Drug Safety Solutions, Inc. and Target e*Pharmacovigilance


Drug Safety Solutions, Inc. (DSS), an independent safety monitoring company is now using Target e*Pharmacovigilance for safety and SAE management. Our good friend and colleague Dr. Gil Price is CEO and Chief Medical Officer.


Drug Safety Solutions’ portfolio of services includes medical monitoring, consulting, SAE management, Data Safety Monitoring Board (DSMB) coordination and management, trend and signal analysis, safety reviews, safety reporting, and coding and coding reviews. Whether an entire project team or a single professional is required, DSS sets the standard for providing high quality, flexible and efficient solutions for today’s clinical research outsourcing needs.


Target e*Pharmacovigilance™ is a secure, user-friendly, web-based software that manages the reporting of serious adverse events for pharmaceutical and device companies. Target e*Pharmacovigilance generates a FDA approved MedWatch Form 3500A and CIOMS 1 Forms fully integrated with Target e*CRF and Target Encoder (AE and medication coding) or as a stand-alone software. Target e*Pharmacovigilance has been used in multiple clinical trials and regulatory approvals.


For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com

Reservoir of Antibiotic Resistance Genes Discovered



Waters polluted by the ordure (offensive filth) of pigs, poultry, or cattle represent a reservoir of 1) ___ resistance genes, both known and potentially novel. These resistance genes can be spread among different bacterial species by bacteriophage, bacteria-infecting viruses, according to a paper in Antimicrobial Agents and Chemotherapy. “We found great quantities of bacteriophages carrying different antibiotic 2) ___ genes in waters with fecal pollution from pigs, cattle, and poultry,” says Maite Muniesa of the University of Barcelona, Spain, an author on the study. “We demonstrated that the genes carried by the phages were able to generate resistance to a given antibiotic when introduced into other 3) ___ in laboratory conditions,” says Muniesa.


Although we often think of antibiotic resistance genes as evolving into existence in response to the antibiotics that doctors use to fight human 4) ___ and that agribusiness uses to fatten farm animals, microbes had undoubtedly been using both antibiotics and resistance genes to compete with each other for millions of years before antibiotics revolutionized human medicine and resistance 5) ___ threatened their efficacy to the point where the World Health Organization considers them to be one of the biggest risks to human health. Thus, the Spanish researchers suspect, based on their study, that these resistance gene reservoirs are the product of microbial competition, rather than pressure from human use of antibiotics. They note that the pasture-fed cattle in their study are not fed antibiotics, and they suggest that even if antibiotic feed additives were banned, new resistance genes might emerge while old ones spread from these reservoirs into bacteria that infect 6) ___. And if resistance genes are being mobilized from these reservoirs, it becomes important to understand how the resistance genes are transmitted from phage to new bacterial species, in order to develop strategies that could hinder this transmission, limiting the emergence of new resistance genes, says Muniesa.


A bacteriophage is any one of a number of 7) ___ that infect bacteria. They do this by injecting genetic material, which they carry enclosed in an outer protein capsid. The genetic material can be ssRNA, dsRNA, ssDNA, or dsDNA along with either circular or linear arrangement. Bacteriophages are among the most common and diverse entities in the biosphere. The term is commonly used in its shortened form, phage. Phages are widely distributed in locations populated by bacterial hosts, such as soil or the intestines of animals. One of the densest natural sources for phages and other viruses is sea water, where up to 9X108 virions per mL have been found in microbial mats at the surface, and up to 70% of marine bacteria may be infected by phages. They have been used for over 90 years as an alternative to antibiotics in the former Soviet Union as well as in France. They are seen as a possible 8) ___ against multi-drug-resistant strains of many bacteria.


