Showing posts with label Antibacterial. Show all posts
Showing posts with label Antibacterial. Show all posts

Wednesday, April 23, 2014

FDA Fails to Protect Against Antibiotic Resistance, Guarantees More Needless Death and Suffering

English: Hinterzarten, Black Forest: young fem...
. (Photo credit: Wikipedia)
 


By Dr. Mercola
Antibiotic-resistant bacteria infect two million Americans every year, causing at least 23,000 deaths. Even more die from complications related to the infections, and the numbers are steadily growing.
It's now clear that we are facing the perfect storm to take us back to the pre-antibiotic age, when some of the most important advances in modern medicineintensive care, organ transplants, care for premature babies, surgeries and even treatment for many common bacterial infections – will no longer be possible.
Experts have been warning about the implications of antibiotic resistance for years, but it's time to face the facts. Many strains of bacteria are becoming resistant to even our strongest antibiotics and are causing deadly infections.
The bacteria are capable of evolving much faster than we are. Secondly, drug companies have all but abandoned the development of new antibiotics because of their poor profit margins.

Antibiotic Resistance: How Did This Happen?

Antibiotic overuse and inappropriate use – such as taking antibiotics to treat viral infections -- bears a heavy responsibility for creating the antibiotic-resistant superbug crisis we are facing today.
According to Dr. Arjun Srinivasan, associate director of the US Centers for Disease Control and Prevention (CDC), as much as half of all antibiotics used in clinics and hospitals "are either unneeded or patients are getting the wrong drugs to treat their infections."1
There's more to the story than this, however, as antibiotic overuse occurs not just in medicine, but also in food production. In fact, agricultural usage accounts for about80 percent of all antibiotic use in the US,2 so it's a MAJOR source of human antibiotic consumption.
Nearly 25 million pounds of antibiotics are administered to livestock in the US every year for purposes other than treating disease, such as making the animals grow bigger faster.
In other parts of the world, such as the EU, adding antibiotics to animal feed to accelerate growth has been banned for years. The antibiotic residues in meat and dairy, as well as the resistant bacteria, are passed on to you in the foods you eat.
Eighty different antibiotics are allowed in cows' milk. According to the CDC, 22 percent of antibiotic-resistant illness in humans is in fact linked to food.3 In the words of Dr. Srinivasan:
"The more you use an antibiotic, the more you expose a bacteria to an antibiotic, the greater the likelihood that resistance to that antibiotic is going to develop. So the more antibiotics we put into people, we put into the environment, we put into livestock, the more opportunities we create for these bacteria to become resistant."
This is a much bigger issue than antibiotics simply being left behind in your meat. For instance, bacteria often share genes that make them resistant. In other words, the drug-resistant bacteria that contaminates your meat may pass on their resistant genes to other bacteria in your body, making you more likely to become sick.  
Drug-resistant bacteria also accumulate in manure that is spread on fields and enters waterways, allowing the drug-resistant bacteria to spread far and wide and ultimately back up the food chain to us. You can see how easily antibiotic resistance spreads, via the food you eat and community contact, in the CDC's infographic below.
Source: CDC.gov, Antibiotic Resistance Threats in the United States, 2013

One-Third of the Most Dangerous Resistant Pathogens Are Found in Your Food

According to the CDC's report, there are 12 resistant pathogens that pose a "serious" threat to public health. One-third of them are found in food. The four drug-resistant pathogens in question are:
  • Campylobacter, which causes an estimated 310,000 infections and 28 deaths per year
  • Salmonella, responsible for another 100,000 infections and 38 deaths annually
  • E. coli
  • Shigella
Previous research suggested you have a 50/50 chance of buying meat tainted with drug-resistant bacteria when you buy meat from your local grocery store.4 But it may be even worse. Using data collected by the federal agency called NARMS (National Antimicrobial Resistance Monitoring System), the Environmental Working Group (EWG) found antibiotic-resistant bacteria in 81 percent of ground turkey, 69 percent of pork chops, 55 percent of ground beef, and 39 percent of raw chicken parts purchased in stores in 2011. EWG nutritionist and the report's lead researcher, Dawn Undurraga, issued the following warning to the public:5
"Consumers should be very concerned that antibiotic-resistant bacteria are now common in the meat aisles of most American supermarkets... These organisms can cause foodborne illnesses and other infections. Worse, they spread antibiotic-resistance, which threatens to bring on a post-antibiotic era where important medicines critical to treating people could become ineffective."

