GMO Archives - Hormones Matter

Do You Know Why Crops are Genetically Modified?

Published on September 28, 2015

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Why are crops genetically modified? What are genetically modified crops modified to do?

Those questions were asked to about 250 people who were in a presentation about microbiome health that was being held in an organic grocery store. I presume that if you asked them their thoughts on genetically modified crops, most of them would say that they are anti-GMO. But at least a dozen wrong answers were shouted before the correct answer was given.

Most genetically modified seeds are modified so that the crops can withstand pesticides, specifically glyphosate.

This isn’t common knowledge, but it should be. People should realize that the majority of GMO seeds are not genetically modified to provide more nutrition or even greater yield, they’re modified so that glyphosate can be poured over the fields indiscriminately.

According to the U.S. Department of Agriculture, “While some GE (genetically engineered) seeds with traits that affect a crop’s nutritional content and agronomic properties are already being commercialized and many more GE seeds are under development and testing, nearly all the GE seeds marketed to date to U.S. farmers are for pest management (pests here are defined to include insects, weeds, and some other organisms that interfere with the production of crops).” (Emphasis added.)

Glyphosate is an herbicide. It kills plants—crops as well as weeds. Genetically modifying seeds so that crops are resistant to glyphosate allows farmers to spray glyphosate all over their crops, killing the weeds but not the genetically modified corn, cotton, soy, sugar beets, etc.

The genetic modification proponents have skewed the conversation so much past reality that people think they’re arguing over increasing the nutritional content of rice, or feeding the world, or saving the papaya industry, or reducing pesticide use (the people who believe that one must be really good at cognitive dissonance). Feeding the world is a worthwhile goal, and increasing the nutritional content of rice may or may not be a good thing to do (the consequences of genetically modifying rice so that it has more vitamin A in it haven’t been played out), but when we’re arguing about whether or not genetic modification of consumable crops is appropriate, the reality is that the majority of GM/GE crops are being modified so that they are resistant to herbicide, not so that they can be better for consumers in any way.

Did you think it was a coincidence that Monsanto sells both genetically modified seeds and RoundUp?

It’s a shrewd business move, but it’s not good for consumers or for the planet.

Genetically modified crops put consumers at risk, much of that risk currently unknown, and provide zero benefits to consumers. The cost/benefit analysis doesn’t work at all for common people, because crops aren’t genetically modified for consumers, they’re genetically modified so that glyphosate can be used indiscriminately and so that Monsanto can dominate agribusiness. We’re guinea pigs in an experiment that doesn’t even benefit us. Welcome to lab-rat status.

Are genetic modification proponents really in favor of exposing people to as-yet unknown health risks so that glyphosate can be poured on crops? Because that’s what “nearly all” genetically modified crops are designed to do.

People need to be aware of what they’re fighting or supporting when they are pro or anti GMO.

I’m anti subjecting myself and everyone else to potential health risks so that Monsanto can sell more RoundUp. I’m anti Monsanto, Dow, Cargill and every other corporation involved with creating and selling genetically modified seeds. These agribusiness corporations are turning once-fertile cropland in the middle of the US into a wasteland (the NPR article, “Cornstalks Everywhere But Nothing Else, Not Even A Bee” illustrates this problem). They’re polluting our water and soil. They’re making farmers throughout the world dependent and indentured. They’re buying our Congressional representatives and putting us further down the path of corporatocracy. They do nothing to serve consumers, they only serve themselves and the monied interests that align with them.

I’m not anti-feeding-the-world—of course I’m not. But that’s not what the reality of the conversation around GMOs should be. The reality, straight from the USDA is that, “nearly all the GE seeds marketed to date to U.S. farmers are for pest management.”

Know that fact next time you get into an argument about GMOs, no matter what side of the argument you’re on.

Evaluating Endocrine Disruptor Research

by Chandler Marrs, PhD

Published on July 30, 2015

3460 views

Every now and again, we see a flurry of press releases flooding social media about new research purporting to prove that endocrine disruptors are safe. Most recently, the press has been focused Bisphenol A or BPA. New FDA proclamations suggest that it has no impact on health. When one reads the actual research upon which these statements are based, it says no such thing. Unless of course, the research is funded by industry, then it is almost always positive. A report in Newsweek found:

In 2013, for example, the American Chemistry Council spent more than $11 million on lobbying expenses, according to the Center for Responsive Politics. Industry groups have also funded, and in some cases written up, research done by governmental scientists. One 2008 investigation, by the Milwaukee Journal Sentinel, found that “a government report claiming that bisphenol-A is safe was written largely by the plastics industry and others with a financial stake in the controversial chemical.”

