Yesterday, a federal magistrate ordered the Food and Drug Administration (FDA) to move ahead with a decades-old effort to withdraw approvals for several uses of antibiotics considered “critically important” to human health by the World Health Organization. This is a solid win for public health advocates and comes as FDA has proven unwilling to take seriously the threat of antibiotic resistance.
In 1977, FDA proposed withdrawing approvals for the use of penicillin antibiotics for growth promotion and the use of several tetracycline antibiotics in animal feed. Research showed then—more than three decades ago—that these uses were likely to select for antibiotic-resistant bacteria that can infect humans. Unfortunately, lobbyists for the pharmaceutical and animal agricultural industries persuaded Congress to delay the restrictions pending additional research. FDA did more research but took no further action for the next 34 years. Read More >
Also contributing to this post is Tyler Smith, Senior Research & Policy Assistant in the Farming for the Future program.
The U.S. Food and Drug Administration (FDA) held a public meeting (video on YouTube) this past Monday at its Rockville campus to discuss reauthorization of the Animal Drug User Fee Act (ADUFA). The current version of ADUFA includes an important provision that requires drug sponsors to report sales of antimicrobial drugs intended for use in food animals to FDA. The agency compiles these sales data and releases a limited summary to the public each year. The 2009 summary report of ADUFA data allowed CLF researchers to calculate the quantity of antimicrobial drugs sold domestically for use in food animals as a percentage of the total quantity of antimicrobial drugs distributed in the U.S. While useful, these public summaries of ADUFA data are very short, comprising just a few pages that provide the quantities of certain antimicrobial drug classes sold in the previous calendar year (see the reports for 2009 and 2010). The summaries do not currently provide many data that non-governmental public health scientists, state and local public health officials, and veterinarians need to better understand patterns in antimicrobial use and resistance. Read More >
Rumor has it the next Farm Bill (minus a few titles) will be completed by the Ag Committee Chairs and handed to the “Super Committee” as early as today. The blogosphere has been atwitter with concern over this undemocratic process and there is a bipartisan effort in Congress to demand the Farm Bill be written through the more usual process—i.e. hearings on Capitol Hill and in the field, numerous briefings by interests groups, many meetings with advocates and Hill staff, etc., all taking place over months and months with the resulting bill being a true representation of the full populace’s input. Read More >
Last Friday, the U.S. Food and Drug Administration (FDA) posted data on antimicrobial drug sales collected under the Animal Drug User Fee Act (ADUFA). ADUFA requires drug companies to report information on sales of antimicrobial drugs intended for use in animals, including food animals. These data provide the most reliable information we have on the use of antimicrobials in animal agriculture. CLF’s Ralph Loglisci and David Love, PhD, used 2009 ADUFA data to calculate the quantity of antimicrobial drugs used in food animal production in that year as a percentage of the total amount of antimicrobial drugs used in the U.S. over the same period—the number, they determined, was almost 80 percent!
The data that FDA posted on its website (October 28) was a PDF that contained sales data for 2010. These data showed a significant increase in antimicrobial drug sales—almost 7 percent. But a funny thing must have happened over the weekend. Read More >
An article just out in Clinical Microbiology Reviews should put to rest the hotly contested debate about antimicrobial misuse in industrial food animal production (IFAP). The review article, “Food Animals and Antimicrobials: Impacts on Human Health,” written by Bonnie Marshall and Stuart Levy of the Tufts University School of Medicine, provides one of the most comprehensive summaries to-date of the evidence linking antimicrobial misuse in IFAP to increased incidence of antimicrobial-resistant infections in humans, and it should silence accusations made by elected officials who contend that there is insufficient evidence to support restrictions on antimicrobial use in agriculture.
These accusations have grown louder in recent months. In June of this year, Rep. Denny Rehberg (R-MT) attached an amendment to an appropriations bill that would have prohibited the Food and Drug Administration from spending money to restrict the use of antimicrobials in the absence of “hard science.” The “hard science amendment,” poorly written and clumsily introduced, was stripped from the legislation before it passed the House. But the arguments presented by Rehberg and other members nevertheless reveal a strident—and unwarranted—skepticism of existing scientific knowledge about antimicrobial resistance. Read More >
The pork and beef industries are having a field day with the recent Government Accountability Office (GAO) report on antibiotic resistance—and they are distorting the findings dramatically. Both industries are saying that the GAO found insufficient evidence to link antibiotic use in food animals and antibiotic resistance in humans. But what the report really tells us is that the FDA and USDA are not doing a good enough job collecting data on the connection between antibiotic use and resistance.
Two years ago, Rep. Louise Slaughter (D–NY) asked the GAO, the impartial research arm of Congress, to look into the efforts of two federal agencies (FDA and USDA) to curb antibiotic resistance that results from the inappropriate use of antimicrobials in food animal production. The GAO’s mandates included an examination of the extent to which these federal agencies are collecting data on the issue, as well as examinations of lessons learned by FDA and regulators in Denmark and the European Union. I think it’s very important to note that Rep. Slaughter did not ask the GAO to evaluate the extensive scientific literature connecting the use of antibiotics in food animal production to antibiotic-resistant infections in humans. Read More >
Nina Federoff, president of the American Association for the Advancement of Science (AAAS) and professor at Penn State University penned an opinion piece in the New York Times recently, asking for less regulation of genetically engineered (GE) crops. Professor Federoff would like to see more grant money available for research and more scientists working on the development of GE foods, but she states in her article that the regulatory bars of the EPA, USDA, and FDA are set too high and are stifling scientists from making innovations.
