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PART 3
Lombard:
*Rats fed on GM Potatoes developed potentially pre-cancerous cell growth – Pusztai. Rats fed on GM tomatoes – seven of 40 died within two weeks.
These tests were never peer-proven. No scientific peer-proven data in support of these tests exists. They were dispelled as flawed by scientists worldwide.
A report in the influential Lancet magazine claimed that scientists who reviewed Pusztai’s experiments came to the conclusion that:
• The study was flawed, since it had been poorly conducted and did not meet acceptable scientific standards.
• The UK Advisory Committee on Novel Food Programmes (ACNFP) concluded that “no meaningful conclusions could be drawn from Pusztai’s study”.
• The Royal Society of London stated: “We found no convincing evidence of adverse effects from GM potatoes. The effects were uninterpretable because of technical limitations of the experiments and the incorrect use of statistical tests.”
Pusztai was subsequently fired from the institution where he worked.
On the tomato issue Pusztai, who had nothing to do with the experiments, said the rats died with unstated reasons.
The GM tomatoes were on the market for three years and consumed by thousands of people, without any ill-effects reported by any medical or health institutions.
They were withdrawn when the company that launched the project ran into technical and financial problems.
Smith:
Potatoes…
I describe Dr. Pusztai’s story in great detail in the first chapter of my book. I interviewed him over several months, and pored over leaked documents, scientific reports and testimonies. Here’s a synopsis.
Dr. Pusztai was awarded a grant by the UK government to develop a safety testing protocol, which would eventually be required for all GM foods. Pusztai’s 20-member research team created a GM potato, engineered to produce its own insecticide, and tested it on rats. The design for the animal feeding study had already been used by Pusztai in about 60 out of the more than 300 peer-reviewed studies he had published, and it was also approved in advance by the UK government.
The results of the potato study were shocking. Nearly every system in the rats’ bodies was adversely affected by the GM potatoes. Another group was fed natural potatoes that were spiked with the insecticide that the GM variety produced. Those rats did fine. Thus, the insecticide didn’t cause the damaged organs and immune system or the prolific cell growth. Rather, it was probably changes in the potato resulting from the process of genetic engineering that was the culprit. (During the GM process, for example, natural genes can be turned off, permanently turned on, deleted, reversed, scrambled, moved or fragmented, all with potential side effects.)
When Dr. Pusztai publicly expressed his concerns about GMOs, he was a hero at his institute. But this quickly became a serious problem for the biotech industry and the pro-GM Blair government. Dr. Pusztai was the world leader in his field; he worked at the country’s most prestigious nutritional institute; using cutting edge research funded by the government, he found problems; and now he claims that GM technology may be inherently unsafe. The press was ravenous. For two days, the institute’s director led the publicity efforts, describing Pusztai’s research as a huge advance in science. Then two phone calls were allegedly placed from the UK prime minister’s office, forwarded through the receptionist, to the director. The next morning, Dr. Pusztai was released from the institute after 35 years and silenced with threats of a lawsuit. His research team was disbanded and the government never implemented any long-term testing protocol. Disinformation was widely circulated. The institute and the biotech gang at the Royal Society staged so-called peer-reviews, but didn’t use all the test data, had no nutritionists doing the critique of a nutritional study, and made sweeping claims that contradicted the research. According to a leaked document obtained by the Independent on Sunday, even three government ministers prepared “an astonishingly detailed strategy for spinning, and mobilizing support for” GM foods, including rubbishing Pusztai’s research.[34]
When Pusztai’s gag order was eventually lifted and he gained access to his data, 23 top scientists from around the world reviewed the research and came to his defense. The study was peer-reviewed and published in the prestigious Lancet (in spite of threats made to its editor by a Royal Society official). Nonetheless, as you can see in Lombard’s reply, the disinformation campaign continues.[For the record, Lombard’s attribution to the Lancet is misleading. A letter from the editor included a quote from the Royal Society’s review, which said the study was “flawed.” But the editor was actually chastising the Society for “criticizing reports of research . . . before those data were reviewed and published in the proper way.”[35] Pusztai’s study, including the statistics, did pass the Lancet review.]
Tomatoes:
Lombard is right that the tomato study was not peer reviewed. It was submitted by Calgene (now a subsidiary of Monsanto) to the FDA for their FlavrSavr tomato review. Industry submissions are almost never peer-reviewed and are usually so poorly designed or reported, they are actually unworthy of publication. In fact, when I asked Dr. Pusztai what his greatest shock was, it turned out to be when he read the confidential studies submitted to the UK government to get GM products approved. This was months before his controversial sacking, while he was still an ardent GM advocate. He described the industry’s studies as so superficial and so poorly done, it was clear that they were doing as little as possible to get their products on the market as quickly as possible. They were not doing real safety assessments.
