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People not cattle

What are FDA officials thinking?

The FDA is poised to approve a front-line antibiotic used for mengingitis and other human infections for use in cattle, according to a report in Sunday’s Washington Post. Approval of the antibiotic could lead to antibiotic resistance developing in animals, and then spreading to people.

Apparently the agency is not thinking; it seems instead to be following a ‘guidance document'.

And that document goes against the advice of the agency’s own scientific experts, the American Medical Association and about a dozen other health groups.

These health groups point to evidence that antibiotic use in animals is linked to the development of antibiotic resistance in the human population. In fact, an FDA advisory committee voted 6 to 4 against approving animal use of the antibiotic, cefquinome, a fourth-generation cephalosporin.

Nonetheless, Stephen Sundloff, the head of the FDA’s Veterinary Medicine Center, told panel members that their vote was “not binding”. Instead, he told the committee that the FDA was bound by “Guidance for Industry #152” which limits bans on antibiotic use in animals; the details are a bit mind-numbing but it seems that it’s only easy to ban an antibiotic for animal use if the drug threatens treatments for food-borne illnesses.

That’s way too narrow a definition, given the ability of bacteria to exchange resistance genes. Let’s hope that, in the end, the FDA is able to make a common-sense and scientifically sound decision.


This is a good example of industry writing laws that benefit industry and paying legislators to slip them through without adequate public analysis. Another excellant example was the 1999 data access act and accompanying 2001 data quality act. Baba et al. wrote a good paper in AJPH about how the tobacco industry initiated these acts which allow industry access to unpublished government-funded research and limit the kinds of research Federal agencies can use in decision making. I've pasted the abstract from the paper below. We all need to stand up and yell about this FDA mess. Human health is more important than Ag industry profits!

Baba, Cook, McGarity and Bero
"Legislating "sound science": The role of the tobacco industry.
In the late 1990s, in an effort to dispute the link between secondhand smoke and lung cancer, Philip Morris initiated a campaign to legislate "sound science." The campaign involved enacting data access and data quality laws to obtain previously confidential research data in order to reanalyze it based on industry-generated data quality standards. Philip Morris worked with other corporate interests to form coalitions and workgroups, develop a "data integrity" outreach program, sponsor symposia on "research integrity," and draft language for the new acts.

The tobacco industry played a role in establishing laws that increase corporate influence on public health and regulatory policy decisions.

The FDA can either ignore its own guidelines or it can change the guidelines.

The current 'guidance document' emerged from a protracted process involving scientists, health groups and industry. But the issue is likely to come up again, and the evidence grows stronger each year that use of antibiotics in animals leads to resistance in human pathogens.

So to me, and I don't know this area in depth, it seems that revising the guidelines would be the prudent option.

Incidentally, Senator Edward Kennedy and others have sponsored a bill to phase out the use of "medically important" antibiotics on healthy animals.

How can the FDA end up making a sound decision? What needs to happen?

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