Alarm sounded over anti-choking devices installed in Perth
Brian Bwoga, of Beldon, has been asking councils across Perth to install LifeVac anti-choking devices after his 22-month-old son Zaza died after choking on a grape in 2024.
The Town of Bassendean is the latest council to consider his request.
The cities of Joondalup and Vincent agreed earlier this year to install the devices.
LifeVac is a self-powered portable suction device developed for clearing the upper airway when standard first aid protocols fail to relieve a choking incident.
But Philip Heimlich says his father Dr Henry Heimlich, who died in 2016, said the drawbacks of such devices were 'obvious', including that they had to be nearby and it would be 'virtually impossible' for victims to use it on themselves.
While he admired the councils' dedication to saving lives, Mr Heimlich said in an email to the Joondalup and Bassendean mayors that studies had shown the dangers of anti-choking devices. The contents of the Lifevac kit. Credit: Supplied
The Royal Life Saving Society WA Inc has said there was limited evidence of efficacy of the anti-choking devices and was concerned they could cause additional harm if not used appropriately or delayed the use of established procedures.
The US Food and Drug Administration choking rescue protocols do not include anti-choking devices as they have not been FDA-approved or cleared.
'Consumers should be aware that using anti-choking devices first could delay action, as consumers usually have to take them out of packaging, assemble them, and follow device instructions, which may delay the use of established rescue protocols,' its website says.
Mr Heimlich said people could suffer brain damage or death in four minutes if the choking object was not dislodged.
'Since my father invented the Heimlich manoeuvre in 1974, untold numbers of choking victims have been saved by his procedure around the world,' he said.
'Each week, there are dozens of news reports on lives saved by his method, and it's extremely rare that the Heimlich manoeuvre is not effective.'
A Heimlich manoeuvre involves a person standing behind a person and squeezing their diaphragm.
The American Red Cross and UK National Health Service recommend abdominal thrusts only if coughing and slaps to the back do not remove the obstruction. They are not recommended on children younger than one year old.
Mr Bwoga told the Town of Bassendean's June 24 meeting about 10 WA councils had agreed to install the devices and they cost less than $200.
'I'm not here to make somebody vote for something they don't wish to vote for but I'm just here as a dad who's trying to make sense out of this tragedy,' he said.
'I don't want to hear another parent go through the same thing that I went through.'
The council voted in support of mayor Kath Hamilton's proposal that the town investigate the costs, benefits and risks of installing LifeVac devices at town facilities where automated external defibrillators are installed and report back by August.
Town CEO Cameron Woods said it was always prudent to do some research but 'cost is not an issue when we're talking about saving young lives'.
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Perth Now
3 days ago
- Perth Now
Alarm sounded over anti-choking devices installed in Perth
The son of the doctor credited with the development of the Heimlich manoeuvre says there are risks from using anti-choking devices to save people's lives. Brian Bwoga, of Beldon, has been asking councils across Perth to install LifeVac anti-choking devices after his 22-month-old son Zaza died after choking on a grape in 2024. The Town of Bassendean is the latest council to consider his request. The cities of Joondalup and Vincent agreed earlier this year to install the devices. LifeVac is a self-powered portable suction device developed for clearing the upper airway when standard first aid protocols fail to relieve a choking incident. But Philip Heimlich says his father Dr Henry Heimlich, who died in 2016, said the drawbacks of such devices were 'obvious', including that they had to be nearby and it would be 'virtually impossible' for victims to use it on themselves. While he admired the councils' dedication to saving lives, Mr Heimlich said in an email to the Joondalup and Bassendean mayors that studies had shown the dangers of anti-choking devices. The contents of the Lifevac kit. Credit: Supplied The Royal Life Saving Society WA Inc has said there was limited evidence of efficacy of the anti-choking devices and was concerned they could cause additional harm if not used appropriately or delayed the use of established procedures. The US Food and Drug Administration choking rescue protocols do not include anti-choking devices as they have not been FDA-approved or cleared. 'Consumers should be aware that using anti-choking devices first could delay action, as consumers usually have to take them out of packaging, assemble them, and follow device instructions, which may delay the use of established rescue protocols,' its website says. Mr Heimlich said people could suffer brain damage or death in four minutes if the choking object was not dislodged. 'Since my father invented the Heimlich manoeuvre in 1974, untold numbers of choking victims have been saved by his procedure around the world,' he said. 'Each week, there are dozens of news reports on lives saved by his method, and it's extremely rare that the Heimlich manoeuvre is not effective.' A Heimlich manoeuvre involves a person standing behind a person and squeezing their diaphragm. The American Red Cross and UK National Health Service recommend abdominal thrusts only if coughing and slaps to the back do not remove the obstruction. They are not recommended on children younger than one year old. Mr Bwoga told the Town of Bassendean's June 24 meeting about 10 WA councils had agreed to install the devices and they cost less than $200. 'I'm not here to make somebody vote for something they don't wish to vote for but I'm just here as a dad who's trying to make sense out of this tragedy,' he said. 'I don't want to hear another parent go through the same thing that I went through.' The council voted in support of mayor Kath Hamilton's proposal that the town investigate the costs, benefits and risks of installing LifeVac devices at town facilities where automated external defibrillators are installed and report back by August. Town CEO Cameron Woods said it was always prudent to do some research but 'cost is not an issue when we're talking about saving young lives'.
