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Avinash Kar’s Blog

FDA Offers Make-Believe Solution to Antibiotic Resistance

Avinash Kar

Posted April 11, 2012 in Health and the Environment

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Instead of taking real action to limit the use of antibiotics in healthy livestock, FDA today announced a final version of their list of recommendations – called a “guidance” – for the livestock industry. (They also put out a draft guidance document with recommendations and guidelines for further voluntary action by industry and a draft proposed rule meant to facilitate such voluntary action.) FDA doesn't actually require the livestock industry to do anything to stop endangering human health. This is an ineffective response to the alarming rise in antibiotic resistance, which threatens human health. The FDA is taking no effective action even as it acknowledges that use of antibiotics in livestock is a (growing) problem.feature_pighazard_adjusted.jpg 

FDA is going ahead with this empty gesture even though a federal court recently ruled that providing guidance is not sufficient to meet FDA’s obligation to regulate the use of certain antibiotics—penicillin and tetracyclines—in animal feed because FDA has already found that the use of those antibiotics in animal feed may pose a risk to human health by promoting antibiotic resistance. Therefore, the agency must withdraw approval for these antibiotic uses unless drug manufacturers prove in an administrative hearing that the uses are safe. The guidance does not meet FDA’s legal obligation. To top it off, final guidance is no more binding than the draft one. The added value is exceedingly small.

So, once again, FDA is pretending to act while barely acting at all.

Public health authorities in the US and around the world agree that the overuse of vast quantities of antibiotics on livestock to hasten weight gain and compensate for crowded, filthy conditions is contributing to a crisis of antibiotic resistance in human medicine. Antibiotic resistance is reducing the effectiveness of common, widely used antibiotics--leading to longer and more severe illnesses, the need to use antibiotics with greater side-effects, and in some cases, lives lost as treatments fail.

FDA’s guidance will not help solve the problem because the guidance has no binding force: it is still entirely up to the livestock industry to decide whether to follow the recommendations or ignore them. And even if we hear encouraging promises from industry, there is no assurance that improvements will actually follow. In fact, based on what we have seen so far we fully expect that non-binding guidance will do nothing to change the overuse of antibiotics in healthy livestock. Why is that? We have essentially been using a system of voluntary action since public health risks were revealed over three decades ago. Also, the guidance has existed in draft form since 2010. There is no reason to expect different results from more of the same.  

Pharmaceutical companies have a vested interest in continuing to sell antibiotics – 80% of antibiotics in the U.S. are used for livestock. Livestock producers also have a vested interest in continuing their existing practices and fattening up their animals faster. Even if a couple of actors make the right moves out of the goodness of their hearts, that won’t ensure change in the whole industry, which is the level at which change is required. FDA has a legal duty to protect public health and to determine if drugs have not been shown to be safe, and if so, to withdraw approval for their use.

NRDC and its partners have been litigating to compel the FDA to act on its statutory obligations, and FDA has repeatedly trotted out its non-binding voluntary guidance as evidence of its ‘action’ on the issue. But this is the opposite of action. Not only is this not what the law requires of FDA, it does nothing to ensure that antibiotic use in livestock is actually reduced to slow the rise of antibiotic resistance.

FDA’s mandate is to protect our food, our health and our families.  That requires them to heed the science, stand up to those who work to obfuscate it, and protect our health.  Last week they failed to do so denying our petition to remove BPA from food.  This week, the agency is blithely continuing its policy of letting the livestock industry police itself.  What is going on here?

This guidance does not satisfy FDA’s duties:  the problem of antibiotic resistance is all too real, unlike FDA’s make-believe solution.  Instead, FDA should move expeditiously to act on the court’s decision.

As a 2003 report edited by the current Commissioner of the FDA pointed out, if we don’t address the drivers of antibiotic resistance, including the overuse of antibiotics in livestock, the “specter of untreatable infections—a regression to the pre-antibiotic era—is looming just around the corner.”    

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Comments

Richard CarnevaleApr 11 2012 02:23 PM

A nuclear radiation symbol on the pig, Avinash?

Really???

Dana PearsonApr 11 2012 03:38 PM

Richard, you are ignorant....that's a biological contamination symbol...

FDA is filled with corporatist cronies injected during the bush years and obama has totally ignored this issue. It is so sad our nation is being carved up by money grubbing soulless corporations and reality checks like the fantastic movie "contagion" are ignored. We are on a far track to hell and I often wish I could wake up from this nightmare. Wish I lived in Nordic countries where their governments still care for and protect their citizens...in the USA we're totally "fracked!"

Harry StaleyApr 11 2012 05:18 PM

Thank you Avinash for telling the truth on this one. This decision has more to do with the Obama administration not wanting to alienate Big Pig and Iowa swing voters than protecting public health. Everyone in FDA, beside the industry shills in CVM, knows this is a punting of the issue. But the White House so orders. And the idea that the vets will be a safeguard on this when they've been fighting an AB ban for years is just a joke.

MarcApr 11 2012 05:50 PM

Avinash: You're doing good work. Congratulations on your efforts and your win at SDNY. I'm writing a paper (for eventual submission to law journals) on NRDC v FDA and the new animal drug withdrawal process (or lack thereof, as it were). I think what the FDA did today in its other pronouncements might be more pernicious than what your post reflects. Namely, with industry's help they seem to be pre-emptively shifting all feed uses to prevention, potentially insulating the agency from having to make any withdrawals (at least for a little while longer).

