FDA May Make Decision That Will Speed Antibiotic Drug Resistance

Posted on March 4, 2007  Comments (0)

FDA Rules Override Warnings About Drug:

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. 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.

This is why it is so important for government decisions that require scientific knowledge be made by knowledgeable scientists.

But Sundlof said that under FDA rules, those decisions must be left up to veterinarians unless there is clear evidence that wider use is causing harm.

“That is our policy” is not a good excuse for endangering public health. The dangers of anti-biotic resistance are obvious, well known, we see the results of bad decisions in the past creating havoc today and still government wants to act as though the inevitable consequences of their actions are somehow out of their hands. A policy that will lead to the deaths of many people should be fought. If you want to claim this policy will not do that, then make that argument. Don’t claim some policy prohibits you from saving lives.

Democratic/Republican forms of government give politicians oversight over bureaucracy to guide decisions for the public good. When politicians don’t understand basic science (in this day and age – when decisions require that understanding) that can lead to very dangerous policies. You would think that adults would be able to understand that just because consequences will be delayed a few years that doesn’t mean you should allow special interests to get what they want today. But the deficit (nearly $8,800,000,000,000 for the federal government now) provides a visible sign how much they care about future consequences of their actions. Combine that with little scientific understanding and that is not a prescription for good decisions.

Maybe we will be lucky and avoid consequences from this bad decision (due to some scientific breakthrough…). But risking the lives of our future selves seems like a very bad idea to me. And we will have no-one to blame but ourselves if these types of decisions come back to haunt us. The risks are known. The risks are well know though difficult to quantify and difficult to pinpoint accountability. Who exactly is to blame? is it the drug company producing the anti-biotic, is it the vet prescribing it, the rancher using it, the consumer buying the beef, the FDA bureaucrat approving the drug, the FDA bureaucrat writing the policy, the congress overseeing the bureaucracy, the lobbyist paying congress, the electorate electing a politician that obviously approves of passing on risks to the future, the education board that didn’t make sure the schools provided an understanding of science, the parents that allowed their children to grow up without understanding science, which anti-biotic specifically caused the increased risk due to increased resistance…).

Given this confusions we seem to have a pattern of taking the risk and then trying to pin blame on someone once the inevitable happens. It would seem to be we wouldn’t want to take such risks but most evidence seems to show I have wrong. Decisions where the consequences accrue at a time when it will be either extremely difficult or impossible to reverse course are the most troubling to me. If we could just take this gamble and discover, “oops that was a bad idea, lets stop doing that” and then stop and return to the original position very quickly then it is a fairly simple matter. But when we are choosing a risky option that once we find out was bad it is too late to return to the original state a cavalier attitude to the consequences is a bad idea.

Related: Articleson the Overuse of AntibioticsCDC on antibiotic resistance”˜Virtually untreatable”™ TB foundThird generation cephalosporin use in a tertiary hospital in Port of Spain, Trinidad: need for an antibiotic policyFinal Report of the Advisory Committee on Animal Uses of Antimicrobials and Impact on Resistance and Human Health (Canada)Antimicrobial Resistance: Implications for the Food System (pdf)Will Political Appointees at FDA Overrule a Panel of Experts and Increase Cefepime Resistance?FDA’s Veterinary Medicine Advisory Committee Meeting on the TopicFDA Risk Assessment

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