A Case With Disturbing
Implications For Present
Two years after the release of the first GM plant, the FLAVR-SAVR tomato in the USA in 1995, there was still not a single publication in peer-reviewed journals probing into the safety of GM foods. As this was of public and scientific concerns..the Scottish Office Agriculture, Environment and Fisheries Department (SOAEFD, as it was called then) called for research proposals to investigate the safety of GM foodcrops; their possible effects on the environment, soil, microorganisms, animals, and whether they presented any risks for human consumers.
Of the original 28 proposals received by SOAEFD, ours was accepted as scientifically the most sound after peer-review by the BBSRC (Biological and Biotechnological Sciences Research Council). In our research plan we specified in detail what we wanted to do and how, with the design of all the experiments, and what we were going to deliver and when, etc.. The tasks of the project were divided between the three research units involved: The Scottish Crop Research Institute (SCRI), University of Durham, Department of Biology and the Rowett Institute in Aberdeen. At the request of the scientists participating in the programme, I co-ordinated it.
In our research to find suitable methods for the risk assessment of GM crops we used GM potatoes as a model for GM crops. These have been developed in Durham by scientists of Axis Genetics, a Cambridge biotechnology company and field-grown at Rothamstead Experimental Station for two years. The Rowett had a profit-sharing agreement with Axis Genetics should the GM potatoes be commercially released.
Artificial feeding trials with aphids at Durham and SCRI have established that the gene product, GNA (snowdrop bulb lectin) expressed in the potatoes did interfere with both the development and mortality of one of the main potato pests, the potato aphid. It was also revealed from previous nutritional-physiological studies that GNA would not pose major health problems for the animals.even at 800-fold concentration of that expected to be expressed in the potatoes. So we started off with a gene coding for a lectin that appeared to control insect damage but wouldn't harm the rat..
Nevertheless problems soon appeared. First, no correlation between the expression level of GNA in the potato plant and the protection against the aphids was found. This was worrying and difficult to understand. There were also disturbing indications that GM potatoes not only harmed the aphids but also non-target and beneficial insects, such as the two-spotted ladybirds which, in nature, control the aphid population.
At the same time the results of the feeding studies at the Rowett did not fit the ideas on which genetic engineering was based. Thus, although the gene product was safe when it was sprinkled on to the diet, it was not when expressed in the GM potatoes. The GM potato-based diets retarded the growth of the rats, particularly on long-term feeding, interfered with the normal development of vital internal organs and depressed the humoral immune system All.these suggested that there must be something wrong with this supposedly precise technology, for which it has been claimed that one can change the phenotype by inserting one gene by a 'neutral' technology. We had two successful lines of GM potatoes coming from the same transformation event, done at the same time and in the same vessel; yet they were different. We were beginning to suspect that the problems were likely to originate from our inability to direct the transgene to sites where it would not interfere with the potato's own gene expression.
These were controlversial ideas at the time. However, after my 150 sec TV interview in August 1998 the Rowett was first happy with the publicity and the Director congratulated me. The Rowett Press Releases on 10 and 11 August and by the Institute Governing Body Chairman to M. Jacques Santer and Frank Dobson were full of praise for our work "of strategic importance to our country and European Union consumers". "A range of carefully controlled studies underlie the basis of Dr Pusztai's concerns". "The testing of modified products with implanted genes needs to be thoroughly carried out in the gut of animals and humans if unknown disasters are to be avoided".
Unfortunately, the Director did not keep to our agreement of not releasing scientific details to the media and disastrously never checked with me about the accuracy of the press releases. He dealt with all enquiries and gave all the interviews resulting in major mistakes. Apparently, when the government instructed him on the afternoon of 11 August that as our results were against the government's pro-GM policy they should be suppressed and I must be silenced, he tried to extricate himself from the responsibility of telling the world about experiments which in fact had never been done. He claimed that I got "muddled" or that I "took" data from an absent colleague. In a further twist he hinted that we have never done any GM-potato experiments but just supplemented our ordinary potato diets with the poisonous Concanavalin A. The Director suspended me on 12 August, gagged me and instituted an illegal Audit even though I was not accused of scientific fraud. All our data were confiscated. My phone was re-directed to his office and my e-mails were intercepted. The Director then wrote a series of letters in which he explicitly threatened me with legal action if I spoke to anyone in or outside the Rowett about our work. Not only the Audit was illegal but also without a nutritionist on the board the composition of the Audit Committee was inappropriate to assess a mainly nutritional work on GM potatoes. The audit was over in less than 10 hours and I was not given a chance to explain our work to them, or the Governing Body or my scientific colleagues at the Rowett.. None of the data in the Audit Report was primary and no statistical analyses were carried out by the Committee to validate the data. All this was so upsetting for some members of the international scientific community that 24 of them published a signed Memorandum (without giving away confidential data) and asked for my re-instatement to carry out further work into the safety of GM-foodstuffs. This publication in February 1999 dramatically re-kindled the GM debate.
