Monsanto name to become Bayer

So, the answer is no, you cannot cite even one safety study that shows the safety of GMOs, who conducted the study, and where the study was done. That will do.

I just gave you a source citing hundreds of studies.

From page 237 of the document (there are MANY more).


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___________________________________________________

What do you make of that one?

Now what were the results of those other safety studies? Your lengthy copy and paste list does not indicate conclusions. I will try to find something on the conclusions of these studies.

See the next post.

The formatting look much better in the actual report that contains the information you're pretending to seek.

Have one of those in particular you'd like to discuss?

Here is a study found in the International Journal of Biological Sciences. It is Titled: A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health. Here is their conclusion:

Patho-physiological profiles are unique for each GM crop/food, underlining the necessity for a case-by-case evaluation of their safety, as is largely admitted and agreed by regulators. It is not possible to make comments concerning any general, similar subchronic toxic effect for all GM foods. However, in the three GM maize varieties that formed the basis of this investigation, new side effects linked to the consumption of these cereals were revealed, which were sex- and often dose-dependent. Effects were mostly concentrated in kidney and liver function, the two major diet detoxification organs, but in detail differed with each GM type. In addition, some effects on heart, adrenal, spleen and blood cells were also frequently noted. As there normally exists sex differences in liver and kidney metabolism, the highly statistically significant disturbances in the function of these organs, seen between male and female rats, cannot be dismissed as biologically insignificant as has been proposed by others. We therefore conclude that our data strongly suggests that these GM maize varieties induce a state of hepatorenal toxicity. This can be due to the new pesticides (herbicide or insecticide) present specifically in each type of GM maize, although unintended metabolic effects due to the mutagenic properties of the GM transformation process cannot be excluded. All three GM maize varieties contain a distinctly different pesticide residue associated with their particular GM event (glyphosate and AMPA in NK 603, modified Cry1Ab in MON 810, modified Cry3Bb1 in MON 863). These substances have never before been an integral part of the human or animal diet and therefore their health consequences for those who consume them, especially over long time periods are currently unknown. Furthermore, any side effect linked to the GM event will be unique in each case as the site of transgene insertion and the spectrum of genome wide mutations will differ between the three modified maize types. In conclusion, our data presented here strongly recommend that additional long-term (up to 2 years) animal feeding studies be performed in at least three species, preferably also multi-generational, to provide true scientifically valid data on the acute and chronic toxic effects of GM crops, feed and foods. Our analysis highlights that the kidneys and liver as particularly important on which to focus such research as there was a clear negative impact on the function of these organs in rats consuming GM maize varieties for just 90 days.
　
http://www.ijbs.com/v05p0706.htm

It seems there is a conflict between authorities here . . .

What's the conflict?

The recommendation is that we should continue to study each GMO more and more. I agree and so do other scientists and the health organizations.

It's worth pointing out that rats and humans have different biologies and despite being close, what effects one doesn't necessarily effect the other.

But that was not the response from Monsanto when confronted with the study I posted. Monsanto responded to the study by stating that the research is "based on faulty analytical methods and reasoning and do not call into question the safety findings for these products."

The IJBS study's author Gilles-Eric Séralini responded to the Monsanto statement on the blog, Food Freedom, "Our study contradicts Monsanto conclusions because Monsanto systematically neglects significant health effects in mammals that are different in males and females eating GMOs, or not proportional to the dose. This is a very serious mistake, dramatic for public health. This is the major conclusion revealed by our work, the only careful reanalysis of Monsanto crude statistical data."

Makes you wonder why Monsanto, or anyone, uses mice, huh?

Some "peer review" of that study you published.

https://www.biofortified.org/2012/09/gm-corn-and-cancer/





Concluding with

Maybe Monsanto was right in this case; see the link I just posted.

In fact, the very journal where the original study was published had to issue a retraction of that study.

https://www.elsevier.com/about/press-releases/research-and-journals/elsevier-announces-article-retraction-from-journal-food-and-chemical-toxicology

Stating:

Concerning your concerns about the controversial work of Seralini, 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."

