Every September, the Animal Health Institute, the trade group of the animal pharmaceutical industry, hosts a party on Capitol Hill called Celebrity Pet Night. The AHI describes its signature social event as a night for “members of Congress and their staff — as well as friends of the animal health community — to gather to celebrate America‘s pets.” Held in the ornate Caucus Room of the Cannon House Office Building, the party receives high marks from D.C. society columnists for its classy setting, loaded double bar and zoological star power. Recent guests of honor include the cat Lord Tubbington from “Glee” and the French bulldog from the Robert Downey Jr. buddy-flick bomb “Due Date.”
As the AHI tells it, these animal celebrities “bring awareness to the connection between animal health and human health.” In this way the evening functions as an extension of AHI’s public relations campaign in defense of the factory farm system and the drugs it requires to function. Most people have never heard of that campaign, which is named “Healthy People, Healthy Animals, Healthy Planet.” But it’s well known in the worlds of Big Ag, Big Pharma, and PR. In 2009, not long after Celebrity Pet Night featured Sprinkles the cat from “The Office,” the League of American Communications Professionals awarded AHI’s campaign its Magellan Award for “best community relations campaign under $1 billion.”
Among independent experts who study the links between animal and human health, the AHI campaign doesn’t evoke Magellan so much as Orwell.
There is a near consensus among public health experts that the bulk antibiotics produced by AHI’s member companies are accelerating the approach of a post-antibiotics nightmare scenario, in which superbugs routinely emerge from our farms and wreak havoc on a human population living among the ruins of modern medicine. The bloc of skeptics who view AHI’s mission with mounting anxiety includes Pet Night party poopers like the World Health Organization and the Infectious Diseases Society of America. Not long ago these authorities joined the American Medical Association and the American Academy of Pediatrics in pressing their concerns on Congress in the form of a letter. “The evidence is so strong of a link between misuse of antibiotics in food animals and human antibiotic resistance,” it stated, “that FDA and Congress should be acting much more boldly and urgently to protect these vital drugs for human illness. Overuse and misuse of important antibiotics in food animals must end.”
Even before getting to the relationship between animal antibiotics and human health, the very need for bulk drugs in factory farms points to the inherent unhealthiness of penning industrial numbers of pigs, cows and chickens in filthy, high-density and stressful conditions. “If your production system makes animals sick in a predictable manner, then that system is broken,” says Lance Price, an epidemiologist at George Washington University who studies the spread of foodborne bacteria. Price is at the forefront of researchers whose work is illuminating how Big Ag’s answer to its own brokenness — sub-therapeutic levels of antibiotics mixed in with daily feed — is fueling the spread of treatment-resistant bacteria through meat and produce tainted by bug-infused feces and fertilizer. Superbugs can also leave farms through the soil, air and water, threatening everybody, irrespective of their diet.
In recent years, a series of pathogenic outbreaks has generated loudening public chatter about agricultural antibiotics. The problem boils down to simple evolution: we are assisting in the mutation of bacterial defenses that make them resistant to our antibiotics.
“Animals are crowded together in very dirty conditions and fed low dose antibiotics that eliminate susceptible bugs in the environment, but allow those that have developed resistance through spontaneous mutation to thrive,” says Robert Lawrence, a professor of environmental health science at Johns Hopkins School of Public Health. “Before you know it, you have situations like Foster Farms.”
Over the last few months, chickens harvested at the high-density pens of Foster Farms in California have sickened nearly 400 people with a new strain of antibiotic-resistant salmonella known as Heidelberg. The rate of hospitalizations has been twice the norm. “This is just the latest example of the enormity of the problem,” says Lawrence, who co-authored a multi-year study of foodborne bacteria for Johns Hopkins. “If we don’t do something, we’ll find ourselves back in the era where young people died of pneumonia. Industrial farming has created a perfect storm.”
Government scientists first reported this storm as a radar blip in 1977. That was the year FDA scientists posted a formal notice in the federal register announcing they would hold hearings on the safety of agricultural antibiotics. If the meat and pharmaceutical industries could not prove during these hearings that the drugs posed no danger to public health, the FDA’s charter required that the agency pull their licenses. The makers and users of bulk animal drugs did not like this. Big Ag and Big Pharma successfully lobbied to delay the hearings, arguing more research was needed. Thirty-six years later, those hearings have still not taken place. With government action held in check, the market for agricultural antibiotics ballooned. It is now a $13 billion trade accounting for 80 percent of all antibiotics sold in the U.S. (The human market, which has its own overuse problem contributing to antibiotic resistance, has held steady over the last decade.)
