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Center for a Livable Future Response to Raymond Op-Ed

Opinion

This piece is co-authored by Dr. Robert Lawrence and Tyler J. Smith of the Johns Hopkins Center for a Livable Future.

We read Dr. Richard Raymond’s recent article on antibiotic use in food animals with great interest.  Dr. Raymond is a physician who has served this country as Under Secretary for Food Safety at the U.S. Department of Agriculture, so we take his writing on this topic quite seriously.

The number of inaccuracies in his commentary surprised us, however.  In particular, his discussion of antibiotic sales data collected by the Food and Drug Administration (FDA) under the Animal Drug User Fee Act (ADUFA) was incorrect and neglected the basic science of antibiotic resistance.  Startlingly, he also seems to have access to unpublished ADUFA data that the FDA withholds from the public.

Just the Facts, Please

Dr. Raymond discusses antibiotic sales data at length but does not adequately explain what these data mean.  For example, he labels the statistic that 80 percent of antibiotics in the United States are sold for use in food animals “a distraction from the real truth.”

He notes that “a 2,500 pound prize bull with pneumonia is going to be treated with a much larger dose of an antibiotic than an 8 pound newborn with the same bacterial infection,” so we should expect food-animal use to be much greater than human use.

This misses the point.  We do not compare the quantity of antibiotics sold for use in food animals to the quantity used in humans to argue that human use should or should not exceed animal use.  We compare these quantities to illustrate that food-animal use is extensive and cannot be ignored by efforts to prevent antibiotic resistance, which have focused primarily on human use.

Furthermore, Dr. Raymond misinterprets antibiotics sales data collected under ADUFA and neglects the basic science of resistance.  He writes, “87 percent of antibiotics used in animals are either never, or very rarely, used in human medicine,” and we should not focus on the misuse of these drugs in food animal production.

First, the 87 percent figure is inaccurate.  According to Dr. Raymond, it comprises tetracyclines, which are important to human medicine, as well as ionophores and other drugs “not approved for use in human medicine.”  In 2010, 70 percent of antibiotics sold for use in food animals were ionophores or tetracyclines.  What drugs not approved for human use make up the remaining 17 percent?

Under ADUFA, the FDA reports the sales of eight antibiotic classes, including ionophores and tetracyclines.  The agency then lumps together the sales of additional classes and reports these as one “not independently reported” (NIR) category, as fewer than three companies manufacture drugs in each of these classes and revealing the sales of each class could reveal the sales of individual companies.

All eight classes reported separately (except ionophores) include drugs approved for human use, so the additional 17 percent could not have come from any of these classes.  The NIR category includes drugs of all levels of importance to human medicine, from none to critical.  Even if he added all NIR drugs to ionophores and tetracyclines, however, Dr. Raymond would only reach 83 percent of the total.

Beyond this questionable math, the larger point is inaccurate: the World Health Organization considers tetracyclines “highly important” to human medicine.  Dr. Raymond even lists diseases of public health importance that tetracyclines are still used to treat, such as chlamydia, Lyme disease, and Rocky Mountain Spotted Fever.  Other drugs may have superseded tetracyclines for many indications, but that does not mean their misuse in food animal production should not concern us.

Finally, a drug used in food animals but not in humans can still select for resistance to drugs that are essential to public health, as Dr. Raymond surely knows.  This is because the same gene can encode resistance to multiple drugs or because two genes, each encoding resistance to a different drug, may be linked.  The “one bug, one drug” he implies is too simplistic.

Interestingly, Dr. Raymond somehow knows the quantity of ciprofloxacin or that of all drugs in its class, fluoroquinolones, sold each year.  These antibiotics are critical to human medicine but fluoroquinolones are NIR drugs under ADUFA and the FDA does not report sales of specific drugs like ciprofloxacin.  Dr. Raymond reports that 11,000 kilograms of either ciprofloxacin or all fluoroquinolones are sold for use in food animals each year, but data on these sales are not available to the public.

Where did Dr. Raymond obtain this datum?  Either the FDA disclosed the figure, which seems unlikely, or he received this information from the drug industry—perhaps from the Animal Health Institute (AHI).  Dr. Raymond cites the AHI for its specious “best guess” at the percentage of antibiotics used in food animal production for growth promotion.  He neglects to mention that the AHI is the lobby for animal-drug companies.  This obvious conflict of interest compromises the AHI as a credible source.

Furthermore, receiving unpublished data on antibiotic sales from the drug industry for use in an op-ed would violate the spirit, although not the letter, of Dr. Raymond’s disclaimer, which suggests that he wrote the piece without industry involvement.

The Path Forward

Dr. Raymond is right on one point: the public lacks detailed data on the use of antibiotics in food animal production.  The Johns Hopkins Center for a Livable Future (CLF), which Dr. Lawrence directs and at which Mr. Smith works, and the Government Accountability Project (GAP) requested additional ADUFA data from the FDA but the agency refused.  GAP sued the agency for these data last month.

CLF and others asked the FDA to enhance ADUFA data collection overall but the agency declined.  Fortunately, Rep. Henry Waxman has announced the Delivering Antibiotic Transparency in Animals (DATA) Act.  This bill would provide the public with essential information, and we strongly support it.

