Your life in their hands

An expression often applied to surgery, but physicians playing God is equally relevant to manipulation by mental health practitioners. Except that it’s Quality of Life that’s at stake. Institutions once committed difficult persons, but today medicating provides that confinement. Mostly beneficial in mental illness, mostly harmful otherwise.

So drawing the line for treatment carries grave responsibility. Complaints of this example of insitutional malpractice I detail here have however, been dismissed by  all governance authorities. In concluding that “Mental health is associated with changes in foot pain. Clinicians dealing with this population should consider the contribution of mental health in their management and treatment of foot pain” the connection is made – unless pain improves, it’s psych. The final page emphasizes the viewpoint, “the results from this current study suggest that foot pain could be related to mental health in the same manner as other chronic musculoskeletal conditions“. *
Except that the author’s data shows no significant association.
The report linked contains an untruth. Table 1 shows that mental health isn’t the factor – but rather it’s Vitality , or energy, which is determinant of recovery. The difference of 12 points equates to an increased likelihood of inability to work due to fatigue of over 60%, according to one validation of the SF-36 (Quality of Life) Vitality scale. Limitations of a self-report survey in judging someone to be suffering mental illness aside, this is a fabricated conclusion. And one which suits the purposes of the Professors in their subsequent trial of an anti-depressant in treating arthritis. This is no maverick opinion – Anita Wluka is musculoskeletal editor for BioMedCentral, and her department hosts the musculoskeletal group for the Cochrane Collaboration. It’s not a typo, else the ‘corresponding’ author would acknowledge the error. Nor did the editor of Arthritis Care & Research care to reply, indeed there appears to be no integrity underpinning the evidence base used by every doctor. The university ethics committee overseeing the study answered my challenge but only after four months had lapsed and I’d been suspended by the Dean, for causing distress to these academics by my complaints. Designated integrity advisor Prof Stephen Holdsworth hasn’t responded.

The misconduct isn’t confined to Monash either, Melbourne University obesity expert Joey ‘Mr Big’ Proietto contributed to the study, so their ethics committee was questioned. The only response was: “Due to the [Business Improvement Program] restructure which resulted in this office losing staff we are unable to reply to your request immediately. We will endeavour to respond as soon as possible. Thank you for your understanding“.

 The study was jointly funded by National Health and Medical Research Council and the Royal Aust College of Physicians. NHMRC Director of Grants Saraid Billiards isn’t fussed by misconduct within her alma mater: “we would anticipate that the institution would manage the allegation of research misconduct in accordance with Part B of the Code “. Rheumatology Assigner Academy and coincidentally co-author Prof Flavia Cicuttini could have taken this handpass, but perhaps too busy allocating funds and simultaneously consuming same? RACP “… has rigorous application, review and reporting procedures to ensure a fair and equitable process. …. but the College does not enter into correspondence regarding its decisions.”, according to research manager Laina De Winne. Spokesperson for federal Treasurer Hockey is concerned at budgetary drain, but “As this matter falls directly into the portfolio responsibilities of the Minister for Health the Hon Sussan Ley, Mr Hockey has asked me to refer this matter through to the Minister for her attention.” Joe’s been sent offshore, as our Govt does with many other children of refugees. Office of shadow Health Minister Cath King informs me that the complaint system is working: “Should you wish to pursue your concerns relating to potential conflicts of interest in the grants application process for NHMRC funding, I would encourage you to raise them with NHMRC directly .”

Evidence-based medicine Prof Paul Glasziou is overwhelmed by the extent of fraud: “Good luck with pursuing this. As I now focus on NON-drug interventions and the overall waste in research processes, I no longer get involved in individual problems in drugs research (as that would consume 10,000% of my time!)“. Adjunct Prof Ken Harvey of Medreach agrees, “As Paul Glasziou noted, it is difficult for those of us concerned about such matters to take up every case. The same, regrettably, applies to NH&MRC and University research and governance bodies although you certainly deserve a reply.” He suggested writing to the publishing journal editor, something attempted thrice without response. “Oh dear“, said Ken.

Members of the team are now collaborating with Mandana Nikpour and Andrew Tonkin on a trial of atorvastatin for arthritis, OAKS. Lipitor remains the world’s highest grossing drug on record, and Pfizer quite generous in granting early career kickstarts of $50-55,000. Mandy’s shy regarding her CardioVascularLipids grant, since it’s not declared in an article with Prof Rachelle Buchbinder ‘Should patients with systemic sclerosis-related pulmonary arterial hypertension be anticoagulated?’ (Internal Medicine Jnl of May 2013 ) even though Pfizer’s apixaban is suggested and a favourable result from her registered trial ACTRN12614000418673 will boost sales of their Eliquis. Again as with pregabalin/Lyrica trial PRECISE, NHMRC sponsored.

Arguably harmful except in the population who’ve already had a heart attack or angina, statins have one certain side effect. Fatigue. Which perpetuates the arthritic pain cycle, but Anita wasn’t going to tell you that. Pharmacology and rheumatology are bedfellows who’re profitable partners.

* Copyright © 2014 by the American College of Rheumatology


Fibromyalgia appears destined to remain the elephant in the room if this month’s Rheumatology edition of Australian Family Physician is anything to go by – not a mention of it. So what do healthcare specialists offer? In 2006 Drs Littlejohn and Guymer published, through their work as Monash Director of Rheumatology and trainee respectively “Fibromyalgia Syndrome: Which Antidepressant Drug Should We Choose”. Linking their Medical Centre with the University seems a worthy approach so as to redress physician misconceptions  – indeed, shortly thereafter the Journal of Clinical Rheumatology published a survey of Southeast Asian rheumatologists. 87% of them believed fibromyalgia incorporated aspects of psychological illness and only 40% of those associated with an institution reported inclusion of FM in their undergraduate training.

