By David Tuller, DrPH
Last week, I wrote to Rob Paull, the co-founder and CEO of Mahana Therapeutics, regarding the company’s misleading claims about the web-based cognitive behavior therapy program for irritable bowel syndrome it recently licensed from King’s College London. I have also written to Professor Rona Moss-Morris, the co-lead investigator of ACTIB, the study that road-tested the program, as well as three of Mahana’s prominent gastroenterology advisors.
So far, no one has responded or attempted to explain why Mahana is making unwarranted statements about the efficacy of the program. Presumably the company would like to have regulators in the UK and the US approve the product for public use. If so, it would be smart for Mahana and Mr Paull to be honest in describing what the findings do and do not show. So far, they have failed that test.
Dear Mr Paull–
I have not heard back from the letter I sent last week about Mahana Therapeutics and the licensing deal for the Regul8 web-based cognitive behavior therapy program for people with irritable bowel syndrome. I realize I asked you some uncomfortable questions. But ignoring them is not going to make them go away. Ignoring the questions is also not going to improve the reported results on symptom severity from the ACTIB study.
As you must recognize, the claims in the Mahana press release and on the website really cannot be justified or sustained, given the responses on the symptom severity measure, the IBS-SSS, from the trial. It is hard to get around the stubborn facts: On the IBS-SSS, the difference at 12 months between the mean scores for the web-based and treatment-as-usual arms was well below the 50-point threshold for clinical significance; at 24 months, the negligeable difference between the groups was neither clinically significant nor statistically significant.
You have been promoting Regul8, renamed Parallel, based on the IBS-SSS results, which the website highlights in a misleading fashion, as I documented on Virology Blog. It should be self-evident to anyone who reviewed the study that these findings for symptom severity cannot reasonably be described as “substantial,” “durable,” “dramatic,” and “potentially game-changing.”
I still welcome your input. (I have cc’d Professor Racaniello, a Columbia microbiology professor and host of Virology Blog, where I will post this letter.)
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley