Showing posts with label testing. Show all posts
Showing posts with label testing. Show all posts

Monday, July 4, 2016

NaturallySavvy's "Top Ten Reasons to Avoid GMOs"

A few days ago, I found myself reading a list entitled "What's So Bad About GMOs? Top Ten Reasons to Avoid Them" (archived here). I first stumbled upon NaturallySavvy.com when they were demonstrating the "toxic" properties in tampons by performing an experiment worthy of a 3rd grade science fair project, in efforts to scare the bejezuz out of you and convince you that their organic femcare products were much better.

I'm going to look over this Top Ten List and figure out if there's any truth to it. I've always tried to have a positive tone in what I write, but I'm pretty sure I'm going to fail miserably today.

(NOTE: I started writing this post back in November, soon after half of the people where I worked had gotten laid off, including myself. Yes... #ScientistsArePeople who get laid off, in this case due to corporate restructuring. Needless to say, I had a lot of pent up rage, so this was probably a healthy way to funnel all that energy. In retrospect, the post seems a bit rage-y, but I'm still going to go ahead and publish it, in the hopes that someone will look for an article debunking the NaturallySavvy piece. If you're not in the mood to read snark, stop reading after bullet #1. Consider yourself warned.)

Where's the syringe in the corn??
Or the creepy scientist that always hovers over GMO corn?
1. Are they safe? The article from NaturalSavvy says that although seed developers claim that GMOs have met safety requirements, "long term studies haven't been done on their impact to the human body." Seed developers are not the bodies that claim that GMOs have met safety requirements. The FDA, USDA, and other regulatory bodies are. Just because the writers at NaturallySavvy feel that long term studies are needed doesn't make it so. In the past, I've reviewed why long term human studies are difficult to conduct. Briefly, since GMOs are substantially equivalent to their non-GMO counterparts, there is generally no mechanism by which there could be an impact on the human body. Tests for allergenicity are conducted to ensure that the protein that is introduced is not an allergen. Most people expect GMOs to be tested like drugs, but drugs are designed to cause a change in the human body. Since drugs are altering something in humans, it's important to know the side-effects that they may cause and whether or not they're causing the anticipated effect (i.e. is it better than placebo). In contrast, GMOs are designed to be equivalent to their non-GE counterparts. GE crops which ARE designed to impact human health, such as vitamin-A enriched rice (i.e. Golden Rice), should be tested in humans.

2. Known health risks: The article from Natural Savvy states: "What we do know is that when genetic modification happens, genes are forced to express certain traits (including pesticides). To do this, the scientists "turn on" all the gene's components, which can mean releasing allergens that would normally not be expressed in a non-GMO variety. Experts like Jeffrey Smith suggest this is directly related to the rise in health issues." For the first time in this blog's history, I will ask: "WTF??" What does that string of random, science-y sounding words even mean? To express certain traits, scientists turn on all the gene's components? And somehow turning on "gene components" means that this would release allergens? And then the article has the major cojones to say that Jeffrey Smith, a person with no scientific training, is an "expert"?? In case you aren't familiar with my blog's history, I spent over half a year reading the section on Health Risks from Jeffrey Smith's website and failed to find a single one that was true. Anyway, I can't debunk this because that word salad is actually verbal diarrhea of the Chipotle variety. 

3. Heavy use of toxic pesticides and herbicides: The article claims "By design, genetically modified seeds require pesticides and herbicides." That is inaccurate in the sense that some genetically modified crops designed to withstand herbicides. At the same time, no GMO requires herbicides: farmers can technically choose not to apply any. Most importantly, there are GMOs that have nothing to do with pesticides/herbicides, such as the Rainbow papaya, which was designed to be resistant to the ring-spot virus, and saved Hawaii's papaya industry. And what about the Innate potato, which resists bruising and browning and will consequently cut back on food waste? Transgenesis is a method used to generate crops and lumping all the crops generated with the technique into a single category is disingenuous. It is important to note that there are non-GE crops made to resist pesticides as well, such as Clearfield seeds (made through mutagenesis) or SU canola (made by gene editing).

4. Pesticides and digestive health: The article claims that pesticides "negatively impact the gut bacteria of humans" and points to Jeffrey Smith's movie as a evidence. A movie does not evidence make. Show me the data. Unfortunately, documentaries are a narrative and are not peer reviewed. The film makers can choose to portray only one story/perspective in that narrative, and as such, they are often highly biased.

