Prof Cathie Martin and the John Innes Centre appear to be intending to test their GM tomato on sick humans before doing animal toxicological tests - a breach of the Nuremberg Code and basic medical ethics.
It's been announced that human trials will be carried out "soon" on heart patients with the GM purple tomato developed by Prof Cathie Martin at the John Innes Centre.
This is extraordinarily irresponsible and breaches medical ethics. This tomato has not, as far as we know, been through proper toxicological testing in animals, a necessary step before commercialising a GMO in the EU.
Martin and the JIC may be trying to sidestep the EU's GMO food and feed regulatory process, which demands a 90-day animal test prior to commercialisation, by classing this as medical research.
But in that case, they will be contravening the Nuremberg Code, which was set up to police medical trials after the horrors of Nazi human experimentation in Germany under Hitler. The Code demands that medicines are tested on animals before being tested on humans.
The World Medical Association (WMA) wording adopting the Helsinki Declaration on ethical principles for medical research involving human subjects is a little equivocal but still implies that animal experimentation is needed before human:
"Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation."
A WMA publication on Ethics and Medical Research is, however, clear and unequivocal. It lays out the necessary procedures for testing a drug as follows:
1. Lab studies
2. Animal toxicological testing
3. Research on healthy volunteers
4. Research on a group of patients who have the disease being targeted, to look for beneficial effects on the disease and side-effects.
5. Full-scale clinical trial, double-blinded so that neither subjects nor physicians know if they are receiving the drug or a placebo.
As far as we can tell from the (lack of) published studies on the GM tomatoes, it looks as if Cathie Martin and the JIC have missed out at least (2) (animal toxicological studies) and (3) (research on healthy volunteers), preferring to go straight to (4).
Martin took the same line in a previous round of media hype on the GM tomato in 2008, claiming breathlessly, “The next step will be to take the preclinical data forward to human studies with volunteers to see if we can promote health through dietary preventive medicine strategies.”
It's interesting to contrast her claims with the more measured press release from one of the JIC's collaborators in the research - the Universita Cattolica del Sacro Cuore. In that press release, Marco Giorgio from the European Institute of Oncology warned, "We have to consider that in this study we have not taken into account any possible toxicity so I shall say we’re far from considering a human trial."
If Martin and the JIC really are planning to rush ahead with human trials on sick people before doing basic animal toxicology testing, then they are putting patients at risk. Sadly this would be typical of the arrogant behaviour we have come to expect of pushers of this technology.