The Royal Commission on Genetic Modification - submissions

Diabetes Youth New Zealand

STRATEGIC ISSUES & OPTIONS — SECTION (A)1

Submission

Diabetes Youth New Zealand (DYNZ) stated that its members wish to ensure:

Continued access to all forms of insulin;

The benefits of ongoing research available in New Zealand;

That current and contemplated research be allowed to continue without undue restraint other than necessary approval and control procedures.

They then stated that the Commission must keep in mind the current and future health needs of New Zealanders during their deliberations.

LAW & LEGISLATION — SECTION A(1)

Submission

DYNZ that regulation and legislative control of medicines, medical techniques, laboratory research and clinical trials is well established. Furthermore, such control has been developed over many years according to an understanding of the risk-benefit ratio of particular activities. They then stated that they supported a regulatory environment that allows an ongoing case-by-case examination of risks and benefits with certain provisos. These are that the regulations do not impose unnecessary burdens of cost and proof that stifle research or reduce access to new technology. DYNZ also supported the streamlining of legislation to place control of medicines under one agency — the Ministry of Health. See also the submission of the Researched Medicines Industry.

RISKS & BENEFITS — SECTIONS A(1), B(b), B(j)(i)

Submission

DYNZ noted that GM derived insulin had been used for approximately twenty years and had a history of safety of production and use. They then submitted that the lives of approximately 32,000 New Zealander’s were absolutely reliant on continued access to GM insulin.

Crystal Bridger, a witness for DYNZ, then gave a moving account of her son’s condition and treatment.. Access to insulin derived from the use of GM technology was stated to be keeping her son alive. She then highlighted that constant improvement in treatment was being achieved through research into diabetes as well as new treatments. Lebuinus J M Vink, who has insulin dependent diabetes, stated that if there is a better way of taking insulin, and if there is better insulin to maintain more regulated blood sugars, he would take it. He would not question how it was made. To him it is not a moral or ethical issue, it is simply a question of access to a better life.

Witnesses from Eli Lilly & Co, a company that specialises in diabetes care and research, then outlined the process by which insulin is derived and the concurrent benefits. The following is a summary of their submission.

Prior to the introduction of human insulin of rDNA origin, diabetics received insulin extracted from bovine or porcine pancreases.

Insulin derived from these sources differed from human insulin. The differences in the amino acid sequences caused differences in pharmakinetics, allergenicity and immunogenicity.

Problems were also noted in respect to the possible transmission of infectious diseases and the ability to maintain supply.

Proinsulin, an inactive insulin precursor, is normally synthesised by the islet cells in the pancreas. Through the insertion of the gene for this precursor into E. coli Eli Lily & Co has gained access to an unlimited supply of this precursor negating the above mentioned supply problem.

The precursor is then enzymatically converted and purified to the pure active form of insulin. This insulin has the same amino acid composition and sequence as human insulin.

Eli Lily’s product underwent a wide spectrum of chemical, toxicological, pre-clinical pharmacological and clinical testing for safety, efficacy, and immunogenicity. These studies indicated that their product has biologic equivalence with pancreatic human insulin.

Furthermore, no toxic or immunological effects were shown that could be ascribed to possible impurities such as E. coli proteins from the fermentation process.

Rigorous clinical trials have also shown that this insulin was significantly less allergenic and immunogenic than the animal equivalent.

The rise in blood sugars in response to food is significantly less comparing rDNA insulin to bovine insulin. This may mean better postprandial control.

Insulin resistance, a condition characterised by al lack of response to insulin in the absence of infection or stress, results in a need for increased insulin dosage. Dose requirements fall with a transfer to human insulin.

A decreased frequency of lipodystrophy is also noted in patients using human insulin.

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