New Book: Potential Health Effects of Foods Derived from GM Plants: What Are the Issues?

Potential Health Effects of Foods Derived from Genetically Modified Plants: What Are the Issues?

By Arpad Pusztai and Susan Bardocz

Publisher: TWN (ISBN: 978-967-5412-42-4)

Year: 2011 No. of pages: 48

ABOUT THE BOOK

This paper examines the potential health effects of foods derived from genetically modified (GM) plants. While such an important topic, the data-base on the likely biological effects of GM foods is woefully inadequate.

In the absence of safety studies, the lack of evidence that GM food is unsafe cannot be interpreted as proof that it is safe, particularly as all well-designed GM safety studies published to date and carried out independently of the biotechnology industry have demonstrated potentially worrisome biological effects of GM foods.

However, the complexity of GM foods makes their biological testing difficult. The authors propose a suggested protocol for GM crop/food health risk assessment, which uses comprehensive toxicological/nutritional methods that will equally be applicable to scientifically examine the veracity of the claimed benefits of genetic manipulation, and screen for its unintended and potentially harmful consequences for human/animal health.

ABOUT THE AUTHORS

DR ARPAD PUSZTAI is a Fellow of the Royal Society of Edinburgh (FRSE) and holds a BSc in Chemistry and a PhD in Physiology and Biochemistry. Pusztai was formerly Head of Protein Chemistry at the Rowett Research Institute, Aberdeen, Scotland. His main research interest is biologically active food components – lectins, plant anti-nutrients, and the effect of GMOs on animal and human health. His research also focuses on cancer prevention by dietary means. He has published over 300 primary scientific papers and nine scientific books. He is holder of the Stilmark Medal; Honorary Professor of the University of Tartu, Estonia; Leverhulm Fellow; Auber Bequest Fellow; and Recipient of the Federation of German Scientists’ Whistleblower Award 2005.

PROF. SUSAN BARDOCZ has a BSc in Chemistry and a PhD in Biochemistry and Pharmacology. She was a lecturer and then senior lecturer in Biochemistry at the University of Debrecen, Hungary, up to 1987. Between 1987 and 2000 she was at Rowett Research Institute, where she was the Head of the Food - Gut - Microbial Interaction Group between 1992 and 1998. She is currently Professor of Human Nutrition at the University of Debrecen, Hungary. She has published over 200 papers and book chapters, as well as written and edited several books.

Both received the Pro Biocultura Prize in 2008 in Hungary, and the Stuttgart Peace Prize in 2009.

Contents

1. INTRODUCTION

1.1 Present state of GM food science

2. ALIMENTARY TRACT AS THE FIRST TARGET OF GM FOOD RISK ASSESSMENT

3. SUGGESTED PROTOCOL FOR GM CROP/FOOD HEALTH RISK ASSESSMENT

3.1 Chemical composition

3.2 Nutritional/toxicological testing with animals

3.3 Diet

3.4 Experimental protocol

4. DIFFERENCES IN NUTRITIONAL PERFORMANCE USEFUL FOR DIAGNOSIS

OF HARM

5. PROBLEMS AND PERSPECTIVES

5.1 Effects of transgenic plant DNA

6. GM DNA SAFETY STUDIES IN THE GASTROINTESTINAL TRACT

7. FINAL GENERAL CONSIDERATIONS AND CONCLUSIONS

ANNEX

REFERENCES

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Pusztai reseña libro sobre rBGH

A review of Dr Samuel S. Epstein's book What's In Your Milk?
(Trafford Publishing)

by Arpad Pusztai
Consultant; Genok (Norwegian Institute of Gene Ecology), Tromso, Norway

Dr Epstein's new book, "What's In Your Milk?," describes and discusses in detail the scientific, and human and veterinary safety issues arising out of the use by Monsanto of recombinant bovine growth hormone (rBGH) in milk production. Despite the well-known considerable difficulties of obtaining financial support for independent studies into the safety of any genetically engineered (GE) product, be it GE food, and GE or cloned meat, Dr Epstein's thesis is well-documented and supported by a large number of academic studies published in peer-reviewed science journals. In short his points are as follows:

*Natural bovine growth hormone, BGH and the various commercial recombinant rBGHs are chemically and immunologically different.

*rBGH milk is chemically and nutritionally different from normal milk and, amongst other things, contains more long-chain fatty acids and less casein protein and can be contaminated with pus, antibiotics, and other chemicals, etc.

*Milk from cows injected with rBGH contains some of the recombinant hormone which, at least in part, can be absorbed from the gut into the blood circulation of consumers with possible, but at present unknown, physiological effects that should need further extensive studies to elucidate.

*There is overwhelming evidence to show that milk from cows injected with rBGH contains elevated levels of the potent growth factor IGF1 that is readily taken up from the gut into the systemic circulation where, according to some evidence, is suggested to be implicated in the development of tumors in breast, colon and prostate tissues and in blocking apoptosis of transformed cells; thus counteracting a natural defence mechanism in cancer.

