THE mother of a Newcastle toddler who became comatose after swallowing a near lethal dose of ethylene glycol has criticised the sluggish pace of the national product safety system, and believes government jitters in the wake of the recent Pan Pharmaceutical court case placed other young lives at risk.
Almost three weeks after Dominic Mellare, 3, was rushed unconscious to the John Hunter Hospital and later flown to the Children's Hospital at Westmead, the gel-based ice packs containing the illegal poison, commonly used in antifreeze and as a brake fluid bearing "non-toxic" labels, remain on store shelves.
Yet the federal Department of Health and Ageing and the Therapeutic Goods Administration have known since last Thursday that the ice pack Dominic chewed on was not an isolated case of ethylene glycol contamination. Earlier in the week the TGA tested seven other Thermoskin ice packs and all were contaminated, some with as high as 50 per cent ethylene glycol content.
"They're still out there for people to buy," said Mrs Mellare, who has been regularly ringing the TGA to demand a national recall of the ice pack for the past two weeks.
The NSW Department of Health referred Dominic's case to the Department of Health and Ageing on August 19, which in turn referred it to the TGA "as a matter of urgency". The same day the Federal Court awarded the former Pan Pharmaceuticals boss Jim Selim $55 million as a result of a botched recall by the TGA in 2003, which led to Pan's collapse.
Mrs Mellare believes the TGA has dragged its heels over issuing a national recall of the contaminated ice packs following the adverse publicity the authority received for its over-zealous recall operations during the court case.
But a spokeswoman from the federal Department of Health, Kay McNeice, told the Herald late yesterday that the TGA had issued a notification for Thermoskin's Australian distributor, United Pacific Industries, to conduct a voluntary recall last Thursday.
Late yesterday the department still had not listed the product on its Product Recalls Australia website, and it appeared retailers had not been informed of the recall either. The ice packs were still on city pharmacy shelves.
Ms McNeice said a notification of the recall would be posted on the website today, and that United Pacific Industries was in the process of placing advertisements to publicise the recall.
The TGA was in the process of collecting samples and paperwork from all manufacturers of ice packs in Australia for further investigation, she said, although at this stage only the Thermoskin brand appeared to be affected.
United Pacific Industries did not return the Herald's calls yesterday.
The department has denied the recall process for the contaminated ice packs had taken longer than usual. Ms McNeice said the six-day time frame between confirmation of contamination of a product and publicising a recall was standard for all "non-life threatening" cases.
But her comments have angered Mrs Mellare, whose son underwent emergency dialysis and was in hospital for a week after nibbling the bright blue "iceblock" with the toxin inside it. The existence of any long-term damage to Dominic's kidney and neurological functions is still unknown. "If Dominic had been a 12-month-old instead of three-year-old, I very much doubt he'd be here today," she said.