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Workers in blue hairnets at ACP put together the individual orders for patients . Each individual order is monitored via a computerised tracking and labelling system .
These are tailored treatments , he says .
His justification for what he does is rooted in his belief that the treatments he and his staff are making actually work — and this is why he is frustrated by his critics and the regulatory regime .
“ The only thing that [ AMI ] has done wrong — and the thing they ’ ve always been hammered on [ by the Federal Court ] — was that they would not give a refund unless the patient went through to the end of their course of treatment , which [ usually ] ended up being an intrapenal injection .
“ They had everything else in line . All their other ducks in a row , all their good practice . A lot of that was okay . It was their marketing [ that was the problem ] and this thing about the refund .”
Mr Knowles says he provided the ketamine treatments at the Aura clinics before they closed .
Some 350 seriously ill patients were given the weekly injections . Mr Knowles says the treatment transformed their lives . And he produced the treatments for MWI over a period of about 15 months before its demise in February .
The MWI medications included metformin and diethylpropion in their ingredients , the latter a well-known appetite suppressant removed from the Australian Register of Therapeutic Goods in 2006 .
In March , the NSW HCCC issued a public warning saying that “ a particularly vulnerable cohort of health consumers was [ being ] convinced to part with large sums of money for pharmaceutical preparations that may have serious contraindications and side effects and for which there is no credible evidence of efficacy for weight loss ”.
Mr Knowles dismisses the claim , as he did when it was first made , as rubbish .
The removal of diethylpropion was a commercial decision by the maker , not because it was a safety risk , he says . MWI ’ s demise , he says , was again a result of its sales and marketing , and not linked with the safety or efficacy of the therapies .
“ I speak to patients because we call every patient . Have the authorities
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ever spoken to one patient out of the 2500 patients who went through MWI ? No . They haven ’ t asked one patient , ‘ Do you think this worked ?’
“ We see patients who ’ ve lost 20 or 30kg . They love it . And when the thing collapsed , we were inundated with : ‘ Where can we get our meds ?’.”
At this point , Mr Knowles stresses an important truth — for all the criticism he has faced , he ’ s not been the one prescribing the treatments .
“ It ’ s up to the doctors to make that decision . Is this person a good candidate ? Are the medicines safe ? It ’ s for the doctor to say .”
“ Who am I to double-guess the doctor ?” he adds .
“ I ’ m the gatekeeper to ensure the medications are safe .”
Regulator rumbles Mr Knowles says his reputation is largely the product of a rocky relationship with the NSW Department of Health ’ s Pharmaceutical Regulatory Unit . In December 2015 , the unit accused him of breaching the Poisons and Therapeutic Goods Legislation . Those accusations went before the NSW Pharmacy Council last year , which , according to Mr Knowles , decided no immediate action was required .
He also has restrictions on his own pharmacy practice . The AHPRA register is not too clear on the specifics of what happened , but Mr Knowles says he was accused of putting patients at risk by selling peptides under prescription to treat muscular dystrophy , cystic fibrosis and multiple sclerosis .
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‘ WHO AM I TO DOUBLE-GUESS THE DOCTOR ?’
— Darryl Knowles , compounding pharmacist
He ’ s done nothing wrong , he says . His appeal is currently before the NSW Civil and Administrative Tribunal .
For critics like Dr Harvey , businesses like MWI , AMI and Aura exist only because compounders like Mr Knowles are slipping through loopholes .
“ Basically they are doing what is an industrial processing [ in producing these drug treatments ] and claiming it ’ s for individual patients ,” says Dr Harvey .
“ I [ also ] think there ’ s a problem with AHPRA , and the Pharmacy Board of Australia and the Medical Board of Australia . I mean , they slap these guys over the wrist with a feather and of course they keep on keeping on .
“ I can ’ t understand why the regulators haven ’ t moved .”
Mr Knowles , when Australian Doctor mentions Dr Harvey ’ s name , is not impressed by the man he dubs “ Crazy Ken Harvey ”.
“ Dr Harvey , who ’ s also forbidden to practise as a doctor ,” Mr Knowles tells Australian Doctor .
“ He can ’ t give clinical advice , can ’ t give clinical opinions or physical advice on patients , but is still out there banging his drum .”
Harsh words , but not quite accurate . At the age of 73 Dr Harvey has semi-retired , changing his AHPRA medical registration earlier this year from ‘ general registration ’ to ‘ teaching only ’. He ’ s not banned .
The TGA way Talking to Mr Knowles as he gets wrapped up in his thoughts , you sense he genuinely feels victimised . And maybe he wants a fresh start . During our interview , he takes us through one of his laboratories and into a huge space , empty , save for some mixing and blending machines . It is here that he says he will start producing medications for clinical trials . But it will be TGA-accredited .
“ I ’ ve been doing battle with these guys for 15 years , and rather than fight anymore , I ’ ve decided I ’ m going do the TGA thing ,” he declares .
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“ It ’ s more expensive , but it ’ s black and white .”
He says that ACP has not made him vast riches . He lives relatively modestly in an apartment close to where he works . He says the money charged by the clinics are not specifically for his treatments .
He says under the regulations , he is required to sell the treatments he produces directly to patients ( he is not a wholesaler ). And he does this relatively cheaply .
The patients are paying the big dollars for the other services the clinics provide , he says .
What services , Australian Doctor asks ?
The consults with doctors , he says , or the access they get to dietary advisors or the fitness experts .
When asked if he is worried about ACP being closed down , he responds : “ My team is so good here they would run ACP without me , no one ’ s indispensable .”
And then he adds words he often repeats : “ Millions of patients , not one report from any patient , or any treating doctor of any harm , ever — and they ’ re saying I ’ m causing harm .
“ This is where our system is broken .”
No sale today The Australian Doctor phone call to the hormone clinic promising to make this publication the man it wants to be isn ’ t going well . The salesman is getting frustrated with the endless questions .
So just explain again what does this youth-generating treatment involve ?
“ It would depend on your blood results , so it is all tailor-made in line with that , so it just depends exactly what you ’ re in need of . It will depend on your blood results and what your main deficiencies are .” Are doctors involved ? “ It ’ s all done through our specialists ; it ’ s not done through GPs . Without putting them down , they don ’ t know the next thing about your hormones .”
“ Is that right ?” Australian Doctor says . But this is a rhetorical question .
A few minutes later , the line goes dead . The sales guy guesses he ’ s not making a sale . ● Australian Doctor reporting team : Brett Evans , Jocelyn Wright , Geir
O ’ Rourke and Paul Smith
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