Whistleblow

Sport Integrity for dopes

A decade on, the Essendon drugs saga won’t go away – because it’s unresolved. Anti-doping ASADA are again fighting NewsCorp’s demand for release of documents under Freedom of Information. In 2019 the Administrative Appeals Tribunal refused disclosure under grounds of a confidentiality agreement. By taking action against 34 players, the AFL deems that culprits have received retribution. In 2013 the Medical Board fined the experiment’s architect Dr Willcourt (in absentia) $7000 for unprofessional conduct, essentially finding that there had been inadequate patient consultation regarding the Essendon supplements. AHPRA withdrew allegation 1D … ” that Dr Willcourt participated in the study and research program without ensuring that the program was approved by a Human Research Ethics Committee and/or acted in accordance with an approved research protocol.” VCAT had decided that since Dr Willcourt had already skipped the country, further sanction or conditions upon practising would result in a ‘mockery’ of such disciplinary action. Willcourt’s practice was just across Chapel st from HyperMed, and their meds are sourced from Nima Alavi’s Compounding around the corner – from which $80,000 worth of growth hormones and steroids were stolen by another artful dodger of AHPRA rules. But who brought the players to HyperMed for injection?

ABC 4Corners report ‘Whatever it Takes’ interviewed spokesperson Graeme Little at HyperMed, where he revealed that supposed villain Stephen Danks simply turned up on the doorstep. At the time, brother Paul Little was Essendon chairman, which weighs against sheer happenstance.

Paul Little, and below, brother Graeme Little

Players obey the coach, and James Hird obeys the orders of club Chairman. There’s hearsay that Hird met Danks at a Thai beach resort, but damned solid evidence the Little family are connected. Well connected. Paul now runs private terminal Melbourne Jet Base, which is also contracted for RAAF VIP aircraft, so used by PM Morrison in 2018 before official opening. In 2020 Paul was appointed to Morrison’s coronavirus economic taskforce, chaired by the CEO of Fortescue Mining (who’s been delaying Court over a quarantine breach). Best we not let this matter rest.

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I was once on a jury for a child sexual abuse case, brought two decades later than her fruitless report to Police. The Defence Barrister made me squirm, with his attempts to undermine her credibility.

“What colour was the garage door?” The Judge did nothing to curtail this. Much as Robert Richter QC was allowed ‘brutal examination’ of victims in the cases brought against Pell or Theophanus. Out of the mouths of babes: https://youtu.be/JUY23_cfI4o?t=64

I’m reading ‘Joe Cinque’s Consolation‘, by Helen Garner. Appalled by the callousness of the crime, she attended Court to observe the Law’s helplessness. “One of the props of the adversarial system, I began to see, is a curious charade that memory is a clear, coherent narrative, a stable and unchanging source of information, so that any deviation from a witness’s original version of an event can be manhandled to look like unreliability, or the intent to deceive.” I’m currently a witness for the Crown in a manslaughter case. At the committal I was twice slammed by the Magistrate for having an ‘aide memoir’ in the witness box – a diary and email device. Yet the barristers have tables spread with documents, and are accompanied by solicitors trucking around files. The incident was over five years ago.

The result of one-sided knowledge of exact facts is that outcomes depend upon language’s power, and the most assertive Counsel wins. The witness to an event can make no statement correcting an assertion. “Just answer the question, Mr Kirwood”.

Australian Admissibility of Evidence law is among the world’s weakest. China is at the other extreme – having allowed torture to get at the truth. But as any whistleblower knows, collecting Commercial-in-Confidence evidence is a crime of theft. The UK brought legislation to permit such, if it’s in the public interest. And surely, where public monies are involved that should apply. Under Sn 70 of our Crimes Act (1914)… A person who, being a Commonwealth officer, publishes or communicates,… any fact or document which comes to his or her knowledge means that Public Servants are liable for 2 years jail – regardless of the extent of corruption uncovered in the course of their work.

https://www.abc.net.au/news/2021-04-29/prosecutors-proceed-case-against-ato-whistleblower-richard-boyle/100105710

I once worked in organised crime, scamming a national infrastructure project. The Cartel (‘mafia’ is inaccurate, as not all offenders were from Sicily) operated with total impunity. The response letter from Attorney General Brandis to me, then working for an ASE listed company, started: “… employer corruption as matters relating to the Royal Commission into Trade Union Governance and Corruption“. And suggested that I make a submission, to blame some Union or other. Upon seeking the advice of Julian Burnside QC, it was explained that “fraud is not covered by confidentiality under the ‘iniquity rule’, whereby serious wrongdoings such as a crime, civil wrong or serious misdeed of public importance cannot be suppressed by a contractual obligation of confidentiality.” Fraud isn’t sufficiently serious to warrant breaching confidentiality in private industry on govt contract, and government has blanket secrecy.

What could go wrong with that?

Switch back to the other end of the severity scale from white-collar crime. “…the first conviction for corporate manslaughter in Victoria occurred as late as 1994, when Denbo Pty Ltd pleaded guilty and was fined $120,000. Note, however, that Denbo was in liquidation at the time and was able to avoid paying the fine— although it did resume its activities under a new corporate name and personality.” *
Boxer Dean Waters confessed to the murder of his father’s ex-lover’s partner, pleading guilty to manslaughter. Acquitted due to his mental state, owing to duress from his father (although 25yo at the time). Another younger boxer who visited for the father’s training, and who set up the hit, served 13 years.
Or consider the benchmark case of Taktak – an addict who procured 2 street prostitutes for his dealer. Called to collect an unconscious 15yo girl, he took her home. As her colour leaves, and she’s vomiting, he calls the dealer – who contacts a GP. She dies, a jury finds him guilty of manslaughter, but the sentence of 13 years is overturned on appeal.
He walks free.
There was uncertainty as to exact time of death, and appropriateness of Taktak’s actions.