In the case of the tomato, FDA documents made public from a lawsuit reveal that GM-fed rats developed stomach lesions. In spite of Calgene’s attempts to explain it away, agency scientists maintained that the findings did not meet their standard of a “demonstration of reasonable certainty of no harm.”[36] The political appointees, however, ignored their scientists and approved the tomato.
When the same lawsuit made Calgene’s rat study available, Dr. Pusztai reviewed it for the attorneys. With respect to the rats’ bleeding stomachs, he pointed out that if similar reactions were to occur in humans, “they could lead to life-endangering hemorrhage, particularly in the elderly who use aspirin to prevent thrombosis.”[37] Pusztai also discovered a paragraph in the appendix which said 7 out of 40 GM-fed rats died within two weeks and were replaced. The cause of death was obliquely described as “husbandry error.” Pusztai was astounded. It is entirely unacceptable for such a study to leave out the data from rat autopsies and substitute only meaningless, unsupported opinions. Likewise, replacing dead animals in the middle of a feeding study is not scientifically justified.
One of the scientists who developed the tomato for Calgene told me that her team had been asked to evaluate the results of the rat experiment. She admitted that as plant molecular biologists, the study was totally out of their field, and they could easily have overlooked the appendix and its implications.
Consumed by thousands without any ill-effects…
Since no one monitors the health impacts of GM foods, to make the claim that there are no ill-effects demonstrates a profound ignorance of the issues.
Lombard:
*Philippines living next to a Bt maize field developed respiratory and skin reactions.
The person who published this information was Norwegian scientist Prof Terje Traavik, an ardent anti-GMO activist. His studies were, however, never peer-proven. When he was challenged to provide scientific data by Dr Nina Gloriani Barzaga from the University of the Philippines-Manila College of Public Health, he said his studies were “only preliminary and not complete.”
He was also challenged by Prof Rick Roush, director, Statewide IPM Program, University of California, USA, who comments as follows: “Traavik never allowed any of his work to be peer-reviewed. He never offered any details of his research to any of the rest of us scientists. His work remains nothing more than a wild and implausible allegation.”
The area was visited by the Philippines Department of Agriculture, a team of medical doctors, and representatives from the College of Chest Physicians and the Manila College of Health. They came to the conclusion that the villagers showed no allergic symptoms or signs of viral respiratory infection.
More than 20 000 ha of GM maize has been grown in the Philippines during the past three years by more than 5000 farmers. Nobody has complained of an allergy.
Smith:
Nobody has complained of an allergy…
According to the Philippine publication Mindanews, “On August 8, 2003, about 100 residents from Sitio Kalyong were documented to have been suffering from headache, dizziness, extreme stomach pain, vomiting and allergies.”[38] The Filipinos lived adjacent to a GM cornfield and developed symptoms only while the corn pollen was airborne. According to the article, similar symptoms appeared in different locations during the following two years, also corresponding with the time of pollination.
Dr. Traavik, a prominent EU virologist and director of the Norwegian Institute for Gene Ecology, tested the blood of 39 of the villagers during the first year. The blood developed an antibody response to the Bt-toxin—the pesticide that the corn was engineered to produce. Dr. Traavik presented preliminary findings in February 2004, at a Malaysian conference on GM food safety. Dr. Traavik explained to the audience, which was mostly delegates to the UN Biosafety Conference that started the next day, that the blood response increased the probability that the symptoms came from the corn. But it wasn’t proof.
I attended Dr. Traavik’s talk, in which he also presented preliminary results of four other studies. Two included results that challenged the safety claims of GM vaccines. Two studied promoters—the viral sequences that turn on the foreign genes that are inserted into GM crops. One study showed that the promoter was active in human cells, and the other showed that the promoter survived digestion in rats and ended up in their organs three days later.
Since I was giving a presentation on the health risks of GM foods at the UN conference, I spent two days interviewing Dr. Traavik and other senior scientists from his Institute about the research. When I gave my talk, I explained, as Dr. Traavik had, that his research was not yet finished, peer-reviewed or published. My job was to explain the preliminary findings in the wider context of known GM health hazards.
On the Philippine study, for example, I described how the potential dangers of breathing GM pollen had been identified years earlier by the UK Joint Food Safety and Standards Group. They had even postulated that inhaled genes might transfer into human DNA, and wrote to the US FDA, warning them about these risks of GM crops. Thus, the link between GM corn and the reactions in the Philippines is far from “wild and implausible,” as Lombard claims.
In accordance with normal scientific protocol, Dr. Traavik said he would not circulate his data or methodology until the papers were published. He is still working on the Philippine study. Three of the five presented in Malaysia have already been published, including the study confirming that GM promoters function in human cells.[39] This means that if promoters were to transfer out of GM food (which they do) and integrate into human DNA (which needs to be studied), they might permanently switch on random genes inside of us, overproducing a toxin, allergen, carcinogen, etc. In fact, if the promoters were to be inhaled in GM pollen and then transfer to human DNA… But wait, that’s probably “wild and implausible.”