ANSWERS: 1) antibiotic; 2) resistance; 3) bacteria; 4) disease; 5) genes; 6) humans; 7) viruses; 8) therapy


Cave Bacteria Finding Suggests Ancient Origins of Antibiotic-Resistant Superbugs


Lechuquilla cave image courtesy of Max Wisshak



Lechuguilla Cave was discovered in 1986. Since then, the U.S. Park Service has tightly restricted access to only a few scientific researchers and cave experts per year. Surrounded by a thick layer of watertight rock, the cave also is geologically isolated. The scientists say it can take up to 10,000 years for water to reach the inner-recesses of the cave where they collected the bacteria samples for their study.

Bacteria are highly-adaptable microscopic single-cell organisms. One of Earth’s earliest life forms, evidence in the fossil record indicates bacteria have existed for about 3.5 billion years. In addition to malaria, examples of other serious illnesses caused by bacterial infection include bubonic plague, tuberculosis, salmonella, and certain types of pneumonia and meningitis. However, not all bacteria are bad or cause disease. Most are harmless to humans. Naturally-occurring bacteria in the human body help digest food, provide vital nutrients, fight cancer cells, and destroy disease-causing microbes. First discovered 70 years ago, antibiotics are only effective against disease caused by bacterial infection. However, decades of widespread overuse, especially in agriculture industries, and via over-prescription by doctors, has made increasing types of disease-causing bacteria – so-called superbugs – immune to antibiotics. There is increasing concern among scientists and medical experts that current antibiotic treatments could become completely ineffective against bacterial infections, which would be catastrophic for millions of people around the world suffering from diseases such as malaria.


But the capacity to fend off antibiotics might actually be lodged deep in bacteria’s evolutionary history. A new study has uncovered dozens of species of bacteria in a 4 million-year-old cave that harbor resistance to both natural and synthetic antibiotics. New research findings suggest the key to finding a whole new variety of antibiotics to treat drug-resistant infections may lie with the resident bacteria in one of the most isolated caves in the world. A team of researchers descended to 400 meters in distant, untrafficked reaches of Lechuguilla Cave in New Mexico to collect samples of bacteria. Few people have entered the cave’s deepest regions since its discovery in 1986, and surface water takes thousands of years to percolate through the nearby dense Yates Formation rock down to the cave. As a consequence, the area is a prime place to study naturally occurring antibiotic resistance. The study results were published online April 2012, in PLoS ONE.


“Our study shows that antibiotic resistance is hard-wired into bacteria,” Gerry Wright, director of McMaster University’s Michael G. DeGroote Institute for Infections Disease Research and co-author of the new study, said in a prepared statement. “It could be billions of years old.” Members of this team had also recently shown that there was genetic evidence of antibiotic resistance in soil bacteria from 30,000 years ago. And other studies had found evidence of resistance in life found in the deep ocean and deep below the Earth’s surface. In both cases, as with the Lechuguilla Cave, it is unlikely that local bugs could be contaminated by modern-day antibiotics. The U.S. scientists who conducted the study say bacteria collected from Lechuguilla Cave in the state of New Mexico appear to possess an innate resistance to antibiotics, despite never having been exposed to any human sources. Some of the bacteria had a pre-existing defense against as many as 14 different antibiotics. In all, the cave-dwelling organisms showed a naturally-developed resistance to virtually every antibiotic currently used to treat bacterial infections.


While this may sound like bad news, the authors explained that finding isolated, drug-resistant bacteria actually is a good thing. They say it suggests there are many types of previously unknown, naturally-occurring antibiotics in the environment that can be developed to use against currently untreatable infections. Meanwhile, the scientists who conducted the new research point out that none of the Lechuguilla Cave bacteria used in their work are capable of making people sick.


