concerns
Advanced Medical Institute( AMI), the multimillion dollar enterprise that during its glory days had clinics stretched across the nation, spruiking treatments to men with erectile dysfunction.
Before it ended up in front of the Federal Court of Australia in 2015, accused of“ unconscionable conduct”, AMI was frequently savaged for its patient care.
Some of the teleconsults lasted only 90 seconds before prescriptions were written for patients whom doctors had never met faceto-face.
Sales staff were also directed by AMI management to warn customers of potential health risks if their erectile dysfunction was not resolved— problems like penis shrinkage.
But there have been other variants. Take the( recently defunct) Medical Weight-loss Institute( MWI). Again, the same set up: marketing, hotlines, sales staff, teleconsult prescriptions. Again the end point was expensive treatment programs running to thousands of dollars. Or the Aura Medical Corporation. Another footnote in Australian healthcare history, two years ago it was running direct-to-consumer advertising targeting patients with severe treatment-resistant depression. There was a hotline number to ring. But this time the medical salvation sold involved ketamine injections, an experimental treatment, which, to the alarm of some psychiatrists, had not been assessed for safety or efficacy by the TGA, and were being administered outside the context of an ethics-approved medical trial. Some patients paid up to $ 3000 for the regime.
Willing doctors According to consumer advocate Dr Ken Harvey, adjunct associate professor at the school of public health and preventive medicine, Monash University, there are two elements essential to the existence of these commercial clinics.
Firstly, they need doctors willing to prescribe medication over the phone. AMI successfully recruited doctors to carry out this service.
Such doctors, famously described as“ cogs in a commercial machine” by one Federal Court judge, are important because they link to the second element— one far less discussed— and that is their ability to prescribe extemporaneous compound pharmacy treatments.
“ Compounded treatments are important, not only because they allow the clinics to charge big dollars for the services they provide. They have the added bonus that they escape the same regulation applied to mainstream drug treatments,” Dr Harvey says.
In fact the regulatory barriers, which usually mean only giant billion-dollar corporates like Pfizer or Bayer are able to bring new drugs to market, evaporate like a mist at sunrise. This is because extemporaneously compound pharmacy treatments are devised specifically for an individual patient and as such, they don’ t have to go through a formal TGA approval process for their safety and efficacy, provided they are being prescribed by a doctor.
The compounding King In a nondescript industrial estate in the southern Sydney suburb of Taren Point is a company called Australian Custom Pharmaceuticals( ACP).
ACP is owned by a pharmacist called Daryll Knowles, a big player in the small world of compound pharmacy. ACP has made and dispensed many of the treatments prescribed by the doctors working for AMI, MWI and the Aura Medical Corporation.
Bearded, voluble, energetic, Mr Knowles accepts he has become a controversial figure. But sitting in his office, he says he has been unfairly targeted by both critics and regulators. There is much misunderstanding about what he does, he says.
“ The giving and helping people thing— that’ s what it’ s all about”, he tells Australian Doctor on a recent visit to his premises.
“ Where I could really help people, I realised, was in this field, which they now call modern compounding.”
His operation is significant. It is spread across four units, a rabbitwarren of labs, sterile zones and stockrooms. Stacked high in one room are huge, 44-gallon drums and scrawled on the masking tape on the shelving unit are the letters‘ AMI’ and‘ MWI’. Carried in the air, through the facility, is that faintly sweet smell unique to chemical labs.
Mr Knowles went to Sydney University and graduated with a Bachelor of Pharmacy in 1980. He then set up as a suburban chemist. But his career turning point arrived in 1989, when the TGA produced a new set of guidelines on the arcane art of extemporaneously compound pharmacy.
There would be no requirement for the products of this labour to be listed on the TGA register of therapeutic goods.
The argument for the light touch was to ensure that there were treatments for patients when an appropriate commercial product was unavailable or unsuitable.
Mr Knowles saw new opportunities.
“ In the 1990s, I was getting a lot of requests for compounding from mothers. The Ritalin thing was just starting and their kids were having trouble with their midday dose with their dexamphetamine and Ritalin.
“ The women kept coming to me saying:‘ How can I do it? He either won’ t take it or he’ s bullied for the dose or they were ashamed of their dose’.”
So he customised the medicines, creating a longer-acting formulation so that the children didn’ t have to take tablets during school hours.
This was the start, but it wasn’ t long before he teamed up with AMI, a new business run by the refugee, one-time urologist and medical entrepreneur Jack Vaisman. The treatments AMI were selling varied— pills, lozenges and nasal sprays— but ACP were contracted to make them up for individual patients based on scripts issued by AMI’ s doctors.
What was different was the scale. It was no longer a few dozen or even a few hundred patients. Back in 2009, for instance, during the height of the AMI business, Mr Knowles says his company produced more than 15 million individual doses of compounded medicines“ in individual dose forms” to patients of AMI clinics and more than 2500 other medical practitioners.
Today Mr Knowles says AMI— which after its history of regulatory problems and its Federal Court case is operating under new management— makes up only a small part of his current business.
A small, but significant, chunk is preparing drugs and placebos for medical trials; the rest is based on dispensing compounded prescriptions. But he insists he is not a mass producer, not an industrial-scale drug-maker. cont’ d next page
www. australiandoctor. com. au 28 July 2017 | Australian Doctor | 11