GMO Salmon and the Banality of Corruption at FDA

Earlier this week, the Food and Drug Administration (FDA) held a meeting on its preliminary assessment that genetically engineered (GMO) salmon are safe to eat. A couple weeks prior, the agency released eleven years’ worth of data on the GMO fish, giving consumer and health advocates precious little time to review the basis for the agency’s conclusion that paves the way for the first GMO animal to travel from the biotech industry’s labs to your dinner plate.

I don’t know about you, but when I find myself lounging around at home and considering the human health impacts of GMO fish, my first thought is invariably: “Let’s ask some veterinarians!”

So imagine my relief when I discovered that the panel overseeing the process this week is the FDA Veterinary Medicine Advisory Committee.  That’s right: the fate of this untested, experimental GMO food, the first such GMO animal food that millions of Americans may be eating, was left to a group of unqualified veterinarians.

(My dog, ever the gourmand, takes comfort that the expertise of one of the committee members is pet food.  No, really, I’m not joking; his bio notes his current role in developing a “Center for Pet Food Nutrition and Safety.” Really!)

The Committee has no member whose primary expertise is food safety and allergies, or growth hormones in food, and there are no fish ecologists. To make this decision, FDA did appoint 4 new temporary members – but 2 of them have worked to develop GMO fish.

A final decision on the GMO salmon isn’t expected from FDA until late November at the earliest. The smart money seems to be betting on the approval announcement coming during the week between Christmas and New Year’s, the same slow-news period that FDA used to announce its finding of the “safety” of cloned food in 2006.

But already the information released by FDA has raised serious concerns.  Consumers Union (CU), the nation’s largest consumer protection organization, took on FDA and exposed the outrageous lengths the agency has taken to promote the GMO industry’s risky food experiment. Rejecting FDA’s food safety assessment, CU notes that FDA

 …too narrowly defines direct and indirect effects, uses small sample sizes, appears to manipulate data, and employs crude scientific measures to come to the conclusion that the [GMO] Salmon are as safe to eat as non engineered salmon. We disagree with the conclusion of this assessment on the grounds that the data are too superficial and of insufficient scientific quality to warrant approval. 

CU notes many deficiencies in FDA’s approach and conclusions, but a quick review shows that the FDA’s assessment was fatally flawed on at least four counts:

Allergies

In its review of the allergy risks of the Frankenfish, FDA considered just two studies, both submitted by Aqua Bounty, the company urging approval of its GMO salmon.

One of the studies was so poorly conducted that FDA admitted it demonstrated “no reliable conclusions.”  The other study looked at just 12 GMO salmon, compared to 6 natural salmon. Only six of the GMO fish were the sterile “triploid” GMO salmon that the company hopes to sell for food. The other 6 were diploid GMO fish, which the company claims it does not intend to market.

The data on GMO versus natural salmon shows that both the diploid and triploid fish were more likely to trigger allergic reactions, by 52% and 20%, respectively. But FDA simply ignored that information on diploid fish, and concluded that the 20% greater allergy risk from triploid GMO salmon was statistically insignificant.      

As CU points out, though, a conclusion of safety does not scientifically follow from findings that are this questionable and from such a small sample size. Instead, this should have prompted the agency to demand further testing. As their comments state,

…the act of genetic engineering [of the GMO salmon] did lead to an increase in allergenic potency, at least based on this test…To base a conclusion of no additional risk on exactly six engineered fish, when those data themselves suggest a possible problem, is not responsible science or responsible risk assessment.  FDA owes it to the thousands of Americans who are allergic to finfish to demand more data on the allergenicity of these engineered salmon from AquaBounty. [emphasis in the original]

Growth Hormone and IGF-1 levels

Here again, FDA looked at just two studies on growth hormone levels in GMO salmon. Neither study found any data on triploid GMO salmon, so FDA based its conclusion of safety on data from diploid GMO fish – even though for the allergy assessment, FDA specifically omitted information on diploid salmon, saying that’s not the fish we’ll be eating.

In other words, when data match their pre-determined conclusion of safety, FDA is happy to include the data, even if it doesn’t come from the GMO fish we’ll be eating. But when it refutes their claim of safety, FDA simply discards the data.