The report goes on to state that the FDA

…dismissed as irrelevant the vast majority of the BPA safety studies its own scientists reviewed in preparation for that official position statement. According to the FDA, for example, all of the 48 epidemiological studies reviewed had ‘no utility’ for the agency’s risk assessment, the formal process it undertakes to decide if a chemical is safe for human health or not.

With such contradictory claims about safety, who should we believe? How do we evaluate the safety research about endocrine disruptors? Here is a primer.

Industry Sponsored Research Is Biased

In a mini-review of research on bisphenol A (BPA) – the endocrine disruptor in plastics, of the 115 studies published on adverse effects of BPA 81.7% (94) reported significant adverse health effects (2004). However, upon review, it was found that 90% of the government funded, academic research found significant adverse effects while 100% of the industry-sponsored research found no ill-effects of BPA – none. This is a common theme across all industries – pharmaceutical included. When billions of dollars are on the line, industry sponsored studies will show favorable results more often than not. Always check the author’s conflict-of-interest disclosures at the back the article. If none are reported though, don’t assume they do not exist. Not all conflicts of interests are disclosed. You may have to do additional digging to identify conflicts.

FDA or EPA Approved Does not Mean Safe or Risk-Free

Both agencies have long histories of approving and then failing to recall dangerous chemicals, drugs and devices from the market. Their work is particularly incompetent in reproductive (endocrine) and women’s health: thalidomide, DES, Yasmin/Yaz, HRT, Mirena, Prolift to name but a few that have garnered the seal of approval by the FDA. Phthalates, BPA, Glyphosate for the EPA. Remember the EPA doesn’t even study the female reproductive dangers unless research shows that a chemical impacts the male reproductive system.

Research Methods Matter

Perhaps more so than in any other field of science, endocrine research requires serious consideration of all aspects of the study protocol. This means that you cannot rely on a press release about the research to determine the study’s relevance. You must read the original research and evaluate the methods. (Reading original research is a good habit to have for all matters that affect your health and well-being). Once you pull the research, here are some things to consider.

Length of study. Most hormone reactions are longer term and span generations. If the study is short duration, as in the case with the industry sponsored GMO research or doesn’t include third generation effects, as with BPA research – question the results.
Population studied. Whether one is investigating a chemical or a drug in humans or in rodents, the sample population matters. Ascertaining safety of efficacy by testing only healthy young men, when the drug or chemical is meant for the real world where women, children, elderly, healthy and not so healthy individuals reside, is common practice and recipe for disaster. Same is true for rodent research – the strain, sex, age and health of the animal must be considered if the work is to be extrapolated to real humans. I read one study claiming that BPA was safe, but they used a strain of rats that was resistant to environmental estrogens. Of course, BPA’s estrogens would not affect these estrogen-resistant rodents.
Outcomes measured. What does the study measure and how does it evaluate change? More often than not, industry sponsored research will not measure the appropriate endpoints or reproductive dangers. Sometimes this is sleight of hand, other times it is simply ignorance of the endocrine system’s far-reaching regulatory control. In either case, one has to evaluate what the study actually measures before determining its validity. Here, you can use a bit of personal experience – what systems, organs or behaviors are affected by your hormones? If the study didn’t measure any of these variables, then it’s probably not a very solid protocol.
‘Gold-standard’ protocols are not always golden. It takes years, decades even for ‘gold-standards’ to become the accepted methods – often well after their utility has run out and newer, more sophisticated tools have reached the market. This has been the case for endocrine testing and endocrine disruptor evaluation. If a study rests all of its findings using a gold standard, it may not be using the most sensitive testing methods.
Clinical significance is not the same as statistical significance. Clinical significance means the chemical/drug has some meaningful impact on the health or well-being of the individual or animal. Statistical significance is just a math equation. A simple increase in sample size while limiting or ‘restructuring’ outcome variables is all it takes to derive statistical significance in most research. Does that mean the drug or chemical has clinically relevant health effects – not necessarily. The opposite is also true. Want to obfuscate the dangers of a drug/chemical? Do a huge study (preferably by combining dozens of poor quality individual studies into a meta analysis), throw everything but the kitchen sink into the analysis, do simple stats and highlight the lack of statistical significance in the death or injury rates. Only a small fraction of the study population died – but it wasn’t statistically significant, so the drug/chemical is considered safe. If the study does not study distinguish between clinical and statistical significance or downplays the death and injury rates as statistically insignificant, approach cautiously.
Hormone reactions do not conform to linear statistics. Damn it, how dare our complex physiology not conform to the simplicity of linear statistics. A common dose-response curve is highly linear, where a small dose elicits a similarly small response and a larger dose increase the response size. This is not case when dealing with endocrine disruptors. Hormone systems are complex and highly non-linear. Hormone dose-response curves are often in the shape of an inverted U where low doses elicit huge responses, mid-level doses elicit minimal responses and high doses again elicit huge responses. And so, any study measuring hormone effects using simple, linear, dose response calculations is bound to miss the effects entirely.
Hormones have metabolites (as does everything else). Metabolites evoke their own reactions. We know that some of the metabolites from BPA are stronger, 1000X stronger in fact, than BPA itself. Studies that don’t address the full complement of hormone products that circulate in our bodies as a result of exposure to something like BPA will severely underestimate the safety issues.

