Not for the first time, a Monsanto dossier submitted with a GM consent application, and purporting to contain the results of careful "safety studies", has been shown -- on careful examination -- to be worthless.
According to Dr Joël Spiroux de Vendômois, who has examined the dossier carefully, the Monsanto / Mahyco experiments designed to demonstrate the safety of the BT eggplant are poor studies that cannot, in any way, considered reliable. The research protocols were ineffective: there were not enough animals, the studies were not conducted for long enough to show up chronic toxicity effects, and sometimes oversize control groups were compared to the treated ones. In addition, the biological results’ interpretations were biased and ignored all the observed anomalies. Were these deficiencies just down to incompetence, or lack of funds, or lack of time? No way. Monsanto has a long track record of making its shoddy and fraudulent studies look impressive, and it knows every trick in the book which will have the effect of masking "inconvenient" effects of GM feedstuffs on animals used in the trials. Yet again, what we have here is another straightforward case of scientific fraud............
Dr Joël Spiroux de Vendômois, MD. CRIIGEN January 2010
This present report only studies the BT Brinjal potential effects on health and none of the environmental ones, even though they could be linked.
This study is based on the files presented by the Mahyco company to get the approval to grow the BT eggplant on the Indian territory. Those files are available for consultation on the following website: http://www.envfor.nic.in/divisions/csurv/geac/bt_brinjal.html
Eggplants are originally from India where there is a wide range of variety (on that account, the impact of the genetic pollution created by the cross of the BT eggplant with wild and native varieties would be worth studying).
Eggplants are consumed a lot, in amount and in frequency, in all parts of India, and that is why it is imperative to make sure of the health innocuousness, on a short, medium and long term, of a transgenic eggplant growing in India.
The BT eggplant is a GMO designed to produce an insecticide in order to fight devastating insects such as moths. Therefore, this insecticide is present in the whole plant and in particular in the fruit and thus is found in the Indian population’s food.
The different ways to make sure that this GMO is safe and isn’t a public health issue are: - To study the fabrication protocol and the aims as well as the effects on the product quality - To quantify how much insecticide the plant produces and what does it become afterwards - To study the in vivo protocols: animals number, experimentation’s length, seeking of acute, semi-chronic and chronic toxicological effects - To study those results and the result’s interpretations - And then to conclude Here is our study’s outline.
1) Fabrication protocol and aims
*The BT eggplant has been designed to produce an insecticide contained in the Bacillus thuringiensis. This really common germ owns a wide range of toxic proteins (more than a hundred). The BT eggplant produces unnatural toxins which contain modified Cry1Ab and Cry1Ac sequences. The effects on health of those proteins (artificial insecticides) have never been studied, only Cry1Ac has!
*The manufacturing process has a resistance gene to an antibiotic inserted: the kanamycin. This is really important since having a resistance gene to an antibiotic in the human food is unacceptable. The resistance to antibiotics is a real public health problem which is growing.
*The BT eggplant’s calorie intake is 15% less than its non GMO control. This difference is important as we know that eggplants calorie intake is already low: 18Kcal/100g.
*In addition, it is important to mention that the effect of the possible insertion’s mutagenesis is never studied.
*In spite of that, Mahyco only gives a brief study of the chemical composition and the phenotype of the BT eggplant compared to its control. The conclusion is, like in every GMO study, that there is “substance equivalence”, belief that has to be fought because scientifically wrong. Indeed, the brief study leading to “substance equivalence” doesn’t take into consideration the amount of pesticide produced by the plant, the metabolic disruption generated by the transgene and its promoter, the possible insertion’s mutagenesis and its effects on health. Due to all those anomalies and lacks previously explained, this “substance equivalence” conclusion is unacceptable and we cannot accept that to prove the innocuousness of the BT eggplant.
2) Amount of pesticide
The amount of pesticide produced by the BT eggplant can be up to 16-17mg/kg. In its studies, Mahyco specifies that the toxic protein is destroyed by heat, therefore by cooking. This point is prone to a real scientific controversy, and in particular, the Pr. Prabhakaran assures that it is wrong and that the insecticide is ingested even though it is cooked.
What are the effects on health on a short, medium and long term? Is it safe to eat pesticides that are not tested thoroughly as for health effects for life? Of course not!
3) Study of the experimental protocols
First of all, it is important to notice that none of the GMO in the world has been studied more than three months on small mammals such as rats or rabbits. Three months studies on young healthy adults are about acute toxicology only and in no way can be considered as semi- chronic or chronic toxicology studies, which could emphasize the occurrence of chronic pathologies, cancers, endocrinological disturbances, even reproduction disorders.
What about the BT eggplant?
- Two studies with rats :
*14 days study, 10 rats per group and by sex. Two doses: 0.5g/kg/day and 1g/kg/day.
*90 days study (the world’s longest) on young adults Sprague Dawley, 10 rats per group and by sex. One dose only (1g/kg/day, 5 days a week) of eggplant powder mixed with peanut oil. Due to the small groups and more importantly the use of only one dose, which doesn’t allow the study of the “dose effect”, this study is really poor even though it lasted 90 days.
