Bad Medicine (Pt3)

What does (S)-3-(aminomethyl)-5-methylhexanoic acid do for you? That depends on whether you’re a doctor prescribing Lyrica, a pharmaceutical company making pregabalin, or a patient:

Stop the drug, swelling goes.  © Canadian Medical Ass’n


It’s four years since my last incredulous post on the alliance between researchers and Pfizer, a collusion formalized in business collaboration at Monash University in Jun ’17. This revisit begins with the TGA (equiv to US FDA) Product Info for health professionals on Lyrica/pregabalin as of Sept ’16. The first condition of painful Diabetic Neuropathy (PDN) lists 5 completed studies in Table 1, showing pain was halved for ~26% of those administered 150mg, and ~45% if on 600mg. This would encourage doctors to increase dosage up to the maximal 600mg daily (double that allowed in the US). The most frequently reported side-effects are weight gain, dizziness and sleepiness. The manufacturer has checked on driver safety, but research simply doesn’t encompass a thought that harms should be measured systematically: Prof Nadine Attal replied to my concern with “I agree… because the methods used to assess side effects are seldom standardized, particularly as regards cognitive effects of drugs“. This is an obvious pharmacovigilance problem, but another risk lurks. Pg13 of the TGA brochure informs doctors that less than 4% of trial participants suffered peripheral oedema (pictured). None of their advice is referenced, so let’s fact-check.

Peripheral Oedema/swelling

Pfizer reported in ‘A Comprehensive Drug Safety Evaluation of Pregabalin in Peripheral Neuropathic Pain’ that they’d run 13 Randomised Controlled Trials of Lyrica for PDN up to May ’12. Somewhat surprising that the TGA only found 6, which also included independent investigations. Oedema was reported in 9% of neuropathy patients. The manufacturer paints a harms picture that’s doubly worse  than the govt regulator does! One Pfizer trial continued for another year with volunteers, of whom 16% reported oedema (10% resolved inside 2 months). Oedema is associated with congestive heart failure, so it matters. And the worsened circulation is associated with non-healing ulcers in diabetics, and that can lead to amputation. Wondering what have you got to lose by starting with this drug – a foot, perhaps? Regardless of adverse events/side-effects, stopping the drug resolves that issue – but at the end of any study there’s limited data captured on withdrawal effects.


Enriched Enrollment Randomised Withdrawal is a legitimate study design, whereby everyone is dosed and only responders continue into the trial. If it didn’t work for you, goodbye. This means that the group randomized to placebo go through withdrawals, and Pfizer ran this protocol thrice (twice including DPN). After an avg of 400mg daily for a month, then 150mg for one week tapering, pain was marginally worse in the placebo group after a month. 2.5% of the Lyrica group withdrew due to adverse events compared with 6.5% of the placebo arm, hinting at withdrawals suffering. The same protocol with backpain participants finished with both groups reporting the same level of pain, although the withdrawal arm experienced worsening sooner. The endpoint is in accord with the PRECISE study’s finding that Lyrica doesn’t work for backpain.

A lengthier and larger study was run, but this time concomitant meds other than paracetamol were disallowed. Previously patients had continued their own opioids or gabapentin (a Lyrica predecessor), but now the effect of withdrawal was pronounced – some 2 months of worsened pain. Interestingly this study team included Dr Cory Toth *, who’s had 9 papers retracted due to fabricated results. The team then ran a study without Toth, which showed no benefit whatsoever for Lyrica in PDN.


Placebo group suffering withdrawals from run-in period

Another protocol requiring drug withdrawal is the crossover design. This study on pre-diabetic neuropathy , again funded by Pfizer, shows a pain spike lasting just 1 week upon switching from drug to placebo.

© 2016 Wolters Kluwer

Another PDN crossover study is intriguing – worse withdrawals were suffered going from placebo onto pregabalin in the first week, altho’ actual withdrawals from the drug lasted 3 weeks. Again, the outcome was of a nearly worthless drug, but it’d seem that the fear of losing relief from pain (even if just an imaginary benefit) caused hurtful anguish.