19.3 million ha …
JS: GM crops are planted to 1.6% of all arable land, 98% of which is found in only 5 countries, 99.9% of which comprise only 4 crops: soy, corn, cotton and canola.
No reports of adverse effects…
This is one of the most unscientific—and dangerous—statements made by Lombard. Thousands of people had died before AIDS was discovered. Millions suffered from cigarettes before the health effects were known. Food-related illness in the US doubled between 1994 and 2001, during the time GM foods were introduced. But I can’t say that the disease rates were GM-related, and Lombard can’t say they’re not. Since no one is monitoring the population for health effects of GM foods, it could take decades to identify even serious problems.
Lombard’s statement is also an insult to the 5,000-10,000 people who fell sick due to a genetically engineered brand of the food supplement called L-tryptophan, which was sold in the US in the 1980s. More than 100 people died and many are permanently disabled. There is a new report on L-tryptophan at www.seedsofdeception.com, by a journalist who spent nearly a decade investigating this deadly epidemic. He reveals how evidence was suppressed or not followed-up, and how the FDA withheld information from the public and Congress in an apparent attempt to protect the biotech industry.
Comments…
Monsanto is a chief contributor to Lombard’s Public Relations services. That is the same company that was fined for bribing 140 Indonesian officials, that sues farmers for patent infringement when the company’s GM seeds blow onto their land, that assured us Agent Orange was safe, and whose executives’ described the ideal future as a world in which 100% of all commercial seeds were genetically engineered and patented. On February 22, 2002, Monsanto was found guilty for poisoning a town next to their factory and covering it up for decades. They were convicted of negligence, wantonness, suppression of the truth, nuisance, trespass, and outrage. According to Alabama law, to be guilty of outrage typically requires conduct “so outrageous in character and extreme in degree as to go beyond all possible bounds of decency so as to be regarded as atrocious and utterly intolerable in civilized society.”[40]
This same company is responsible for conducting the safety studies on its own GM foods. And in South Africa, the only country that allows the genetic modification of a food staple, the government has entrusted Monsanto with the health of its people.
Jeffrey M. Smith is the author of the bestselling book on GM foods, Seeds of Deception, and producer of the DVD, Hidden Dangers in Kids’ Meals, available at www.seedsofdeception.com or by calling 888-717-7000. He is working with a team of international scientists to compile all known risks of GM foods.
Spilling the Beans is a monthly column available at www.responsibletechnology.org. Publishers and webmasters may offer this article or monthly series to your readers at no charge, by emailing column@responsibletechnology.org. Individuals may read the column each month by subscribing to a free newsletter at www.responsibletechnology.org.
REFERENCES
[1]Ian F. Pryme and Rolf Lembcke, “In Vivo Studies on Possible Health Consequences of genetically modified food and Feed—with Particular Regard to Ingredients Consisting of Genetically Modified Plant Materials,” Nutrition and Health, vol. 17, 2003
[2]A. Pusztai and S. Bardocz: GMO in animal nutrition: potential benefits and risks. In "Biology of Nutrition in Growing Animals", R. Mosenthin, J. Zentek and T. Zebrowska (Eds.), 2OO5. Elsevier Limited, pp. 513-540
[3]A. Pusztai and S. Bardocz: GMO in animal nutrition: potential benefits and risks. In "Biology of Nutrition in Growing Animals", R. Mosenthin, J. Zentek and T. Zebrowska (Eds.), 2OO5. Elsevier Limited, pp. 513-540
[4]William Freese and David Schubert, Safety Testing and Regulation of Genetically Engineered Foods, Biotechnology and Genetic Engineering Reviews – Vol. 21, November 2004
[5]Andrea Baillie, “Suzuki Warns of Frankenstein Foods,” CP Wire, October 18, 1999
[6]Personal communication with Fran Sharples, November 14, 2005
[7]SAFETY OF GENETICALLY ENGINEERED FOODS: APPROACHES TO ASSESSING UNINTENDED HEALTH EFFECTS, Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health, Institute of Medicine and National Research Council of the National Academies, THE NATIONAL ACADEMIES PRESS , Washington, D.C., 2004
