Throwing Biotech Lies at Tomatoes – Part 1: Killer Tomatoes

Remember the pictures of the fish tomatoes? For years they were an unofficial emblem of the anti-GMO movement. They depicted how anti-freeze genes from an Arctic fish were forced into tomato DNA, allowing the plants to survive frost. Scientists really did create those Frankentomatoes, but they were never put on the market. (Breyers low-fat ice cream, however, does contain anti-freeze proteins from Arctic fish genes, but that’s another story.)

The tomato that did make it to market was called the Flavr Savr, engineered for longer shelf life. Fortunately, it was removed from the shelves soon after it was introduced.

Although there are no longer any genetically modified (GM) tomatoes being sold today, the FDA’s shady approval process of the Flavr Savr provides a lesson in food safety—or rather, the lack of it—as far as gene-spliced foods are concerned. We know what really went on during the FDA’s voluntary review process of the Flavr Savr in 1993, because a lawsuit forced the release of 44,000 agency memos.

(Those same memos, by the way, also showed that FDA scientists had repeatedly warned their superiors about the serious health risks of genetically modified organisms [GMOs]. They were ignored by the political appointees in charge, who allow GMOs onto the market without any required safety studies.)

Bleeding stomachs

Calgene, the tomatoes’ creator-in-chief (now a part of Monsanto), voluntarily conducted three 28-day rat feeding studies. Before I share the gory details, I must commend the Calgene scientists who were committed to transparency and full disclosure with the FDA. Unlike all other subsequent voluntary submissions from biotech firms to the agency, Calgene provided detailed feeding study data and full reports. Dr. Belinda Martineau, one of Calgene’s tomato makers, writes in First Fruit about their commitment to an open process while they attempted to introduce the world’s first GM food crop.

Calgene tested two separate Flavr Savr tomato lines. Both had the same gene inserted into the same type of tomato. The process of insertion and the subsequent cloning of the cells into GM plants can cause lots of unique and unpredicted consequences. The two lines, therefore, were not considered identical.

The rats that ate one of these Flavr Savr varieties probably wished they were in a different test group. Out of 20 female rats, 7 developed stomach lesions—bleeding stomachs. The rats eating the other Flavr Savr, or the natural tomatoes, or no tomatoes at all, had no lesions.

If we humans had such effects in our stomachs, according to Dr. Arpad Pusztai, a top GMO safety and animal feeding expert, it “could lead to life-endangering hemorrhage, particularly in the elderly who use aspirin to prevent thrombosis.”

The lab that performed the study for Calgene acknowledged that the results “did suggest a possible treatment related” problem. FDA scientists repeatedly asked Calgene to provide additional data in order to resolve what they regarded as outstanding safety questions. The director of FDA’s Office of Special Research Skills wrote that the tomatoes did not demonstrate a “reasonable certainty of no harm,” which is the normal standard of safety. The Additives Evaluation Branch agreed that “unresolved questions still remain,” and the staff pathologist stated, “In the absence of adequate explanations by Calgene, the issues raised by the Pathology Branch … remain and leave doubts as to the validity of any scientific conclusion(s) which may be drawn from the studies’ findings.”

Oh yeah, some rats died

The team that had obtained the formerly secret FDA documents sent the full Flavr Savr studies to Dr. Pusztai for review and comment. While reading them, he happened across an endnote that apparently the FDA scientists either did not see or chose to ignore. The text nonchalantly indicated that 7 of the 40 rats fed the Flavr Savr tomato died within two weeks. The dead rats had eaten the same tomato line as those that developed lesions. In the other groups, fed the other Flavr Savr line, a natural tomato control, or a water control, only one rat had died.

But the endnote summarily dismissed the cause of death as husbandry error, and no additional data or explanation was provided. The dead rats were simply replaced with new ones.

When I discussed this finding with Dr. Pusztai over the phone, he was beside himself. He told me emphatically that in proper studies, you never just dismiss the cause of death with an unsupported footnote. He said that the details of the post mortem analysis must be included in order to rule out possible causes or to raise questions for additional research. Furthermore, you simply never replace test animals once the research begins.

