Last December, after decades of ignoring the issue of the non-medical use antibiotics in farm animals, the FDA finally released industry-friendly guidance on the topic, politely asking drug companies to stop selling their antibiotics to farmers for anything other than disease treatment and prevention. And yet the folks at Swiss drug giant Novartis continue to push one of their antibiotics as a way for pig farmers to make bigger pigs.

For those still unfamiliar with the backstory, here’s a short version: About 80% of the antibiotics sold in the U.S. go to farmers, who then put these drugs in animal feed, primarily because they have the happy side effect of promoting growth. Alas, decades of research shows that this over-use of antibiotics is aiding in the development of drug-resistant pathogens.

The FDA guidance was intended to curb the medically unnecessary use of these drugs by asking the antibiotics makers to only sell the drugs for disease treatment or prevention. However, since most of the drugs marketed for growth promotion are also still approved for medical use, this is really just asking the drug companies to pay lip service to the idea of reducing antibiotics use by simply requiring farmers to change the stated reason for buying the drugs.

But on its website for Denagard, an antibiotic approved for controlling dysentery and treating diseases like pneumonia in pigs, Novartis continues to market the feed additive’s properties as a growth promoter.

“Denagard plus CTC-medicated pigs showed significantly higher daily gain and achieved a significantly higher body weight at the end of the trial period than OTC pigs (+3.9 lbs.) and nonmedicated pigs (+5.7 lbs.),” reads a statement on the Denagard site.

Novartis also touts the efficiency of Denagard in putting on weight, touting a 1.89 Feed-to-Gain ratio (meaning that adding the Denagard/CTC mixture to feed resulted in 1 pound of weight gain for every 1.89 pounds of feed).

And finally, there’s this gem: “Denagard plus CTC provided a 4:1 return on investment.”

Granted, we’re not livestock farmers, but none of the above statements sound like they have anything to do with disease prevention or treatment.

So the folks at Keep Antibiotics Working have written to Mike Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine, to point out just how ineffective the FDA’s guidance has been in reversing the drug companies’ marketing of antibiotics for livestock.

In the wake of the FDA guidance, representatives for both the livestock and drug industries shrugged off the new not-quite-rules, with antibiotics makers stating that they didn’t believe the changes would have any impact on their bottom lines.

“Companies intent on avoiding reductions in sales that are likely to result from the withdrawal of growth promotion claims have several avenues open to them,” reads the letter (Full text below). “The most obvious is to market drugs with approved label claims for disease prevention and control, which FDA is not restricting, as growth promoters. Many of the drugs approved for production uses like growth promotion also have approvals for disease prevention and control and can be administered in essentially the same manner as for growth promotion (i.e. no requirement for diagnosis, herd or flock wide use, and unlimited duration). Companies that persuade animal producers of the production benefits of the use of these drugs can expect more use over longer periods of time in greater numbers of animals — in short, higher sales.”

The letter points to other efforts being taken by drug companies to continue selling antibiotics for non-medical use.

“For example, drug maker Phibro has stated that it is seeking a change in the status of its product virginiamycin so that it is no longer considered medically important and therefore not covered by Guidance #213, and further that it will seek new indications for products that currently only have production claims,” explains KAW in the letter, which calls on the FDA to ask Novartis to stop marketing the growth-promotion aspects of Denagard and send a general notice to all drug manufacturers “that it will not tolerate the claims of production benefits in advertising associated with any medically important animal antibiotics.”

The one hiccup here is that Novartis and other drug makers don’t necessarily need to market the growth-promotion tendencies of their drugs. Livestock farmers are well aware of these side-effects and will continue to use the antibiotics, though they will likely claim the use is solely prophylactic.

Similarly, there is nothing to prevent researchers from “independently” releasing studies showing growth-promotion effects of these drugs. And if a livestock farmer just happens to see such research, then the drug company’s marketing has been done for them.

So until the FDA actually puts stricter limits on the uses of antibiotics in farm animals, the concerns about over-use and drug-resistant pathogens will not go away.

We’ve reached out to Novartis for comment but have yet to receive a response. If we hear anything, we will update this story.

UPDATE: Congresswoman Louise Slaughter of New York, who has been a vocal critic of the over-use of antibiotics in livestock and has introduced legislation aimed at curbing this abuse, points to the Denagard marketing as evidence that the FDA’s guidance must be strengthened.