Unlucky 13. The Law is not only inexact – it’s utterly random.

* Arenson, Bagaric & Gillies, 2014

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Bad Medicine (ad finitum)

Anti-convulsant drugs are mainly used in the
treatment of epilepsy. However, they are also
used as mood stabilisers, which means that
they help to reduce intense changes in mood.
Some examples of anti-convulsants that have
been used for anxiety are gabapentin (brand
name Gabapentin) and pregabalin (brand
name Lyrica). Anti-convulsants have mainly
been used in bipolar disorder, as well as major
depression that has not responded to other
medications or psychological therapies. They
have also been used for anxiety disorders,
since depression frequently co-occurs
with these conditions. (pg59 of ‘A Guide to What Works for Anxiety’)

Part 5 of my series on pregabalin/Lyrica covered this drug’s damage to neuron synapses, and the rising count of fatalities due to abuse has prompted our regulatory TGA to box-label warn of its risk a fortnight ago. They only mention its applicability to epilepsy and neuropathic pain. But Pfizer insidiously searches for new customers, and the mental illness market has had their attention awhile.

I quote above Beyond Blue’s 2019 3rd edition of “an evidence-based review” where gabapentinoids get two thumbs-up for Generalised Anxiety Disorder. It’s the first entry (alphabetically) found under medications, and the 2013 initial print references only studies by Feltner et al (Pfizer consultant, who included 2 Pfizer employees on his team) and Pande et al (who’d done 3 studies with Feltner, and whose team had done several studies with Pfizer). The latest edition omits the blatantly industry biased studies, but offers a 2017 Cochrane review of the evidence. Not only does that one rely wholly upon the same Pfizer studies, but corresponding author Dr Stein forgot his previously declared conflict-of-interest with Pfizer. Other systematic reviews by Generosa or Boutros were also proffered, requiring a journal subscription, and my search for other studies only turned up a 2015 trial by López-Gómez & Olivarex et al including Pfizer staff, and an independent open-label by Jovicevic & Cvjetkovic-Bosnjak et al. The latter would be excluded in Cochrane for the lack of blinding as to administering of the placebo/control(Zoloft) or Lyrica. The only study outside the manufacturer’s influence is dropped. Interestingly, they found 225mg daily more beneficial than the anti-depressant alternative. Industry studies by Feltner and Pande had both tested 600mg – a dangerous level of intoxication.

Wondering why the references were changed from original studies to aggregated reports on the same data? The veneer of respectability, otherwise known as the fog of obscuration. Dr Stein declined to reply, likewise the overseeing/overlooking Cochrane group: Global Mental Health. Lead author of the book, Prof Reavley answered to explain the switch from individual studies to meta-analyses as being in order to simplify for the lay-person, and “Cochrane reviews, in particular, are done to a very high standard.” This however, was despite being presented with evidence of corruption within Cochrane.

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Cochrane and Gotzsche

Marcellus: Something is rotten in the state of Denmark (Hamlet 1.4.5)

These words, spoken to Horatio and Hamlet as they look upon wanton and drunken behavior, which has destroyed the nation’s reputation, are apt to the sacking of Danish Prof Gotzsche by the Cochrane Collaboration – the gold standard in medical evidence. Archie Cochrane founded an independent scrutineering of medical trials in 1993, so as to impartially evaluate claims of drug efficacy. Rules and tools for trainsmashing data from systematically gathered results are intended to provide an overview of pros and cons. Peter Gotzsche was an early appointee, directing the Nordic Centre of six neighbouring countries. The last half a dozen years has seen increasingly vocal criticism of commercial influence, and doubters of the Cochrane ideal often focused on mental health solutions. Gotzsche was stubbornly strident in criticism of psychiatry, disregarding my advisory sent 5th Nov ’14 that his condemnation of the profession as being the most lucrative for industry kickbacks was wrong – per his reference it was actually 4th most (in Australia 2009), with rheumatology #1. The download of a chapter ‘Pushing children into suicide with happy pills’ , linked in the flyer for his 2015 Mentalaz tour, concludes thus: Our citizens would be far better off if we removed all the psychotropic drugs from the market, as doctors are unable to handle them.

Followon book to ‘Deadly Medicines and Organised Crime’

Not that the rheumies were off the hook. Peter’s 1989 ‘Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal anti-inflammatory drugs in rheumatoid arthritis’ warned that “the quality of RCT trials in rheumatology may be so weak that it may be impossible to place any confidence in the … conclusion“. And on pg84 of Deadly Medicines “A rare admission that doctors’ opinions are for sale to the highest bidder was provided by Canadian rheumatologist Peter Tugwell, who wrote a letter to several major companies soliciting funds for CME conferences on behalf of an organisation called OMERACT: We think that support for such a meeting would be very profitable for a company with a worldwide interest in drugs targeted in these field.” Gotzsche aint a team player. Tugwell co-authored with Gotzsche, as well as 19 times with revered Cochrane founder Dave Sackett, whose HARLOTplc article at least gave humour to the reality that their business is for profit.

