By David Tuller, DrPH
Last week I wrote about the recently announced licensing deal between Mahana Therapeutics and King’s College London. The deal involves a web-based course of cognitive behavior therapy designed to treat irritable bowel syndrome. In a major study, the reported improvements in symptoms among participants in the web-based program were modest at best. Yet Mahana is promoting these improvements as “dramatic” and “potentially game-changing for patients.”
On Monday, I e-mailed Mahana Therapeutics with a few questions. I have not heard back, although I followed up my initial e-mail with two nudges. On Friday, I sent the following e-mail to Professor Rona Moss-Morris, the study’s co-investigator. (Professor Moss-Morris has stock options in the company and has received payment as a consultant.).
Dear Professor Moss-Morrisâ€”
I am a senior fellow in public health and journalismÂ at UC Berkeley’s Center for Global Public Health, which is part of the School of Public Health. I have written about research on ME/CFS and other illnesses in the category of so-called “medically unexplained symptoms” for a few years. Much of this workÂ appears on Virology Blog, a science site hosted by Vincent Racaniello, Higgins Professor of Microbiology and Immunology at Columbia University. (I have cc’d Professor Racaniello; you can read about him here.)
In the last week, I have posted three pieces related to the ACTIB study. The first was a comment on the study itself and on the robustness of the findings. The next two involved the licensing deal between Kingâ€™s College London and Mahana Therapeutics for the Regul8 program. In case you haven’t seen these blogs, here are the links:
I am writing to invite you to respond to the questions I have raised about the study, Mahana’s description of the findings, the potential for conflicts of issues, etc.Â I would be pleased to post your full comments on Virology Blog–unedited and at whatever length you would like. (If I respond to your response, I will do so in a separate post.)
Please consider this a standing invitation.
In the interest of the UK’s international medical science reputation and out of respect for other academics far and wide, I’d have thought that Professor Moss-Morris should be keen to engage with the questions put forward here in relation to the ACTIB study and should be more than willing to discuss the study’s findings and Mahana Therapeutic’s description of them. Well, I believe that was the way that UK science worked in the past, in the days before questions and legitimate criticism were met with cries of harassment and abuse in order to stifle and silence important scientific debate.
I believe that around 17% of the adult population are thought to suffer with IBS -[https://www.bjmp.org/content/irritable-bowel-syndrome-primary-care-physicians ] so that’s 8 million plus UK sufferers? With the charge (including VAT) of the Regul8 app coming in at Â£225 per user, there’s potentially an awful lot of money to be made by Mahana Therapeutics out of selling this app to the NHS for its IAPT MUS programme. Wouldn’t it be both clinically and financially reckless then for NICE to base its use on one study that seemingly showed no clinically significant change in the primary outcome IBS-SSS score for web-based CBT? Am I missing something here?
Yes, it seems I was missing several things. According to the “Digital therapy technology endorsement for IAPT project eligibility and prioritisation criteria”, products that are deemed suitable for IAPT by an expert panel then apparently have to go through an in-service evaluation (in local IAPT services) with data collected over 2 years. So I wonder where Regul8 has reached now in the process – has it been deemed suitable for in-service evaluation? Is this evaluation going on currently, or has it completed or not started yet?
In reference to my other comment above, it’s possible that the majority of IBS sufferers don’t bother their doctor, so that would drastically reduce the number of IBS patients presenting to their doctor and the number who could potentially be referred by them to IAPT. I read in a 2015 NICE document that there may be upwards of 1.6 million IBS patients seen in the NHS in England and Wales each year. Put with a (probably generous) guesstimate that IBS now costs the NHS around Â£300 million a year, that would mean that each IBS patient costs the NHS less than Â£200 per year. Shouldn’t this be borne in mind when considering the cost-effectiveness of delivering Regul8 to patients via IAPT? It’s possible that the suggested cost per user of Regul8 (of Â£225 including VAT) may not be the cost per patient treatment episode as I had assumed above – e.g. the ‘user’ may be otherwise defined or patients may be given indefinite access to the app or for an extended period of time, thus reducing the cost to the NHS IF the treatment was clinically effective. NB These are just my musings, but I think they raise questions that need answering about the cost-effectiveness of this direction of travel for the NHS.
Lastly, for those who don’t have IBS and aren’t sure how this is relevant to ME or CFS, it looks to me like a similar app may be planned for CFS within the MUS arm of IAPT.