Unless you've had a severe respiratory or food-borne infection you have probably never heard of cefepime. It's a fourth-generation cephalosporin antibiotic forming the last line of defence in humans suffering from specific food-borne multiple drug resistant strains of bacterial infections. It is administered with great care because the last thing we would want is for bacteria to successfully mutate enough to render cefepime ineffective.
The Bush administration is about to do just that. (Emphasis mine)
The government is on track to approve a new antibiotic to treat a pneumonia-like 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.You might want to stop for a minute to understand that the division of drug classes means that the most potent and effective are held exclusively for use by medicine to combat microbiological mutations that occur after treating animals with a lower class or generation of drugs.
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.
The American Medical Association and about a dozen other health groups warned the Food and Drug Administration that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotics, as has happened with other drugs. Those super-microbes could then spread to people.It would stand to reason then, that the US Food and Drug Administration would simply reject the sale and deployment of cefquinome on the basis of an increasing health risk to humans. It's what used to happen. But, no, things have changed and the reason is horrifying.
Yet by all indications, the FDA will approve cefquinome this spring. That outcome is all but required, officials said, by a recently implemented "guidance document" that codifies how to weigh the threats to human health posed by proposed new animal drugs.Right. Because the World Health Organization is a part of the United Nations and Bush doesn't need a hall pass from the UN... for anything.
The wording of "Guidance for Industry #152" was crafted within the FDA after a long struggle. In the end, the agency adopted language that, for drugs like cefquinome, is more deferential to pharmaceutical companies than is recommended by the World Health Organization.
"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,' " said Edward Belongia, an epidemiologist at the Marshfield Clinic Research Foundation in Wisconsin. "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."Make no mistake about it. The industry we're talking about here is big pharmaceutical companies. It's the manufacturers of the drugs who are pushing this. While cattle ranchers, I'm sure, would like to reduce the mortality rates of their herds due to pneumonia with a stronger drug, it is big pharma trying to cash in that is driving this. And the logic they use would never have worked twenty years ago. They would have had to prove no risk from use of a drug in animals to humans. The new Guidance #152 places the onus on the FDA to prove that a risk to humans exists. In other words, the drug companies are willing to err on the side of their ability to market a product which they do not know will not cause a microbiological mutation and pass on food-borne infections to humans. Because they don't know it and the FDA cannot state categorically that it will, the FDA, under its new guidance, must approve use of the drug.
The FDA knows how hard it can be to close that door. In the mid-1990s, overriding the objections of public health experts from the Centers for Disease Control and Prevention (CDC), the drug agency approved the marketing of two drugs, Baytril and SaraFlox, for use in poultry. Both are fluoroquinolones, a class of drugs important for their ability to fight the bioterror bacterium that causes anthrax and a food-borne bacterium called campylobacter, which causes a serious diarrheal disease in people.There's the dig. It's already happened in a different class of drugs. The fact that one of the big pharmaceuticals was defiant in the FDA's attempt to withdraw Baytril demonstrates the lack of concern they actually have for the health of the populations they sell to.
Before long, doctors began finding fluoroquinolone-resistant strains of campylobacter in patients hospitalized with severe diarrhea. When studies showed a link to poultry, the FDA sought a ban. But while Abbott Laboratories, which made SaraFlox, pulled its product, Baytril's manufacturer, Bayer Corp., pushed back.
"They fought this tooth and nail. It took years," said Kirk Smith, an epidemiologist at the Minnesota Department of Health.
Finally, late in 2005, Bayer gave up, but not before fluoroquinolone resistance had spread even further.
InterVet developed cefquinome to treat bovine respiratory disease, the most common disease in cattle. Recognizing the potential public health implications of using a close cousin of cefepime in animals, the FDA's Center for Veterinary Medicine, which oversees animal drug approvals, convened its expert advisers in September.So, why a new drug? Because a drug company wants to position itself in the marketplace as having the most effective defence against bovine respiratory diseases, which develop as a result of cattle being kept in tightly confined spaces and being shipped thousands of miles in cramped rail cars. The FDA, however, wasn't allowed to point that out and had to stick to the language of Guidance #152.
One of the first things the group learned was that more than a dozen medicines are already on the market for the respiratory syndrome, and all are still effective.
"If we have no susceptibility problem, why do we need one more new drug?" asked James E. Leggett Jr., a professor of medicine at Oregon Health & Science University, whom the FDA brought in as a consultant on the cefquinome question.
A related problem is that the guidance's definition of "food-borne" is conservative, said Margaret Mellon of the Union of Concerned Scientists, a science policy advocacy group. For example, most urinary tract infections are caused by intestinal bacteria acquired from food, and cefepime is prescribed for those infections. If the FDA counted those infections as food-borne, then the guidance's formula would call for rejecting cefquinome for cattle.In short, the veterinary pharmaceuticals fully intend to proceed and the FDA with the new guidance document is virtually powerless to stop them.
"But FDA didn't do that," Mellon said. "That restricted the analysis right there."
Moreover, the guidance does not take into account that when microbes become resistant to fourth-generation cephalosporins, they often gain resistance to third-generation versions, too.
How many times have we heard Bush, Cheney or any other of a number of Bush administration mouthpieces state that the first job they have is the protection of the American people?
Yeah, it wasn't believable then either.More at Robert Prior.
Thanks to reader Cat.