The gmo deception, p.5
The GMO Deception, page 5
Biotechnology, including technologies based on genetic engineering or genetic modification, is becoming increasingly important in the global economy, ecology and politics. Agricultural biotechnology for food production has been the subject of much interest and debate in international politics, but in terms of market value, health care represents the largest sector of biotechnology, with pharmaceutical substances playing the major role. Most biotechnological pharmaceuticals are produced in microbes, but the use of genetically modified plants (often called “pharmacrops”) to this end has gained increasing attention.1 The first field trial permit for GM plants based on an application using the term “pharmaceutical” was issued in January 1991 in the US By the year 2006 there had been 237 applications for field trials in the US alone; however, no commercial products have resulted to date.2 Among the drugs being produced in plants are vaccines, antibodies, antigens, hormones, growth factors and structural proteins.
The possible advantages of plants over other systems in producing drugs include the production of larger volumes of drugs, more flexibility and cost-effectiveness in manufacture, better suitability of plant cells for production, and the potential of using plants and seeds for drug storage and delivery.3 Plants have also some safety advantages over other pharmaceutical production systems, such as safety from contamination with human pathogens, endotoxins and tumorigenic DNA sequences.4
On the other hand, pharmacrops present important new risks and safety issues. By definition, they are used to produce substances that have potent biological effects on humans and other higher animals. Pharmacrops contain higher concentrations of active substances than these animals are ordinarily exposed to in GM plants. Several genetic modifications are often carried out simultaneously, increasing risks.5 Risks arise not only from biological but also socio-economic factors.
Pharmacrops consequently introduce special challenges to regulation. This is inherent in their position between agricultural, medical and general industrial biotechnology, and the special ecological-physical and socio-technological characteristics of these technologies. Some of these regulatory challenges include:
• The extension of new-generation GM crops to novel processes wherein the plants are not intended to be utilized as food crops but rather as plant-based ‘drug factories.’
• Emergence of new forms of biopollution in possible gene transfers of GM pharmacrops to conventional crops.
• New methods required to evaluate drugs derived from plants that are grown in open fields.
• The need to align environmental, food and agricultural, as well as pharmaceutical and medicinal policies and regulatory procedures.
• The subsequent introduction of new actors, new interests and new contested issues regarding the development and application of the technology.
Risk issues are particularly urgent when pharmaceuticals are produced in plants that are potential food crops.6 The need to control these risks has been stressed, by both consumers and food processors.7 Currently pharmacrop risks are still addressed mainly within the conceptual frameworks of other GM food plants, and it is unclear how to accomplish the protection and management of food supplies as the distinction between food and pharmaceuticals becomes blurred.
The main direct risks associated with pharmacrops can be categorized in terms of causative agents (for instance, the drug being produced); dispersal processes (especially gene flow) and environmental fate of the produce; exposed organisms or systems (such as animals which feed on pharmacrops in field trials); and biological (toxic, allergenic, ecological), agricultural and social effects. All of these need to be accounted for in the life-cycle of the technology (see Figure 1).
Figure 1. Risks along the cycle, to multiple targets. Many of these targets are routinely excluded from assessment.
Indirect risks arise in complex socio-ecological processes, also from attempts to control risks which inadvertently create new risks, for instance when using unproven ‘terminator’ technology to render GM plants sterile, combating vandalism by non-disclosure of information on field trial sites, or causing losses of relative benefits from pharmacrops as compared with conventional drug manufacture.8 Some risks may be irreversible, especially in regard to gene flow into the environment. Accidental outbreaks from field trials and associated food chain contamination scandals indicate that the transgenes cannot be totally contained.9 The crucial questions become how the different kinds of risks are judged and weighed against each other, what risks are deemed acceptable and on whose criteria, and what are feasible and justified risk abatement or prevention options.
The risks of pharmacrops are unevenly distributed geographically. The map of field trials in the United States (Figure 2) shows that transgenic corn with pharmaceutical proteins has been tested mainly in the Corn Belt. Threats to food production systems, biodiversity, worker safety and rural development also vary according to location. If a pharmacrop is grown near fields of the same species, the risk of transferring the “drug gene” to a conventional crop is increased. The benefits are unevenly distributed as well; those who stand to directly benefit from a field test (such as pharmaceutical companies or landowners paid to allow test plots on their land) do not necessarily share the risks, and thus the presence of potential risks does not necessarily inform decisions such as location of field plots. For example, Iowa and Nebraska—two of the top corn producing states in the United States—have some of the highest numbers of corn pharmacrop test plots, despite the heightened risk of contamination or cross-pollination.