Questionable follow-up study

Calgene repeated the rat study. This time, one male rat from the non-GM group of 20, and two females from the GM-fed group of 15, showed stomach lesions. Calgene claimed success. They said that the necrosis (dead tissue) and erosions (inflammation and bleeding) were “incidental” and not tomato-related. The FDA staff pathologist, however, was not convinced. He responded that “the criteria for qualifying a lesion as incidental were not provided.” Further, he said that the disparity between the studies “has not been adequately addressed or explained.”

In reality, the new study was not actually a “repeat.” They used tomatoes from a different batch and used a freeze-dried concentrate rather then the frozen concentrate used in the previous trial. Dr. Martineau explained to me that by freeze-drying, it allowed them to put more of the concentrated tomato into each rat. But Dr. Pusztai said that altering the preparation of the food can lead to different results. He also pointed out that humans were more likely to consume frozen concentrate compared with freeze-dried.

In spite of the outstanding issues, the political appointees at the FDA concluded that the lesions were not related to the GM tomatoes. To be on the safe side, however, Calgene on its own chose not to commercialize the tomato line that was associated with the high rate of stomach lesions and deaths. The other line went onto supermarket shelves in 1994.

Faulty science rules the day

This was the very first GM food crop to be consumed in the US. It was arguably the most radical change in our food in all of human history. It was the product of an infant science that was prone to side-effects. Yet it was placed on the market without required labels, warnings, or post-marketing surveillance. One hopes that the FDA would have been exhaustive in their approval process, holding back approvals until all doubts were extinguished. But the agency was officially mandated with promoting biotechnology and bent over backwards to push GMOs onto the market. As a result, their evaluation was woefully inadequate.

Having discovered problems in the stomach, for example, Dr. Pusztai said they should have looked further down the digestive system at the intestines as well, but they didn’t. They should have increased the number of animals in the experiment to strengthen the findings, but they didn’t. And they should have used young (e.g. month-old) and pregnant animals as is done with pharmaceutical studies, but they didn’t.

They did, however, use rats with vast differences in starting weights. This invalidates any conclusions that there were no significant differences in weight gain, feed intake, or organ weights between GM- and non-GM-fed groups. The starting weights in the Flavr Savr experiment ranged from 130 to 258 grams for males, and 114 to 175 grams for females. Contrast that with the hundreds of rat feeding trials conducted by Dr. Pusztai, where the starting weights were within a range of 1 or 2 grams.

Dr. Pusztai also pointed out that the experimental tomatoes were grown at different locations and harvested at different times, which further increases the variability of results.

The FDA’s defense that the bleeding stomachs did not come from the Flavr Savr diet was also an exercise in faulty science. They blamed the lesions on mucolytic agents in the tomato (i.e. components that dissolves thick mucus); but according to Dr. Pusztai, tomatoes are not known to contain mucolytic agents. The FDA also claimed that it might be the food restriction in the rats’ diet—but the rats ate as much as they wanted. Or maybe it was the animal restraint—but the rats were not restrained.

The explanation that stuck to the wall was that the process of force-feeding the tomatoes through tubes was the reason for the stomach lesions. But as Dr. Pusztai and FDA scientists both observed, there was no adequate explanation as to why the rats fed GM tomatoes in the earlier study had the higher rate of lesions.

Dr. Pusztai said the “study was poorly designed and executed and, most importantly, led to flawed conclusions.” He warned, “the claim that these GM tomatoes were as safe as conventional ones is at best premature and, at worst, faulty.”

Fortunately, the Flavr Savr tomatoes lacked flavor. They also got mushy (unless they were handled in such a way that the company spent more money getting them to market than it could sell them for). They were taken off the market by the time Monsanto bought Calgene in 1997.

After the Flavr Savr’s superficial review and controversial approval, no subsequent GMO producer has ever presented such detailed safety test data to the FDA.

Read Part 2 >

Throwing Biotech Lies at Tomatoes – Part 2: The Liars

I write about the Flavr Savr in Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods. Two biotech advocates, Drs. Chassy and Tribe, created a GMO disinformation site that allegedly discredits all 65 health risks highlighted in the work. I have already shown that their attack on the first risk, Dr. Pusztai’s potatoes, was based on pure PR spin and scientific sleight of hand. Below I respond to their accusations regarding the Flavr Savr.