The scientific literature, meanwhile, has deepened in favor of the disco-era FDA whistleblowers. In recent years, studies have offered stronger evidence linking human cases of resistant E. coli and Salmonella to industrialized poultry and cattle farms. Among the findings of these studies is that bacteria are fast and fluid “learners.” Repeated exposure to one antibiotic quickly helps the resistant bacteria develop a gene mutation that provides resistance assistance to other classes of antibiotics. When mutations knock down our first line of antibiotic defense, the second and third sometimes fall, too, like dominoes. What worries observers is the lack of anything solid behind them. The development of new fourth- and fifth-line defenses has sputtered and stalled. Between 1982 and 1986, there were 16 new antibiotics brought to market. In 2008 and 2009, two new antibiotics were introduced. None of the treatments in development are effective against the kinds of highly adaptive germs (known as “gram-negative”) that make up a growing percentage of infections.
Throughout the 1980s and ’90s, the public health and scientific communities sounded their tocsins against a background of regulatory and political crickets. As evidence mounted that more pathogens were moving from factory farms to the human population, industry held the line against FDA hearings, often relying on friendly former executives ensconced high up in relevant government agencies. (As Mark Bittman noted last week, the FDA’s current deputy commissioner for foods and veterinary medicine is an ex-Monsanto executive.) The makers and users of animal antibiotics claimed, and continue to claim, that their science is sounder, and shows the drugs to be safe. They also maintain that their routine administration is essential to feeding the world at an affordable price. Yet when Denmark became the first country to strictly regulate agricultural antibiotics in the mid-1990s, its animal food industries not only didn’t collapse, they saw benefits. The American National Academy of Sciences has estimated that similar reform in the U.S. would cost the average American grocery shopper between $5 and $10 annually.
Last spring, word leaked that the FDA was preparing to act, at long last. But it soon became clear the regulations would amount to the thinnest of gruels. The proposed regime would discourage the use of certain antibiotics for growth-promotion purposes while allowing for the continued use of bulk antibiotics to prevent illness in healthy animals. What’s more, these new guidelines, written with the cooperation of the affected companies, were just suggestions. They would arrive with no enforcement mechanism or penalties attached.
The new guidelines, known as Final Guidance 213, were officially released two weeks ago, just in time for Christmas.
“Two-thirteen is an early holiday gift to industry,” says Avinash Kar, a health attorney at the Natural Resources Defense Council. “The FDA has essentially followed a voluntary approach for more than 35 years, but use of these drugs to raise animals has increased. There’s no reason why voluntary recommendations will make a difference now, especially when FDA’s policy covers only some of the many uses of antibiotics on animals that are not sick.”
“The effect will be to change the label, not the practice,” says Kar’s colleague Jonathan Kaplan, director of the NRDC’s Food and Agriculture programs. “It’s clear that the agencies are extremely reluctant to challenge two of the most powerful lobbies in the country. Unwilling to pick that fight, they’re trying to make progress with things like this voluntary system.”
Meat and vet pharma trade groups — who were alone among “stakeholders” in having advance notice of the exact timing of the official announcement — were ready with press releases full of praise for the new FDA. The National Chicken Council hailed the agency’s “open and collaborative process.” In a press call organized by the Animal Health Institute, a rep from the National Pork Producers praised the FDA’s sensitivities to the concerns of “impacted industries,” though she declined to guess whether or how the new limits would actually reduce the use of farm antibiotics. “We don’t focus on numbers,” she said. Ron Phillips, the AHI’s vice president for legislative and public affairs, lauded what he called the “orderly change” brought about by the government’s light touch. “One of the reasons that we have cooperated with the FDA,” said Phillips, “is because it’s a regulatory approach, not a legislative one, and we hope to avoid the negative consequences of the sudden action [taken] in Europe.”
If anything frightens the AHI’s member companies, it’s the strict mandatory regulations adopted by Denmark and now being considered throughout Europe. They dismiss the Danish approach as “politically driven” and say it has shown no benefit to human health. One AHI press release bemoans that the Danish law has led to an increase in “animal sickness, suffering, and death.” Leaving aside the spectacle of the Lords of Factory Farming wringing their hands over animal suffering and death, the World Health Organization has found much to recommend in the Danish approach. Which right now is the exact opposite of the American approach.
“We woke up a sleeping dragon over decades of overusing antibiotics,” says Jason Newland, head of Pediatric Infectious Diseases at Children’s Mercy Hospital in St. Louis. “The bacteria have had the same genetic material for eons, but these [resistant] genes were turned off. When someone is trying to kill them, they turn those suckers on. In 1965, we didn’t see ceftriaxone-resistant E coli. Now we do. Because we started using antibiotics like crazy.”
The results of “using antibiotics like crazy” are catalogued in a slick 114-page report issued in September by the Centers for Disease Control. That report, “Antibiotic Resistance Threats in the United States: 2013,” is the first public siren on the issue attempted by the CDC since a national monitoring system was set up in 1996. It seeks to explain why 2 million Americans fall seriously ill each year, and 23,000 die, from microbes that resist treatment by one or more antibiotics. These numbers are meant as a warning as much as a snapshot. A return to the pre-antibiotics age, a prospect raised by the CDC, would make current fatalities look like coal mine canaries. It would mean losing the foundation that supports much of what we think of as modern medicine: surgeries, transplants, managing infectious diseases, curing pneumonia, even neutralizing infections from the common rose-garden finger cut. Losing antibiotics to current trends in increased microbial resistance, warns the CDC, will have “catastrophic consequences.” Britain‘s top health official has put the threat on par with climate change. You can find similar quotes down the line stretching around the world.
In a reminder of how much shorter and nastier life was before antibiotics, and how recent a time this was, the CDC paper highlights growing resistance by the bug whose cure during World War II announced the age of mass penicillin. Of more than 800,000 annual gonorrhea infections in the U.S., nearly a quarter now thwart the old surefire treatments, such as tetracycline, which allowed earlier generations to shrug off the clap with a visit to the clinic.
The inevitability of antibiotic resistance was well known even at the dawn of penicillin. Its pioneers appreciated that it is in the nature of organisms to mutate and evolve. Since the dance between man’s antibiotics and pathogenic germs was understood to be never-ending, the smart course involved slowing the speed of resistance through the prudent use of these “miracle molds.” We have been walking down the opposite path, at an accelerating pace, for 70 years.
Alexander Fleming, the British bacteriologist who named penicillin in 1928 after finding the fungus in a pile of dirty petri dishes, was the first to put a finger to his lips and point at Newland’s sleeping dragon. Fleming ended his Nobel acceptance speech in 1945 with the bacteriological equivalent of Eisenhower’s prophecy about the military-industrial complex. “I would like to sound one note of warning,” Fleming said. “It is not difficult to make microbes resistant to penicillin in the laboratory by exposing them to concentrations not sufficient to kill them, and the same thing has occasionally happened in the body.”
To illustrate the danger, Fleming offered a hypothetical scenario involving the common and once-fatal infection known as strep throat.
Mr. X. has a sore throat. He buys some penicillin and gives himself, not enough to kill thestreptococci, but enough to educate them to resist penicillin. He then infects his wife. Mrs. X gets pneumonia and is treated with penicillin. As the streptococci are now resistant to penicillin the treatment fails. Mrs. X dies. Who is primarily responsible for Mrs. X’s death?
As “educated” bugs spread and afflict growing numbers of people, threatening a return to 19th-century medicine and triggering dire warnings from public health authorities, now is the time to stay focused on the question of responsibility for the death of Mrs. X.
During the spring of 1943, while Allied generals planned their first thrust into Axis Europe, their soldiers practiced a different kind of thrust. In the brothels of Algiers and Tunis, they contracted venereal disease by the thousands. Among the infected were a disproportionate number of those commandos and paratroopers tasked with spearheading the upcoming invasion of Sicily. Officers watched with anxiety as their most elite troops fell sick with a bacteria infamous to foreign armies since Roman legions occupied the same African cities:Neisseria gonorrhea.
Dr. Howard Florey was debriefed on the situation when he landed in Morocco that May. The Oxford pharmacologist was the first to recognize penicillin’s clinical potential, and would share a Nobel Prize after the war. During his tour of desert field hospitals, his experiments with the new wonder fungus proved it more effective than the old method of covering fetid gashes with rags drenched in antiseptics. But penicillin mold had not yet been put into mass production. Florey had to be stingy in his experiments, often recycling doses from the previous subject’s urine. To better understand its uses and scale-up manufacture, the U.S. and Britain launched a joint program involving nearly 40 labs and more than 1,500 scientists. Among wartime research efforts, only the Manhattan Project was larger.
Florey made medical and martial history when he cured 10 hard cases of gonorrhea with penicillin injections. His discovery sparked the first official debate over the proper use of antibiotics. According to the penicillin historian Alex Lax, senior British medical officers blushed at using their precious store of the drug to cure the “self-inflicted” wounds of “libertines.” The chain of command temporized all the way up to Winston Churchill, who personally approved the treatments. One by one, Florey’s injections ended the bacterial legacies of Allied adventures in Tunis brothels. In July, the second front in Europe was finally opened. And so was the age of mass antibiotics.
