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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.

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.”

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.

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.

Forensic 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.

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