About Those Industry Funded GMO Studies . . .

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This essay previously appeared on REALFOOD.ORG and Biofortified.org

Let’s talk about those GMO funded studies. You know the ones. The ones you always hear about from Anti-GMO folks when you read the comment section for any story about GMOs. According to those folks, the whole scientific consensus on GMOs is based on those studies. According to peanut gallery, the only studies that show that GMOs pose no different risks than conventionally bred crops were all bought and paid for by Monsanto. That would make the consensus suspicious right? It would if there weren’t also a ton of independently funded studies that show the same thing.

Instead, what the complaints about industry funded studies show is an ignorance of the literature and a lazy desire to dismiss inconvenient evidence in order to preserve predetermined ideological commitments. It’s just plain old confirmation bias and motivated reasoning run amok.

Let’s put aside the fact that this line of thinking would mean that while fossil fuel behemoths Exxon Mobil (market cap:$394.83B), Chevron (market cap:$215.45B) and BP (market cap:$150.07B) (total: $760.35B) have been completely stymied in their efforts to buy the scientific consensus they desire on climate change, a medium large company like Monsanto (market cap: $57.43B) has been able to manipulate tens of thousands of scientists performing thousands of studies for three decades with no whistleblowers resulting in a scientific consensus that has been bent completely to their will. Let’s put that aside.

Instead, let’s first take a look at the evidence, before moving to unravel some of pretzeled logic often employed to dismiss the weight of that evidence in support of the scientific consensus on GMOs.

Take for example the EU. Politicians in the EU aren’t that friendly to GMOs and they wanted to be very careful about them. So they ponied up €200 million over the course of decade to look into the matter. The studies they carried out are neatly summarized in A Decade of EU Funded GMO Research [pdf].

This new publication presents the results of 50 projects, involving more than 400 research groups and representing European research grants of some EUR 200 million. This figure brings the total Commission funding of research on GMO safety to more than EUR 300 million since its inception in 1982 in the Biomolecular Engineering programme.

. . . The main conclusion to be drawn from the efforts of more than 130 research projects, covering a period of more than 25 years of research, and involving more than 500 independent research groups, is that biotechnology, and in particular GMOs, are not per se more risky than e.g. conventional plant breeding technologies.

Elsewhere, the fine folks at Biofortified have begun working on a database of GMO research, while that work is still in progress, they have gathered a collection of 126 studies with independent funding. Not all of the studies are supportive of the position that GMOs are no riskier than their conventionally bred counterparts, but the vast majority support that proposition.

Let’s look at two types of papers from the list that are of particular value to the non-scientists among us. For the lay person, sticking with literature reviews and meta-analyses are a great way for getting a sense of the weight of the evidence on a given topic. They help us avoid single study syndrome and keep us from missing the forest for the trees. Here are four of those types papers from the Biofortified list of studies with independent funding.

1. Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: A literature review

The aim of this systematic review was to collect data concerning the effects of diets containing GM maize, potato, soybean, rice, or triticale on animal health. We examined 12 long-term studies (of more than 90 days, up to 2 years in duration) and 12 multigenerational studies (from 2 to 5 generations). We referenced the 90-day studies on GM feed for which long-term or multigenerational study data were available. Many parameters have been examined using biochemical analyses, histological examination of specific organs, hematology and the detection of transgenic DNA. The statistical findings and methods have been considered from each study. Results from all the 24 studies do not suggest any health hazards and, in general, there were no statistically significant differences within parameters observed.

2. A Meta-Analysis of Effects of Bt Crops on Honey Bees

Honey bees (Apis mellifera L.) are the most important pollinators of many agricultural crops worldwide and are a key test species used in the tiered safety assessment of genetically engineered insect-resistant crops. There is concern that widespread planting of these transgenic crops could harm honey bee populations.

Methodology/Principal Findings: We conducted a meta-analysis of 25 studies that independently assessed potential effects of Bt Cry proteins on honey bee survival (or mortality). Our results show that Bacillus thuringiensis (Bt) Cry proteins used in genetically modified crops commercialized for control of lepidopteran and coleopteran pests do not negatively affect the survival of either honey bee larvae or adults in laboratory settings.

