International Research Standards: Xenotransplantation

For practical purposes, ethical standards in research are set on a national basis. There are, of course, important international documents like the Declaration of Helsinki and the Nuremberg Code. But for most purposes, ethics standards are “local” — both because to a certain extent local conditions and national values differ, and because ethical standards are most effective when they have the force of law and regulation behind them. But in some cases, there’s a particularly good argument for international standards. Here’s one.

From Australian Life Scientist: Xenotransplantation trial to commence in NZ

New Zealand biotechnology company, Living Cell Technologies (LCT), has announced today that it has gained approval from the New Zealand government to begin clinical trials of its DiabeCell treatment for insulin-dependent diabetes.

DiabeCell are pig cells that produce insulin and when implanted into the abdomen have been shown to lead to near-normal blood glucose levels in patients, reducing or eliminating the need for insulin injections.

Here’s the interesting part:

Trials in Australia are currently banned as a result of a moratorium in place by the Australian Government on xenotransplantation.

The Australian Government imposed a five year moratorium on xenotransplantation in 2004, prohibiting the transplantation of organs or cells from animals to humans until more information is available about possible health risks.

Now, from what I understand, the key health risk in xenotransplantation is zoonosis — roughly the trans-specific spread of contagious disease. There may be diseases carried by, say, pigs, that are neither very contagious nor very serious to pigs, but which, if they made the leap to humans (say via having pig parts transplanted into humans) could turn out to be deadly, or contagious, or both. And if we’re talking about contagious diseases, the risk is not simply a risk to the health of the individual patient/research subject. It’s to the population. So presumably Australia’s ban exists because of the fear (justified or not) that xenotransplantation poses a public health risk.

So: New Zealand’s standards for research ethics permit xenotransplantation. Australian standards forbid it. The problem is that zoonosis (if it happened) would be a problem highly unlikely to respect international borders. Now, admittedly, NZ is an island. But there are flights between countries these days. If ever there were a case that calls for international harmonization of standards, wouldn’t this be it?

~ by Nancy Walton on July 6, 2009.

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