The US Food and Drug Administration (FDA) has been repeatedly (and rightfully) accused of ignoring the elephant in the room when it comes to antibiotic-resistant disease, namely factory farming practices where antibiotics are routinely fed to animals to promote growth. According to the landmark “Antibiotic Resistance Threat Report” published by the CDC1 in October 2013, two million American adults and children become infected with antibiotic-resistant bacteria each year, and at least 23,000 of them die as a direct result of those infections. Even more die from complications.2 A recent article in Rodale Magazine3 highlights what the FDA knew, and hid, about antibiotics in animal feed, thereby allowing the problem to persist and grow unchecked: “The Food and Drug Administration (FDA) has known for more than a dozen years that use of antibiotics in factory farms is harmful to humans, yet the agency has taken no meaningful action to stem their use. That's the conclusion of a new report4 from the Natural Resources Defense Council (NRDC), published after the environmental nonprofit collected data from the agency through a Freedom of Information Act request. The data came from an internal review on the safety of feed additives belonging to penicillin and tetracycline classes of antibiotics. The review started in 2001 and ended—for unknown reasons—in 2010. The findings: Twenty-six of the 30 drugs reviewed didn't meet safety guidelines set in 1973, and none of those drugs would meet the safety guidelines of today.” [Emphasis mine]
“The Food and Drug Administration (FDA) has known for more than a dozen years that use of antibiotics in factory farms is harmful to humans, yet the agency has taken no meaningful action to stem their use.
That's the conclusion of a new report4 from the Natural Resources Defense Council (NRDC), published after the environmental nonprofit collected data from the agency through a Freedom of Information Act request.
The data came from an internal review on the safety of feed additives belonging to penicillin and tetracycline classes of antibiotics. The review started in 2001 and ended—for unknown reasons—in 2010.
The findings: Twenty-six of the 30 drugs reviewed didn't meet safety guidelines set in 1973, and none of those drugs would meet the safety guidelines of today.” [Emphasis mine]
As reported in the featured article, the FDA is supposed to look at three factors when determining the safety of an antibiotic-based feed additive. Based on these three factors (below), the NRDC’s report5 concluded that virtually ALL feed additives containing penicillin and tetracycline antibiotics—both of which are used to treat human disease—pose a “high risk” to human health and should not be permitted: The chances that antibiotic-resistant bacteria are being introduced into the food supply The likelihood that people would get exposed to those bacteria The consequences of what happens when people are exposed to those bacteria—would they still be able to get treated with human antibiotics? Despite the fact that both penicillin and tetracyclines are used in human medicine, about HALF of the total sales for these two antibiotics end up in animal feed. All in all, an estimated 80 percent of total antibiotic sales in the US end up in livestock, so the impact of agricultural antibiotics on human disease is very significant indeed. Basically, unless you’re eating organically raised meats, every single piece of meat you eat will give you a small dose of antibiotics, and this low-dosing is a major part of the problem, because when the bacteria are not killed by the antibiotic, they become stronger. The NRDC report also found that as far back as the 1970s, when many of the antibiotics now used in feed were being reviewed for FDA approval, 18 of the 30 antibiotics were already considered “high risk” for human health, but were approved for use in animal feed anyway. Even more shameful, there’s NO human safety data for 12 of the 30 drugs, because the drug manufacturers never submitted any safety data for them. It’s a fair question to ask: WHY has the FDA not taken any action to remove these antibiotic-based feed additives from the market? Especially once federal investigators determined that many of them fell short of regulatory standards for protecting human health?
Today, we’re facing an increasingly complex and dire picture, as many bacteria are developing cross-resistance; a situation where bacteria become resistant to multiple drugs, making them virtually impossible to eradicate once they infect you. For example, some penicillin-resistant bacteria have also developed resistance to cephalosporins6—broad-spectrum antibiotics that are very important for the treatment of human infections. According to the Infectious Disease Society of America (IDSA), just one organism—methicillin-resistant Staphylococcus aureus, better known as MRSA—kills more Americans each year than the combined total of emphysema, HIV/AIDS, Parkinson’s disease, and homicide.7 This death toll is really just an estimate, and the real number is likely much higher. The true extent of superbug infections remains unknown because no one is tracking them—at least not in the US. “Despite all this, the FDA has refused to withdraw approvals for any of the penicillin and tetracycline drugs that their own scientists reviewed and found risky,” Rodale states. “NRDC filed a lawsuit against the agency in 2011 forcing it to act on a citizen's petition that requested FDA take action to limit the use of antibiotics important to human medicine. A year later, a district court ruled in their favor, but FDA appealed and the lawsuit is currently in limbo.”
