The anti-GMO study released late last week has raised so many bad science red flags that I’m losing count. Orac and Steve Novella have both discussed fatal flaws in the research, the New Scientist discussed the researchers’ historical behavior of inflating insignificant results to hysterical headlines. And all this new paper seems to be proof of is that these researchers have become more savvy at manipulating press coverage. The result of this clever manipulation of the press embargo and news-release stenography by the press is predictable. The internet food crackpot army has a bogus paper to flog eternally with Mike Adams predicting the end of humanity, and Joe Mercola hailing this as the bestest study of GMO Evar. Lefty publications that are susceptible to this nonsense like Mother Jones have largely uncritical coverage and repeat the researchers’ bogus talking points. It’s a wonder Mark Bittman, organic food booster and anti-GMO half-wit hasn’t used it for his assertion that the evidence against GMO is “damning”. He substantiates this claim, by the way, by linking an article without a single scientific citation, just links to crankier and crankier websites.
Orac and Steve Novella do a good job dissecting many of the methodological flaws of this paper. Similarly, my read (or reads since this paper is unnecessarily obtuse in its data presentation), is that this paper is so flawed as to be meaningless.
Critically, these rates of tumor formation are well established from the pre-GMO era. This paper is exceptional for a low rate of tumor formation in the controls compared to historical controls and knowledge of tumor formation in this rat strain.
Second, the sample groups were small, and the parameters measured were large, almost guaranteeing false-postive events would outnumber true-positive events. Take a data set like they generated, and then perform subgroup analysis, and false-positive yet statistically-significant events are going to jump out at you like mad. The researchers then indeed seem to engage in this behavior, selecting a single time point to present their measurements of various biomarkers, rather than showing them over time. This is particularly notable in figure 5 and table 3. This is a sign of sloppy thinking, sloppy experimental design, and a failure to understand Bayesian probabilities. If you study 100 variables at random, you are likely to find false-positive statistically significant events about 5 percent of the time, even though there is no actual difference between groups. The pre-test probability of an effect being meaningful should determine whether a test should be performed and reported, and this “fishing trip” kind of experiment should only be the beginning of the process. It’s simply not possible to know the relevance of any of these ostensibly significant results found by subgroup analysis until they are subsequently studied as primary endpoints of a study.
The histology in figure 3 is demonstrative of nothing, and the scary rat tumor pictures notably lack a control rat – and we know the controls make tumors too. So why aren’t any control tumors shown? With the concern for bias throughout this paper I find the entire figure to be of no value, since it’s purely qualitative and highly susceptible to bias. Histology slides should be used to show something meaningful in terms of big qualitative effects, unusual structure, or a specific pathology. If one is to make claims about differences between groups by histology, you still have to subject it to rigorous and blinded analysis. I’ve done it, published on it, etc. It can be done. Worse, we know the controls have tumors, and that in this strain tumors are frequent. Why are the control samples always completely normal if not for biased selection of samples? Don’t show me one kidney, show me all the kidneys. Don’t show me one control slide, show me ten, or ideally the results of a blinded quantitative evaluation for tumors or histopathologic grade.
Similarly with figure 4, I don’t see a significant difference between the fields examined, and looking back at previous papers from the same group none of their ultrastructural evaluation of glyphosphate exposed or glyphosphate-resistant feed exposed cells and animals appears consistent or convincing. I don’t think many people have exposure to EM anymore as an assay, but having performed it, it’s very hard to say anything quantitative or meaningful with it. You’re going to find something in every grid, and it largely serves as a qualitative evaluation of cellular ultrastructure. I’m very wary of someone saying, upon presentation of a couple EM slides, that two groups of cells are “different”, and I’m confused by the assertion that the areas they describe represent aggregates of glycogen. What is the significance of glycogen being more dispersed in one cell versus another? You found some residual bodies, so what? They’re everywhere. Is this really a consistent effect? Show me numbers – summaries from 10 grids. Is there any clinical significance of such a change? The answer is no. If I were a reviewer I would have told them to junk the figure unless they wanted it to provide evidence of no difference between the cells.
In general the paper is confusing and poorly-written. Others have pointed out that Figure 1 is unnecessarily complex and better representation of the same data shows no consistent pattern of effect. I would say, given the sample sizes and effect sizes that the likelihood is the researchers are studying noise. There simply is no signal there, if there were there would be a consistent dose-response effect, rather than in many cases the “low dose” group having more tumors than the “high dose” groups. Without error bars it’s hard to be sure but my read of figure 1, in particular the inset panels, is that there really is no difference between any of the groups in terms of tumor formation.
We also have to consider that in the end, this whole idea is kind of dumb. Is there really a plausible explanation for how eating feed with an enzyme that’s resistant to glyphosate generates more tumors in rats, and so does exposure to glyphosate? Why would this protein be tumorigenic? If indeed the roundup-ready crop may have residual levels of glyphosate on it, and that’s the explanation for the similarity between groups, then aren’t you just admitting you’ve done a completely uncontrolled analysis of exposure to the compound? Couldn’t and shouldn’t this have been assayed? Isn’t this whole study kind of crap?
This paper should not have passed peer-review and represents a failure by the editors and reviewers to adequately vet this paper.
Anti-GMO study is appropriately dismissed as biased, poorly-performed
Comments
60 responses to “Anti-GMO study is appropriately dismissed as biased, poorly-performed”
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Well it’s not different to the CDC, NIH inflating the swine flu scamdemic to global proportions, ripping off every health service in most countries except Poland and then claiming they stopped the end of the world.
If that’s your kind of woo or course. -
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Do you have ANY concerns about the safety of GMOs? Given that this is a subject that must terrify a lot of parents, do you feel your disrepectful tone toward people like Dr. Mercola is appropriate? You are entitled to your opinion, but I would expect a medical doctor to be a gentleman, and not mock people with legitimate concerns.
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They said last week organic food not good!! This week gmo not good!!
what the f can we eat????? i am freaking out man!!!
Save the planet kill yourself!! -
Dave, stick to the facts. The study is fatally flawed and will be misused and misrepresented and lied about for many years to come. Do you dispute any of those points? Otherwise your comment is an attempt to change the subject, which isn’t a good sign.
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Considering GM crops are almost all designed to increase the use of pesticides, I think it’s fair to tie the ill-health effects of those pesticides to the GM crops themselves, too.
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surpisingly the most well done study on the safety of GMO’s is dismissed simply because it finds a result unfavorable to the biotech companies, yet much less stringent studies are accepted as adequate proof of the safety of these products. Clearly the Biotech industries web of influence runs deep in the european parliament
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dave, Mercola is a quack, who has a vested interest in selling his quackery via Internet, who uses fear-mongering as his primary marketing device, who cares not a whit about the “safety of GMOs.”
Having been an advocate of organic farming until recently, I am simply through with people like you with your shrill, whiny, strident tone and your thoughtless adoration of the likes of Mercola, Adams, Shiva, etc. They do NOT deserve “respect.” -
What’s your stance on zombies, Dave? The subject of zombies is one that must terrify a lot of people. Would you think that one would need to maintain a respectful tone to a doctor advocating preparedness for a potential dead rising, brain eating epidemic?
Of course not. Because that doctor would be demonstrably full of shit.
Mercola has also long since been proven to be similarly demonstrably full of shit. That actually would be an understatement. There might not be a word in the English language to describe the order of magnitude of the fullness of shit that Joe Mercola is full of. -
glasshouse:
Please provide evidence that the CDC &c “inflated” the swine flu pandemic or retract your claim.
dave:
Mercola is a quack who espouses all sorts of harmful, dangerous garbage. He deserves no respect. -
Dave,
No, I do not have concerns about the health and safety profiles of GMOs. The basis for these concerns is based upon a shoddy, science-fiction view of how biology works. We have covered this in multiple posts.
As far as being disrespectful to Joe Mercola I don’t even see how anything I said was “ungentlemanly”. But it is true I have absolutely no respect for the man and the reason for my disrespect is because I am a medical doctor. Joe Mercola spreads medical disinformation for the sake of profit. I can think of no one who deserves less respect. He is the epitome of a quack. Quackwatch of course has a good summary of his misdeeds including anti-vaccination crankery, fluoridation paranoia, pushing fake cures, spreading disinformation on mammography, and pushing placebo pills all for his personal profit. -
Glasshouse, I would disagree. Swine flu and H1N1 are actual threats to human health and safety. Granted it may seem like we overreact to each potential epidemic, but that doesn’t mean these viruses aren’t dangerous.
I have seen these viruses kill, personally. Especially H1N1 was different for how it killed even the young and healthy. The virus killed children and adults in their prime. I do not think they overreacted.
The health risk criticisms of GMO, however, are largely baseless. Concerns about bt are pretty silly, and forget that bt has been applied for decades as a non-transgenic pesticide. A concern about an enzyme that degrades a herbicide is even more implausible from a health risk perspective, although, concern about herbicide contamination is of course reasonable.
Are there some risks to the technology? Sure. Transmission of genes to other related plant species and concurrent resistance to pesticides would be one, however, resistance is a problem with conventional technology as well. Other valid concerns include the patent law issues and economic abuse of patentable technology. Companies with licensing control over their product act atrociously towards small farmers, engage in monopolistic behavior, and are ferocious in their control over their technology. They’ve been known to sue farmers for reseeding after their crops have cross-polinated non-GMO fields.
But these concerns are separate from health risks of a transgenic plant which I find to be vanishingly small. -
Disclaimer (as per usual!) I am a Monsanto employee, my comments here reflect my own views and opinions and not those of my corporate overlords. (may they eat you first)
The enzyme in RR crops does not, afaik, degrade the roundup, it is not inhibited by it, it allows the enzymatic pathway to continue as was, rather than shutting it down.
“Companies with licensing control over their product act atrociously towards small farmers”
Not really.
“They’ve been known to sue farmers for reseeding after their crops have cross-polinated non-GMO fields. ”
Not really. Not without clear intent to do so. -
this is the year of the vaccine!!
if gmo make it its own pesticide and if you eat corn on the cob!!
well..
how much did they pay you?
to the rest of us save the planet kill yourself!! -
You are a disgusting anti-human, corporate lapdog pushing poison on the human race. GMO is poison and it’s sad you are so brainwashed to defend Monsanto and these companies. You are a disgusting piece of dung.
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The main problem of GMO studies many have bais for GMO compagnies. The studies was finance by Europeans Supermarket s groups for have indepandant point of view. Cause last time they trust governemant agencies that about the Bovine spongiform encephalopathy with many economic problems after.