In the past I've written on the topic of GMOs and the gut microbiome, and have reviewed several papers on the topic. None of the papers point to negative health impact. But don't let that get in the way of the outstanding evidence in the movie!

I'm losing all hope for this Top Ten list from Naturally Savvy...

5. Cancer: The top ten list from Natural Savvy states: "Both pesticides and GMOs have been connected with an increased risk of certain types of cancer. There are additional health concerns too including reproductive issues, autism and even heart disease." The reference in that statement is to a news article from 2012 that covers the publication of a scientific article which has since been retracted due to its inherent crumminess and republished elsewhere. Many scientists and organizations have written about the notorious Seralini study, which was a 2-year feeding study on rats claiming that the GM feed and low levels of glyphosate cause tumors and other health impacts. Despite claims from activists that the findings from the paper were ignored or that institutions were paid off to refute the paper, Seralini's paper led to several in-depth reviews and studies (see information here from the EFSA and information here about the GRACE project).

As for the sentence about alleged reproductive issues, autism, and even heart disease: no, no, and what???

6. Environmental impact: Naturally Savvy claims: "GMO crops and their companion pesticides and herbicides wreak havoc on the environment including polluting air, water and soil. Glyphosate—marketed by Monsanto as the herbicide Roundup—is in effect, an antibiotic, which can destroy soil quality and thus impair the plant's nutritional value as well." You know, all the farmers that I've spoken to say that they keep buying GM seed year after year because it destroys their soil quality and consequently, the crops. They don't care if the crops have lower yield due to the soil that's been destroyed. They just want to leave their mark in the world by contributing to the environment's demise.

Seriously, how is it possible that this article has 15K facebook likes??

7. Superbugs and superweeds: Naturally Savvy claims: "Despite the claims that pesticides and GMO crops can relieve farmers of crop-destroying insects and plants, the opposite is showing to be true. Farmers in the Midwest are now battling superbugs and superweeds resistant to pesticides. They're damaging crops and farm equipment and costing the farmers more money in having to apply heavier doses of toxic pesticides." Pesticide and herbicide resistance is not unique to GMOs. It's evolution in action. There's even a paper describing how pulling weeds by hand can give rise to superweeds. Thinking that GMOs are to blame for pesticide/herbicide tolerance narrows the scope of the issue and deters efforts of finding genuine solutions to the problem. But hey, let's not let facts get in the way of NaturallySavvy's top ten list!

8. Patent issues: "At the core of the GMO industry is the corporate ownership of seed and seed patents. Companies like Monsanto are notorious for suing small farmers for saving seeds or if GMO crop drift pollinates on their land." Farmers moved away from saving seeds quite some time ago, primarily due to hybrid vigor, meaning that the seeds that farmers buy perform much better than the seeds they replant, and it's not just for GMOs. Additionally, farmers have plenty of options on the market. If they do not like the contracts that biotech companies such as Monsanto make them sign, then they can find different seeds. Monsanto has taken farmers to court for having broken this contract. Additionally, such contracts are not unique to GMOs, and farmers have been sued by companies other than Monsanto for replanting non-GMO seeds. As for lawsuits due to "GMO crop drift" pollination, I rebut your pure and utter BS with this lawsuit: OSGATA vs Monsanto, where Organic Food and Seed distributors together with anti-GMO activists tried to invalidate several of Monsanto's patents due to the possibility of a lawsuit due to inadvertent contamination. You read that correctly. Organic Food and Seed Distributors took Monsanto to court. When the judge asked them for evidence that Monsanto might sue them for inadvertent contamination "The appellants concede that Monsanto has never specifically alleged that they infringe its patents, nor threatened suit against them. Nevertheless, the appellants contend that in light of Monsanto’s evident history of aggressive assertion of its transgenic seed patents against other growers and sellers (144 suits and 700 settlements), they must assume that if they infringe those patents, they will also be sued—even if they only infringe inadvertently." Just to make that absolutely clear, Organic Food and Seed Distributors could find no evidence that Monsanto has threatened to sue them due to inadvertent contamination, and based their entire case (which was thrown out) on the possibility that Monsanto might sue them.

See what I did there, NaturallySavvy? I provided an original source that is relevant to the argument.

