Dr. David H. Gorski

It’s safe to say the Carman-Vlieger paper does not survive the encounter. Among Dr. Gorski’s observations:

– “The only seeming hypothesis was “GMOs bad,” and the study was designed to find bad things associated with GMOs.”

– “Carman’s study resembles the Seralini study in that it basically looks at a whole lot of outcomes in a fairly arbitrary fashion and cherry picks the inevitable “positive” result.”

– “Analyzed correctly, there is no statistically significant (or, no doubt, biologically significant) difference in stomach inflammation in this study.”

– “This study abused a fairly large number of innocent pigs to produce no useful data.”

To date, about 20 rebuttals to the Carman-Vlieger paper have been posted, according to www.rbutr.com.

The headline-grabbing finding was that the experimental group supposedly had worse stomach inflammation than the controls. The paper was illustrated with grisly photographs of reddened stomach linings of autopsied pigs.

Trouble is, a professor of veterinary medicine who’s an expert in swine health management says you can’t identify inflammation just by color.

“It was incorrect for the researchers to conclude that one group had more stomach inflammation than the other group because the researchers did not examine stomach inflammation,” wrote Dr. Robert Friendship of the University of Guelph in Ontario, Canada. “They did a visual scoring of the colour of the lining of the stomach of pigs at the abattoir and misinterpreted redness to indicate evidence of inflammation. It does not. They would have had to take a tissue sample and prepare histological slides and examine these samples for evidence of inflammatory response such as white blood cell infiltration and other changes to determine if there was inflammation. There is no relationship between the colour of the stomach in the dead, bled-out pig at a slaughter plant and inflammation.” See the full statement at http://t.co/o4WUZ1jvsa

So the authors should have done more scientific verification to have a valid study. But that would have been hard, so they didn’t do it.

The authors also should have paid more attention to the mathematical verification of their study, which was based on only 168 pigs but tries to project its findings to the millions of pigs raised in the United States every year. In any study based on a small sample of the larger population, researchers use standard statistical tools to help determine if their observations result from an actual cause (in this case, the GMO grain) or are merely the working of chance. The analysis given in the paper struck some researchers as incomplete.

Luis Apiolaza of the University of Canterbury in New Zealand ran a standard statistical analysis showing that the differences claimed by Carman and Vlieger were actually due to mere chance:

“The odds ratios would be 1 for no difference between the treatments,” Apiolaza wrote. “The graph shows that the confidence limits for all levels of inflammation include 1, so move on, nothing to see. In fact, GMO-fed pigs tend to have less inflammation for most disease categories.” See his analysis at http://www.quantumforest.com/

The authors of the paper, veteran anti-GMO campaigners Judy Carman and Howard Vlieger, have attempted to fight back, insisting that their methods are correct, but so far they have gotten support only from journalists and commentators who can be counted on to promote anti-GMO views. Perhaps most of the mainstream media learned from last year’s Seralini fiasco to be a little skeptical of sensational anti-GMO papers.

The paper was written by Judy Carman, a well-known anti-biotech campaigner in Australia, and Howard Vlieger, an Iowa businessman who sells equipment to the “sustainable farming” channel. The publication was aggressively promoted by the anti-biotech industry, calling far more attention to it than a paper in a virtually unknown journal would usually get. Among the readers were several scientists and knowledgeable journalists.

Their verdict: this paper is junk.

Agronomist Andrew Kniss (PhD) of the University of Wyoming took the data in the Carman-Vlieger pig study and applied the usual statistical tools, and the differences between the different groups of pigs disappeared.

Kniss summarizes his analysis:

“If I were to have analyzed these data, using the statistical techniques that I was taught were appropriate for the type of data, I would have concluded there was no statistical difference in stomach inflammation between the pigs fed the two different diets. To analyze these data the way the authors did makes it seem like they’re trying to find a difference, where none really exist.”

See “The evidence of GMO harm in pig study is pretty flimsy”

[The thing to look at is the p-value. A relatively high p-value means the data result more from chance than from the factors being studied. You're looking for a p-value of 0.05 or less. So the p-values of 0.5669 or even 0.2408 are sky-high and indicate that the implied hypothesis -- that GM grain is bad for pigs -- is not supported by the data.]