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Monsanto only test for 90 days, rats live longer than 90 days, because the tumors don’t start to form for 4-7 months. You are very naive to dismiss this, why hasn’t anyone else ever performed a full test of the entire life span of the rat? No one except the French has ever done a 2 year study, no one!!!
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Ewan R, thanks for the explanation, I had a different idea about the mechanism. This makes it seem even less likely that the RR crops would be dangerous. It’s not even a new enzyme.
As far as those continuing to rant GMO is poison, where is the proof? If this paper is the best you can do, then your argument is lost.
No one seems to be sticking up for the methodology here except for ken, to whom I’ll respond.
Ken, studies have been performed over multiple generations on other GM crops bt corn but true not for the RR crops. However, the problem is this study doesn’t show anything. Read it. The full text is linked above. I’ve been looking for the last few days at the coverage by sciencebloggers and scientists evaluating the paper. I have yet to see one that was not highly critical of their methods, in particular their apparent statistical fishing trip they needed to go on to find the models they applied. Why wasn’t ANOVA sufficient? Hell, if they’re just going to look at a single time point, how about a t-test..
Worse, previous studies on this same rat species from the pre-GMO era showed the same rates of tumor formation as seen in this study! If anything, the exception was the low rates in their controls. To me, that kills it.
Let me state it again. This paper shows nothing. The results are either statistically meaningless, or highly suspect given the criticisms shown above. The authors engaged in some very fishy behavior to prevent expert review of the paper before press coverage and with good reason. Every expert that has subsequently commented has said this paper is a stinker.
It’s not just me, it’s Orac, Steve Novella, Andre Kniss, The New Scientist, Emily Sohn at Discovery, Revkin at the NYT, the list goes on. No one with any scientific chops finds this paper meaningful.
It’s not just me, it’s pretty much every scientist that sees this paper says it’s garbage. And inevitably we’re then accused of being influence by Monsanto. How? I’m funded by NIH. I don’t study transgenic plants. Orac is an oncologist, Novella a Neurologist, both are highly skilled at evaluating the literature, and they agree. Are we all on the payroll?
No this paper is just a joke. The ones with bias are the cranks that are ideologically opposed to GM that will support this study, in the face of the rest of the literature, the legitimate and fatal criticisms of the methodology, and every scientist sought to comment on it who have said the same thing. This study is junk. -
Mark I hope u soon wake up from all the illusions we are expected to swallow just like that. I woke up 2 years ago and there is no going back now. It was scary in the beginning but got easier along the way. Best wishes.
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Woah. That did it Gandhi. I’m convinced. All science is wrong. GMOs are bad. All I needed was your pity for my belief that science matters.
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Dear Mark,
As a young scientist who will hopefully enter the foray of science blogging to do exactly as you are doing, I would like to thank you.
There has been much discussion especially here in Australia as to what to do with troll like behaviour on the internet and it was one of my concerns when I decided to finally take the leap and decide to start a blog (although I haven’t started yet – finish thesis first!). Your approach is enlightening, although I have to admit, I have no idea how you don’t scream at the computer at some of these ridiculous and unguarded statements.
I admit, because science is conducted in such an Ivory tower, normal, even well educated people who do not understand the scientific method make rash and seriously flawed statements because of information they may have pieced together from various (sometimes dangerously false) sources of information. I think we forget that we have been trained on how to think and analyse information and given all the tools to enable us to critically and effectively analyse a piece of data to decide whether we believe it is coherent or not. Unfortunately, it is easy to forget that this training is not embraced by all, particularly the general public, and as such, view which appear silly to a scientist may be perfectly logical to someone else.
Either way – thank you for attempting to educate people and being part of the sway to bring down the Ivory tower. I am of the opinion that it is what science and indeed the world requires to proceed as I think secrecy is damaging the great work we can do.
Thank you,
Ania -
I don’t think it is necessary for “all science is wrong” for it to be true that “GMOs are bad”.
Mining and construction companies were perfectly happy to sell asbestos.
The livestock industry in England was perfectly happy to stick with practices that caused the spread of CJD.
The pharmaceutical industry is notorious for releasing only that fraction of its research data that assists its marketing efforts.
And judging by the gene technology industry’s appalling behaviour in selling GMOs that encourage increased use of pesticides, in trying to patent people out of their livelihoods, in selling people ineffective crops that are sterile, and in suing farmers for theft after GMO pollen has blown onto the farmers’ land, it would seem that the likes of Monsanto are up there with the worst of the evil, dishonest money-grubbing corporations. -
I found it interesting to review this paper and its criticisms. Note that, in general, I find animal testing to be distasteful, of questionable scientific value, and easy to manipulate.
That said, while this study is not perfect, the scienceblogs commentary makes some good points but is also biased itself. For example, he states,
“Others have pointed out that Figure 1 is unnecessarily complex and better representation of the same data shows no consistent pattern of effect (http://www.emilywillinghamphd.com/2012/09/was-it-gmos-or-bpa-that-did-in-those.html)… my read of figure 1, in particular the inset panels, is that there really is no difference between any of the groups in terms of tumor formation.”
This is interesting because if you look at the revised graphs he refers to in the link, there is overall a significantly higher rate of tumor formation in the GMO/Roundup groups than the control group. Occasionally the control group is equal or slightly higher than one of the test groups, but the difference is more than made up for the cases where the GMO/Roundup groups are much higher than the control.
As for the supposed small size of the study group, the study looked at 200 rats–far more than in a standard GMO diet study.
Another point to consider: “In our study the tumors also developed considerably faster than the controls, even though the majority of tumors were observed after 18 months. The first large detectable tumors occurred at 4 and 7 months into the study in males and females respectively, *underlining the inadequacy of the standard 90 day feeding trials for evaluating GM crop and food toxicity*…” (emphasis mine)
This study was actually much more rigorous than a lot out there. A 2-year feeding trial on 200 rats, monitored for outcomes against more than 100 parameters – a greater duration and with more detailed analyses than any previous studies, by environmental and food agencies, governments, industries or researchers institutes. Why aren’t those critics concerned by the many methodological flaws in several widely-promoted pro-GM studies?
This article references several studies that have found evidence of harm:
http://www.responsibletechnology.org/doctors-warn
Anyways, this critique is far from exhaustive, but I hope I’ve at least highlighted how the issue is not as clear-cut as the article you posted made it out to be. -
I found it interesting to review this paper and its criticisms. Note that, in general, I find animal testing to be distasteful, of questionable scientific value, and easy to manipulate.
Well you’ve already failed the biologist test. > 98% of biologists believe animal testing to be necessary for biologic science according to polls by nature.
This is interesting because if you look at the revised graphs he refers to in the link, there is overall a significantly higher rate of tumor formation in the GMO/Roundup groups than the control group.
Did you do the t-test yourself? I don’t see any statistics in those figures. And I’ll tell you, there’s no way they can be significant. They’re working with groups of 10, and the differences are between 1 and 2 tumors per group. Worse, the low dose group is always the highest, and each time the high dose group is the same or even lower than the control. No dose response, tiny numbers, this is just noise.
Occasionally the control group is equal or slightly higher than one of the test groups, but the difference is more than made up for the cases where the GMO/Roundup groups are much higher than the control.
Much higher is debatable. The bar may look higher but it reflects the underpowered nature of this study that that will be affected by one or two animals. Not one of those bars is consistent with dose-response. “much higher” is also not an accurate way to describe the differences. Biggest difference is 2.5 vs 1. Which in a comparison of groups of 10 or 20 is not meaningful.
As for the supposed small size of the study group, the study looked at 200 rats–far more than in a standard GMO diet study.
You can’t just add up all the animals in the study and say that’s the size of the study group. The study groups were small because comparisons were being made between groups of 10 and 20.
Another point to consider: “In our study the tumors also developed considerably faster than the controls, even though the majority of tumors were observed after 18 months. The first large detectable tumors occurred at 4 and 7 months into the study in males and females respectively, *underlining the inadequacy of the standard 90 day feeding trials for evaluating GM crop and food toxicity*…” (emphasis mine)
Those were two Wilm’s tumors, as others have pointed out, if GM crops caused Wilm’s tumors we would have detected it already as every single Wilm’s tumor is registered in this country. It’s actually another hit against the paper interestingly enough.
This study was actually much more rigorous than a lot out there. A 2-year feeding trial on 200 rats, monitored for outcomes against more than 100 parameters – a greater duration and with more detailed analyses than any previous studies, by environmental and food agencies, governments, industries or researchers institutes. Why aren’t those critics concerned by the many methodological flaws in several widely-promoted pro-GM studies?
The bigger the claim the stronger the data needs to be. And it’s not 200 animals per group. That would have been interesting. A study on “200 animals” is not impressive if the comparisons being made and hyped up are on subgroups of 10. Worse, the more parameters the less I trust it. If you study more parameters without good pre-test odds that they’re meaningful, you’re just going on a subgroup fishing trip. You’re going to find lots of statistically-signficant, but ultimately spurious results. I’m not impressed by more parameters especially with their selective display of changes in those parameters along with fishy statistical analysis using non-standard models rather than ANOVA.
This article references several studies that have found evidence of harm:
http://www.responsibletechnology.org/doctors-warnNow you’ve totally lost me. That website is a crankfest. If that’s what you think good evidence is, you’re capacity to judge the quality of evidence is poor. I’ve been all through that website before. It’s full of quote-mining, conspiracy theories, and Jeffrey Smith’s anti-GMO crankery.
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10-20 animals is a standard test group size. How can you criticize that, and not have a problem that all the regulatory tests, which had similar sizes but were much shorter in duration (not useful for detecting chronic long-term conditions), are “hyped up” as proving GMOs safe? Precautionary principle, anyone? Furthermore, why is it that when somebody actually does a study like this, it’s heaped with criticism, but nobody is upset that this type of test was not required to begin with?
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“OMG” is GMO backwards.
Please stop resisting us and let them label it!! Just label it!!
“Your resistance only makes my pxxnis harder”
We are not 100% idiots!!
Scientist has gone mental.
“They are modifying seeds that could end up cross pollinating with other plants and destroy the plant genetic diversity as we know it!” No one has the right play god at that level. 2012 is not the end of the world and without plants humans can not live!!
The earth don’t need our help to survive. The earth started out without humans and earth will end without humans. How will the earth die? When the sun burns out or when it become the “Red Giant” and scorch the earth!! CO2, Comet strikes or nuclear weapons, Global warming or humans or harpoons will kill the earth a 100%. It will give life to new evolutions of life!! Micro organism will still survive those events and thrive!! Earth will take back that is his..