What Happens When a Country Takes Its Livestock Off Antibiotics?

In the US, concentrated animal feeding operations (CAFOs) are hotbeds for breeding antibiotic-resistant bacteria because of the continuous feeding of low doses of antibiotics to the animals, who become living bioreactors for pathogens to survive, adapt, and eventually, thrive. The European Centre for Disease Prevention and Control (ECDC) ruled that antibiotic resistance is a major threat to public health, worldwide, and the primary cause for this man-made epidemic is the widespread misuse of antibiotics.6
Measures to curb the rampant overuse of agricultural antibiotics could have a major impact in the US, as evidenced by actions taken in other countries. For example, Denmark stopped the widespread use of antibiotics in their pork industry 14 years ago. The European Union has also banned the routine use of antibiotics in animal feed over concerns of antibiotic-resistant bacteria.
After Denmark implemented the antibiotic ban, it was later confirmed the country had drastically reduced antibiotic-resistant bacteria in their animals and food. Furthermore, the Danish 'experiment' proved that removing antibiotics doesn't have to hurt the industry's bottom line. In the first 12 years of the ban, the Danish pork industry grew by 43 percent -- making it one of the top exporters of pork in the world. As reported by Consumer Reports:7
"What happens when a country takes its livestock off antibiotics? In 2000 Denmark's pork industry ceased using antibiotics to promote the growth of its animals. Instead of eviscerating the nation's pork industry, those moves contributed to a 50 percent rise in pork production, according to a 2012 article in the journal Nature.8
Frank Aarestrup, D.V.M., Ph.D., head of the EU Reference Laboratory for Antimicrobial Resistance and author of the article, attributes Denmark's success to three factors: laws banning the improper use of antibiotics, a robust system of surveillance and enforcement, and rules that prevent veterinarians from profiting from selling antibiotics to farmers.'Farmers and their livestock can thrive without the heavy use of antibiotics,' Aarestrup wrote. 'With a little effort, I believe that other countries can and must help their farmers to do the same.'"

What's Standing in the Way of Curbing Antibiotic Use in the US?

In a word, industry. For instance, the American Pork Industry doesn't want to curb antibiotic use, as this would mean raising the cost of producing pork by an estimated $5 for every 100 pounds of pork brought to market. The pharmaceutical industry is obviously against it as well. Even though they're not keen on producing new antibiotics to bring to the market, they want to protect those that are already here – especially those incredibly lucrative varieties that are used perpetually in animal feed. Even Dr. Aarestrup, who helped Denmark cut the use of antibiotics in livestock by 60 percent, wrote about the intense industry pressures he faced:9
"Reducing Denmark's reliance on antibiotics was far from easy. My lab was visited by pharmaceutical executives who did not like what we were finding, and I would be cornered at meetings by people who disagreed with our conclusions. I have even been publicly accused of being paid to produce biased results. Despite such challenges, it has been satisfying to see that Danish farmers and their livestock can thrive without the heavy use of antibiotics. …The practice continues unabated in the United States, despite a statement from the Food and Drug Administration [FDA]… suggesting that farmers should stop voluntarily."

FDA Again Fails to Take Appropriate Action on Agricultural Antibiotics

The FDA issued its long-awaited guidance on agricultural antibiotics on December 11, 2013.10 Unfortunately, it's unlikely to have a major impact in terms of protecting your health. The agency is simply asking 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.11This would prevent farmers from legally using antibiotics such as tetracyclines, penicillins, and azithromycin for growth promotion purposes. But it certainly does not go far enough to protect public health. The guidance contains far too many loopholes for any meaningful protection.
For example, farmers would still be allowed to use antibiotics for therapeutic purposes, which would allow them to continue feeding their animals antibiotics for growth promotion without actually admitting that's the reason for doing so. As reported byScientific American: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 short, while giving the superficial appearance of taking warranted action to protect public health, the reality is that they're simply shills for the industry. Michael Taylor,13 FDA Deputy Commissioner for Foods and Veterinary Medicine, and former VP for public policy at Monsanto, is again responsible for caving in to industry at the expense of human lives.

Why Did FDA Ignore Risk Factors from the Very Beginning?