Australian geneticist David Tribe (PhD) (University of Melbourne) analyzed the study on his GMO Pundit blog:

“The paper by Carman and colleagues avoids rigorous analysis of whether the differences are attributable to chance. In the study there is no clear-cut hypothesis about what component(s) of the diet is different and what affect the component might have specifically on the animal.

“Instead of a well formulated prior hypothesis the investigation consists of a survey of a fairly large number of parameters -18 are mentioned in one table, 17 in another, and there is no necessary statistical analysis to check for false discovery of effects because of repeated searching for differences.

“It’s what some call a fishing expedition in search of a finding, and a known pitfall of animal feeding trials on whole foods . . . Using the standard criteria of a one in 20 chance that observed differences are randomly generated, about one or two apparent effects in this study might be a false discovery.”

See “Pigs in the real world — feed them different diets, measure many health parameters, some with show differences– but what does it all mean?”

Dr. Mark Hoofnagle (MD/PhD) analyzes the study on his Denalism blog saying:

“Looking at the data there were no differences in any of the major variables evaluated by the study, such as weights, veterinary costs, illnesses, or mortality. No significant differences in blood biochemistry were found. At autopsy most organ weights were similar between groups. There was a statistically significant (but likely clinically-meaningless) increase (0.1kg vs 0.12kg) in uterus weights in the GM group. At pathology there were nonsignificant decreases in cardiac and liver abnormalities in the GM group (half as many), in stomach pathology there was one significant finding of more ‘severe inflammation’ (on a 4-point scale from no inflammation to severe) in the GM group. This is the finding that has been amplified as variably ‘damning’ or ‘concerning’ depending on which source is reporting.”

See “Pollan and Bittman, the Morano and Milloy of GMO anti-science”

An analysis by the Science Media Centre (UK) found:

“The paper does not support the claim that GM crops cause stomach inflammation or increased uterus weight . . . it is let down by an inappropriate choice of statistical analysis methods.”

See “GM pig feed and stomach inflammation”

Camille Ryan (PhD), University of Saskatchewan, noticed the signs of flagrant bias on the part of the authors and their supporters:

“You only need glance at the acknowledgement list at the end of the paper to see that it is a ‘who’s who’ of the anti-GMO world. This kind of makes the statement “The authors declare that there are no conflicts of interest” pretty much ‘moot.’ One author – Howard Vlieger - is the President of Verity Farms, Iowa, an organization that markets itself as non-GM. Judy Carman (lead author) is widely known as a long-time anti-biotech campaigner. She even has a website called ‘GMOJudyCarman‘ (launched in late May – timely, no?)

See “From ‘I smell a rat to ‘when pigs fly,’ bad science makes its rounds”

UK science writer Mark Lynas says of the study:

“This is propaganda dressed up as science, which is why it didn’t make a proper peer-reviewed journal” and he also points out that the Journal of Organic Systems does not appear in PubMed, the science journal clearinghouse, “suggesting it is not taken very seriously in the scientific community. It only publishes about twice a year, mostly with research touting the benefits of organic agriculture.”

See “GMO pigs study - more junk science”

The paper has reportedly been the the works for several years. The authors did not reveal when the pigs were actually raised. The conditions apparently were not good, since about half the pigs were suffering from pneumonia when they were finally slaughterered.

Podevin and du Jardin 2012, Possible consequences of the overlap between the CaMV 35S promoter regions in plant transformation vectors used and the viral gene VI in transgenic plants, GM Crops and Food - Biotechnology in Agriculture and the Food Chain

“Multiple variants of the Cauliflower mosaic virus 35S promoter (P35S) are used to drive the expression of transgenes in genetically modified plants, for both research purposes and commercial applications. The genetic organization of the densely packed genome of this virus results in sequence overlap between P35S and viral gene VI, encoding the multifunctional P6 protein. The present paper investigates whether introduction of P35S variants by genetic transformation is likely to result in the expression of functional domains of the P6 protein and in potential impacts in transgenic plants. A bioinformatic analysis was performed to assess the safety for human and animal health of putative translation products of gene VI overlapping P35S. No relevant similarity was identified between the putative peptides and known allergens and toxins, using different databases. From a literature study it became clear that long variants of the P35S do contain an open reading frame, when expressed, might result in unintended phenotypic changes. A flowchart is proposed to evaluate possible unintended effects in plant transformants, based on the DNA sequence actually introduced and on the plant phenotype, taking into account the known effects of ectopically expressed P6 domains in model plants. “

Response

This paper does not actually raise any concerns about the safety of biotech crops, but was interpreted in that manner by commentators. The European Food Safety Authority released a statement that said, in part:

“The data published in the paper ‘Possible Consequences of the overlap between the CaMV 35S promoter regions in the plant transformation vectors used in the viral gene VI in transgenic plants’ do not represent a new discovery of a viral gene nor do they indicate safety concerns in previously evaluated GMOs.