9. Corporate protection: "Earlier this year, the U.S. government passed a bill nicknamed the "Monsanto Protection Act." In essence, it grants biotech companies immunity from the courts, even if a judge determines it's unlawful to plant GMO crops, the companies can do it anyway." It's a scientific fact that if you add "Monsanto" to anything, it becomes 1048 times scarier. How do I know this? Well, truthiness is on my side and my gut tells me so.

You know what? I'm not even going to bother with this one, since the act already expired. If you're curious about it, read this article that goes over the legislation.

10. Prolific presence: "Whether or not GMOs are safe has yet to be determined, yet every day, millions of Americans eat them unknowingly due to the lack of labeling requirements. Are you a lab rat? Don't you at least have the right to know what you're eating?" You know what, NaturallySavvy? I think that your readers have the right to know when they're being deceived. Because when the leading scientific organizations in the world state that GMOs are no more risky than traditionally bred crops and when the scientific literature overwhelming supports the relative safety of GMOs, then a scientific consensus is formed. You're trying to scare your readers into buying whatever organic, non-GMO nonsense is for sale on your site. And no. I'm not a lab rat, any more than you're a lab rat for eating organically grown pluots. How long were those tested? Pluots have genes from plums AND APRICOTS!!! That's NOT natural! It took scientists decades to make pluots because these frankenfruits don't happen naturally. Don't you have the right to know what variety of pluots are in your organic Kashi? Oh, the horror!!! WON'T SOMEONE PLEASE THINK OF THE CHILDREN!!!!!

And NaturallySavvy? Despite having infinite combinations of scary words at your disposal and the ability to interject science-y words to give your list the aura of truthiness, your outline of arguments #1 and #10 on your list are the same. You should consider having a serious chat with the author of the piece. Wait... The author is also the Founder and "Chief Passionista" of your company??

No comment...

Tuesday, December 15, 2015

Why aren't GMOs tested on humans?

How much corn is enough corn for a feeding study?
From Wikimedia
A very common question or criticism of GMOs is that they are not properly tested, particularly on humans. The spouse and I had a discussion about this a while back and he asked why GMOs weren't tested like drugs since they're regulated by the FDA. I've read comments such as "I won't believe GMOs are safe until they're tested for 5 years on humans and we examine long-term impact", so I thought we should explore this point.

The regulation of GMOs is based on the principle of "substantial equivalence", meaning that the nutritional content of the GE crop and the non-GE crop that it originated from is the same. In the past, I've reviewed papers that have done comparisons between crops generated by transgenesis (the method used to make GMOs) vs crops generated by traditional cross breeding and mutagenesis. The transgenic crops had far fewer unintended consequences than the crops generated by traditional breeding methods. What remains to be demonstrated is that the protein introduced poses no greater risk to human health than non-GE crops, which is why studies on allergenicity and animal feeding studies are performed.

So "why don't we do clinical trials on GMOs the same way we do for drugs?" Drugs are designed to cause a change in the human body: that's the whole point behind them. Since drugs are altering something in humans, it's important to know the side-effects that they may cause and whether or not they're causing the anticipated effect (i.e. is it better than placebo). In contrast, GMOs are designed to be equivalent to their non-GE counterparts: they aren't drugs or nutritional supplements. GE crops which ARE designed to impact human health, such as vitamin-A enriched rice, should be tested in humans to determine if the desired outcome is achieved (i.e that the rice actually delivers vitamin-A to the body). But such studies are not the same as looking for unknown long-term effects.

Another reason why is that there's no plausible mechanism for harm. In the past, I've explained how nothing can truly ever be proven to be 100% safe, whether it's water, a computer or a car. Researchers examine safety when there's a plausible mechanism whereby harm can occur. For example, a cholesterol lowering drug may act by interfering with cholesterol synthesis in the liver, so it may make sense to see if it impacts other metabolic functions in the liver. But when it comes to the traits that are introduced into GE crops, there isn't really a mechanism of harm: for example, the Arctic Apple is engineered to have a gene turned off, and the gene doesn't even exist in humans, so how could that harm us? This is why most scientists wouldn't want to spend years trying to secure grants for a long term feeding study when the likelihood of having an important discovery or contribution to the field is so low. Safety is relative, and there have been many long-term feeding studies in animals which haven't observed any harm, suggesting that follow-up testing of GE crops in humans is unnecessary.

