Monsanto name to become Bayer

I just posted responses to the criticisms. If you have a problem with those responses, let me know which ones, and we can look into them and find out what the research will bear.

You say that the study in question is statistically flawed. What led you to that conclusion? I've posted an interview with a statistician who was currently the only member of the French Academy of Sciences who is 100% specialised in statistics.

Remember this:

Paul Deheuvels is an eminent statistician and a member of the French Academy of Sciences. Yet he was not consulted when the Academy released a statement discrediting the results of the study on GMOs, led by Gilles-Eric Séralini. Revolted by these methods, Paul Deheuvels goes back over this matter where pressures and conflicts of interest got the upper hand. Here is the beginning of an interview with him:

[Rebelle-Sante:] How did you find out about the French Academy of Sciences’ position on this matter?

[Deheuvels:] In November 2011, during an award ceremony at the Academy, I exchanged a few words with one of my colleagues at the Institute, Professor Alain-Jacques Valleron, a biostatistician, for whom I have huge respect.

He made me aware that the Academy was preparing a statement on Gilles-Eric Séralini’s article. As I am currently the only member of the French Academy of Sciences 100% specialised in statistics, I was astonished not to have been consulted to judge this research, which has an important statistical content. Alain-Jacques Valleron told me that he found this study absolutely worthless. According to him, it had no value; it did not demonstrate anything and deserved to be exposed to public contempt. In return, I gave him a completely different opinion with solid arguments that I tried to get across.

During this discussion, I accidently found out that Professor Jean-François Bach, president of the Academy, intended to make public a very critical opinion of the same study. Finding it strange I asked to be in contact with Bach. The next day, he contacted me by telephone and told me that he thought that Professor Séralini’s work should be categorically rejected. Unsurprisingly, I exposed my arguments leading to a position opposing his. During this discussion, Professor Bach kindly tempered his statements, telling me that, in the main, he and I should be able to reach a consensus. I told him that if we were able to find common ground, my reservations should be at the very least added to any communication that the Academy would be willing to make about this question, in order for the debate to remain balanced. He replied: "Too late, the shot has been fired."
______________________________________________________

But first, which responses to the Séralini study did you have a problem with, and why?

Lets start with the fact that because the study involved 200 mice split up into 20 different equally sized groups and that their "data" would suggest that the more roundup male mice consumed the better they were protected from cancer, it tends to suggest that the sample sizes are too small to draw any meaningful conclusions from and that more testing/data is needed.

The sample of 200 rats, 20 rats per group, is the same number of rats used by Monsanto in its 3-month study. So, are you being critical of Monsanto's study?

And let's look at the biotech industry's study that the EFSA accepted as proof of safety.

It has the following weaknesses:

Six irrelevant "reference" control diets were introduced. These only served to introduce "data noise", which largely masked the effects of the genetic modification. In fact, significant differences were revealed in liver and kidney measurements, but these were masked by the wide range of variables introduced by the six irrelevant "reference" diets. This is scientific sleight-of-hand.

The rats were only followed over 90 days, a relatively short period equivalent to around 7-9 human years. This is inadequate to assess health risks to humans, who can be expected to eat a GM food over a lifetime.

Statistically significant differences were found but were dismissed as not treatment-related or not biologically meaningful, without scientific justification. The study period was not extended to see if these differences were in fact biologically meaningful.

Blood and urine samples were analyzed from only ten rats out of groups of 20. Yet organ weights were measured for all 20 rats per group. So the Monsanto researchers selected ten rats per sex out of 20 to analyze. What were the selection criteria? Did they choose those whose organ weights were the healthiest? Or did they analyze all 20 rats from each group and select the ten most favourable measurements to report? The method of selecting well may have been objective and random, but there is no way of knowing, and apparently, EFSA does not care. This practice invalidates the study as it introduces a scientifically unacceptable selection variable.

Fewer parameters were measured than in Séralini’s study, and less often.

