Newly Disclosed Documents Reveal Livestock Antibiotic Use by FDA Despite 'High Risk' to Humans
The U.S. Food and Drug Administration (FDA) quietly allowed 30 potentially harmful antibiotics—including 18 rated as "high risk"—to remain on the market as additives in farm animal feed and water, despite an internal review that raised significant red flags, according to agency records obtained by the Natural Resources Defense Council (NRDC).
The data show the use of these drugs in livestock likely exposes humans to antibiotic resistant bacteria through the food supply. The FDA’s scientific reviews of these antibiotics occurred between 2001 and 2010, yet the drugs remain approved and, in many cases, on the market for use in industrial animal agriculture operations.
"The evidence is clear—drugmakers never proved safety," said Carmen Cordova, NRDC microbiologist and lead author of the new analysis. "And FDA continues to knowingly allow the use of drugs in animal feed that likely pose a ‘high risk’ to human health."
"That’s a breach of their responsibility and the public trust,” continued Cordova. “This discovery is disturbing but not surprising given the FDA’s poor track record on dealing with this issue. It’s just more overwhelming evidence that FDA—in the face of a mounting antibiotic resistance health crisis—is turning a blind eye to industry’s misuse of these miracle drugs.”
The FDA’s documents, captured in the analysis Playing Chicken with Antibiotics, show safety reviews of various drugs in the penicillin and tetracycline drug classes—antibiotics considered important to human medicine, which together comprise nearly half of all antibiotics used in animal agriculture in the U.S. The documents were acquired through a Freedom of Information Act (FOIA) lawsuit filed by NRDC and reveal:
- None of the 30 antibiotics would likely be approved as new additives for livestock use if submitted under current FDA guidelines, because drugmakers have not submitted sufficient information to establish their safety.
- 18 of the 30 antibiotic feed additives reviewed (nearly two out of three) were deemed to pose a “high risk” of exposing humans to antibiotic resistant bacteria through the food supply and of adversely affecting human health.
- Drug manufacturers never submitted sufficient information for the remaining 12 products to establish safety, meaning there is no proof of their safety for humans when used in animal feed and the products could not be approved today.
- 29 of the reviewed additives fail to satisfy the FDA’s first iteration of safety requirements from 1973.
The significance of these findings extends far beyond the 30 antibiotic feed additives reviewed. A large body of scientific work on bacterial cross- and co-resistance has established that the misuse of one antibiotic can actually lead to bacterial resistance to other antibiotics. Consequently, the 30 penicillin- and tetracycline-based animal feed additives in this analysis could reduce the effectiveness of a range of other medically important antibiotics that are solely used to treat people.
The FDA first recognized the risks from the use of antibiotics in animal feed in 1977 when it proposed to withdraw approvals for animal feed containing penicillin and most tetracyclines. NRDC won a lawsuit against the FDA for failing to follow through and address the threat posed by the misuse of penicillin and tetracyclines in the livestock industry. Instead of acting on their own scientific findings and heeding the court ruling, the FDA appealed, and a decision is now pending in the U.S. Court of Appeals for the Second Circuit, in New York.
The World Health Organization lists penicillins as critically important for human medicine and tetracyclines as highly important. Penicillins are commonly used to treat bacterial meningitis and syphilis in humans. Tetracyclines are commonly prescribed for eye infections, Lyme disease, gonorrhea and chlamydia. The FDA also recognizes both as highly important. Unfortunately, both penicillins and tetracyclines are no longer effective for treating some infections because of high levels of resistance in bacteria, brought on, in part, due to their widespread use in industrial farms. Increasing resistance to these drugs decreases the options available for human treatment.
The FDA’s failure to act on its own findings on the 30 reviewed antibiotic feed additives is unfortunately consistent with the agency’s decades-long history of failure to effectively deal with this issue. Today, 70 percent of all medically important antibiotics sold in the U.S. are sold for use in livestock production—not on humans. The FDA is responsible for regulating the use of antibiotics in animal agriculture, but has done little to address the growing misuse and overuse of these drugs by the industry since first recognizing the health risks nearly four decades ago.
In 1977, the agency itself concluded that feeding animals low doses of certain antibiotics used in human medicine, namely penicillin and tetracyclines, could promote antibiotic-resistant bacteria capable of infecting people, and posed a risk to human health. Since then, the science on the human health risks of these practices has only gotten stronger but drugs sales for livestock use have continued to trend upwards nearly unchecked.
