Trial By Error: CBT and Irritable Bowel Syndrome

FMMM1 said:
@Trish @Andy anyone got contacts in the APPG on ME? I just wonder if someone can suggest to a friendly MPs that they "report ---suggest---" that the Public Accounts Committee investigates this whole debacle and the role it played in formulating government policy.

I haven't read @rvallee post carefully but for some reason I recall a defence presented in court (by the defendant!) that they couldn't benefit from their own wrongdoing. With "good" legal advice these guys can come up with some strange defences. So these folks took £5 million in public money now they can't be scrutinised since what they did is covered by "commercial in confidence". As rvallee states Universities aren't generally considered as "commerce" quite an "own up" by these guys.

Has the freedom of information commissioner made any progress -- is that where the defence of commercial in confidence came in?

Possibly ask for the £5 million in public money --- if they are not prepared to provide information reasonably required in relation to the contract. Also, possibly if there's a threat to bar them from further contracts, because of their failure to provide information --- then they'll see the economic bigger picture! I guess this university has benefited from further government projects of this nature since then --- so they have something to lose!
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Can anyone remember the name of the person who lives in Carol Monaghan’s constituency? Carol would be an excellent person to raise this question with Public Accounts Committee.

perhaps even @EspeMor could mention this question to Carol M at the next Forward
-ME or APPG ‘meeting’ please?
 
As the world continues to wrestle with the coronavirus epidemic, President Trump is calling on us here in the US to get back to work. So I decided to start seeking answers again from Mahana Therapeutics, which announced in January that it had licensed a web-based cognitive behavior therapy program for irritable bowel syndrome from King’s College London.

According to the results of the major study that road-tested the program, the benefits in symptom severity at 12 months over treatment-as-usual were statistically significant but clinically insignificant, and at 24 months they were neither statistically nor clinically significant. In other word, the web-based program proved to be pretty much of a dud. Yet Mahana falsely promoted these results as “dramatic” and “potentially game-changing” on its website.

Apparently, those words have recently been removed–at least, I didn’t see them this morning when I checked the Mahana website. That’s a positive step. Yet the website continues to include misleading statements. This morning, I sent Robert Paull, Mahana’s CEO and co-founder, the following letter.
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https://www.virology.ws/2020/04/15/trial-by-error-revisiting-mahana-and-irritable-bowel-syndrome/
 
Trial By Error: A Follow-Up to the Follow-Up Letter to Mahana

On the Mahana Therapeutics website, Robert Paull, the CEO and co-founder, explains in a statement that his personal interest in developing treatments for GI problems arose out of the longtime suffering of a family member. His account is heartfelt and compelling.

Unfortunately, Mr Paull and his company have placed their bets on the wrong horse. I am hard-pressed to understand this deal with King’s College London except as a failure of due diligence. Mahana now has the rights to a product that cannot honestly be marketed as a proven effective treatment for reducing symptom severity in patients suffering from irritable bowel syndrome.

Mr Paull likely has no idea why I have latched onto this issue and have no plans to let go. I thought it might be helpful to explain the context to him. So this morning I sent the following letter.
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https://www.virology.ws/2020/04/18/trial-by-error-a-follow-up-to-the-follow-up-letter-to-mahana/
 
Trial By Error: More on the Mahana Mess…
Today I sent a third letter to Dr Mel Heyman, a prominent gastroenterologist at the University of California, San Francisco. Dr Heyman is one of Mahana Therapeutics’ science advisers. I’ve been trying to understand why the company decided to license a web-based cognitive behavior therapy program for irritable bowel syndrome. After all, a major study documented that the program did not produce clinically significant benefits in symptom severity over treatment-as-usual.

As I have previously noted, Mahana has implicitly acknowledged my criticisms by removing its laughable description of the symptom severity reductions as “dramatic” and “potentially game-changing.” But marketing strategy isn’t the problem if a program doesn’t perform as promised. At this point, Mahana’s science advisers need to make it clear whether they believe this program has clinically significant benefits in reducing symptom severity or not.
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https://www.virology.ws/2020/04/25/trial-by-error-more-on-the-mahana-mess/
 
I'm wondering if economics isn't starting to play a significant role here. That the efforts to license some of this work comes because the entire premise of the BPS model is to save money, which it systematically fails at by spending resources that actually amplify the losses, and some people who have been sponsoring this are starting to demand that some of the promised savings actually make it back in some form, whatever form.

Whether in its official form within IAPT or as commercial programs, the entire premise of this approach is that it is cost-effective, that although it provides no medical benefits, at least it promises to lower total health care expenses, despite the calculations being pure fantasy of course. So far it's been nothing but expenses and zero benefits. The expenses may be rather small but this is starting to become problematic with the IAPT expansion, the numbers start adding up very quickly at this scale, and anyway given enough time even small expenses add up to quite a lot. We are 3 decades into this and at some point empty promises start to wear thin.

There is basically no justification for this licensing deal in any way that relates to health care. It is not and has nothing to do with providing health benefits to anyone. It seems to be a stop-gap attempt at showing there can be some returns on investment, a promise that has wildly over-promised while delivering absolutely nothing but failure.
 
Back in February, I wrote to some science advisers to Mahana Therapeutics to alert them to the company’s unjustified claims about the impact of its web-based program on the symptoms of irritable bowel syndrome. Two of them–Dr Peter Lu and Dr Carlo di Lorenzo–are gastroenterology specialists at Nationwide Children’s Hospital in Columbus, Ohio, a renowned medical center. I did not hear back.

Given the coronavirus situation, I have refrained from continuing to pursue this matter for the last two months. During that same period, Mahana has continued to misrepresent the web-based program on its site. The company presumably still hopes this program will pass muster with regulatory officials in the US and the UK. Perhaps Mahana believes health agencies will not notice that the reported benefits for the program over treatment-as-usual in reducing symptom severity cannot accurately be defined as clinically significant.
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https://www.virology.ws/2020/04/28/...-nudge-to-mahanas-gasteroenterology-advisers/
 
chrisb said:
Is the silence to be expected
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It's a product, they want to churn it out and make money. That's their focus, and where they see their time and energy best spent. As long as politicians and businesses can get their hands on a "study" that meets the evidential standard of "barely plausible", that's the science box checked, they've got what they wanted from science to wave around and now it's time to make money / implement a policy. They've done all the science they need and they're not going to revisit it, they've moved on to sales and marketing now. They don't have time for some bloke on the internet harassing them about science at this stage. Please, they are trying to run a business.
 
dave30th said:
I don't expect to hear from anyone. But I think it puts them on notice that they will likely have problems marketing this in the way they think they want to, if they manage to get through approval processes.
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Even if there is no response, there's no longer any deniability either. There's a nice public record of them being told quite clearly that their claims are misleading and why.

If people are harmed by this in future, even if by having their correct diagnosis delayed, then the company may well be implicated. They were warned, publicly.
 
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