© 2015 Wolters Kluwer

An independent review aggregated 15 trials up until Mar ’16 and concluded …”an overall small effect size with significant heterogeneity in the findings. Reporting bias was a particular concern, due to the high number of unpublished studies.” The 5 TGA examples chosen were an obvious cherrypick of the best results from the picture, being Refs: 17, 18, 19, 21, and 22. It seems that the benefit is arguably small, and data on withdrawals is limited. A recent review on Lyrica’s abuse potential coincides with transfer to Class C schedule in the UK underway, informed by little more than frequent discovery in prisons. Public forums are informative: this group, including recreational users, has a couple of hundred user comments… ** Surprisingly, a ‘comprehensive’ report in Oct ’17 came up with only 4 reported cases of withdrawal symptoms ever, where usage had been within therapeutic guidelines. The gulf of understanding between medicine and its recipients widens.

Although not the decision makers, patients were treated to $USD344m of Lyrica TV advertising in 2016 (per Nielsen). Half of which was promoting use in diabetic pain. Small comfort can be found in Pfizer’s report that glycaemic control is only fractionally worsened. I do not feel the need to examine every condition for which Lyrica is approved – one instance of systemic failure suffices. For more on the politics of pain, read on…. Geoff Kirwood GDip Clin Research

* Cory apologized, but whether he was ‘sincerely’ sorry is questionable (Confidence Interval bounds not given): “I am significantly apologetic”. His resignation isn’t mentioned on the faculty page, and vice-dean MacQueen accepted his declared failure to oversee his 9 instances of data manipulation. She consults to Pfizer. Scott Reuben went to jail for fraud in 21 papers, which must exceed the threshold of acceptable levels of mistakes. Colleagues Buvanendran and Kroin on Reuben’s retracted pregabalin study went on to publish a favourable study on pregabalin. Paid for by Pfizer.  However it doesn’t taint the evidence base, oh no, no, no.

** Bluelight  is dedicated to drug harm reduction, and is named after the flame of crystal meth.



Out of control at the PROM

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.

Covington has since taken down their gloating, boastful article

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 (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.

HealThy Self

Both the happiness that I strive for, and the suffering that I wish to be free of, are results. Recognizing that, one seeks out the causes that lead to these results: to well-being, or to grief and suffering. HH the Dalai Lama ’97.

Three years ago this blog kicked off with a rationale to ‘Fight’. Exploitation of the vulnerable, chronically ill as stable generators of revenue by Pfarma led to further posts exposing many of the tricks played within medical research. The worst example being a university assignment to investigate SmART which highlighted thousands of lives were deliberately put at risk and dozens were killed. “Shouldn’t we tell an authority?” Replied Prof Rory Wolfe: “Happens all the time“. I’m loathe to shatter the hopes of those trusting in drugs and their peddlers, but our understanding of the molecular basis of autoimmunology is barely embryonic. Pills have approval based upon short-term feedback, so “results may vary” because our knowledge of the body’s adaption to this newly created chemical imbalance is mostly guesswork. That’s paraphrasing Prof Eric Morand, head of rheumatology translational (from lab to patient) research at Monash. Prof David Healy describes medical kidnapping at his site
by well-intentioned physicians, who’re unfortunately stuck with a corrupted evidence base. Offering addictive, longterm palliative relief whilst waiting on the big breakthrough … one that  would then impact upon research institution sponsor’s revenue stream. Sure, that’s going to happen  Cynical, yes. Honest? Judge for yourself. Even a notification that misconduct would be published openly to the scientific community wasn’t enough to warrant regulatory interest. Self-regulation within industry is a nonsense.

