skephu
Senior Member.
It only cites two rat feeding studies for oncogenicity testing, and both are unpublished and both are by Monsanto, either directly or paid by them.
Bad science in the paper 'Long term toxicity of a Roundup herbicide and a Roundup-tolerant GM maize'
- Thread starter Mick West
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Dan Wilson
Senior Member.
There are more than 2 by Monsanto and others not by Monsanto, one of which was an NIH publication. Do you think there are flaws with any of them, including the Monsanto ones?
....
- NTP, 1992, Technical Report on Toxicity Studies of Glyphosate (CAS No. 1071-83-6) Administered in Dosed Feed to F344/N Rats and B6C3F1 Mice, Toxicity Report Series Number 16, NIH Publication 92-3135, July 1992, U.S. Department of Health and Human Services, National Toxicology Program (NTP), Research Triangle Park, NC.
- Tierney, W. J. 1979, A Three Month Feeding Study of Glyphosate (Roundup Technical) in Mice. Unpublished report, Bio/Dynamics, Inc. East Millstone, NJ.
skephu
Senior Member.
Those were not chronic oncogenicity studies. Only these two were:
Stout, L. D., and Ruecker, F. A. (1990). Chronic Study of Glyphosate
Administered in Feed to Albino Rats. Unpublished report, Mon-
santo Environmental Health Laboratory, St. Louis, MO.
Lankas, G. R. (1981). A Lifetime Feeding Study of Glyphosate
(Roundup Technical) in Rats. Unpublished report, Bio/Dynamics,
Inc., East Millstone, NJ.
The first by Monsanto, the second by a company hired by Monsanto. Both unpublished.
Dan Wilson
Senior Member.
Multiple feed toxicity studies were done that made it a point to mention that no significant carcinogenic effects were observed, which disagrees with Seralini's toxicity study.
http://ntp.niehs.nih.gov/ntp/htdocs/st_rpts/tox016.pdf
Again, is there something wrong with the Monsanto studies?Salivary gland lesions are relatively uncommon in toxicity studies; however, both spontaneous and chemicallyinduced changes of a similar nature to those seen in the glyphosate study have been described. Socalled "basophilic hypertrophic foci" occasionally may be seen as a spontaneous lesion in the parotid gland of rats and mice (Chiu and Chen, 1986); however, these are infrequent and focal in nature.
skephu
Senior Member.
Again, those were short-term studies. We are talking about long-term studies. So don't cite a short-term study.
Are you really asking whether I see a problem in an unpublished study?
deirdre
Senior Member.
it doesnt matter if there was something wrong or not. those studies arent the issue in this thread. The point is other studies had been done. But again, who cares if he is saying its the first of its kind.. that has nothing to do with the science in it.
william wiley
Member
This issue is the guy in the video in th OP is just wrong on all important points.
I've pointed this out. He claims the wrong rat was used. Yet they used the same rat as Monsanto did .
At the 6.24 minute mark he says
I've pointed this out. He claims the wrong rat was used. Yet they used the same rat as Monsanto did .
At the 6.24 minute mark he says
The same rat recommended by the National Toxicology Program. The guy in the opening video has no clue. He didn't even know what a Sprague Dawley Rat was.
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william wiley
Member
No other long term studies had been done on those issues. None.
deirdre
Senior Member.
you cant have it both ways. Either they used the same rat because it was a short study, or they used the wrong rat because it was a 2 year study. Pick one.
deirdre
Senior Member.
Fine, have it your way. Who cares. It has nothing to do with the bad science in the paper anyway
MikeC
Closed Account
Your quotes appear to show precisely WHY seralini's trials and conclusions are suspect - Monsanto's trial was for 90 days. Seralini's lasted 2 years - and as has been established already the rats develop tumours after 1 year.
and
This study constitutes a follow-up investigation of a 90-day feeding study conducted by Monsanto in order to obtain commercial release of this GMO, employing the same rat strain .....
By the beginning of the 24th month, 50% to 80% of female animals had developed tumors in all treatment groups, with up to three tumors per animal, whereas only 30% of controls were affected.
Spectrar Ghost
Senior Member.