News.com.au
4 days ago
- News.com.au
Biocurious: Dimerix could be riding big and beautiful kidney drug success earlier than expected
With the FDA's blessing, Dimerix will use phase III trial endpoints that could lead to accelerated approval for its kidney disease drug Dimerix is confident of phase III success because an expert 'peek' at the blinded data shows it's on the right track The company is well cashed up, courtesy of four global distribution deals When it comes to clinical trials, the choice of primary endpoints can mean the difference between a trial failing and a billion-dollar blockbuster drug emerging. Plenty of drug candidates have looked successful at mid stage, but then floundered because a later stage trial has failed to meet strictly defined goals. This appears to be the case with Opthea (ASX:OPT) and the recent failure of its two phase III eye disease trials. In other cases, strictly enforced endpoints mean that a trial is too long and too expensive. But regulatory attitudes are changing. In the case of Dimerix (ASX:DXB), the US Food & Drug Administration (FDA) has delivered the kidney disease drug developer a concession on endpoints for its ongoing phase III trial. The FDA's stance not only means that the endpoints are more likely to be achieved, reducing risk. It also means the company could win accelerated FDA marketing approval before the study has completed. 'That sparked a lot of interest in the sector because suddenly the trials are more manageable,' says Dimerix chief Dr Nina Webster. The 286-patient study is testing Dimerix's candidate DMX-200 for the regressive focal segmental glomerulosclerosis (FSGS). A rare – but not ultra rare – disease, FSGS usually results in end-stage kidney failure. Endpoints have delayed the endgame Previously, the FDA had set an endpoint of how well a drug preserves kidney function. But this meant a trial had to track the patient to kidney failure or death, which could take years. This makes a trial too long and too costly. 'In rare diseases, no-one is going to do these studies,' Webster says. About five years ago the FDA became more amenable to the use of 'surrogate' endpoints These are measures that substitute a true clinical endpoint to expedite drug development. The FDA allowed the use of the kidney function biomarker, called estimated global filtration rate (eGFR). Under the dainty banner of 'Parasol' – and, no it's not an umbrella group – experts advised the use of proteinuria as a further alternative endpoint for FSGS. Proteinuria is kidney proteins seeping into the urine, while eGFR is the rate at which the spuds can cleanse blood. If proteinuria is present and the eGFR is not up to scratch, they are sure signs the kidneys are not working as they should. Conversely, if a drug reduces proteinuria or the eGFR 'slope rate' – the rate of decline – it is accepted as being effective. Parasol promises faster Action Dubbed Action 3, the Dimerix trial involves two years' treatment, as measured against placebo. The study is due to complete in 2027 when the last patients have been treated. But Dimerix now is working with Parasol to establish the exact surrogate endpoints required to front the FDA for accelerated marketing approval. Expedited approval is as allowed for some orphan drugs, such as DMX-200. 'The full study is for two years and that doesn't change,' Webster says. 'Th question is whether we can get interim approval and go to market earlier.' One possibility is that proteinuria alone could be the accepted endpoint, given proteinuria and eGFR appear to point to the same thing. That is: deteriorating kidneys. Dr Webster says an accelerated endpoint must reasonably predict the outcome of the trial. 'The question is, what do we need to see at point X to prove the end at point Y? Parasol is working with us on that. 'We're collecting all of our data on eGFR and proteinuria anyway, so it gives us a lot of flexibility in the program.' (Other geographies such as Japan and Europe still require an eGFR endpoint). Surrogate change spurs others … The FDA's stance on surrogate endpoints could be a double-edged sword for Dimerix, as it also provides succour to potential rivals. In this vein, a drug called sparsentan (brand name Filspari ) won FDA approval for a kidney condition called IgA nephropathy. The drug failed its Phase III endpoint for eGFR. But now its owner Travere Therapeutics is having a crack at FDA marketing approval for FSGS using a proteinuria endpoint. The data from the supportive trial was unblinded, which means the study custodians can't change the endpoints retrospectively. 'But the FDA is in a hard spot with this one because is an area of such high unmet need,' Webster says. 'These patients currently have limited treatment options and Filspari looks like it is doing something for them. 