In a nutshell, we have to do our homework. There is no simple ‘Good Housekeeping Seal of Approval’ for products that impact health and well-being. We wouldn’t trust the marketing put out by car manufacturers or, worse yet, a car salesmen, about the safety, gas efficiency, repair history and comfort of a new/used car; why do we trust the makers of chemicals to give us the straight story. We shouldn’t. We have to become educated consumers of health research in order to protect ourselves.

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This article was published previously in March 2013 and updated and edit for republication in 2015.

Who’s in Charge of GMO Regulation?

by Lisbeth Prifogle, MFA

Published on May 9, 2014

3427 views

We’ve all seen, and probably shouted, the catchy slogans – Say No to GMO! Keep your genes out of our meats and greens! We’ve read countless articles on the dangers of the genetically modified organisms (GMO) as well as the chemicals and foods they are sprayed and fed. We sign petitions, hit the “share” button to the various social media outlets, and get into screaming matches with friends and family members who don’t see the harm in GMOs. But do any of us really know how GMOs are approved? Do we know the best way to fight them? I’m going to guess no since it’s the eighth day of an open public commenting period about the use of DOW’s 2,4-dichlorophenoxyacetic acid (2,4-D), one of the main components of Agent Orange used in Vietnam, at the Environmental Protection Agency (EPA) and there are only a whopping 340 comments at this time. It actually didn’t occur to me that I didn’t really understand the full approval process until stumbling across the “public commenting period.” What I found was rather shocking.

Genetically modified foods and the chemicals that are sprayed on them as a result of their herbicide and pesticide resistance properties fall under the regulatory span of the United States Department of Agriculture (USDA), Food and Drug Administration (FDA), and EPA. What follows is a brief explanation how each agency works and what acts have been passed to monitor, or attempt to monitor, GMOs. Under the regulations of all three of these agencies, only the following categories of GM crops are monitored:

Plant-Incorporated Protectant (PIP) – a plant that produced pesticidal proteins or other chemicals as a result of genetic material from a bacterium into the plant. In these plants, scientists add modify the genes of corn, for example, to express a pesticidal property so that when pests digest the crop it releases a bacterial protein that will kill the pest. Yes, if we digest this plant we are also digesting this poisonous bacterial protein.

Genetically Modified Microbial Pesticides – bacteria, fungi, viruses, protozoa, or algae that has been modified to express a pesticidal properties like a PIP. In this case, the microbial pesticides are sprayed on the crop.

Herbicide-Tolerant Crops – this is the answer to the problem of weed-killer killing the crop it’s sprayed on. Like PIPs, the crop has been genetically modified to withstand the herbicides by adding the herbicide to the genetic make-up of the crop. The most commonly herbicide-tolerant crop is tolerant to glyphosate, a known carcinogen and hormone disrupter. Like most chemical substances, the weeds are becoming resistant to glyphosate in Monsanto’s Round Up. Thus Monsanto has teamed up with DOW Chemical to create crops resistant to 2, 4-D, as I mentioned before this is the main chemical ingredient for Agent Orange. Like PIPs, we are not only ingesting and breathing 2,4-D, being sprayed on our food, but it is actually part of our food.