Lechuquilla cave image courtesy of Max Wisshak



Wright and his colleagues found that of the 93 bacterial strains tested from the cave, most were resistant to more than one of the 26 different antimicrobials. And some bacteria were resistant to more than a dozen antibiotics used by doctors, such as telithromycin, ampicillin and daptomycin, which is currently a treatment of last resort to combat resistant infections. The cave bacteria were not likely to cause infection in humans, but could provide the genetic traits that confer resistance to that are. The finding hardly exonerates humans for our role in creating conditions that exert a strong selective pressure on bacteria to become tolerant and resistant to antibiotics. But it does mean that pathogenic drug-resistant bacteria might deploy genetic traits that were already circulating in the environment and put them to use against our pharmaceutical armamentarium. “Most practitioners believe that bacteria acquire antibiotic resistance in the clinic,” Wright said. “The actual source of much of this resistance are harmless bacteria that live in the environment,” responding to naturally occurring antibacterials. “This has important clinical implications,” Wright said. “It suggests that there are far more antibiotics in the environment that could be found and used to treat currently untreatable infections.”


Scientists have long believed that the ability of disease-causing bacteria to outwit antibiotic medicines was a man-made phenomenon, said Eileen Choffnes, director of the Institute of Medicine’s forum on microbial threats. The growing use of antibiotics derived from plants and synthesized in laboratories was thought to have spurred adaptations that made many of these bacterial pathogens less vulnerable to drugs used to fight tuberculosis, malaria, gonorrhea, influenza, pneumonia and AIDS.


But the new research demonstrates that antibiotic resistance emerged millions of years before those medicines were used – and in an environment far too forbidding for the bacteria to have come into any contact with the drugs, Choffnes said. he findings make it clear that humans will always have to contend with the problem of antibiotic resistance, no matter what steps are taken to prevent it, said Dr. Brad Spellberg, an infectious disease researcher at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center: “There’s never going to be a point where we can say, ‘OK, we’re up, we’re ahead, they’re done.’”


Researchers have harvested bacteria on the Earth’s surface that was thousands of years old and reported last year that some of them were resistant to antibiotics. That might have been due to exposure to natural antibiotic threats in their environment. “This pushes it way back,” Spellberg said.


For the new study, about 500 strains of bacteria from three sites in the cave were brought to the surface by Hazel A. Barton, a spelunker and microbiologist at the University of Akron in Ohio. To harvest them, she burrowed into areas of the cave where the National Park Service could ensure that no more than six humans had ever been near. Barton’s samples were kept alive in lab dishes that approximated their nutrient-poor origins. The 93 strains that survived and were chosen for evaluation were subjected to 26 antimicrobial agents, ranging from natural products such as vancomycin to completely synthetic agents such as ciprofloxacin and linezolid. In one group of bacterial strains – the “gram-positive” strains – 70% of the samples were resistant to between three and four classes of antibiotics, on average. The same was true of 65% of the “gram-negative” strains. Tetracycline antibiotics were effective against all of the bacterial samples. But sulfamethoxazole, trimethoprim and fosfomycin were not. Three ancient strains of bacteria in the Streptomyces genus proved resistant to daptomycin, the newest class of antibiotic approved for clinical use.


In an interview, Barton said that the discovery that ancient bacteria were immune to so many modern medicines was “a eureka moment.” In addition to familiar patterns of resistance, the researchers also discovered a new mechanism of resistance, suggesting that more drug-evading tricks might be waiting in nature’s wings. “This fact further underlines the importance of judicious use of antibiotics,” the researchers wrote in their paper. Our pill-popping culture and over-zealous livestock farmers typically take the blame for the widespread resistance of many harmful strains of bacteria to entire classes of antibiotics.


The Food and Drug Administration has taken a move, with a new voluntary plan to help curtail the over-use of antibiotics in agriculture.


The study was led by researchers from McMaster University and the University of Akron, both in the state of Ohio.  A report on their findings is published in the journal, PLoS One (Public Library of Science One).


Sources: Katherine Harmon, ScientificAmerican.com; Melissa Healy, The LA Times, The New York Times, Wikipedia

Silent Heart Attacks are Common and Can Predict Risk of Death


According to an article published in the Journal of the American Medical Association (JAMA. 2012;308(9):890-896), magnetic resonance imaging (MRI) is more effective than electrocardiography (ECG) at identifying “silent” heart attacks, also known as unrecognized myocardial infarctions. Overall, the study found that silent heart attacks are more frequent than previous studies have reported, particularly in certain populations such as older adults with diabetes. Silent heart attacks appear to be much more common than those with recognized symptoms.


