FDA restricts anitibiotic use in farm animals

Posted by Christine, January 8, 2012

The New York Times reports:

WASHINGTON — Federal drug regulators announced on Wednesday that farmers and ranchers must restrict their use of a critical class of antibioticsin cattle, pigs, chickens and turkeys because such practices may have contributed to the growing threat in people of bacterial infections that are resistant to treatment.

Veronica Lukasova for The New York Times

Cephalosporins commonly treat humans as well as animals like chickens.

The medicines are known as cephalosporins and include brands like Cefzil and Keflex. They are among the most common antibiotics prescribed to treat pneumonia, strep throat, and skin and urinary tract infections. Surgeons also often use them before surgery, and they are particularly popular among pediatricians.

The drugs’ use in agriculture has, according to many microbiologists, led to the development of bacteria that are resistant to their effects, a development that many doctors say has cost thousands of lives.

Antibiotics were the wonder drugs of the 20th century, and their initial uses in both humans and animals were indiscriminate. Farmers became so enamored of the miraculous effects of penicillin and tetracycline on the robustness of cattle, chickens and pigs that the drugs were added in bulk to feed and water, with no need for prescriptions or any sign of sickness in the animals.

By the 1970s, public health officials had become worried that overuse was leading to the birth of killer infections resistant to treatment. Since then, the Food and Drug Administration has undertaken fitful efforts to wean farmers, ranchers and veterinarians from excessive use of the medicines, but the vast majority of antibiotics used in the United States still go to treat animals, not humans. Meanwhile, outbreaks of illnesses from antibiotic-resistant bacteria have grown in number and severity.

A decade ago, the F.D.A. banned indiscriminate agricultural uses of a powerful class of antibiotics, called fluoroquinolones, that includes the medicine Cipro. Wednesday’s announcement was another of the F.D.A.’s incremental steps.

“We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals,” said Michael R. Taylor, deputy commissioner for foods at the agency.

Cephalosporins are not used as widely in livestock as penicillin, since they require a prescription from veterinarians. But the drugs are routinely injected into broiler eggs and used in large doses to treat infections in cattle and other animals.

The new rule will restrict only some of these uses and is therefore a modest step that, while applauded by consumer advocates, led many to call for far tougher measures.

“This is particularly important because cephalosporins are so important to human health, but it’s only a first step,” said Laura Rogers of the Pew Charitable Trusts, which has advocated restricting agricultural uses of antibiotics.

The F.D.A. initially proposed cephalosporin restrictions in 2008 but withdrew the rule before it could take effect because of opposition from veterinarians, farmers and drug companies. The rule announced Wednesday is less strict than that one, since it still allows veterinarians to use the drugs in to treat sick animals in some ways the F.D.A. has not specifically approved, and wide discretion to treat small-scale-production animals like ducks and rabbits. The rule bans routine injections of cephalosporins into chicken eggs and large and lengthy dosing in cattle and swine.

Dr. Christine Hoang, assistant director of scientific activities at the American Veterinary Medical Association, said the new rule was a vast improvement over the one proposed in 2008.

“We thought the original order was too broad and unnecessarily prohibited uses that were not likely to cause problems for human health,” Dr. Hoang said.

Dr. Scott A. Brown of Pfizer, which makes cephalosporins used in animals, said the company “acknowledges the intent of the proposed order to respect veterinary discretion in determining the appropriate and responsible use of cephalosporin antibiotic medicines in the interest of animal health and human health.”

The F.D.A. has yet to make final a guideline proposed in 2010 that would edge the agency closer to banning uses of penicillin and tetracycline in feed and water for the sole purpose of promoting the growth of animals or preventing illness that results from unsanitary living conditions. This issue has generated intense controversy among farmers and ranchers who contend that public health officials have exaggerated the danger of agricultural uses of antibiotics to humans.

When asked about the penicillin guideline, Mr. Taylor of the F.D.A. said, “We’re hopeful that in the coming months, we’ll be able to carry forward on that work.”

Representative Louise M. Slaughter, a Democrat from New York and a microbiologist, said the F.D.A. had been too slow and too timid. “We are staring at a massive public health threat in the rise of antibiotic-resistant superbugs,” she said. “We need to start acting with the swiftness and decisiveness this problem deserves.”

But Dr. Gatz Riddell, executive vice president of the American Association of Bovine Practitioners, a veterinarian group, said the dangers of agricultural uses of antibiotics had been greatly exaggerated. “It is highly misunderstood in the human-health community how much antibiotics are used in animals who are not sick or at risk of becoming sick,” he said.

BUT RP Siegel sees it differently:

Maybe it all goes back to high school science. Maybe the reason I’m sitting here, writing, with urgency about the importance of sustainability, is because over the past fifty to a hundred years, businesses, with a few notable exceptions, have spent too much time concentrating on Physics and Chemistry and not enough time on Biology (not to mention Earth Science).

