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.