By David Tuller, DrPH
I’ll soon post a blog on why I’m spending so much time on this IBS issue when I’m supposed to be focused on ME (or CFS, ME/CFS, CFS/ME, or whatever term is being used to refer to this illness or cluster of related illnesses). In the meantime, here’s a copy of the letter I sent this morning to two more of Mahana Therapeutics gastroenterology advisors, after the one I sent to a UCSF guy last week. (I received an auto-response, which informed me that the doctor was currently out of town.)
This time I wrote to Dr Peter Lu and Dr Carlo di Lorenzo. Both are well-regarded gastroenterologists at Nationwide Children’s Hospital in Columbus, Ohio.Â Mahana has more than a dozen gastroenterology and psychology advisors. I guess that means it is likely I will send additional letters while I continue to wait for answers.
Subject line: Mahana Therapeutics unwarranted claims about web-based CBT for IBS
Dear Dr Lu and Dr Di Lorenzo–
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 write frequently about research on illnesses in the category of so-called “medically unexplained symptoms.” Much of my workÂ appears onÂ Virology Blog, a science site hosted by Vincent Racaniello, a professor of microbiology at Columbia. (I have cc’d Dr Racaniello on this e-mail.)
I am touching base because I noticed that you are both serving as gastroenterology advisors to a company called Mahana Therapeutics. I have recently written about Mahana’s licensing deal with King’s College London, which was announced last month. The deal is for a web-based cognitive behavior therapy program for treating irritable bowel syndrome, which is apparently slated to be Mahana’s first product.
I realize that you were not authors of the study that road-tested this web-based program, called Parallel by Mahana. However, Mahana has not responded to three e-mailÂ messages I have sent in my efforts to get responses to my concerns. So I thought I would reach out to you, and others, in your capacity as company advisors. (I am also cc-ing Mahana’s press department.)
I critiqued the relevant study, called ACTIB,Â in this post. Then I wrote two posts–hereÂ andÂ here–noting that Mahana is presenting what seems to be a very misleading description of the clinical efficacy of the web-based program.
According to the study, the program generated very modest reported benefits in reducing symptom severity. At 12 months, the mean score of patients receiving the intervention on the IBS-SSS was 35.2 points lower than the mean score for those who received treatment-as-usual. (For an individual, a reduction of 50 points or more on the scale is required for the change to be considered clinically significant.) At 24 months, the 12.9-pointÂ difference in mean scores between the two groups was not statistically significant.
In its press release about the licensing deal, Mahana described these results as “substantial” and “durable.” On its website, Mahana is promoting these symptom severity results as “dramatic and potentially game-changing for patients.” I do not think these statements, and other information provided on the website, accurately reflect the findings.
The IBS-SSS was the only instrument in the study specifically designed to assess IBS symptoms rather than more generic domains. Modestly positive reports on those additional instruments might be expected from a round of CBT and should not be taken as evidence of successful treatment of IBS. In any event, Mahana is touting the IBS-SSS results themselves as evidence of successful treatment–even though these results would appear to demonstrate the opposite.
As Mahana gastroenterology advisors, you might or might not have already scrutinized the company’s website and checked out the IBS study. In any event, here are a few of the questions I’d like to ask:
Do you believe the study findings represent “substantial,” “durable, “dramatic,” and “potentially game-changing” reductions in symptom severity, or do you agree that the company appears to be engaging in exaggeration and hype? If you agree with the latter, do you think that this sort of inflated rhetoric, which would seem likely to induce unrealisticÂ hopes in patients,Â is acceptable and appropriate when marketing medical products? If you think it is not acceptable or appropriate, do you plan to urge Mahana to reconsider its approach, given your roles as prominent gastroenterology advisors to the company? Can you explain why Mahana decided in the first place to license a program that produced such minimal benefits over treatment-as-usual in reducing symptomÂ severity? Finally, are your advisory positions compensated?
Thanks much! I look forward to hearing from you. To keep Virology Blog readers informed of my reporting efforts, I postedÂ my initial letter to MahanaÂ on Virology Blog and also plan to post this letter. (It would be fine if you’d prefer to talk on the phone rather than send a response.)
I am sending similar letters to others on the list of science advisors. It is of course frustrating when a company disseminates unjustified claims about medical treatments and then fails to respond in a timely manner to legitimate questions.