Conclusion: those protocols are insufficient to emphasize effects on health other than acute toxicity of a rare violence.
- Study with rabbits : 90 days study, 6 white rabbits per group and by sex. Those young adults had fresh eggplants at their disposal 6 hours a day, and a traditional diet as a complement for the rest of the time.
Conclusion: this protocol is insufficient because of the group size, the fact that it is impossible to know exactly the amount of eggplant ingested, and to quantify a “dose effect”.
- Study with goats : 90 days study, 6 one year old goats per group and by sex. 500g of eggplant are given to the goats 2 hours a day before giving them a traditional diet. There is an unexplained anomaly in this study as 3 females disappeared during the experiment!
Conclusion: this protocol is unacceptable for the same reasons as the other protocols but also and above all for the fact that the experiment lasted 90 days for an animal that lives about 15 years.
- Study with milk cows : 42 days study, 8 milk cows per group. 2kg of eggplant are given daily to the cows. The aim of this experiment is to quantify the daily food consumption, the milk production and the amount of insecticide in the milk and the blood.
Conclusion: this protocol is obviously insufficient.
- Study with birds: 42 days study, 40 unsexed broiler chickens per group. One group gets a 5% BT eggplant diet, another one gets 10% eggplant diet, and 200 chickens get different non GMO diets.
Conclusion: this protocol is insufficient by its length, its differences in size between the groups treated with different diets. This has an effect on the statistical results as the low effects that could be emphasized in the control groups are clouded. A scientifically valid protocol just has to compare a GMO with its non GMO isogenic.
- Study with fish : 45 days study on common carps. 6 pools of 60 carps which get BT eggplants and 18 pools of 60 carps which get non GMO eggplants. The aim of this study is to evaluate the fish growth.
Conclusion: the results of such an experiment can’t be studied because of the big difference in size between the treated and control groups.
4) Results’ study: We have just noticed that the experimental protocols are unsuitable to conclude the innocuousness of the BT eggplant. This constitutes one more reason to take seriously the physiological anomalies found in the tested animals. Let’s keep in mind that the BT eggplant is likely to feed the Indian people in a regular basis, even part of the world. Nevertheless, let’s take a look at those experiment’s results.
- About the rats: the Mahyco study shows, among other things, diarrheas, livers weight anomalies, decrease in the water intake…
- About the rabbits: the study shows, among other things, an increase in total bilirubin in males and females fed with the GMO, an increase in hepatic markers in males and a blood sugar level decrease in females. - About the goats: change in the growth evolution, increase in total bilirubin in males, food intake decrease for the animals that ate BT eggplants.
- About the cows: the cows eating BT eggplants for only 42 days produce 14.3% more than the controls as if it was acting like a hormonal treatment.
- About the birds: we can notice the differences with regard to the food quantity eaten by the chicken fed by the GMO.
- About the fish: average feed conversion and efficiency ratios were significantly higher in the BT group versus closest control, at 45% brinjal in the diet.
All those signs cannot be ignored like Mahyco does. This behavior, which is the exact same one as Monsanto’s, neglects all those studies’ results assuring that the biologic and anatomopathologic signs emphasized are not biologically significant.
5) Overall conclusion
Following this study, we can only notice that the experiments realized to highlight the innocuousness of the BT eggplant are poor studies that cannot, in any way, prove it. Indeed, the protocols are ineffective: not enough animals, not long enough to emphasize chronic toxicity effects, sometimes oversize control groups compared to the treated ones. In addition, the biological results’ interpretations are biased and always lead up to ignore all the anomalies.
Therefore, this GMO, the BT eggplant, produced by Mahyco, cannot be considered as healthy and suitable for the human diet as well as the animal diet.
Without any sufficient information to take a definite and final decision about the innocuousness of the BT eggplant, it is essential, and also the duty of the different governments, to ask to do the experiments again but for a longer period of time, as well as to change the standards and the evaluation authority.
It is essential to do the experiments with transparency and independency. The experiments have to be done on life time with at least one or two little mammals and also on a transgenerational way. Furthermore, the experiments have to be done with big enough groups so it assures the results to be statistically powerful in order to avoid unproductive discussion on what is worth keeping or not. And finally, the experiments have to be completed with biological elements missing like endocrinal markers for example.
Comment on the same dossier by Prof Jack Heinemann: "The Bt-brinjal dossier I viewed in August 2008 is, in my opinion, nowhere near the sophistication and quality of the LY038 dossier, and that dossier was still unacceptable to Europe. Many of the Bt-brinjal experiments, at least as described, would not satisfy Codex Alimentarius guidelines as applied by careful regulators." Bt brinjal analysis "too poorly conducted" to assume safety - Prof Jack Heinemann - Part I Letter to:Mr. Jairam Ramesh,Minister, Environment and Forests, Government of India