Figure 2. Pharmacrop corn field trials by state through November 2007 (APHIS data; map courtesy of Barbara Parmenter, Tufts University)
Castle (2008) singled out informed consent, risks to agricultural policy and intellectual property rights as the key global challenges for ethical production of vaccines in plants. The awareness, willingness (political) and capacity to respond to these issues varies between and within societies, and as a result there can be a mismatch between risks and responses. The geographical heterogeneity of risks and regulation increases from small nations to the US, the EU and the global systems.10
In the US, the policy toward pharmacrops has been relatively lax, but the regulatory procedures for assessing and managing their risks have been upgraded in response to contamination accidents. In the EU, even after passage of a moratorium on GM plants, a more precautionary stance contributes to the lag of pharmacrop applications. The specific regulatory risk management options for pharmacrops are focused on technical measures at production sites, particularly containment, while options in other stages of the product life-cycle and risks of other dimensions have been given less attention (see Table 1).11 Additionally, critics point out that the seemingly self-evident options of restricting pharmacrops to closed systems and to inherently safer self-pollinating or non-food species have been a secondary consideration.12
In Europe, pharmacrop field trials have been carried out since 1995, but the number of trials declined after 1996; the cultivation acreage was nearly zero in 2002–2004. The onset of a more cautious approach to GM plants in general influenced these fluctuations. The regulatory approach in EU countries was pro-GM until the 1990s, only later to be replaced by a de facto moratorium on commercial cultivation of GM crops for human consumption, due largely to growing concerns among consumers and Member States.13
Table 1. Alternative framings of pharmacrops and plant-made pharmaceuticals (PMPs) along key dimensions of risks and governance.
However, even if the European stance toward GMOs has been precautionary overall for over a decade, pharmacrop risks have not been officially singled out. Increased R&D activities suggest that the EU may seek to switch back to a more pro-pharmacrop policy despite official caution, due in part to reasons of global trade policy and competition. Biopollution and other risk issues have been debated in connection with the proximity of GM crops to organic or conventional farms and with the buffer distance required to ensure safe coexistence of GM and non-GM plants.14 These issues are potentially even more pronounced with pharmacrops, because crops can be contaminated with the pollen and residues of pharmacrops and because pharmacologically modified plants (PMPs) carry particular potency; yet such distances have not been specified in the EU for pharmacrops (see Table 1).
The politics and practices of pharmacrop development and application involve the interplay and also tensions and clashes between different concepts of and approaches to risks, technology and regulation, and between interests and actors in various sectors and geographical regimes. Some of the polarization and conflicts in GMO politics influences pharmacrop policies, even if differently and as yet more subtly, due in part to the promises of producing wonder cures. Framing and evaluations of the risks from new-generation pharmacrops and other GMO “industrials” are only emerging, and the confidence in their safety vary greatly between and even within regulatory cultures.15 Because of the complexity of the processes and influential factors, the trajectories of the technology and of regulation remain uncertain.
Although pharmacrops have been pursued actively, especially in the United States, some caution seems to hold commercialization back. It remains to be seen whether a fertile hybrid of pharmaceutical, agricultural and industrial technology will arise, and how the particular risks of pharmacrops will be dealt with. The development is likely to be uneven and turbulent. It will introduce the need to integrate activities on pharmacrops in partly new forms of communication, cooperation, negotiation and conflict resolution. These take time and effort to develop, due to differing concepts and traditions among actors and different views of the value-laden issues. Whatever action is taken needs to allow the legitimate involvement of a broader range of stakeholders. Even so, regulatory practices are as yet poorly equipped to deal with pharmacrops and their multi-dimensional largely unknown risks on a commercial scale. Meanwhile, certain concrete steps—such as restricting pharmacrops to closed systems and self-pollinating or non-food species—could provide a more immediate buffer against the risks, but even such solutions require the active engagement and interaction of concerned citizens including scientists and experts as well as regulators, consumer representatives and others.
3
A Conversation with Dr. Árpád Pusztai
BY SAMUEL W. ANDERSON
Dr. Árpád Pusztai has published nearly three hundred papers and several books on plant lectins [a group of proteins on the cell membrane that bind to particular carbohydrates]. Since the “Pusztai affair” described below, he has given nearly two hundred lectures around the world and received the Federation of German Scientists’ whistleblower award. He was commissioned by the German government in 2004 to evaluate safety studies of Monsanto’s Mon 863 corn. This article originally appeared in GeneWatch, volume 22, number 1, January–February 2009.
Dr. Árpád Pusztai became the center of a political firestorm in Britain in the late 1990s when, on a television program, he expressed his concern with the results of a study he and a colleague had conducted on genetically modified potatoes. In the study, rats were fed either a) potatoes that had been genetically engineered (by a biotech company now called Axis Genetics) to express a protein called snowdrop lectin, b) conventional potatoes, or c) conventional potatoes mixed with snowdrop lectin. To Dr. Pusztai’s surprise, the group of rats that had been fed GM potatoes showed damage to their intestines and immune systems, while the other groups did not.
