The men who knew

By Emma Schwartz


FRONTLINE News Oversight
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Today’s debate over the use of antibiotics in food animals is hardly new. Nearly 40 years ago, the U.S. Food and Drug Administration (FDA) tried — and failed — to restrict the use of these drugs in animal feeds on the farm.

That battle of 1977 is critical to understanding why the agency has taken so long to act today — and why today’s efforts remain so limited.

The beginnings

One of the early American researchers in the emerging field of antibiotic resistance was Stanley Falkow, a young microbiologist at the University of Washington. In the 1950s and ’60s, researchers were just beginning to establish how any use of antibiotics could generate resistance — and realizing that these “miracle drugs” could lose effectiveness in treating human illness.

Falkow knew overuse of antibiotics in hospitals was a problem, but he soon learned that a large percentage of antibiotics were also used routinely in the feed and water of animals raised for meat. He wondered: Could this use be a threat to human health?

In the 1950s and ’60s, researchers were just beginning to establish how any use of antibiotics could generate resistance.

Early scientific research certainly suggested bacteria could transfer between people and animals, and in 1969, the British government published the Swann Report, the first major warning about antibiotics used in farm animals. It called for a ban on using the drugs to promote growth in animals raised for meat.

Against this backdrop, Falkow gave a lecture at the U.S. Department of Agriculture’s research center in Beltsville, Md., in 1970, laying out his concern and the need to reign in the use of antibiotics in food animals.

“You would have thought I had dropped atomic bomb,” he recalled to FRONTLINE. “I was taken aside, and they said, ‘Boy you are dabbling with price of pork, and these are forces you will never know.’”

Worried he might have the science wrong, Falkow spent the next year scouring the latest research on resistance, and his convictions were reinforced. He vowed to push the government to take action.

Concern at the FDA

The Swann report also generated concern inside the FDA, prompting the agency to create two committees to examine the potential public health impact of antibiotic farm practice.

Falkow joined one of the FDA subcommittees in 1974. Two years later, it released a report with a stern warning: that low doses of tetracycline and penicillin in animals posed a risk to human health and should be banned.

The report came at an auspicious time. President Jimmy Carter took office in 1977 and the FDA also got a new leader, Commissioner Donald Kennedy.

Kennedy saw antibiotic use in animal feed as a public health problem. (FDA archival portrait)

A respected biologist from Stanford University, Kennedy was committed to improving the use of science in making public policy decisions.

With Falkow as a key outside adviser, Kennedy saw antibiotic use in animal feed as a public health problem government needed to address. “We knew that bacteria … could move and back and forth between animals and people, and one of the things we were most worried about is that there would be some cross-infectivity between what was being used in the animals and humans,” Kennedy told FRONTLINE.

At the time, the state of knowledge about genetics was still young. But research indicated that bacteria could share resistance with other bacteria through the transfer of genetic material, known as plasmids. By sharing plasmids, it was thought, bacteria could more easily spread resistance through the environment and between people and animals.

The science didn’t show that a particular antibiotic used on animals directly created resistant bacteria that made a person sick. Even today, science hasn’t been able to show such a direct link. But the theories of plasmid transfer Kennedy spoke of have only proved more certain with modern science.

“We went into it with a lot of passion, what we thought was a lot of evidence, and we thought that people would respond to the human health part of this,” Tom Grumbly, a former aide to Kennedy at the FDA, told FRONTLINE.

That concern soon translated into action. Kennedy proposed banning the use of two classes of antibiotics — penicillin and tetracycline —in animal feed. The proposed rules would also place veterinarians in charge of prescribing all other antibiotics used on the farm. Kennedy declared that “known routes of transfer exist by which antibiotic use in animals can contribute” to disease threats to human health, and these bacteria “form a linked ecosystem of their own in which action at any one point can affect every other.”

The response

The proposed FDA rules drew a favorable response from scientists and health professionals across the country. But it very quickly became clear that farmers and animal drug makers were unhappy, describing the changes as “financially ruinous” and lacking clear scientific evidence.

The farm lobby had clout. They turned to Rep. Jamie Whitten (D-Miss.), the longtime chair of the subcommittee that controlled the FDA’s budget. His ties to the farm world were so strong and his tenure was so lengthy that he was described in an obituary as “a kind of shadow Secretary of Agriculture.”

Whitten threatened to cut the FDA’s budget if the agency moved forward with the proposed rules.

Back at the FDA, Kennedy consulted with his boss, then-Secretary of Health and Human Services Joseph Califano, who, according to Grumbly, “was afraid if we didn’t stand down, not only would Rep. Whitten follow through with his threat … he would cut other parts of the agency, and maybe it could have a negative impact on the department as a whole.”

Left with little choice, Kennedy shelved the regulation. Perhaps, Grumbly remembered, he would try in another year or two. But by then, Kennedy had returned to Stanford.

“People just basically said, “This is in the ‘too hard category,’” Grumbly explained.

And that’s where these efforts remained for decades — with the proposals still sitting in limbo. Advocacy groups petitioned the FDA to review its 1977 proposals but the agency never did. Then, after the groups sued in 2011, the agency withdrew the proposals, saying it would take a new approach to restricting growth-promoting antibiotics.

That effort finally began in December 2013, when the FDA published a new plan to voluntarily ask pharmaceutical companies to change the label on antibiotics so that growth promotion was no longer allowed. It will also require that all antibiotics be under the supervision of a veterinarian. The agency said that by taking a voluntary approach, it believes it would get results quicker. So far all of the 26 manufacturers have agreed to phase in these new rules over the next three years.

But not everyone agrees. Says Gail Hansen, a veterinarian with Pew Charitable Trust’s antibiotic campaign: “I think FDA has, is very cautious. And because of the history that they had in the ’70s where they tried this big step and Congress told them no. I think FDA is taking some baby steps. I think they could be much bolder.”