*Injection of cows with rBGH increases the development of adverse veterinary effects, such as mastitis with a need for medication with antibiotics and other chemicals some of which contaminate the milk from these cows and/or the frequently observed digestive and reproductive disorders, including reduced fertility, that are now fully or partly acknowledged to occur by Monsanto and the FDA.

*Most of these points are not only confirmed by published studies but they are also corroborated by Monsanto's own studies as described in a batch of confidential files to the FDA that were leaked to Dr Epstein anonymously in October 1989.

In addition to describing the ins-and-outs of the safety of rBGH milk, one of the prominent and nowadays unfortunately commonplace scientific controversies arising out of the involvement of industrial and business interests in what used to be mainly scientific issues, Dr Epstein's book has very strong social, political and ethical messages for scientists and also for the general public. Dr Epstein very commendably gives fully all the arguments, pro- and contra, that appear to support the respective cases of the opposing sides in the controversial issue of the safety for human consumption, animal health and other pertinent issues associated with the use of rBGH-treated cows, their milk and meat.

However, those not directly immersed in the scientific issues of rBGH milk and who are not familiar with the published papers cited in support of safety may not find it easy to apportion what weight, if any, to attach to the scientific value, strength and validity of the publications referred to. Although it may not surprise those scientists who are familiar with such controversies and who have themselves been financed by commercial money that in some of the industrial responses to Dr Epstein's charges concerning the possible dangers of the rBGH technology, the references are not always what they appear to be.

For example, in the "Previously Unpublished Industry Response from Cyanamid" (August 16, 1989, pp. 56-63) it is said: "His (i.e. Dr Epstein’s) allegations are unsubstantiated and ignore the fact that results of this research (i.e. supporting the industry's case) are "published in peer-reviewed journals which are subjected to intensive scrutiny by the scientific community at large." One would therefore expect that the Cyanamid authors to support their case quoted mainly peer-reviewed papers. In fact, most of what purported to be peer-reviewed papers were abstracts or short resumes of talks given at conferences. Thus, to rebut Dr Epstein's thesis on negative energy balance in rBGH-treated cows all five references cited were conference communications. Or to discredit Dr Epstein's allegation of increased incidence of infectious diseases, one of the papers cited in the text was not given in the reference list, two were conference pieces and one was a general paper not directly pertinent to the rebuttal. Again, on the questionable efficacy of milk hormones the authors quoted four papers, all of which were conference reports. And so on!

Although this finding does not necessarily question their validity, it is disappointing that the authors' arguments were not based on more peer-reviewed publications that are "subjected to intensive scrutiny by the scientific community". Unfortunately, the FDA scientists' response to Dr Epstein's charges published in Science (vol. 249, pp. 875-884, 1990) has also been rather disappointing. Apart from the fact that the paper contains little, if any, direct clinical evidence to support the claimed human safety of rBGH-milk or meat, practically all the work cited comes from previously unpublished confidential industry studies on animals (all in all 16 references) with very little independent work supporting their results. One would expect in such a scientific, and even more importantly, public health controversy that reliance should not be based only or mainly on research by scientists working for the very industry that is to commercialise the product.

Should some readers regard the rBGH story, for the want of a better expression, as a showcase for scientists squabbling amongst themselves about a topic only interesting to them, they would be quite mistaken. The book is exciting reading for all. It vividly describes the developing story and controversy between the antagonists with all the turns of an exciting detective novel. Every trick in the book by the industry is illustrated, particularly the shenanigans of Monsanto in cohoots with the FDA and the US administration, aided and abetted by the "revolving door" between official and industry personnel, setting up hit-squads to discredit "awkward" scientists, putting out misleading or false information in the press, suppressing nationally and internationally relevant scientific information on safety, or the lack of it, of their product, leaning on political, regulatory and other bodies, committees and organizations and putting pressure on their personnel, just to name a few of the strategies used.

That, after all, the Monsantos of this world still fail in this case is due to Dr Epstein's persistence, scientific track record and international standing, his hard detective work and unflagging drive to get to the truth in the unfailing belief that it is the duty of an honest scientist to serve the public. This is a great book and one which all other books in the field of genetic engineering will be measured against.

Pusztai's latest

GM Potato Controversy - A case with disturbing implications for present day science

By Dr. Arpad J. Pusztai

Mar 28 2007

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 concern, 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 coordinated 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 had 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 had 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 harmed not only 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 facts 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 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, which action 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 & 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 the Lancet editor 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 scientific 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 against the interest not only 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 .

References
1.Ewen SWB, Pusztai A. Effects of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine. Lancet 1999; 354: 1353-54.

2.Flynn L, Gillard MS. Pro-GM food scientist 'threatened editor'. Guardian 1999; Nov 1: 1-2.