The FDA has not taken antibiotic misuse in food animals seriously enough—we must push the agency to do more.  More and better data and greater transparency would be a start.  The guidance documents praised by Dr. Raymond will likely amount to little; a lawsuit by the Natural Resources Defense Council and others to force stronger action is more promising.  This year could be a year of action on antibiotic resistance, but as public health advocates we have our work cut out for us.

© Food Safety News

  • MicroQueen

    I want to know when professionals in human medicine are going to start examing their OWN overuse/misuse of antibiotics.  This is NOT just a problem of use in food animal production.  When professionals IN human medicine are asked to join conversations with those in food animal production, they tend to hold themselves ABOVE accountability and start pointing the finger elsewhere.  I find it interesting that folks with little to NO experience in food animal production systems are the ones directing the commentary on the subject in the first place.  Maybe they ought to spend MORE time looking at their own policies on antibiotic use and finding ways to constructively and productively contribute to One Health initiatives where everyone’s interests are FAIRLY represented with factual information. 

  • Mackenzie Dierks

    You use the term “misuse” a good deal in this piece. I am not looking for an argument, I’m simply curious how you would define the term in regards to this topic. Any antibiotic use in livestock? Therapeutic use? Sub-therapeutic use? 

    The way both sides seem to go about this topic – lawsuits, smear campaigns, etc.- is upsetting. I know personally that farmers can be a challenge, especially when it comes to getting them to change their mind or their ways. But the part of Dr. Raymond’s piece that I found to be important was the one stressing that there is a chance for the Ag sector to do something here. Why not have scientists and researchers work with them to make sure the changes happen? Hold open courses and extension education seminars on alternatives, they exist though some are much “prettier” than others. This is a public argument so the information and it’s presentation should be free and open to the public.
    Everyone wants sustainable food/agriculture – to say farmers don’t would be to say they hope to lose everything they have worked for -environmentally, socially, economically – and consumers (which includes farmers) want to know that they will be able to feed themselves and their families while pursuing whatever dream they have. It’d be amazing to see people sit down and work towards that goal rather than continue to shout at each other from the tops of opposite hills. True, no one would be 100% happy but there would still be an element of choice involved and I’m positive it’d be better than the direction we seem to be headed. 

  • doc_raymond

    I wrote my piece to try and move the conversation forward on antibiotic use in animals raised for food. It h as certainly stimulated conversation, but most of it seems to be the same old verse. So here are a few more points that could come under CLF’s request of  ”Just the Facts, Please”:
    1. The FDA documents on sales state quite clearly that the sales are of antibiotics used in ALL animals, animals raised for food as well as companion animal such as horses and dogs. None of the anti-antibiotic crowd ever mention that.
    2. I included links to the data that I used in the OpEd. I do not understand CLF saying the antibiotic data was incorrect. And I do not understand how they can question the sourc e when all they have to do is click on the links.
    3. I acknowledged the AHI gave a “best guess”. I did not state it as a fact. Any AHI numbers came from presentations and can be found on the web.
    4. I have neverhad a conversation with Ron Phillips or anyone else that I know of employed by AHI  
    5.The quantities of antibiotics used in human medicine are quite detailed by class and broken down even further by specific types within each class and again, is included in the second link.
    6. The drugs not used in human medicine in addition to the ionophores can be found in the first link
    7. I added the disclaimer to be transparent, and I will repeat this one more time. No one in the industry knew I penned the piece until they first read it on FSN. I did not “sugggest” as they say that I wrote the piece without industry involvement. I stated it very clearly and will stake my reputation on that fact. And that, CLF, is “JUst the Facts”

    On the tetracycline issue, perhaps WHO considers the class of importance because it only costs pennies and maybe that is all some can afford. But in America it is only used as a very poor second choice.

    As the best example I can give to support that last statement, the last time I prescribed tetracyclin was in the 1980s.  I know for a fact it was the 80s because I was still in rural Nebraska and remember my patient had to drive 100 miles to find a pharmacy that had any in stock. That is how UNIMPORTANT the tetracyclines are in human medicine in the US.

    Tetracyclines have to be taken four times a day, and have to be taken two hours before and two hours after any food or drink is consumed. They are bacteriostatins, they only slow bacterial growth, not kill bacteria. How many patients can take a drug 4 times per day on an empty stomach to maintain a level that does not drop below therapeutic and leads to resistance? Darned few, I would suggest, and that is  why they are unimportant. Anyone that does not want to take my word on this need only ask their personal physician or health care provider when was the last time they prescribed the 4 times per day tetracyclines. 

    A bit tongue in cheek here, but maybe the WHO should be more concerned about where third world countries can find affordable proteins and a little less about an antibiotic that is way past its prime. 

  • doc_raymond

    I am curious. Could the authors tell us how much antibiotics Hopkins buys every year to assist them in their research efforts by preventing bacterial overgrowth—and then dump them down the drain into a public water system? 

    • MicroQueen

      I would like the answer to that question as well, Doc!!!  This is what I mean, medical professionals are quick to be pointing the finger at agriculture when there are OTHER potential sources within their OWN field that need to be investigated as part of the ENTIRE conversation on resistance.  And like Chuck Jolley, I was STUNNED to find out what kind of information was being generated from a Johns Hopkins-supported effort in the name of public health.