1. (Chassy and Tribe) FDA records clearly show that experts stated that the process of introducing stomach tubes can damage the rats’ stomachs and/or end up placing test material in the lungs. . . The reader is not told that regulators approved the tomato because their concerns had been fully satisfied that the GM tomato was not toxic.

As indicated in Part 1, the actual scientists at the FDA wrote memo after memo declaring that the higher rates of lesions in the GM-fed group could not be explained away, and that they were not fully satisfied by the explanations. The discrepancy between what the political appointees at the agency stated publicly, and the concerns expressed in private memos by the scientific staff, has been clearly documented.

In fact, one memo reveals that during their Flavr Savr review, the FDA was making blatant and possibly illegal exceptions. One person wrote, “It has been made clear to us that this present submission [Flavr Savr] is not a food additive petition and the safety standard is not the food additive safety standard. It is less than that but I am not sure how much less.” According to attorney Steven Druker, who is an expert in US food safety law, the FDA’s own regulations clearly state that a lower standard should not have been applied in this instance.

As for the stomach lesions, without repeating the study with the same tomatoes, in the same concentration, with larger sample sizes, we can’t be confident that the GM line was the cause. But likewise, we can’t be confident that they were not. It’s another example of too few data.

2. No real differences were seen between groups of animals in the study. Contrary to Smith’s claims, expert pathologists stated that mild gastric erosions were seen at similar levels in both GM and non-GM fed rats.

This is quite a bizarre statement, given that seven female rats had stomach lesions in the first study, compared to none in the other feeding groups. Even the experimenters said that the results suggest a treatment-related effect. I guess if you completely ignore the main rat study in question, which apparently Chassy and Tribe would like us all to do, then you will not see significant differences. But putting blinders on to ignore inconvenient evidence does not prove safety or demonstrate good science.

3a. Rats might have been injured . . . by accidental administration of test material into the lung instead of the stomach.

3b. Gastric lesions can be caused by acidosis brought on by fasting.

Neither of these arguments address why 7 of 20 females fed GM tomatoes had lesions while the controls, reared under the same conditions, did not. Furthermore, since the rats did not fast but ate as much as they wanted, why would they throw in this irrelevant point (if not to obscure the truth)?

4. Smith is actually asking the reader to believe that the FDA would approve a lethal product.

Believe it! The FDA approves lethal products all the time. According to a report by the United States General Accounting Office, more than half of the drugs approved by the FDA between 1976 and 1985 had severe or fatal side-effects that had not been detected during the agency’s review and testing. In other words, after drug companies spent an estimated 12 years and $231 million dollars to research, test, and secure new drug approval through a very hands-on FDA approach, most of the drugs had to be taken off the market or required major label changes due to missed safety issues.

With GMOs, the situation is far more dangerous. The FDA doesn’t require a single study, the complex biology of GM crops may produce far more side-effects than drugs, GM foods are fed to the entire population, and they are not labeled or monitored, so symptoms are difficult or impossible to track.

5. There is no evidence of animal deaths. . . . Smith may have confused the words necrosis and dead cells with animal deaths. Careful reading reveals that the regulatory record does not mention any animal deaths which surely would have been of concern had they occurred. . . . This claim (in Pusztai and others 2003) appears to be blatantly untrue.

They would hope it was untrue. But just because they didn’t have access to the 44,000 documents made public from the lawsuit does not mean that the deaths did not occur. I can assure you they did, and that Dr. Pusztai, widely recognized as the world’s leading expert in his field and author of more than 300 studies, would not mistake dead cells for animal deaths.
In fact, on page 18 of the IRDC Report, it refers to “necroscopy data” on each animal. Necroscopy is an examination of a dead body, not dead cells.

The reason why the FDA scientists did not raise this issue is that they apparently either did not read the endnote, or simply accepted the unsupported conclusion on face value, which said that the necroscopy suggested that the deaths were due to a husbandry error and not test-article related. Even the Calgene scientists didn’t raise eyebrows at the finding. It wasn’t until a highly experienced animal feeding study expert like Dr. Pusztai reviewed the original papers that this oversight became apparent.