The rest of the interview can be seen here:

http://gmwatch.eu/latest-listing/52...h-academy-of-sciences-hatchet-job-on-seralini

______________________________________________________


So already we see how things work.

I'm seeing how conspiracy theories may work.

The website I posted has some scientific critique about the Seralini study.

Do you have any thoughts on those?

Yes, I do.

After the publication of the study by Gilles-Eric Seralini, the first study carried out on rats fed NK603 maize over their whole lifespan, which shows that the toxicity of these GMOs on rats, many criticisms and questions have arisen about the conditions in which the study was carried out and its credibility. Dr Joel Spiroux, co-author and assistant director of the study, and president of Criigen (Committee for Research and Independent Information on Genetic Engineering) responds.

First criticism: 200 rats is too small a sample for a solid study ...

- The sample of 200 rats, 20 rats per group, is the same number of rats used [GMW note: analysed] by Monsanto in its 3-month study. In contrast, we studied many more toxicological endpoints. An experiment with more rats would have cost more money. The study already cost 3.2 million Euro.

The type of rats used, Sprague-Dawley, is known to easily develop tumours ...

- Yes, but this type of rat is used the world over for toxicological research. These rats have the advantage of being stable in biological and physical levels. They all pretty much the same profile, the same weight ... These are the rats used from the beginning in the research on GMOs by the firms that produce them, including by Monsanto. And the facts are there: those that were fed GM corn, with or without Roundup, develop more diseases. And much faster.

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

- One must look at the speed which 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.

Scientists point to the lack of information on the exact composition of the diet on which rats were fed ...

- These are standard biscuits/chow, the same again as those used by the producers of GMOs in their studies. The only difference is that we have precisely measured the concentration of GM maize: 11% for the first group, 22% for the second and 33% for the third.

The amount of GMO consumed by the rats is more than is consumed by humans...

- Think again. The doses of NK603 maize are comparable to what humans eat over a lifetime in America, where GMOs are sold freely, unlabelled, untraceable. This prevents them being identified as a cause of disease and opens the door to denial. This is why we hear for example that Americans have been eating GMOs for 15 years and are not sick.

The magazine chosen to publish the study, "Food and Chemical Toxicology," is not the most prestigious in the United States.

- It is far from being secondary: it is an internationally known scientific journal. Publications are subject to peer review, and the peer reviewers express contradictory opinions. And it's the same journal in which Monsanto and other manufacturers publish their counter-studies.

We also hear that Gilles-Eric Seralini is committedly anti-GM, that he got the results he wanted.

- Absolutely not. Gilles-Eric Seralini the Criigen (Committee for Research and Independent Information on Genetic Engineering) and researchers in his lab at the University of Caen are also working on genetically modified organisms, because it gives them access to the knowledge of life. They have nothing against GMOs for the manufacture of drugs. Insulin, for example, is produced from GMOs. This does not prevent me from prescribing it to my patients with diabetes. One can recognize these medicines by the presence on the label of the term "recombinant protein". So yes to GMOs in the pharmaceutical laboratory. However, Gilles-Eric Seralini and we are against agricultural GMOs, because they are inadequately labelled and their long-term toxicity is poorly studied.

You are not oncologists, what do you know about tumours?

- No, we are not oncologists and have never said otherwise. This is a toxicity study, not a carcinogenicity study, which follows other protocols. Moreover, we have nowhere stated that tumours were cancerous. These are fibro-adenomas and kerato-acanthomas [?chirato-acantomes], which can turn into cancer in older rats.

A counter-study is needed.

- We agree. We also want a counter-study, but it must be carried out by independent researchers. Not by those who produce studies for manufacturers of GMOs. That is not the position of the EFSA at the moment (European Food Safety Agency).

Here are some responses to the issues raised concerning criticisms of the Seralini study which are supplied by scientists with expertise in this field.
________________________________________

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 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.

Just to illustrate the point by analogy. We know that a small proportion of people who never smoke get lung cancer. If you smoke, the rate/risk of getting lung cancer is about 12 times higher than if you don't smoke. The measurement is called a "relative risk". So, imagine that there is an ethnic group of people with a higher rate of naturally occurring lung cancer. We know that if people in that group smoke, their rate of lung cancer will still increase like everybody else.