Despite the FDA’s own scientific findings—and two federal court orders in 2012 resulting from NRDC litigation that require the FDA to act on the misuse of antibiotics on animals that are not sick—the FDA has never followed through. Instead, they've issued Voluntary Guidance 213: loophole-laden recommendations that offer no meaningful improvement over its lack of action over the last 36 years. Meanwhile, the FDA has appealed the court orders and a decision is pending the Second Circuit Court of Appeals.
For decades, leading health groups, medical doctors and other scientists from the American Academy of Pediatrics to Infectious Disease Society of America have sounded the alarm, stating that “overuse and misuse of important antibiotics in food animals must end, in order to protect human health.” These groups and others, including the Centers for Disease Control and the World Health Organization, warn that the overuse and misuse of antibiotics in animals that don’t need them can create dangerous drug-resistant “superbugs” capable of infecting humans.
Antibiotic resistance in humans has reached a crisis point, threatening the efficacy of many life-saving drugs. The Center for Disease Control recently confirmed the link between antibiotic use on industrial farms and the rise of antibiotic resistance in Antibiotic Resistance Threats in the U.S., 2013, saying there is “strong scientific evidence of a link between antibiotic use in food animals and antibiotic resistance in humans,” and warns of “potentially catastrophic consequences” if resistance is not slowed. The Center for Disease Control also stated that “up to half of antibiotic use in humans and much of antibiotic use in animals is unnecessary and inappropriate and makes everyone less safe.”
This was originally posted to NRDC’s Media Center.
Visit EcoWatch’s FOOD page for more related news on this topic.
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By Arkilaus Kladit
My name is Arkilaus Kladit. I'm from the Knasaimos-Tehit tribe in South Sorong Regency, West Papua Province, Indonesia. For decades my tribe has been fighting to protect our forests from outsiders who want to log it or clear it for palm oil. For my people, the forest is our mother and our best friend. Everything we need to survive comes from the forest: food, medicines, building materials, and there are many sacred sites in the forest.
Map of the Knasaimos traditional lands.
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By Farah Aqel
Overthinkers are people who are buried in their own obsessive thoughts. Imagine being in a large maze where each turn leads into an even deeper and knottier tangle of catastrophic, distressing events — that is what it feels like to them when they think about the issues that confront them.
Ruminating<p>According to the late Susan Nolen-Hoeksema, a professor of psychology at Yale University, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5796420/" target="_blank">ruminating</a> involves replaying a problem over and over in your mind. We ruminate by obsessing over our thoughts and thinking repetitively about various aspects of a past situation.</p><p>It usually involves regret, self-loathing and self-blaming. Rumination is associated with the development of depression, anxiety and eating disorders. </p><p>People prone to such patterns of thought may, for example, overanalyze every single detail of a relationship that breaks up. They often blame themselves for what has happened and are overcome with regret, with typical thoughts being: </p><p>- I should have been more patient and more supportive. </p><p>- I have lost the most perfect partner ever. </p><p>- No one will love me again.</p>
Worrying<p>Worrying is wanting to predict the future. It involves negative thoughts about things that might and might not happen.</p><p>- They'll not like me in the interview; they'll not give me the job. </p><p>- I haven't heard back from other employers. How long will I be unemployed?</p><p>These thoughts are energy-draining and distressing. They could happen to anyone under stress. But when you reach the point where your thoughts and worrying are preventing you from doing what you want to do — from living your life to the fullest — then you should take action.</p>