The fight within. External forces can be blamed for a situation, or salvation can be sought in a medication, a therapy, even prayerful belief in higher power. Paramedic turned documentary filmmaker Daniel McGuire interviewed several Balian, or shaman, supernatural doctors (including Ketut from ‘Eat, Pray, Love’). These healers are sought when Western medicine has failed them, providing what’s essentially psychotherapy.  “I am like a bridge.” says one, Mangku Pogog: “I span a region between sickness and health. But the patient has to walk across.”
This is a putting to use of the character strengths of self-regulation and bravery. Chronic sickness can be a comfort zone, writes Daniel, referencing Joseph Campbell on mythology as a means of tricking oneself onto the path to becoming well. Leave one identity as recipient of healthcare behind, to then courageously explore another, uncertain world. Believe more in yourself than that  faith placed in doctors or deity.

Balian doctor Ketut

Balian doctor Ketut

Negativity bias. You may know it as survival instinct. Defensively reacting out of self-protection. Competitive skills from the jungle don’t help in survival any more, not when the backstabbing of office politics is destroying your peace of mind. As well as your health. A new era in mind and body healing has begun, focused on positives. Not just optimistic, positive thinking. But starting from a realization that your weaknesses are less of a vulnerability in an evolved society, then means  it’s more fruitful to be dedicating focus onto strengths. Positive psychology develops the strength within – recognizing that ‘cover your arse’ is a sign of pathetic submission to a toxic culture. Reactive, fear-driven living stimulates the fight or flight adrenal axis and your body suffers. Forever. Self-defense, and even self-esteem (which relies on comparisons to others) are less helpful than self-worth, which values your positive attributes over perceived failings.

Nobody needs to know of further weaknesses in healthcare provision. There’s enough reasons already presented to start making changes in your thinking, so this blog will now quiesce in order to concentrate on solutions.

Taking the easy way out

If you torture the data long enough, it will confess…..Ronald Coase (economist)

Carole is backtracking from PostGrad qualifications in Coaching, to undertake an undergrad Psychology degree.  I’m overwhelmed by the depth of statistical expertise expected of her, and despite having a GradDip in Clinical Research I draw a blank on something called factor analysis. Psychologists doing investigations gather together factors which may be influential on the patient outcome, and search for interactions in the data. Medicine doesn’t do this. In fact post-hoc analyses are anathema. Data dredging – shame! The example often given is from 1988, in the Lancet, when studying the benefit of aspirin after a heart attack it was found that subgrouping by starsign significantly affected recovery. [Laughter 🙂 ]

Subgroups behaving badly

Subgroups behaving badly

Actually, this is worth thinking about. If you’ve been told since birth the behaviours expected from a Taurean, it’s quite possible you need additional counselling to subdue the inner beast. And not simply a different med dosage. But everyone except the doctors mines data nowadays. The social sciences statistical packages are being heavily adopted by business to glean profitability trends, most notably since IBM acquired SPSS.

All clinical trials have a single purpose, ie to test a hypothesis, even if multiple outcomes are considered and when multi-arm interventions (factors) are being tested (see Bonferroni). If the analysis isn’t declared upfront in the protocol, the ensuing report will be discredited by colleagues. Worthless even, since physicians’ distrust of their peer’s integrity leads to a presumption of bias – doing unethical selective analysis so as to claim ‘Eureka’ for something, anything! Earnest conferences churn out checklists for marking studies – GRADE, CONSORT, SPIRIT, PRACTIHC, STROBE, and even specialty specific guidelines such as PEDro (for Hispanic physiotherapists?). All seemingly ensuring transparency in the system, but somehow we’re forever growing the numbers of malcontents who claim that the regulatory oversight is broken.

Myself included. The problem arises from the cartel of institutional research, and I’ve written here often about our delusional confidence.  The investment in years to attain a medical qualification, followed by the personal sacrifice of a research-entitling doctorate  leaves medicos with little choice but to play the game. I don’t have evidence as to whether the psych’s datamining or the physician’s approach to test a hypothesis yields more fruit but am concerned that despite their claims to foster creativity, the universities stultify nonconformists as we make progress by degrees. Just getting funding is enough grounds to claim a breakthrough.

