University of Minnesota bioethicist Leigh Turner has been threatened with a lawsuit by a stem cell clinic-related business. Threats in this arena come up every so often and as much as they are unpleasant realities, they can also reveal some important aspects of the stem cell arena. Ars Technica reported yesterday that Leigh’s recent paper on stem cell clinics and businesses associated with them with listings of non-FDA approved offerings in Clinicaltrials.gov was the impetus for the threat of a lawsuit and intention of asking for a retraction/correction.
An email to Leigh from Duncan Ross, the president of The Kimera Society (one of several organizations discussed in Leigh’s paper), included the reported litigation threat, which was quoted in Ars this way:
“I encourage you to amend your publication or I am going to bring suit against the institution for defamation or slander. I am going to lobby the journal for the retraction of this publication. I followed the letter of the FDA as it exists at this time and I am not going to have my name disparaged because of your lack of interest in due diligence…You continue to assume I’m being devious in some way and I’ve had enough.”
As someone who not only does stem cell research, but also writes about stem cell research and clinics, this struck me as an important development and I wanted to learn more about it. I asked Leigh for comment on this situation and he sent me his perspective along with his view of the larger context (you can read his full comment here):
“My article accurately states that the Kimera Society registered on ClinicalTrials.gov a pay-to-participate study in which adipose derived stem cells are administered to individuals with Chronic Obstructive Pulmonary Disease. The ClinicalTrials.gov listing does not disclose that study subjects are charged but this information is in the public domain and Duncan Ross, founder of Kimera, acknowledges that study subjects with COPD pay to participate in this study. My article also argues that studies involving administration of autologous adipose-derived stem cells to individuals with COPD appear to require an Investigational New Drug application that has been submitted to the FDA for review and cleared by CBER. In response, Duncan Ross has called for a retraction of my article and threatened that he will sue for libel or defamation if the article is not corrected or retracted.”
For balance I also asked Duncan Ross for a comment on this situation. I thought this was particularly important to do since Leigh and I have published work together, and share some concerns about direct-to-consumer marketing of stem cells. Here’s the comment that Ross emailed me for this piece:
“My issue with Dr. Turner’s approach is this. Even in the case of your one page blog post, you chose to reach out to me to understand what I, personally, hoped to achieve and/or had done to support the publication of the trial. In fact, I had received IRB approval, whereas Dr. Leigh insinuates throughout his publication that no IRB approval is needed for publication on clinicaltrials.gov. By writing these types of sensational articles, without due diligence, he piques the interest of journalists. These journalists write an article based on a DRAFT guidance, not fully understanding what that means. Then in an email back and forth that I have limited time to attend to, I send only the 2015 approval. That get’s printed. In fact I renewed the IRB every year but didn’t care to continue my discussion with Leigh. What you end up with is someone with a non-scientific background, taking all his time to research and call out companies by name, making them look illegal when in fact I have been in contact with the FDA and done what they require AT THIS TIME. I stood up at the scientific meeting, not public, and suggested that there should be some mechanism to regulate stem cell clinics. There is none at this time. I would pursue it myself through my non-profit. SO failing a pathway, and if IRB approval is not good enough for Leigh, he is going to continue to run around half-cocked and telling half truths. If someone, and I suppose it is going to be me, does not highlight his wholly negative approach, then we might end up curtailing the positive clinical outcomes that the pharmaceutical industry is taking note of and working towards. In fact, my research and the direction of my company is wholly focused on exosome therapies now, a discovery that came out of my experience with these types of autologous stem cell therapies.If you would like a big red box that says “paid trial’ on clinicaltrials.gov then lobby for its inclusion. If you would prefer stem cell clinics NOT get IRB approval, which I doubt you do, then state that to. I don’t see how choosing the only groups actually working through the requirements available to fulfill today is helpful or professional. Why not discuss the warning letters that were issued and how they were based in large part on sterility.”
Overall, there are hundreds of clinics and associated businesses marketing fat stem cell and other kinds of stem cell treatments for any of a whole medical encyclopedia worth of health conditions. Leigh and I reported on this in our paper in Cell Stem Cell last year. In my opinion, Leigh’s overall scholarship in this area is meritorious and has unique, positive impact. Even so, writing about stem cell direct-to-consumer businesses in any form whether it’s an academic paper or blog can be dicey.
In his comment to me, Leigh highlighted the possible impact that litigation threats can have:
“Mr. Ross’ threat is all-too-representative of the responses that emerge from individuals associated with businesses that charge patients for unproven stem cell interventions. When critiqued, they have a habit of attempting to threaten critics and intimidate them into silence. Such threats have a chilling effect on scholarship. In particular, they make academic journals and researchers wary of identifying businesses by name and critiquing specific commercial practices. The threat of litigation has impeded the ability of researchers to conduct research on such business and publish articles that address important ethical, legal, and scientific issues associated with their marketing claims, business practices, and clinical activities.”
However, one of the challenges for potential plaintiffs in such situations is that just the filing or even threat of a suit poses the risk of bringing them a hefty amount of often negative media attention a la “The Streisand Effect”.
Beyond the potential litigation issue, the Ars piece provides helpful background and new quotes from various parties including stem cell clinic leadership. One of the other interesting aspects of the Ars piece was that it got a meatier FDA quote on stem cell clinics than pretty much anything else I’ve seen from the agency in the recent past:
“We recognize that there are a number of clinics operating, which do not register with FDA. Consumers are encouraged to contact FDA and the appropriate state authorities in their jurisdictions to report any potentially illegal or harmful activity related to stem cell based products. We also encourage patients and health care providers to report adverse events associated with cellular therapies to FDA.”
Does this mean the FDA soon will actually do something concrete to bring more clarity and order to the stem cell commercial arena?
I doubt it, at least most likely not any time soon. We’ll see if as indicated in the new FDA Commissioner’s blog post the upcoming policy statements from the agency in September and then in later months might clarify the regulatory path forward for stem cell offerings such as adipose stem cells as well as other big issues such as non-homologous use and minimal manipulation. One of the rare areas of relatively greater agreement amongst many of the various stakeholders involved in or discussing stem cell clinic practices is the desire for more clarity and consistency from the FDA.
Will Kimera follow through and actually file suit against the University of Minnesota or Turner? If history is any guide, such threats almost always do not result in an actual lawsuit, but it’s possible. Regardless, I’d ask you readers a couple more questions: what is this situation telling us about the stem cell commercial arena today, and what risks and considerations are involved in being a public critic of specific commercial or other practices in the life sciences?
It’s definitely not for the faint of heart.
Note: This piece has been updated since its original posting with a few edits to reflect new information that arose in the comment thread including from Kimera’s Duncan Ross that Kimera may be more of a stem cell clinic-associated business (e.g. supplying cells to clinics) rather than a clinic itself.