Other GMOs that interchange DNA from one plant or animal species to another do not fall under the regulation of these agencies (and as far as I have researched, they do not seem to fall under any other regulating agency either).

USDA

The USDA is the U.S. federal executive department responsible for developing and executing federal government policy on farming, agriculture, forestry, and food. It aims to meet the needs of farmers and ranchers, promote agricultural trade and production, work to assure food safety, protect natural resources, foster rural communities and end hunger in the United States and abroad. The USDA is not responsible for monitoring the safety of GMOs for human or animal consumption, but rather how it affects plant health. Within the USDA is the Animal and Plant Health Inspection Service (APHIS), which is responsible for protecting agriculture from pests and diseases. Under APHIS is the Biotechnology Regulatory Services (BRS) which is part of a science-based federal regulatory framework to protect America’s agricultural resources and the broader environment. The BRS has strict regulations for any new organism either imported, crossing state lines or being introduced, but only to ensure that it does not present a plant pest risk.

As long as GMOs either introduced to American farms or imported do not present a risk to plants, the USDA does not have regulate it. The responsibility of safety for human and animal consumption is passed to the FDA.

FDA

The FDA is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics and veterinary products. As far as GMOs go, under the Federal Food, Drug, and Cosmetic Act (FFDCA), as long as the bioengineered food is substantially equivalent to non-GM crops or is generally recognized as safe, it does not require pre-market approval. There are no specific regulations for GMOs and they fall under the same regulation as conventional foods. In 1992, the FDA published a policy statement titled: Food for human consumption and animal drugs, feeds, and related products: Foods derived from new plant varieties; policy statement, 22984. This policy statement specifically addresses genetically modified foods, but disturbingly there is little regulation within this policy:

Under this policy, foods, such as fruits, vegetables, grains, and their byproducts, derived from plant varieties developed by the new methods of genetic modification are regulated within the existing framework of the act, FDA’s implementing regulations, and current practice, utilizing an approach identical in principle to that applied to foods developed by traditional plant breeding. The regulatory status of a food, irrespective of the method by which it is developed, is dependent upon objective characteristics of the food and the intended use of the food (or its components).The method by which food is produced or developed may in some cases help to understand the safety or nutritional characteristics of the finished food. However, the key factors in reviewing safety concerns should be the characteristics of the food product, rather than the fact that the new methods are used.

In other words, as long as a protein remains a protein and a carb remains a carb, it doesn’t matter how it’s produced. In 1997, the FDA started a voluntary consultation process for GM crop developers, but seeing as it is voluntary, I would hardly call that legitimate legislation. In 1998, Monsanto’s then director of corporate communications, Phil Angell, stated:

“Monsanto should not have to vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its safety is the FDA’s job.”

The FDA’s role should be to monitor the safety of these new genetically modified plants that are used both as human food and animal food, however, there are simply no regulations specifically for GMOs.

GMO Labeling

In regards to labeling, per the FFDCA, the only labeling required from the producer is the common or usual name, or in the absence thereof, an appropriate descriptive term. The only exception is if a safety or usage issue exists due to the genetic mutation and consumers must be alerted. For example, if peanut genes are added to a tomato, the tomato can no longer be called a tomato because potential allergic reactions. I’ lettersizeLogo m sure in cases like this, the marketing department is full of clever titles like tomatut or peanato. Currently, 25 states have introduced mandatory GMO labeling legislation. Vermont and Connecticut have actually passed laws forcing GMO products to be labeled. The Non-GMO Verification Project is a nonprofit organization that provides third party volunteer testing and labeling for products. I always look for Non-GMO Project Verified label when I shop.

The USDA only cares about the plant, the FDA doesn’t care as long as a tomato remains a tomato. A majority of people don’t believe the various reports of cancer and infertility caused in lab mice fed GMOs and ignore the fact that there have not been any comprehensive studies on the affects of human consumption of GMOs, but even if we deny that GMOs could be dangerous, there is no denying that spraying dangerous chemicals such as glysophate and Agent Orange on fields and backyards is dangerous and should be regulated, right? That’s where the EPA comes into play.

EPA

The EPA is another regulatory agency. It has primary responsibility for enforcing many of the environmental statutes and regulations of the United States. Congress authorizes the EPA to write regulations that explain the critical details necessary to implement environmental laws and Presidential Executive Orders.