With the permission of his employer, the Rowett Institute in Aberdeen, Scotland, Dr. Pusztai raised his concerns in a TV interview. The day after the program aired, the Rowett Institute suspended him and dismantled his research team, and he was ordered by the government not to speak on his research. According to one Rowett Institute colleague, the Institute had received phone calls from the British government, and the line of communication could be traced to Monsanto via the US government. The incident, referred to in the press as “the Pusztai affair,” sparked fierce debate in the scientific community, with many criticizing the study even though it had not yet been published. Many people credit (or blame) Dr. Pusztai for tipping public opinion in Britain against GM foods.
Today Dr. Pusztai continues to work and remains one of the world’s foremost experts on lectins. He spoke with GeneWatch by phone from Hungary, where he teaches.
Dr. Árpád Pusztai: So you’re interested in whether there have been any attempts to repeat our experiment?
GeneWatch: Yes, you said that nobody has had the courage to do it.
Pusztai: I don’t think that there has been any attempt. It would need a very . . . how shall I put it . . . a very brave person. I don’t think that anybody will have the, I can say, the audacity to try to repeat our experiments—because they know perfectly well that they will get something very similar, if not identical results.
GeneWatch: You said that the methodologies you’ve established are not necessarily specific to GM materials—so what did you find was different in those studies, if anything?
Pusztai: Any new source of protein has to be tested. And you can just regard GM material as a new source of protein. And most of the time, what you do is you try to assess the nutritional value of this new protein source. There are quite a number of protocols for this, and the essence of all of them is the comparison. So for that reason, you can only compare things that are what you think is, protein-wise, nitrogen-wise, energy-wise, identical or very similar in these various tests. . . . But the first essential part of any evaluation is to feed the animals with that diet in comparison with the appropriate non-GM material.
And then you do all sorts of more sophisticated tests—you do immunity studies, you do allergenicity studies, you see how much of that nitrogen you’re putting in is retained . . . see what is happening metabolically. If you are, for example, exposing animals early on to chemical carcinogens, then you can compare the effect of the GM diet versus non-GM diet, how long it takes for the tumors to develop. These are all using models that are already accepted and are already being used for this testing.
Now, with the GM, it’s very seldom done.
GeneWatch: Why is that?
Pusztai: Because there is a problem of finances. Most of these studies are either financed by the biotechnology companies, or at least you need their agreement to carry out such studies. And not just the agreement, but to get the material from them, bona fide GM material—and very importantly, the appropriate parent line for the comparison. You are at the mercy of these companies, there is no other way to describe it. If they don’t give you that material, you are going to have real difficulties. And that was the reason why we did use GM potatoes, because they were developed by a Cambridge team together with our friend in Durham to transfer the transgene into potatoes to make them resistant to aphid attacks. Because we could get this material and the parent-line potatoes in sufficient quantities—they were grown side-by-side in the UK under controlled conditions—so we had the material to carry out these studies.
Most of the people who incidentally tried to get to the bottom of this, whether they think the GM is as good as the non-GM, or what are the advantages or disadvantages—they are at the mercy of the biotech companies, such as, for example, Monsanto. Monsanto would never give you any material to do independent studies—or if they agreed to it, you have to sign a contract with them to say that all the results belong to them. Not just that they belong to them, but you would not be allowed to publish it without their consent. This is something that you have to always take into account when they are talking about safety studies and all that. The companies’ interpretation of GM safety is not necessarily the last word in this matter.
GeneWatch: In other words, you can’t just go and actually buy the product from, say, Monsanto, if you’re going to conduct studies on it?
Pusztai: You go and try to do it! Particularly if—the seed, it has to be a direct comparison, so you need the isogenic line. You may be able to buy the GM material somewhere, by hook or crook, but you will never get the isogenic line. And I speak from experience. This is the reason we used the GM potatoes.
GeneWatch: So potatoes weren’t your ideal crop?
Pusztai: I knew perfectly well that potatoes, on their own, are not one of the best materials, because they contain little protein, less than ten percent. Most of the animals that you are testing for nutritional value of the crops you feed them on require at least ten percent protein input. So with the potatoes, alone as the protein source in a full balanced diet, we had some difficulties. Nevertheless, that was the thing that was available.
So I was told by the Ministry that it was 1.6 million pounds, 3 million dollars—you have to use potatoes. And that’s it. You never say no to such a proposition.
GeneWatch: So your funding depended on using the potatoes?
Pusztai: Yes. I mean, it had an economic importance for Britain, particularly for Scotland, so it was in their interest that we do the study on potatoes. Remember, I said it many times, I really did believe that the idea [of GM crops] was great, and it was only during the testing process that we found too many snags and started to think about what could be the reason for the snags. So I’m a late convert to skepticism.
Because when we started, I thought that it was great, a great idea. I was still at the university when that guy got a Nobel Prize for the genetic determinism, that you take one gene and that gene is expressing a particular phenotype and whatever. It sounded all right to me, it’s just that as we were going ahead with our studies, we started to get results that did not fit into this pattern. And now I know—and anybody in the business, whether they are admitting it or not—they know perfectly well that you cannot splice a gene construct into another crop without making major changes in the genome of the crop that you spliced into.