'We are waiting with bated breath in the hope that Filspari is approved and gives hope to these patients.' Travere has licensed the European and local sparsentan rights to our own CSL (ASX:CSL). … but we're friends, not rivals Webster says rather than rivalling DMX-200, sparsentan could be used in unison. An angiotensin receptor, sparsentan targets high blood pressure – a key cause of kidney disease in the first place. (High blood pressure causes inflammation which causes scarring and cell death). Thus, sparsentan needs to be better than the current blood pressure medication. But DMX-200 works on the secondary inflammatory pathway, with the patients already on blood pressure meds. 'It's not apples for apples with study design, which is why we are compared against the placebo and not a comparator,' Webster says. In effect, DMX-200 faces a lower comparative hurdle. 'Our drug is complementary, not competitive,' Webster says. Data 'peek' hints at trial success While a trial result is never certain, Dimerix is confident it won't meet the fate of Opthea or Percheron Therapeutics (ASX:PER). (The latter's neurological disease trial also failed to meet primary endpoints). One reason is that the Action 3 trial already has been subject to a blinded interim analysis by an arm's length expert committee, which peeked at the data. 'Blinded' means that Dimerix, the trial investigators and the patients don't know the results. In March last year the 72-patient analysis reported that DMX-200 worked better than placebo. As per protocol, the experts did not disclose the extent of this efficacy. But it was enough for the company to know that it's on the right track. 'We just know at that point in time, we were doing better and that if we carry on that trajectory, we have a shot at the endpoint,' Webster says. 'That was a big moment for us, because we wanted to confirm something similar to our smaller phase II study in a larger cohort of patients.' FDA approval could come sooner rather than later Dimerix has received over $65 million of cash, courtesy of four distribution deals that may deliver up to $1.4 billion of milestone payments plus royalties. While a further capital raising is a case of 'never say never', it's unlikely. Naturally, most of the milestones are back ended to achievements such as phase III success and FDA approval. But with accelerated approval possible after the interim analysis, the latter might be sooner than investors think. Many drug developers view the Trump Ascendancy Mark Two with trepidation. In contrast, Webster notes Trump nominated kidney disease as a key health priority in his first stab at POTUS. The financial motive alone is compelling, in that dialysis costs the US health system around US$125 billion annually. 'We are in the sweet spot of being a rare disease (with pricing benefits) and having the potential to reduce US healthcare costs,' Webster says.
Sydney Morning Herald
5 days ago
- Sydney Morning Herald
Melbourne breast cancer trial to test Optiscan imaging device
ASX-listed medical technology company Optiscan Imaging has started recruiting up to 50 patients for a Royal Melbourne Hospital clinical trial of its innovative precision surgery and digital pathology imaging devices, aiming to improve a common breast cancer surgery. The groundbreaking clinical study will utilise Optiscan's InVue microscopic precision surgery device, as well as its InForm digital pathology imaging system, to create a new, improved treatment regimen for breast cancer patients. The company will investigate the clinical workflow and real-time imaging capabilities of the two platforms in its first in-human breast cancer study. Optiscan will use data from the trial in its submissions for United States Food and Drug Administration (FDA) registration for the devices. Surgeons will use the InVue device during surgery to capture live imaging data from a woman's breast tissue after removing a tumour. It will provide the surgical team with immediate feedback on tumour clearance, ensuring there is a margin of healthy breast tissue around the site where the tumour was removed. Achieving a clear surgical margin, where no cancerous cells are left at the edges of the removed tissue, is critical to a patient's long-term health outcome but poses a significant surgical challenge. 'We believe our innovative real-time microscopic imaging platform represents a genuine breakthrough in surgical cancer management by bringing live cellular imaging to the bedside.' Optiscan Imaging chief executive officer and managing director Dr Camile Farah Using topical dyes, the removed tissue will then be examined with the InForm device to back up the InVue imaging. The additional InForm pathology data will be fed back into the company's imaging and pathology workflows ahead of its FDA application. The study will also incorporate InForm imaging of tissue samples taken chairside or from pathology laboratories to match its other ex vivo patient data. InForm can assess new tissue samples quickly and accurately with high resolution and magnification. While each device was designed to operate independently, Optiscan says it purposefully included both in the trial to maximise data collection, minimise the need to recruit patients into further trials and accelerate its regulatory submissions.