Fewer doses of the maize were administered than in Séralini’s study (two, to Séralini’s three). The Monsanto researchers tried to draw a dose-response conclusion from feeding just two doses (11% and 33% maize), but a minimum of three doses are necessary to draw a valid dose-response conclusion, since with only two points you can draw a straight line between them regardless of how they relate to one another. Three doses are required by the OECD 408 protocol on which Monsanto researchers base their studies; it is unclear why Monsanto 90-day studies habitually use only two.
　
Now, rather that having a discussion with yourself, respond to the above, if you will.

Also, you claimed that the industry's tests follow guidelines and standards set out by the FDA. And what guidelines might those be?
　
GM foods were first commercialised in the US in the early 1990s. The US food regulator--the Food and Drug Adminstration (FDA)--allowed the first GM foods onto world markets in spite of its own scientists’ warnings that genetic engineering is different from conventional breeding and poses special risks, including the production of new toxins or allergens. The FDA overruled its scientists in line with a US government decision to "foster" the growth of the GM industry. The FDA formed a policy for GM foods that did not require any safety tests or labelling.

The creation of this policy was overseen by Michael Taylor, FDA’s deputy commissioner of policy--a position created especially for Taylor. Taylor was a former attorney for the GM giant Monsanto and later became its vice president for public policy.
　
Here is link to actual documents containing FDA scientists' concerns:

http://biointegrity.org/list.html

Sure. I'm critical of that study too then at first blush. Do you have a link, we can talk about it.

But it's 10 mice per group. They separate by gender as well, which is smart.


10 mice gave them statistical oddities (if you believe their conclusion) such as male mice appearing to be better protected by cancer the more GM food and roundup they consumed.


I imagine that there are more studies about this than just the Montesanto one that you mention (being that I posted hundreds of studies about many types of GMOs); did they use more mice?

Yeah, me too.

So GMOs and Roundup weedkiller protects against cancer? That's odd, considering the legal case against Monsanto for hiding the results of their research into the negative effects of glyphosate.

That’s not what I’m saying, I’m saying the data in the study you posted suggests that. You didn’t read that part?

That criticism was addressed:

Criticism: Looking closely, male rats fed GM corn does not generally develop more tumours than the controls ...

Response: One must look at the speed with which tumours are triggered. In all three treatment groups of rats, tumours or diseases of the kidneys and liver begin in the 4th month and explode in the 11th and 12th months. Which corresponds to the age of 35 to 40 years in a human. In the control group, tumours occurred mostly at the end of life, in the 23rd and 24th months, which seems to be normal in these rats.

Did you not read that part?
______________________________________________________

Now let's look at Monsanto's record of deception when it comes to its safety studies concerning Roundup. Why do you think they were deceptive?

Also, has the FDA ever tested GMOs for safety? And if so, what was their conclusion?
___________________________________________________

And here is another study:

Feeding Study with Bt Corn (MON810: Ajeeb YG) on Rats: Biochemical Analysis and Liver Histopathology

Full-Text HTML Download as PDF (Size:1857KB) PP. 185-195

DOI: 10.4236/fns.2014.52024 6,611 Downloads 14,884 Views Citations

Author(s)
Eman Mohamed Abdo, Omar Mohamed Barbary, Omayma El-Sayed Shaltout

Affiliation(s)
Food Science Department, Faculty of Agriculture (Saba-Basha), Alexandria University, Alexandria, Egypt.

ABSTRACT

Bt corn “MON810: Ajeeb YG” produces delta endotoxins in the whole plant due to the genetic modification process. The chemical analysis of this variety showed significant differences from its conventional counterpart “Ajeeb”. Further, feeding studies on rats were designed to complete assessing the safety of “MON810: Ajeeb YG”. Three groups of rats (6 males and 6 females’ rats/group) were fed on control diet, non-Bt corn and Bt corn for 1.5 months and 3 months. After 1.5 months, 3 males and 3 females from each group were sacrificed, and after another 1.5 months, 3 males and 3 females from each group and their offspring were sacrificed. Histopathological examination, blood haematology and serum biochemical analysis were determined. Results indicated significant differences among the tested parameters in the three groups especially Bt group. Severe changes in the liver of Bt group after 3 months were observed.

Hm...that doesn’t address the fact that fewer mice grew tumors. Just that those who did grow them grew them more quickly.