I'm rusty on my statistics, but what is the chance of those variations being by chance? In a sample size of 10 it can't be too low...
william wiley
Member
I can see why you would think that but it's not how it works . Sprague Dawley rats are recommended for 2 year cancer studies
You might wonder why they would recommend a rat known to develop tumors for such a study. The thing is you need to have a rat sensitive to tumors do do a study.
But, a cancer study will have 50 rats per group. So with 50 rats per group and a rat known to have tumors you can get some meaningful statistics.
Seralini though was doing a toxicology study so they only used 10 rats per group, but recommended a cancer study be done with 50 rats per group.
Here is the actual quote from the National Toxicology Program
http://ntp.niehs.nih.gov/testing/types/cartox/index.html
The rats that were fed Monsanto products, Roundup and the transgene corn developed massive tumors and lots of them.
It's disturbing
william wiley
Member
You need 50 Sprague Dawley rats per group to be reasonably sure it's not due to chance. After all they are prone to tumors
But seeing the numbers we do in the Seralini study is enough to start asking questions. Remember this test had never been done before. Monsanto doesn't have to do this kind of study, yet a two year study with 50 rats is the only way to know if the toxicological problems are causing tumors.
But the more they were fed, the less tumors they got, and the rats that were NOT fed Monsanto products also developed tumors.
Myles Power is basically giving the paper the same criticism it received from the broader scientific community, and which ultimately led to its retraction:
https://en.wikipedia.org/wiki/Séralini_affair
You might nit-pick his wording, but this is pretty much what he said, along with criticizing the showing of photos of rats with tumors, which give the impression that control rats did not develop tumors, when of course they did. He also pointed out the study seems bizarrely complex in the way it presented data. All of these criticisms have been shared, with other people having very similar initial impressions:In November 2013, Elsevier announced that FCT was retracting the paper, after the authors refused to withdraw it.[5][89] The journal's editors concluded that, after an in-depth look at the study's raw data, no definitive conclusions could be reached regarding the role of either NK603 or glyphosate in overall mortality or tumor rates, given the high incidence of tumors in Sprague-Dawley rats and the small sample size. Normal variance could not be excluded as the cause of the results.[5][90]
https://en.wikipedia.org/wiki/Séralini_affair
The Washington Post quoted Marion Nestle, Paulette Goddard professor in the Department of Nutrition, Food Studies and Public Health at New York University and food safety advocate: "' can’t figure it out yet....It’s weirdly complicated and unclear on key issues: what the controls were fed, relative rates of tumors, why no dose relationship, what the mechanism might be. I can’t think of a biological reason why GMO corn should do this.....So even though I strongly support labeling, I’m skeptical of this study.[/i\'"[43] Likewise, Dan Charles, writing for NPR, noted that in the study, rats that ate 33% GM food developed fewer tumors than did those who ate 11% GM food, suggesting the absence of a dose response.[44]University of Calgary Professor Maurice Moloney publicly wondered why the paper contained so many pictures of treated rats with horrific tumors, but no pictures of control group rats.[45]
But the key point I was highlighting
MikeC
Closed Account
Yep - but neither Monsanto nor Serilini were actually doing a cancer study - they were all toxicology studies, and Serilini decided the cancer results were worth publishing even though outside his terms of study!!
Seralini wrote:
so he wasn't looking for cancer, knew that if he was looking for cancer he should have had larger controls, and then he decided to publish results about cancer anyway......Because of recent reviews on GM foods indicating no specific risk of cancer 2,16], but indicating signs of hepatorenal dysfunction within 3 months 1,7], we had no reason to adopt a carcinogenesis protocol using 50 rats per group. However, we prolonged to 2 years the biochemical and hematological measurements and measurements of disease status, as allowed, for example, in OECD protocols 453 (combined chronic toxicity and carcinogenicity) and 452 (chronic toxicity). Both OECD 452 and 453 specify 20 rats per sex per group but require only 50% (ten per sex per group, the same number that we used in total) to be analyzed for biochemical and hematological parameters.