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.


CRITICISM: The statistical analysis was flawed. Didn't use standard methods. A "statistical fishing trip".

RESPONSE: The statistical analysis was one of a number of valid methods that could have been used to evaluate a diverse set of data sets. An expert statistician was part of the research team and this was certainly not a "fishing trip". Significance in many liver and kidney parameters are shown and highlighted in the Tables 1 and 2.


CRITICISM: No data was given about the rats' food intake or possible contamination of the maize with fungus, which could have influenced results.

RESPONSE: The rats had unrestricted access to food and water and there were no differences in consumption or drinking levels between controls and test groups except for the group exposed to the highest Roundup concentration, which drank less water, perhaps due to the presence of high amounts of this herbicide making the water taste different.

All feeds were biochemically analysed to make sure they were nutritionally equivalent and no other toxins were present.


CRITICISM: Why were some test groups healthier than controls? How does one address the 30% premature death rate of males within the control group?

RESPONSE: From the mortality and tumour incidence rates in Figures 1 and 2 some test groups were not significantly better or worse than the controls. Yes, there were some premature deaths not only in the male but also female control groups. However, the levels are still lower than that observed in most test groups.


CRITICISM: Another red flag was that tumour rates didn't increase in line with the dose of GMOs fed to animals, as scientists would expect to see if the genetically engineered corn were to blame, said Kevin Folta, a plant molecular biologist at the University of Florida in Gainesville. Instead, "you are likely seeing variation of normal tumour incidence in a small population of rats," he said.

RESPONSE: We are not dealing here with a regular poison effect where increasing the dose will increase toxic effects. What is observed is due to hormonal system disturbances, which are known to display nonlinear effects ("U" or "G" shape responses to exposure). That is, for example, a low dose can have a disturbing effect and a higher dose can have no effect and then an even higher dose can elicit a response (U-shape response). Indeed, non-linear responses were to be expected in the rats treated with Roundup, as glyphosate, its active ingredient, is known to disrupt the endocrine system. In addition, in this case a threshold effect was also observed where a low dose appeared to saturate the system and so a higher dose had no additional effect.

(For an authoritative review on non-linear dose responses in hormonal systems, which the data implies is taking place in Prof Seralini's study, see Hormones and Endocrine Disrupting Chemicals: Low Dose Effects and Nonmonotonic Dose Responses, Vandenberg et al 2012).


CRITICISM: The mechanism is unclear. Why should GM maize cause tumours? Why should Roundup have the same effect?

RESPONSE: These are very good questions that only future research will provide clear answers. However, Prof Seralini's team hypothesises that the reason why the GM maize alone [without Roundup added] is affecting the liver and mammary gland systems is due to the EPSPS GM gene. The function of this GM gene may be the reason why the authors found that the GM maize had significantly lower amounts (up to 50%) of substances (caffeic and ferulic acids), which have protective effects against cancer formation and even mammalian tumours. Moreover, these phenolic acids and in particular ferulic acid may modulate estrogen hormone function as does glyphosate in the Roundup.

Future research will ascertain whether these hypotheses are significant contributory factors or whether the cause lies elsewhere, such as disturbances arising from the mutagenic effects of the GM transformation process.


CRITICISM: The results are out of line with other long-term studies that have investigated the safety of GMOs fed to a range of animals including chickens, rats, mice, quail, monkeys and fish, said Agnes Ricroch, a geneticist at the University of Paris XI and Pennsylvania State University, who co-wrote a review of 24 such studies that was published this year.

RESPONSE: It is scientifically incorrect to compare this long-term study with this particular variety of GM maize to other investigations using different GM feeds and different animals. Different animals have different anatomies and biochemistry; different GM feeds will have different compositions. One needs to compare like with like.

