John Day MD graduated from the University of Texas Med School, Houston. He is Board Certified in Family Medicine and usually works in public health.
The following is his comment on Seralini's study (which found toxic effects in rats fed GM NK603 maize over their lifetime), 's own 90-day feeding trials on its GMOs, Seralini's re-analysis of the Monsanto data, and the general quality of industry tests.
Misinformed by "science"
John Day, MD
The Automatic Earth
There are a lot of pictures of deformed albino Sprague-Dawley popping up over the past 2-3 days. Those kinds of pictures are easy to come by.
What is really going on?
Monsanto had to fund scientific studies to "prove" that it's GM corn/maize varieties were "safe" for human and animal consumption in OECD member countries.
So firstly, the intent of these studies is clear. The intent of these studies is to find no fault, no metabolic danger to living organisms.
Monsanto has done this dance before, and knows how to do it. It is general knowledge, anyway. It is a very common dance. Industry funds most of this research, and funds the researchers who provide the desired results most reliably. I'm not jaded. I've been involved in physiologic research studies on lab rats for years in college and med school. I've had long discussions with researchers, often about other researchers, and methodologies used, tossing out a couple of bad data points to get where you need to be, things like that. My critical reading of medical and physiological research has generally led me to conclude that 80-90% of published, peer-reviewed research is biased, meant to prove some predetermined "fact".
In order to justify conclusions, researchers are supposed to reveal all raw data and all statistical methods of analysis. This is Greek to most readers.
Let's look at how Monsanto stacked this data in their own favor.
Yes, this is ALL Monsanto data we are discussing, and it is 12 years old, and it has been kept secret, pried out by Greenpeace lawsuits and such.
We only have Monsanto data to talk about here, but now, after more than a decade, the raw data and methods are available for review.
Toxic effects show up more over longer times, with more animals to look at, with higher doses of the toxins, and with more tests, to look at more specific types of acute and chronic change in physiology.
As Monsanto I want studies with shorter time frames, fewer animals fed my corn, animals fed lower doses of my corn (maybe give some of my corn to the control group, by not genetically analyzing their feed, so they are secretly more similar to the test groups), and I don't want to do very many liver or kidney or sex hormone tests, and I don't want to do them very often, and I want to end the whole study well before cancer has a chance to start, or "long-term-toxicity" can kick in.
Monsanto bought study protocols that really only had 10 rats in each group fed specific GM corn products.
With 10 rats per group, you just can't find anything but high frequency effects. They only fed a maximum of 33% GM corn to any group, and the lower dose was 11%. There were very large groups of hundreds of rats used as various sorts of controls, so the study looks better with hundreds of rats, but they were not the ones in the test groups, so it is fluff. The lack of rigor in defining the diets of some "control group" rats left open the possibility to mix some of the study maize into their feed, while nobody was looking, and that was all the time. Nobody looked. there was no genetic analysis of the feed given to the most general control group.
This information never formally existed, but if I were a crooked researcher, I would have spiked the feed of the control groups at night with the same GM corn that I was giving the experimental groups. Monsanto knows how to get what they pay for, right?
The small groups of test-group rats at low feeding concentrations only got to participate for a maximum of 3 months, then Game Over. Long term toxic effects were specifically excluded from the short term study, but the conclusion was that the GM corn was safe in long term use for billions of humans and animals. "Science".
Evidence of cancer was excluded by the very short term [duration] and by not looking for any cancer or tumor markers. Check!
Evidence of teratogenicity was excluded by strictly avoiding pregnancy and not even looking at any reproductive hormone levels.
The final firewall was the statistical techniques used.
How can you justify a safety conclusion on such a small dose, small cohort, short time study group, which you checked so few things on?
You just say it's so, and hide all your records.
That worked until Monsanto lost the court cases...
If your design gives a 70% chance that you will fail to find major toxicity, and you don't find it, then you just say you did a careful study, and it wasn't there and the data is proprietary. Check!
What can the very limited raw data reveal about the few rats fed low concentrations of 3 GM corn varieties for 3 months, and tested as little as possible? [ http://www.biolsci.org/v05p0706.htm]
The 3 GM corn varieties are prefaced by NK, which is "Roundup Ready" and therefore contains traces of "Roundup", as well as 2 MON (Monsanto) prefaced varieties, containing […] never-seen-before-in-the-living-world "novel Bt" toxins. These are pesticide toxins derived from Bacillus thuringiensis, which makes them as part of its daily chores in the world.
The novel Bt is really something to look at closely, but not for Monsanto... Cows abort when eating Bt feed, we now know, but this study stays completely away from that whole realm. A lot of the suspicion rests on these inseparable pesticide contents of these GM corn varieties, but not all of the suspicion, because these are not necessarily the only "improvements", just the obvious ones.
I will not give a blow-by-blow breakdown for each feed group, but there were sex differences and dose differences and time differences in pretty much all groups, despite efforts to ignore them by study design. There were liver and kidney effects all around, sometimes more for males, sometimes females. There were suggestions of reduced cardiac muscle mass, possibly overall muscle decrease (not looked at) in the Roundup Ready group, which could be due to eating a little Roundup. Some of the Bt[-fed] rats showed some liver changes associated with diabetes, and gained weight, but liver enzyme studies which might show signs of liver inflammation were strictly avoided. There were kidney effects which raised the possibility of renal toxicity, and showed different grouped levels of toxins excreted by the kidneys. These feeds really seemed to have different effects on the kidneys, and on male and female kidneys, but tests for early kidney damage, such as protein leakage into the urine, were avoided.
Some of these groups definitely gained more weigh than others.
Why? Sorry, beyond the scope of the study. Who cares?
Obviously, a proper statistical analysis of the expertly-constrained data reveals nothing reassuring about even short-term effects of these GM corn varieties. It points to differences in metabolic effect from each variety, even with just a few rats to look at for a short time, and totally avoids looking at birth defects, intergenerational issues, different species, and even cancer and long-term toxicity.
Monsanto got what they paid for, even if they had to slide some extra loot under the table.
It is not enough to justify their GM corn existing in the world at all, let alone being fed to any other organism.
In America, you can't legally find out if it is in your Fritos, tortillas, or popcorn.
It's illegal to tell you that.
It's probably pretty hard for companies to even know that about the lots they buy.
Don't ask, don't tell.
Who is going to do the studies that need to be done, which would take over a decade to do properly?
Will this stuff be taken off the market pending the proper studies, as actually required by regulators, but never done?
Here is the reanalysis of Monsanto's raw data and techniques. It's dense, but it isn't lies. It's French...