Conclusions/Significance: Although the additional stresses that honey bees face in the field could, in principle, modify their susceptibility to Cry proteins or lead to indirect effects, our findings support safety assessments that have not detected any direct negative effects of Bt crops for this vital insect pollinator.

3. A Meta-Analysis of Effects of Bt Cotton and Maize on Nontarget Invertebrates

Although scores of experiments have examined the ecological consequences of transgenic Bt crops, debates continue regarding the nontarget impacts of this technology. Quantitative reviews of existing studies are crucial for better gauging risks and improving future risk assessments. To encourage evidence-based risk analyses, we constructed a searchable database for nontarget effects of Bt crops. A meta-analysis of 42 field experiments indicates that nontarget invertebrates are generally more abundant in Bt cotton and Bt maize fields than in nontransgenic fields managed with insecticides. However, in comparison with insecticide-free control fields, certain nontarget taxa are less abundant in Bt fields.

There is one more literature review from the Biofortified list that I want to look at, but in the context of making an important point.

The point is this. Yes, there are lots of industry funded studies. The majority in fact. But, as I hope that I’ve demonstrated, there is a robust literature of independent studies. How can we judge if the results of the industry funded studies are reliable? Well, one indicator would be if that the independent studies and the industry studies, in the aggregate, come to the same conclusions. When we look, that is in fact, what we find.

Let’s parse out the findings of a 2007 literature review on human and animal toxicological/health risks studies for GM foods/plants and the 2011 follow up.

2007’s “Toxicity studies of genetically modified plants: a review of the published literature” found little to no evidence that genetically engineered crops posed significantly different risks than conventional crops, while sounding several cautious caveats and underlining that the body of literature seemed too scant for drawing confident conclusions. One statement caught me eye. “Moreover, most published studies were not performed by the biotechnology companies that produce these products.”

They followed up in 2011 and found a much more robust literature, but also a shift in the proportion of industry funded studies. This was unsurprising since prior to 2006, companies hadn’t been publishing their test results (aside from in their patent applications) but an industry-wide push for transparency had changed that.

4. A literature review on the safety assessment of genetically modified plants

The main goal of the present review was to assess the current state-of-the-art regarding the potential adverse effects/safety assessment of GM plants for human consumption. The number of citations found in databases (PubMed and Scopus) has dramatically increased since 2006. However, new information on products such as potatoes, cucumber, peas or tomatoes, among others was not available. Corn/maize, rice, and soybeans were included in the present review. An equilibrium in the number research groups suggesting, on the basis of their studies, that a number of varieties of GM products (mainly maize and soybeans) are as safe and nutritious as the respective conventional non-GM plant, and those raising still serious concerns, was currently observed. Nevertheless, it should be noted that most of these studies have been conducted by biotechnology companies responsible of commercializing these GM plants. These findings suggest a notable advance in comparison with the lack of studies published in recent years in scientific journals by those companies.

Domingo and his team are certainly no cheerleaders for biotech crops. Yet, despite the increase in industry funded studies between their reviews of the literature in 2007 and 2011, they still find plenty of evidence to affirm their cautious stance towards the technology.

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A more robust review of the total literature published last year was more conclusive in there findings. “In a meta-review recently published in a peer-reviewed, high impact factor journal, Critical Review of Biotechnology, where the authors collected and evaluated 1,783 research papers, reviews, relevant opinions, and reports published between 2002 and 2012, a comprehensive process that took over 12 months to complete. The review covered all aspects of GM crop safety, from how the crops interact with the environment to how they could potentially affect the humans and animals who consume them.” And their conclusion?

The scientific research conducted so far has not detected any significant hazards directly connected with the use of genetically engineered crops.

According to an interview with the lead author, Alessandro Nicolia, an applied biologist at the University of Perugia in Italy, ”Our goal was to create a single document where interested people of all levels of expertise can get an overview on what has been done by scientists regarding GE crop safety. We tried to give a balanced view informing about what has been debated, the conclusions reached so far, and emerging issues.”

