I’ve flashed back to the 80s, when jokes could be made about mass shootings, which is also a terribly long stretch from the actual theme. The PROM under consideration is the Patient Reported Outcome Measure, which divests control of medical studies from institutions and doctors – and gives it to the community.
History backtrack: after the WW2 Nuremberg trials, and other human rights violations in the name of research, a number of principles were established ~’81 including mandatory oversight by a Human Research Ethics Committee (called an Institutional Review Board in the US). Atrocities became a rare event, but governance was still lacking. Drug studies with displeasing outcomes were buried, and exclusively positive results biased efficacy reports in favour of the pills. A 2-pronged approach was advocated by AllTrials among others, first being registration of every trial upfront and second being reporting of all these publicly visible studies. The former worked since journal editors were in accord that unregistered trial’s reports would never be published. Reporting of negative outcomes remains problematic however, having half the likelihood of being published than a positive outcome has. And when the pre-eminent BMJ charges authors £2000 to publish, why would you continue to spend on the failures? *

It’s also expensive to run long term real-world studies (phase IV), when TGA/FDA approval only requires short term results from a ph III study, and subsequent investigations of the market such as by Australia’s Drug Utilisation Sub-Committee are quite inconsequential. Lyrica is the only drug in the top20 by expenditure which has no treatment effect other than symptom masking. Its promotion has put prescription rates far ahead of market projections, but reviews don’t consider what health benefit is being achieved.

In the US health insurers are driven by commercial imperative to recover monies wasted on meds marketed on the basis of deceptive trials. Eli-Lilly paid out $1.2bn in ’06 and $1.4bn in ’09 for inappropriate promotion of antipsychotic Zyprexa. Yet consumer litigation against Eli-Lilly’s antidepressant Cymbalta failed, despite prevalence of harm being indicated by eleven and a half thousand members joining FB group ‘Cymbalta Hurts Worse’.

I’ve written on this matter previously. Over 600,000 thousand subscribers to PatientsLikeMe.com (PLM) are now ‘donating their data towards a cure’, to use their recruiting hook. Clearly this is most applicable to diseases of uncertain etiology, eg participating fibromyalgia sufferers have grown from 20 to 96 thousand in the past few years. That five-fold increase surpasses the 50% increase in total PLM subscribers over the same period, reflecting this syndrome’s perplexing of established medicine’s oracles. The intent of PLM is to find those in a similar situation and share your successes or seek their support. Such power in numbers also encompasses pathology results, wellbeing scores, medication regimes, BMI, personal factors eg stress… but unless you’d care to test ethical waters by typing individual records into a statistical processor, the interface given to the public doesn’t allow queries such as meds vs outcomes – it previously did, until I sent a memo to management thanking them for their database. Sorry 😦 This is a business, and those insights are sold to industry. But the current patient-centric mantra popular with Health Depts eg Safer Care Victoria raises interest in the worth to the consumer of their treatments, hence initiating tracking via PROM. Monash have been early adopters, but the collection guidelines aren’t yet available. Interested product vendor ePROM/OceanEHR integrates outcome collection with myHealthRecord portability, which is an unmitigated IT disaster largely due to its being a challenge to a clinic’s jealous guarding of your medical records.

‘Patient Reported Outcome Measures in Rheumatic Diseases’, 2016 edited by Yasser El Miedany has a chapter on survey instruments for fibromyalgia that may be useful to researchers. But no mention of community forums such as PLM. OMERACT (Outcome Measures in Rheumatology) is a biennial conference, upcoming in NSW from 14th May ’18. It has 14 pharmaceutical companies for sponsors. Again, there’s no consideration of community, and focus is wholly on identifying symptoms for patient classification. Disengagement with chronic illness sufferers is increasing, so continued disinterest in the huge patient support groups is foolishness.

* The Journal of Negative Results ceased publication in Sept 2017, claiming that their mission of reform was successful. Meanwhile a journal for negative results, Null Hypothesis is being launched. The truth is out there, somewhere.