Less than a decade later, around the time American meat producers realized they could grow fatter swine and chickens by feeding them low-level antibiotics, a young graduate student at the University of Kentucky began research on a master’s thesis on the science of antibiotic resistance. Her name was Louise Slaughter. In 1987, she became the only microbiologist in Congress when she was elected to represent New York’s 25th district. It’s a distinction she holds still. Given Slaughter’s background, it’s fitting that she has emerged as Washington’s leading voice for antibiotics reform.
“Antibiotics are one of the greatest advances in the history of medical science, but we have just watched as their efficacy has been lessened, in some cases literally ruined, by their overuse, partly by the medical profession, but far more by the livestock producers,” says Slaughter. “This is a catastrophe waiting to happen. Scientists of great repute say that if this continues, within a decade strep throat or a cut could become fatal. The American public has got to get around to this fight.”
In March, Slaughter reintroduced H.B. 1150, “The Preservation of Antibiotics for Medical Treatment Act,” or PAMTA. It calls for mandatory bans on the routine preventative use of common antibiotics on factory farms. Following the nascent European model, it allows only for their targeted use on individual sick animals. Slaughter’s office has been consulting with the Danish and German embassies to counter U.S. industry claims about meat shortages, sick animals and price spikes. Europe is much farther ahead on the issue, and the results of their national reform experiments double as potent replies to the bulk-antibiotics lobbies.
The corporate lobbyists who swarm the Capitol are less interested in lessons from around the world than they are in blocking hearings and keeping any antibiotic reform voluntary. As the issue has gained new traction with the public, they’ve stepped up spending on Congress, with one notable exception.
“I’m the one person the lobbyists don’t bother,” says Slaughter. “We’ve read things that have been said about us and the science by the Cattleman’s Association, the pork producers, the poultry producers, but we have over 400 groups pushing this bill with us that are the last word in medicine. Everybody who is doing anything in this country for healthcare and food supply is on that list. What we don’t have are enough co-sponsors.”
While Slaughter rallies support for PAMTA, the cases of treatment resistant Heidelberg salmonella keep piling up. The FDA, meanwhile, has been typically quiet. The only recall since the Foster Farms outbreak has been voluntary, by Costco, after they discoveredSalmonella still on their rotisserie chicken products after the chicken had been cooked at 180 degrees. The Heidelberg outbreak has seen hospitalizations at more than 40 percent, twice the rate of most foodborne Salmonella infections, and with a higher number of blood poisonings.
The meat and pharma industries have already spent millions this year to blunt the impact of events like Foster Farms and keep the public from connecting the dots and organizing behind Slaughter’s bill. More than 80 percent of all lobbying over PAMTA has been in opposition. Among Big Ag, the American Farm Bureau has led the herd with $3.3 million spent during the first three quarters of 2013. On the pharma side, Eli Lilly has spent $8 million, with Merck close behind at nearly $7 million. Though Agribusiness still skews right, both industries have executed a bipartisan strategy, especially since Citizens United opened the soft money floodgates.
This money will be less effective in blocking reform enforced through the courts. In May 2011, a coalition of health, green and consumer groups led by the NRDC filed suit against the FDA for failure to act in defense of public health. Just as the NRDC’s lawyers were to begin arguing the case, the FDA rescinded its initial 1977 notice in the Federal Register — deleted it, basically — and argued there was no longer any basis for the suit. The gambit failed. In March 2012, a federal judge in New York’s Southern District ordered the FDA to begin hearings on agricultural penicillins and tetracyclenes, as well as review all other classes of antibiotics deemed important in human health. The FDA appealed the decision, which is where the case remains.
As the court mulls its decision, an historic amount of lobbying cash continues to flow down both sides of the aisle. Among the most strategic recipients of this money in the House is Oregon Democrat Kurt Schrader. A veterinarian and member of the Agriculture Committee, Schrader is a reliable and smooth public voice against strengthening regulations in the Danish style. Before appreciative industry audiences, he bemoans the “demagoguery” and shoddy science of those who would shut down the agricultural antibiotics spigot.
But Schrader isn’t all business. This September, while celebrating with his friends in the “animal health community,” the congressman brought a light touch to his turn hosting of the Animal Health Institute’s 2013 “Cutest Pets on the Hill” contest, a sideshow of Celebrity Pet Night that features a three-judge panel of D.C. journalists. Among this year’s winners in the Exotic Pet category was a turtle owned by a staffer to Dianne Feinstein. The reptile’s name was Senator.
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