“Despite all this, the FDA has refused to withdraw approvals for any of the penicillin and tetracycline drugs that their own scientists reviewed and found risky,” Rodale states.
“NRDC filed a lawsuit against the agency in 2011 forcing it to act on a citizen's petition that requested FDA take action to limit the use of antibiotics important to human medicine. A year later, a district court ruled in their favor, but FDA appealed and the lawsuit is currently in limbo.”
The FDA issued its pathetic guidance on agricultural antibiotics on December 11, 2013.8 However, the agency only went so far as to ask drug companies to voluntarily restrict the use of antibiotics that are important in human medicine by excluding growth promotion in animals as a listed use on the drug label.9 This would prevent farmers from legally using antibiotics such as tetracyclines, penicillins,and azithromycin for growth promotion purposes. But this guidance is not likely to protect your health at all, and was exactly what the drug companies were hoping for. As previously reported by Scientific American:10 “[T]he success of the FDA’s new program depends on how many companies volunteer to change their labels over the next 90 days in alignment with the FDA cutoff period. (Companies that do change their labels will have three years to phase in the changes.) And then there are myriad questions about how this would be enforced on the farm.” Another proposed amendment to the FDA’s animal drug regulations (the veterinary feed directive)11 would require farmers to obtain a veterinary prescription before using antibiotics in animal feed for any reason. If this amendment makes it through the comment period intact, it might have a far greater impact. Comments on the proposed rule are being accepted until March 12, 2014. (For instructions on submitting comments, please see the Federal Register page.12)
“[T]he success of the FDA’s new program depends on how many companies volunteer to change their labels over the next 90 days in alignment with the FDA cutoff period. (Companies that do change their labels will have three years to phase in the changes.) And then there are myriad questions about how this would be enforced on the farm.”
In light of the growing problem of antibiotic-resistant disease, it would behoove you to become savvy to techniques and strategies that will not only reduce your own risk of falling victim, but also help curtail the spread of antibiotic resistance in general. While the problem of antibiotic resistance really needs to be stemmed through public policy on a nationwide level, the more people who get involved on a personal level, the better. Such strategies include: Using antibiotics only when absolutely necessary. For example, antibiotics are typically unnecessary for most ear infections, and they do NOT work on viruses. They only work on bacterial infections, and even then, they’re best reserved for more serious infections.As an all-around preventive measure, make sure your vitamin D level is optimized year-round, especially during pregnancy, along with vitamin K2. A number of other natural compounds can also help boost your immune system function to help rid you of an infection, including oil of oregano, garlic, Echinacea, and high-quality colloidal silver.Manuka honey can also be used for topical applications. Clinical trials have found that Manuka honey can effectively eradicate more than 250 clinical strains of bacteria, including some resistant varieties, such as MRSA. Avoiding antibacterial household products, such as antibacterial soaps, hand sanitizers and wipes, etc., as these too promote antibiotic resistance. Properly washing your hands with warm water and plain soap, to prevent the spreading of bacteria. Be particularly mindful of washing your hands and kitchen surfaces after handling raw meats, as about half of all meat sold in grocery stores around the US is likely to be contaminated with pathogenic bacteria. Purchasing organic, antibiotic-free meats and other foods. Reducing the spread of antibiotic-resistant bacteria is a significant reason for making sure you're only eating grass-fed, organically-raised meats and animal products. Besides growing and raising your own, buying your food from responsible, high-quality, sustainable sources is your best bet, and I strongly encourage you to support the small family farms in your area. The FDA’s stance toward antibiotics in livestock feed is unconscionable in light of the harm it wreaks, and its weakness makes being proactive on a personal level all the more important. Quite simply, the FDA has been, and still is, supporting the profitability of large-scale factory farming at the expense of public health. Perhaps one of the strongest messages you can send is to change how you spend your food dollars. By opting for antibiotic-free, pasture raised and finished meats, you’re actively supporting farmers who are not contributing to the man-made plague that is antibiotic-resistant disease. Avoiding antibiotics in all its forms as much as possible will further help curb the growing resistance.The FDA said volutantary guidelines "is the most efficient and effective way to change the use of these products in animal agriculture." NRDC attorney Avinash Kar stated, "The FDA's failure to act on its own findings about the 30 reviewed antibiotic feed additives is part of a larger pattern of delay and inaction in tackling livestock drug use that goes back four decades," Kar told Reuters.FDA Deputy Commissioner and ex-Monsanto attorney Michael Taylor will leave quite a legacy behind. He's not only served Monsanto and the other pesticide producers quite well, he seems to carry the same sentiment over to the antiobiotic crisis.It would appear that Taylor's concern for human health takes a very distant back seat to industry profits. Consider this evidence when taking advice from our federal agencies. Who are they truly working for?
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