The study involved 936 participants aged 67 to 93 years, enrolled in the Age Gene/Environment Susceptibility-Reykjavik Study (AGES). Of the participants, 670 were randomly selected and 266 were selected because they were known to have diabetes. Because 71 of the randomly selected participants also had diabetes, the overall study population consisted of 337 people who had diabetes and 599 who did not.


Results from cardiac MRI indicated that more participants, both with and without diabetes, had silent heart attacks (21% and 14%, respectively) than recognized heart attacks (11% and 9%, respectively). ECG was less effective, detecting silent heart attacks in only 5% of the participants in both groups. Silent heart attacks identified by cardiac MRI were associated with a higher risk of mortality during the study period, while silent heart attacks identified by ECG were not. However, participants who had either form of heart attack were significantly more likely to die than those who had neither. The analysis also found that people with silent heart attacks displayed many cardiovascular risk factors associated with recognized heart attacks, such as high blood pressure and evidence of atherosclerosis (a disease in which plaque builds up inside the arteries). Yet, fewer study participants who had a silent heart attack were taking medications such as statins or aspirin compared with survivors of recognized heart attacks (36% vs. 73%).


According to the authors, people who may have an increased risk for silent heart attacks, such as older people with diabetes, may benefit from following cardiovascular disease prevention methods, given the high prevalence of silent heart attacks and their association with increased mortality.

High Blood Pressure is Out of Control for Too Many Americans


In spite of its epidemic proportions, hypertension is a modifiable risk factor for cardiovascular disease. Just think about the potential saving in healthcare costs and improved productivity if we can just get hypertension “under control.”


According to the CDC, high blood pressure (hypertension) is a major risk factor for heart disease and stroke and affects one in three adults in the US. Hypertension contributes to one out of every seven deaths and nearly half of all cardiovascular disease-related deaths in the US. Nearly one-third of all American adults have hypertension and more than half of them don’t have it under control and many don’t even know they have it. Millions are taking blood pressure medicines, but their blood pressure is still not under control. There are many missed opportunities for people with hypertension to gain control and doctors, nurses and others in health care systems should identify and treat their patients at every visit.


In February 2011, CDC published a report in Morbidity and Mortality Weekly Report (60:103-108) which analyzed data from the National Health and Nutrition Examination Survey (NHANES) on the prevalence, treatment, and control of hypertension among U.S. adults aged >18 years. Hypertension was defined as an average blood pressure >140/90 mmHg or the current use of blood pressure lowering medication. Control of hypertension was reported as an average treated systolic/diastolic blood pressure <140/90 mmHg.


Results showed that during 2005-2008, approximately 68 million (31%) U.S. adults aged >18 years had hypertension, and this prevalence has shown no improvement in the past decade. Of these adults, 48 million (70%) were receiving pharmacologic treatment and 31 million (46%) had their condition controlled. Although 86% of adults with uncontrolled blood pressure had medical insurance, the prevalence of blood pressure control among adults with hypertension was especially low among participants who did not have a usual source of medical care (12%), received medical care less than twice in the previous year (21%), or did not have health insurance (29%). Control prevalence also was low among young adults (31%) and Mexican Americans (37%). Although the prevalence of hypertension did not change from 1999-2002 to 2005-2008, significant increases were observed in the prevalence of treatment and control.