6. Interestingly, eating too many tomatoes can kill rats.

It is odd that Chassy and Tribe first claim that no rats died and then try to argue that if rats did die, tomato overdose could be the culprit. Since all the rats were fed under similar conditions, their killer-tomato argument fails to explain why 7 of 40 GM-fed animals died, compared to only 1 in the other groups.

7. These products are assessed carefully for safety before they are marketed, and—more importantly—there is no scientific reason to believe they pose and (sic) new or different risks.

To claim that there are no new potential health hazards from GMOs is absurd. Fran Sharples, the Director of the Board on Life Sciences at the US National Academy of Sciences (NAS), told me, “The academies have issued numerous reports on assessing the risks of transgenic plants. If the academy believed there were no such potential risks, why would we have delved into these matters in these reports?” One of those NAS reports even acknowledged that the current system of regulating GMOs might not detect “unintended changes in the composition of the food.”

The Royal Society of Canada stated that it is “scientifically unjustifiable” to presume that GM foods are safe and that the “default presumption” is that unintended, potentially hazardous side-effects are present. A WHO spokesperson said that current regulations are not adequate to determine the health effects; the Indian Council of Medical Research called for a complete overhaul of existing regulations; and the American Academy of Environmental Medicine called for a moratorium of GM foods altogether.

Since Chassy and Tribe are fond of using the FDA policy as support for their position, I am happy to quote Linda Kahl, an FDA compliance officer, who directly contradicts their ridiculous assertion. In a memo that summarized the position of FDA scientists about GMOs, she stated, “the processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks.”

What’s Chassy and Tribe’s real motive?

Many of the arguments presented by Chassy and Tribe are easily and completely countered by the evidence. If one were feeling especially generous, one might guess that they simply weren’t aware of the strong concerns voiced in quotes by FDA scientists, the incidence of stomach lesions in the first study, or the fact that the rats didn’t fast. But these points were contained within the very passage of Genetic Roulette that they were supposedly critiquing. If they actually read the book, which we must assume they did, then they absolutely knew that their counter-arguments were directly contradicted by FDA memos and study reports, and thus were utterly false.

Why then did they construct their website in the first place? It appears that they are not really motivated to make cogent scientific counter-arguments, but instead are hoping that the readers blindly accept their baseless condemnation of Genetic Roulette and never actually read the book.

This tactic is similar to other techniques used by the biotech industry that I describe in Genetic Roulette. GMO advocates, for example, often write up lengthy studies or reports that hardly anyone ever reads in detail. Instead, people generally look at the abstract and/or conclusion and accept the authors’ declaration that the findings demonstrate GMO safety. But when an expert actually takes the time to go through the details, he or she discovers that the conclusions are entirely unsupported and unjustified. In some cases, they are in direct opposition to the data.

It took the biotech industry three years to create their so-called academic review of Genetic Roulette. The mere fact that after all that time they could not put together even the most basic scientific arguments is a tribute to the authenticity of the book. If they could have used science to counter it, they would have. But they didn’t. They used spin.

It will continue to be my delight to go through each of their pages to expose their “scientific” sleight-of-hand. But I am much more motivated to spend my time taking steps that will end the genetic engineering of the food supply, rather than trying to convince the handful of people who accidentally wander onto Chassy and Tribe’s disinformation site. So have patience.

GE Salmon? Are You Out of Your Minds?!

No Frankenfish! Act Now

To help stop GE salmon, please sign petitions to the food industry and Congress.

Has the FDA gone completely mad? Why are they trying to open the flood gates to genetically engineered (GE) salmon—a move that will go down in history as one of the most asinine and dangerous ever made by our government? What’s it going to take for them to actually start protecting public health?

Frankenfish can promote disease

The FDA is reviewing data submitted by AquaBounty, the company that spliced a growth hormone gene into Atlantic salmon, forcing it to grow up to five times faster, and reach market size in about 18 months instead of 3 years. But according to the evidence, their buff salmon might have higher levels of a cancer promoting hormone IGF-1, more antibiotics, and more of a potentially life-threatening allergen(s).

The FDA failed to learn their lesson with their idiotic approval of genetically engineered bovine growth hormone. It also has higher levels of IGF-1 and more antibiotics. Now it’s condemned by the American Public Health Association and the American Nurses Association, banned in most other countries, and has been banished by most US dairies. Even Wal-Mart won’t allow the stuff into their milk.

