Will FDA Put Humans at Risk with Cow Drug?

The government is on track to approve a new antibiotic to treat a pneumonialike disease in cattle, despite warnings from health groups and a majority of the agency's own expert advisers that the decision will be dangerous for people.

The drug, cefquinome, belongs to a class of potent antibiotics that are among medicine's last defense against several serious human infections. No drug from that class has been approved in the United States for use in animals.

The American Medical Association and about 12 other health groups warned the Food and Drug Administration that giving cefquinome to animals probably would speed the emergence of microbes resistant to that important class of antibiotic, as has happened with other drugs. Those supermicrobes could then spread to people.

".... Marshfield Epidemiologic Study Area (MESA)

The Marshfield Epidemiologic Study Area (MESA) is a geographic region of 24 ZIP codes where nearly all residents receive their medical care from Marshfield Clinic and affiliated hospitals. This rare resource for conducting population-based health research within a comprehensive medical care system is particularly useful for measuring the occurrence of illness, studying the full clinical spectrum of disease, and identifying population-based cohorts for further study. ....."

Public Health Consequences of Use of Antimicrobial
Agents in Food Animals in the United States, CDC Report

In a recent risk assessment, the FDA
concluded that the use of fluoroquinolones in chickens in the
United States has compromised the treatment with fluoroquinolones
of almost 10,000 people a year; meaning that each
year, thousands of people with Campylobacter infections seek
medical care and are treated with fluoroquinolones, but their
infection is already fluoroquinolone resistant.

In addition to causing more human illnesses, increasing antimicrobial
resistance in foodborne pathogens may result in
treatment failures if the foodborne pathogen is resistant to an
antimicrobial used for treatment. As previously described, resistance
is emerging to antimicrobials commonly used for treatment
of serious Salmonella infections, that is, fluoroquinolones
in adults and extended-spectrum cephalosporins in children.

FDA may approve cow drug

BEIJING, March 5 (Xinhuanet) -- The U.S. Food and Drug Administration (FDA) is expected to approve a powerful antibiotic for cattle despite warnings it would be dangerous for people, U.S. media reported on Monday.

The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine's last defenses against several serious human infections. No drug from that class has been approved in the United States for use in animals.

FDA set to approve controversial cow drug: report

The FDA's own advisors, the Veterinary Medical Advisory Committee, voiced such concerns when they voted in September to reject approval of cefquinome by InterVet Inc. of Millsboro, Del., which makes it.

Yet the Post quoted experts as saying the FDA was moving toward approval anyway, overriding the advice of the panel, the American Medical Association and other health groups.

The Post said the FDA was being pressured to approve the drug because of an internal guidance document called "Guidance for Industry #152" on how to weigh threats to human health from by proposed new animal drugs.

It quoted experts saying the rule makes it difficult for the FDA to deny a new animal drug unless it is likely to threaten the effectiveness of an antibiotic critical in treating food-borne illness.

Edward Belongia, an epidemiologist at the Marshfield Clinic Research Foundation in Wisconsin, said that made it difficult for the FDA to say no to some drugs, according to the newspaper.


"The industry says that 'until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use,"' it quoted Belongia as saying.

"But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open," he was quoted as saying.

InterVet developed cefquinome to treat bovine respiratory disease, the most common disease in cattle. But more than a dozen antibiotics are on the market for the respiratory syndrome, and all are still effective.