Leave the earth untouched for future generation!!
Who are we to f up the world for them!! We could have 500,000 generation after we are dead!! Truth is no one knows!! If you are lucky you could live 28,000 days. Half of that time you be a sleep!! The simple answer is earth will out live all of us!!
Google Plants can talk, say scientists
i am not surprised at this news..!! At this rate they can tell you chilling stories where ever you turn!!!! -
Mark, are you open to the possibility that their is corruption in the FDA, and that GMO crops were allowed in part because of that? Or do you completely trust the FDA?
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10-20 animals is a standard test group size.
Well, one quick search away and I find a paper testing RR corn with sample sizes double that of this paper per test group. Another on Bt safety again with twice the sample size per group. A Bt multi-generation study with sample sizes in the 20-30 range. A cornbearer resistant strain study with sample sizes twice these etc. Seralini et al performed 10 of each rat sex/sample. Your claim that 10 of each sex/sample is standard seems to be incorrect. The standard seems to be at least twice that.
Further a “standard” number is a deceptive term. Significant results may be obtained in comparisons of 5 animals, or even 3, depending on the magnitude and variance of an effect. Play with a power calculator sometime. For a sample with a known incidence of an effect of 70%, an alpha of 5% (standard) and beta of 50(standard), the difference between the known incidence and test incidence for a sample of 10 has to be about 40%. Which it was! Fascinating coincidence that their result is exactly the limit of the power of their assay, and remember those assumptions also allow a false result 20% of the time. Anyway, this is a huge effect. It would suggest cancer rates should be increasing astronomically, doubling in fact, with chronic exposure. But this is not seen in our labs (all animals are GMO exposed these days – you think we’d notice) or out in the world (cancer incidence actually appears to be dropping).How can you criticize that, and not have a problem that all the regulatory tests, which had similar sizes but were much shorter in duration (not useful for detecting chronic long-term conditions), are “hyped up” as proving GMOs safe?
Well for one, you’re wrong, glyphosate has been studied in chronic models. These new results conflict with others in the literature.
Given we know from the literature the rats have a rate of about 70% developing tumors in 2 years, their finding that all their test groups had rates of tumor formation between 50-80% in 2years is non-exceptional. The exception was their control in which only 30% developed tumors. The tests groups fit in well with the historical average. If these tests were repeated with more animals we would likely see a regression towards the mean. This exceptionally low value for their controls relative to the historical data on these animals is the source of the magnitude of this result.
Exceptional claims require exceptional proof. We need better evidence than sample groups of 10, and a control group that conflicts with the known behavior of the rat line.
Their claim is truly extraordinary, that is that both glyphosate in the water, and glyphosate resistant crops that merely carry a transgenic enzyme (read protein) both double the rate of tumor formation in rats. The first claim is in direct conflict with the literature. The second claim is biologically implausible since the enzyme is a protein that already exists in plants! The only difference is the RR version is resistant to glyphosate (thanks Ewan for pointing that out), it’s not even really a new gene product. Both claims rest on a control group out of sync with what is known about these rats.Precautionary principle, anyone? Furthermore, why is it that when somebody actually does a study like this, it’s heaped with criticism, but nobody is upset that this type of test was not required to begin with?
Since this is not actual evidence of risk, the precautionary principle doesn’t apply. The study, when considered in light of the literature and known tumorigenicity of this rat line demonstrates the test groups had similar rates to those observed since before GMOs were introduced. The only precaution one should take after reading this study is never trusting anything written by these authors ever again.
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Mark says:
“But it is true I have absolutely no respect for the man and the reason for my disrespect is because I am a medical doctor”.
Well, well, well! Here we have the pinnacle of medical arrogance. You are a medical doctor, so what? There are just as many stupid doctors in the world as there are stupid plumbers & stupid acupuncturists.
No wonder the tide against medical/pharma arrogance/self-righteousness is growing.
I think Mercola is wrong on many fronts, but I would rather have him on my side in my efforts to keep mysely & my family healthy, than your good self! -
Jeffrey, is it Mercola’s denial that HIV causes AIDS that you think makes him a good doctor? Or his belief that vaccines cause autism? Or his belief that microwaves ovens emit dangerous radiation? Or that the FDA has chastized him multiple times for making false claims in order to sell his products?
I say have no respect for him because I’m an MD, I stand by this. As an MD I find the idea of someone denying that HIV causes AIDS is a public health threat. Similar denialists in Africa are thought to be responsible for hundreds of thousands of deaths. As an MD I find someone who spreads misinformation about vaccines is a public health threat. It is the efforts of vaccine denialists that are responsible for the resurgence of measles and whooping cough. When someone lies to peddle a remedy that does not do what they describe, that makes them a fraud and a quack. As an MD, I’m opposed to frauds and quacks. So yes, as an MD and PhD trained in medical science and molecular biology I have no respect for someone who lies for profit and helps the spread of infectious disease.
And Dave I do not believe the FDA to be corrupt. They are underfunded and weaker after 8 years under a president who did not believe in regulation for public health and safety, but I do not buy into any conspiracy theories that they’re in the pocket of big pharma/monsanto/you name it like all the cranks and crackpots. They’re public servants trying to do a service with limited resources, just like the rest of us. -
If my cat got cancer from a vaccine (fibrosarcoma) and had to have her leg amputated, am I a crackpot for feeling the federal agencies cannot always be trusted to regulate what their supposed to be regulating? My vet TOLD me the tumor was from the vaccine.
Should I trust that all human vaccines are safe because the FDA says so? -
Dave I don’t understand your argument. For one, veterinary biologics do not go through as rigorous a process as human biologics do. Second, just because the FDA approves a drug doesn’t mean it’s without risk. Often they have known risks and it’s up to physicians to weigh the risk versus benefit.
Vaccines in cats are known to have this specific risk. Cats are weird in terms of their reactions to vaccines, and each vaccination increases the risk of soft tissue malignancies, likely through an inflammatory mechanism. You have to weigh the risk of your cat developing a malignancy versus the benefit from the vaccine. For instance since my cats are indoor-only, I did not vaccinate them against rabies or FLV. Their risk of exposure is minimal and, unlike humans, there is no “herd immunity” issue since the diseases come from a untreated reservoir of strays and wild animals. If they were outdoor cats I would have vaccinated them.
It’s not like the complication is unknown. Similarly with human vaccines they are safe, yes, but with very well known potential complications and side effects. These vaccines have been used, often for decades, on millions of humans. We know their risks. And we know autism isn’t one of them if that’s what your getting at. In this instance the risks of allergic reaction, fever-induced seizures etc. that occur in very rare instances are less than that of say, a whooping cough epidemic, which has the potential to kill hundreds of kids and has started doing so again now that the herd immunity is failing. -
I was alluding to a couple of issues.
I don’t believe you can make the statement that “vaccines are safe” when we know of at least one example when they can seriously harm.
My experience is that the FDA does not protect us adequately. I believe Celebrex and Vioxx should not have been approved. It is one thing to look at studies dispassionately; try telling the widows of people who died from Vioxx that the FDA protected them. The government does have a history of letting us down. Thalidomide should not have ever been prescibed, and the fact that it was gives reasonable cause for the lay person to not trust the regulatory agencies.
Thirdly, it is inappropriate to use terms like crackpot. It is disreapectful, and I expect better of a medical doctor. You can make your points without using words like that. -
I don’t believe you can make the statement that “vaccines are safe” when we know of at least one example when they can seriously harm.
I don’t understand what you mean by safe then. All medicines involve risk. If we insisted the FDA only approve drugs that can’t harm anyone ever, no drug would be approved. Aspirin can kill the wrong patient, but it’s a great, safe drug. When I load a patient with phenytoin to prevent seizures I know to be cautious because it can cause a dire cardiovascular collapse (I’ve seen it), but I still use it because of the risk of seizure after brain injury is greater. I think of lots of drugs as safe, like statins, or metformin, but statins, especially when mixed with gemfobrozil, may rare cause dangerous rhabdomyolysis. Metformin can cause an acidosis, and is harmful to patients with kidney dysfunction or when combined with other renal-toxic drugs. I think of dangerous drugs as things like Warfarin, heparin, or insulin. Drugs with narrow therapeutic windows or drugs that with even slight errors in administration can cause rapid death. Hell, even tylenol (emphasized for it’s safety by the manufacturer) has a narrow therapeutic window. About 15-20g can cause acute liver failure, that’s only about 4-5 times the maximum daily dose of 4g. Tylenol kills hundreds of people (intentionally or unintentionally) per year. When we take someone to surgery there is risk of infection, bleeding, even death from complications or the anesthesia. Nothing in medicine is absolutely safe. Your criteria that “one example” renders something unsafe is unsupportable.
My experience is that the FDA does not protect us adequately. I believe Celebrex and Vioxx should not have been approved. It is one thing to look at studies dispassionately; try telling the widows of people who died from Vioxx that the FDA protected them. The government does have a history of letting us down. Thalidomide should not have ever been prescibed, and the fact that it was gives reasonable cause for the lay person to not trust the regulatory agencies.
You are wrong on both counts I’m afraid. The rarity of the injury from Vioxx could not have been detected in pre-approval trials, they were too small. It was only after large enough groups of the population used it that the rare association was identified. The FDA did protect us in that instance by requiring post-approval safety verification, however, the drug companies were successful, and possible criminal in their delays in reporting of this data which they sat on. Second your thalidomide example is terrible for your argument, because the FDA never approved thalidomide. Most thalidomide injuries occured outside the states, and the ones within this country came from a clinical trial. The FDA resisted pressure from the manufacturer and protected the US population from the drug. Oddly enough, now the drug is being used again as a possible anti-angiogenic in cancer – with very tight controls.
Thirdly, it is inappropriate to use terms like crackpot. It is disreapectful, and I expect better of a medical doctor. You can make your points without using words like that.
Crackpot is too mean? Heavens. Everyone is going after me with the civility argument in this thread. I’m sorry you don’t like the term, but I’m going to keep using it to describe people like Joe Mercola and Mike Adams. If there was a picture in the dictionary next to crank, crackpot, or kook, it should be of one of them. How else do you describe people that deny HIV causes AIDS? Both of them do. Or fluoridation conspiracy theories? Sheesh. I thought that went out decades ago but no. They prescribe to the most bizarre beliefs imaginable, and we should be honest in describing what they are. They’re absolutely, positively crackpots, denialists, cranks, and kooks. Pick your poison. I hope you understand I was referring to those two in my argument, and not you. If that was your understanding then I apologize if I wasn’t clear enough.
