Biotech Encounters

By Keith Kloor | February 28, 2013 10:46 am

Science journalist Emily Anthes has a book coming out in March that I’m eager to read.

Great title, cool cover!

Virginia Hughes recently talked with Anthes about her book. Here’s an excerpt from that interview:

VH: I want to start with the AquAdvantage salmon, the genetically modified fish that grow super fast. When you wrote about them in the book, the FDA was still — after 17 years! — making up its mind about whether it would allow the fish to be sold as food. Finally, at the end of December, the agency issued a draft document declaring AquAdvantage safe, and we’re now nearing the end of the 60-day public comment period.

So, if the approval happens, what would it mean for the U.S. biotech industry? Why is this fish such a big deal?

EA: The short answer is that this fish is much more than just a fish — it’s a test case. If the fish are approved, they’ll be the first transgenic animals approved as consumer products in the U.S. (The FDA has approved a pharmaceutical that is extracted from the milk of genetically modified goats, but the AquAdvantage salmon would be the first whole GE animals cleared for human consumption.)

Many, many researchers and entrepreneurs who are interested in animal biotechnology are watching this case very closely. If the fish, which have been politically controversial, are approved, it means that good science can still triumph over politics. If they’re not approved, it will send the opposite message, discouraging further research and innovation in all sorts of promising biotech applications.

Check out the rest of  Q & A here.

CATEGORIZED UNDER: biotechnology, science, Uncategorized
MORE ABOUT: biotechnology, science
  • http://twitter.com/mem_somerville mem_somerville

    I’m certainly looking forward to this. I’ll have to gear up for the book tour comment threads around the country I expect too :)

    Anyone wanna bet on how long it takes for “Monsanto” to show up on the Amazon reviews page?

    • jh

      yummm!! Monsanto Lab Burgers! Delicious meat grown from pure, natural molecular slime in all natural hand made petri dishes!

      • facefault

        In vitro meat is a great idea. It’d free up lots of farmland, be less prone to contamination, and (after the start-up costs) be a lot more efficient than growing whole animals.

        Every attempt thus far has been disgusting and prohibitively expensive, of course. But it’s not like Norman Borlaug’s work happened overnight.

        • jh

          Today I heard an add on NPR (I call them adds) from the Dairy Farmers of Washington. They want us to know they’re making the extra effort to provide fresh bedding for the cows so the cows are always comfortable. I think a genuine Native American hand made petri dish would ensure that the lab meat is grown in a comfortable environment.

    • dogktor

      The Monsanto octopus: http://www.dna.com/newsroom

  • dogktor

    Many, many researchers and entrepreneurs who are interested in animal biotechnology are watching this case very closely. If the fish, which have been politically controversial, are approved, it means that good science can still triumph over politics.

    I spent a couple of hours reading over the notesof the VMAC meetings, and I failed to find the good science. http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm280853.htm What I found instead is a regulatory agency which is attempting to regulate the growth hormone as a new animal drug, which for a veterinarian is an anguishing exercise in mental gymnastics. The animal ( fish) doesn’t need the drug, because acquiring the drug also means acquiring triploidy ( biological containment method) leading to ulcerative jaw lesions, heart /gill/ fin anomalies, abnormal levels of hemoglobin carried in anomalous red cells ( requiring higher oxygenation of the water) and aberrant glucose levels. From the animal welfare standpoint this animal will thus suffer during its shortened lifespan.
    If the new animal drug is designed for animals and people, I failed to find the science on the benefits nor four phases of clinical trials to convince me of this new animals’ drug benefit and safety, and thus conclude that the benefit to risk ratio is decidedly skewed against the new fish drug.
    Ecologically speaking the jury is still out depending on whether you buy the Trojan gene hypothesis or not.
    On a practical level, it will remove an important tool in my toolbox for dealing with allergic pets, in whom elevated omega 3 fatty acids are important as an anti-inflammatory agent.