Guideline 452 is available here - this requires 20 rodents per sex per group
Guideline 453 is available here - this requires 50 rodents per sex per group - I see nothing in it allowing 20 rats per sex per group as claimed above, so it seems to me his claim as above is not true.
william wiley
Member
that's not so important with only 10 rats per group, especially when one considers the well known and documented "threshold effect". they refer to the "threshold effect" in the paper.
addedin edit:
And, yes all the rats develop tumors but there is a legitimate question to be studied here.
It's plain wrong to claim the "wrong sort of rat" was used. I think I have demonstrated that.
It's not nit picking to point out he is wrong about important facts.
I can point to scientists who support Seralini too. Different people get different "impressions" too.
Some would get a certain impression by the fact Myles poisoned the well by putting Alex Jones in his video.
But regardless if some of Myles points were right there is no ground to make some of the claims he did. No grounds, and I think I've demonstrated that.
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william wiley
Member
Do you think that if those guidelines are good enough when it comes to the number of rats they might also be good enough when they say all tumors (lesions) must be reported?
MikeC
Closed Account
He didn't just report the numbers of tumours tho - he said they were due to Roundup:
Results
Biochemical analyses confirmed very significant chronic kidney deficiencies, for all treatments and both sexes; 76% of the altered parameters were kidney-related. In treated males, liver congestions and necrosis were 2.5 to 5.5 times higher. Marked and severe nephropathies were also generally 1.3 to 2.3 times greater. In females, all treatment groups showed a two- to threefold increase in mortality, and deaths were earlier. This difference was also evident in three male groups fed with GM maize. All results were hormone- and sex-dependent, and the pathological profiles were comparable. Females developed large mammary tumors more frequently and before controls; the pituitary was the second most disabled organ; the sex hormonal balance was modified by consumption of GM maize and Roundup treatments. Males presented up to four times more large palpable tumors starting 600 days earlier than in the control group, in which only one tumor was noted. These results may be explained by not only the non-linear endocrine-disrupting effects of Roundup but also by the overexpression of the EPSPS transgene or other mutational effects in the GM maize and their metabolic consequences.
william wiley
Member
He doesn't say they were. He says they may be. <scratches head>
Spectrar Ghost
Senior Member.
I'm sorry? He didn't say "might be". He said "may be", as in you may [can] explain them that way. And what reason is there to even suggest that causation in a non-cancer study?
deirdre
Senior Member.
well if your science, your scientific data, was to accidentally stumble upon such a thing it would be ok to suggest it. But the science doesnt.
MikeC
Closed Account
He shouldn't even say that.
I cant' find a transcript of the press conference when he announced the results , but the wiki page has him highlighting the cancer results as a major output, and this is a typical report from newspapers about the initial announcement:
- Washington Post
In a telephone conference call with U.S. reporters on Wednesday afternoon, Gilles-Eric Seralini, a biologist at Caen University and the study’s lead author, noted that GM animal studies typically conclude after three months, likely because companies behind genetically modified foods don’t want to know the long-term consequences of their products.
“After four months” Seralini said about his own long-term study on 200 rats, “the tumors began.”
“After one year, there was a . . . high increase in the number of tumors,” continued Seralini, who is also the president of CRII-GEN’s scientific board. He said that most of the female rats had two or three tumors.
Spectrar Ghost
Senior Member.
I'd accept a note about a correlation that needed further study. The paper went a step further and suggested a causal relationship and a physiological basis for it. That's what's out of line. How did they determine this?
MikeC
Closed Account
Very badly - the EFSA final review of Seralini et al is scathing in it's identification of shortcomings - here's just one para:
2.6.2. Statistical analysis
Member States (DE BVL/BfR, FR ANSES and FR HCB) conducted statistical analyses on the tumour
and mortality data that could be derived from the Séralini et al. (2012a) publication. They concluded
that the results of their independent analyses did not support the conclusions drawn by Séralini et al.
2012a).
It's the wrong sort of rat if you have just ten of them. Because they will randomly develop tumors anyway. You need rats that don't develop tumors.
Dan Wilson
Senior Member.
That's not a rule here. Studies involving 90 days to 6 months of treatment with concentrations that are above what a human would naturally consume offer relevant and useful data. When that data shows no significant evidence of tumorigenicity, it suggests that the substance is not particularly carcinogenic.
I asked a bad question, sorry about that.
william wiley
Member
the report also has the following to say.
