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