It is Biology, after all, that comprehends the web of connectedness that forms an ecosystem, the fundamental unit of our natural world. And it is our lack of attention to this web that has gotten us into so much trouble. Yet we have been running our world based largely on the laws of Physics and Chemistry, ignoring the laws of Biology at our peril. Today’s story is a prime example.

The FDA is putting the brakes on plans to regulate the consumption of antibiotics by healthy livestock raised for human consumption. The news was conveniently announced during the low news period between Christmas and New Years, despite the fact that the agency has been stalling on their decision since October. They gave no reason for its action, stating only that it intends to “focus its efforts for now on the potential for voluntary reform and the promotion of the judicious use of antimicrobials in the interest of public health.”

Scientists have understood the dangers of antibiotic resistance, also known as anti-microbial resistance (AMR), for quite some time. In fact, 70,000 people die in this country, every year, from infections such as MRSA that they acquire in the hospital from bugs that are resistant to drugs. Worldwide, more than twice that many people die each year from multi-drug resistant tuberculosis (MDRTB), alone.

The World Health Organization (WHO) claims that the proliferation of AMR threatens a return to the pre-antibiotic era, rolling back decades of medical progress in public health, as diseases that that once been under control once again become uncontrollable.

FDA’s Center for Veterinary Medicine, released an animation which clearly states: “Not only do antimicrobial-resistant bacterial pathogens in animals pose a risk in terms of animal health, they also affect public health when transmitted to humans as foodbourne contaminants.  Thus addressing the issue of antimicrobial resistance is one of the most urgent priorities in the fields of public health today.”

If just a few bacteria are able to survive in a human or animal that has been treated with antibiotics, those organisms can then thrive in an environment where they will have little competition for food and will rapidly reproduce.

The Centers for Disease Control CDC warns people to only use antibiotics when they can be beneficial, and not against viruses or other non-bacterial pathogens. “Exposure to antibiotics,” they say, “provides selective pressure, which makes the surviving bacteria more likely to be resistant.” This means that the use of antibiotics is a double-edged sword, and their use should be minimized as much as possible.

And yet, despite this admonition, the US now consumes over 50 million pounds of antibiotics per year, an alarmingly high number considering the significant potential for harm. But what is even more alarming is the fact the somewhere between 60-80 percent of that is given to farm animals who aren’t even sick. This flies in the face of everything that agencies like WHO, FDA, and CDC have been trying to tell us for decades.

Back in August, I wrote about a number of doctors who had come forward to express their concern about antibiotic overexposure. In fact, Physicians For Social Responsibility, along with the American Medical Association and the Infectious Diseases Society of America, have been pushing for a piece of legislation called the Preservation of Antibiotics for Medical Treatment Act, which keeps getting buried in Congress under heavy pressure from lobbyists representing both the pharmaceutical companies and the meat packing industry.

These medical groups later took out large ads in Politico and The Hill, which stated, “Hundreds of scientific studies conducted over four decades have shown that feeding low doses of antibiotics to healthy food animals leads to drug-resistant infections in people,” they wrote in the ad. “In fact, America’s leading medical, scientific and public health organizations have been warning of the danger for years.”

This immense public pressure on both sides of the issue is one reason why the FDA wanted to get minimal press for their announcement to move toward voluntary adoption.

Avinash Kar, an attorney for NRDC, said that he believed that the move was in response to a lawsuit his organization filed against the FDA that would require them to withdraw approval of the dangerous practice of adding antibiotics to the feed of healthy animals. Kar said that voluntary regulation has not worked in the past. Indeed the use of antibiotics is clearly on the rise.

Stephen Roach, of the Food Animals Concern Trust, who is also involved in the lawsuit against the FDA, made the following comment about the FDA’s latest move.“It is totally at odds with their mission to protect the public. This month we had a salmonella outbreak in the north-east that was resistant to penicillin and the drug that replaced penicillin, cephalosporin. We are going to continue to have multi-drug resistant salmonella outbreaks and E.coli drug-resistant outbreaks.”

All of this has me wondering if it is indeed Physics and Chemistry that companies are focusing on, or perhaps it is more likely Political Science and Economics.

Clearly, we have not heard the end of this. People need to become informed and let their representatives know if they are willing to let their health and safety be compromised in order for a small number of companies to increase their profits.

RP Siegel, PE, is the President of Rain Mountain LLC. He is also the co-author of the eco-thriller Vapor Trails, the first in a series covering the human side of various sustainability issues including energy, food, and water.  Like airplanes, we all leave behind a vapor trail. And though we can easily see others’, we rarely see our own.

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