What the FDA Isn’t Telling Us About GE Salmon
By Tim Schwab
In September 2010, the U.S. Food and Drug Administration (FDA) appeared primed to approve AquaBounty’s genetically engineered (GE) salmon, the hormone-enhanced fish that, nevertheless, can’t live up to its fast-growth hype. Trumpeting unprecedented transparency, the FDA released to the public hundreds of pages of the agency’s favorable risk assessment, along with an announcement of a days-away public meeting in Rockville, Maryland. The extremely short timeline seemed designed to limit public participation and independent criticisms of the FDA’s scientific work, as few people could drop everything and rush to Maryland.
On the Friday before Christmas 2012, the agency that protects 80 percent of our food supply gave us an encore performance. On a day when few people are at work and many are making plans for extended vacations, the FDA issued its environmental assessment, a 160-page document that basically regurgitates verbatim the agency’s weak 2010 assessment. This moves AquaBounty’s GE salmon within one step of full approval.
The FDA’s risk assessments are noteworthy, not for what they do tell us, but for what they don’t. Instead of scrutinizing the flawed science, limited data, examples of bias and lingering safety concerns that independent scientists have highlighted, the FDA continues to treat its risk assessment as an exercise in churning out the Frankenstein refrain: GE salmon. Safe. Good.
On food safety, the agency only looked at a handful of fish, which exhibited 50 percent higher rates of allergenicity and 40 percent higher rates of a growth hormone linked to cancer in humans. The FDA played with the data to show the differences weren’t “statistically significant,” even though an independent statistician invited by the FDA called the agency’s analysis woefully flawed.
The FDA is also failing to address AquaBounty’s track record of dangerously lax stewardship, which should trigger questions about the likelihood of GE salmon escapes from their facilities. In a 12 to 15-month period between 2008 and 2009, AquaBounty appears to have lost most of its GE salmon to mechanical failures, falling trees, unusual storms and disease.
AquaBounty’s grow-out facility in Panama experienced a devastating storm in 2008, which led the company to report to their shareholders that GE salmon were “lost.” Initially, AquaBounty said the “unusually severe storm” caused a mechanical failure, then later said a tree fell on the facility and the “lost” fish actually died. The FDA has never publicly acknowledged or verified this.
Within about a year of this calamity, AquaBounty’s other experimental facility—in Canada—was being ravaged by deadly disease called infectious salmon anemia virus (ISAV). How it got into AquaBounty’s facilities is a question that, conveniently, remains unasked and unanswered by the FDA. What we do know is that AquaBounty began voluntarily killing most of its broodstock.
Though the catastrophic ISAV outbreak occurred in 2009, the FDA didn’t mention it in its 2010 risk assessment or public meeting. More galling, when AquaBounty’s president spoke at the 2010 meeting, he criticized his competitors—Chilean, English, Scottish and Norwegian salmon growers—for ISAV outbreaks at their facilities. He didn’t mention his own company’s struggles with ISAV.
But what is perhaps most suspect about FDA’s risk assessment is the agency’s failure to verify that GE salmon can actually do what AquaBounty says they can do: grow fast. Many salmon growers and scientists have now labeled GE salmon’s purported growth-rates as little more than hype, with one grower openly challenging AquaBounty.
The flawed scientific work by the FDA on GE salmon sets an extremely dangerous precedent for the future of our food system. The pro-biotech bent at the FDA shouldn’t be terribly surprising given that the agency’s policy makers on GE have historically come from the biotech industry. The Obama administration, likewise, isn’t immune to the half-billion dollars in campaign contributions and lobby money spent by the biotech industry in the last decade. It also isn’t terribly surprising that the FDA waited to issue this controversial risk-assessment until after the election.
Your members of Congress need to know that the FDA has dropped the ball on GE salmon, a dangerous fish that consumers don’t want to eat, growers don’t want to produce, and society doesn’t need. You can also tell the FDA directly to stop the experiment.
Visit EcoWatch’s GENETICALLY MODIFIED ORGANISM page for more related news on this topic.