According to a recent report14 from the Natural Resources Defense Council (NRDC), the FDA has known that using antibiotics in factory farms is harmful to human health for over a dozen years, yet it took no action to curb its use. And now, all they're doing is asking drug companies, who make massive amounts of money from these products, to voluntary restrict their use.
The report also found that 26 of the 30 drugs reviewed by the FDA did not meet safety guidelines issued in 1973, and NONE of the 30 drugs would meet today's safety guidelines... As reported by Rodale Magazine,15 the FDA is supposed to look at three factors when determining the safety of an antibiotic-based feed additive. Based on the three factors listed below, the NRDC's report16 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:
  1. The chances that antibiotic-resistant bacteria are being introduced into the food supply
  2. The likelihood that people would get exposed to those bacteria
  3. The consequences of what happens when people are exposed to those bacteria—would they still be able to get treated with human antibiotics?

Looking on the Brighter Side

The impending superbug crisis has a three-prong solution:
  1. Better infection prevention, with a focus on strengthening your immune system naturally
  2. More responsible use of antibiotics for people and animals, with a return to biodynamic farming and a complete overhaul of our food system
  3. Innovative new approaches to the treatment of infections from all branches of science, natural as well as allopathic
There are some promising new avenues of study that may result in fresh ways to fight superbugs. For example, Dutch scientists have discovered a way to deactivate antibiotics with a blast of ultraviolet light before bacteria have a chance to adapt, and before the antibiotics can damage your good bacteria.17
And British scientists have discovered how bacteria talk to each other through "quorum signaling" and are investigating ways of disrupting this process in order to render them incapable of causing an infection. They believe this may lead to a new line of anti-infectives that do not kill bacteria, but instead block their ability to cause disease.18 But the basic strategy that you have at your disposal right now is prevention, prevention, prevention—it's much easier to prevent an infection than to halt one already in progress.
Natural compounds with antimicrobial activity such as garliccinnamonoregano extract, colloidal silverManuka honey, probiotics and fermented foodsechinacea, sunlight and vitamin D are all excellent options to try before resorting to drugs. Best of all, research has shown that bacteria do not tend to develop resistance to these types of treatments. The basic key to keeping your immune system healthy is making good lifestyle choices such as proper diet, stress management and exercise.

You Can Take Action to Help Save Antibiotics from Extinction

Avoiding antibiotic-resistance is but one of several good reasons to avoid meats and animal products from animals raised in concentrated animal feeding operations (CAFOs). This is in part why grass-fed pastured meat is the only type of meat I recommend. If you're regularly eating meat bought at your local grocery store, know that you're in all likelihood getting exposed to antibiotic-resistant bacteria and a low dose of antibiotics with every meal... and this low-dose exposure is what's allowing bacteria to adapt and develop such strong resistance.
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.
You can help yourself and your community by using antibiotics only when absolutely necessary and by purchasing organic, antibiotic-free meats and other foods from local farmers – not CAFOs. Even though the problem of antibiotic resistance needs to be stemmed through public policy on a nationwide level, the more people who get involved on a personal level to stop unnecessary antibiotic use the better. You can help on a larger scale, too, by telling the FDA we need a mandatory ban on sub-therapeutic doses of antibiotics for livestock—not weak, voluntary guidance.
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. The FDA claims that a voluntary guideline "is the most efficient and effective way to change the use of these products in animal agriculture." It would appear that Taylor's concern for human health takes a very distant back seat to industry profits...
To make  your voice heard, please sign the Organic Consumer's Association's petition, calling for a mandatory ban on sub-therapeutic doses of antibiotics for livestock.
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Friday, February 14, 2014

What the FDA Knew (and Hid) About Antibiotics in Animal Feed

English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)

By Dr. Mercola
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]

Why Did FDA Ignore Risk Factors from the Very Beginning?

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:
  1. The chances that antibiotic-resistant bacteria are being introduced into the food supply
  2. The likelihood that people would get exposed to those bacteria
  3. 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?

Antibiotic-Resistant Disease Is a Highly Lethal Man-Made Plague

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.”

FDA’s Action on Agricultural Antibiotics Is Gross Negligence

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 tovoluntarily 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)

How You Can Help Stop the Spread of Antibiotic-Resistant Disease

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:
  1. Using antibiotics only when absolutely necessaryFor 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.
  2. Avoiding antibacterial household products, such as antibacterial soaps, hand sanitizers and wipes, etc., as these too promote antibiotic resistance.
  3. 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.
  4. 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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