That’s the problem with these small sample sizes. Tons of noise.

No. Tell me what you think this means:

In all three treatment groups of rats, tumours or diseases of the kidneys and liver begin in the 4th month and explode in the 11th and 12th months. Which corresponds to the age of 35 to 40 years in a human. In the control group, tumours occurred mostly at the end of life, in the 23rd and 24th months, which seems to be normal in these rats.

What do you think of Monsanto's record of deception when it comes to its safety studies concerning Roundup. Why do you think they were deceptive?

Also, has the FDA ever tested GMOs for safety? And if so, what was their conclusion?

Let me know what you find in that 600 page report.

I’m going to sleep now.

CRITICISM: Strain of rats used Sprague-Dawley (SD) is prone to tumours

RESPONSE: SD rats have been used in most animal feeding trials to evaluate the safety of GM foods, and their results have been used by the biotech industry to secure approval to market GM products. They were used in the 90-day feeding trial that was conducted by industry to evaluate the toxicity of NK603 GM maize as part of the application for approval within the EU. They were also used in the original glyphosate two-year toxicity studies conducted in 2002 for regulatory approval within the EU.

The industry standard for toxicity tests performed by industry for regulatory purposes is the international protocol set out by the OECD (Organisation for International Cooperation and Development). This says that long-term carcinogenicity studies should be performed with the same strain of rat as used in shorter mid-term experiments, because this allows effects seen in the shorter experiment to be tracked to see how they develop in the long-term experiment, without the confounding factor that would occur if a different strain of rat was employed. Therefore, based on the past use of SD rats in trials of GM food and glyphosate it was scientifically correct and consistent to use this strain in Prof Seralini's long-term study.

The rats that consumed NK603 GM maize and/or Roundup in Prof Seralini's trial had an incidence of tumours, which was not just significantly greater than the control rats but also significantly greater than observed in previous studies of SD rats. The tumour incidence in the test groups in his study was overall around three times higher than that the normal rate observed in the Harlan Sprague Dawley rat strain he used, as reported in the literature (Brix et al., 2005) including in the largest study with 1329 Sprague Dawley female rats (Chandra et al., 1992).

Furthermore, the key is that there were both quantitative and qualitative differences in the tumours arising in control and test groups. In the control rats they appeared much later and at most there was one tumour per animal if at all. In the treated rats the tumours began to be detected much earlier (four months in males; seven months in females), grew much faster and many animals had two or even three tumours. Many animals in the test groups had to be euthanised under animal welfare rules due to the massive size of the tumours; none of the control animals had to be euthanised but died in their own time. One should not ignore these biological facts.
____________________________________________________

CRITICISM: The control groups were far too small. Looks like "random variation" in rats liable to develop tumours.

RESPONSE: This two year life-long experiment was conducted in a GLP environment according to international OECD guidelines in terms of animals used.

Standard practice is for the control group to be matched in size to the experimental groups. The experimental groups were 20 animals [10 male + 10 female] and therefore the control group should be 20 animals.

Prof [Anthony] Trewavas is not correct to say: "The control group is inadequate to make any deduction. Only 10 rodents so far as I can see and some of these develop tumours. Until you know the degree of variation in 90 or 180 (divided into groups of ten) control rodents these results are of no value." The 20 animal control group is big enough to get a measure of tumour frequency. You don't need to look at hundreds of animals. If he believes this, then he should also agree that the studies done by others including industry are also invalid.

The key thing is that there are big differences between the tumour frequencies in the control and the experimental groups (see previous answer). Claims that the results are just the result of random variation in a rat line that has a high frequency of tumours are not valid. The evidence for this is that the differences between the groups are much larger than the standard deviations of the two groups. In Seralini's study, the differences are so large that it is not necessary to use a statistical test. This study used more rats in test groups, for a far longer duration, than any previous investigation employed by industry to obtain approval for NK603 GM maize and other GM crop products.

I learned a phrase today that describes PERFECTLY the game I was referring to.

Sealioning.

https://www.google.com/amp/s/www.urbandictionary.com/define.php%3fterm=Sealioning&amp=true