who have completed infertility treatment have a deep sense of responsibility for remaining embryos. The survey results indicate that research donation is viewed as a responsible choice for a majority of those surveyed. These results are consistent with the views of individuals in California (we wrote about that here).

Dr. Matthews contrasted the stem cell experience with a recent experience in Texas where 5 million blood samples from a newborn screening program had to be destroyed (more about that here).

The blood samples were to be used for responsible research, but the problem in Texas was that people were not asked for their permissions for such use. Matthews pointed out that the vast majority of families are supportive of responsible research but want to be asked before their materials are used.

The Texas example underscores the importance of providing comprehensive informed consent for research donation. CIRM, SCN and our collaborators have placed emphasis on obtaining consent for research it is a case of science being informed by public opinion.

Co-written with Lisa Willemse, Director of Communications at Stem Cell Network. This entry is cross-posted on SCN's Signals blog.