This month saw the publish of the ‘Handbook of Academic Integrity’, 72 chapters and starting price $USD400. To prove there’s no sanctimony on my part, here’s a sneaky free link to half a dozen chapters.

Shameless, actually

Shameless, actually

Everyone’s guilty of wrongdoing, sin is in our nature. Doing something even more wrong here:

Important: This article may arouse emotions including despair. If afflicted with intolerable, chronic pain then I suggest discussing these issues with your support network.

'No future', the anthem for fans of Johnny Rotten

‘No future’, the anthem for Johnny Rotten/John Lydon fans.

Fibromyalgia (FM) pioneer Prof Fred Wolfe looked up the endgame result for 8,000 fibromites and 10,000 osteoarthritis sufferers over a period of up to 35 years. Neither condition showed increased mortality overall, but for those 15 with FM who succumbed to suicide this risk was treble the national average.  His report is similar to one in Denmark reporting a six-fold increased risk, and not unlike the outcomes found from tracking registry CFIDS for Chronic Fatigue. Some insights can be found from a survey on symptoms of pain and Quality of Life which shows medical professionals failing to validate their illness to be the major determinant of poor subjective score.

Women’s Healthy Aging Project (WHAP) has tracked a cohort of 440 in Melbourne for 25 years to study disease impact on Quality Affected Life-Years. Although musculoskeletal has been included in scope (above the red line), requests for any available research rheumatologist to partake have been unfruitful.

Govt priorities

Aussie Govt priorities: cancer, heart, neuro, mental, lung, diabetes, injury, and lastly arthritic.

Leaving aside the prioritised ranking of #8 (a Dutch burden report puts it up at #1, and cancer as #8), this is remarkable since Monash homes the Cochrane evidence base for musculoskeletal. Their collation of clinical guidelines by 700 active health care professionals, researchers and consumer representatives is a task shared with Ottawa, however the Canadian Govt recently pulled funding to Tugwell’s team. Although this group claims to be inclusive of FM, there’s no reviews of treatment efficacy published. Those are instead posted on the Pain, Palliative, and Supportive Care (PaPaS) group site, where 16 interventions are evaluated. Repeat – there’s no consideration given to treating FM syndrome, but focus is wholly upon symptomatic pain relief. In perpetuity, which makes the FM meds market rather attractive and trial sponsorship good business sense.

A challenge was issued to PaPaS editorial manager Prof Andrew Moore re the inclusion of a Pfizer employee, Dawn Carroll, in a 2009 ‘independent’ review of Pfizer products Lyrica and Neurontin (considered as helpful: “For gabapentin and pregabalin only we found reasonably good second tier evidence for efficacy” in the latest version). His reply was thoughtful and extensive, particularly in regard to their recent policy decision to segregate FM from neuropathic pain. This decision isolating distinct conditions is at odds with our TGA & PBS approvals for Lyrica/pregabalin for neuralgia but not FM – despite being the most commonly prescribed treatment. Further insanity is shown in the single approved med for FM, the SNRI (anti-depressant) milnacipran not actually being distributed in Australia.

But I can’t help but be troubled by their letter to the BMJ dismissing Dr Des Spence’s criticism of Cymbalta (and he’s someone who’s also skeptical of Lyrica’s benefit). Prof Moore reveals that he’s paid as a consultant by Eli-Lilly, the manufacturer of Cymbalta. Examination of publications reveals that Robert A Moore is the same person – the moniker varies depending on whether writing as an independent or apologist for a drug company.

Hope comes from bold rheumatologists who offer scrip for Disease Modifying Anti-Rheumatic Drugs in FM, and patient communities who share their experiences. Over 100,000 fibromite subscribers to one site donate their data in hopes of cure or remission. 1.6% are on a DMARD (including the aggressive biological agents). There’s no formal trials ever run on these drugs suitability, this is instead totally circumventing a broken system. For other solutions, see here.