So, we can observe that there is little daylight between what independent and industry funded studies find. What if we were a little more rigorous in our scrutiny. Johan Diels of The Biotechnology College of the Portuguese Catholic University led a team that did exactly that. The results were interesting, but not without some problems, which we will take a look at.

First, though let’s look at what they found.

Association of financial or professional conflict of interest to research outcomes on health risks or nutritional assessment studies of genetically modified products

In a study involving 94 articles selected through objective criteria, it was found that the existence of either financial or professional conflict of interest was associated to study outcomes that cast genetically modified products in a favorable light (p = 0.005). While financial conflict of interest alone did not correlate with research results (p = 0.631), a strong association was found between author affiliation to industry (professional conflict of interest) and study outcome (p < 0.001).

“Regarding financial COI (conflict of interest), no association was observed between the presence of such conflict and article outcome (p = 0.631).” Did you get that? Let that sink in for a minute.

They did find a correlation between industry affiliation and favorable study outcome. I’ll grant that. But realize how far we have moved the goal posts. We started with the proposition that we couldn’t trust any of the research because it was it was all paid for by the industry. Then we showed that wasn’t true. Now we have researchers looking into the matter and they can’t find a relationship between industry funding and favorable study outcomes. What’s left is griping about the industry ties of some of the researchers. Before looking a little closer at that, let’s get one thing out of the way. When a company pays for a study, they are paying because they want to find out something. Fudging the data does not help them in their business. Maybe somewhere on the margins in a 60 Minutes kind of way, but by and large it would be highly counter productive. That’s why it didn’t show up in the data.

Now, about the association between author affiliation and study outcome. There are a few things that might explain that correlation besides a lack of independence. Half the sample was undeclared regarding COIs, so on that central question of the hypothesis, half of an already small sample was noise.

On the question of whether industry ties correlates with favorable study outcomes, they show a significant correlation. However, in the professional COI category nearly 10% of the sample size was categorized as undetermined. Moreover, while 43 authors had COIs, 28 of the studies were compositional studies. These are nearly always funded by the companies and they are close to always favorable since substantial equivalence is nearly a sure fire bet. Remove those 28 studies from the set of 43 with financial or professional COIs and the P values will shift towards insignificance.

Another thing to keep in mind, especially where compositional studies are concerned is that the company has already performed in-house studies. They are contracting independent scientists to confirm their findings. This is going to skew the results of the sample towards industry favorable study outcomes. This doesn’t mean the studies were suspect. They were just more likely to result in a favorable outcome to begin with. If the in-house study had an unfavorable outcome in compositional assessment or other tests, then the current version of that plant would be scrapped and it’s back to the drawing board for the breeders. There is no need for follow up testing by outside independent researchers. That’s a big reason why so many studies in that sample will produce favorable results.

In written conversation, independent researcher and professor of horticultural sciences, Kevin Folta put it this way, “I think the other factor is that industry recruits independent experts to independently reproduce findings. They show in house that x+y=z. They then hand the test to a university, that finds x+y=z. If the test fails in-house, then it does not go for independent verification. That will skew statistics too, because the outcomes of the university-based tests have already been demonstrated. The reason the results frequently agree is because they are frequently correct.”

On his blog, Folta looked at the question of industry funding at his employer, the University of Florida:

First, I went to an easy source at my university, the University of Florida. The Institute for Food and Agricultural Sciences (IFAS) publishes their financials every year. You can find this online here.

How much Big Corporation money did we spend? Not that much. It is buried somewhere in that “other sponsored funds” piece of the money pie.

If corporations are fueling scientific discovery at universities,

they sure aren’t contributing too much. Somewhere in “Other Sponsored Funds”

Now wait, I can hear critics already screaming that “other sponsored funds” is almost 10% of the research dollars spent, and that’s a significant amount at a place like the University of Florida. So let’s use the record to break that down:

Yikes. Corporate sponsorship is a pretty small sliver of that pie.