[8]World Health Organization questions safety assessment of Genetically Engineered foods, Press Advisory, Californians for GE-Free Agriculture, October 14, 2004
[9]Ashok B. Sharma, “ICMR Wants Overhaul Of GM Foods Regulation,” Financial Express, New Delhi, India July 25, 2004
[10]Personal communication with John Boyles, MD
[11]Mark Townsend, “Why soya is a hidden destroyer,” Daily Express, March 12, 1999
[12]Evaluation of Allergenicity of Genetically Modified Foods, Report of a Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology 22 - 25 January 2001
[13]“Statement of Policy: Foods Derived from New Plant Varieties,” Food and Drug Administration Docket No. 92N-0139
[14]Rick Weiss, “Biotech Food Raises a Crop of Questions,” Washington Post, August 15, 1999, p. A1
[15]Carl B. Johnson, Memo on the “draft statement of policy 12/12/91,” January8, 1992
[16]EPA Scientific Advisory Panel, “Bt Plant-Pesticides Risk and Benefits Assessments,” March 12, 2001, p. 76. Available at: http://www.epa.gov/scipoly/sap/2000/october/octoberfinal.pdf
[17]Bernstein, et al., (1999). Immune responses in farm workers after exposure to Bacillus thuringiensis pesticides. Environmental Health Perspectives 107(7), 575-582
[18] V. E. Prescott, et al, Transgenic Expression of Bean r-Amylase Inhibitor in Peas Results in Altered Structure and Immunogenicity, J. Agric. Food Chem. 2005, 53
[19]Genetically-modified Bt cotton a cropper: Study, Deccan Herald april 13,2005,From R Akhileshwari DH News Service Hyderabad
[20]Abdul Qayum & Kiran Sakkhari. Did Bt Cotton Save Farmers in Warangal? A season long impact study of Bt Cotton - Kharif 2002 in Warangal District of Andhra Pradesh . AP Coalition in Defence of Diversity & Deccan Development Society, Hyderabad, 2003.
[21]Abdul Qayum & Kiran Sakkhari. Did Bt Cotton Save Farmers in Warangal? A season long impact study of Bt Cotton - Kharif 2002 in Warangal District of Andhra Pradesh . AP Coalition in Defence of Diversity & Deccan Development Society, Hyderabad, 2003.
[22]Angry Andhra uproots Monsanto, Financial Express, June 04, 2005
http://www.financialexpress.com/fe_full_story.php?content_id=92868
[23]New report on Bt cotton problems in India (8/11/2005), http://www.gmwatch.org/archive2.asp?arcid=5918
[24]Abdul Qayum & Kiran Sakkhari. Did Bt Cotton Save Farmers in Warangal? A season long impact study of Bt Cotton - Kharif 2002 in Warangal District of Andhra Pradesh . AP Coalition in Defence of Diversity & Deccan Development Society, Hyderabad, 2003.
[25]http://www.gmwatch.org/profile1.asp?PrId=108
[26]Crop protection association seeks sweeping review of Insect, Financial Express, August 26, 2000, http://www.financialexpress.com/fe/daily/20000826/fco26064.html
[27]http://www.gmwatch.org/profile1.asp?PrId=196
[28]Wilting of Bt cotton in MP [Madhya Pradesh], farmers demand ban on companies, NewKerala.com, 14 Nov 2005 http://www.newkerala.com/news.php?action=fullnews&id=52326
[29] Gargi Parsai, Bt cotton seeds fail to germinate, The Hindu, 10 Nov 2005 http://www.hindu.com/2005/11/10/stories/2005111007110500.htm
[30] Gargi Parsai, Centre admits failure of Bt cotton in 2 States, The Hindu, Nov 27 2005, http://www.hindu.com/2005/11/27/stories/2005112716091200.htm
[31]Marketing of Bt Cotton in India – Aggressive, Unscrupulous and False…., http://www.grain.org/research_files/Marketing_in_India.pdf
[32]Abdul Qayum & Kiran Sakkhari. Did Bt Cotton Save Farmers in Warangal? A season long impact study of Bt Cotton - Kharif 2002 in Warangal District of Andhra Pradesh . AP Coalition in Defence of Diversity & Deccan Development Society, Hyderabad, 2003.
[33]Press Notice, Debt Burden Cotton Growers Suicides in West Vidarbha (Maharashtra-India) Has Crossed 114 Mark Today in Last 150 Days, November 17, 2005
[34]Editorial, “Less Spin, More Science,” Sunday Independent (London), May 23, 1999
[35]Richard Horton,Genetically modified foods: “absurd” concern or welcome dialogue? The Lancet 1999; 354:1314-1315
[36] See www.biointegrity.org for FDA memos
[37] Arpad Pusztai, “Genetically Modified Foods: Are They a Risk to Human/Animal Health?” June 2001
[38]Allen V. Estabillo, Farmer's group urges ban on planting Bt corn; says it could be cause of illnesses, Mindanews,19 October 2004
[39]Myhre, et. al., European Food Research and Technology (2005) DOI 10.1007
[40]Michael Grunwald, “Monsanto Held Liable for PCB Dumping,” Washington Post, February 23, 2002
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© Copyright Jeffrey M. Smith 2006
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