The GE soy and corn on the market, which the FDA continues to pretend is just the same as the natural stuff, also has higher levels of allergens, and has been linked to numerous disorders. Now the American Academy of Environmental Medicine condemned genetically modified organisms (GMOs) and urged all physicians to prescribe non-GMO diets. “GMO-Free” is one of the fastest growing health claims among US brands for the past two years, and a tipping point of consumer rejection of all GE ingredients appears to be just over the horizon.

Then there is the threat of Frankenfish escaping into the wild. Here too, the FDA ignores the lessons from GE crops which, in spite of early assurances to the contrary, have been contaminating non-GE crops and wild relatives all over the world for more than a decade. Their self-propagating genetic pollution is irreversible; it can outlast the effects of global warming and nuclear waste. But somehow escaped GE salmon carry an even greater hazard.

Frankenfish can wipe out natural salmon

According to a Purdue University computer model that tracked the effects of releasing just 60 Frankenfish (not salmon) into a population of 60,000, there was a shocking complete extinction in just 40 fish generations. Apparently their bigger size, which attracted mates more easily, combined with a slight reduction in survival rates, was a killer combination.

Canadian scientists engineered their own set of fast growing salmon and tested their behavior in tanks with other fish. When there was sufficient food, all was fine. When food stocks decreased, the Frankenfish freaked. They became cannibals, attacking and killing other fish—whether GE or natural. Their unexpected behavior resulted in population crashes or complete extinctions in the fish tanks. The study also suggested that if released, these ravenous aggressive salmon would pursue and consume other types of fish.

I’m not sure which scenario is worse: The complete extinction of salmon, or gangs of voracious mutant freaks scouring the ocean, attacking anything that can feed their rapidly-expanding, always-hungry bodies. (Heck, let’s just give the fish automatic weapons.)

Never mind that the GE AquAdvantage salmon are supposed to be grown in inland tanks and are supposed to be sterile. In reality, they won’t all be sterile; and there are numerous ways that these salmon, whose eggs will regularly be shipped from Prince Edward Island, Canada to growing tanks in Panama, can escape into the ocean. It only takes one!

Corporate interests and politics run the FDA show

US consumers have been clear for years that we don’t want Frankenfish, Frankenpigs, Frankenmosquitoes, Frankenanything that walks, flies, slithers, or swims. And most Americans are now uneasy about the Frankencrops already growing in our fields. So who is clamoring for GE salmon? Who’s getting the FDA to push open the doors to GE animals against public opinion?

Thank you Union of Concerned Scientists for the answer. Your September 12th survey of 1710 FDA employees explains who is really driving the bus at the agency. One staff member said, “Food safety has succumbed to the higher priority of global corporate profits.” In fact, 38 percent of respondents agreed or strongly agreed that “public health has been harmed by agency practices that defer to business interests.”

Another employee points to political interference: “I have been here for 26 years and it still amazes me . . . how politics filter down to the lowest levels of government.”

So its corporate profits and politics. Anyone surprised? About 1 in 4 surveyed admit that they had personally experienced, either frequently or occasionally, “situations where corporate interests [or members of Congress, or special interests] have forced the withdrawal or significant modification of [an agency] policy or action designed to protect consumers or public health.”

If there is one face that best captures the FDA’s conflict-of-humanity’s-interest, it would be Michael Taylor. Taylor is the US Food Safety Czar. You’d think that if there were significant safety concerns about the GE salmon, our Czar would step in to preserve and protect. Don’t count on it.

Back when the first Bush White House had instructed the FDA to promote biotechnology, the agency created a special position for Taylor to be in charge. He had been the outside attorney for biotech giant Monsanto, where he had dreamed up a regulatory facade that would allow GMOs to be brought to market with maximum speed and minimum oversight. Then he took a position with the FDA where he could apparently implement it himself. His GMO policy falsely claimed that the agency was unaware of information showing GM foods to be different. On that basis, no testing or labeling was required. Years later, 44,000 documents made public from a lawsuit revealed that the consensus among FDA’s own scientists was that GM foods were unsafe, and should be carefully tested for allergies, toxins, new diseases, and nutritional problems.

