HAPPY NEW YEAR!
Like you, I've done a lot of thinking the last couple of months. I'm working hard right now on a new book, titled HOMESTEAD ANIMAL HAPPINESS that hopefully will be available sometime mid-to-late summer. I've realized that I can't keep up a daily frenetic blog rate; it's too much and it tempts me to wander where I shouldn't.
Beginning now, my blogs will come at a much slower rate; perhaps weekly. They will come only when I think I have something important and necessary to say. Some may be longer, like this one. My co-author of the May 2020 released book BEYOND LABELS, Dr. Sina McCullough, is one of the most thorough pit-bull researchers I've ever encountered. We don't agree on everything, I suppose, but I have learned to pick my arguments carefully.
Sina and I are going to occasionally collaborate on topics in the BEYOND LABELS format for this blog and I hope you will find them entertaining and enlightening. If you like this material, the book has tons of it and in shameless promotion, you should get it. ha! Welcome to 2021, where most of us are in different places physically, spiritually, and emotionally than we expected to be a year ago
FIRST Genetically Engineered Pig Approved for Human Consumption
(Part One)
The FDA approved the first genetically engineered (GE) pig for human consumption.
The GE pig, named GalSafe® pig, is designed to help individuals who have an allergy or sensitivity to alpha-gal sugars. These sugars are naturally found on cells and in tissues of most mammals (they are not normally found in fish, reptiles, birds or people). When alpha-gal sensitive individuals consume beef, pork or lamb, they can experience a mild to severe allergic reaction. The condition is known as alpha-gal syndrome.
The GalSafe® pig, created by Revivicor Inc., is genetically engineered to stop producing alpha-gal sugar on the surface of its cells. Scientists “knocked out” the gene naturally present in pigs that creates the alpha-gal sugar. Hence, in theory, people with alpha-gal syndrome can eat the GE pig meat without triggering an allergic reaction.
Sina: In true FDA style, they declared the GE pig meat safe for us to consume, yet the GalSafe® pig was not properly reviewed for safety. For example, the FDA did not approve the GE pigs themselves; the genetic mutation was approved.
The FDA regulates GE animals under the "new animal drug" provisions of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321 et seq.). Thus, the genetic modification (not the GE pig itself) is considered a “new animal drug” and is, therefore, subject to FDA review. According to the freedom of information summary provided by the FDA:
"GalSafe® pigs themselves are not a drug and are not subject to FDA approval; rather, the intentional genomic alteration (the pPL657 rDNA construct), which is contained in GalSafe® pigs, is the regulated article subject to FDA approval. For approval, the sponsor must show that the IGA [genetic alteration] is safe and effective for its intended use."
In other words, the company can obtain approval from the FDA by simply demonstrating the genetic modification (i.e. the “new animal drug”) worked and didn’t hurt the pig.
This is the same regulatory pathway used by Monsanto when applying for approval of recombinant bovine growth hormone (rBGH), which was the first genetically engineered hormone introduced into our food supply. That FDA-approved “drug” resulted in sick cows, sick milk and, consequently, sick people.
Both of these companies followed FDA guidelines, which is the problem. Those guidelines provide companies with a short cut. For instance, review of an animal drug by the FDA is a much less extensive and time-consuming process than review of a human drug. A human drug typically requires two years of carcinogenicity tests and birth defect testing. The review process for a human drug is also grossly inadequate, but you understand my point; by classifying these products as animal drugs, they require less scrutiny.
Since humans will be consuming the GE pig meat, shouldn’t an expert in human nutrition and human medicine have reviewed the “drug”?
Joel: Tests like this almost never (I think never, but I’ll leave some wiggle room if there’s a time I don’t know about) replicate actual practice, which is known as a cocktail. In other words, when studying an herbicide, the tests never add a pesticide or another herbicide. As a practical matter, farmers never use one thing; they use a cocktail of things. In fact, this is the way life is. This specific gene in these tests was not studied in the farmer’s cocktail of vaccines, pharmaceuticals, different feedstocks and other variables. Studying a substance in isolation yields far different results than when it interacts with other substances. In typical FDA fashion, the relational element was never studied in these tests, making them completely bogus in the practical world.
Sina: Exactly! I’m reminded of when Monsanto claimed glyphosate was safe and did not cause cancer, even though their lead toxicologist admitted in her deposition that Monsanto “cannot say that Roundup® does not cause cancer” because “[we] have not done the carcinogenicity studies with Roundup®.” Only glyphosate was tested for safety; the final product, or cocktail, was never tested. However, we know that Roundup® contains other ingredients, such as surfactants, that help glyphosate enter cells. We don’t know all of the ingredients contained in Roundup® because they are not required to be listed on the label. However, the final product has been reported to be more damaging than glyphosate alone. The same concern holds true for the GE pig, as you so eloquently explained.
