MONSANTO AND THE CORRUPTION OF SCIENCE AND RESEARCH
How the Corporation has developed a special type of expertise
The recent revelations from the French research group at CRIIGEN has shown how Monsanto "locks in" its research results, designs its scientific research to give the results it wants, and misrepresents raw data in the drawing of health and safety conclusions (1). The corporation has developed some of these techniques to the level of a fine art, assisted by a regulatory system based upon "advocacy science" and by hand-picked regulators (for example in ACNFP and EFSA) who see it as their task in life to "enable" approvals for GM crops and foods to be given. Monsanto is also greatly assisted in its quest for global domination of the food supply by a system which allows the corporation to select its own contracted researchers, to influence experimental design, and to veto the publication of "inconvenient" findings. It can also make research replication by independent scientists impossible simply by refusing to supply them with GM seed or other materials. And the regulators allow them to get away with this, as do the editors of scientific journals who accept selected papers for peer review and publication. They should be ashamed of themselves for their role in the perpetration of corrupt science.
It was crucial in the MON863 case that Monsanto contracted out the rat feeding studies, but undertook the analysis of the researchers' raw data in-house. This allowed the corporation of use a range of statistical techniques to mask out harmful effects, and to write up its analyses and conclusions in such a manner as to indicate -- falsely -- that the crop was entirely safe. It then refused to release the raw data into the public domain until forced to do so by a court ruling in Germany.
This example of research manipulation is by no means an isolated one. Exactly the same thing happened with the Monsanto GM potato rat feeding study by the Russian Institute of Nutrition in 1998. The raw data showed clear evidence of harm to the animals fed on the GM potatoes, but this evidence was disregarded in the analysis and conclusions to the work (2). Monsanto then used the corrupt research to obtain Russian consent for the commercialization of the GM potato in Russia, and also tried to keep the Feeding Study Report out of the public domain. Greenpeace managed to obtain a copy of the report, and to publish it for the English-speaking world in 2007, but only after two court cases and the passage of eight years.
In South Africa the watchdog group Biowatch has had to go to court to obtain a release of Monsanto GM experimental data into the public domain, but has been ordered by the court to meet Monsanto's costs (3). This indicates once again just how far Monsanto will go to get its way, while denying access to its key research findings. It appears to be blissfully unconcerned about its "public approval ratings."
A memo leaked in Canada in 1999 and written by Dr George Paterson described a private deal which resulted in rapid approval for two new kinds of GM NewLeaf potatoes made by Monsanto (4). Until the deal was negotiated, the potatoes had been held up in the regulatory system because Monsanto refused to provide key scientific information to regulators assessing the products' health and environmental effects. Michele Brill-Edwards, a former Health Canada drug regulator said of the Paterson memo: "What you're seeing is a high- level example of a very dirty game that practically nobody knows about. These kinds of meetings go on all the time........... people are careful not to let this kind of thing be known."
And let's not forget that Monsanto was responsible for another scientific scandal involving the GM growth hormone rBST, which was approved in the United States but not in Canada (5). In the latter country, the tactics used by Monsanto (and supported by George Paterson) appalled both the regulators and the media, and some of the malpractice related to the scientific data submitted -- reluctantly and belatedly -- in support of its application for approval. This was revealed by a later "gap analysis" of the research data which showed that significant areas of required research had just not been covered. Some of the whistleblowers were later fired. Later still, after a very careful "meta-analysis" of all the supporting data submitted by Monsanto, Dohoo and others (6) revealed that a good deal of uncomfortable information relating to health damage, in a multitude of documents, was simply masked out or disregarded in the pursuit of approval. The authors were too polite to refer to scientific fraud, but that is what they were dealing with.
In 1993 David Kronfeld (7) showed how sampling methods, data pooling techniques and finally the careful choice of analytical statistics were used by Monsanto to support its application for rBST approval in the United States, and to hide disease in cattle which were given the growth hormone. Scrutiny of this sort of dishonest science is very difficult and time-consuming, as Monsanto knows full well.
The dangers inherent in the system of "advocacy science" and unquestioning regulatory approvals have been highlighted in an article by Michelle Marview in 2002 (8). As a means of preventing scientific fraud, she called for larger sample sizes, explicit quantifications of statistical power, and a transparent and full disclosure of safety data from industry tests in an easily accessible database. We might add a requirement for a written commitment from all GM approval applicants that they will provide the necessary raw materials and allow replication and improvement of all their experiments by independent scientists.
If all this was to happen, we might be getting somewhere.........