So in contrast to what has been claimed in recent posts here the EFSA says Seralini did not draw conclusions with regard to the tumors.
william wiley
Member
No it'snot the wrong sort of rat, and for a toxicology study you have ten rats. This is exactly the same number that Monsanto used and it's the number recommended in the guidelines previously linked 448, 452 and 453. Come on.
Sprague Dawly rats are used in toxicology studies and they are used in cancer studies.
They are used in cancer studies because they are prone to tumors!!!!
In a cancer study you get lots of tumors but you use lots of rats too, which helps get rid of random noise. this sounds counterintuitive but if you get less tumors the results might not be as robust. If you tested 50 rats in each group and got a handful of tumors only then how will you know which ones are unrelated and just by chance? But if you get a large number of tumors you can get something meaningful. Does that make sense?
Imagine if you flipped a coin 50 times and rolled a 20 sided dice 50 times. I you get 35 heads and 15 tails you'd be suspicious. But if you got the dice rolling say, the number 7, a small number of times it would not tell you much about bias in the dice. How many rats can we use in each study
Furthermore if you use rats that don't develop tumors then how can you use them in a cancer study? None of the rats will develop tumors. (and yes I realise you weren't actually saying that but I think it helps to make the point)
I think you are still misunderstanding this, and it's a little complicated and there is a lot of "noise" around it, and a lot of misinformation to confuse people.
1.SD rats are used in toxicology studies.
2.Toxicology studies have 10 rats per group.
3.Monsanto used 10 rats per group in a toxicology study
4.Seralini also used 10 rats per group in a toxicology study.
5.SD rats are also used in cancer studies.
6.SD rats are acceptable in cancer studies because they are prone to tumors
7.Cancer studies have 50 rats per group
8.Seralini noticed more tumors in the rats fed Monsanto products.
9.Seralini could not draw conclusions about cancer from that because he only had 10 rats per group.
10.Seralini could say "I wonder if the greater incidence of tumors is related to the greater toxicological issues we see'?
Do you disagree with any of those 10 points?
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william wiley
Member
If you don't have an hypothesis then how can you design a test?
From the paper
Having already suggested the incidence of tumors be properly investigated the obvious place investigate are the areas they mention.....aren't they?
Or should they investigate some other explanation?
skephu
Senior Member.
No, we are talking about long-term studies, and you also bolded the "multiple lifetime studies" part. OECD guidelines also prescribe 2 years for carcinogenicity testing.
deirdre
Senior Member.
yes. which is why making any insinuation about tumors in the paper was bad science. see?
yes #10. he could also say "I wonder if the greater incidence of tumors is related to playing rock and roll music in the lab" or "I wonder if the greater incidence of tumors is related to stress brought on by humans in white coats". see?
MikeC
Closed Account
452 says you use 20 rats for tox studies ads I noted above.
skephu
Senior Member.
Looking at the "Tumor incidence" section of the republished Seralini paper, it seems to me that they found a statistically significant effect only in one case:
I think the study probably justifies the need for a larger, more focused study, but in itself it's too weak. And it doesn't justify the media hype the authors generated.
And in the methods section:Using a non-parametric multiple comparison analysis, mammary tumor incidence was significantly increased at the lowest dose of R compared to controls (p < 0.05, Kruskal-Wallis test with post hoc Dunn's test).
Why did they only apply the statistical analysis to the mammary tumors? I think they probably applied it to other types but those were not significant and they did not report them. They did not report the results for the other treatments and other doses either. In the end, we don't know how many analyses they made to obtain this single significant result. And BTW p < 0.05 is a very loose criterion which very often yields false positives.Differences in the numbers of mammary tumors were studied by a non-parametric multiple comparisons Kruskal-Wallis test, followed by a post hoc Dunn's test with the GraphPad Prism 5 software.
I think the study probably justifies the need for a larger, more focused study, but in itself it's too weak. And it doesn't justify the media hype the authors generated.
skephu
Senior Member.
But that is from 2009. The Seralini study was started in 2008.
skephu
Senior Member.
How would that explain the difference between the treatment and control groups?
william wiley
Member
10 of each sex.
skephu
Senior Member.
No, it says 20 per sex.
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