The EPA’s role in the environmental safety of GMOs falls under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to the EPA website:

FIFRA provides for federal regulation of pesticide distribution, sale, and use. All pesticides distributed or sold in the United States must be registered (licensed) by EPA. Before EPA may register a pesticide under FIFRA, the applicant must show, among other things, that using the pesticide according to specifications “will not generally cause unreasonable adverse effects on the environment. FIFRA defines the term ”unreasonable adverse effects on the environment” to mean: “(1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act.”

FIFRA was first passed into law in 1947, but has been amended since then. In 1972, FIFRA was essentially rewritten and amended by the Federal Environmental Pesticide Control Act. In 1996, it was again significantly amended as the Food Quality Protection Act.

While the EPA seems to hold the strictest regulations of the three agencies discussed in this article, it seems they are still coming up short. In order for a new pesticide to acquire a license from the EPA, the producer must provide more than a hundred scientific tests and studies. But, like the FDA, the producer of the pesticide provides the tests and the EPA does not actually conduct any tests on the new product. Furthermore, if it is being licensed for use on a crop less than 300,000 acres it is not considered sufficient economic incentive for registration.

EPA and GMO Regulation

Whether or not the EPA is actually regulating safe limits of pesticide aside, let’s look at their role in GMOs. Under FIFRA, the EPA provides legal requirements for registration and licensing of pesticides and therefore only monitors GMOs that are pesticidal in nature (PIP, Genetically Modified Microbial Pesticides, or Herbicide-Tolerant Crops).

The EPA also sets tolerances, and exemptions from tolerances, for the allowable residues of pesticides applied to food and animal feed under the FFDCA. However, given the pollution levels and a new study conducted by the California Department of Public Health showing a high number of California children being exposed to high level of pesticides at schools located near farms, I don’t have much faith in the EPA’s ability to safely regulate the use of pesticides.

Are GM Foods Safe?

In the end you have to ask – are GMOs safe for me and my family? Some people believe that the USDA, FDA, and EPA regulations are enough proof that they are safe, however, studies in rats fed GMO food over the course of a life time suffered premature deaths (up to 50% of males and 70% of females) and had severe organ damage (specifically liver and kidney). Also, the rats drank trace amounts of Roundup in their water (within legal limits set by these regulatory agencies) and had a 200% to 300% increase in large tumors (for more information and photos, click here).

What can YOU do?

Learn more. Do your own research on whether or not GMOs and the chemicals used on our crops are safe for consumption and the environment.

Spread the news. My friends and family are sick of hearing me telling anyone who will listen about the dangers of GMO, but I believe one person can make a difference so I keep fighting the good fight.

Buy organic, non-GMO foods. There are plenty of websites, like the Environmental Working Group, dedicated to helping families buy organic on a tight budget. Buying from local farmers can reduce cost (depending on where you live) or even buying your online. Another budget friendly tip – don’t eat out. We vote for or against GMO every time we check out at the grocery store or favorite fast food chain – make your vote count!

Get involved. I don’t mean you should quit your job to travel across the country leading protests (although if you can, go for it!). Simply watching legislation and writing in to the EPA and FDA and telling them you DON’T want Agent Orange sprayed in your backyard, is something everyone can do. We have until May 30th to tell the EPA we do not approve. Click here to add your comments. There are numerous organizations that write and submit petitions against GMOs. The Center for Food Safety is running a campaign against the use of DOW Chemical’s 2,4-D.

What do you and your family do to stop the spread of GMOs? What are your favorite NON-GMO products?

Is it Time to Include Inactive Ingredients in Chemical Safety Testing?

by Chandler Marrs, PhD

Published on February 4, 2014

3033 views

Pesticides, herbicides, fungicides dangerous to human health

The answer to that question is an unequivocal and very loud YES. For generations, the industrial chemical companies, whether they be pharmaceutical, agricultural, energy or from other sectors, have maintained that only certain ingredients in their products must be measured and accounted for – the so-called ‘active ingredients’. The adjuvants, those chemical compounds that dilute, preserve or in some way maximize the delivery of the primary chemical, are considered inert or inactive by regulatory agencies. As a result, and much to the benefit of the chemical manufacturers, those adjuvants fall outside the purview of testing and regulation. That is, not only are most of these chemicals not identified in the primary product, but they are not tested for safety – ever. Only the active ingredients are tested, singly, and never with the entire chemical cocktail that is the product itself.