Catch Yourself Overthinking<p>Reuben Berger, a psychotherapist at the university hospital in the western German city of Bonn, recommends several practical steps that you could employ in your daily routine when you catch yourself worrying or ruminating.</p><p>One effective remedy, says Berger, is the <a href="https://www.uofmhealth.org/health-library/uf9938" target="_blank">thought-stopping technique.</a></p><p>"When the negative thoughts come or ruminations start, you say to yourself: 'Stop!,'" he says, adding that it is more effective when you actually say the word out loud.</p><p>He even recommends having a rubber band around your wrist to ping against yourself while saying the word. Adding a visual component by imagining a stop sign also makes the technique more powerful, he says.</p><p>The main idea here is conditioning yourself to stop the loop of worrying (making future predictions) or rumination (obsessing over past events).</p><p>Berger says the technique could take up to two weeks to take effect and that it needs to be practiced every day. "Consistency is very important," he says. </p>
Thoughts Are Just Thoughts<p>Another way of dealing with negative thoughts often used in modern therapy is realizing that thoughts aren't facts, says Berger.</p><p>He says it is important when we think something to ask: Is that real? Did that really happen? What is the worst thing that could happen?</p><p>Flight anxiety is one example where untrue thoughts are accepted as facts. Although air travel is the safest way to get around, people suffering from fear of flying accept their thoughts and fears as reality, then act upon them by refusing to fly.</p>
Mindfulness<p>Berger also recommends the use of mindfulness techniques, in which attention is paid to experiences in the moment without judging them, as a way of reducing worrying.</p><p>"Mindfulness helps you to distance yourself from your thoughts and to be more present in the moment," he says.</p><p><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3432145/#R2" target="_blank">Several studies</a> have shown that mindfulness has a positive impact on reducing stress-related behaviors such as rumination and worrying, as focusing on the moment makes anxiety about other problems impossible.</p><p>Mindfulness can be practiced during routine activities by paying attention to your body and your surroundings. For instance, when you leave for work in the morning, you can focus on sensing the breeze, listen attentively to birds, feel the gravel under your feet and monitor your breath. </p>
Trick Your Brain Into Happiness<p>People plagued by obsessive thoughts do not always choose healthy ways like mindfulness to distract from them, however.</p><p> Dr. Edward Selby, a psychologist at Florida state university, has shown in a study that people try to avoid rumination by engaging in a range of uncontrolled behaviors, such as binge eating and substance abuse.</p><p>But he says that a much better way to overcome such distress is by distraction and shifting attention away from problems that are obsessing us.</p><p>There are many activities that can be used to distract from rumination, he says, and people should choose the one that works best for them. Here are some examples:</p><p>- Listen to music</p><p>- Read a book</p><p>- Take a hot shower</p><p>- Dance or exercise </p><p>- Talk to a friend (not about the problem)</p><p>- Watch a movie</p><p>- Mindfulness meditation</p>
Changing the Perception of Events<p>The way people perceive a situation largely influences their emotions and behavior. It is not the situation itself that determines how they feel, but rather the way they interpret it.</p><p>Reframing negative thoughts can lead to positive emotions and, subsequently, healthier behaviors — including a reduction in damaging overthinking and worrying.</p><p>Cognitive behavioral therapy (CBT) is currently a gold standard in psychotherapy. CBT aims to change the way people think and act. It largely involves challenging unhelpful beliefs or attitudes such as overgeneralization — thinking "I always fail at public speaking" when you have had one bad experience in front of an audience, for example — or "catastrophization," i.e., imagining the worst possible outcome to a situation. </p><p>A psychotherapist can teach people how to implement such thought-changing techniques into their lives. Techniques vary depending on their issues and goals.</p>
Solutions Are at Hand<p>Try to find ways of avoiding worrying, rumination and overthinking that make you feel most comfortable.</p><p>Incorporating any routine in your life when you're stressed isn't an easy task, but you can do it! If you feel overwhelmed, you can always seek professional help. </p><p><em>If you are suffering from serious emotional strain or suicidal thoughts, do not hesitate to seek professional help. You can find information on where to find such help, no matter where you live in the world, <a href="https://www.befrienders.org/" target="_blank">at this website.</a></em></p>
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By Michael Baker, Amanda Kvalsvig and Nick Wilson
On Sunday, New Zealand marked 100 days without community transmission of COVID-19.