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EcoWatch Daily Newsletter
By Brian Bienkowski
Fish exposed to endocrine-disrupting compounds pass on health problems to future generations, including deformities, reduced survival, and reproductive problems, according to a new study.
Low Levels Lead to Generational Impacts<p>Researchers exposed inland silverside fish to bifenthrin, levonorgestrel, ethinylestradiol, and trenbolone to levels currently found in waterways.</p><p>"Our concentrations were actually on the low end" of what is found in the wild, DeCourten said, adding that it was low amounts of chemicals in parts per trillion.</p><p>Bifenthrin is a pesticide; levonorgestrel and ethinylestradiol are synthetic hormones used in birth controls; and trenbolone is a synthetic steroid often given to cattle to bulk them up.</p><p>Such endocrine-disruptors have already been linked to a variety of health problems in directly exposed fish including altered growth, reduced survival, lowered egg production, skewed sex ratios, and negative impacts to immune systems. But what remains less clear is how the exposure may impact future generations.</p><p>For their study, DeCourten and colleagues started the exposure when the fish were embryos and continued it for 21 days.</p><p>They then tracked effects on the exposed fish, and the next two generations.</p>
Inherited Problems<p>DeCourten said the altered DNA methylation is one of the plausible ways that future generations would experience health impacts from previous generations' exposure. Hormone-disrupting compounds have been shown to impact DNA methylation, which is an important marker of how an organism will develop.</p><p>"Methyl groups are added to specific sites on the genome, [the exposure] is not changing the genome itself, but rather how the genome is expressed," she said. "And that can be inherited throughout generations."</p><p>In addition, Brander said there are essentially different "tags" that exist on DNA molecules, which tell genes how to turn on and off. She said the exposure to different compounds may be "influencing which methyl tags get taken on or off as you proceed through generations."</p><p>The researchers said the study should prompt future toxics testing to consider impacts on future generations.</p><p>"The results … throw a wrench in the current approach to regulating chemicals, where it's often short-term testing looking at simple things like growth, survival, and maybe gene expression," Brander said.</p><p>"These findings are telling us we really at least need to consider" the next two generations, she added.</p>
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By Laura Beil
Consumers have long turned to vitamins and herbs to try to protect themselves from disease. This pandemic is no different — especially with headlines that scream "This supplement could save you from coronavirus."
Vitamin D<p><strong>What it is: </strong>Called "the sunshine vitamin" because the body makes it naturally in the presence of ultraviolet light, <a href="https://www.sciencenews.org/article/vitamin-d-supplements-lose-luster" target="_blank">Vitamin D is one of the most heavily studied</a> supplements (<em>SN: 1/27/19</em>). <a href="https://health.gov/our-work/food-nutrition/2015-2020-dietary-guidelines/guidelines/appendix-12/" target="_blank">Certain foods</a>, including fish and fortified milk products, are also high in the vitamin.</p><p><strong>Why it might help: </strong>Vitamin D is a hormone building block that helps strengthen the immune system.</p><p><strong>How it works for other infections:</strong> In 2017, the <em>British Medical Journal</em> published a meta-analysis that suggested a daily vitamin D supplement <a href="https://www.bmj.com/content/356/bmj.i6583" target="_blank">might help prevent respiratory infections</a>, particularly in people who are deficient in the vitamin.</p><p>But one key word here is <em>deficient. </em>That risk is highest during dark winters at high latitudes and among people with more color in their skin (melanin, a pigment that's higher in darker skin, inhibits the production of vitamin D).</p><p>"If you have enough vitamin D in your body, the evidence doesn't stack up to say that giving you more will make a real difference," says Susan Lanham-New, head of the Nutritional Sciences Department at the University of Surrey in England.</p><p>And taking too much can create new health problems, stressing certain internal organs and leading to a dangerously high calcium buildup in the blood. The recommended daily allowance for adults is 600 to 800 International Units per day, and the upper limit is considered to be 4,000 IUs per day.</p><p><strong>What we know about Vitamin D and COVID-19:</strong> Few studies have looked directly at whether vitamin D makes a difference in COVID.</p>
