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 Kingâ€™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 outcomesâ€”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 â€œBack-to-Normalâ€ 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 â€œhealth care curmudgeonâ€ who seems to object to banal and/or useless digital programs that sell themselves as â€œtherapeutics,â€ highlighted my Virology Blog posts busting Mahana in his Twitter thread.
Once Mahana makes its official announcement public, I will likely have more to sayâ€”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.
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: â€œTodayâ€™s Best Practice Will be Rubbished Tomorrow.â€
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 practiceâ€”about how to treat middle-aged men having heart attacks and infants experiencing dehydration, for example–were in fact bunk. Todd then writes:
â€œThere 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 onâ€¦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.â€
Wow! Todd is placing GET and CBT for chronic fatigue syndrome in the same category as his other targets–as onetime â€œbest practiceâ€ that has now been â€œrubbished.â€ 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 â€œrubbished.â€ The removal of the recommendations from the recently released draft represents the NICE committeeâ€™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 Britainâ€™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 historyâ€™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 â€œevidence-based.” All in all, itâ€™s a shoddy tale, and some enterprising UK journalists should take a deep dive into the muck.
One cautionary note: We donâ€™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.