Public expectations and reality of stem cell therapies translation

by Alexey Bersenev on December 7, 2012 · 1 comment

in misconceptions

Needless to say how much stem cell topic is overhyped today. Just turn on TV or radio and look at local newspaper or Internet – stem cells are everywhere! The public opinion and perception of stem cell research and therapy is based almost entirely on media reporting. But how close/ far this perception from the reality? Many professionals can speculate that this gap is big. But do we have a data? Tania Bubela just published a study, which indicates that public belief and optimism for stem cell research and translation is largely unjustified and even delusional. This study is very unique and important! We as a field can learn a lot from it!

Our goal is to uncover the nature of the biases in the public discourse on stem cell research that separates fact from fiction. This is the first step to creating better communication strategies among the clinical research community and the public, patients, and policy makers.

They measured public expectation by media coverage and compare it with clinical trials data. Media coverage data were retrieved from Factiva.com database and included 13,249 newspaper articles. The data, retrieved from clinical trials databases (ClinicalTrials.gov + WHO portal) reflect the “reality” in stem cell clinical translation. They analyzed 3,404 “stem cell clinical trials”. Importantly, trials were “hand coded”, means carefully picked and “filtered”.

As one would expect, the authors found a huge difference between “expectations” and “reality”. First gap was in cell types:

…hESCs dominated newspaper coverage of SC research, with slight coverage of the discovery of iPSCs in November 2007, mainly focused on their being an ‘ethical’ alternative to hESCs (Figure 1A) [6]. This leaves hESCs front and center in the public mind with respect to the type of stem cell in clinical development.

In contrast, all CTs (n = 3,404) were dominated by use of adult SCs, primarily hematopoietic SCs, with some trials using umbilical cord blood derived SCs.

In contrast, while newspapers referred to adult SCs and occasionally their tissue of origin, they rarely referenced terms such as hematopoietic and mesenchymal, or synonyms for these such as blood SCs.

Second, the gap in conditions for which stem cells are intended therapeutically:

.. newspaper articles focused disproportionately on neurological conditions, primarily, multiple sclerosis, stroke, Parkinson’s disease, spinal cord injury and Alzheimer’s disease with significant coverage also of cardiovascular disease and diabetes (Figure 2A). Neurological diseases were significantly linked to coverage of hESC research and therapies.

As we know, there are no currently ongoing clinical trials for hESC in neurological conditions. But how much this overhyped expectation was exploited by bogus “stem cell tourism clinics”?!

CTs for cancers and graft-versus-host disease (GVHD), which composed most of the ‘other diseases’ category, dominated the SC CT landscape (Figure 2B). Nevertheless, there was a steady increase in CTs for cardiovascular disease beginning in 2001 and a small number of trials for neurological, ocular conditions and diabetes.

Even if every layman can dig into clinical trials database today and get some sense of reality, the whole picture is still not there. General public won’t comprehensively appreciate the complexity of trials, their length, regulatory issues, cost and failures:

In reality, most therapies fail in phase I and II, and those that are proven both safe and effective take between US$200 million and US$1 billion in investment over a span of 10 to 15 years before they are approved and adopted by the medical community [31].

Public should realize that a number and variety of stem cell trials in early phases (1/2) doesn’t necessarily mean the delivery of the therapeutic promise:

While our analysis demonstrates that most SC CTs are in phases I or II, participants may conflate such early stage safety trials with therapeutic benefit.

Finally, public should know about the potential pressure and conflicts in a course of trials:

Given these system costs, the bar for therapeutic value, which compares the benefits of SC therapies with existing treatments, will be high. The model also belies the anticipated health system savings promised by proponents of SC research. These financial pressures, such as the scientific and regulatory issues, are absent from media reports and are hidden from public discourse, contributing to the disconnected state of current expectations.

I can’t resist to cite the whole conclusions section:

Given the research, regulatory, commercialization and health system hurdles involved in the clinical translation of SC research, it seems likely that patients and political supporters will become disappointed and disillusioned. In this environment, proponents need to make a concerted effort to temper claims. It is simply ‘unfair to raise people’s hopes to unrealistic levels when they and their families are desperate for treatments that will relieve their suffering and improve their health’ [35].

For a field that, lacking significant private investment, is largely reliant on public support, there needs to be a more honest acknowledgement of the expected therapeutic benefits and the timelines to achieving them.

I love this report! Highly recommend you to read! The article is freely available (.pdf).

{ 1 comment… read it below or add one }

Iván Coral December 7, 2012 at 11:53 pm

Greatings
I’m alternative MD, doing by my own SCtherapy with the studied system is impossible. Using methods from biological medicine is a chance. In my country SC therapies are prohibited, with complete reason, a lot of pseudo scientist offered improbable expensive healings in serius diseases, with genetic and chemical bases impossible to develop here. When it was permited I performed an art from conducing bone narrow SC in different Tissues. Few but happy examples were seen in Pk disease & Type I diabetes.
I hope new approaches in SC can be heard.

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