Another problem with the FDA’s approval is, according to the FDA, safety of the GE meat was not evaluated for people with alpha-gal syndrome:
"FDA evaluated human food safety for the general population (not specifically for people with AGS) and concluded there is reasonable certainty of no harm to human consumers of food products made from GalSafe® pigs… These conclusions were based on toxicology and microbial food safety evaluations."
Joel: You’d think efficacy would be the number one objective, so to study safety in terms of the general population and not actually determine efficacy for the alpha-gal group is scientific idiocy. If you have a problem, you want to develop something that proves efficacy over a problem or shows safety within a problem, not the greater universe unrelated to the problem.
Sina: To make matters worse, no human or animal studies were conducted to determine if the GE meat is safe for any human to consume.
Revivicor Inc. did not conduct any studies where humans, or any other animal, consumed the GE meat and then were tracked to determine if the product is safe once consumed. Without testing the GE meat on living organisms, how do you know if the intended mutation didn’t produce collateral damage or unintended consequences?
Here’s the kicker: The FDA does not require these types of safety studies prior to approval of GE animals for human consumption. According to the FDA guidelines:
“Potential adverse outcomes via the food exposure pathway should be identified by determining whether there are any biologically relevant changes (1) to the physiology of the animal (assessed partly in Step 3: Phenotypic Characterization), and (2) in the composition of edible tissues from the animals whose genomes have been intentionally altered that suggest reason for toxicological concern compared with the appropriate comparator.”
This means nobody knows the potential health consequences, short-term or long-term, when humans consume the GE meat because nobody tested it.
Joel: Because random replicated studies are inherently time-consuming and costly, nobody wants to do them. But we know that many things take a long time to show their ugly hand. It took 14 years to link DDT to eagle mortality and infertile amphibian eggs. Look how long it took to figure out the negative consequences of hydrogenated vegetable oil—decades.
The Precautionary Principle, if it applies anywhere, should apply to how we produce our food. Biological systems are not mechanical; they are highly dynamic and relational. They aren’t just spare parts you insert or extract depending on the whim of the moment. Every nanosecond quadrillions of decisions, trades, and responses occur in living things; the very notion that we can create an unnatural situation in one component without affecting the rest of the biological community is nonsense.
Sina: As a scientist, I completely agree with you, Joel. Real-world application is one of the biggest cruxes of science. In a laboratory setting, the goal is to control for as many variables as possible in order to ideally determine a cause and effect relationship. But the real world isn’t a controlled environment. Whether it’s rBGH, genetically modified plants, or genetically engineered pigs, nobody knows how they will respond outside of the laboratory. Life is too complex for us to anticipate the plethora of unintended consequences that can occur when scientists boldly change the unique genetic make up of organisms. As you said, the Precautionary Principle should be applied when attempting to alter our food supply in such a profound and potentially irreversible way. However, the exact opposite has occurred with the GE pig.
For instance, to determine if the meat is safe for human consumption, Revivicor Inc. completed a very cursory toxicology and microbial evaluation, including:
1. The process required to generate the genetic modification
2. The molecular characterization of the genetically modified pig DNA
3. The phenotypic characterization of pigs with the genetic modification
4. The health of the GE pigs
5. Unintended effects associated with indirect toxicity due to changes in the physiology of the GE pigs
6. Changes in the composition of the meat of the GE pigs
Revivicor Inc. met these remedial requirements, including an analysis of the nutritional composition of the meat using 93 analytes. In the analysis, they admitted the GE meat showed three statistically significant differences yet the differences were dismissed. The obvious concern is that you can only test for what you know. If, for example, the intended mutation resulted in a second unintended mutation, how do you test for the unintended mutation? In addition, what if that unintended mutation results in the production of an allergen that elicits an immune response in humans? How do you know which markers to test to determine allergenicity if you don’t know the mutation even exists?
Another concern with the evaluation is that Revivicor Inc. admitted to basing the safety analysis on a “very limited number of samples,” which means the first-ever GE pig was approved for our consumption based on a “very limited number of samples.”
In addition, the FDA declared the mutated gene to be a possible food safety hazard and then dismissed it:
The FDA did declare the mutated gene to be a potential food safety hazard based on the fact that it can possibly lead to the development of antibacterial resistance and may be a potential toxicant or allergen to humans who consume the gene. But these concerns were downplayed:
"Based on the review of the information, FDA identified the nptII gene in the pPL657 rDNA construct as a potential food safety hazard... FDA assessed the risk for the inserted nptII gene and its expressed protein to promote the emergence or selection of antimicrobial-resistant bacteria of human health concern in or on GalSafe® pigs…A potential concern about the presence of the nptII gene and/or its expression product in GalSafe® pigs is that complete genes like nptII might be transferred from tissues into bacteria and other organisms. Although the presence of the nptII gene represented a potential hazard, FDA concluded that the microbial food safety risk is low…” (Emphasis added)
In other words, you might eat antibiotic resistant bacteria, aka superbugs, in or on the GE pig meat. It’s also possible for the inserted gene to be transferred to bacteria in your gastrointestinal tract where it can promote antibiotic resistance within your own body. But, the FDA believes the risk is “low” based solely on “the literature search” as well as “findings of submitted proprietary information” that you and I are not allowed to see.