Zinc<p><strong>What it is: </strong>Zinc, a mineral found in cells all over the body, is found naturally in certain meats, beans and oysters.</p><p><strong>Why it might help: </strong>It plays several supportive roles in the immune system, which is why zinc lozenges are always hot sellers in cold and flu season. Zinc also helps with cell division and growth.</p><p><strong>How it works for other infections: </strong><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6457799/" target="_blank" rel="noopener noreferrer">Studies of using zinc for colds</a> — which are frequently caused by coronaviruses — suggest that using a supplement right after symptoms start might make them go away quicker. That said, a clinical trial from researchers in Finland and the United Kingdom, published in January in <em>BMJ Open</em> <a href="https://bmjopen.bmj.com/content/10/1/e031662" target="_blank" rel="noopener noreferrer">did not find any value for zinc lozenges</a> for the treatment of colds. Some researchers have theorized that inconsistencies in data for colds may be explained by varying amounts of zinc released in different lozenges.</p><p><strong>What we know about zinc and COVID-19:</strong> The mineral is promising enough that it was added to some early studies of hydroxychloroquine, a drug tested early in the pandemic. (Studies have since shown that <a href="https://www.sciencenews.org/article/covid-19-coronavirus-hydroxychloroquine-no-evidence-treatment" target="_blank">hydroxychloroquine can't prevent or treat COVID-19</a> (<em>SN: 8/2/20</em>).)</p>
Vitamin C<p><strong>What it is: </strong>Also called L-ascorbic acid, vitamin C has a long list of roles in the body. It's found naturally in fruits and vegetables, especially citrus, peppers and tomatoes.</p><p><strong>Why it might help:</strong> It's a potent antioxidant that's important for a healthy immune system and preventing inflammation.</p><p><strong>How it works for other infections: </strong>Thomas cautions that the data on vitamin C are often contradictory. One review from Chinese researchers, published in February in the <em>Journal of Medical Virolog</em>y, looked at <a href="https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.25707" target="_blank">what is already known about vitamin C</a> and other supplements that might have a role in COVID-19 treatment. Among other encouraging signs, human studies find a lower incidence of pneumonia among people taking vitamin C, "suggesting that vitamin C might prevent the susceptibility to lower respiratory tract infections under certain conditions."</p><p>But for preventing colds, a 2013 Cochrane review of 29 studies <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD000980.pub4/full" target="_blank" rel="noopener noreferrer">didn't support the idea</a> that vitamin C supplements could help in the general population. However, the authors wrote, given that vitamin C is cheap and safe, "it may be worthwhile for common cold patients to test on an individual basis whether therapeutic vitamin C is beneficial."</p><p><strong>What we know about Vitamin C and COVID-19: </strong>About a dozen studies are under way or planned to examine whether vitamin C added to coronavirus treatment helps with symptoms or survival, including Thomas' study at the Cleveland Clinic.</p><p>In a review published online in July in <em>Nutrition</em>, researchers from KU Leuven in Belgium concluded that the <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD000980.pub4/full" target="_blank" rel="noopener noreferrer">vitamin may help prevent infection</a> and tamp down the dangerous inflammatory reaction that can cause severe symptoms, based on what is known about how the nutrient works in the body.</p><p>Melissa Badowski, a pharmacist who specializes in viral infections at the University of Illinois at Chicago College of Pharmacy and colleague Sarah Michienzi published an extensive look at all supplements that might be useful in the coronavirus epidemic. There's <a href="https://www.drugsincontext.com/can-vitamins-and-or-supplements-provide-hope-against-coronavirus/" target="_blank" rel="noopener noreferrer">still not enough evidence to know whether they are helpful</a>, the pair concluded in July in <em>Drugs in Context</em>. "It's not really clear if it's going to benefit patients," Badowski says.</p><p>And while supplements are generally safe, she adds that nothing is risk free. The best way to avoid infection, she says, is still to follow the advice of epidemiologists and public health experts: "Wash your hands, wear a mask, stay six feet apart."</p>
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