This month Cochrane’s Governing Board sacked Gotzsche, sparking outcry and protest resignations by 4 other of its 13 members. Six weeks earlier he’d written a critique of a Cochrane review for the HPV vaccine’s efficacy against cervical cancer. Peter’s team had worked on this since Jan 2017, when their analysis protocol was published. Points of disagreement raised were uncontroversial and moot, other than that the outcome of concern only developed after such a long time that surrogate indicators of lesions were instead analysed as being predictive of protection. Rather than dismissal being an exasperated or last straw reaction, the timing was merely coincidental. The Board’s statement informs us that lawyers had been on Gotzsche’s case since March, with a QC conducted independent review underway a month before publishing of the HPV challenge caused contention.

I suggest coincidence, rather than ruse, since the February trigger was possibly a letter attacking a Cochrane chief editor – Andrea Cipriani of the Common Mental Disorders group, over their recent review of 21 anti-depressants as being flawed and untrustworthy. However that team declare no conflicted-interest, and perusal reveals no alarming endorsements. Yet there’s no reference to the unwarranted attack or its target in the Board’s attempt at damage control – is this to protect the privacy of an innocent party, from their shaming by a woefully ill-informed press? Another, diplomatically worded re-analysis of Cipriani’s earlier 2009 anti-depressant report did highlight shortcomings of trial quality assessments, cautioning against the endorsement given for Pfizer’s Zoloft.

The muddy waters turn darkly Stygian.  Cipriani is Prof of Psychiatry at Oxford, which also homes Cochrane’s Pain & Palliative group under Prof Robert Andrew Moore (aka RAM, aka Andrew Moore), whose authoring name varies with context – independent and impartial, or sponsored spokesperson. There’s much overlap between pharmacotherapies with these groups, notably duloxetine/Cymbalta. Cochrane Editor-in-Chief David Tovey would be aware of the industry influence, since he acknowledged an email in March 2015 titled: ‘A 2nd Cochrane group is recruited’ – complaining about the rheumatology group and also including this: [Dr Nnoaham’s] 2008 Cochrane review on TENS for chronic pain and fibromyalgia was censored by your organisation’s Pain, Palliative and Supportive care (PaPaS) editors. Who are excellent examples of transparency, by not hiding their allegiances. Phil Wiffen and Andrew Moore et al chose to include a Pfizer employee in 2010 when conducting their own review into anti-convulsants for pain – surprisingly finding that “For gabapentin and pregabalin only we found reasonably good second tier evidence for efficacy..” (quoting the 2013 update). They reckon duloxetine’s pretty good too – http://www.bmj.com/content/348/bmj.g139/rapid-responses (well you would if you were paid as a consultant by Eli-Lilly, wouldn’t you?)

Grounds for disallowing Nnoaham’s complementary therapy review were that it shall be split into two reviews of TENS – one for fibromyalgia, and one for neuropathy. Except that Wiffen and Moore’s 2013 ‘Lamotrigine (an antiepileptic drug) for chronic neuropathic pain or fibromyalgia’ is an allowable combo! PaPaS also censored an unfavourable review of Pfizer’s gabapentin & pregabalin for pain relief in fibromyalgia on the grounds that lead author Nurcan Üçeyler had been paid speaker’s fees by Pfizer at neurology conferences. However Cochrane’s rule that neither the majority of authors nor the lead can be on the manufacturer’s payroll was also broken by their 2014 review into Neurontin/gabapentin, although Moore then complied in their 2017 update – by re-arranging the order of names to put Phil Wiffen first.

This is a coverup of misconduct. A façade. Gotzsche was certainly going beyond boundaries of expertise, and using his senior position within Cochrane to add weight to his personal opinions, which is contrary to the spokesperson policy allowing only statements on behalf of the collaboration. Years of emotive rants took a toll on his reputation – a tragic folly, when misconduct was there for all to see.

Disclaimer: I consider that the psychiatric profession takes prescribing of psychotropic meds VERY seriously, but worry about GPs playing at amateur shrink on the basis of dubious research evidence. I do not endorse Prof Gotzsche’s attitude, best expressed in his memo to Dr Dawson “Incidentally, I found out that some one has written about you and the way you treated my paper about the 10 myths in psychiatry. See attached [‘Asshole of the day – George Dawson MD’]”. George seems rather professional, actually: http://www.youtube.com/watch?v=ZyINjdCXkAQ

 

 

 

 

 

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Beyond Belief

If a belief is taken beyond the safety of rational thought, it’s then an act of faith. Brave and bold, but delusional. I’d argue that medicating is well down this path – devoutly taking risks with side-effects, perhaps even shortening lifespan, yet ‘smoke and mirrors’ is a fair description of the governance in clinical research. A blog on a fabricated conclusion in an NHMRC sponsored study is linked, and my notification of the misconduct to the publishing Arthritis Care & Research journal editor Dr Gary Firestein was never acknowledged. Likewise concerns about deception in drug trial PRO-HEART (linked) to the manager of research also went unanswered, and were subject to a Freedom of Information legal demand for disclosure. The Austin Hospital refused the FoI on the grounds of ‘trade secrets’, despite donated monies to peak bodies Beyond Blue and Heart Foundation sponsoring the scam.

A third matter is detailed below, and these were chosen from this site’s 43 posts to submit to Public Library of Science as a manuscript exemplifying medical research scams. Publication assistant Rebecca Green replied that “unfortunately such a paper would fall outside the scope of PLOS Medicine“. Dirty research can’t be retracted, furthermore making the case for a multitude of scandals won’t be published. Enough to shake one’s confidence in the system? Ditto the BMJ, even Accountability in Research journal were uninterested in research fraud criminality.

