FDA Should Share Data About Livestock on Drugs

To my mind, the most urgent argument for making the data public is that this syndrome of drug misuse in food animals is one cause of antibiotic-resistant bacteria that infect humans.
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Let's say you have a sore throat, or a bad knee, or it's time for your annual exam. You visit your doctor. Your physician asks about your consumption of all manner of drugs: prescription drugs, over-the-counter drugs, illegal drugs, alcohol, tobacco, and supplements. She doesn't ask you these questions because she's nosy, or because she wants to judge you. She asks because if she's going to treat your condition or advise you about preventing illness, she needs to know.

You might fudge your answers a little bit -- "only three drinks a week" -- but deep down you know that your well-being depends on your doctor having the full story on the drugs you consume.

Unfortunately, in the U.S. there are billions of animals on drugs, and the drugs they consume are intricately linked with human health. These are our "food animals" -- the cows, pigs, chickens, and turkeys we eat. And too often, the people responsible for feeding our food animals misuse drugs, mainly antibiotics, in order to make the animals grow faster and larger and to compensate for the animals' crowded and unsanitary living conditions. (These people used to be called farmers; now they are more often referred to as producers.) In just a moment, I'll explain more about why this misuse poses a grave risk to humans.

What I'd like to highlight today is how the public health community is taking steps to uncover the truth about how our food animals are being drugged: exactly which drugs, at what dose, and why the drugs are being administered to the animals. Believe it or not, this information is not made available to the public, although, for the good of public health, it should be openly accessible.

Two years ago, the Johns Hopkins Center for a Livable Future approached the Government Accountability Project (GAP) for help obtaining antibiotic sales data reported to the Food and Drug Administration (FDA) by drug companies. After 20 months of back-and-forth between the FDA and GAP, including a Freedom of Information Act request, which was denied, GAP filed suit in federal court last week.

Since 2008, when the Animal Drug User Fee Act (ADUFA) began requiring drug companies to report basic information about antibiotic sales to FDA, the agency has released limited summaries of these data to the public. Sadly, though, the FDA conceals most of what gets reported by the drug companies. This concealment protects the producers and the drug companies, both of which make tidy profits from injudicious dosing of food animals.

Under ADUFA, drug companies pay millions of dollars to FDA each year in fees. This puts FDA in a bind; if the agency releases data that the drug companies don't want released, they will be biting the hand that feeds them. This creates an obvious conflict of interest: FDA is mandated to protect the public's health, and yet they are protecting producers and drug companies.

It's my hope that GAP's lawsuit against FDA will finally compel the agency to break ties with drug companies and release the information that the public health community needs to monitor the use -- and misuse -- of antibiotics and other drugs in food animal production.

So why do we scientists want the drug data so badly? We know that every year, more than 13 billion kilograms of antibiotics, or about 80 percent of all antibiotics sold in the U.S., are sold for use in food animals, and we know from some studies that food animals consume other drugs, too, such as caffeine, acetaminophen, antidepressants, arsenic, and more. But we don't have a lot of details.

To my mind, the most urgent argument for making the data public is that this syndrome of drug misuse in food animals is one cause of antibiotic-resistant bacteria that infect humans. By now, we've all heard about these "superbugs" that are impervious to antibiotics. One of these germs, methicillin-resistant Staphylococcus aureus (MRSA), takes 18,000 lives in the U.S. every year. And now there is what may be an even more frightening type of superbug known as carbapenem-resistant enterobacteriaceae, or CRE, which is becoming notorious for its ability to resist the last-resort, most potent class of antibiotics.

With these data, scientists could better understand patterns of antibiotic-resistance in different geographic areas and communities, they could better assess threats to human health, and they could better analyze current incidences of infection.

But there's more. In addition to using these data to analyze, predict, and understand, we would use it the same way a doctor would use information that a patient has been abusing drugs. We would tell the livestock industry to stop misusing the drugs. Like any physician of integrity, we'd say it as convincingly and as loudly as we can. When we learn the truth from industry, we'll blow the whistle on them.

So you can see why the producers and the drug companies don't want the public health community to have the data. But what should FDA protect -- the profits of the industries, or the health of the public?

If GAP prevails in its lawsuit against FDA, the American public will win a big victory over the industries that are profiting from our ignorance, and we will be better armed to protect our health. I imagine that shifting to this kind of transparency would be a rocky road for FDA at first. Any transition to transparency is painful in the beginning. But in the long run, it will pay off many times over.

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