-
Red Herring argument:
Tom Saunders, Head of Diabetes & Nutritional Sciences Division, Kings College, London UK : “This strain of rat is very prone to mammary tumors particularly when food intake is not restricted”
Rebuttal – The Sprague-Dawley rats used by Seralini et al. (2012) were used in most industry studies (e.g. Hammond et al., 1996, 2004, 2006; MacKenzie et al., 2007). In these and other industry studies (e.g. Malley et al. 2007) feed intake was consistently free choice – unrestricted.
Thus…If there are concerns with this breed of rat or method of feeding, would they not invalidate industry-conducted as well as independently-funded research? The key point is that industry studies ran only 90 days. The tumors found by Seralini et al. (2012) occurred after 90 days – underscoring the need for longer term testing for chronic exposure – a point which appears to have been lost in the distraction. -
Thanks for bringing up Bittman–I get so exasperated as most of his columns. He brings every (dare I say it?) crackpot in town out of the woodwork to testify to the evils of whatever he is ranting about as well as a host of off topic nonsense. I do about twenty replies before I give up trying to combat the nonsense.
He should realize if he reads the comments at all, how people react and you’d think he might clean up his act a little, but no such luck. The last one, all about Alzheimer’s being diabetes 3 was a doozy. I have no idea as to the actual validity of this hypothesis and his article did little to clear it up and much to spread fear and suspicion. -
Duncan, the issue of tumors in the industry trials isn’t relevant because they are not performing chronic studies, just 90 days then they are euthanized and studied. The rats don’t develop these tumors until the second year of life. It’s ok to use these rats for such studies, and even for chronic studies as long as they’re powered to detect changes in tumor formation rates on the high background of tumors from the strain itself. But if your rate of tumor formation is 70+/-15% at 2 years just from the strain itself, it becomes very difficult to detect changes over background that are significant.
-
Mark, I did not say that I thought Mercola was a good doctor. He is not. But he is less dangerous than the average medic who has blind faith in the FDA & Big Pharma.
As far as your defence of the FDA, I prefer to believe Dr Marcia Angell, former Editor of the NEJM for 20 years when she states in her book ‘The Truth about the Drug Companies: How They Deceive Us & What to do About it’:
“The FDA is now so dependent on the pharmaceutical industry that it has become big pharm’a handmaiden…the FDA’s advisory committees should not include experts with financial ties to industry” pp242-244.
I would rather trust Dr Jerome Kassirer who has written a wonderful book emphasising exactly what Dr Angell stated in – ‘On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health’.
Or Dr Peter Baratosy in his criticism of vaccinations in his groundbreaking book ‘ Can You Really Believe What Your Doctor Tells You?’.
Or Dr Ray Strand in his shocking expose in his book ‘Death by Prescription’ about the fiasco that is the FDA.
All of the above are doctors like you, but they think you are wrong Mark.
They think the FDA is corrupt, & that is why I would prefer a Mercola to a Mark. He doesn’t have blind faith in the the FDA, big pharma or modern medicine.And there is where the real danger of medicine lies.
I will continue to think critically of all institutions, including the most dangerous one – modern medicine.
And by the way, I am a doctor too. -
I’m a big fan of Marcia Angell, I’ve cited her work on multiple occasions. Also note that a big problem with that critique is from the declawing of the agency during the Bush administration. They now have fewer staff, can perform fewer inspections, and forget about doing independent research anymore. Instead drug companies provide the capital for the FDA to do it’s investigations. It’s a terrible system, I agree. But there is a difference between a toothless agency and a corrupt one. There also has been a great deal of variability between administrations. Kessler, for instance, was a serious hard-ass on the drug companies. During the Bush administration the FDA was a revolving door between industry and government, and this was a problem in multiple agencies.
I don’t blindly have faith in the FDA or any agency in government. But I have more trust in actual scientists, and a general belief that they do a better job than the likes of Mike Adams or Joe Mercola give them credit for.
Now you sayOr Dr Peter Baratosy in his criticism of vaccinations in his groundbreaking book ‘ Can You Really Believe What Your Doctor Tells You?’.
Or Dr Ray Strand in his shocking expose in his book ‘Death by Prescription’ about the fiasco that is the FDA.
All of the above are doctors like you, but they think you are wrong Mark.
They think the FDA is corrupt, & that is why I would prefer a Mercola to a Mark. He doesn’t have blind faith in the the FDA, big pharma or modern medicine.And there is where the real danger of medicine lies.
I will continue to think critically of all institutions, including the most dangerous one – modern medicine.
And by the way, I am a doctor too.And you have shown your true stripes. Baratosy, is a crackpot, vaccine denialist, who beyond calling vaccines unsafe suggests that they don’t even work. Strand? That placebo-pusher is pushing the discredited anti-oxidant hypothesis all over his website, despite the fact that prospective studies have repeatedly shown anti-oxidants have no effect or worsen mortality. I hate to see such quacks listed next to Marcia Angell who has legitimate criticisms but also is an actual scientist and skeptic.
So, nice try. I think we’re done here, I don’t argue with cranks, not even crank doctors. Defend your HIV/AIDS denialists and anti-vaccine denialists with your bogus civility argument all you like. They will remain crackpots and cranks to me. Skepticism is more than distrusting everything, it also requires recognizing when evidence is sufficient for trust, rather than the perpetual paralysis and inaction of the goalpost mover. The overwhelming body of evidence that demonstrates vaccines are effective, safe, and for the love of all that is good don’t cause autism. You have now suggested a HIV/AIDS denialist and a vaccine denialist are better doctors simply because they distrust the FDA. Your credibility in judging experts or valid sources of information seems adequately impeached. -
Your continual defence of the FDA is a mirror image of the defence conventional doctors raise when any criticism is levelled at the appalling rate of iatrogenesis in Australia: blame the government! We aren’t to blame because we are short-funded & trying to tap dance with one leg tied behind our back. The patients died because we were overworked.
The problem with modern medicine is that just as much “woo” passes as evidence-based medicine as is found in the alternative realm.
Even in the CDC Web page of March 2012 it states that 50% of all antibiotic prescriptions are unnecessary. OMG!
Imagine if 50% of all supplements prescribed by naturopaths were deemed to be unnecessary by their regulatory body. The sceptics would have a field day, but where are the screams of protest from the pro- medic/pharma brigade? Hardly a whimper.
BTW, there are other medics who I haven’t mentioned who also are outspokenly scathing in their attack on much of the medical nonsense touted as science – Drs McDougall/ Fuhrman/Ornish/ Esselstyn/ Ritchie etc.
It seems that these doctors must also be quacks in your eyes.
Regarding vaccinations, if you can prove to me the existence of herd-immunity theory, & prove to me that vaccines caused the drop in infectious diseases from 1890 on (morbidity & mortality), I’ll reconsider my stance on vaccinations.
As far as I/m concerned, herd immunity relies on the herd-mentality. After studying this subject for 30 years, that is my honest position. I realise that the vast majority of doctors disagree with me, but then again, the majority is often wrong, & besides, intelligence & stupidity are not incompatible.
“The overwhelming body of evidence” also showed that HRT & Vioxx were safe. That word body is just so apt! -
The FDA authenticated a letter in 2010 to POTUS from the scientific body that stated their scientific advice was routinely ignored in lieu of corporate or political favor. I think that’s a textbook definition of corruption.You think the FDA stopped the revolving door SINCE the Bush administration? Look up Michael Taylor.
-
Imagine if 50% of all supplements prescribed by naturopaths were deemed to be unnecessary by their regulatory body. The sceptics would have a field day, but where are the screams of protest from the pro- medic/pharma brigade? Hardly a whimper.
Ha! If there were a regulatory body studying this they would more than likely find 100% of naturopathic remedies are unnecessary. I think they’re synonyms actually.
Duncan, I think corruption comes in degrees. Every regulatory agency is in a adversarial stance with those they regulate, and the regulated naturally are going to try to soften the process by infiltrating the agencies. I think this was worse under the Bush administration, but I’m sure it happens to some degree under all administrations. Part of the problem is that in any industry, the people who really are experts at one time or another are going to be sought out by both industry and regulators for their knowledge. Which brings us to Michael Taylor, reading his Wiki I think it’s the same unreasonable guilt-by-association bullshit that anyone who has worked for industry, ever, is beholden to them as their slave. He sounds to me like an expert in melding sound scientific policy and law, who has experience working both inside the FDA, USDA, and industry, and on balance has strengthened regulatory policy with regards to food. Further the rBGH fuss discussed in the article make it sound as though he did a good job recusing himself in instances of conflict of interest. Most of the anger at his appointment is that he was present when GMO passed into the food supply with little scrutiny, and sources I read suggest he had recused himself anyway and despite multiple investigations seems to have avoided COI issues admirably. Since I find the safety arguments against GMO to be mostly composed of biologically implausible nonsense lifted from science fiction movies, I’m not similarly offended by their approval during his tenure, recused or not. Further he seems to be doing a good job in a food safety issue I agree with. After 35 years of fighting industry over antibiotics the FDA is making headway in making them limit their use. I see a reasoned critique from Grist on Taylor, that I think raises good points about his actual policy initiatives, but still gives him credit for being devoted to food safety and for being a gifted technocrat. Just painting him as a Monsanto puppet is the kind of sloppy anti-intellectual reactionary BS I dislike, feeding into this worldview that Monsanto is some all-powerful evil juggernaut run by the illuminati. No, it’s just a corporation, and corporations have good and bad qualities, and good and bad people working for them. Monsanto definitely has some bad qualities, but the idea that all of their employees and former employees are somehow permanently soiled by association with everything they’ve done, right or wrong, is unfair and small-minded . It also ignores the reality that if we want to regulate industry it helps to have people that are knowledgeable about how the sausage is made.
My reading on the FDA under Obama from non-crankosphere sources suggests that the current director, Hamburg, is a very vigilant director that the Obama administration, if anything, is constantly trying to restrain from saying things that are too “nanny state” and may generate additional criticism. Maybe the real problem isn’t the FDA but a political atmosphere where everyone is constantly trying to score points by being as extreme as possible in their interpretation of everything. -
Ha! If there were a regulatory body studying this they would more than likely find 100% of naturopathic remedies are unnecessary. I think they’re synonyms actually
This is just the narrow-minded attitude which will perpetutae the great divide between the pro & con sides.
