Trial by Error: FDA Approves Web-CBT for IBS; GET/CBT as Tomorrow’s “Rubbish”

By David Tuller, DrPH

Mahana set to announce FDA approval for ineffective IBS program

Earlier this year, I spent a lot of time blogging about the unethical and dishonest manner in which a San Francisco start-up called Mahana Therapeutics was promoting an eight-week web-based program of cognitive behavior therapy for patients suffering from irritable bowel syndrome. The company had recently licensed this product from King’s College London and was seeking marketing approval in the US and the UK.

I wrote multiple letters to company officials and medical advisers as well as key investigators to express my dismay about the way the findings were being hyped and thoroughly misrepresented. No one ever answered.

The web-based program was road-tested in a major trial with more than 500 participants. Unfortunately for the investigators, the trial essentially demonstrated the program’s ineffectiveness. To begin with, the trial was an unblinded study relying on self-reported outcomes—a design highly prone to major bias even under the best of circumstances. Just as important, the findings for the web-based program were unpromising.

All participants received standard care. At the primary end-point of 12 months, those who also used the web-based program reported statistically significant but clinically insignificant reductions in symptom severity over those who received standard care alone. At 24 months, there were no statistically or clinically significant benefits of the intervention. (The trial included a third arm receiving telephone-based CBT that reported moderately better results. Yet Mahana is marketing the web-based version.)

The trial was led by two leading lights of the biopsychosocial ideological brigades–Professor Trudie “Back-to-Normal” Chalder and Professor Rona Moss-Morris, both from KCL. KCL spun the findings as a success–despite the trial’s failure to demonstrate that the web-based program produced clinically significant improvements in symptom severity.

On Friday, Matthew Holt, an IT expert in the San Francisco Bay Area, revealed via tweet that the US Food and Drug Administration has approved the web-based program and that an announcement from Mahana is forthcoming. Holt, a self-described “health care curmudgeon” who seems to object to banal and/or useless digital programs that sell themselves as “therapeutics,” highlighted my Virology Blog posts busting Mahana in his Twitter thread.

Once Mahana makes its official announcement public, I will likely have more to say—and more letters to write. Given the web-based program’s lack of documented clinically significant benefits in reducing symptom severity, this marketing effort sure smells like a scam.

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Today’s GET/CBT as tomorrow’s rubbish

The British Journal of General Practice is produced by the Royal College* of General Practitioners [*Correction: I originally wrote “Royal Society of General Practitioners”] and is read by, well, general practitioners in the UK and beyond. The journal, like many, also has a running blog, and a November 25th post carries the following headline: “Today’s Best Practice Will be Rubbished Tomorrow.”

The author of the article, Charles Todd, qualified as a GP in 1981. He writes of his own experiences in discovering that long-held axioms in clinical practice—about how to treat middle-aged men having heart attacks and infants experiencing dehydration, for example–were in fact bunk. Todd then writes:

“There are numerous other examples of once best practice being quietly abandoned, often years after evidence of lack of effectiveness or harmfulness emerged. Bed rest for back pain and milk diets for peptic ulcer have all but disappeared. Antibiotic treatment for asymptomatic bacteriuria in older people and arthroscopic treatment of knee arthritis are hanging on…The voice of patients has been crucial in challenging the usefulness of graded exercise therapy and CBT in chronic fatigue syndrome, resulting in these being dropped as recommended treatments by NICE.”

Wow! Todd is placing GET and CBT for chronic fatigue syndrome in the same category as his other targets–as onetime “best practice” that has now been “rubbished.” I am not surprised by his conclusion, of course. He appears to be a perceptive observer of medical trends. When open-minded experts not associated with certain Russell Group psychiatry/psychology departments review the evidence base, they recognize that these interventions are ineffective and should in fact be “rubbished.” The removal of the recommendations from the recently released draft represents the NICE committee’s repudiation of the arguments and theoretical ruminations of investigators clinging to past glories.

What does surprise me a bit is that, a mere two weeks after the NICE draft was issued, a leading news organ for Britain’s general practitioners is pointing out in such explicit terms that the paradigm so fiercely defended for years by Professor Sir Simon Wessely and associated grandees has now been relegated to history’s trash can–or is about to be. This cabal has long wielded undeserved hegemony over this field, publishing flawed studies and heralding the uninterpretable results as “evidence-based.” All in all, it’s a shoddy tale, and some enterprising UK journalists should take a deep dive into the muck.

One cautionary note: We don’t know if or how the final version of the NICE guidelines, to be released in April, might differ from the current draft. We can only hope that voices of reason and science hold firm against the behind-the-scenes onslaught inevitably being waged by those who have the most to lose.  

Comments on this entry are closed.

  • CT 7 December 2020, 2:54 am

    Trust works both ways. The powers that be and the regulators need to understand that and not leave patients suffering for decades while they cover their ears, dismiss patient concerns and take no action. Better still, they should scrutinize the evidence and anticipate and evaluate the risks properly and openly in the first place and then listen intently to, and speedily act on, what patients feed back. Then we may trust them more.

  • jimells 7 December 2020, 9:30 am

    FDA Approval = Freedom to Damage Anybody

    Just one more entry in a long list of corrupt FDA decisions. No laws were violated, of course. Envelopes of cash kickbacks are so last century; there are much better ways to engage in mutual back-scratching these days.

    Parasites like Mahana have killed the host. The “Greed Is Good” philosophy is reaching its inevitable and very ugly end. The US has openly given up trying to control the virus while Mahana is counting on an endless river of Long Covid sufferers with gut problems to turn all the Mahana owners into billionaires.

  • Ian Hodgson PhD 8 December 2020, 1:36 am

    “We also explored outcome variations between individual therapists. More specifically, we determined if variation in treatment outcome of stepped care could be explained by therapists’ attitudes toward manualized treatment of CFS and the use of eHealth.”

    Internet-Based Cognitive Behavioral Therapy for Chronic Fatigue Syndrome Integrated in Routine Clinical Care: Implementation Study
    J Med Internet Res. 2019 Oct; 21(10): e14037.

    There is always a way out – more research needed, perpetuates the myths.

    Therapists who “believe” get better results, this is the hallmark of CBT for ME. I would think that therapists who are Cons get better results. You always have to find a way of explaining those heightened fatigue episodes which just require more dedicated focus of both therapist and patient. Keep going, you are doing well, you will get there.