    Given the classical sloppy safety studies, composed of a statistically under-powered number of fish with multiple confounding factors, atypical culling procedures– it is impossible to state with any degree of medical certainty that the fish is not allergenic, nor that the new fish drog doesn’t carry elevated levels of IGF1 I; a possible emerging carcinogen, given its presence in rBST -milk).
    The CAFO- like conditions of confinement will likely elevate the new animal-drug’s cortisol levels, and I suspect given multiple statements on this animal-drug’s lack of fitness ( the only silver lining if the animal drug is to escape) –it will required regular doses of antibiotics/ antifungals typically used with livestock raised in high density stressful unnatural conditions, which along with infectious agents ( ISAV) will be rinsed out in the effluent into our already polluted bodies of water. In conclusion, after reading over 500 pages of notes, the big picture perspective is that people engaged in these mental gymnastics are articulate nuts. If someone knows where the bus station is in this Brave New World of genetically engineered trout/telapia/ shrimp/ crab/tuna/ spiders/spider goats and mosquittoes, this one individual really wants to get off.

    • jh

      “a regulatory agency attempting to regulate the new animal drug through reductionist mental gymnastics to the growth hormone- transgene construct in isolation of the whole fish”

      Wow. That’s a great sentence. What does it mean?

      • dogktor

        I am sorry JP for that awkward sentence. I tried to stuff a bunch of concepts into one sentence and failed.
        So….the FDA is regulating the transgene constructed with an antifreeze promoter (split in 2) and the growth hormone as a new animal drug.

        The FDA is not regulating triploidy, which is evidently used in conventional aquaculture and is used by Aquabounty to induce sterility in case the animal-drug escapes. In fairness, the company invested a great deal of time and effort to create a redundant security system, and triploidy is the biological component.

        So, if someone asked you a very narrowly focused literal question: is the transgene safe to eat?” is the transgene allergenic? You would have to answer yes and no, respectively. There is nothing inherently unsafe about the GH. You could probably eat it and drink it without any adverse effects because it is digested. If you injected it, or maybe snorted it ( which might allow a small portion to be absorbed)it would be different. But this new animal drug will be eaten in a triploid fish, which the FDA is not regulating.

        So, how do you wrap your brain around the issues and separate the effects of the transgene from the effects of triploidy in a living organism, which is not a modular system into which you can snap in independent components without affecting the organism? The animal is not a car. Snapping in a new battery or installing a tire on a car will not alter the item in complicated synergistic/ antagonistic/ upredictable ways, unlike snapping in a transgene and snapping in triploidy and then trying to extrapolate the effects of each independent of the other.

        And yet, that is what the FDA is doing– the data in the safety studies was often based on diploid transgenic fish, while the fish which would be marketed will be a triploid.

        The other reason that the word reductionist seemed like a good one ( rightly or wrongly) is that when you reduce a complex question to a small limited one, you start losing the forest for the trees. There are bioethical animal welfare questions which were not on the table ( among others). I know that rapid growth can lead to painful disorders. We see this in our giant breed dogs when they are going through growth spurts often referred to by lay people as growing pains. We know that assessing pain and distress in animals, even ones we know very well and live with on a daily basis, is very difficult because they are stoic, because they don’t conceptualize pain and because they often hide discomfort and distress to avoid being picked on and killed. So, how do you assess pain and distress in a fish? The only indirect way I know of is by measuring cortisol levels, which were not done, because social, economic and bioethical questions are not in the FDA purview.

        Hope that makes more sense.
        Thanks.

        • jh

          Dogktor,

          Wow again! Thanks for the explanation. I’d have to look up triploidy again to get to the details of your concerns, but I get the gist of it.

          I see how your concerns with animal welfare conflict with this, er, product, if you will. I’m not sure I share your concerns with unintended consequences. And, although I’m certain that many animals have much more intellectual and emotional depth than we give them credit for, I’m not that worried about growing pains affecting a fish.

          I think a common feature of products like this is that, once their in production, they can be improved, both to the benefit of the animal and the consumer.

  • Nullius in Verba

    I’d like to thank Dogktor for the links, which enabled a pleasant morning reading through some of the science on the transgenic salmon. For those who don’t have the patience, I thought a quick summary of some of the highlights might be interesting.

