The regenerative medicine movement is finally finding its stride and emerging at a healthy pace, along with growing systems of support and accountability. Because of this progress, patients need now more than ever to be able to depend upon neutral interpretations of information. In this editorial, Doug Oliver responds to Leigh Turner’s recent interview and perspective on how, why and when cell therapy providers allegedly exploit ClinicalTrials.gov.
Douglas Oliver, MSW1
1Founder, The Regenerative Outcomes Foundation, P.O. Box 40211, Nashville, TN 37204; [email protected]
I would like to offer my comments and observations regarding Dr. Leigh Turner’s recent interview with RegMedNet. Dr. Turner talks about his perspective, recently published in Regenerative Medicine, describing cell therapy providers promoting “pay-to-participate” clinical studies on NIH’s public-facing research database, ClinicalTrials.gov.
I enjoyed the interview because Dr. Turner himself provides his own concise summary of the research and, in doing so, gives us a number of clues that might motivate us patients to become good consumers of research.
Let me note that, having been an activist myself, I get it. I admire Dr. Turner for his tenacity at holding practices he sees as harmful, unethical, dangerous, or otherwise problematic in the stem cell space to the light. It’s a needed role and he fills it well, although he is not the only torchbearer.
That being said, I believe there are several statements he makes that create questions for patients who may be referencing ClinicalTrials.gov, perhaps with Dr. Turner’s interview in mind. Here is my attempt to ask a few of those questions, under headings denoting my criticism.
Revealing a clear presumptive bias
What criteria did Dr. Turner use to determine that any given stem cell clinic is using ClinicalTrials.gov “in an attempt to confer legitimacy on their commercial practices”? This statement is problematic because it’s an interpretation of motive and could represent bias. It might even set a patient up to be suspicious instead of objectively curious.
The numbers don’t add up
Given the small sample size of clinics that met his criteria for the three categories of businesses who allegedly exploit ClinicalTrials.gov, how does Dr. Turner establish it as a trend, rather than a small percentage of the whole that are misbehavers?
There are over 3,000 stem cell clinical studies in the U.S. that are listed on the clinical trials registry. While the percentage represented by the sample of about 20 clinics, split between 4—5 businesses, is not known, it might be reasonable to assume 33%, or 1000 studies. Even at half of that, the snapshot upon which the study is built is almost surely minute.
Use of hyperbole
Is there a reason Dr. Turner uses the word “proclaim”, rather than a less hyperbolized word such as “claim”, to describe the manner that stem cell clinics describe how they communicate their presence on the registry list to the public?
Use of hyperbole is of known and serious detriment to patients. Policy groups have consistently identified it as a problem common in the research community as well and it is described as causing confusion for the public and for practitioners alike. Policy groups urge researchers to use restraint in expansive language overstating advances and breakthroughs and I apply the same principle to negative hyperbole, which is also problematic and harmful to all of us. Choosing the word “proclaim” is, in my opinion, a clear example of negative hyperbole.
Insignificant results blamed on inclusion constraints
Dr. Turner mentions that the first out of three distinct categories he assigns to companies listing on the site are those who disclose their studies as patient-funded. This all sounds good, but he actually found only two such companies in the U.S. meeting his criteria for that “distinct category”. In the interview, however, Dr. Turner quickly explains this away, saying that there are likely more that qualify since he concluded his study, but how many more?
A small sample cannot establish a significant trend
Dr. Turner’s math seems hard to support. If his total sample ended up being just over a dozen out of 3000 such studies registered on ClinicalTrials.gov and this distinct category consists of only two clinics with multiple sites, how are they representative of a problematic trend? Why does he qualify each category as potentially having more sites, if they’d only met his criteria?
We all know what would happen if the study included the many clinics that are obviously in this third category, right?
When explaining the third category of companies who allegedly are not forthcoming on charging patients on or off the ClinicalTrials.gov site, he cited his belief that there were indeed many more sites that would nearly meet his criteria, but he was reluctant to list them or their projects.
NIH doesn’t know what’s going on
One additional document that might add credence to this idea would be a record of first-person contacts with NIH that demonstrated they could not answer Dr. Turner’s questions, such as a freedom of information request. Instead, the interview closes with another invitation to innuendo: “I Wonder”
I respect Dr. Turner’s knowledge and activism focused on exposing problems like the one he sees in how ClinicalTrials.gov does or does not handle the potential for abuse and patient confusion. He attempts prompting accountability to protect the public. However, patients need and deserve more than a “wink and nod”. If opinions are opinions, they need to be represented as such.
If there is anything patients can demonstrate today, it’s that they have information, knowledge and motivation to use it to help themselves and others. Many of the issues, from lack of regulation to data transparency and vulnerabilities inherent with the use of an ill-fitting registry for a new field, are being addressed actively. A Regenerative Medicine Registry Work Group, of which I am a part, is meeting this week in Milwaukee. The Federation of State Medical Boards is assembling a Stem Cell Policy Work Group, of which I am also a part, this September. NIH is beefing up its own data policies and FDA CBER is in the final stages of issuing its draft guidance for implementing its clarified mandate under The 21st Century Cures Act.
The sky is still above us.
Read Leigh Turner’s response to this article here, or read Leigh’s interview or original paper here (exclusively free for RegMedNet members).
Financial & competing interests disclosure
- Regenerative Medicine. “Pay-to-participate” stem cells studies: an interview with Leigh Turner. Published 19 July 2017, accessed 7 August 2017.
- Turner, L. ClinicalTrials.gov, stem cells and pay-to-participate clinical studies. Regen. Med. doi: 10.2217/rme-2017-0015 (2017) (Epub ahead of print). Available free to RegMedNet members here: http://bit.ly/2uZl7XR
- International Medical Travel. Journal Scientists Warn Against Stem Cell Medical Tourism. Published 6 June 2016, accessed 9 August 2017.
The opinions expressed in this article are those of the author and do not necessarily reflect the views of RegMedNet, Future Medicine Ltd or any of its affiliates.