Impunity in both corrupting the medical evidence base and inappropriate commercial allegiance has led some to crossing of the boundary from immoral to illegal.  ‘Dog and pony show’ is another idiom pertinent to NHMRC funded program BackTrack. BackTrack-dogjumpDSC_0477Managed by qualified dogcatcher Bernie Shakeshaft, their modus operandi is to attend a rural court where juvenile offenders have run out of warnings, and are due for detention. An alternative offer is made for these feral kids to voluntarily labour on a remote farm, where they’ll also be taught to handle dogs. This goes down well with the Magistrate “… if I can forward them to a structured program like BackTrack, I certainly feel like there would be less recidivism.” In 2013 while Bernie’s brother, University of NSW (UNSW) Prof Shakeshaft, was on the NHMRC council their grant application “This study quantifies the benefits/costs of combining cognitive-behaviour therapy with a community-reinforcement strategy to reduce substance-related harms among young Indigenous Australians” was approved for $386771. A year later Bernie took off on a study tour of the USA, Canada and Italy. Bernie’s been done for Driving Under the Influence, so has learnt by experience the perils of alcohol abuse. But he’s naïve about CBT, and the majority of incarcerated kids aren’t Indigenous. This is revealed in a book submitted by Helena Pastor for her PhD by observation from the local Uni. An excerpted page Wild_Boys_—-_(Pg_253) describes physical abuse and isolation from both social workers and community elders.

The majority of finance comes from the philanthropic Vincent Fairfax Foundation. So besides taking Aboriginal kids away from their community support, these souls are in Christian hands. This situation is ongoing, not some historical ‘taking the children away’. Barnaby Joyce redirected $200k from Indigenous Affairs to these criminals (harsh? The AFP described the affair as ‘fraud’, which I understand to be a crime).

A report was produced, ‘The Feasibility of Embedding Data Collection into the Routine Service Delivery of a Multi-Component Program for High-Risk Young People’ *, which described their use of a routine survey. This sufficed for NHMRC, whose Ethics & Governance dept disclaimed accountability for their spend of our funds “…allegations of misconduct would need to be addressed by raising your concerns with the research institution through which the research was conducted.” Director of Integrity at UNSW, Bronwyn Greene, has been working on her answer to this since May 5th. So too has bureaucrat David Baragry, whose previous diplomatic statement was careful not to tread on toes in Canberra: “The Ombudsman has the discretion not to investigate certain complaints… respects the role, expertise and decisions of the NHMRC and … tends to consider only questions related to the NHMRC’s administrative processes.” Then Minister for Science & Research, SEN Kim Carr, recognizing the need for an Office of Research Integrity left the task to the key funding bodies NHMRC and Aust Research Council to establish an independent review body. They did so, but within their own organisations. This Committee, ARIC hasn’t replied either. In its first year 2011 it accepted only one complaint against its NHMRC parent, then rejected all allegations but for a procedural matter regarding sending of a letter. It’s not listed under https://www.nhmrc.gov.au/about/nhmrc-committees but buried as a paragraph in the NHMRC Annual Report – the latest stating on pg98 that one matter was dismissed, and another is an ongoing investigation. That’s about all they have to show in five years (check the reports for yourselves: search for nh15, nh162, nh166, nh169 & nh172). The cries of dissent are more voluble – links available from http://www.bmartin.cc/pubs/plagiarismfraud.html are a start.

19th Oct update: After the UNSW and ARIC four missed dates that they’d offered as targets for a response, it’s obvious that this will be stonewalled rather than whitewashed. Pity, since we miss out on the comedic material unearthed by America’s ORI being taken to court by a fraudster… “Dr. Sauer admitted that the images in his publications and grant applications were knowingly and intentionally falsified, but denied culpability, claiming that a member of an anti-gene technology activist group had falsified Dr. Sauer’s data in order to subvert gene-technology research.  As evidence for his claim, Dr. Sauer submitted an uncorroborated declaration purportedly by an individual named “Rune Dreser,” who allegedly stated that he had hacked into Dr. Sauer’s computers and altered Dr. Sauer’s research results.  The declaration, written in German and purportedly notarized by a notary in Germany, did not contain the notary’s name, and the signature of the notary was illegible.  Noticing this irregularity, the HHS attorney for ORI emailed the notarial office in Germany to inquire about the authenticity of the notarization.  The director of the notarial office responded that the notary seal and signature were most likely forgeries. ”

1st April: comedy gold from UNSW – when offered right-of-reply to a manuscript documenting their history of research misconduct eg  harbouring of Khachigian, they came back with a ‘Strictly Confidential’ status report (which said that nothing had been done yet, after 9 months).

* Int. J. Environ. Res. Public Health 2017, 14, 208; doi:10.3390/ijerph14020208

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Having it both ways

In earlier critiques of Bad Medicine I’d wondered at the contradiction of regulatory authorities handing down $bn punitive fines for wicked off-label promotion of meds, while sponsoring trials that potentially expand the range of approved conditions and thus the on-label market. Part(3) of this series on pregabalin/Lyrica concludes herewith.