At any rate, like the first allergy study, the first hormone study on the Frankenfish was pretty sketchy: it was conducted in 1992, included just five fish, and tested young fish that were nowhere near their market weight (the fish weighed two ounces, about 15-30 times smaller than supermarket salmon). Even so, the study found 41% more growth hormone in GMO salmon (FDA deemed the difference statistically insignificant).

The second study was no better. It focused on market weight fish, but used a testing method that was not sensitive enough to detect hormone levels. Guess what they found? No hormones at all, in any of the natural or GMO fish tested! Based on this study, FDA logically concludes that (since they both seem to have no hormones) there is no relevant difference between GMO and natural salmon. As CU notes, “This would be like the police using a radar gun that cannot detect speeds below 120 mph and concluding that there is no ‘relevant difference’ in the speed of cars versus bicycles.”

CU also notes that a study by independent researchers looking at GMO Coho salmon used a more sensitive test and found twice as much growth hormone in the GMO fish. But FDA didn’t include this study in their review.

Related to hormone levels are levels of a substance called IGF-1. Consumption of foods high in this hormone-like compound has been linked to numerous human cancers, including breast and prostate cancer, as well as lung cancer, colorectal cancer and other health problems. FDA says that they looked at data on IGF-1 in natural salmon compared to GMO salmon and concluded that “there did not appear to be a statistically significant difference.”

But CU looked at the data, and found that FDA systematically excluded four of the eleven natural salmon with the lowest levels of IGF-1, thereby artificially raising the level of IGF-1 that the agency claimed was “average” for natural fish. They also added a sample to the six GMO salmon and assigned it the lowest IGF-1 level that would be detectable, thus artificially lowering the level of IGF-1 FDA claims is “average” for GMO salmon.

Once the IGF-1 levels were properly rigged to raise the level in natural salmon and lower the level in the GMO fish, FDA was delighted to find that the difference between natural and GMO levels was not statistically significant! As CU drily notes, such “manipulation of data … is scientifically unsound.” (A less staid assessment might be that the agency’s action was disingenuous, outrageous, and corrupt.)

Fatty-acid levels

Nutritionists urge us to eat foods high in Omega-3 fatty acids, in order to balance the levels of fatty acids in our diets (Americans typically eat far more foods high in Omega-6 fats that tend to promote inflammation, while Omega-3’s are said to reduce health problems related to inflammation). Wild salmon have a beneficially high ratio of Omega-3 to Omega-6 fats, while the levels in farmed salmon are considerably lower. According to FDA’s data, the GMO salmon is slightly lower than other farmed salmon, yet the agency concluded that the difference was not “material.”

Production Process

Aqua Bounty plans to produce GMO salmon eggs in Canada, raise the salmon in Panama, then sell the finished salmon, unlabeled, to unsuspecting consumers in the US. But the company provided no data at all on salmon raised this way – the scant data they did submit was on fish raised in Canada. Since warm-water rearing conditions in Panama are markedly different from those in Canada, they could influence the final product in unexpected ways: levels of allergens or toxins in the fish, for example, might be more potent in warm-water raised fish.

Moreover, the FDA is reviewing the GMO salmon as a new drug, and the agency’s own rules state that any change in the production process requires a drug maker to submit new data on the drug as it is to be produced, to show that the production method has not compromised the drug’s, I mean the Frankenfish’s, safety or efficacy. FDA claims that the GMO salmon is safe despite the complete lack of this data requirement.

So What Does It All Mean?

It means that FDA came to the conclusion that GMO salmon is safe for millions of Americans to eat by ignoring critical information, manipulating data, abusing science, and side-stepping their own rules.

Dr. David Graham, an FDA regulator for 25 years and a vocal critic of the agency’s attention to industry interests over public interest recently noted:  “FDA is inherently biased in favor of the pharmaceutical industry.  It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs as it can, regardless of whether the drugs are safe or needed.”

Substitute “biotechnology” for “pharmaceutical” and “GMO foods” for “drugs” in Graham’s statement, and you know pretty much everything you need to about how FDA came to its “safety” conclusion on GMO salmon. Sadly, distortion and corruption of science at FDA has become a banal, everyday occurrence.

Good thing it’s only the health of millions of Americans that’s at stake.

(See our take on this week’s FDA meetings on GMO salmon labeling, Truthiness and Fairness on GMO Labels at FDA)

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