And I nearly fell off my chair when I read your comment about the FDA making headway against anti-biotic use, after 35 years of let’s play heads-in-the-sand. The CDC has stated that 50%of antibiotic use is unnecessary. That means literally many thousands of death a year through unnecessary infections like C. Diff & staph. simply because of seriously bad medicine (SBM). What an absolute tragedy that the medical profession has been allowed to prescribe unneccessary & deadly drugs in a totally unscientific manner for many decades. And you now say the powers that be are making headway. Hello, is anybody out there half awake?
This is not science, this is religious pseudo-science, where the sheeple swallow the lies, cover-ups & corruption of a malignant medical system, but then you can fool most of the sheeple most of the time..
The 20% of magnificentl work found in science-based medicine (crisis & reconstructive surgery especially) is tragically swamped by the 80% of seriously bad medicine (read most treatments for chronic & acute disease), & the FDA is, as Dr Angell says, in bed with the drug companies in this crime against humanity, & you still blame the government &/ or politics.
The great divide just gets greater.-
The headway I was referring to was the use of antiobiotics in livestock, not humans. Try reading for comprehension. And the FDA doesn’t regulate doctors’ behavior. The over-use of antibiotics stems from a belief that they are safe drugs. According to my criteria, I disagree, and think they’re actually quite unsafe, but part of that is my bias as someone who treats more ICU patients than outpatients, so I see the worst of it. I don’t see it as some kind of medical religion, rather it stems from laziness. Patients see a doctor and want a prescription. It’s harder to take the time to explain your rationale, talk to the patient, and reassure them to try to recover normally than it is to just write a “harmless” prescription. It is also a complete red-herring in regards to regulatory malfeasance. And this entire discussion is a red herring in regards to this being a critique of a poorly-performed study.
That still won’t change my attitude towards naturopathy as some kind of superior, evidence-based practice. It is largely a scam, but luckily since it’s mostly placebo-driven, a relatively harmless one except for the economic reasons.
-
-
You: “Given we know from the literature the rats have a rate of about 70% developing tumors in 2 years, their finding that all their test groups had rates of tumor formation between 50-80% in 2 years is non-exceptional. The exception was their control in which only 30% developed tumors. The tests groups fit in well with the historical average. If these tests were repeated with more animals we would likely see a regression towards the mean. This exceptionally low value for their controls relative to the historical data on these animals is the source of the magnitude of this result.”
Well, a simple reading of the paper reveals:
“All treatments in both sexes enhanced large tumor incidence by 2–3-fold in comparison to our controls but also for the number of mammary tumors in comparison to the same Harlan Sprague Dawley strain (Brix et al., 2005), and overall around 3-fold in comparison to the largest study with 1329 Sprague Dawley female rats (Chandra et al., 1992).”
http://www.ncbi.nlm.nih.gov/pubmed/1444814
http://www.ncbi.nlm.nih.gov/pubmed/16036865
Did you deliberately ignore these studies, or is it that you’re simply regurgitating the talking points that industry PR have come up with against this study?
–
“Well for one, you’re wrong, glyphosate has been studied in chronic models. These new results conflict with others in the literature.”
Seralini et al are, again, way ahead of you (and short-sighted standard “toxicology”)…
“Moreover, the effects of mixtures
are also neglected in long-term studies, when supposed
active principles of pesticides are not assessed with their
adjuvants, which also are present as residues in GMOs.
Such pesticides may have the capacity to disrupt the
“cell web”, i.e., to interfere with a signaling pathway, and
this could be unspecific. For instance Roundup is
known to disrupt the EPSPS in plants, but is also
known to interact with the mammalian ubiquist reductase
[21] common and essential to cytochromes P450, a
wide class of detoxification enzymes. The so-called
Roundup active principle, glyphosate, acts in combination
with adjuvants to increase glyphosate-mediated
toxicity [21,31], and this may apply to other environmental
pollutants [22]. Moreover, all new metabolites in
edible Roundup ready GMOs, as acetyl-glyphosate for
the new GAT GMOs, have not been assessed for their
chronic toxicity [11], and we consider this as a major
oversight in the present regulations.
Therefore, as xenobiotic effects are complex, the
determination of their toxic effects cannot be determined
using a single method, but rather converging
pieces of evidence.”
http://www.enveurope.com/content/23/1/10
You: “Their claim is truly extraordinary, that is that both glyphosate in the water, and glyphosate resistant crops that merely carry a transgenic enzyme (read protein) both double the rate of tumor formation in rats. The first claim is in direct conflict with the literature. The second claim is biologically implausible since the enzyme is a protein that already exists in plants! The only difference is the RR version is resistant to glyphosate (thanks Ewan for pointing that out), it’s not even really a new gene product. Both claims rest on a control group out of sync with what is known about these rats.”
Once again, you are looking at things too simplistically. If you had actually read Seralini’s work objectively, you would have known this:
“One of the pivotal requirements for regulators nowadays,
in order to interpret a significant difference as biologically
relevant, is to observe a linear dose-response.
This allows them to deduce a causality. However, this
dose-response cannot be studied with only two points,
which is nonetheless the case for all major commercial
GMOs today, which are given in the diet in 11% and
33% concentrations only, in subchronic tests. This is
true overall if no preliminary data has been obtained to
choose the given doses, which is the case in regulatory
files. As we have already emphasized, most of pathological
and endocrine effects in environmental health are
not directly proportional to the dose, and they have a
differential threshold of sensitivity in both sexes [34].
This is, for instance, the case with carcinogenesis and
endocrine disruption.”
You: “Since this is not actual evidence of risk, the precautionary principle doesn’t apply. The study, when considered in light of the literature and known tumorigenicity of this rat line demonstrates the test groups had similar rates to those observed since before GMOs were introduced. The only precaution one should take after reading this study is never trusting anything written by these authors ever again.”
This study is not perfect, but for you to reject it wholesale for such frivolous (or downright false) reasons reveals your unscientific bias. The appropriate response is to seek out opportunities to further understand these findings (which are consistent with many other studies finding harm from GM foods). Of course, these are ALWAYS dismissed as “statistical noise” by the biotech industry.
“Industry says these are the most carefully tested foods ever,” said Charles Benbrook of the Center for Sustaining Agriculture and Natural Resources at Washington State University. “But there have been no studies on prenatal effects, on birth defects, on the long-term impact of exposure during fetal development.”
Washington State’s Benbrook also found several issues with [Seralini’s] study. “On the other hand,” he said, “the study is actually more carefully designed and has the same sample size as the original study conducted on behalf of Monsanto and submitted to regulatory agencies in support of the approval of the tech in the first place. If industry thought that study had a good design, it’s a little disingenuous of them to be criticizing this study.
“I do think that this new study again raises an alarm bell, and ought to be followed up by much more careful studies with larger sample sizes, more than one species of lab animal and conducted by people that have no dogma on the side, haven’t done research in the area and don’t have an opinion in area,” he continued.
http://www.huffingtonpost.com/2012/09/21/gmo-proposition-37-study-funding-research_n_1904535.html -
You: “Given we know from the literature the rats have a rate of about 70% developing tumors in 2 years, their finding that all their test groups had rates of tumor formation between 50-80% in 2 years is non-exceptional. The exception was their control in which only 30% developed tumors. The tests groups fit in well with the historical average. If these tests were repeated with more animals we would likely see a regression towards the mean. This exceptionally low value for their controls relative to the historical data on these animals is the source of the magnitude of this result.”
Well, a simple reading of the paper reveals:
“All treatments in both sexes enhanced large tumor incidence by 2–3-fold in comparison to our controls but also for the number of mammary tumors in comparison to the same Harlan Sprague Dawley strain (Brix et al., 2005), and overall around 3-fold in comparison to the largest study with 1329 Sprague Dawley female rats (Chandra et al., 1992).”
http://www.ncbi.nlm.nih.gov/pubmed/1444814
http://www.ncbi.nlm.nih.gov/pubmed/16036865
Did you deliberately ignore these studies, or is it that you’re simply regurgitating the talking points that industry PR have come up with against this study?
–
“Well for one, you’re wrong, glyphosate has been studied in chronic models. These new results conflict with others in the literature.”
Seralini et al are, again, way ahead of you (and short-sighted standard “toxicology”)…
“Moreover, the effects of mixtures
are also neglected in long-term studies, when supposed
active principles of pesticides are not assessed with their
adjuvants, which also are present as residues in GMOs.
Such pesticides may have the capacity to disrupt the
“cell web”, i.e., to interfere with a signaling pathway, and
this could be unspecific. For instance Roundup is
known to disrupt the EPSPS in plants, but is also
known to interact with the mammalian ubiquist reductase
[21] common and essential to cytochromes P450, a
wide class of detoxification enzymes. The so-called
Roundup active principle, glyphosate, acts in combination
with adjuvants to increase glyphosate-mediated
toxicity [21,31], and this may apply to other environmental
pollutants [22]. Moreover, all new metabolites in
edible Roundup ready GMOs, as acetyl-glyphosate for
the new GAT GMOs, have not been assessed for their
chronic toxicity [11], and we consider this as a major
oversight in the present regulations.
Therefore, as xenobiotic effects are complex, the
determination of their toxic effects cannot be determined
using a single method, but rather converging
pieces of evidence.”
http://www.enveurope.com/content/23/1/10
You: “Their claim is truly extraordinary, that is that both glyphosate in the water, and glyphosate resistant crops that merely carry a transgenic enzyme (read protein) both double the rate of tumor formation in rats. The first claim is in direct conflict with the literature. The second claim is biologically implausible since the enzyme is a protein that already exists in plants! The only difference is the RR version is resistant to glyphosate (thanks Ewan for pointing that out), it’s not even really a new gene product. Both claims rest on a control group out of sync with what is known about these rats.”
Once again, you are looking at things too simplistically. If you had actually read Seralini’s work objectively, you would have known this:
“One of the pivotal requirements for regulators nowadays,
in order to interpret a significant difference as biologically
relevant, is to observe a linear dose-response.
This allows them to deduce a causality. However, this
dose-response cannot be studied with only two points,
which is nonetheless the case for all major commercial
GMOs today, which are given in the diet in 11% and
33% concentrations only, in subchronic tests. This is
true overall if no preliminary data has been obtained to
choose the given doses, which is the case in regulatory
files. As we have already emphasized, most of pathological
and endocrine effects in environmental health are
not directly proportional to the dose, and they have a
differential threshold of sensitivity in both sexes [34].