If you read this, I'd very much appreciate a chance to chat. I'll also try to reach out by other means, but this is the easiest thing I can do while in the library.

Regards,
Marc

A TApr 12 2012 07:28 AM

This is so disheartening. It is one more example of the gov't not doing it's job. It is obvious that industries will not regulate themselves. I think the talking points of bloated government and it's intrusion into business thus stunting growth is a smoke screen.
Here is a perfect example of it.
It's disgusting.

BOBApr 12 2012 12:39 PM

Dana - we wish you lived in the Nordic countries too..... that way we wouldn't have to put up with incompetent people who don't want to be in this great country.
Please do your research before you people post comments.... there is no good scientific study that links antibiotic use in animals to antibiotic resistance in humans. All studies done so far, clearly fail to make a cause-and-effect relationship. PERIOD.

Avinash, it is quite interesting that you have a graduate degree, yet you are so one sided as well. Science is about testing a hypothesis. You fail to mention that the hypothesis has been tested and the null hypothesis has never been rejected. How about all the antibiotics that are handed out like candy by human practitioners??? Has anyone ever done that study, to see if it is the antibiotic use by humans that is leading to the antibiotic resistance in humans..??????

If you cook your meat, do you really think the bacteria are making it into your body and then causing antibiotic resistance? If so, where is the study that proves that?


Meghan ByrneApr 12 2012 06:24 PM

As a microbiologist, I can say from experience that continuously using low levels of antibiotics is exactly what you want to do if you want to culture antibiotic-resistant bacteria. This is something microbiologists do in the lab all the time.

Ask any scientist who works with bacteria on a regular basis: "What do you do if you want to culture bacteria that have antibiotic resistance?"

The scientist will say something like, "Use a low concentration of antibiotics continuously."

Doing this will kill off all bacteria except those that have a gene that confers antibiotic resistance. The number of antibiotic-resistant bacteria can then grow, because they no longer need to fight with other bacteria for resources.

This is exactly what is happening when farmers give their animals food that contains low concentrations of antibiotics. The bacteria that are susceptible to the antibiotics die and the bacteria that are resistant have more access to resources and are able to grow in number.

This is why, when you get sick with a bacterial infection, your doctor gives you a relatively high dosage of antibiotics and tells you to take the entire amount, even if you are feeling better. You want all the bacteria to be killed off. You don't want a few bacteria left that may have some resistance to the antibiotic. This is also why most antibiotic-treatment regimens are limited in duration. You don't want to expose the bacteria to antibiotics for longer than necessary. If you do, this will give any antibiotic-resistant bacteria that might be out there more opportunity to take hold.

Interestingly, there is long list of rigorous studies, published in well-respected journals, showing that using antibiotics in animal feed leads to increasing numbers of antibiotic-resistant bacteria and that these bacteria can be passed to humans. A great bibliography of studies has been assembled by the PEW Charitable Trusts and is available at http://www.pewhealth.org/uploadedFiles/PHG/Content_Level_Pages/Issue_Briefs/HHIFBibliographyFinal%20with%20TOC_110211.pdf.

For instance, there was a study published in 1976 in the New England Journal of Medicine (a very well respected scientific journal) showing that adding antibiotics to chicken feed led to significant increases in the number of antibiotic-resistant bacteria being excreted by chickens within 24-36 hours! (See the abstract at www.ncbi.nlm.nih.gov/pubmed/950974.) More interestingly, within 5-6 months of adding antibiotics to the chickens' feed, people who lived on the farm had significantly more antibiotic-resistant bacteria in their bodies.

Another study, published in 1980 in the Journal of the American Medical Association (another well respected journal), related a case in which a woman and her newborn were infected with an antibiotic-resistant strain of Salmonella. This antibiotic-resistant Salmonella strain was traced to the dairy cows on her farm. (Go to www.ncbi.nlm.nih.gov/pubmed/7351786.) These observations support results from other studies showing that antibiotic-resistant bacteria can move from farm animals to farm workers. The study published in JAMA also discussed how other babies in the hospital nursery where the newborn was treated became sick with the same bacteria – an example of how antibiotic-resistant bacteria can move from farm workers to others who do not work on farms.

This issue is serious. It's amazing to me (considering the number of well-respected health organizations that have spoken out on this issue and the wealth of studies showing that using low concentrations of antibiotics in animal feed contributes significantly to antibiotic resistance) that the FDA has not acted more forcefully on this issue. I am grateful that NRDC has taken on the fight. Keep it up! And what can we do to help?

Susan HolldorfApr 13 2012 02:03 PM

Thank you so much NRDC for taking on this issue. I get the feeling nothing responsible will be done by the powers that be until there is an epidemic that takes thousands of lives. Hospitals all ready deal with antibiotic-resistant infections on a daily basis. To all the folks who only see dollar signs, think about MRSA and then think about the possibility of this infection taking over your child, parent or other close relative.

SusanApr 13 2012 09:31 PM

That's a biohazard symbol not radiation, or are you ignorant of the symbolism????

SETH HIRSHApr 17 2012 12:21 AM

All of the policy makers on the FDA should be ARRESTED on CRIMINAL MANSLAUGHTER (MASS MURDER)CHARGES FOR THEIR LACK OF ACTION ON THIS ISSUE !!!!!!!!!!!!!!!!!!!!!!!!!

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