The study by Prof Seralini is the first long term feeding trial with this particular variety of Roundup tolerant GM maize, fed at three different doses. The only previous investigation with NK603 GM maize is a 90 day feeding study conducted by industry as part of its application for approval within the EU. This involved only two doses and a much narrower range of analyses. However, upon close independent scrutiny even this short term feeding trial showed signs of liver and kidney toxicity. The paper referred to [Ricroch] is a review of 24 GM feeding studies that are mostly short to medium term (90 days) and also measure a small range of organ and biochemical functions compared with Prof Seralini's work.

Some of the studies referred to in this [Ricroch] review do in fact show statistically significant signs of toxicity to liver, kidney and immune systems arising from the consumption of GM soy and maize. Nevertheless, the authors dismissed these as not biologically relevant, without further empirical investigation. Despite these early signs of toxicity, the authors of this review did not recommend extending these mostly short and medium-term studies to see what would happen. Prof Seralini's work has now filled in this gap with a two-year lifetime trial and has provided hard data which raises serious concerns.

I’m out running errands but I don’t see these quotes attributed to any particular scientists

And then we have EFSA (European Food Safety Authority) who chimed in on the Séralini paper. About that, they said this:

Taking into consideration Member States’ assessments and the authors’ answer to critics, EFSA finds that the study as reported by Séralini et al. is of insufficient scientific quality for safety assessments.

However:

In 2012 the European Court of
Auditors issued its report on the conflicts
of interest policies at four European agencies,
EFSA among them. The Court concluded
that, while EFSA's policies were
among the most advanced, none of the
agencies adequately managed conflicts of
interest.

EFSA experts involved in assessing the
risks of GM foods have attracted criticism
for their closeness to industry. In 2010,
12 out of 21 experts on the genetically modified
organism (GMO) Panel that issued a scientific
opinion that was key to the approval of a GM
potato had conflictsof interest as defined by the
Organisation for Economic Cooperation and
Development (OECD).
　
The Séralini affair was the latest in a long
series of controversies over EFSA's closeness
to industry. An earlier dispute involved the
long-standing relationship of the chair of
EFSA's management board, Diána Bánáti,
with the industry-funded International Life
Sciences Institute (ILSI). ILSI is funded by the
same agribusiness, food and biotechnology
companies whose products EFSA assesses for safety.
　
EFSA was accused by scientific organisations
and individual scientists of applying
double standards to studies on GM foods.
They said that EFSA rejected Séralini's
findings yet accepted less rigorously
designed studies from industry as proof of
safety of GM foods.

Even the design of EFSA's GMO risk assessment
standards was influenced by an
ILSI task force headed by a Monsanto
employee. They are based on the concept
of comparative assessment, a rewording of
the controversial concept of substantial
equivalence. Substantial equivalence
assumes that GM crops are equivalent to
non-GM crops and do not require rigorous
safety assessment. Currently, in the EU,
substantial equivalence must be measured, but
the analysis is confined to known basic components
of the GM food such as protein and fats.
Unexpected changes such as novel toxins
or allergens are likely to be missed.
　
In 2012, EFSA's scientific committee published an
opinion recommending the of the threshold of
toxicological concern in the risk assessment of chemicals
in food. The opinion stated that an exposure level
of 0.15 μg per person per day is acceptable for genotoxic
substances (substances that damage DNA, possibly giving
rise to cancer and birth defects). EFS's opinion
contradicted its own previous opinion which stated that it is
current practice to assume that there is no safe level of
exposure for genotoxic substances. It also undermined the
pesticide Regulation, which forbids approval of genotoxins.

The impartiality of the 2012 opinion is
in doubt, since 10 of the 13 members of
the EFSA working group on the threshold
of toxicological concern had a publishing
history favouring its use or had previously
advocated its use. Eight had formal links
with ILSI.
___________________________________________________

Sometimes conspiracy theory is conspiracy fact, eh?

Yeah, everything I'm reading about this study suggests that it's statistically flawed and does not hold up to scientific scrutiny.

Maybe someone should recreate it in a scientifically valid way.


Pick one of the ones I posted and let's review them next!

Or let's look at real life people.

There have to be countries for example where GMO foods are not as prevalent as in the USA.

How do we compare?