This is, for instance, the case with carcinogenesis and
endocrine disruption… For
instance, as previously cited, U or J curves may be
characteristic of endocrine effects [37], and spiky
irregular curves may be detected in carcinogenesis.”
You: “Since this is not actual evidence of risk, the precautionary principle doesn’t apply. The study, when considered in light of the literature and known tumorigenicity of this rat line demonstrates the test groups had similar rates to those observed since before GMOs were introduced. The only precaution one should take after reading this study is never trusting anything written by these authors ever again.”
This study is not perfect, but for you to reject it wholesale for such frivolous (or downright false) reasons reveals your unscientific bias. The appropriate response is to seek out opportunities to further understand these findings (which are consistent with many other studies finding harm from GM foods). Of course, these are ALWAYS dismissed as “statistical noise” by the biotech industry.
“Industry says these are the most carefully tested foods ever,” said Charles Benbrook of the Center for Sustaining Agriculture and Natural Resources at Washington State University. “But there have been no studies on prenatal effects, on birth defects, on the long-term impact of exposure during fetal development.”
Washington State’s Benbrook also found several issues with [Seralini’s] study. “On the other hand,” he said, “the study is actually more carefully designed and has the same sample size as the original study conducted on behalf of Monsanto and submitted to regulatory agencies in support of the approval of the tech in the first place. If industry thought that study had a good design, it’s a little disingenuous of them to be criticizing this study.
“I do think that this new study again raises an alarm bell, and ought to be followed up by much more careful studies with larger sample sizes, more than one species of lab animal and conducted by people that have no dogma on the side, haven’t done research in the area and don’t have an opinion in area,” he continued.
http://www.huffingtonpost.com/2012/09/21/gmo-proposition-37-study-funding-research_n_1904535.html -
Oh good! Someone who wants to talk about the paper rather than rail against the FDA.
Did you deliberately ignore these studies, or is it that you’re simply regurgitating the talking points that industry PR have come up with against this study?
I think you misread what I wrote, and are missing the semantic trick the authors are using. By singling out individual subtypes of tumors they’re engaging in subgroup analysis to find significance where likely none lies. Note they were describing literary references to mammary tumors, not the rate of tumor formation overall, which was similar to the paper I originally cited, and abnormally low for the controls.
In their hands they had a higher rate of mammary tumors as an overall proportion of the tumors the animals got. Ok. I’m not sure what to make of that. Maybe it’s the BPA like Sohn suggested. But with a nonviable control I can’t interpret this result.“Moreover, the effects of mixtures
are also neglected in long-term studies, when supposed
active principles of pesticides are not assessed with their
adjuvants, which also are present as residues in GMOs.
Such pesticides may have the capacity to disrupt the
“cell web”, i.e., to interfere with a signaling pathway, and
this could be unspecific. For instance Roundup is
known to disrupt the EPSPS in plants, but is also
known to interact with the mammalian ubiquist reductase
[21] common and essential to cytochromes P450, a
wide class of detoxification enzymes. The so-called
Roundup active principle, glyphosate, acts in combination
with adjuvants to increase glyphosate-mediated
toxicity [21,31], and this may apply to other environmental
pollutants [22]. Moreover, all new metabolites in
edible Roundup ready GMOs, as acetyl-glyphosate for
the new GAT GMOs, have not been assessed for their
chronic toxicity [11], and we consider this as a major
oversight in the present regulations.
Therefore, as xenobiotic effects are complex, the
determination of their toxic effects cannot be determined
using a single method, but rather converging
pieces of evidence.”Well they didn’t read the literature I read then, as the papers I linked did look at adjuvants and metabolites. If the herbicide is particularly dangerous this is separate from the GM issue, and maybe less surprising. Herbacides and pesticides are known to affect things other than herbs and pests, and I’m not about to start drinking roundup, or stop washing my vegetables. Further when they say these haven’t been assessed for chronic effects, I dont know why they couldn’t find the review I immediately found upon searching the literature it seems to contradict these points.
“One of the pivotal requirements for regulators nowadays,
in order to interpret a significant difference as biologically
relevant, is to observe a linear dose-response.
This allows them to deduce a causality. However, this
dose-response cannot be studied with only two points,
which is nonetheless the case for all major commercial
GMOs today, which are given in the diet in 11% and
33% concentrations only, in subchronic tests. This is
true overall if no preliminary data has been obtained to
choose the given doses, which is the case in regulatory
files. As we have already emphasized, most of pathological
and endocrine effects in environmental health are
not directly proportional to the dose, and they have a
differential threshold of sensitivity in both sexes [34].
This is, for instance, the case with carcinogenesis and
endocrine disruption… For
instance, as previously cited, U or J curves may be
characteristic of endocrine effects [37], and spiky
irregular curves may be detected in carcinogenesis.”This is what we usually refer to as “hand-waving” in scientific circles. That you think this is a sophisticated argument is a little frightening. I find it enormously disingenuous of them to say, “it’s endocrine, so dose-response no longer matters”. Hmmm. And their curves aren’t exactly J shaped or U shaped. They’re “all kinds of” shaped. It’s not a consistent effect. To say that a non-linear response may not be expected is fine. But it still doesn’t explain why the effect is largest at the lowest dose. If the effect then leveled off, that would be one thing, but to then go back to the same as the controls? This is total bullshit, and as beautiful an example of handwaving as I’ve seen. To just say, “it’s j shaped” when it’s not! The balls on these guys.
You: “Since this is not actual evidence of risk, the precautionary principle doesn’t apply. The study, when considered in light of the literature and known tumorigenicity of this rat line demonstrates the test groups had similar rates to those observed since before GMOs were introduced. The only precaution one should take after reading this study is never trusting anything written by these authors ever again.”
This study is not perfect, but for you to reject it wholesale for such frivolous (or downright false) reasons reveals your unscientific bias. The appropriate response is to seek out opportunities to further understand these findings (which are consistent with many other studies finding harm from GM foods). Of course, these are ALWAYS dismissed as “statistical noise” by the biotech industry.And sometimes industry is right. A broken watch is right twice a day and all that. I don’t dismiss it for anything industry said, or from reading their talking points. I saw a description of the paper in my rss feed, read it, and then laughed my ass off. It’s just not very convincing.
Washington State’s Benbrook also found several issues with [Seralini’s] study. “On the other hand,” he said, “the study is actually more carefully designed and has the same sample size as the original study conducted on behalf of Monsanto and submitted to regulatory agencies in support of the approval of the tech in the first place. If industry thought that study had a good design, it’s a little disingenuous of them to be criticizing this study.
“I do think that this new study again raises an alarm bell, and ought to be followed up by much more careful studies with larger sample sizes, more than one species of lab animal and conducted by people that have no dogma on the side, haven’t done research in the area and don’t have an opinion in area,” he continued.You have one expert, and it actually sounds like he and I agree on about 90% of it. And I’m not sure that he picked up on how weird their control population was. Well a survey of biotech experts was pretty much universally negative, and repeated many of the points I made. So where are we then. Everyone agrees – repeat it, more animals, unbiased researchers etc., why not. It’s probably worth it if only to put the issue to bed. But it certainly doesn’t scare me or make me think some drastic regulatory action needs to be taken. And when it is repeated and confirms our suspicions that this is an aberration what then? Will the GMO critics accept it? Never. Just like when the global warming deniers hired a guy to study Mann’s findings and he confirmed them, they immediately just wrote him off and called him a plant. They’ll just keep dragging up this paper again and again, and attribute any difference in any new study to conspiracies and industry bias. How many times in this thread have I been accused of industry bias? I’m not in industry! I’m an academic researcher! So’s Orac, so’s Steven Novella. What the hell?
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You: “Critically, these rates of tumor formation are well established from the pre-GMO era. This paper is exceptional for a low rate of tumor formation in the controls compared to historical controls and knowledge of tumor formation in this rat strain.”
This is from the study you posted in defense of that –
“Spontaneous endocrine tumors were found in 81 of 100 Sprague-Dawley rats (42 males and 39 females) which survived for more than 2 years… Particularly, aged animals surviving for more than 2 years tended to show higher incidence of spontaneous endocrine tumors…”
http://www.springerlink.com/content/n42p116vh43q5161/
This study specifies the rate of tumor formation in SD rats OVER two years; whereas the study we are referring to was only two years long, the tumors in the treated group appeared earlier, and there a higher mortality from the large tumor size that prevented many of the treatment group animals to die well before the 2-year mark was even reached. Cherry pick much?
“In our colonies of Sprague-Dawley rats the incidence of tumors was 22% in females and 5% in males…” (this study was over two years long)
http://www.pnas.org/content/76/11/5910.full.pdf
You: “Well they didn’t read the literature I read then, as the papers I linked did look at adjuvants and metabolites… Further when they say these haven’t been assessed for chronic effects, I dont know why they couldn’t find the review I immediately found upon searching the literature it seems to contradict these points.”
You’re still missing the point. Those reviews looked at the effects of those compounds *individually*, not for their synergistic effects. It can’t be assumed that tests on individual compounds can be extrapolated like this. These are the kinds of things that can lead to unpredictable results (for example, a non-linear dose-response curve, that still shows an overall harmful effect) -
You: “Critically, these rates of tumor formation are well established from the pre-GMO era. This paper is exceptional for a low rate of tumor formation in the controls compared to historical controls and knowledge of tumor formation in this rat strain.”
This is from the study you posted in defense of that –
“Spontaneous endocrine tumors were found in 81 of 100 Sprague-Dawley rats (42 males and 39 females) which survived for more than 2 years… Particularly, aged animals surviving for more than 2 years tended to show higher incidence of spontaneous endocrine tumors…”
http://www.springerlink.com/content/n42p116vh43q5161/
This study specifies the rate of tumor formation in SD rats OVER two years; whereas the study we are referring to was only two years long, the tumors in the treated group appeared earlier, and there a higher mortality from the large tumor size or other causes, such that more of the treatment group animals died well before the 2-year mark was even reached. Cherry pick much?
“In our colonies of Sprague-Dawley rats the incidence of tumors was 22% in females and 5% in males…” (this study was over two years long)
http://www.pnas.org/content/76/11/5910.full.pdf
You: “Well they didn’t read the literature I read then, as the papers I linked did look at adjuvants and metabolites… Further when they say these haven’t been assessed for chronic effects, I dont know why they couldn’t find the review I immediately found upon searching the literature it seems to contradict these points.”