“The viral gene (Gene VI) belongs to a plant virus (Cauliflower Mosaic virus) that cannot infect animals or humans and therefore presents no threat to human or animal health. This virus naturally infects many plants with no recorded health effects.”

http://www.efsa.europa.eu/en/faqs/faqinsertedfragmentofviralgeneingmplants.htm

Seralini Again
Some of the same critics also cite the “work” of Gilles-Eric Seralini, a prominent anti-biotech campaigner whose paper demonstrated no more than the well-known fact that Sprague-Dawley rats develop tumors whether or not they are fed glyphosate. The Seralini paper has been rejected by every distinguished scientific body that looked at it. Details:

Seralini et al 2012, Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize, Food Chemical Toxicol
“The health effects of a Roundup-tolerant genetically modified maize (from 11% in the diet), cultivated with or without Roundup, and Roundup alone (from 0.1 ppb in water), were studied 2 years in rats. In females, all treated groups died 2–3 times more than controls, and more rapidly. This difference was visible in 3 male groups fed GMOs. All results were hormone and sex dependent, and the pathological profiles were comparable. Females developed large mammary tumors almost always more often than and before controls, the pituitary was the second most disabled organ; the sex hormonal balance was modified by GMO and Roundup treatments. In treated males, liver congestions and necrosis were 2.5–5.5 times higher. This pathology was confirmed by optic and transmission electron microscopy. Marked and severe kidney nephropathies were also generally 1.3–2.3 greater. Males presented 4 times more large palpable tumors than controls which occurred up to 600 days earlier. Biochemistry data confirmed very significant kidney chronic deficiencies; for all treatments and both sexes, 76% of the altered parameters were kidney related. These results can be explained by the non linear endocrine-disrupting effects of Roundup, but also by the overexpression of the transgene in the GMO and its metabolic consequences.”

Response
The Seralini paper caused a tremendous stir in Europe (Seralini being based in France). The paper was criticized for its experimental design, statistical analysis, and interpretation and presentation of results. Problems included the well-known fact that the strain of rats used in the study (Sprague-Dawley) are prone to develop tumors at around age two regardless of their diet; Seralini attributed the tumors to the GM corn rations. Seralini’s data analysis was also unusual; the German risk assessment agency found it “impossible to comprehend.” At the request of the European Commission, the European Food Safety Authority reviewed the paper and released an opinion which it summarized as follows:

“EFSA’s final review reaffirmed its initial findings that the authors’ conclusions cannot be regarded as scientifically sound because of inadequacies in the design, reporting and analysis of the study as outlined in the paper. It is not possible, therefore, to draw valid conclusions about the occurrence of tumours in the rats tested. Based on the information published by Séralini et al., EFSA finds there is no need to re-examine its previous safety evaluations of NK603 or to consider these findings in the ongoing assessment of glyphosate.”

(“Frequently Asked Questions on review of Séralini et al. (2012) study,” http://www.efsa.europa.eu/en/faqs/faqseralini.htm)

EFSA also released a compendium of reports from agencies of EU Member States and scientific bodies that reviewed and rejected the Seralini paper. These included reports from:

• Belgium: BAC (Biosafety Advisory Council);
• Germany: BVL (The Federal Office of Consumer Protection and Food Safety) and BfR (The Federal Institute for Risk Assessment);
• Denmark: DTU (The National Food Institute)
• France: ANSES (French Agency for Food, Environmental and Occupational Health & Safety);
• France: HCB (High Council For Biotechnology);
• Italy: ISS (Istituto Superiore di Sanità ) (National Institute of Health) & IZSLT (Istituto Zooprofilattico Sperimentale delle Regioni Lazio e Toscana);
• Netherlands: NVWA (Nederlandese Voedsel-en Warenautoriteit) (Dutch Food and Consumer Product Safety Authority).