Soon after leaving the FDA, Michael Taylor went to work as Monsanto’s vice president.

So the person who lied about GMO safety to push them on the market now sits above the folks that are looking at GE Salmon. Not a comforting thought.

Stacking the deck for approving salmon

How else does corporate influence play out in the current FDA debacle?

Consider Alison L. Van Eenennaam. She too used to work for Monsanto, and now has been added as a temporary voting member on the committee that advises the FDA about the salmon. She also advises the USDA and promotes GE animals on Youtube.

Kevin G. Wells was also added as a temporary voting member for salmon. He works at Revivicor, a company that genetically engineers pigs. Do you suppose there is any conflict of interest for him establishing an easy ride for GE animal approvals? Perhaps.

Gregory Jaffe was also imported into the committee as their supposed consumer advocate. In reality, he is with the pro-GMO Center for Science in the Public Interest (CSPI), an organization that consistently ignores the mounting evidence of adverse health impacts from GE crops. Jaffe even filed a complaint to the FDA in 2001 complaining of companies that label their products as non-GMO. What further qualified Jaffe for his committee position was his published article Questions About Genetically Engineered Animals, where he touts the environmental benefits of AquAdvantage salmon.

The engineered bias of the FDA advisory committee is made even more clear by who is absent. There are no experts on allergies or hormones who can address the possible health damaging effects of the fish, and no fish ecologists who can figure out whether our grandchildren will live in a world without wild salmon.

Institutionalized stupidity

But even before the committee was picked, the deck was stacked in favor of approvals. In 2008, the Bush administration rolled out a policy in which GE animals would be approved as if they were animal drugs. This latest square peg is part of a continuing effort to regulate GMOs without asking Congress to pass any new laws. So, since 1992, the government has been jerry-rigging inadequate pre-existing laws to handle the unique and complex safety and environmental considerations of genetically engineered organisms.

Even if GE animals weren’t infinitely more complex than some drug compound, using the FDA drug approval process shouldn’t give us great confidence. Between 1976 and 1985, for example, more than half of their drug approvals turned out to have lethal or serious side effects, forcing withdrawal or added label warnings. Try conducting a recall of GE salmon from the ocean.

Failing grades all around

Even with stacked committee membership, an antiquated approval policy, and an agency that is officially mandated to promote biotechnology, the Frankenfish did not swim past the advisory committee on September 19th and 20th. That’s because the committee agreed with safety experts like Dr. Michael Hansen of the Consumers Union (they publish Consumer Reports) that the evidence presented by AquaBounty was abysmal and insufficient. Using a sample size of only 6 fish, employing insensitive detection methods that could easily miss cancer-promoting hormones or allergens, and testing fish that were raised in a completely different climate than what is planned, were among the sloppy science that the FDA had accepted. (See addendum below for examples.)

In fact the only person on the committee who had any experience with fish, Gary Thorgaard, completely disagreed with the FDA’s conclusion that the Frankenfish didn’t threaten the environment. He called for a full Environmental Impact Statement.

Hansen says, “The data and analysis of food safety risks from the AquAdvantage Salmon are so sloppy and inadequate that, if this were an undergraduate paper, it would get a failing grade.  No self-respecting scientist could conclude that these data demonstrate that AquAdvantage salmon are safe to eat.”

Thus, in spite of the fact that the company had been submitting data to the FDA for more than ten years, the advisory committee concluded that the evidence was insufficient to conclude that GE salmon was safe for the environment and for human health. They told AquaBounty to go back and to do more testing.

I propose a different recommendation. This little exercise made it perfectly clear that AquaBounty is either completely incompetent to evaluate the safety of their own creation, or they’re intentionally hiding evidence. In either case, let’s not send the same folks back to do more research, hoping they’ll get it right. Instead, tell these jokers that they have proved to the world that they are never ever ever to be trusted with the future of salmon or the safety of the human food supply.

And what about the FDA—the brain cell behind the Don’t-ask-don’t-tell food safety assessments? They have again demonstrated that they too are not competent to protect the public from the unique unpredictable dangers of genetically engineered foods.