An additional issue is that the experimental design would be incredibly difficult. Unlike animal feeding studies, you cannot control for other dietary factors or for lifestyle of the humans in the study. In animal feeding studies, all the animals are inbred so there's very little genetic variability. All the animals live in the same type of cage, get the same amount of food, sleep, water, etc, but none of this applies to humans. As a mental exercise, let's imagine that we're going to embark on a study examining the long term effects of GM crops. We'll narrow it down to a single GM crop: Bt-Corn. Since corn derivatives are found in many processed foods, we'd have to eliminate other sources of Bt by making all the participants adhere to an organic diet. Most sweet corn in the US is not of the Bt-variety, but since we want to be able to keep track of how much GE corn our participants are ingesting, we'll have to use this type. Then, we have to figure out the duration of our experiment: how long will these people have to eat Bt-corn to get this unknown effect? 1 year? 2 years? 5? 10? Let's keep it simple and say one year (although I seriously doubt that any die-hard anti-GMO activist would be satisfied with 1 year). Then we have to figure out who we will be feeding: will we focus on individuals of a single genetic background to eliminate other variables? Will we include children? Pregnant women? (I mention these specific categories because there's no end to anti-GMO blog posts about the dangers of GMOs for these individuals). Next, we'd have to grow all the corn in the same place: studies have shown that geographic and seasonal variability changes the nutritional content of crops more than whether the crop is a GMO or not (see here and here). Since we want all the participants to get the same corn for the entire duration of the study, we'd have to grow it all in a single place, process it, and all the participants would need a deep freezer to store their 1 year's worth of sweet corn. Then, we have to decide how much corn they'd need to eat in order to observe this unknown effect. One ear a week? A day? Who would sign up for a study eating an ear of corn a day for a year?? And then who is going to pay for this 1 year study on many people of organic food consumption plus GE-corn? If Monsanto or other seed developers pay for it, will anyone trust the data?

There are FDA guidelines for examining the impact of food additives in humans has several important points including this one: "A food or food additive generally will be considered suitable for clinical testing if the substance is unlikely to produce significant toxic effects at the levels to which the subjects of the clinical study will be exposed. This usually is determined from the results of toxicity studies in animals or by examining existing data on population exposure. However, in cases where the type of toxic response associated with the consumption of a food or food additive by experimental animals is judged to be severe, exposure of subjects in clinical studies to the additive may need to be significantly below the level found to produce no toxic effects in an appropriate species." If the individuals who want to do long-term feeding studies in humans are looking for evidence of harm due to "long term toxic effects", then based on the statement above from the FDA, such studies would never be cleared by an ethics panel. Other important points from the document include the fact that such studies should have different dosages and the language used for long-term studies is weeks/months, not years.

This isn't a cop-out. If we're looking for a harmful effect but don't know what it is because we don't have a reasonable mechanism whereby harm may occur, how can you design the experiment? What variables will you measure? As this document from the FDA outlines, clinical trials for drugs go through very specific phases and can be variable in duration and size. However the thing they all have in common is that they're looking for a very specific effect (improvement of the disease or its symptoms in the patient). Doctors know exactly what to measure, and look for any possible side-effects, which end up getting listed in the package insert for the drug, even if they are not causal.

The final point is this: what is exclusive or unique about GMOs that merits such rigorous testing, yet excludes other crop modification techniques? If your argument is that GMOs are made by scientists in a lab and are consequently riskier, so are seedless watermelons. If your argument is that GMOs have genes from other species and are consequently riskier, so do sweet potatoes which have genes from bacteria naturally introduced thousands of years ago. If your argument is that we've had thousands of years to co-evolve with other crops but not to GMOs, then I ask you how it is that I, an individual of Iranian descent, have a passion fruit vine, which is native to South America, growing in my backyard in California? I'm pretty sure that the passion fruit and I didn't co-evolve and adapt to one another throughout our evolutionary history. The passion fruit, the sweet potato, and the seedless watermelon did not undergo any testing, animal or human, yet many continue arguing that all GMOs regardless of trait should undergo animal and human testing.

Well, I hope you all have a wonderful holiday season. If you don't subscribe to this blog, please consider doing so or you could also follow me on twitter where I post everything I publish from this blog and Biofortified.