    What they did was to take the gene for a growth hormone from a Chinook salmon (which we already eat) along with regulatory genes for the anti-freeze protein in Atlantic pout (another fish that we already eat) and insert them into a non-coding region of the Atlantic salmon genome (that was confirmed). The change is inherited, so the bacterial plasmids they used to insert the gene are not found in any animal used for food, only the descendants. (They checked for fragments of the bacterial carrier too and didn’t find any.)

    To ensure breeding is entirely under their control, they use two standard methods that are already used in commercial fish farming. (These actually sound somewhat more disturbing than the genetic engineering bit, but nobody is interested in making trouble for non-GE farming.) One is that all the breeding stock are female – they then turn some of them into males using hormones (called ‘neomales’). But because they don’t have the right sort of genitals, the only way for the sperm to get out is to kill the fish and take them from the body. These are then used to fertilise non-GE salmon eggs, which grow up to become the animals actually used for food.

    The other measure is to use high pressure to induce triploidy – a genetic abnormality in which the animal has three copies of each chromosome (two non-GE and one from the GE neomale ‘father’). The eggs are tested to ensure at least 95% of the animals are triploid. (This, incidentally, is the reason they also tested diploid GE fish for safety, since a few of the fish might be.) The process renders the animals sterile, but it does apparently increase the rate of minor birth defects from around 5% to a considerably higher and very variable number. The numbers are very peculiar, varying far more from sample to sample than would be expected from the sample sizes. This indicates that other causes of deformities exist that apply to a whole batch systematically, and that change from year to year. Whatever the cause of that may be, the incidence of the most severe deformities hovers around 1%, and seems mostly associated with the triploidy. Mortality is the same.

    (I get the impression that they’d have likely used these control methods anyway, even without the requirements of GE security, to help protect their IPR – it is apparently a standard process used for non-GE breeds too.)

    It’s worth noting that the weakest fish are routinely culled as part of normal commercial practice to control the numbers and improve the quality, so the sampling is potentially biased. However, that reflects more accurately what would happen in practice, and was done to both GE and non-GE populations equally.

    There are a few real differences noted, such as an increase in spinal deformities and jaw infections, that are associated with the growth gene, but they’re basically lost in the noise of what gets done to farmed fish generally.

    The other thing they looked at was the food safety aspect. For the growth hormone itself and most of the substances on the same metabolic pathway, they confirmed that levels were within the same ranges found in salmon generally. The only one they weren’t sure about was IGF1, for which they did a additional study to show it would only increase human exposure by about 0.3%, if the average level was presumed to be the peak level observed and someone ate silly amounts of it.

    The other result they raised some minor objection to about was the allergen test, which the company apparently messed up. It was shown that the triploid form had no more allergen than normal non-GE salmon, but the diploid form (which might constitute up to 5% of the population) might have a 40% higher allergen load. The difference is barely detectable with the small sample sizes, though, and could be due to a couple of outliers. I’d say the test result wasn’t statistically significant, but they say more testing should be done if in future they decide to stop using triploidy to sterilise the fish.

    If you are allergic to salmon you’ll be allergic to GE salmon, but you’ll be avoiding salmon anyway, so what difference does it make?

    Again, there were a few minor differences in nutrition found, but nothing that poses a significant risk.

    My overall conclusion was that the sample sizes and tests were weaker than one would ideally like, but as they say, it would be hard to produce better tests without going to commercial levels of production, which of course they’re not allowed to do, even if that was financially viable.

    No evidence of any significant risk has been found, and there’s no obvious reason to expect one. The most likely sources of potential risk have been examined and come up blank. It’s all well within the risk range we normally tolerate for other foods. However, there’s certainly still plenty of scope for surprises, as there is in life generally.

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About Keith Kloor

Keith Kloor is a NYC-based journalist, a senior editor at Cosmos magazine, and adjunct professor of journalism at New York University. His work has appeared in Slate, Science, Discover, and the Washington Post magazine, among other outlets. From 2000 to 2008, he was a senior editor at Audubon Magazine. In 2008-2009, he was a Fellow at the University of Colorado’s Center for Environmental Journalism, in Boulder, where he studied how a changing environment (including climate change) influenced prehistoric societies in the U.S. Southwest. He covers a wide range of topics, from conservation biology and biotechnology to urban planning and archaeology.

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