According to the authors, hypertension affects millions of persons in the US, and less than half of those with hypertension have their condition controlled. Prevalence of treatment and control are even lower among persons who do not have a usual source of medical care, those who are not receiving regular medical care, and those who do not have health insurance. The authors added that to improve blood pressure control in the US, a comprehensive approach is needed that involves policy and system changes to improve health-care access, quality of preventive care, and patient adherence to treatment. Health-care system improvements, including use of electronic health records with registry and clinical decision support functions, could facilitate better treatment and follow-up management, and improve patient-physician interaction. Allied health professionals (e.g., nurses, dietitians, health educators and pharmacists) could help increase patient adherence to medications. Patient adoption of healthy behaviors could improve their blood pressure control. Reducing dietary intake of salt would greatly support prevention and control of hypertension; a 32% decrease in average daily consumption, from 3,400 mg to 2,300 mg, could reduce hypertension by as many as 11 million cases. Further reductions in sodium intake to 1,500 mg/day could reduce hypertension by 16.4 million cases.

Ginkgo Biloba Extract Does Not Reduce the Risk of Progression to Alzheimer’s Disease


Clearly prevention strategies are urgently needed to tackle the growing burden of Alzheimer’s disease but as we can see from the following report, “hope” is not necessarily the best way to go forward. Understanding the science of a disease and identifying targeted therapies may be a better use of our limited resources.


A study published online in The Lancet (6 September 2012) was performed to assess efficacy of long-term use of standardized ginkgo biloba extract for the reduction of incidence of Alzheimer’s disease (AD) in elderly adults with memory complaints. In a randomized fashion, the study enrolled adults aged 70 years or older who spontaneously reported memory complaints to their primary-care physician in France. Subjects were randomly allocated in a 1:1 ratio according to a computer-generated sequence to a twice per day dose of 120 mg standardized ginkgo biloba extract (EGb761) or matched placebo. Participants were followed-up for 5 years by primary-care physicians and in expert memory centers. The primary outcome was conversion to probable AD in participants who received at least one dose of study drug or placebo.


Between March, 2002, and November, 2004, the study enrolled and randomly allocated 2,854 participants, of whom 1406 received at least one dose of ginkgo biloba extract and 1414 received at least one dose of placebo. By 5 years, 61 participants in the ginkgo group were diagnosed with probable AD (1.2 cases per 100 person-years) compared with 73 participants in the placebo group (1.4 cases per 100 person-years; p=0.306). In addition:


  1. 76 participants in the ginkgo group died compared with 82 participants in the placebo group (p=0.68)
  2. 65 participants in the ginkgo group had a stroke compared with 60 participants in the placebo group (p=0.57).
  3. Incidence of other hemorrhagic or cardiovascular events also did not differ between groups.
  4. The overall incidence of adverse events was much the same between groups.


According to the authors, long-term use of standardized ginkgo biloba extract in this trial did not reduce the risk of progression to AD compared with placebo.

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area.


FDA Approves Orphan Drug for Chronic Myelogenous Leukemia



An estimated 5,430 men and women will be diagnosed with chronic myelogenous leukemia (CML) in 2012. Most people with CML have a genetic mutation, called the Philadelphia chromosome, which causes the bone marrow to make an enzyme called tyrosine kinase. This enzyme triggers the development of too many abnormal and unhealthy white blood cells called granulocytes. Granulocytes fight infection.


The FDA has approved Bosulif (bosutinib) to treat CML and it is intended for patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML who are resistant to or who cannot tolerate other therapies, including imatinib. Bosulif works by blocking the signal of the tyrosine kinase that promotes the development of abnormal and unhealthy granulocytes. Other drugs recently approved by FDA to treat various forms of CML include imatinib (2001), dasatinib (2006) and nilotinib (2007).


The safety and effectiveness of Bosulif was evaluated in a single clinical trial that enrolled 546 adult patients who had chronic, accelerated or blast phase CML. All patients had disease that progressed after treatment with imatinib or imatinib followed by dasatinib and/or nilotinib, or who could not tolerate the side effects of prior therapy. All patients in the trial were treated with Bosulif.


In patients with chronic phase CML, efficacy was determined by the number of patients who experienced a major cytogenetic response (MCyR) within the first 24 weeks of treatment. Results showed 34% of patients who had been previously treated with imatinib achieved MCyR after 24 weeks. Of the patients who achieved MCyR at any time, 52.8% had their response last at least 18 months. Among patients previously treated with imatinib followed by dasatinib and/or nilotinib, about 27% achieved MCyR within the first 24 weeks of treatment. Of those who achieved MCyR at any time, 51.4% had their MCyR last at least nine months.