In 2011 the Pharmaceutical Benefits Scheme refused Pfizer a subsidy for Lyrica on the grounds that none of the studies thus far had shown efficacy against neuropathic pain. Just 12 months later, they changed their mind. What new data could have influenced this, when the drug’s ineffectiveness was already the source of a joke on its side-effect of dizziness (Schwindel, translated in German)? Significant adverse events of dizziness and somnolence were manifest at the lowest dosage of 150mg consistently in 38 trials  ‘The adverse event profile of pregabalin: A systematic review and meta-analysis of randomized controlled trials’ (Zaccara & Specchio et al, 2011).

Courtesy of rheumatologist Dr L.Kirsch MD, Jun 2012

 

This somewhat contradicted Pfizer’s sponsored investigation into Lyrica:  ‘Cognitive effects of pregabalin in healthy volunteers’  (Stalinsky, Storzbach & Muniz 2009) offering a conclusion of “… negative cognitive effects and neurotoxicity complaints”. The drug only works (wirksam) to relieve pain at larger doses, at which point there’s been an exponential increase in Schwindel.

Pfizer’s 2012 re-submission to PBAC had two new studies; Boyle, Gribble & Johnsen et al , finding “…there was a significantly higher number of adverse events in the pregabalin treatment group. Conclusions: There was no significant difference in analgesic efficacy between amitriptyline, duloxetine and pregabalin.“, and Trial 1107 – an unpublished, internal study run by Pfizer. I’ll repeat that. The former showed no superiority of the med over amitriptyline, a 50 year-old mainstay known as Endep, furthermore it had worse side-effects. And the in house report …. one can only hope that it was run with more probity that their Trovan trial, best described as a crime against humanity. In summary – this one piece of evidence, from behind closed doors, sufficed to allow “The PBAC recommended an Authority Required (Streamlined) listing of pregabalin (all strengths) for the treatment of refractory neuropathic pain not controlled by other drugs on the basis of acceptable cost-effectiveness compared with placebo in patients dissatisfied with their current pain relief.”

There was another study submitted to PBAC, a comparison showing pregabalin as better than amitriptyline in cancer pain. At a dose of 600mg – at which point conscious state is altered.

What else changed from 2011? Dr Suzanne Hill, co-editor of ‘Evaluating Pharmaceuticals for Health Policy and Reimbursement’ *, was appointed chair of PBAC. This went down well with the pharmaceutical industry. She’s since returned to WHO in the Expert Committee on the Selection and Use of Essential Medicines , replaced with Prof Andrew Wilson per command of Health Min Sussan Ley – who’s been recently forced to resign due to misconduct. I have no idea if governance has improved, nor can inform as to whether it ever existed.

The drug really didn’t work. The 2012 NHMRC grants round allocated $0.62m (plus topups) to try Lyrica for sciatica – leg pain from back nerve damage. Last month PRECISE’s results were posted: no benefit over placebo, and 40% reported the adverse side-effect of Schwindel. Pfizer still won though – they didn’t have to pay for the study. In the interim, the musculoskeletal team of experts had railed against alternative approaches such as imaging – although that’s done with a view to inspecting the problem source for potential intervention at the site. Dr Hill’s colleague at WHO, Prof Lisa Bero didn’t ever respond to concerned memos regarding the probity of PRECISE, nor to complaints about the Monash/NHMRC cases of misconduct.

On the one hand, we trust pharma to do the studies, and on the other, we fund universities to do the studies on their behalf. Win, win for the industry.

*Page 37: “There is evidence that the research methods of trials sponsored by drug companies are at least as good as the trials sponsored by public resources, and in many cases they are better“, referencing Bero – “Study design in drug company sponsored clinical trials better than in research where no stated sponsorship”  in her thoughts. My opinion is that trial 1107 should publicly release the names of researchers, or am I asking too much? They’re kept secret, and bound by confidentiality, per NCT00407745: “There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI’s rights to discuss or publish trial results”.

 

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Mammon

Healthy participants volunteering to receive first-in-human safety trials of a drug are well compensated, and receive round the clock monitoring. But sick persons opting into an experimental program pay to exploit a legal loophole, and there’s no oversight. This truly exemplifies survival of the fittest.

Drugs are priced by preparedness to pay.

Drugs are priced by preparedness to pay.

A doctor, accused of administering banned substance Thymosin beta 4 (TB4) to footballers, was exonerated by the Medical Board in June of trying out etanercept on stroke patients. This genetically-engineered bioagent is the subject of an earlier blog , and is a last resort in arthritis. It trades improved Quality of Life, for reduced Quantity. This is a moral decision, but one informed by solid clinical evidence of the risks vs benefits of blocking autoimmune responses. The AHPRA letter declares that his “… decision to use etanercept was based on high-quality evidence. All patients were informed before attending and fully understood the position in Australia…”,  and ends with an apology for the stress of their investigation. The doctor wrote in his defence that “Griffith Uni was in the process of doing clinical trials with the drug“. Uhh, no. Dr Rick Williams has approval only for his trial protocol, but insufficient funding to begin. This footage from 60Minutes is the only ‘proof’ of efficacy:

Clinical notes show that patients were informed that this would cost $6k in Florida. So a vulnerable person was injected on the basis of pricepoint. Some had also signed off on a 29 point consent form, which includes unspecified “immune stimulating injections”. I have no idea how such conduct can be condoned, but it is indeed compliant with the Good Medical Practice Code-of-Conduct Sn2.2.6. Providing treatment options based on the best available information. With no definition of what constitutes an evidence base, misconduct is unfettered. Snake-oil salesman Dr Tobinick had been challenged to support a clinical trial, but sued detractors instead – a case thrown out by the US District Court 30 Sept 2015.

The doctor presented at a Florida conference in 2015: “Thymosin beta-4 affects immune responses and is integral to formation of growth of normal tissue when damage has occurred rather than the chaotic formation of scar tissue that normally happens.” and his Aust website states: “Peptides such as AOD 9604, Thymosin beta-4 and Follistatin are peptides … Agewell is a world leader in the use of these medications.” The TGA site is more enlightening: “These substances are currently used illicitly to enhance sporting performance and more broadly across the community often for body building and image enhancement purposes…

  • No form of Thymosin Beta 4 is yet approved for human therapeutic use anywhere in the world.
  • The medications are considered experimental in humans, with potential side effects including carcinogenicity and cardiovascular problems.”

Injecting room at HyperMed

Compounded concoction in the injecting room at HyperMed

But they’re still legal, with the doctor’s scrip. Which doesn’t even require a consultation, as an order from Peptide Clinics demonstrates. Fairfax’s sports journalist Jon Pierik and crime reporter Cam Houston were shown evidence of all this a month ago, but only wanted to know whether celebrity sports stars were implicated. Or had I seen any bikies? The consumer is left uninformed, and quite unprotected by regulatory authorities.

Stephen Dank administered peptides to rugby player Jon Mannah, who had been in remission from cancer but then died in 2013 after relapse. Dankenstein sued the Daily Telegraph for claiming that he had a case to answer for manslaughter, and the Supreme court agreed with the paper – dismissing the defamation complaint. No charges have yet been laid however, there’s uncertainty over the drug used. In April of this year, a peptides patient died suddenly, but there’s more chance of prosecution since TB4 is written in clinical records. Nonetheless, the Crown hasn’t yet taken action after 7 months – so perhaps it’ll suffice to blame the victims, rather than the perpetrators? That’s what the Essendon players discovered.

I recently lodged formal complaint to AHPRA over the disparaging statement by a guest Professor on radio “… holistic nature of alternative medicine albeit not evidence based … alter some of the biological behaviour in an adverse fashion, but that’s not out there in the public, so people who spruik these things may get away with it“. This was dismissed since the Private & Confidential letter states: “It cannot be concluded that these comments unreasonably reduce confidence in the therapy, as it is reasonable for Prof XXX to proffer this opinion“. That’s what I’d spent several months attempting to obtain directly, an admission that his ‘opinion’ had no supportive facts whatsoever, and indeed the therapy has a substantial gold-standard evidence base (used in cancer support at the Alfred Hospital). The man is a great oncologist (albeit one ignorant about complementary therapies), so I won’t further his embarrassment with naming. Doctors’ unfounded ideas are taken as advice from the Oracle, even justifying deadly human experimentation, but complaints are dealt with in secret and there’s no rights to appeal.

It’s a dog eat dog world. Some are rabid.

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Gagging

Endemic corruption within medical research is of no concern to government, since the issues previously raised have been put to Health Ministers and even to PM Turnbull. Without a response. Few have the integrity to whistleblow, due to lack of both regulatory authority and legal protection. After all, there’d be no shortage of backfill for your position upon dismissal from the increasing numbers of vulnerable foreign workers on tenure of a temporary visa. The blue bar charted shows post-docs, paid the same as a burger-flipper while Australia trains them in our wily ways. Employment Minister Eric Abetz denied existence of this scam in correspondence of 16th Sep ’15, despite a University advising “The Department of Immigration and Border Protection has limited the value of the living assistance which can be provided by the University to subclass 402 – research stream visa holders. The maximum contribution by the University to living expenses is approximately $34,000 per annum (at October 2012); this amount may alter on an annual basis.”

402

Report BR0169

This matter has been raised with Immigration Minister Peter Dutton several times, but the office has never responded. Wouldn’t he be concerned about history judging him harshly, should the truth ever come out regarding misconduct? Uhh, no. Already looking at a pension of 1/6th of a million dollars annually, that means his CV needn’t be without a fault or three. Even if it’s already blemished by his  previous portfolio as Health Minister resulting in his poll ‘win’ from Australian Doctor magazine as being the worst performer in its 35 year history. No remorse at that failure either – last months confrontation with doctors of Lady Cilento childrens hospital showed his contempt for human rights also.
Your vote comes with no guarantee of governance, as there’s no accountability for policy made up on the fly. President of the amoral AMA turned politician, Dr Brendan Nelson, surprised both the Air Force and Defence Materiel by purchasing $7bn in Super Hornets from ex-parliamentary colleague Andrew Peacock, then a Boeing salesman. “It just flawed me … there was no independent analysis,” recalls AVM Peter Criss, a retired Air Commander of Australia. John Howard approved the suggestion in 2006 without seeking expert opinion, and far from showing remorse for events as they’ve unfolded is instead reveling in regularly being voted Australia’s best PM by Murdoch press conducted polls. That’s despite being outed as a liar regarding ‘children overboard’ by Admiral (rtd) Ritchie, onetime Chief of Navy.

The first planes were delivered in 2010, but six years later we’re still investing heavily in a future around the Joint Strike Fighters (JSF). That’s a project we’d supported by pre-purchasing 100, but both the budget and time were wasted during the cocaine-fuelled ‘nought-ies’ (the era which led to the GFC). Both aircraft are already outclassed by the Russian SU-30 & 35s purchased by five SE-Asian neighbours. “This thing [Super Hornet] will not survive in a fight now in our region,” says Criss. While the JSF struggles to achieve operational readiness, the SU ‘Flanker’ continues to evolve.

Photo courtesy LAC/W (RAAF) Kim Eager Sarah McLeod from the Ducati team with Dr Brendan Nelson. Minister for Defence Dr Brendan Nelson launched the Defence Motorcycle Awareness Campaign at the Sutton Road DriverTraining Centre, ACT near Queanbeyan on the 4th August, 2006.

Photo courtesy LAC/w (RAAF) Kim Eager
Sarah McLeod with ‘Top Gun’ Dr Brendan Nelson on the 4th August, 2006.

If Brendan ‘need for speed’ Nelson didn’t know what he was doing (he dropped out of his economics degree), nor do we know what they’re thinking. There’s a Senate inquiry into the JSF concluding in May 2016, but a previous report is pertinent “… the arguments are of a highly technical nature and much of the data necessary to form an understanding of the performance of the JSF is classified and not available for public scrutiny“.  The quid pro quo of political understandings with business here doesn’t work so well strategically however. Regardless of commitments to JSF, or however many M1A1 battle tanks Howard purchased, it’s been made crystal clear that our new “best friends” are Japan. Regional instability as a consequence of South China Sea conflict won’t be America’s problem, even if they are the trigger.

The secrecy that allows medical research to fester is the cause of the problem here, too. Any misconduct in national affairs remains secret, and public servants intending to whistleblow should pay heed to Sn 70(2) of the Crimes Act, 1914: A person who, having been a Commonwealth officer, publishes or communicates, without lawful authority or excuse (proof whereof shall lie upon him), any fact or document which came to his knowledge, or into his possession, by virtue of his office, and which, at the time when he ceased to be a Commonwealth officer, it was his duty not to disclose, shall be guilty of an offence.
 Penalty: Imprisonment for two years.

The USA, on the other hand, rewards with a payment up to 10% of the public monies recovered.

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Rage, rage against the dying of the light

… from ‘Do not go gentle into that good night’, Dylan Thomas

pfizer

staree

 

Before delving into the massive NHMRC research investment of public money  ($5.1m upfront) into Pfizer’s Lipitor that is STAREE, some preliminaries:

Few Australians would be unaware of the furore raised by Catalyst (The Heart of the Matter), and subsequent retraction by ABC management of the program. A couple of opinions on Dr Demasi’s journalism by Drs Briffa and Coleman, and their arguing in blog comments shows that even those in general agreement were discordant. Instead of ‘playing the ball’ and take on the well-orchestrated industry, I’ll ‘play the man’ and focus upon individual proponents of statin therapy. And their complicity. It’s a softer target due to a weakness in humanity – insatiable need for funding.
Heart Foundation CEO Jen Johns immediately warned that sales of statins would be harmed, and a month later they published a poll by their Rob Grenfell showing 10% had stopped the therapy. Their corruption is further detailed at this update, and is unsurprising given that the decade-long president is father of Pfizer’s lobbyist Andy Thirlwell. Even before the exposé aired, Prof Emily Banks had pointed the bone * thus: “It’s likely that if this program goes ahead, and it does the unwarranted undermining of statins, that there will be people who didn’t have to have a heart attack and didn’t have to die from a heart attack, who will die through reducing use of statins“. An expert in this field, having authored ‘Erectile Dysfunction Severity as a Risk Marker for Cardiovascular Disease Hospitalisation and All-Cause Mortality’, she’d be appreciative of Pfizer’s infamous blue pills for ED. Dr Grenfell concurs with a warning, “These results tell us that every man who is suffering from any degree of erectile dysfunction should be seeking medical assistance as early as possible“.

Grenfell and Tonkin et al wrote of the confusion in lipid management in May 2015 ‘Clinical Guidelines on Hyperlipidaemia: Recent Developments, Future Challenges and the Need for an Australian Review’ – considering the perspective of the American Heart Association “… the maximum tolerated dose of a statin be generally employed”, but their own concern is absence of an optimal target level: “Whilst the cost-benefit analysis of statin therapy is generally favourable, it is very sensitive to the absolute risk level of the patients selected for therapy”. Andrew Tonkin had already made his mind up in 2005 though, as chair of the Heart Foundation’s consensus Position Statement on Lipid Management a number of guidelines and criteria are given to prescribers. Along with a conflict-of-interest declaration. The same “provision of consulting services to Pfizer” should also have been disclosed in a JAMA report ‘Association of LDL Cholesterol…with Risk of Cardiovascular Events Among Patients Treated With Statins’, that was subsequently amended due to medico complaints to the journal.

Bias is a relevant fact in STAREE (STAtins for Reducing Events in the Elderly), but frequently missing. Monash colleague Sophia Zoungas should also have declared a 2007 Pfizer personal grant of $55k in articles such as ‘Treatment of Dyslipidemia and Cardiovascular Outcomes: The Journey So Far—Is This the End for Statins(?)’ advocating “the first [Randomised Controlled Trial] to determine the effects of statin therapy vs. placebo in an apparently healthy elderly cohort living independently” ie preventative Lipitor for the over 70s. This is not however, a trial designed to test a hypothesis. It’s an experiment on the elderly to see what happens. Lipitor is the hammer, let’s see if it nails aging! Extending of life is the outcome being investigated – meaning that if they’re wrong, then shortening of life may become apparent.  A successful trial is assured, since my previous example from this department shows an outcome can be invented with impunity. And worsened death rates ‘adjusted for’.

One example of deception is apparent already. In July ’14 Current Opinion in Cardiology neither professor mentions Pfizer’s backing, but offer panacea in claiming: “In a meta-analysis of observational studies, statin therapy was associated with reduction in risk of dementia, Alzheimer’s disease and mild cognitive impairment“. The cited references of Richardson et al (in response to the Lipitor label warning of additional risks, imposed by the FDA in 2012): “Published data do not suggest an adverse effect of statins on cognition.  The strength of available evidence is limited…” and a Cochrane review by McGuinness et al : “Demonstrated lack of benefit of statins compared with placebo on cognitive measures” actually contradict this claim! These issues were raised with Monash Chancellor Finkel, but the reply from his Director, Tony Calder abdicates responsibility: “The matters you allude to in your email are matters that are dealt with by University management therefore the Chancellor, as head of Council, will not be providing a response to your email.”

Solving the problem of an aging population?

Solving the problem of an aging population?

Two years after Catalyst aired, a Med Jnl of Aust article advises that over the first eight months 61,000 have made up their own, negative opinion of the meds: “…changes in statin use occurred despite warnings in the Catalyst program that its content should not be taken as medical advice”. Co-author Sallie-Anne Pearson is noncommittal on consequence, having just published a study that concludes: “Deprescribing of statins may be indicated for some older people, because the evidence for benefit in primary prevention of cardiovascular disease is limited and there is an increased risk of side effects in old age.” Other, collaborative colleagues are more determined to restore Lipitor to its heyday position of the highest grossing drug. That popularity arose due to trial results on a surrogate outcome of LDL (Low Density Lipid) levels, without epidemiology data as to whether the drug improves survival rates in the community. We’re a trusting lot.

On the other hand the Brits stay true to form, by constant whinging about risks: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4714436/ 😉

* Indigenous Australian’s forewarning of death as punishment

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Manipulating the market.

Once upon a time, doctors were hanged for unethical human experimentation. Of 16 found guilty of war crimes, 7 were executed by hanging. Nuremberg, then Helsinki, countless other, and most recently the 2010 Singapore Statement on research ethics have convinced us that society has matured. But humanity hasn’t evolved, and the same Hippocratic oath persists.hangedDr

The forthcoming ‘Handbook of Academic Integrity’ has a chapter by Prof Vaux, whose accusation of misconduct against Uni of NSW researcher Levon Khachigian led to his standdown in 2013. That team had received $8.3m in a 2014 cardiovascular grant from NHMRC. The UNSW has just last month cleared Prof Khachigian of all charges, since: ….” breaches were the result of Professor Khachigian’s genuine error or honest oversight, not deliberate or intentional conduct.” The sacked whistleblower who brought the scandal to public attention, Dr Ying Morgan, wasn’t interviewed or requested to make a submission to the confidential inquiry. This was a case of fabricated data, whilst my previous post blogged how un-tampered data can be described howsoever as the study author chooses in order to suit their intent. Then there’s statistical adjustments.

David Vaux quotes Stanford biostatistician Prof Ioannidis, who finds procedural errors interpreting data in the majority of trial reports i.e. most studies are falsely presented. The figure given is 90%, which would mean that only 1 in 10 regulatory approved meds are truly beneficial. Deliberate obfuscation of harm also occurs, and Peter Gotzsche or David Healy are worth reading. The tutorial given at Monash in the Advanced Statistical Methods for Clinical Research subject MPH5270, on how to coverup dozens of deaths in a trial gone awry has already been discussed here . This post moves on from the blatant misconduct, to the insidious – market analysts determining what treatment you can receive.

Naltrexone blocks opioid receptors, and is approved to treat substance abuse. In 1985 Dr Bihari found that a one-tenth strength dose improved survival in HIV and postulated that the body’s endorphins were being boosted. Prof Mark Hutchinson and a team determined in 2009 that a similar molecule, naloxone alleviated chronic neuropathic pain by suppressing neural immune response to a perceived allergen attack, which has relevance in MS, fibromyalgia, Traumatic Brain Injury, and other inflammatory cytokine conditions. This led to Prof Jarred Younger of Stanford Uni trialing Lowdose Naltrexone (LdN) successfully in fibro, using a gold-standard randomised crossover protocol. The FDA didn’t accept the evidence as warranting their approval, and independent researcher budgets were never going to be able to satisfy their demands. A state of play report is available from this open-access rheumatology journal, and rheumatologist Emma Guymer visited their lab. But then reportedly told an LdN advocate that she couldn’t prescribe “for contractual reasons”. Buyers clubs solve this roadblock. There is a growing, loyal online community procuring LdN by either doctors scrip and a compounding pharmacy, or import from Canadian or Israeli sources. This established market seemingly deserves support by US insurance company rebate or else Australian PBS subsidy, so pfarma was approached to start the approval process.
Bristol Myers Squibb held the original patent for Revia/naltrexone, and after deliberating on the request for five months their Medical Director Marian Gandy determined there to be no opportunity: “I have explored the options with our global teams who determine the development programs for our products and regret to inform you that there are no plans to seek any further indications for ReVia“.

Bad drugs are pushed, good drugs are withheld. The system is so broken that suggested reforms, such as voluntary conflict-of-interest declarations, can only ever be window-dressing. That’s right – disclosing commercial allegiance is opt-in, since Australia has no equivalent to the US Sunshine Act. Nor an Office of Research Integrity where Dr Morgan could present her allegations. Because as PM Abbott said, “We’re open for business”.

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