After my TV interview I was violently criticised by the scientific establishment, including the Royal Society even though I gave no experimental details in the 14 sentences of the interview. However, I made a strong plea for proper scienific risk assessment to be done before the GM crops are released, so we should not need to use our own unwilling citizens as guinea pigs. Despite this, the Royal Society's main attack line was that that:our results were unreliable, obtained by a flawed experimental design and execution and as they were not peer-reviewed they could only be 'publiished' on TV. Incidentally, the Royal Society never had the design of our experiments or the methods used by us. They only had an edited internal Rowett Report which, against my wishes, had been passed on to them by the Director. In any case, the Royal Society has never before peer-reviewed scientific results. Moreover, against natural justice, the Royal Society did not publish our data but only their criticism of it, that The Lancet Editorial called a 'breathtaking impertinence' against a senior scientist. As there was no work done on GM potatoes by the Royal Society or anyone else, their report must be regarded as a collection of opinions. However, in science opinions that are not based experimentation and published after peer-review have no scientific validity even if they come from the President of the Royal Society.
Our paper was accepted on both scientific merit and public interest, as explained by The Lancet Editor after having been refereed by six referees.instead of the usual two and published in The Lancet (Ewen and Pusztai, 1999). As the Rowett still had the right to scrutinise our papers, the publication was a little delayed that gave an opportunity for pro-GM people to try to stop it. The scientific establishment had to find some reason for rubbishing the paper to justify their rejection of our work. So that was probably the reason why the President of the Royal Society said, 'We still cannot accept this publication because Dr Pusztai did not use the right low protein controls'.But surely the six referees could not have missed something as important as this? You needn't be a Nobel Prize winner to read our paper and see that all diets contained the same amount of protein and energy. According to The Guardian, a senior fellow of the Royal Society who was involved with the biotech industry phoned Richard Horton and threatened him if he dared to publish our paper. Interestingly, when this became public the Royal Society washed their hands of the whole affair. Another Royal Society fellow told the Independent that the Lancet editor must have had political motives for publishing the paper, because 'the referees' did not accept it. Although not a nutritionist he claimed that the design of our experiment was so terrible that if it was presented by one of his students, he would fail him/her 'because what we did was wrong, by changing horses in mid-stream' i.e. started the feeding with the control diet and then we switched to GM and vice versa. It is difficult to judge whether he was scientifically incompetent or did he knowingly misrepresent our experiment? It appears that peoples' attitude profoundly changes when their interests are jeopardised or threatened by some scientific findings.
Unfortunately, ethics have low priority in science nowadays. Powerful scientific committees, such as the Nuffield Council on Bioethics take the side of the establishment most of the time, regardless the merit of the case. Additionally, most of the important decisions are taken by the wrong people who have long retired from active scienti fic work and these people on the committees have little time to properly read anything. Many of them also either directly or indirectly receive funding from the industry and/or the allied scientific establishment. It is thus not surprising that the whole industrial and political complex came down so heavily on me and on our findings. However, it may have become obvious by now even to those who condemned our work at the time because it was against their interest that suppression of 'unpleasant' but true facts uncovered by independent scientists is not only against the interest of society but in the long run also of their own. Hopefully, it is now generally realized that when Academic freedom is denied to professional scientists progress in science becomes impossible .
1. Ewen SWB, Pusztai A. Effects of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine. Lancet 1999; 354: 1353-1354.
2. Flynn L, Gillard MS. Pro-GM food scientist 'threatened editor'. Guardian 1999; Nov 1: 1-2.
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