The promotion of a product hailed as a new option for the management of early stage Alzheimer’s disease is under the microscope following complaints from public health expert, Dr Ken Harvey.
In a recent article on The Conversation, Dr Harvey, Adjunct Associate Professor of Public Health at La Trobe University, revealed he had submitted complaints to the TGA and the therapeutic products Complaint Resolution Panel (CRP), arguing the promotion of Souvenaid, which has contained the words “clinically proven” - breached the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code 2007.
“This is because the product appears to be a therapeutic good but isn’t listed on the Australian Register of Therapeutic Goods (ARTG) and lacks approval to be promoted as therapy for a serious disease,” he said.
“Souvenaid contains a mix of omega-3 fatty acids, vitamins, minerals and other nutrients recommended by Australian Dietary Guidelines 2013.
“With one exception (uridine monophosphate), all the ingredients are listed as suitable for use in complementary medicines by the TGA.
“The claims, ingredients and recommended dose satisfy the definition of a therapeutic good contained in the Therapeutic Goods Act 1989.
“If Souvenaid were classified as a therapeutic good it should be listed with the TGA on ARTG and comply with the Therapeutic Goods Advertising Code 2007.
“The advertising code prohibits the promotion of products for serious diseases such as Alzheimer’s disease. It’s possible to obtain advertising approval from the TGA for a restricted representation but a case must be made, including substantiating evidence and an explanation why approval would be in the public interest.”
Dr Harvey was also critical of the scientific studies cited by Nutricia Australia Ltd – the sponsor of Souvenaid – to support the claim that the “memory drink” has been shown to reduce the risk of developing memory impairment and dementia.
Speaking at APP2013, Dr David Wilkinson, director of the Memory Research and Assessment Centre at Moorgreen Hospital, Southampton, UK, said the development of Souvenaid was “good news” in a field which had seen a lot of disappointing trial outcomes.
“It does what it was intended to do, providing nutrients that enhance memory in these patients – principally those with mild dementia,” he said. “Important studies covering its use for 12 weeks and six months respectively showed demonstrable improvements compared to people taking placebo.”
A spokesperson for Nutricia told Contact that Souvenaid was classified as a Food for Special Medical Purposes.
“According the Food Standards Code, Standard 2.9.5 - Food for Special Medical Purposes, Souvenaid is classed as a Food for Special Medical Purposes . This group of products are often referred to as 'medical foods'," the spokesperson said.
"As people with Alzheimer's disease have medically determined nutritional requirements, Souvenaid has been developed to nutritionally support the processes in the brain responsible for synapse formation and as such nutritionally supports memory function during the early stages of the disease.
"Souvenaid is designed to be taken in addition to a normal healthy diet as recommended for people living with Alzheimer's disease. It is not recommended that Souvenaid be consumed as a sole source of nutrition. As a Food for Special Medical Purposes, Souvenaid is intended to be used under medical supervision.
"It is not regarded as a Therapeutic Good. Alzheimer's disease is a serious, complex neurodegenerative disease. Souvenaid does not cure, prevent or treat Alzheimer's disease, nor is it a replacement for prescription therapies approved for use in the treatment of the disease.
In the introduction of Souvenaid in Australia, Nutricia Advanced Medical Nutrition has adhered to all necessary regulations surrounding Food for Special Medical Purpose. As per the requirements of the Food Standards Code and other relevant legislation, practices related to Souvenaid have been compliant.
"The development of Souvenaid is supported by extensive pre-clinical research and a robust clinical trial programme. Trial results have been published in reputable peer reviewed medical journals.”