You’re still missing the point. Those reviews looked at the effects of those compounds *individually*, not for their synergistic effects. It can’t be assumed that tests on individual compounds can be extrapolated to real-world situations where many chemicals are inter-reacting in complex biological systems. These are the kinds of things that can lead to unpredictable results (for example, a non-linear dose-response curve, that still shows an overall harmful effect).-
Cherry picking huh? Ok. Let’s delve in a little deeper into the literature. I cited one paper that many others determined as the standard for these estimations. Sadly, I can’t drop by the library over the weekend so I can’t figure out if “over 2 years” referred to is significantly different, although it admittedly is vague. Luckily, a quick pubmed search on “Spontaneous endocrine tumors in Sprague-Dawley rats” got me a non-paywalled result showing at 2 years 60% of ad libitum fed females had lethal pituitary tumors. This was similar to this paper’s result. That’s just a subset of possible endocrine tumors. This is sounding increasingly fatal for your point. Then I found this lovely paper from all the way back in 1966 on the formation of mammary tumors in Spraque-Dawley rats. They graph the rate of mammary tumor formation in controls versus various surgical groups all the way up to 3 years. Guess what? At 2 years about 50% of the females had mammary tumors. See chart 4 and look at the line at about 730 days. And in chart 2 look at the variation between lots! Between 40 and 70% had mammary tumors at 2 years. Seralini et al report a rate for their controls far lower than the historical data, and as far as them dying early read the study! They didn’t die, they were euthanized based on mysterious criteria with no evidence of blinding of the researchers to the groups, which basically allows the researchers to completely bias the result. You want early deaths from GMO? Just kill some rats. So, I’m done. This argument is no more, it has ceased to be, it has expired and gone to meet its maker, it’s stiff, bereft of life, it rests in peace, this is an ex-argument.
And agiain, if you’re going to defend a curve because it’s not linear, the higher doses should at least be the same or higher than the lowest dose. Maybe not linear but higher. It makes absolutely no sense that the highest doses had the same or lower rates than the control. J shaped curves, U shaped curves whatever, they have in common is that they are non-linear, but they aren’t consistent with higher doses having no effect. Higher doses did nothing? Bizarre.
As far as “synergy”, give me a break. That’s just more handwaving. They study the glyphosate, they studied the metabolites, they studied the adjuvants. The most damning aspect is the low bioavailability of the compounds in humans. The compound is excreted unchanged. And these are two separate issues. I’ll give you, a herbicide quite plausibly could cause harmful effects in humans. I think the evidence here is weak. You can handwave and say synergy, whatever, I don’t care. That’s why we wash our veggies. But explain to me how a gene product, a protein, that already exists in these plants, but that has been slightly modified to be resistant to glyphosate would now cause cancer. What possible mechanism explains that result? That’s a pretty extraordinary claim. Why would it also do the exact same thing as the herbicide exposure? And given the only way to see this effect is to have a control that is different from historical controls, then what’s going on here?
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Well, rates of tumor formation vary widely in Sprague-Dawleys. This study (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2696827/) found that high tumor rates can result from lack of exercise and laboratory confinement. The first study you referenced is interesting. Firstly, it shows that animals that were allowed to overeat had high cancer rates – and so is chronic overeating an indication for human degenerative diseases. Why is this relevant? Because animals (such as rats) have often been observed *avoiding* GM grains. So it could very well be that the animals in the higher concentration groups ate less, which could explain their lower rates of tumor formation. (Feeding data is not currently available, but then, with editing constraints, no study publishes ALL of their data.)
You: “They didn’t die, they were euthanized based on mysterious criteria with no evidence of blinding of the researchers to the groups, which basically allows the researchers to completely bias the result.”
*You* read the study –
“Animal experiments were performed according to ethical guidelines of animal experimentations (CEE 86/609 regulation)… Animals were sacrificed during the course of the study only if necessary because of suffering according to ethical rules (such as 25% body weight loss, tumors over 25% body weight, hemorrhagic bleeding, or prostration)… In black [fig,1] are represented the necessary euthanasia because of suffering in accordance with ethical rules (tumors over 25% body weight, more than 25% weight loss, hemorrhagic bleeding, etc.); and in hatched areas, spontaneous mortality.”
Note that the extraordinary results were mainly the *size* of these tumors, more than the sheer amount.
You: “As far as “synergy”, give me a break. That’s just more handwaving. They study the glyphosate, they studied the metabolites, they studied the adjuvants.”
Synergistic effects are EXTREMELY important. For example, mercury and aluminum are known to be highly reactive, and to increase each other’s toxicity in combination by about an order of magnitude over their individual effects. (see, for example: http://www.flcv.com/suscept.html)
As Dr. Robert Willner puts it, “A specific compound isolated from its natural environment in the structure of a plant, for example, may lose some synergistic, buffering or even antagonistic action or balance that is present when ingested in its natural form.” So studying those compounds individually does NOT give information on their effects in combination, much less nutritionally as an experimental genetic expression in food crops.
Here is further defense of the common criticisms to the study:
” – The French researchers were accused of using the Sprague Dawley rat strain which is said to be prone to developing cancers. In response Séralini and his team say these are the same rats as used by Monsanto in the 90-day trials which it used to get authorisation for its maize. This strain of rat has been used in most animal feeding trials to evaluate the safety of GM foods, and their results have long been used by the biotech industry to secure approval to market GM products.
– The sample size of rats was said to be too small. Séralini responded that six is the OECD recommended protocol for GM food safety toxicology studies and he had based his study on the toxicity part of OECD protocol no. 453. This states that for a cancer trial you need a minimum of 50 animals of each sex per test group but for a toxicity trial a minimum of 10 per sex suffices. Monsanto used 20 rats of each sex per group in its feeding trials but only analysed 10, the same number as Séralini.
– Séralini has not released the raw data from the trial. In response he says he won’t release it until the data underpinning Monsanto’s authorisation of NK603 in Europe is also made public.”
http://www.guardian.co.uk/environment/2012/sep/28/study-gm-maize-cancer
P.S. with regards to the sample size, it is common to use small samples in exploratory research. The point is to indicate that there may be cause for further, more extensive studies. It is *not* conclusive in and of itself. Also note that the longer time frame of this study increases its power. Seralini et al. have obtained Monsanto’s data through the FOIA and found that it evidenced the early stages of organ damage that should have been followed through by lengthening the study beyond 90 days. This is the reason they ran this study. Monsanto could easily defray Seralini by releasing the data that the “safety” approval was originally based on – unless they had something to hide. Let’s put this into perspective.
P.P.S. – this is not the first study to note potential health damage from consuming GM foods. Here is a partial list for your reviewing pleasure-
2. Hines FA. Memorandum to Linda Kahl on the Flavr Savr tomato (Pathology Review PR–152; FDA Number FMF–000526): Pathology Branch’s evaluation of rats with stomach lesions from three four-week oral (gavage) toxicity studies (IRDC Study Nos. 677–002, 677–004, and 677–005) and an Expert Panel’s report. US Department of Health & Human Services. 16 June 1993. http://www.biointegrity.org/FDAdocs/17/view1.html
3. Pusztai A. Witness Brief – Flavr Savr tomato study in Final Report (IIT Research Institute, Chicago, IL 60616 USA) cited by Dr Arpad Pusztai before the New Zealand Royal Commission on Genetic Modification: New Zealand Royal Commission on Genetic Modification; 2000.
4. Prescott VE, Campbell PM, Moore A, et al. Transgenic expression of bean alpha-amylase inhibitor in peas results in altered structure and immunogenicity. J Agric Food Chem. 16 Nov 2005; 53(23): 9023–9030.
5. Malatesta M, Biggiogera M, Manuali E, Rocchi MBL, Baldelli B, Gazzanelli G. Fine structural analyses of pancreatic acinar cell nuclei from mice fed on genetically modified soybean. European Journal of Histochemistry. Oct-Dec 2003; 47: 385–388.
6. Malatesta M, Caporaloni C, Gavaudan S, et al. Ultrastructural morphometrical and immunocytochemical analyses of hepatocyte nuclei from mice fed on genetically modified soybean. Cell Struct Funct. Aug 2002; 27(4): 173–180.
7. Vecchio L, Cisterna B, Malatesta M, Martin TE, Biggiogera M. Ultrastructural analysis of testes from mice fed on genetically modified soybean. Eur J Histochem. Oct-Dec 2004; 48(4): 448-454.
8. Malatesta M, et al. A long-term study on female mice fed on a genetically modified soybean: effects on liver ageing. Histochem Cell Biol. 2008; 130: 967–977.
9. Tudisco R, Lombardi P, Bovera F, et al. Genetically modified soya bean in rabbit feeding: Detection of DNA fragments and evaluation of metabolic effects by enzymatic analysis. Animal Science. 2006; 82: 193–199.
10. Brasil FB, Soares LL, Faria TS, Boaventura GT, Sampaio FJ, Ramos CF. The impact of dietary organic and transgenic soy on the reproductive system of female adult rat. Anat Rec (Hoboken). Apr 2009; 292(4): 587–594.
11. Séralini GE, Mesnage R, Clair E, Gress S, de Vendômois JS, Cellier D. Genetically modified crops safety assessments: Present limits and possible improvements. Environmental Sciences Europe. 2011; 23(10).
12. Séralini GE, Cellier D, Spiroux de Vendomois J. New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. Archives of Environmental Contamination and Toxicology. May 2007; 52(4): 596–602.
13. Kilic A, Akay MT. A three generation study with genetically modified Bt corn in rats: Biochemical and histopathological investigation. Food Chem Toxicol. Mar 2008; 46(3): 1164–1170.
14. de Vendomois JS, Roullier F, Cellier D, Séralini GE. A comparison of the effects of three GM corn varieties on mammalian health. Int J Biol Sci. 2009; 5(7): 706–726.
15. Finamore A, Roselli M, Britti S, et al. Intestinal and peripheral immune response to MON810 maize ingestion in weaning and old mice. J Agric Food Chem. Dec 10 2008; 56: 11533–11539.
16. Trabalza-Marinucci M, Brandi G, Rondini C, et al. A three-year longitudinal study on the effects of a diet containing genetically modified Bt176 maize on the health status and performance of sheep. Livestock Science. 2008; 113(2): 178–190.
17. Duggan PS, Chambers PA, Heritage J, Michael Forbes J. Fate of genetically modified maize DNA in the oral cavity and rumen of sheep. Br J Nutr. Feb 2003; 89(2): 159–166.