If everyone knew how these GE products found their way onto our dinner plates, I bet there would be massive pushback. No matter what your opinion may be regarding GE animals, I encourage everyone to read the original documents for yourself.
Joel: Good point, Sina. The whole resistant idea really comes down to adaptation. I think most of us have no clue just how adaptable life is. Wormers developed for livestock, for example, only work well for a few years before the parasites develop resistance. Life is incredibly adaptable, meaning that it constantly morphs and moves, like a perpetual boxing match. As different players come on the scene, old players learn how to handle newcomers. Before you know it, the newcomers don’t have new moves anymore. Bacteria living within cells constantly trade information and adapt. The fact that we already have a mutated strain of Covid-19 is a perfect case in point for adaptation and mutation. You don’t want your body containing organisms that make diseases stronger (resistant bacteria).
The cavalier attitude the FDA takes to these kinds of issues is hubris on steroids. I wonder how many pandemics it will take before credentialed experts realize we are not just machines and technology can’t possibly keep up with a quadrillion adaptations per milli-second? At some point you have to realize manipulation and mechanics is not all there is to life and you have to nourish life so it can develop its own natural responses that don’t carry artificially hyped information from genetic engineering.
Sina: I feel for the individuals who suffer from alpha-gal syndrome. I know what it’s like to have food allergies and sensitivities. It can be challenging and frustrating, especially in social settings. However, GE pigs are not the answer.
Alpha-gal syndrome can be reversed. Just like other food allergies can be reversed, or diabetes, heart disease, and cancer can be reversed, so can alpha-gal syndrome.
Alpha-gal syndrome is triggered, in part, from certain tick bites. The alpha-gal molecule has been found in the saliva of certain ticks, including a lone star or blacklegged tick. The tick can transfer alpha-gal sugar molecules into the human through their bite. In some individuals, an IgE-mediated immune response (or “true allergy”) is triggered, which can produce an allergic reaction when the person consumes alpha-gal sugar in certain meats. In addition to the development of a “true allergy,” a sensitivity to beef, pork or lamb can also develop if the alpha-gal sugar molecules trigger other metabolic pathways, such as: IgG, IgA or IgM antibodies or immune complexes.
However, not everyone bitten by these ticks develops alpha-gal syndrome, which indicates that some individuals are more susceptible. The reason for this discrepancy largely lies in the robustness of the immune system. Heal the immune system and you can reverse alpha-gal syndrome.
Unfortunately, the ability of the body to heal from these types of conditions is not well known among the general public. Consequently, the proposed solution is to change nature to accommodate our needs instead of discovering true healing by changing our diet and lifestyle to more closely align ourselves with nature.
I propose we change the narrative. Instead of looking to scientists to change the genetic makeup of an animal so it can be eaten by a population of people who react to that animal, let’s look to nature and nature’s laws to heal ourselves of these allergies and food sensitivities. It is possible to heal your body without harming animals, adulterating our food supply, and potentially creating new health issues in the individuals consuming the GE meat products.
We cannot possibly predict all of the unintended consequences based on our limited knowledge of how life operates. So, let’s place our faith in nature by trusting our innate ability to heal from any illness regardless of circumstance.
Joel: I couldn’t agree more about the overall function of an immune system to deal with these things. In our 60 years of farming, we’ve never had a sickness outbreak in animals that occurred just because. It always had a cause, and it was always our fault. We might have overcrowded, not kept things sanitary enough, picked the wrong genetics, compromised the diet, stressed the animals through discomfort or wrong handling—a host of things can trigger problems. If as a culture we put as much attention on building the immune system as we do on techno-sophisticated bandaids like this, we’d be a lot healthier.
As for ticks, yet another reason to keep a flock of backyard chickens. Implicated in more and more diseases, the lowly tick is now far more prevalent than it was long time ago because domestic fowl are no longer kept around homes and the total bird population is a fraction of what it was a century ago. Birds, including poultry, are nature’s default pesticide. But nothing is more bird habitat unfriendly than suburban manicured yards. If we incorporated more fowl, whether domestic or wild, we’d have a lot fewer ticks.
We’d love to hear your opinion!
The GE pig meat will initially be sold by mail order. However, eventually it may appear in grocery stores, restaurants, hospitals, schools, and military bases, etcetera.
Do you think animals should be genetically engineered and sold for human consumption?
Original sources:
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/10168
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFonsi/2942
https://www.fda.gov/media/74614/download
https://www.revivicor.com/technology.html