Dr Littlejohn then contributed to the 2009 yearlong study on effectiveness of duloxetine/Cymbalta led by Eli-Lilly employee Amy Chappell, which was discredited by exclusion on quality grounds from the independent Cochrane musculoskeletal group’s systematic review of studies on SNRIs . Their supposedly * impartial conclusion drawing upon another five, unbiased assessments was that 10% more people reported significantly reduced pain with duloxetine than those duped by a placebo, however another 9% discontinued treatment due to side-effects. Withdrawal in itself is harmful, the US FDA has published a safety advisory for Cymbalta Discontinuance Syndrome. Agreements posted in 32,000 blogs are somewhat alarming! Any benefits obtained are ‘figure-atively’ outweighed by weightgain reducing propensity to exercise, consensus being that moderate exercise is beneficial for fibro.

2009 was a bad year for pharma. Eli-Lilly pleaded guilty to illegal marketing of anti-psychotic drug Zalprexa for off-label use, and was fined $1.4bn. A recent out-of-court settlement was made with the family of a boy who suicided whilst on Cymbalta, whose claim being that another suicide during drug trials should have prompted warnings.  And Pfizer paid a record $2.3bn for fraudulent marketing of painkillers, including Lyrica. Nonetheless these two medications remain highly profitable with an estimated $18bn in sales in 2012…. which trivialises the settlement for $43m with US attorneys generals that year for once again marketing Lyrica other than for an approved purpose. With such monetary power, when federal NHMRC funding was approved for only 17% of applications for 2014 is it any wonder that Littlejohn and Guymer are reliant on consultancy fees paid by  Eli-Lilly and Pfizer declared (inconsistently*) under their conflicts of interest? “The medical profession—in the US, Europe, and beyond—remains heavily reliant on industry funded continual medical education, and many doctors have accepted substantial hospitality and consultancy fees. Very few have been prosecuted. Disclosure remains patchy and inconsistent. Yet it is their decisions that ultimately determine if medicines are reaching patients for whom they are not suitable. If drug companies need to change their attitude, so do prescribers“. Andrew Jack, Financial Times correspondent writing in the BMJ July 2012.

Evidence update: Two books elaborate these concerns from a practitioner’s perspective. Dr Ben Goldacre’s ‘Bad Pharma’ and leader of the Nordic Cochrane Centre, Prof Peter Gøtzsche’s ‘Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare’. Peter’s alarmist chapter title: ‘Very few patients benefit from the drugs they take’  explains that “… apart from such scientific misconduct, insufficient blinding can also make us believe that ineffective drugs are effective.” In damning the exalted gold-standard comparison – the randomised control trial, he warns of assessor bias if they’re aware to whom they gave placebo. To give weight to this claim that doctors lie, his colleague Asbjørn Hróbjartsson is cited … the effect was exaggerated by 36% when evaluated by nonblinded observers. Wow, this Cochrane review ‘Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors.’ needs a read. Ooops, the title omits the keyword ‘subjective’, and 71% of the studies were surgery or the like. cochraneFigure 1 meta-analysis shows that two weighty transmyocardial laser revascularisation outcome reports by Oesterle et al and Burkhoff et al dragged the conclusion from one of no significant difference to a non-blinded bias Odds Ratio of 0.64! So, if you ask F.I.G.J.A.M. whether they THINK the patient’s angina has improved recently, there’s a leaning towards affirmation if they’re aware that surgery has been done? Cardiologists genuinely believing that their interventions are beneficial can hardly be extrapolated to mandating that all trials must be blinded in order to avoid falsification of data, but that’s what’s happened. Peter’s Mentalaz speaking tour claimed that all anti-depressants were ineffective – arguing that severe side-effects results in unblinding. And the effect size was typically <36%, whereby he proves all benefit of the med resulted from bias! And these are the watchdogs? When Cochrane’s doctors stretch the truth about the 36% shift in truth by other research doctors, they’re all damned.
 infinityCochrane pioneers Gotzsche and Chalmers are much alike in their evidence fudging. The Handbook warns  that sneaky research doctors will try to break the blind and fudge the facts. The last para of ‘Rationale for concern about bias’ cites a study by Schultz, Altman, and Sir Iain Chalmers et al in Feb 1995 JAMA. Just one review, covering studies particular to pregnancy & childbirth actually contradicts their own argument: “Trials with inadequate sequence generation yielded estimates of treatment effects that were similar to those derived from trials with adequate sequence generation, after adjusting for the other three methodological dimensions”. But on pg410 a subgroup analysis limited to those trials reporting adequate allocate concealment only managed to find a statistically insignificant p=0.07 (ie close, but no cigar) exaggeration in effect size as a result of poor sequence generation.

This cracks me up. That’s a negative outcome elsewhere than the Cochrane Collaboration, and it relied upon data dredging to obtain a semi-significant conclusion. But it underpins one of their criteria for downgrade of all studies – sanctimonious dogma used thereafter in box-ticking exercises, which actually detracts from quality analysis of evidence trustworthiness. This recalls the classical Ouroboros, the snake eating itself – as a symbol of perpetuation.
*Aust Family Physician Oct 2013: “Competing interests: None”

<Jan 2016 update: an Austrian survey found 89% of GPs would refer fibromyalgia to a rheumatologist, but only 12% of those wanted to treat the patient. With great neuro research nearby by Uçeyler, Sommer & Hauser you’d hope for more than just a handpass: >