All these agencies were extremely critical of the Seralini project and stated that it provided no new grounds for concern about the carcinogenicity of the genetically modified corn studied. The EFSA final review and annex with the national reviews may be accessed at
http://www.efsa.europa.eu/en/efsajournal/pub/2986.htm

Numerous independent scientists wrote letters of rebuttal and protest to the journal Food and Chemical Toxicology. These may be accessed at http://www.sciencedirect.com/science/article/pii/S0278691512005637

Karl Haro von Model, moderator Patrick Michaels, Jon Entine, and Kevin Folta

But Smith and Seralini backed out when they realized they would also be up against Kevin Folta, a plant geneticist from the University of Florida who is very active in debunking anti-biotech claims. Rounding out the panel was Karl Haro von Mogel, a graduate student at the university of Wisconsin and proprietor of the Biofortified blog.

Folta pointed to the use of scary-sounding statements by anti-biotch forces, noting “the use of fear is pervasive” in those circles. Activists like Smith try to frighten people by claiming that the rise of biotech corps is linked to the alleged rise in autism, diabetes, and other disorders, he said.

“But you shouldn’t confuse correlation with causality,” Folta said. “Just because two things happen at the same time does not mean they are linked.” He noted that the increase in both diabetes and autism tracks almost perfectly with the increase in organic food sales.

“But I wouldn’t say one causes the other,” he said. “Obviously not. And we must make decisions based on data and evidence, not on fear.”

“It underwent seven years of test cultivation,” the Post noted in an editorial published Sunday, June 2, 2013. “The Food and Drug Administration had no questions that this variety was as safe as others.”

Wheat has been modified throughout history as humans sought better varieties, the paper pointed out.

“With contemporary techniques, scientists in a lab can quickly make genetic changes that would have taken much longer to accomplish through old-school selective breeding, and they can do it with more precision,” the Post wrote.

“Just as cultivating better and better strains of wheat helped feed ancient societies, newer techniques offer humanity one way to help sustain a growing population on a warming globe,” the Post wrote. “The world should embrace that opportunity.”

Read the full editorial at http://wapo.st/13wwgeq

Senator Debbie Stabenow (D-Mich.), the chair of the Agriculture Committee, pointed out that labeling is against a science-based regulatory process and could also create a barrier to the positive impact GM crops are having worldwide.

“This particular amendment would interfere with the FDA’s science-based process to determine what food labeling is necessary for consumers,” Senator Stabenow said.

“It’s also important to note that around the world now we are seeing genetically modified crops that have the ability to resist crop diseases and improve nutritional content and survive drought conditions in many developing countries,” she added.  Read more.

“While there are some changes that could make the bill more defensible from a constitutional standpoint, the bill would remain subject to significant challenge in the courts,” she warned.

Maine L.D. 718 would require that all genetically engineered food offered for retail sale in the state would have to carry a label, or be accompanied by a sign, that states “Produced with Genetic Engineering.” The bill would not go into effect unless similar legislation is adopted in at least five other states or in states with a combined population of at least 20 million.

“If enacted, L.D. 718 is certain to face legal challenges on constitutional grounds and these constitutional issues are significant,” Mills wrote to legislative leaders. “To date, no other state has enacted a law requiring the labeling of genetically engineered food. Litigation on constitutional grounds will be costly, and the outcome is far from certain.”

The legislature’s Agriculture Committee endorsed the bill on a 12-4 vote, sending it to the House of Representatives for a floor vote. Read more.

“Bowman planted Monsanto’s patented soybeans solely to make and market replicas of them, thus depriving the company of the reward patent law provides for the sale of each article,” Justice Elena Kagan wrote for the full court. “Patent exhaustion provides no haven for that conduct.”

The industry’s trade association, the Biotechnology Industry Organization (BIO), applauded the ruling.

“The Supreme Court’s commitment to uphold valid intellectual property rights in this case creates business certainty that will benefit all of biotechnology - as well as the patients, farmers, and consumers who benefit from biotechnology’s help in healing, feeding and fueling the world,” BIO President Jim Greenwood said.

The text of Justice Kagan’s opinion is available here: http://1.usa.gov/16ursLm

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