Compounder further responds to criticism


Pharmacy connected with beleaguered weight loss clinic defends itself from serious allegations by leading public health figure

Last week AJP wrote about a complaint submitted to AHPRA and the ACCC by Dr Ken Harvey from Monash University’s School of Public Health, regarding the Medical Weightloss Institute (MWI) and Australian Custom Pharmaceuticals.

The reason behind the complaints were reports to Dr Harvey from people saying they had received scripts from the institute for what he calls “a cocktail of complementary and prescription drugs” without having been seen or examined first.

He alleges the institute is “misleading, deceptive and exploitative, lacks an evidence base and preys on a vulnerable population, the overweight and obese,” and calls for any associated parties to be prohibited from further practice.

Harvey says he has also received reports of MWI-prescribed medications arriving by mail from Australian Custom Pharmaceuticals, a compounding pharmacy based in NSW.

He calls out the pharmacy for their association with MWI and failure to provide appropriate advice on the “cocktail of drugs” they are dispensing, including the ingredient diethylpropion, an appetite suppressant that Dr Harvey claims has been inappropriately prescribed.

He says the Pharmacy Board Guidelines on Compounding of Medicines state:

“A compounded medicine should be prepared only in circumstances where an appropriate commercial product is unavailable” (section 2).

“A related weight loss medication, phentermine (Duromine modified release) is registered by the TGA for the management of obesity as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction,” he explains.

He also says following a review of the risks and benefits of diethylpropion and related anorectic drugs by the European Committee for Proprietary Medicinal Products (CPMP), the European Commission decided that the drugs’ licences should be withdrawn. Licences were withdrawn in the UK on April 9, 2000 and the drug was also withdrawn by the sponsor in Australia, Canada, and the majority of other countries of the world,” says Dr Harvey.

Pharmacy and owner of Australian Custom Pharmaceuticals, Daryll Knowles, strenuously denies any allegations of wrongdoing.

“ACP imports diethylpropion through its agent under the strict requirements of a TGA Import Permit,” he told AJP.

Diethylpriopion has been on the market since 1958, he points out, racking up 36 adverse drug reactions and no deaths in Australia.

AJP notes there are several other compounding pharmacies across Australia that also dispense diethylpropion for weight loss.

In response to the drug’s withdrawal from the Australian market, Knowles says it was withdrawn voluntarily by the sponsor mainly due to economic reasons, not due to its safety profile.

He says phentermine, which is still marketed on the ARTG as Duromine, was also withdrawn from the European Union market at the same time along with every other anorectic drug on the market at the time except for Orlistat.

“Curiously, even though the Europeans removed Phentermine (Duromine) from the market, the TGA did not remove it from the ARTG,” says Knowles, “even though Duromine has 149 single drug adverse reactions (four times that of diethylpropion) and two deaths!”

“Would Ken Harvey prefer we use this ‘safe’ TGA ARTG-registered drug?” he asks.

Harvey has no further comment, except to say it’s now up to the NSW Pharmacy Board to decide whether or not Daryll Knowles has contravened guidelines in compounding the substance on behalf of MWI.

Note: Channel Nine has notified AJP it will be looking into MWI in a “special investigation” to be screened tonight (Thursday 22 September).

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2 Comments

  1. Without getting into the issues at hand, I’ve got to say I’m intrigued by the ongoing pharmacy media discussion about the processes thus far. It seems to me that someone who has an acknowledged track record and reputation as leadind consumer advocate in the medical field, has submitted his concerns, rightly or wrongly, which will be examined by the responsible authorities in sccordance with established procedures. On which case, Why do we need ongoing speculation, alternating comments of outrage and/or affirmation etc?
    There’s an old but true gem here!
    If you’re right you can afford to question an issue-if you’re wrong you can’t afford not to!

  2. Geraldine Moses
    22/09/2016

    May I just say that one should never use pharmacovigilance data to compare the safety of one drug with another. The number of reports on the TGA’s (or any other) pharmacovigilance database reflects nothing more than the diligence of the people who were bothered to submit a report . These are spontaneously reported ADRs, not data from clinical trials.
    Hundreds and thousands of adverse drug reactions occur every day that never get reported. Especially if people think we know that side effect already…. They usually perceive little benefit from reporting it again.
    So it is wrong to take the number of ADRs on file and portray it as anything but a “signal” of safety issues. Especially if one of those drugs hasn’t even been on the market for decades. You can only make head-to-head comparisons of drugs from sufficiently-powered, specially-designed studies where you can calculate the numerator and denominator for the frequency of the adverse effect concerned.

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