Brian John GM Free Cymru 16 March 2007
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NOTES
(1) http://www.gmfreecymru.org/pivotal_papers/greenpeace.htm
http://www.gmfreecymru.org/
(2) http://www.gmfreecymru.org/pivotal_papers/vilar.htm
(3) South Africa GMO watchdog group wins case against Monsanto, but is ordered to pay costs: When Monsanto released genetically modified seeds in South Africa in 1997, activists rallied and successfull1999 GMO Act to insure regulation of the experimental crops. The watchdog group Biowatch sued to gain access to information on the experiments from Monsanto. In 2005, the court ordered Monsanto to make public the information requested. But in an unlikely move, the judge has ordered Biowatch to pay court costs because Monsanto has to "protect" its business interests. Biowatch is appealing this decision and the case will be heard on April 23. Activists have charged manufacturers with purposefully contaminating African crops with GMO's before safety regulations could be put in place. Read more. (http://www.biowatch.org.za/main.asp?include=docs/date.html)
(4) These were NewLeaf Y and NewLeaf Plus potatoes, closely related to the GM-RB potatoes which figured in the infamous 1998 Russian rat feeding trials. George Paterson (now the Scottish Director of the FSA) was personally involved in pushing through the GM potato approvals in Canada in the face of grave concerns among colleagues (and potato growers) about Monsanto's refusal to provide key safety data.
http://www.gmwatch.org/profile1.asp?PrId=101
http://members.tripod.com/~ngin/fsa.htm
Extract: Until the deal was negotiated, the potatoes had been held up in the regulatory system because Monsanto refused to provide key scientific information to regulators assessing the products' health and environmental effects.
Dr. Brill-Edwards said such tactics point to deliberate efforts by Monsanto to prevent damaging information about its products from reaching the potato growers. "It's like a courtroom where you don't want the evidence against you to get out."
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(5) KEEPING MILK SAFE: CANADA BANS BST
http://www.cbc.ca/newsinreview/mar99/milk/acrim.htm
Acrimony, Controversy, and Disapproval
Extract: For the past nine years, the Monsanto Chemical Company has been trying to gain approval for the use in Canada of its bovine growth hormone. During those nine years there have been allegations of bribery of Canadian officials, files have been stolen, documents have been shredded, and gag orders have been placed on Health Canada scientists. All these irregularities caused Senator Eugene Whelan, co- chair of the Senate’s agricultural committee and former federal Minister of Agriculture, to exclaim during the Senate hearings, “I don’t believe I’m in Canada when I hear [something like this.]”
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Whistleblowers at Health Canada fired
Integrity of our regulatory system in question
http://www.beyondfactoryfarming.org/english/overview/ regulatory_integrity.shtml
Extract:
rBGH - Genetically Modified Cow Growth Hormone.
In 1990 Monsanto applied to Health Canada for approval of this drug. It was approved in the USA in1993. In 1997 Health Canada asked Shiv Chopra, Gerard Lambert and two others to do a "gaps analysis" of the data submitted by Monsanto and Eli Lily. They found that the companies had not provided data on the impact of this hormone on babies and children, nor was the question of IGF-1 (associated with increased breast and prostate cancers) answered. The scientists were asked to appear as witnesses before the Senate Committee on Agriculture. As a result, rBGH was not approved for use in Canada’s dairy sector.
rBST and the Drug Approval Process, Interim Report by the Standing Senate Committee on Agriculture and Forestry, March 1999 www.parl.gc.ca Biotech clampdown continues by Stephanie Power, August1998 users.westnet.gr The Evidence on rBST: The Safety of rBST for Humans www.parl.gc.ca rBST (Nutrilac) "Gaps Analysis" Report by rBST Internal Review Team Health Protection Branch, Health Canada April 21, 1998 www.nfu.ca
See also Ottawa Citizen, Nov 30, 1999 http://members.tripod.com/~ngin/fsa.htm
(6) Dohoo et al. 2003. A meta-analysis review of the effects of recombinant bovie somatotropin 1. Methodology and effects on production. Canadian Journal of Veterinary Research 67:241-251 and Dohoo et al. 2003. A meta-analysis review of the effects of recombinant bovie somatotropin 2. Effects on animal health, reproductive performance, and culling. Canadian Journal of Veterinary Research 67:252-264
(7) Kronfeld, D. 1993. Ch. 2 Recombinant Bovine Growth Hormone: Cow Responses Delay Drug Approval and Impact Public Health. pp. 65-112. In: W.C. Liebhardt (ed). The Dairy Debate. Consequences of Bovine Growth Hormone and Rotational Grazing Technologies. Univ of California, SAREP, David, CA.
(8) Ecological Applications, 12(4), 2002, pp. 1119–1124 q 2002 by the Ecological Society of America IMPROVING RISK ASSESSMENT FOR NONTARGET SAFETY OF TRANSGENIC CROPS by MICHELLE MARVIER Conclusion: In the studies reviewed here, the lack of a statistically significant effect was invariably interpreted as evidence of the crop’s safety, with no exploration of the statistical power of the experimental design. Unfortunately, a nonsignificant statistical test that is not accompanied by a power analysis provides little insight as to whether or not an effect really exists. Given the enormous challenges that risk analysis entails, the use of sufficiently large sample sizes, combined with an explicit quantification of statistical power, is a necessary step toward increasing our confidence in a verdict of ‘‘safety.’’ Finally, a transparent and full disclosure of safety data from industry tests in an easily accessible database may go a long way toward quieting the public’s uneasiness regarding the safety of this new technology.