My FOI Request to King’s College London; My Letter to Mahana Therapeutics

Dear Sir/Madam,

I am writing for information under the freedom-of-information law regarding the licensing agreement with Mahana Therapeutics, as announced here:

https://apnews.com/Newswire/602a5329f3427608ddfc7f740ebb7f26

Please provide the following:

1. The amount Mahana Therapeutics has paid to license the intervention and for how long.

2. The proportion of the money paid by Mahana Therapeutics that will be received by the researchers.

3. How much the National Health Service will have to pay for each patient who receives the intervention.

4. A copy of the agreement with personal information removed.

I am happy to receive this information in electronic format.

Thank you for your help.

Best–David Tuller

David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley

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Dear Press Person–

I am a journalist and public health researcher at the School of Public Health at the University of California, Berkeley. I often examine research in the fields of ME/CFS and other complex chronic illnesses. I publish much of my work on Virology Blog, a well-regarded science site hosted by Professor Vincent Racaniello, a microbiologist at Columbia University.

I recently noticed the press release about Regul8, the web-based CBT program for IBS that Mahana has licensed from King’s College London. In fact, I wrote a post last week about the findings of the study, as published in two separate papers. As I explained, the reported results were not especially robust–especially those for the group who received the web-based program.

I wrote another post today about the Mahana-KCL deal.

As I have documented, the reported benefits on symptom severity for the web-based program were not really “substantial,” as the press release stated, but modest at best. At 12 months, the mean for the web-based group was 35.2 lower than the mean for the treatment-as-usual group on the IBS-Symptom Severity Scale, for which a clinically significant change requires a reduction of at least 50 points. At 24 months, the mean in the web-based group was only 12.9 points lower than the treatment-as-usual group–and that finding was not statistically significant.

Does Mahana actually interpret these reported results for symptoms severity as  “substantial”? And “durable,” as was also claimed in the press release?

In addition, the published results only apply when the web-based program is used as it was in the trial–that is, supplemented by some hours of telephone-delivered guidance and support from a therapist. Does the Mahana licensing deal envision that patients who receive access to Regul8 will also receive telephone-delivered guidance and support from a therapist?

If not, can you explain why you believe the published findings are fully relevant?

Thanks. I look forward to your response.

Best–David

David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley