The influx of Chinese to the Californian goldfields brought with them homegrown remedies for the pain and inflammation of their labour. So impressive was the effectiveness of their snake-oil, that an entrepreneur also made extracts from the local rattlesnakes. It was ineffectual, and sales events were followed by the salesman’s hasty exit. But Chinese water-snake’s oil is 20% EPA – more than that from our preferred source of omega-3, salmon. It’s vital for the species in the cold conditions, whereas the rattlesnake’s blood has no issue with glugging up in the desert.

Why the history lesson?

It’s because Harvard Med School has just blogged that fish-oil supplements are worthless as preventatives. This surprised me, since my BP reduces markedly on the minimal dosage of 2000mg fish oil, twice that obtained from an ACE inhibitor. Sure, that’s just a surrogate outcome and not reflective of survival into senility. So is the American Heart Association to be trusted? Our Heart Foundation’s never untangled themselves from industry ties, so….

The detailed article needs to be read from bottom to top, starting with declarations of conflicted-interest. Dariush Mozaffarian has received no grants or support from industry? That’s not what Mozza’s CV says on pg8&10: $83k from Pfizer to trial Lipitor in ’02, and $5.1m from GSK & SigmaTau pharmaceutical companies to trial fish oil on cardiac patients. His collaborator on that one, Jason Wu also forgot to disclose same in the article. He’s done a lot of work with the George Institute, a partner in the Australian public’s generously sponsoring of a $5m NHMRC trial of Lipitor. Pfizer and SigmaTau also ran a 5 year trial of omega-3 supplements on twelve and a half thousand elderly patients having cardiovascular risk factors, finding no advantage conferred to survival rates. That’s a big study, and pretty generous of Pfarma.

You have to wonder: why do we pay to study Pfarma’s meds, and they pay to study the competition?

The Harvard expert Eric Rimm’s quoted in their blog: “Taking fish oil… may not only have no benefit, it may even have some risks that we don’t realize because we haven’t studied them.” And they’re the ones dismissing complementary medicine’s lack of evidence base! Dr Rimm’s Pfizer-sponsored study on erectile dysfunction is a rerun of the  Heart Foundation’s apologists Grenfell and Banks advisories to take Pfizer’s infamous blue pills OR DIE. Despite this geek’s degree being Computer Sc, he’s pulled $400k to study floppys, and is now a Professor of Medicine.

In the movie ‘Dope’, drug-hustling Malcolm is fixated on Harvard. For the easy money?

It’s ironic to think that better treatments were available in the Wild West, and those cowboys had no problems with shooting their gun.

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

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

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

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, but are now subject of a Freedom of Information legal demand for disclosure.

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? Have heart, the BMJ may come to the party.

Impunity in both corrupting the medical evidence base and inappropriate commercial allegiance has led some to crossing of the boundary from immoral to illegal. Fraud. ‘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 social workers.

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’.

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.

There’s more, and worse. UNSW’s harbouring of Khachigian, for instance. I awaited Aust Fed Police response in vain, since they decided that others were better placed to investigate the ‘fraud’ (as they termed it). There’s so much finger pointing going on that I’d think eye protection was needed.

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. 

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

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”.

 

There is a cult of ignorance in the United States, and there always has been. The strain of anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means that “my ignorance is just as good as your knowledge.” Isaac Asimov, 1980

More scientist than sci-fi novelist, the Biochemistry Prof at Boston Med School was a keen observer of humanity. Pres-elect Trump is a man foretold by this futurist, emerging from an ideas vacumn borne out of presentation pizazz. In life’s great reality show, it’s hardly surprising that the winner of the popularity contest would be another actor rather than an intellectual. Nonsensical lies, regardless whether delivered with aplomb or hysteria, can be convincing – and internet memes circulate too fast for any factual repudiation, particularly if response is limited to 140 characters on social media.

Cardiologist and Dean of Harvard Med School from 1935-’49 Dr Burwell advised new students: “Half of what we are going to teach you is wrong, and half of it is right. Our problem is that we don’t know which half is which.” Facts must constantly be re-evaluated in light of new understanding, but that doesn’t happen. Just as the consumer swallows whatever their doctor says, the faculty implicitly trusts their academics. Their faith isn’t tested by apparent misconduct – because it’s not placed in the person, but rather in the institution of medicine. Which intersects with politics.

 

twitter.com/DanielAndrewsMP/status/751641006144036865

twitter.com/DanielAndrewsMP/status/751641006144036865

Glib words, easily misinterpreted. The Victorian Premier was commenting on a maverick colleague of Dankenstein, and not necessarily everyone who gains financial advantage from their chosen career in healthcare. But there’s underlying truth. Commercial influence on treatment decisions isn’t just a risk due to the ‘bad apples‘ experimenting recklessly. Universities contribute to global evidence bases regardless of their fictional truth’s lack of veracity. No better example is given than the UNSW’s sacking of whistleblower Dr Ying Morgan, and exoneration of Prof Levon Khachigian – despite inarguable guilt. Photoshop is a new inclusion to the researcher’s armamentarium, equally as valid as ‘Adjusted for’. Perhaps the governance applied to physicians in practice can correct for this corruption of the evidence base? The Medical Board’s public listings of judgements are over 12 months delayed after decision (and an indeterminate time after the complaint), and any miscreants are protected by anonymity. Sadly, no.

Number 1 in scrips written is Lipitor, for obvious reasons (nothing to do with actually working tho’ – improved life expectancy from statin usage in an ideal, ie recruited into the trial, population is just 4 days). Our number 1 expenditure on medications, running at $3bn p.a., are the Hep C drugs – priced exorbitantly because they work. This could be considered extortion, and sets dangerous precedents. The up and coming big tickets on the PBS are the BioDiseaseModifyingAntiRheumaticDrugs, the _mab immunosuppressants (Enbrel fails to follow the _mab suffix naming convention). The early phase (I & II) drug trial centre Nucleus Network at the Alfred Hospital is fast expanding, largely due to rapid developments of these expensive, specifically targeted bio-agents. By the time efficacy is proven in a phIII Clinical Trial, and it will be proven, the drugs budget will be under assault.

There’s inadequate reports from phIV comparisons of treatment options among the general community, although 10 registries across Europe and the US have been collecting _mab outcome data for half a dozen years. One recent example published is that an incremental increase of 4 Quality-Adjusted Life Years results in a net saving to the healthcare bill with adalimumab, hence it’s recommended for younger patients. Though slowly, the picture is becoming clearer.

If only the politicians refrained from unsupervised social media usage, and also didn’t mistakenly boast of initiatives to supply psychotropic drugs to kiddies thus: “Last month, I visited a secret facility. I can’t tell you where it is, but I can tell you what’s going on there. It’s where we’re growing Victoria’s first crop of medicinal cannabis – a crop that will improve the lives of hundreds upon hundreds of kids suffering from severe epilepsy.

Premier Andrews confused cannabis with cannabidiol.

Premier Andrews confused cannabis with cannabidiol (source:FaceBook).

Positivity – soon to be classified as an illness?

Radio presenter and psychiatrist Assoc Prof Steve Ellen has informed listeners that the American Pschological Association is considering inclusion of Excitable Optimism (EO) as a mental disorder. The Diagnostic & Statistical Manual (DSM) draft has been circulated, as was the case with DSM-5, and evaluation will include prevalence and burden assessments. Steve said “My wife finds my intolerable cheerfulness to be just that, but if the proposed change in DSM-6 goes ahead then it’ll validate my illness, and remove that stigma from other sufferers”. Steve’s upbeat persona might seem invaluable in his role as a director at Peter MacCallum Cancer Centre, but its intrusiveness into personal relationships led him to study the condition through Monash Alfred Pschiatry research centre.

Steve runs a selfie-help group

Steve runs a selfie-help group

A formal diagnosis of EO will require more than just positivity, the discriminant being a manic aspect of excitement on top of delusional belief in things getting better. EO is mooted to join ADHD in the standalone category formed in DSM-5, having both cognitive and behavioural domains (Coghill & Seth, 2011). The plan has already been bookmarked in the International Classification of Disease (ICD) update at ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/Publications/ICD10CM/2017/ where ADHD is renamed HyperKinetic Disease, and sits alongside HyperAffective Disorder (HAD) – an extended definition of the previous ICD coding for Death & Injury Resulting from Terrorism.

These examples are the first application of ideas about endogenous disease affecting others globally, although the association between EO and ADHD isn’t new, indeed being well documented. What isn’t known, but is being keenly investigated, is the contribution of nature or nurture in positivity. “Shared environmental influences on low extreme ADHD traits may reflect passive gene-environment correlation, which arises because parents provide environments as well as passing on genes”, said behavioural geneticist Dr Corina Greven from the Dept of Cognitive Neuroscience at Radboud University.

The proposal reflects growing divisions within Psychology due to the increased adoption of Eastern Buddhist traditions into therapy, most obviously arising from mindfulness in treating disorders. “Positive Psychology is plagued with problems of confusing directionality, and submerged in a lack of rigorous science.” writes psychologist Michael Booth from the Science-Based Medicine organisation. “Mindfulness introduces many things that cannot be refuted or invalidated, and can be used as an ad hominem against an individual. For example: you aren’t meditating correctly, which is why we did not obtain the promised result.”

Results are much clearer in clinical trials. Of the 16 persons reporting persistent high-intensity backpain in a two-year community study, negativity was strongly associated. Positivity affect from family and peers was also associated, but not significantly so. “This is a statistical limitation of the small numbers of participants, with a tripling of study size the p value of 0.08 would have decreased and achieved significance”, author Assoc Prof Anita Wluka advised. “Larger investigations are warranted, to show that pathological optimists are literally a pain in the backside”. The Monash team already has an application in for funding to trial amitriptyline in households with a chronic pain patient where an EO sufferer also resides. Medicating persons other than the patient is controversial, with few precedents being available. Director of NHMRC grants, Saraid Billliards declined to comment, due to the matter still being under review. Further details are available on the clinical trials registry under ref ACTRN12612000131853.

In the immediate term if you, or a person you know has been affected by HAD, the Australian Government has a support line: 1800 123 400

 

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.