By David Tuller, DrPH
On its website, Mahana Therapeutics has listed sixteen gastroenterology and psychology advisors from prominent academic and medical institutions. Companies often add such names to their rosters as a way of signaling their significance and their access to great minds. Sometimes these people are compensated; sometimes not. In many instances, these advisors play little role in day-to-day company activities.
In the case of Mahana, that means those advisors not directly involved in the development of the web-based cognitive behavior therapy program for treating irritable bowel syndrome might have little knowledge or awareness of the details of the matter. However, that doesn’t mean they have no responsibility to express their thoughts on the company’s promotional strategy–especially because Mahana itself has so far failed to respond to my questions.
One of the advisors is Dr Mel Heyman, a prominent specialist in pediatric gastroenterology at the University of California, San Francisco. This morning I sent him the following e-mail. After I sent it, I received an automatic notice that Dr Heyman would be out of the office until later this month, with minimal e-mail access. (In the e-mail below, I have noted [sic] in two places, because the glitches identified were in the message as sent.)
I am a senior fellow in public health and journalism at 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 work appears on Virology Blog, a science site hosted by Vincent Racaniello, a professor of microbiology at Columbia. (I have cc’d Dr Racaniello.)
I am touching base because I noticed that you are a gastroenterology advisor to Mahana Therapeutics–one of two such advisors from the University of California. 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 an author of the study that road-tested this web-based program and that your focus is inflammatory bowel disease rather than IBS. However, Mahana has not responded to three e-mail messages I sent last week. I am still seeking responses to my concerns, so I thought I would reach out to you in your capacity as an advisor to the company.
I critiqued the relevant study in this post. Then I wrote two posts–here and here–noting that Mahana is presenting what seems to be a misleading description of the clinical efficacy of the web-based program, which it calls Parallel.
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 Symptom Severity Scale was 35 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 13-point difference in mean scores between the two groups was not statistically significant.
On its website, Mahana is promoting these symptom severity results as “dramatic and potentially game-changing for patients.” I do not think that statement 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.)
As a Mahana gastroenterology advisor, you might or might not have alreaduy [sic] scrutinized the company’s website and checked out the IBS study itself. In any event, here are a few of the questions I’d like to ask:
Do you believe the study findings represent a “dramatic and potentially game-changing” reduction 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 unrealistic hopes in patients, is appropriate when marketing medical products? If you think it is not appropriate, do you plan to urge Mahana to reconsider its approach, given your role as a science advisor 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 symptom severity? Finally, is your advisory position compensated?