Therapeutic Misconception At Its Worst
The International Society for Stem Cell Research (ISSCR) has created a website that aims purportedly to help patients assess the claims made by stem cell companies and researchers offering cures via stem cell research.
On their dedicated website, www.closerlookatstemcells.org, ISSCR warns "patients" of potentially costly, unproven, and harmful "treatments" that some have described as the "21st century version of snake oil".
But the true hucksterism here is in fact the ISSCR website itself which promotes precisely so many of the purported harms that it allegedly is trying to prevent. Let's just start with the language on the front page. "A Closer Look at Stem Cell Treatment." Treatment. Perhaps I missed a step in the advances of stem cell research. Did we quickly jump over the experimental phase and already move into having effective stem cell therapies? Someone must have hit the fast-forward button while I was blinking.
Just on the landing page of closerlookatstemcells.org alone are the words "clinic", "patient", and "treatment" all of which suggest that stem cell research is much closer to medical care than what it is which is in fact experimental human subjects research.
But it gets worse. The "What to Ask" page begins with a section entitled "The Treatment", but it doesn't take more than about 1/3rd of the page for the language to slip back into "clinical trial", "the study", "federal oversight", "IRB", and other mainstays of actual human subjects research. Too bad you have to read down below the fold and understand the difference between that language to really comprehend what it means to be a consumer of "stem cell treatments" from "clinics", as ISSCR describes them.
So not only does this site actually induce the therapeutic misconception, I would argue that it also induces consumer confusion of the highest order. If I were even a relatively educated patient reading this site, I would have to wonder, "Are they talking about medical treatment? Or this research? Am I a patient? Am I a research subject?" According to this website, one could be either. And maybe that could be true. 5 years from now. But not today.
The true icing on the cake is ISSCR's goal for the website on their FAQ page. The purpose of closerlookatstemcells.org is "provide patients, their families and doctors with as much information as possible so that they can make an informed decision about stem cell-based treatments. The ISSCR respects patients' rights to utilize this information in the manner they see appropriate and to make their own choices."
What information is ISSCR providing, you might ask? A list of stem cell research organizations that meet two criteria: 1) involvement of a "medical ethics committee" to "protect the rights of the patient" and 2) documentation of the involvement of a federal regulatory agency. Wow. Now that is a high bar. And based on these standards and being listed on this website, is this not an implicit endorsement of the organization in the eyes of an inquiring patient? It would be hard to argue otherwise, even though they do.
I am usually reluctant to argue against patient education and empowerment, but this website does precisely the opposite. It only muddies the waters and will confuse patients desperate for cures who are turning to stem cell trials as a last resort and want very much to believe that the research laboratories that they are walking into are "clinics" and the trials they are enrolling in are "therapeutic." Unfortunately, that is not yet the case. And ISSCR should just come out and say so.
Summer Johnson, PhD
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Many thanks to Dr. Johnson for having no reticence to call out the "naked emperor". Far too often we bemoan therapeutic misconception among potential research participants and patients, when we should berate those within research and health care provision who propagate and perpetrate the misconception by conflating "therapy" and "research", thereby confusing the purposes of each, resulting in the confounding of the ethics of both.
- by Greg Manship on Jul 19, 2010 at 12:48 PM | link
Dr Johnson's argument, rich in polemic, appears to ride on the assumption that a clear delineation actually exists between research and clinical treatment. This assumption is problematic not only because clinical research often does occur within hospitals and biomedical institutions with attending medical and health professionals, but research subjects often do expect that their participation in a study will be of some benefit, if not to themselves, then to some imagined 'others' in the future. This 'therapeutic misconception' has been shown in countless studies that have investigated participant experiences in clinical trials and occurs regardless of how much time independent personnel might spend explicating the differences between treatment and research. Hence, the therapeutic misconception is arguably unavoidable and philosophical preoccupation with it distracts from evidence that strongly suggests that participation is research is less about altruism than it is about reciprocity, where benefits are expected in return for participating in research. This expectation arises not from a misunderstanding of the information contained within consent forms or promotional materials, but because it is part of the moral obligations that are tacitly negotiated with participants when they take part in research.
Perhaps the ISSCR should be clearer about the lack of proven therapies that have thus far been generated from stem cells, of any type. And perhaps they should be stronger in fingering out the doctors, organizations and institutions that are found to be advertising false claims about purported treatments and therapies that, to date, do not exist. However, I suspect they have defamation lawyers that would sensibly advise against doing so. But also, if the aim is to reach out to those people who are thinking about undergoing one of these so-called "treatments", will they think they're in the right place if the website was to instead refer to them as something else, such as "frauds" or "scams" or the like? This is a rhetorical question of course, no empirical research has been done on how patients or prospective research subjects might interpret this language, so I don't know. But neither does Dr Johnson, so I'm not sure how she can conclude that the website will "confuse patients desperate for cures" anymore than they probably already are.
As for her criticisms of the criteria that should be met by an organization doing research on humans, I wonder what she thinks they should be? I would have thought that, at a bare minimum, organizations should indeed have approvals from an ethics review committee and the relevant regulatory authorities. And if they don't, then people should be strongly advised against participating in their research. Perhaps what is missing is greater reflection on what differentiates experimental research from novel medical procedures because this, it appears, is how operators in the highly regulated contexts of the US and the UK are slipping through the regulatory net to exploit vulnerable and desperate sick people.
- by Tamra Lysaght Ph.D on Aug 10, 2010 at 6:22 AM | link