18. US Food and Drug Administration. Biotechnology consultation note to the file BNF No 00077. Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. 4 September 2002. http://www.fda.gov/Food/Biotechnology/Submissions/ucm155759.htm
19. Pusztai A, Bardocz S. GMO in animal nutrition: Potential benefits and risks. In: Mosenthin R, Zentek J, Zebrowska T, eds. Biology of Nutrition in Growing Animals. Vol 4: Elsevier Limited; 2006:513–540.
20. Ewen SW, Pusztai A. Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine. Lancet. Oct 16 1999; 354(9187): 1353-1354.
21. Fares NH, El-Sayed AK. Fine structural changes in the ileum of mice fed on delta-endotoxin-treated potatoes and transgenic potatoes. Nat Toxins. 1998; 6(6): 219-233.
22. Poulsen M, Kroghsbo S, Schroder M, et al. A 90-day safety study in Wistar rats fed genetically modified rice expressing snowdrop lectin Galanthus nivalis (GNA). Food Chem Toxicol. Mar 2007; 45(3): 350-363.
23. Schrøder M, Poulsen M, Wilcks A, et al. A 90-day safety study of genetically modified rice expressing Cry1Ab protein (Bacillus thuringiensis toxin) in Wistar rats. Food Chem Toxicol. Mar 2007; 45(3): 339-349.
24. Kroghsbo S, Madsen C, Poulsen M, et al. Immunotoxicological studies of genetically modified rice expressing PHA-E lectin or Bt toxin in Wistar rats. Toxicology. Mar 12 2008; 245(1-2): 24-34. -
One more thing –
“We conclude that when nonmonotonic
dose-response curves (NMDRCs) occur, the effects of low doses cannot be predicted by the effects observed at high doses. Thus,
fundamental changes in chemical testing and safety determination are needed to protect human health… the definition of a NMDRC is based upon
the mathematical definition of nonmonotonicity: that the
slope of the dose-response curve changes sign from positive
to negative or vice versa at some point along the range
of doses examined (42). Often NMDRCs have a U- or
inverted U-shape (43); these NMDRCs are thus also often
referred to as biphasic dose-response curves because responses
show ascending and descending phases in relation
to dose. Complex, multiphasic curves have also been observed
(41, 44, 45)”
http://edrv.endojournals.org/content/early/2012/03/14/er.2011-1050.abstract -
By the way, this report (http://earthopensource.org/files/pdfs/GMO_Myths_and_Truths/GMO_Myths_and_Truths_1.3.pdf) is the source of those citations. See pages 37 – 39 for the evidence of possible harm, which are often buried in the body of the text of these papers, but are significant. These papers often declare that there are no adverse effects, yet they downplay evidence suggesting that GM crops are not “substantially equivalent” to conventionally-bred crops.
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Well, rates of tumor formation vary widely in Sprague-Dawleys. This study (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2696827/) found that high tumor rates can result from lack of exercise and laboratory confinement. The first study you referenced is interesting. Firstly, it shows that animals that were allowed to overeat had high cancer rates – and so is chronic overeating an indication for human degenerative diseases. Why is this relevant? Because animals (such as rats) have often been observed *avoiding* GM grains.
I call bullshit. Link proof of this please. Also the rats were only given one type of food, it’s not like they could chose a non-GMO option.
*You* read the study –
“Animal experiments were performed according to ethical guidelines of animal experimentations (CEE 86/609 regulation)… Animals were sacrificed during the course of the study only if necessary because of suffering according to ethical rules (such as 25% body weight loss, tumors over 25% body weight, hemorrhagic bleeding, or prostration)… In black [fig,1] are represented the necessary euthanasia because of suffering in accordance with ethical rules (tumors over 25% body weight, more than 25% weight loss, hemorrhagic bleeding, etc.); and in hatched areas, spontaneous mortality.”And yet they had images showing rats with tumor burden clearly greater than that. These are still subjective determinations without evidence being demonstrated of rigorous tumor tracking.
Note that the extraordinary results were mainly the *size* of these tumors, more than the sheer amount.
Clinically meaningless. I’d rather have a big benign tumor than a small malignant one. Without data on tumor size being presented also meaningless.
Synergistic effects are EXTREMELY important. For example, mercury and aluminum are known to be highly reactive, and to increase each other’s toxicity in combination by about an order of magnitude over their individual effects. (see, for example: http://www.flcv.com/suscept.html)
Ah, now you’re linking garbage from the mercury-militia. Not a good sign and handwaving to say the same thing happens here. Not completely implausible, but one example of something is not proof that synergy exists here.
As Dr. Robert Willner puts it, “A specific compound isolated from its natural environment in the structure of a plant, for example, may lose some synergistic, buffering or even antagonistic action or balance that is present when ingested in its natural form.” So studying those compounds individually does NOT give information on their effects in combination, much less nutritionally as an experimental genetic expression in food crops.
You just cited another HIV/AIDS denialist! You are completely incompetent at judging reputable sources, you realize that don’t you? From Wilner’s Wiki “Willner’s Florida medical license was suspended in 1990 following a Florida Board of Medicine ruling that Willner had made inappropriate medical claims for food products.[1]”
Here is further defense of the common criticisms to the study:
” – The French researchers were accused of using the Sprague Dawley rat strain which is said to be prone to developing cancers. In response Séralini and his team say these are the same rats as used by Monsanto in the 90-day trials which it used to get authorisation for its maize. This strain of rat has been used in most animal feeding trials to evaluate the safety of GM foods, and their results have long been used by the biotech industry to secure approval to market GM products.
– The sample size of rats was said to be too small. Séralini responded that six is the OECD recommended protocol for GM food safety toxicology studies and he had based his study on the toxicity part of OECD protocol no. 453. This states that for a cancer trial you need a minimum of 50 animals of each sex per test group but for a toxicity trial a minimum of 10 per sex suffices. Monsanto used 20 rats of each sex per group in its feeding trials but only analysed 10, the same number as Séralini.And yet I found and linked multiple articles in the literature that tested twice that. Yes, Monsanto may have started there, but there is additional data in the literature with more animals. It is also comparing apples and oranges. In a 90 day feeding study with a low tumor incidence the variability will be smaller than a 2 year study with an established tumor incidence of 50% +/- 20% as shown by the study I linked.
– Séralini has not released the raw data from the trial. In response he says he won’t release it until the data underpinning Monsanto’s authorisation of NK603 in Europe is also made public.”
This strikes me as childish. But demands for raw data are annoying, so, meh.
P.S. with regards to the sample size, it is common to use small samples in exploratory research. The point is to indicate that there may be cause for further, more extensive studies. It is *not* conclusive in and of itself.
And that would be fine if the reaction to this study hadn’t been OMG! The GMOS!!!!
Also note that the longer time frame of this study increases its power.
False, false, false. Because the magnitude of the effect and the variability of the tumor formation the power is substantially decreased. Go back to the power calculator I linked.
Seralini et al. have obtained Monsanto’s data through the FOIA and found that it evidenced the early stages of organ damage that should have been followed through by lengthening the study beyond 90 days. This is the reason they ran this study. Monsanto could easily defray Seralini by releasing the data that the “safety” approval was originally based on – unless they had something to hide. Let’s put this into perspective.
Wait, now they have Monsanto’s data? I’m confused. Also, they’re two completely different types of studies. Further, the glyphosate studies I linked suggest these effects are not meaningful.
P.P.S. – this is not the first study to note potential health damage from consuming GM foods. Here is a partial list for your reviewing pleasure-
Please don’t link dump like I’m going to sift through more noise from a biased source. And sorry, I’m going to take the side of the National Academy’s review, or the european commissions review, or the Royal Societies review over the selective review by biased sources, in which many of Seralini’s flawed, and much criticized studies, are a part.
We conclude that when nonmonotonic
dose-response curves (NMDRCs) occur, the effects of low doses cannot be predicted by the effects observed at high doses. Thus,
fundamental changes in chemical testing and safety determination are needed to protect human health… the definition of a NMDRC is based upon
the mathematical definition of nonmonotonicity: that the
slope of the dose-response curve changes sign from positive
to negative or vice versa at some point along the range
of doses examined (42). Often NMDRCs have a U- or
inverted U-shape (43); these NMDRCs are thus also often
referred to as biphasic dose-response curves because responses
show ascending and descending phases in relation
to dose. Complex, multiphasic curves have also been observed
(41, 44, 45)”Ok, so by this reasoning we should consume larger amounts of glyphosate and GMO because those doses are protective. Hmm. Also, this is an extremely implausible scenario because it suggests glyphosate is an endocrine disruptor – which has never been shown, and also somehow the GMO-modified enzyme is as well, even though the unmodified version of that enzyme is consumed in all plants and does not have the effect. This is classic handwaving. You are defending shoddy-data by making an even more extraordinary set of claims, that the reason for the absence of effect at higher levels is one of these rare situations with endocrine-disrupting chemicals like DES or Tamoxifen, when there is no evidence that glyphosate or the RR-modified protein has these activities. This on top of the fact that the study animals had rates of tumor formation consistent with historical controls in the supposedly high-incidence groups. This is just handwaving on top of handwaving. There isn’t adequate evidence yet that either of these two experimental groups is having endocrine effects other than this magical synergy argument, supported with a quote from an HIV/AIDS denialist who had his medical license suspended for making false claims about food.
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I was actually researching about the ethics of GMOs when I came across your post. I think that GMOs just need a good PR move.
I’m an undergraduate at the University of Southern California, and as part of an international synthetic biology competition (iGEM), my team has made the bacteria E. coli sing. :]
Our intention was to add a bit of light-heartedness to the often heavy debates on the ethics of synthetic or genetically modified organisms.
We made a video illustrating how we managed to get E. coli to sing:
http://www.youtube.com/watch?v=s_VsqPCiNXo
While singing bacteria actually has practical applications of bacteria-researcher communication, we hope that our project can erase some of the fear and stigma associated with GMOs. -
Mark I’m interested in your comment that naturopathy is a scam. What is naturopathy in your eyes? Could you give me your definition of it please.
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Researcher: Roundup or Roundup-Ready Crops May Be Causing Animal Miscarriages and http://www.Infertilityfarmandranchfreedom.org/gmo-miscarriages
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Mark please disclose who is paying you to argue so intensely as a advocate of GMO, or do you just plainly love it for it’s health benefits…. Your right nothing is profit motivated is it it’s for the good of humanity. What a quack
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