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Beauty and the bucks

A couple of years ago twoglobal companies battled it out in Australia over the patent of a cosmetic“filler”product.
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If you haven’t been on the internet for the past five years orpaying attention as you’ve wandered around your local shopping centre recently, a“filler” is material injected into people’s faces–reportedlyto reduce wrinkles and helprecipients“turn back the clock without surgery”.

And when I say people, it’s probably more accurate to say women. Some men go down the“filler” path, but they’re in the minority.

“Fillers” and anti-wrinkle products can take many forms. Submissions to a NSW parliamentary inquiry have citedbotulinum toxin, a“neurotoxic protein” sold as Botox;the now not-so-commonly-used collagen; fat transfers from one part of the body to the face;andhyaluronic acid, a lubricating fluid found in the human bodyand a component of cartilage.

You can walk into any number of outlets these days–sometimes in your local shopping centre –throw your money down and have one or a number of these products injected into your face.

I’d rather hit my head with a brick a few dozen times if it came down to it, but each to his or her own. The issue is about whether it’s safe for people to have the procedures, over and above the usual caveats about all interventions and procedures carrying risk, and whether Australian regulators are keeping up with the rise of the cosmetic procedure industry.

There are big bucks in it.

The Australian Medical Association’s NSW branch told the inquiry Australians spent $350 million on Botox injections alone in the past year. That figure has been consistent for a number of years and is only available because it is a prescription drug.

Because the cosmetic procedure industry is largely unregulated, and some of the materials being injected aren’t prescription drugs or are being imported illegally,we don’t have solid figures on how many people are receiving other injectables or how much is being spent.

We do know people have died in this unregulated field, which is why regulators and governments are scrambling to respond.

For the past fouryears I’ve been writing about the pelvic mesh scandal and the failure of regulators, the medical profession, health departments andgovernments to protect women implanted with devices that might have been approvedfor use, but where too many devices had very little credible evidence to back their safe use.

It was quite shocking to discover how much pharmaceutical industry money sloshed through that device approval and marketing process, and how profoundly the health system failed women despite their complaints about the devices from a very early stage.

The rise of the cosmetic procedure industry –fuelled by the internet and operators able to advertise directly to consumers, and largely unregulated because doctors are only involved with some aspects of it –mirrors the pelvic mesh scandal in one main respect.

Everything boils down to consumers or patients giving“informed consent” in situations where too many people believe that if a product or procedure is legally available to them, then it must be safe. Our health system wouldn’t let anything that’s a riskbe out on the market, right?

Let’s go back tothe patent dispute between two global companies. Company A was challenging Company B over the granting of a patent for a filler with a “non-sulphated glycosaminoglycan” to reduce wrinkles, an anaesthetic, and a compound to reduce bruising and bleeding. Company A objected on a number of grounds, including that combining the three chemical compounds wasn’t a new product at all, but just a combination of existing compounds.

My favourite part of the decision, that ultimately went Company B’s way, relates to a study or studies involving rabbits that was cited in some of the material before the Australian Patent Office.

The studies found the filler product with its enhanced capabilities reduced inflammation and irritation when injected into rabbits. Leaving aside concerns –fine, possibly just my concerns –for the poor bunnies, Company A objected to Company B being able to claim the filler product would be effective in humans, based on the bunny studies.

The Patent Office helpfully noted that “a rabbit is not considered to be an individual in need of treatment with a dermal filler”, but for various other reasons found in Company B’s favour. Its product was patented.

The decision didn’t have to consider the efficacy of the product and whether it isfit for purposeor safe. Other agencies do that. It didn’t have to consider whether medical supervision is required. Other agencies consider that. It simply had to consider whether one company’s product could be distinguished enough from another company’s to be registered as a completely different product, presumably to be marketed in Australia.

We’ll go back to the issue of informed consent becausein the end, and sometimes even when things go wrong, it is the consumer’s willingness to pay for a service and incur the risks that is the only protection.

As the NSW Health Care Complaints Commission put it in a warning issued in September, 2017: “Individuals seeking cosmetic procedures or cosmetic surgery should be vigilant in their research prior to proceeding.”

That includes checking what exactly is in the compounds someone’s proposing to put in your face; what recognised evidence is available supporting its safe use; what emergency procedures are in place if things go wrong; the complaint history of the person holding the injection, and the list goes on. And if it sounds like it’s more than a person should reasonably be expected to know or be able to find out, that’s exactly the point.

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