 

So about two percent of our funds come from corporate interests. For the anti-scientific critics out there, that’s about two dollars out of every hundred.

 

If we are bought and paid for, we’re bought really cheap and not paid well.

Elsewhere in that conversation, Kevin Folta had this to say, “The other important thing to remember is that almost no university researcher is going to commit career suicide by fudging data, especially for some damn company. That’s why companies come here. If the results don’t agree with what they found, it means that they are not reproducible. That’s the answer they NEED to know, and why they go independent in the first place!

. . . Even if a university gets a building, how does that make an individual researcher change research, essentially torpedo a career? Even if a company finances a lab (which is rare) they want the real answer, not some fabrication. To suggest that we’re all somehow sellouts is insane. Show me where my data do not hold up.”

I’m not saying that people shouldn’t pay attention to potential conflicts of interest or take industry funded research at face value. What I am saying is that dismissing an entire body of research because it’s supposedly bought and paid for is simply foolish and lazy. Or as I’ve said before:

When you start hollering ‘Conflict of Interest’ before evaluating the evidence and analysis, it becomes a ‘Get of Jail Free Card’. It becomes an excuse for discounting inconvenient evidence. Asking about conflicts of interest should be safeguard against getting snookered. Instead, it becomes a way to justify motivated reasoning. Awareness of conflict of interest should be a tool for explaining weak evidence and poor analysis. Instead it becomes an excuse for dismissing strong evidence and sound analysis. It leaves you lost in a hall of mirrors, surrounded by industry funded research, revolving door regulators, and defending bad research that confirms your biases. It leaves you lost in a fever swamp of paranoia without firm footing.

Examining the soundness of the evidence and the strength of the analysis must come first. Then you can decide whether questions of funding and loyalties are relevant. This is how you maintain a firm footing and hew to solid ground. This is how you can use awareness of conflicts of interest to avoid motivated reasoning. Otherwise you are only fueling the fire of your own biases

POST SCRIPT: When I first wrote this piece I had in my notes to include some discussion of the agreement on access to materials and permissions that was reached in 2009, but that did not make the final piece. This issue is most frequently brought up in regards to a 2009 editorial in Scientific American decrying the state of affairs. Most people citing that piece fail to realize that A.) the ability to do the research existed all along and further that a deal was hammered out between public university researchers and the large seed producers. That story has been ably covered by Nathanael Johnson at Grist.

It should also be noted that recent analysis of the GENERA database show that half, rather than a third of research on BE crops is non-industry funded.
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Sources:

A Decade of EU Funded GMO Research (2000-2010) [pdf].
European Commission | Directorate-General for Research

Studies with independent funding
Biofortified.org

Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: A literature review
Chelsea Snella, et al. | Food and Chemical Toxicology | March 2012

A Meta-Analysis of Effects of Bt Crops on Honey Bees
Michelle Marvier, et al. | PLOS One | 9 January 2008

Toxicity studies of genetically modified plants: a review of the published literature
José L. Domingo | Critical Reviews in Food Science and Nutrition | 2007

A literature review on the safety assessment of genetically modified plants
José L. Domingo, Jordi Giné Bordonaba | Environment International | May 2011

An overview of the last 10 years of genetically engineered crop safety research
Alessandro Nicolia, et al | Critical Review of Biotechnology | 16 November 2013

Association of financial or professional conflict of interest to research outcomes on health risks or nutritional assessment studies of genetically modified products
Johan Diels, et al | Food Policy | April 2011

Unintended Compositional Changes in Genetically Modified (GM) Crops: 20 Years of Research
Rod Herman, et al | Journal of Agricultural and Food Chemistry | 15 February 2013

Single study syndrome – clutching at convenient confirmation
Graham Coghill | Science or Not | 23 October 2012

Do Seed Companies Control GM Crop Research?
Editors | Scientific American | 20 June 2009

Genetically modified seed research: What’s locked and what isn’t
Nathanael Johnson | Grist | 5 August 2013

New resource shows half of GMO research is independent
Karl Haro von Mogel | BioFortified.org | 25 August 2014

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