Changed thinking about the mind

In 1994 rheumatologist Elliot Pellman chaired the NFL’s council on Mild Traumatic Brain Injury (TBI – there is NO ‘Mild’ in this issue). “Concussions are part of the profession, an occupational risk,” … a football player is “like a steelworker who goes up 100 stories, or a soldier. Veterans clear more quickly than rookies…They can unscramble their brains a little faster, maybe because they’re not afraid after being dinged“.

“There’s going to be some controversy about you going back to play.”  Pellman personally sent a concussed Wayne Chrebet back onto the field soon after he had been knocked unconscious by a hit, reportedly telling him, “This is very important for your career.” Days later, Wayne is sluggish and his head aches. In 2005 Pellman et al published their seventh study in the official journal of the Congress of Neurosurgeons, concluding: “Return to play does not involve a significant risk of a second injury either in the same game or during the season.” And remember that the identities of the physician peers who reviewed and approved this nonsensical article are kept secret.

This may be perplexing to non-US residents. The opening of 2012 Southpark episode ‘Sarcastaball’ explains why taking a massive hit is a game tradition, using the naivete of kids.

0Forensic pathologist Dr Bennet Omalu’s investigations from 2002-’09 are documented in the book by Jeanne Marie Laskas, ‘Concussion’ (and now a Ridley Scott film). An outsider to medicine despite attaining eight degrees,  his strongly principled clash with the industry is a repeat of the tobacco deception. Right down to the NFL sharing the same law firm, Covington & Burling! US Congress questions were the turning point for transparency over subsequent years, and not the medicos. NFL boss Roger Goodell still thinks the concussion protocol just needs tweaking.

Self-regulation failed again.

It was only a month ago that the National Institutes of Neurological Disorders & Stroke, and of Biomedical Imaging & Bioengineering defined the ‘neuropathological criteria for the diagnosis of chronic traumatic encephalopathy‘ (CTE). Mostly unintelligible to layfolk, it’s nonetheless of sufficient importance to be published in a public journal. Like boxing, CTE is estimated in about a quarter of gridiron players, and is manifest in mental disturbances – but the tau tangles are invisible to imaging, until staining of brain slices post-mortem. Higher risk is posed to the spectrum of disease from Alzheimers to Parkinsons, and the month prior funds were allocated to research on diagnostic tests in the living. Although the NFL contributed nothing, the Players Union did. Professor Stern’s lab website is linked, and the urgency of guidelines for safer ages to start playing football fires discussion of their work, since the myelin sheath on neurons improves protection after the age of 14. Demyelination diseases include MS, so research implications go far beyond these elite professionals turning violent. Omalu also found CTE in a TBI war veteran who suicided, hence the penny has dropped regarding ‘Walking Wounded’.

I clashed with our Ski Patrol MO, then a Resident at Box Hill hospital, over management of a teenager who’d bounced off a tree. His mother’s concern was that the subdued manner was totally opposite to his usual bouncing off walls. A doctor trumps a paramedic, and I was chastised for trying to turn him into a victim. She sent them home, saying “Don’t worry about vomiting, he’s likely to be carsick“. Next day I rang the family – he slept for 21 hours.

How can this come to pass? I suspect the teaching in a medical degree that anything above the ears is the province of psych, must be addressed first. Holistic medicine is the only sensible way to treat.


‘The Strange Case of Dr Jekyll and Mr Hyde’ was an 1886 novel written to contrast public and private lives of a reputable gentleman. Duplicity is a constant failing, but often what’s revealed is just an iceberg’s tip above massive issues. Thanks to the only mandatory Pfarma reporting in Oz, Medicine Australia’s Education Events, we know that Pfizer spent an average of $12k on each of the 23 rheumatologists they recently sent to European and American conferences EULAR and ACR. The full reports give an insight into specialist’s lives outside the surgery, as $43.3m was spent on them in the 6 months to Sept 2015. Worse still in 2010 pharmaceutical companies reported $637m expenditure on research, but nobody knows who received the money *. There is monumental potential for conflict-of-interest as the scope of new-gen bio-agents increases (monoclonal antibody drugs, hereafter referred to as the  _mab drugs).

