Q: So what’s up with research? A: It’s complicated.

Author: Lisa Willemse, 09/06/12

It seems to me that the number of media stories on stem cell clinical trials (not just preclinical work) is on the increase. Take, for example, news last month of a new clinical trial to test cord blood stem cells as a treatment for autism. This particular announcement was met with a wide range of response – from pronouncements of a cure from one news source, to skepticism from others (see Emily Willingham’s summary of the trial’s “spurious” rationale, ScienceBlog’s condemnation of the IRB that approved the trial), and other comments from the research community here and here.

And more recently, interim results from a spinal cord injury trial (Phase I-II) in which two of the three patients treated thus far report sensation below their injury site – spurring another flurry of positive news stories.

As a person on the receiving end of emails and phone calls from hopeful patients, I can say that when there are a number of these stories in quick succession, our office gets more enquiries about where to find similar treatments, when they will be made widely available, and why they are not available now. While the progress into more clinical trials does indicate that the field is slowly maturing, the answer we give at the Stem Cell Network, as do many others in the research field is: wait. It’s not ready yet.

I was recently asked why there is such a disconnect between what the media tells us and what we hear from the research community. (The question was put something like this: “What’s up with research? Can’t you just get it done, already?” but for the sake of this blog let’s just assume they were pointing out the disconnect.) Actually, I’m not a researcher (I’m a communicator), I don’t have a PhD in biology (or any field for that matter), but for reasons it would take too long to explain, I’ve been working in research for a dozen or so years. What I can say is that I like the passion most researchers have for discovery and in making life better and I enjoy the challenges in trying to bridge the gap between research and the public. My relationship with research has given me a bit of perspective on “what’s up with research”. Here’s some of what I’ve gleaned.

As passionate as they are, researchers tend to be a cautious lot. Their language typically includes words such as “may” “appears to” “suggests” and, seemingly inevitable conclusions such as “needs more study” or “requires validation”. Research, at its core, is about the quest for understanding (although for many it is also be motivated by a desire for a cure, and sometimes less altruistic aims such as personal recognition or career progression). And anybody who’s spent time in a lab can tell you that knowledge is incremental; rarely does it arrive in one neat package. Quite often progress is measured by missteps. So you leave the back door open, just in case you need to make an exit from a particular line of inquiry.

The want of a definitive can be highly frustrating for those of us outside the research world. In trying to write accurate materials at a lay level, my interviews with researchers are often full of questions that attempt to get at something that will resonate with the public – a nugget they can hold on to. But not all research delivers these nuggets, at least, not ones that are big or interesting enough to grab. And that’s okay – not every novel is deserving of the Pulitzer, nor will every research study result in a major advance. As I said, it’s incremental.

The problem is that we want them all to be Pulitzers. By “we” I’m not just referring to the public. I mean the collective “we”, which includes industry (looking to capitalize on medical products or services), governments (looking for returns on their investment of public funds), universities (looking to increase their standing), even the researchers themselves (looking for the next grant). And of course, there are the patients, for whom the stakes are the highest. For them, advances could mean a reprieve from disability, discomfort or even death.

Add to this mix of parties and interests the fact that stem cell research, no matter which perspective you take, holds a great deal of promise. Throw in a host of ethical and legal controversies such as source of cells and whether your own cells should be considered a drug, and you’ve got a magnet for attention. And anything that receives this much scrutiny on a regular basis is bound to suffer from an equal degree of tension. The pull, on the part of any of the above entities (and I include myself in this mix, somewhere), to overstate or hype results is almost unrelenting. Everybody wants it to succeed. Now would be a good time.

But the reality is, when it comes to human testing of stem cell therapies, the research community is just now beginning to walk, albeit with tiny baby steps. Those steps are guided by peer review and regulations around safety and efficacy. Of course, there are those who choose to operate outside these research parameters. From the researcher’s point of view, these are purveyors of stem cell tourism – and, with fewer or no regulations to be concerned with, no data to turn over to their peers for evaluation and the potential for substantial financial gain, they are leading the race. They hit their stride years ago, and can turn a new scientific advance into an advertised “cure” in a matter of days.

In terms of risk, the research community and unregulated clinics exemplify the opposite ends of the spectrum, but there is much that falls between; for example, clinics that do operate under approvals granted by IRBs with questionable membership and motives, or, as exemplified by the autism trial above, a clinical trial based on less-than-conclusive evidence. And these are just the risks associated with the practice side of things – an entirely different sort of risk is negotiated by the patients who opt not to try experimental therapies, who enter into a clinical trial, and who choose to pay for a therapy with uncertain (and possibly dangerous) outcomes. (On this point it gets murkier, as there is another, highly-nuanced discourse relevant to a patient’s right to choose an experimental therapy; questions and conspiracy theories related to conflicts of interest and the motives of researchers in speaking out against unregulated clinics; as well as largely untouched questions for the medical community in how to care for patients for whom an unregulated therapy has failed to work or caused harm, particularly if that care results in diminished medical resources for others.)

These are tricky waters, to be sure. As is evidenced in the autism trial noted above, not everybody agrees on the best way forward. Deciding when the risk is necessary or can be managed is something that I’m sure will continue to be debated in the years to come. It is my hope that these debates will include a broad spectrum of stakeholders, including patients, in order to better define issues such as risk and safety. I think a part of their discussions should be to identify and acknowledge the myriad of interests and perceptions in play to help ensure that pressure(s) or hype do not dictate the course of research and the pace with which key decisions are made. Because the worst kind of failure would be one that cuts the legs off the little momentum we’ve got.

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Lisa Willemse

Lisa Willemse

Director of Communications at Stem Cell Network
Lisa has been with the Stem Cell Network since 2008 and launched this blog (first as the Stem Cell Network Blog) in 2009, where she serves as co-editor and occasional contributor. Prior to joining SCN, Lisa worked as a science communicator in the fields of language and literacy development and high-speed networking/computing. Her background also includes stints as an editor, journalist and photographer. Her work has been published in numerous magazines, blogs and newspapers, including Scientific American, and iPolitics. Follow her on Twitter @WillemseLA.
Lisa Willemse

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3 Responses

  1. David Lee says:

    Thanks Lisa for a great blog!

    • Lisa Willemse says:

      Glad you liked it!

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