“This latest effort to undermine regulations on antibiotic use in agriculture proves that the FDA’s voluntary guidance is riddled with loopholes and completely inadequate to halt the growing antibiotic resistance crisis in this country,” explained Rep. Slaughter in a statement. “When a company is offered the choice to comply with a regulation or work around it, it’s not surprising when the company chooses the most financially attractive option – more often than not, that option is noncompliance. We need mandatory limits on antibiotic use if we have any hope of avoiding the World Health Organization’s grave prediction of a ‘post-antibiotic era’ where routine infections like strep throat become fatal and life-saving surgeries like heart transplants that require antibiotics become obsolete.”

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Here is the full text of the letter from KAW to the FDA:

Dear Deputy Commissioner Taylor,

Keep Antibiotics Working is writing to alert FDA to corporate efforts to undermine the public health impact of its animal antibiotic resistance policy.

Keep Antibiotics Working (KAW) is a coalition of health, consumer, agricultural, environmental, humane, and other advocacy groups members dedicated to eliminating a major cause of antibiotic resistance: the inappropriate use of antibiotics in food animals.

Animal drug companies have consistently stated that FDA’s Guidance for Industry #213 and proposed changes to the Veterinary Feed Directive regulations will not significantly reduce animal antibiotics sales and KAW agrees with them.

Companies intent on avoiding reductions in sales that are likely to result from the withdrawal of growth promotion claims have several avenues open to them. The most obvious is to market drugs with approved label claims for disease prevention and control, which FDA is not restricting, as growth promoters. Many of the drugs approved for production uses like growth promotion also have approvals for disease prevention and control and can be administered in essentially the same manner as for growth promotion (i.e. no requirement for diagnosis, herd or flock wide use, and unlimited duration). Companies that persuade animal producers of the production benefits of the use of these drugs can expect more use over longer periods of time in greater numbers of animals — in short, higher sales.

To illustrate this tactic, we have attached promotional materials downloaded from the website of drug maker Novartis. The materials can also be viewed online at this web address:
http://www.us.denagard.com/product-information/grow-finish.htm. Novartis’ product, a feed additive containing tiamulin hydrogen fumarate in combination with chlortetracycline hydrochloride, is approved in swine to control dysentery and to treat pneumonia and enteric disease, yet the marketing materials emphasize its benefits for production. The materials tout benefits to performance in terms of daily gain, body weight achieved, feed to gain ration, and return on investment, all indicators of productivity not animal health. This product was never approved for growth promotion, but is included in the list of products affected by Guidance for Industry #213.

KAW fears that promotions of this type will become increasingly common as companies withdraw growth promotion claims. Antibiotic use engenders resistance. To the extent that companies succeed in blunting downward pressure on use, they will have rendered ineffective the public health impact of FDA’s policy.

In addition to promoting the production benefits of drugs approved for control and prevention, drug makers are publicly announcing other steps to avoid downward effects on antibiotic sales from the FDA plan. For example, drug maker Phibro has stated that it is seeking a change in the status of its product virginiamycin so that it is no longer considered medically important and therefore not covered by Guidance #213, and further that it will seek new indications for products that currently only have production claims.

We ask that FDA immediately contact Novartis and require the company to stop promoting the production benefits of its tiamulin-chlortetracycline drug approved for disease prevention and control. The Agency should also send a general notice to all drug manufacturers that it will not tolerate the claims of production benefits in advertising associated with any medically important animal antibiotics.

We also ask that FDA either withdraw, or require drug makers to modify, approvals for prevention and control indications that do not meet current safety standards for medically important antimicrobials established under Guidance #152 and #213. Those standards would limit the use of medically important antibiotics to select groups of animals for a defined duration after a veterinarian has determined that the group to receive antimicrobials is at risk for the disease to be controlled.

FDA should require drug makers to make these changes in parallel and under the same timeline as the changes recommended under Guidance #213.
The allowance of routine preventive use of antibiotics in food animals is the major loophole in FDA’s resistance policy. The materials we have enclosed demonstrate that drug companies intend to run circles around FDA through that loophole.

Once again, KAW urge the Agency not to let this happen.

Sincerely,

Steven Roach
Food Safety Program Director
Food Animal Concerns Trust
Keep Antibiotics Working Member Organization

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