Tony Abbott recovers after finishing Pfarma-sponsored 'Pollie Pedal' in 2013

Tony Abbott recovers after finishing Pfarma-sponsored ‘Pollie Pedal’ in 2013

Amgen sponsored 799 events in the last 6 months. Focusing in more closely, we really can’t be sure just how safe is their anti-inflammatory _mab for arthritis, Enbrel. Regulatory authority TGA advises physicians under Adverse Effects: “In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life-threatening, or requiring hospitalisation or intravenous antibiotics) was observed“. Uhuhh.

Allegations it caused Eagles frontman Glenn Frey’s death due to pneumonia can’t be verified. In the latest EULAR journal ‘Annals of Rheumatic Diseases’ Winthrop & Smolen et al suggest it’s a good idea to track outcomes of _mabs. ‘Opportunistic infections and biologic therapies in immune-mediated inflammatory diseases’ reveals the shortcoming that “no consistent OI [Opportunistic Infection] definition was identified across [368] studies“. Hence a list of OIs was drawn up, topped by the pathogen responsible for pneumonia. The best evidence for their recommendations was the publicly accessible meta-analysis by Kourbeti, Ziakas, & Mylonakis which put the odds of infections 1.8 times higher for _mab recipients than controls (usually patients on frontline med, methotrexate)  in Rheumatoid Arthritis (RA) trials – a small but significant risk. But note that RA doubles that risk over healthy comparators already.

That’s short term though, a trial median of around 6 months for the drug to prove its worth. Aust Rheumatology Association’s Rachelle Buchbinder established the ARAD tracking database a decade ago to determine _mab safety. It’s paid for by Pfizer, BMS and AbbVie. The few reports published in journals thus far inform us of customer satisfaction such as subjective Quality of Life surveys, and that no increased risk of cancer occurs, and that herpes/shingles virus infection rates are 1.7 times higher. Specifically for Enbrel, this result came after a median of 3 years followup. So the longterm prognosis is much like the brief studies would indicate. A worsening, but hardly deadly. Glenn’s manager wisely declares he has taken legal advice to limit his accusation.

This drug inhibits TNF, a cytokine messenger that augments our innate immunity system. As understanding of the molecular basis of many diseases improves, an inflammatory aspect is a recurring theme. The prospects for treatment with anti-TNF therapy look promising, but for the fact that the body needs to be regulated by internal controls. And not shareholders, salesfolk, or Jekyll. Interestingly, a trial for Enbrel in Alzheimers found that TNF levels rose. Feedback systems are adaptive.

Future studies could well heed the EULAR belief that their “… list of infections should be considered potential indicators of alterations in host immunity, and that this list and the associated case definitions should be used to standardise reporting of OIs in future biologic and other disease modifying antirheumatic drug clinical trials“. It’d also be helpful if an outcome tracking registry reported on all OIs, instead of the trickle of data from ARAD. But unease over industry manipulation of research is fuelled by the doctors themselves. When a weakened version of the US Sunshine Act for disclosing contents of the unmarked envelope was being considered by the Aust Competition and Consumer Commission, the AMA submission sought a deferral: “A twelve month delay in implementing the ACCC’s condition would allow health practitioners to think about and plan for their ongoing relationships with pharmaceutical companies.”

Gap payments cover the weekender, the kid's schooling ....

Gap payments

EULAR 2016 is in London. The UK has an Office of Research Integrity, let’s hope some fresher ideas than creative accounting are brought home.

* Source: College of Psychiatry submission to the ACCC. They’re concerned: “Clinical research should be included in the transparency model. All payments above the threshold that are made to individual researchers, or research institutions, including hospitals, should be publicly reported. This would better enable doctors and other health professionals to interpret the research outcomes while taking into account their funding sources.”