In patients with accelerated CML previously treated with at least imatinib, 33% had their blood counts that returned to normal range (complete hematologic response) and 55% achieved normal blood counts with no evidence of leukemia (overall hematologic response) within the first 48 weeks of treatment. Meanwhile, 15% and 28% of patients with blast phase CML achieved complete hematologic response and overall hematologic response, respectively.


The most common side effects observed in those receiving Bosulif were diarrhea, nausea, a low level of platelets in the blood (thrombocytopenia), vomiting, abdominal pain, rash, low red blood cell count (anemia), fever and fatigue.


Bosulif is marketed by New York City-based Pfizer.

Marinara Sauce from Scratch (salt-free)




  • 3 onions
  • 8 cloves of garlic
  • 1 red bell pepper
  • One dozen Roma or Plum tomatoes
  • 1 can (about 7 oz) tomato paste (use this until you make your own….will give recipe soon)
  • One box of Shitake or Cremini mushrooms (they have the best flavor and worth the cost)
  • 2 teaspoons Extra Virgin Olive Oil
  • Italian seasoning
  • 1 and ¼ teaspoons of oregano
  • 1 basil leaf (remove before serving)
  • ¼ teaspoon fine black pepper
  • 1/3 cup fresh parsley, chopped (use the tiny curly leaf parsley, not flat leaf)
  • 2 teaspoon, red wine (use real red wine and not cooking wine)
  • 2 packets Splenda sugar substitute



  • Cut a thin slice off the top of each tomato before boiling, also cut an X in the bottom to make it easier to peel after blanching. Blanch the tomatoes in boiling water for a few minutes. Let the tomatoes cool, then peel them, slice them in half and squeeze the halves out over a bowl, to get rid of all those seeds and excess liquid. (save this juice, until the end, and add it, if the sauce gets too thick).
  • Slice the mushrooms and fry in a tiny bit of the oil in a large pan, stirring constantly.
  • Chop the onions, garlic and pepper really well. Add the rest of the oil to the pan with the mushrooms, and add the onion, garlic, and pepper and cook really well, until they start to get golden, or clear (5 to 10 minutes). Stir constantly, so nothing burns.
  • While the onions & garlic are cooking, throw the tomatoes into a blender and mostly puree, not completely, leave some chunks. Or you can just chop the tomatoes well by hand.
  • When the onions are starting to brown, or they’re clear, start putting in the tomatoes and stir well.
  • Put in all of the above seasonings, plus the sugar substitute, stir well and bring to a boil. Then reduce heat and simmer for 20 minutes, stirring constantly, so it doesn’t stick.
  • If this sauce gets too thick, add a little of the saved tomato juice, but remember, this sauce is supposed to be a little thick. If the sauce is too thin, cover and continue to simmer it until more of the liquid boils away and you reach the desired thickness.
  • Serve with your favorite pasta. To cut calories in half (or even less), we have weaned ourselves off the usual pasta and onto a Japanese pasta called Shirataki, which is a soy pasta. After you prepare this Shirataki pasta, you should cut (we use kitchen scissors) this pasta into shorter pieces. Shirataki pasta comes in different widths and we use both. You should make 3 bags at a time.

Shirataki Tofu Pasta



Cremini Mushrooms

Without Better Regulations, We Are All Going To Get Sick – Farm Use of Antibiotics Defies Scrutiny


Graphic: Ellen Weinstein
Based on an article published in The New York Times, September 4, 2012, by Sabrina Tavernise



The numbers released quietly by the federal government this year were alarming. A bacterium resistant to many types of antibiotics had increased tenfold on chicken breasts. However, instead of learning from a broad national inquiry into a troubling trend, there was a lack of available data. While 80% of the antibiotics sold in the US goes to chicken, pigs, cows and other animals that people eat, producers of meat and poultry are not required to report how they use the drugs – which ones, on what types of animal, and in what quantities. This dearth of information makes it difficult to document the precise relationship between routine antibiotic use in animals and antibiotic-resistant infections in people.