As one might suspect, the inactive ingredients are far from inactive, either when tested alone or when combined with the active ingredients. In chemistry when compounds interact, it is not always a simple, linear, one to one relationship; sometimes 1+1 = 10 or more. That is the case with adjuvants. Indeed, that is their function – to maximize the strength of the active ingredients, and so, by definition and by design, failing to test adjuvant safety represents the height of scientific dishonesty.

Slowly and despite the chemical industry’s promulgations to the contrary, independent scientists are demonstrating just how active, inactive ingredients really are. In the field of agricultural chemical safety testing, one lab stands out – the Seralini Lab in France. Over the last several years, researchers from the Seralini Lab have conducted and released a series of controversial studies on agricultural chemical safety. Here are just a few that we have covered on Hormones Matter: Controversy, GMO Research and Women’s Health and Inert Ingredients in Glyphosate Herbicides are Toxic Too.

Adjuvants Matter

Just recently, the Seralini Lab published another damning set of experiments showing just how toxic the cocktail of chemicals found in common, presumed safe, pesticides, herbicides and fungicides really are. The study: Major Pesticides are More Toxic to Human Cells than their Declared Active Principles, demonstrates clearly the egregious inanity of testing only manufacturer declared active chemicals.

In the present study, researchers measured the toxicity of nine common, commercially and consumer available formulations, three from each category, pesticides, herbicides and fungicides, against three types of human cells, embryonic-kidney (HEK293), placental (JEG3), and young adult liver (HEPG2). What they found was striking. Eight of the 9 formulations tested were several hundred to several thousand times more toxic than the active chemical alone and at levels significantly less than currently allowed by regulatory standards and used commercially. The single formulation that was not more toxic than declared, contained no adjuvants.

Fungicides were found to be the most toxic chemical formulations at levels 300-600 times lower than currently accepted agricultural dilutions. Next in line was Roundup, one of the most heavily marketed and used herbicides, worldwide. Roundup toxicity ranged from twice to 10 times that of the other herbicide and pesticides and its total formulation was 125X more toxic than its declared active chemical, glyphosate.The placental cells were most sensitive to the toxins, followed by embryonic and liver cells, respectively.

Mechanisms of Toxicity

The most common mechanisms of toxicity were cell membrane disruption and the interruption of mitochondrial respiration rather than an immediate initiation of cell death or apoptosis. The authors note that apoptosis was difficult to measure because cell-death occurred via a necrotic progression rather than an immediate apoptosis reaction. This is important for a number of reasons.

The job the adjuvant is to maximize the insect, fungal or weed killing properties of the active ingredient. Seralini’s work shows us that these adjuvants work as designed, even in human cells. They maximize the killing properties of the active ingredients by weakening cell membranes (all the better to absorb the poison intracellularly and leak cell contents out into the extracellular space) and disrupting mitochondrial respiration (impaired energy and nutrient processing, make surviving the toxin that much more difficult).

Adjuvants increase toxicity by specific mechanisms that call into question, not only, their absence in testing, but the nature of toxicology testing in general. Specifically, these adjuvants evoke cell injury versus cell death. They increase the permeability of the cell wall and decrease mitochondrial respiration. These mechanisms evoke complex and chronic health conditions that are difficult quantify in standard dose-response toxicology curves with humans. Here is it is not the dose per se that increases death rate, even though higher doses would expedite the process, but the time lapse required between the exposure and the necrotic reactions in cells to reach critical mass to be clinically relevant. Imagine a slow and painful death versus the immediate and easily recognizable death.

In lower organisms like bugs, weeds and fungi, where mass is smaller, life cycles are shorter and chemistry simpler, the time frame is quicker, the injuries are more obvious and death more expedited. A standard dose response curve may appear appropriate because with the expedited time frame of the organisms life cycle e.g. the critical mass of necrotic cells can be reached more quickly to initiate death.

In contrast, however, those same deleterious mechanisms activated in higher animals and humans, would not be so easily detected, within the short time frame generally allocated for these types of studies. Initiating mitochondrial dysfunction in humans and large animals would be unrecognizable at first, and perhaps chronically, making connecting the dots between exposure to these toxic chemicals and ill health particularly difficult. When the mechanisms action of the poison evokes a process that is time dependent, larger doses appear safe, at least in the short term and with lower organisms.

