NZORD's submission on LCT clinical trial

Submission to National Health Committee on LCT Clinical Trial application - July 2008

Earlier this year the Minister of Health asked the National Health Committee to report on the proposed clinical trial by Living Cell Technologies using transplantation of pig islet cells to human patients with diabetes. As part of its task the NHC called for submissions and here is what NZORD submitted:

NZORD is an umbrella network for rare disease patients, families and their support groups, and works to ensure their voices are heard in a range of important research, clinical care and policy areas. There is a detailed archive of many submissions we have made and positions we advocate, on our website at www.nzord.org.nz These submissions include a wide range of issues including genetic modification, xenotransplantation, screening, health services and priorities, assisted reproductive technologies, primary prevention strategies, privacy, ethics, patient safety, and genetics education in the community. We have conducted a wide variety of discussions, conference sessions, newsletter promulgation of topics, and received a wide variety of feedback from many individuals and groups affected by rare diseases, on all of these broad issues over many years.

In respect of xenotransplantation we have had more limited discussion with directly interested groups such as Diabetes Youth. We have actively networked with researchers and attended seminars sessions on the topic, and made submissions to the Bioethics Council consultation early in 2005. In August 2005 we issued a statement calling for a relaxation of the moratorium, and in December that year we made newsletter comment on the Bioethics Council’s final report.

We do not propose to canvass all the detailed issues relating to xenotransplantation. We believe they are well covered in the range of references supplied by you for this consultation, and in items we have referred to. Instead we invite you to consider our earlier comments found at those links above, along with extensive commentary from a wide range of government, research, regulatory, and bioethics agencies, which we believe offer support from the development of controlled clinical trials to determine the safety and efficacy of xenotransplantation as a potential therapy.

In addition we add the following comments relevant to your specific questions:

  • NZORD considers there is no reason to consider the theoretical risk of animal disease transmission to humans via xenotransplants to be an unacceptable risk. To the contrary, the advice of reputable bodies such as the WHO, other regulators, and even the researchers who posed the original concerns that lead to the moratorium in most countries, all advise that controlled clinical trials are appropriate provided there is suitable regulation.
  • We consider that the proposal from the company and the consideration of that proposal by Medsafe, GTAC, and the ethics committee, and the conditions attached to their consideration, do demonstrate that any risks are appropriately managed.
  • In respect of your three questions about ethical, cultural and spiritual issues, we consider that the extensive public consideration given by the Bioethics council and the specific consideration of this particular application by the ethics committee, has adequately addressed these issues.

Our position is consistent with that expressed by Diabetes Youth NZ in their submission to you on 24 July and we endorse their additional comments made. We consider our position also to be entirely consistent with the widely held view among the vast majority of rare disease support groups and patients, and indeed in the community as a whole, that innovation in the search for treatments for disease should be supported provided adequate controls are in place to address and manage risks to safety, and that ethical, cultural and spiritual matters are adequately addressed.

NZORD urges the National Health Committee to give advice to the Minister of Health that the proposed procedure does comply with the criteria in Section 96F(1) of the Medicines Act.

John Forman
Executive Director