Advocates contend that there is already overwhelming epidemiological evidence linking the two, something that even the FDA has acknowledged, and that further study, while useful for science, is not essential for decision making. The blank spots in data collection are a serious handicap in taking on powerful producers of poultry and meat who claim the link does not exist. “It’s like facing off against a major public health crisis with one hand tied behind our backs,” said Keeve Nachman, an environmental health scientist at the Johns Hopkins Center for a Livable Future, which does research on food systems.


Antibiotics are considered the crown jewels of modern medicine. They have transformed health by stopping infections since they went into broad use after World War II. But many scientists say that their effectiveness is being eroded by indiscriminate use, both to treat infections in people and to encourage growth in chickens, turkeys, cows and pigs. Whatever the cause, resistant bacteria pose significant public health risks. Routine infections once treated with penicillin pills now require hospitalizations and intravenous drip antibiotics. Infections from such strains of bacteria are believed to cause thousands of deaths a year.


“The single biggest problem we face in infectious disease today is the rapid growth of resistance to antibiotics,” said Glenn Morris, director of the Emerging Pathogens Institute at the University of Florida. “Human use contributes to that, but use in animals clearly has a part too.” The FDA has tried in fits and starts to regulate the use of antibiotics in animals sold for food. Most recently it restricted the use of cephalosporins in animals – the most common antibiotics prescribed to treat pneumonia, strep throat and urinary tract infections in people.


In 1977, the FDA announced that it would begin banning some agricultural uses of antibiotics. The House and Senate appropriations committees – dominated by agricultural interests – passed resolutions against any such bans.


Antibiotic use in people can be closely monitored through the vast infrastructure of the nation’s health care system, but there is no equivalent for animals, making it harder to track use on farms and ranches, said William Flynn, the deputy director for science policy at the FDA Center for Veterinary Medicine. Many drugs are sold freely over the counter through feed suppliers, something the agency is trying to curb. In April, FDA proposed eliminating the use of certain antibiotics to stimulate growth in animals, and requiring meat and poultry producers to obtain a prescription before giving certain antibiotics to their animals. The agency just finished taking public comments to update the requirement.


The scale of the problem became clear in 2010 when the FDA began publishing total pharmaceutical company sales of antibiotics for use in animals raised for human consumption. It turned out that an overwhelming majority of antibiotics produced went to animals, not people. But there is still a glaring lack of information about how the drugs are used. The one set of data that is regularly released – a measure of antibiotic-resistant bacteria carried by meat and poultry – contains such small samples that most are reluctant to rely on it. The dramatic rise in the presence of salmonella on chicken breasts that was resistant to five or more classes of antibiotics, for example, was based on samples from just 171 breasts, an infinitesimal fraction of the more than eight billion birds raised and sold as food in the US every year.


Another problem is that regulatory responsibility is fractured. The FDA regulates drugs, but agriculture is the purview of the federal Department of Agriculture. The Centers for Disease Control and Prevention also has a role. John Glisson, the director of research programs at the U.S. Poultry and Egg Association, an industry group, said that poultry feed mills “keep detailed records of antibiotic usage in the feed they manufacture.” The FDA “has the authority to inspect and audit these records,” he said, adding that the agency “can have access to these records anytime.” But regulators say that in reality, access is not easy. While they may have authority to look at the records from any food manufacturer, they cannot collect or publish the data. Indeed, in July the National Pork Producers Council argued that its members should not be required to report on antibiotic prescriptions for their animals because it would add complexity.


FDA said that it was moving as fast as it could to make sure antibiotics are used judiciously in farm animals and that the plan to require animal producers to get prescriptions for certain antibiotics “an important shift.”