Ignoring the rest of her argument that GE seeds dramatically improve crop yields (they don’t and in fact agricecological farming methods are not only better for the environment but better for yields), reduce the use of chemicals (they don’t; pesticide use has increased since the introduction of GE crops in the U.S.), improve the lives of farmers (not in India or the U.S.), and have not been shown to cause harm to the environment (she forgot about the development of superweeds, pollution of waters, and harm to soil), let’s focus on her idea that regulations are too complicated and stringent. As you will see, this is simply not the case. In fact, regulations may be too lax, as they allow corporations driven by profit, not protecting public health, to drive the research (or lack thereof) to demonstrate safety, and, as well explained in many of the above articles, the U.S. experience with GM crops has indeed led to environmental problems. Read More >
The FY 2012 Agriculture appropriations bill, voted out of the House Appropriations Committee last week, includes an amendment that would severely limit the authority of FDA to regulate the use of antimicrobials, including antibiotics, in food animal production-a key concern of public health researchers. Sponsored by Rep. Denny Rehberg (R-MT), the amendment would prohibit the agency from spending any money appropriated by the bill on actions “intended to restrict the use of a substance or a compound” unless certain conditions are met. Although the amendment is broad-affecting any “substance or compound,” notably including tobacco-Rep. Rehberg has told The Washington Post that his goal was to block FDA action on the use of antimicrobials by food animal producers. Indeed, the amendment would, among other things, preempt upcoming FDA restrictions on the misuse use of cephalosporin-the antibiotic of choice for serious Salmonella infections in children. (Researchers have reported increased incidence of cephalosporin-resistant Salmonella infections [Foley and Lynne, 2008].) Joining many others in the public health community, researchers at the Center for a Livable Future recently sent a letter to Congress , urging members to strike the amendment from the legislation before final passage.
The Rehberg amendment reads as follows (we have broken it into numbered and lettered points to make the language easier to follow):
None of the funds made available by this Act may be used by the Food and Drug Administration to write, prepare, develop or publish a proposed, interim, or final rule, regulation or guidance that is intended to restrict the use of a substance or a compound unless the Secretary
- bases such rule, regulation or guidance on hard science (and not on such factors as cost and consumer behavior), and
- determines that the weight of toxicological evidence, epidemiological evidence, and risk assessments clearly justifies such action,
- including a demonstration that a product containing such substance or compound
a. is more harmful to users than a product that does not contain such substance or compound, or
b. in the case of pharmaceuticals, has been demonstrated by scientific study to have none of the purported benefits. Read More >
Researchers at Cambridge University say they have found a new strain of methicillin-resistant Staphylococcus aureus (MRSA) in milk from England, Scotland and Denmark, which they are calling LGA251.
The findings – published online by The Lancet Infectious Diseases – can be seen as a further signal that the routine use of antibiotics in industrial food animal production is producing novel public health risks, and diminishing the effectiveness of antibiotics in human medicine.
Center for a Livable Future Director Robert Lawrence said the new findings “underscore the urgent need to protect the effectiveness of a critical medical and public health resource – and this unambiguously translates to the obvious step of eliminating the irresponsible administration of antibiotics to food animals.”
In December, the U.S. Food and Drug Administration confirmed that 80% of the antibiotics used in the United States are used in food animals.
The authors of the Lancet study stressed that current testing protocols would fail to identify this new strain as MRSA, and that “new diagnostic guidelines for the detection of MRSA should consider the inclusion of tests for [LGA251].”
When moms talk you can bet lawmakers listen, not to mention food retailers. That is exactly what the Pew Campaign on Human Health and Industrial Farming is counting on following the release of a nationwide poll of 804 American moms, which found that 80 percent are concerned that food animals produced on industrial farms are being given large amounts of antibiotics. Each of these moms is a registered voter and has kids aged 16 or younger. Not only were most of the moms polled concerned about antibiotic use, more than three-quarters said they would support federal regulations to limit its use in food animals.
No doubt this news has the animal agriculture industry concerned. Despite the warnings from scientists and public health experts of the risks of the low-dose use of antibiotics in livestock and poultry, food animal producers have for years fought proposed federal regulations claiming there is little proof the practice poses a risk to humans. Top leaders of the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration disagree with animal producers. Former FDA Deputy Commissioner Joshua Sharfstein testified in front of Congress stating the links are undeniable and in a letter to the Johns Hopkins Center for a Livable Future (CLF) the director of the CDC, Dr. Thomas R. Frieden, confirmed that the CDC, “feels there is strong scientific evidence of a link between antibiotic use in food animals and antibiotic resistance in humans.”
More and more research continues to pour in, almost on a daily basis, linking antibiotic-use in intensive food animal production facilities to the growing threat of antibiotic resistant infections in people. Earlier this month, a Pew funded nationwide study of grocery store meats revealed nearly 50 percent of the meat and poultry we buy carries antibiotic-resistant Staphylococcus aureus and that DNA tests indicate the animals themselves were the primary sources. Read More >