In humans, the effects of the formulation would also be dispersed across multiple tissues and organs systems but how and where the toxins wreak the most havoc would be inconsistent and dependent on other factors such as previous exposures, genetic predispositions, other illnesses, medications or stressors that would modulate the current exposure. All factors that are not accounted for in toxicology in general, but especially in toxicology studies that ignore all but the manufacturer’s declared active principle – the active ingredients.

Final Thoughts

Any toxicology study that purports product safety but does not test the entire chemical formulation, adjuvants and other presumed inactive ingredients included, should be thrown out. Simple, dose-response curves are inadequate for all but most preliminary investigations. Long term studies must be conducted to evaluate the onset of disease and cumulative exposure effects, including endocrine disruption. Finally, Seralini points out, that his research is among the first to test the safety of these chemicals in human cells. This is beyond unconscionable, particularly considering these products have been on the market for decades. Regulatory agencies must test product safety against human cells. Otherwise, why even bother.

Controversy, GMO Research & Women’s Health

by Chandler Marrs, PhD

Published on October 8, 2012

4488 views

If you’ve been on the internet at all over the last several weeks, you’ve likely come across these pictures- the white rats with grotesquely large mammary tumors warning of the dangers of GMO foods. A controversial and not yet even officially published study out of France on the Long term toxicity of Roundup herbicide and a Roundup-tolerant genetically modified maize is responsible.

In this 2 year study (compared to the 90-120 days for most previous protocols) researchers purportedly demonstrated the ill-effects of glyphosate (active ingredient in Roundup herbicide) and its adjuvants (putatively inactive ingredients that enhance the absorption, distribution or metabolism of the active ingredient), but also inadvertently, and despite the rampant criticism of the study, may have identified a mechanism of action for the growth of these tumors; a disruption of the estrogen pathway perhaps linked to primary kidney and liver damage. Moreover, and again perhaps inadvertently, the research points to a possible player in the development of fibroid type tumors.

How GMO Research is Conducted

There is great debate over the safety of herbicide rendered or engineered, genetically modified organisms (GMO) within the food and water supply. Studies on the side of industry, suggest no major ill-effects, while those on the side of environmentalist indicate differently. Research design likely contributes to the disparate findings. Much research to date has been short-term (90-120 days) and/or has limited the analysis to testing or manipulating only the active ingredient in the herbicide (glyphosate) and not the variety adjuvants found in the total herbicide formulation and that would be dispersed into the natural environment (food, water) post herbicide use.

The current study sought to remedy some of those short-comings and approximate what humans might be exposed to with current regulatory standards in place and in an ‘natural environment’ where exposure rates and types would necessarily vary. (Whether lab rats can approximate human physiology or the lab can be considered a ‘natural environment’ are debates for another day).

The Seralini GMO Study

Using healthy male and female Sprague-Dawley rats, the researchers evaluated the long-term (two years), across a life-span effects, of eating Roundup treated foods (maize) and water with Roundup residue at levels below the currently parts per billion standard and consistent with what humans might be exposed to in the current environment. Control rats were fed non-GMO diets and the test rats were fed varying levels of GM maize (11%, 22% and 33% of the total diet) and water with Roundup – well below the approved levels found in the environment.

Tumors, Toxicity, Death and the GM Diet

Compared to control rats fed a non-GM diet, those fed the GM-maize and Roundup water, died five times sooner and developed huge tumors, often greater than 25% of their body weight and requiring euthanasia to reduce suffering. There were distinct differences between the male and female treated animals. The females died more quickly and developed primarily mammary tumors, followed by a lower percentage of pituitary tumors and kidney and liver toxicity. While the males, demonstrated more severe kidney and liver disease along with skin tumors. The females were more susceptible to the Roundup in the water and both groups were equally susceptible to both the lower and higher percentage (11% and 33%) exposure to GM food, suggesting a threshold effect for disease initiation rather than a cumulative or additive effect.

Endocrine Disruption

The endocrine effects were also telling and pointed to sex-dependent differences in the tumor and disease expression. The ratio of testosterone to estradiol was disrupted in both males and females. Males in the highest Roundup treatment group (33% of total feed maize), demonstrated double the levels of circulating estradiol (see Evolution or Extinction of Men for details on male endocrine disruption) when compared to the control group. Whereas the exposed females showed increased testosterone levels.