If you want to GE salmon stopped for good, now is the time to raise your voice. Since the FDA has been ignoring US citizens in favor of business interests and politics, please join me in inviting the food industry and Congress to stop in and stop this madness. Go to our action alert pages to sign the petitions today.

. . .

Addendum: How Not to Do a Food Safety Assessment

The FDA’s evaluation of GE salmon is the first of its kind. Because it will set a precedent for all future GE animal approvals, the bar should be set very high. According to Dr. Michael Hansen, who testified at the FDA advisory committee meeting on behalf of Consumers Union, the FDA set the bar a foot off the ground.

When AquaBounty looked for potentially dangerous growth hormones in the salmon, for example, they used a detection method so insensitive, it couldn’t find any hormones in any fish. The FDA therefore concluded that there was no relevant difference in hormone levels in GE salmon. Dr. Hansen told the committee, “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.”

Because the company also used an insensitive test to measure cancer-promoting insulin-like growth hormone factor one (IGF-1), levels were detected in only a few fish. Of these, the GE salmon was 40% higher. Again, insufficient data combined with faulty reasoning allowed the FDA to conclude that IGF-1 from GE salmon is not a problem.

Even then, these test results were not from the type of GE salmon that the company plans to market. Instead, the tests were conducted on the GE salmon variety that will produce the fish eggs in Canada. The DNA of these “egg-layers” have the normal two sets of chromosomes (diploid). The GE salmon to be grown from their eggs in Panama, however, end up with three sets of chromosomes (triploid)—so that most will be sterile. It’s the Panama-grown triploid variety that will go onto our dinner table if the FDA has their way. So what was the response by the FDA and AquaBounty when asked for the IGF-1 levels of the actual fish (raised in the actual conditions) that people would actually eat? “Well…er….uhm…we’ll get back to you.”

The situation with allergies is worse. According to Hansen, the tests conducted by AquaBounty confirmed that “the act of genetic engineering did lead to an increase in allergenic potency.” In fact, when the flesh from egg-laying (diploid) fish was exposed to the blood (sera) of people who are allergic to salmon, there was a whopping 52% increase in reaction levels. Furthermore, the specific allergen that had increased in the Frankenfish was not supposed to be affected. It did not come from the inserted gene. Rather, the increase in this potentially life-threatening allergen was just one of the unpredictable side-effects that can result from the process of genetic engineering itself.

The FDA decided this time to ignore this troublesome finding, since it was from the egg-laying diploids. The company did test the allergic reaction to the triploids (the ones we’ll eat), but used fish that were raised in Canada, not Panama. This should have disqualified the fish study, according to Hansen, since the composition of GE salmon can obviously be affected by water temperature, and growing conditions. Still, the Canadian raised Frankenfish still elicited an allergic response level that was 20% higher than normal salmon. But the FDA dismissed this figure since it was not statistically significant and concluded that the GE salmon was safe to eat. But of course it wasn’t statistically significant. They used just six fish in the sample size! The easiest way to prevent statistical significance is by using a pathetically small number of subjects in your experiment. Hansen said:

“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.”

Thank you Dr. Hansen for helping to protect us from the bungling Frankenfish promoters. Let’s hope they will listen.

Don’t forget to sign the petitions to the food industry and Congress.

International bestselling author and filmmaker Jeffrey M. Smith is the executive director of the Institute for Responsible Technology. His first book, Seeds of Deception: Exposing Industry and Government Lies About the Safety of the Genetically Engineered Foods You’re Eating, is the world’s bestselling and #1 rated book on GMOs. His second, Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods, documents 65 health risks of the GM foods Americans eat every day. Both are distributed by Chelsea Green Publishing. To help you choose healthier, non-GMO brands, use the Non-GMO Shopping Guide.

Action Alert: Rise Up Against GE Salmon

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Jeffrey Smith, author of Seeds of Deception, stops by UW Radio to discuss the FDA’s pending approval of genetically modified salmon. Sean and Jeffrey will be addressing the dangers of consuming GMO foods, how GMO foods adversely affect the small farming community, and the many reasons we should all say NO to GMO salmon. Jeffrey’s book is available in theUW Store! Hosted by Sean Croxton ofUndergroundwellness.

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