Penicillin in peril

July 10, 2008|By David Wallinga and Margaret Mellon

The miracle drugs of the 20th century are under threat. Doctors are frustrated by rising numbers of illnesses resistant to their arsenal of antibiotics. When these medicines don't work, patients suffer or even die, and our nation's health tab ratchets upward.

Drugs such as penicillin and tetracycline, used routinely to treat respiratory disease and heart infections in humans, are also fed routinely to farm animals - not to treat diagnosed disease but to promote growth and to compensate for the overcrowded, stressful, unsanitary conditions on factory farms.

This reckless use in animals of tried-and-true human antibiotics has contributed to the development of serious antibiotic-resistant human disease. For example, scientists have long linked excessive antibiotic use in animals with a greater prevalence of resistant forms of food-borne infections - such as those caused by salmonella bacteria - and systemic blood infections.

Recent studies now suggest that antibiotic use in livestock operations may also be driving the emergence of a new type of community-acquired (or CA) superbug, methicillin-resistant Staphylococcus aureus (MRSA). CA-MRSA causes serious, sometime deadly, resistant infections among healthy individuals - tragically including many high school students and athletes.

Researchers recently found CA-MRSA in 70 percent of pigs tested on Iowa and Illinois hog farms. More alarming, they found the identical staph strain in about 40 percent of people who work on the farms, suggesting transmission of the strain from pigs to farmworkers and perhaps to the wider community.

The most straightforward way to address resistant diseases such as CA-MRSA is to curb the unnecessary use of all antibiotics important to human medicine in U.S. livestock operations, including penicillin and tetracycline. While Congress has begun to hear this call to action, it has not yet seriously addressed the crisis. Instead, Congress has set its sights on reauthorizing the Animal Drug User Fee Act, a bill that distorts the Food and Drug Administration's priorities to favor faster approvals for animal drugs. The FDA genuinely needs more funding to do its job in an increasingly complex world. But reliance on user fees is a dangerous way to get that funding. User fees set up a scheme where the FDA becomes dependent on the very industries it regulates.

Over the past five years, the FDA has consistently neglected taking the difficult steps to address the problem of antibiotic resistance for the long-term benefit of human health. Unless the Animal Drug User Fee Act is revised to include and fund safety goals for what happens after new animal drugs get marketed, our public health will continue to get short shrift.

The new bill must make public health a priority by addressing the way overuse of antibiotics in animals has eroded the efficacy of those drugs. Congress should establish a process to impose firm new timelines on the FDA to review antibiotics approved long ago. Such a process could cost as little as $1 million to implement, well within the FDA's annual budget for review of antibiotic resistance associated with animal agriculture.

These public health provisions are not radical. When the Prescription Drug User Fee Act for human drugs was reauthorized last year, it included increased fees to provide for post-market human drug safety.

Congress must act now to add provisions to the Animal Drug User Fee Act to achieve a prompt review of antibiotics approved well before concerns rose about resistance. If it fails to do so, it risks passing a bill that compromises America's public health.

Dr. David Wallinga, director of the Food and Health Program at the Institute for Agriculture and Trade Policy, and Margaret Mellon, director and senior scientist at the Union of Concerned Scientists, are members of the Keep Antibiotics Working Coalition.

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