Deaths From COVID-19 Per Million Population<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzU0ODIyOS9vcmlnaW4ucG5nIiwiZXhwaXJlc19hdCI6MTY0MjkzMDc1OX0.7Yp1h1hokihlMJUurDukGmq-Y8NJB0V-07O1ukEjGt0/img.png?width=980" id="0fe6a" class="rm-shortcode" data-rm-shortcode-id="6bce85a610aee18e2f4f1c1caca7b8a0" data-rm-shortcode-name="rebelmouse-image" />
<div id="77fff" class="rm-shortcode" data-rm-shortcode-id="ce7b34f8986d3d36bee5d4d83ac0822c"><blockquote class="twitter-tweet twitter-custom-tweet" data-twitter-tweet-id="1292270210238447616" data-partner="rebelmouse"><div style="margin:1em 0">COVID-19 Update There are no new cases of COVID-19 to report in New Zealand today. It has been 100 days since t… https://t.co/Cz55ixGZUz</div> — Unite against COVID-19 (@Unite against COVID-19)<a href="https://twitter.com/covid19nz/statuses/1292270210238447616">1596936201.0</a></blockquote></div>
Getting Through the Pandemic<p>We have gained a much better understanding of COVID-19 over the past eight months. Without effective control measures, it is likely to continue to spread globally for many months to years, ultimately infecting billions and killing millions. The proportion of infected people who die appears to be <a href="https://www.medrxiv.org/content/10.1101/2020.05.03.20089854v4" target="_blank">slightly below 1%</a>.</p><p>This infection also causes serious <a href="https://www.bmj.com/content/370/bmj.m2815" target="_blank">long-term consequences</a> for some survivors. The largest uncertainties involve <a href="https://www.nature.com/articles/d41586-020-02278-5" target="_blank">immunity to this virus</a>, whether it can develop from exposure to infection or vaccines, and if it is long-lasting. The potential for treatment with antivirals and other therapeutics is also still uncertain.</p><p>This knowledge reinforces the huge benefits of sustaining elimination. We know that if New Zealand were to experience widespread COVID-19 transmission, the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3310086/" target="_blank">impact on Māori and Pasifika populations</a> could be catastrophic.</p><p>We have previously described critical measures to get us through this period, including the use of fabric face masks, improving contact tracing with suitable digital tools, applying a science-based approach to border management, and the need for a dedicated national public health agency.</p><p>Maintaining elimination depends on adopting a highly strategic approach to risk management. This approach involves choosing an optimal mix of interventions and using resources in the most efficient way to keep the risk of COVID-19 outbreaks at a consistently low level. Several measures can contribute to this goal over the next few months, while also allowing incremental increases in international travel:</p><ul><li>resurgence planning for a border-control failure and outbreaks of various sizes, with state-of-the-art contact tracing and an upgraded alert level system</li><li>ensuring all New Zealanders own a <a href="https://www.nzma.org.nz/journal-articles/mass-masking-an-alternative-to-a-second-lockdown-in-aotearoa" target="_blank">re-useable fabric face mask</a> with their <a href="https://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=12354409" target="_blank">use built into the alert level system</a></li><li>conducting exercises and simulations to test outbreak management procedures, possibly including "mass masking days" to engage the public in the response</li><li>carefully exploring processes to allow <a href="https://blogs.otago.ac.nz/pubhealthexpert/2020/06/16/preventing-outbreaks-of-covid-19-in-nz-associated-with-air-travel-from-australia-new-modelling-study-of-alternatives-to-quarantine/" target="_blank">quarantine-free travel</a> between jurisdictions free of COVID-19, notably various Pacific Islands, Tasmania and Taiwan (which may require digital tracking of arriving travellers for the first few weeks)</li><li>planning for carefully managed inbound travel by key long-term visitor groups such as tertiary students who would generally still need managed quarantine.</li></ul>
Building Back Better<p>New Zealand cannot change the reality of the global COVID-19 pandemic. But it can leverage possible benefits.</p><p>We should conduct an <a href="https://blogs.otago.ac.nz/pubhealthexpert/2020/06/11/five-key-reasons-why-nz-should-have-an-official-inquiry-into-the-response-to-the-covid-19-pandemic/" target="_blank">official inquiry into the COVID-19 response</a> so we learn everything we possibly can to improve our response capacity for future events.</p><p>We also need to establish a specialized national public health agency to <a href="https://blogs.otago.ac.nz/pubhealthexpert/2017/12/20/the-havelock-north-drinking-water-inquiry-a-wake-up-call-to-rebuild-public-health-in-new-zealand/" target="_blank">manage serious threats to public health</a> and provide critical mass to <a href="https://blogs.otago.ac.nz/pubhealthexpert/2020/02/05/a-preventable-measles-epidemic-lessons-for-reforming-public-health-in-nz/" target="_blank">advance public health generally</a>. Such an agency appears to have been a key factor in the success of Taiwan, which avoided a costly lockdown entirely.</p><p>Business as usual should not be an option for the recovery phase. A recent <a href="https://www.nzherald.co.nz/business/news/article.cfm?c_id=3&objectid=12353555" target="_blank">Massey University survey</a> suggests seven out of ten New Zealanders support a green recovery approach.</p><p>New Zealand's elimination of COVID-19 has drawn attention worldwide, with a description just <a href="https://www.nejm.org/doi/full/10.1056/NEJMc2025203" target="_blank">published</a> in the New England Journal of Medicine. We support a rejuvenated World Health Organization that can provide improved global leadership for pandemic prevention and control, including greater use of an elimination approach to combat COVID-19.</p>
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