Potential Fibroid Connection

The explosive growth of tumors in the female treated rats is notable both because of the large size and location of the tumors (mammary and pituitary) but more so perhaps because of the nature and physiology of the tumors themselves. In all but two cases, the tumors were non-cancerous, non-infective or non-metastatic. The tumors were benign adenomas and fibroadenomas, those commonly found in human women as they age (also common in this strain of lab rat as it ages). Fibroadenomas are comprised of fibrous and glandular tissue located in the breast. Fibroids are similar in tissue composition, but are found in the uterus. In the present study, fibroadenomas were found in the mammary tissue and adenomas in the pituitary gland. There was no mention of uterine fibroids or adenomas in other female reproductive regions. Similarly, although, the authors make no such claim regarding the expression of fibroid type tumors, relative to hormone changes and concurrent liver dysfunction (where the enzymes and proteins involved in the hormone regulation reside), I surmise that perhaps there is a connection there as well. It is conceivable that the combined insult of aging and environmental toxins on liver function alters hormone pathways sufficiently to promote this type of tumor growth.

Controversy and Criticism

As this study was released both pro- and anti-GMO factions got their pants in a bunch. On the anti-GMO side, this study represented proof-positive that GMO foods were bad. The results of this study, and in particular, the pictures of the tumor-ridden rats went viral on the internet. On the pro-GMO side, the criticism was as swift as it was vitriolic, with claims ranging from poor methodology, to outright scientific fraud. I suspect the truth lay somewhere in between.

My Take

Releasing to press first. This merited all sorts of criticism, most of which has no bearing on the actual study but does suggest a less than forthright approach to media relations. However, given the politics surrounding this topic, one can understand this PR approach.

Sprague-Dawley rats are prone to tumors. Yes, they are and as they age, tumors become more frequent. But here we have a little pot and kettle action going on. Sprague-Dawley and other outbred strains of rats and mice, all have predilections for certain diseases and tumors, but are nevertheless what is used in all industry supported (even the studies supporting the safety of GMO) and academic research. The choice of lab rat/mice is important, but even within specific strains there is huge variability. Nullifying the study because the researchers used the same strain of lab rats that other researchers also use, is a weak criticism at best and more than a little disingenuous. Perhaps a better criticism would be the use of lab rats in general to extrapolate human physiology.

Sprague-Dawley rats are prone to tumors as they age. Well guys, so are women. By the time a woman reaches age 50, upwards of 70% of women have fibroid type tumors. And frankly, aging, whether in animals or humans, increases disease expression. Our bodies just don’t work as well when we are older. Simply measuring the effects of a toxin for a short period of time in youthful animals does not, in any way, mirror the real life of the animal or a human, where effects are cumulative over time and sometimes even multiplicative and synergistic.

The study was too long and the control rats were dying too. Life is longer than adolescence. If one wants to evaluate how a treatment or toxin affects an organism over time and as it ages, one has to evaluate across that life span. This study compared tumor progression, disease and death rates between the non-GM controls and the GM fed groups, across the rodent’s life span, which is about 2+/- years. As the rodents aged, both groups developed tumors and some died, but there were more tumors and earlier deaths in the experimental group.

Failure to observe or measure is not synonymous with non-existence. Neglecting to measure a particular toxin or analyte, a specific symptom or disease process, or failing to evaluate long term effects does not mean that the toxin, analyte, symptom or disease process in question did not happen or does not exist. It simply means that you chose not to measure it. So claiming that a 3-month study in youthful rodents nullifies results from a longer study, regardless of any other methodological issues with either study, is an utterly false, and more than a little dishonest argument.

The dose response-curve was not linear. Damn it, how dare our complex physiology not conform to the simplicity of linear statistics. A common dose-response reaction is highly linear, where a small dose elicits a similarly small response and a larger dose increase the response size. This is not case when dealing with endocrine disruptors. Hormone systems are complex and highly non-linear. Hormone reactions occur at extremely low doses and often interact synergistically with other factors and respond differently over time and with cumulative exposures. This was the case in the current study.

In spite of the flaws with this study and contrary to the criticism, the Seralini study represents one of the only, if not the only, long term evaluation of the effects of Roundup and GM feeding on health. Long term studies, even in rodents, are not common place. They should be.

The next long term study (and there should be many more) should include different strains of rodent, measure additional hormones and steroidogenic proteins altered with liver disease and if they want to be really ingenious, look at the estrogen, androgen and progesterone receptor densities in the tumors.

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