Media Releases
Information released for people who use bovine insulin
Australia's Chief Medical Officer, Professor Richard Smallwood announced that a detailed audit of bovine (beef derived) insulin used in Australia has shown that some beef insulin available in Australia may contain small amounts of Dutch-derived bovine insulin.
22 March 2001
Information released for people who use bovine insulin
Australia's Chief Medical Officer, Professor Richard Smallwood today announced that a detailed audit of bovine (beef derived) insulin used in Australia has shown that some beef insulin available in Australia may contain small amounts of Dutch-derived bovine insulin.
The vast majority of bovine insulin products in Australia are sourced from North America which is classified as BSE-free while a small number of cases of BSE have been reported in the Netherlands
"The NHMRC Special Expert Committee on TSE's (Transmissible Spongiform Encephalopathies) has reviewed this information and advised that available evidence and evaluation of the manufacturing processes involved indicate there is a very low risk of BSE transmission through these products," Professor Smallwood said.
"It is clear that the potential risk from this product is infinitesimally small.
"Nowhere in the world is there any direct evidence to link bovine insulin to vCJD .On a theoretical basis, the risk of contracting variant Creutzfeldt Jakob Disease (vCJD) from this insulin is estimated at one in a 100 million years of treatment in the worst possible case."
Professor Smallwood said, that on the other hand there is a very real risk to the health of people if their current treatment using bovine insulin is disrupted.
"In Australia most people with diabetes are using recombinant human insulins which are very effective, with no risk of vCJD transmission, but some people still rely on bovine insulin to stabilise their condition. These people should speak to their doctors about the balance of risk should they wish to change to other forms of insulin," he said.
As a precautionary measure, the TGA has moved quickly to ensure that all stocks still held by the supplier (Aventis) have been quarantined.and that all future batches of bovine insulin be certified as sourced from BSE-free countries.
Professor Smallwood said the Commonwealth had been liaising with Diabetes Australia in the management of this issue to ensure that the people who are still using bovine insulin are contacted and informed of the situation
"It is estimated between 300 and 400 people in Australia rely on bovine insulin products. However, because of the need for people with diabetes to maintain their treatment, and the extremely low risk of BSE transmission, the insulin containing a small quantity of Dutch bovine material will not be recalled," he said.
Mr Brian Conway, from Diabetes Australia, said his organisation would be advising people who rely on bovine insulin to talk to their medical practitioners about further management of their condition.
"Based on the evidence provided by the Commonwealth, people who are currently using bovine insulin and those who have used it in the past should not be alarmed as the risk of the transmission of BSE is extremely remote," Mr Conway said.
More information can be obtained by ringing a special BSC/vCJD information phone line on 1800 200 701 or by visiting the internet on www.health.gov.au
Media inquiries: Kay McNiece, Commonwealth Dept. Health & Aged Care 0412 132 585
