Target e*Studio Version 2 – New Revolution in EDC Being Released May 1 2013

 

Since 1999, Target Health Inc. has been providing EDC services using our proprietary EDC software Target e*CRF®. To date, there have been 25 unique EDC approvals world-wide, and yes 3 approvals in 2012. Several years ago a decision was made to create new software to allow programmers and data managers, anywhere in the world, to be able to configure EDC applications easily and without “breaking the bank.”

 

So what did we do? We built and released Target e*Studio® Version 1 for programmers. Basically, Version 1 allowed a more modern-looking graphical user interface (GUI), better workflow, and the facilitation of the application build with more controls.

 

We also collaborated with our colleagues at LSK in Korea, led by our friend and colleague Dr. Jack Lee, where LSK is now fully up and running and building applications in both English and Korean, yes Korean.

 

The Target e*Studio software has proven so successful that we decided to create Version 2 with the following additional built-in features:

 

1. Form and edit check builders

2. Library of studies

3. Library of edit check functions

4. Randomization module

5. Drug and device supply management

6. Full integration with Batch Edit Checks

7. Full integration with Target Encoder®

8. Full integration with Target e*PharmacovigilanceTM

9. Full integration with Target e*CTR® (eClinical Trial Record; eSource)

10. Online monitoring Reports

11. and many more features

 

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

Deadly Bacteria That Resist Strongest Drugs Are Spreading

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Deadly infections with bacteria that resist even the strongest 1) ___ are on the rise in hospitals in the United States, and there is only a “limited window of opportunity” to halt their spread. These dangerous bacteria are referred to as CRE, which means Carbapenem-Resistant Enterobacteriaceae. The bacteria, normally found in the 2) ___, have acquired a lethal trait: they are unscathed by antibiotics, including carbapenems, a group of drugs that are generally considered a last resort. When these resistant germs invade parts of the body where they do not belong, like the bloodstream, lungs or urinary tract, the illness may be untreatable. The 3) ___ rate from bloodstream infections can reach 50%.

 

Dr. Thomas R. Frieden, director of the CDC (4) ___ ___ ___ ___ ___ ___), has called the organisms “nightmare bacteria” and has noted that they could pass their trait for drug resistance – encoded in a scrap of genetic material called a plasmid – along to other bacteria. Most people who contract these infections already have other serious illnesses that require complicated treatment and lengthy stays in hospitals, nursing homes or long-term care facilities. One bit of good news is that the infections do not seem to have spread beyond 5) ___ into the community at large. But that could easily happen.

 

According to a new report by the disease centers, among all infections with gut bacteria, the proportion caused by carbapenem-resistant types rose to 4% in 2012, from 1% in 2001; among infections caused by one type of bacteria, Klebsiella, 10% have become resistant, compared with 2% a decade ago.

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Klebsiella bacteria

 

Drug-resistant Klebsiella, traced to one patient, caused a notorious outbreak in 2011 at a hospital at the NIH ( 6) ___ ___ of ___). Seventeen other people were infected, and six of them died.

 

Forty-two states have had cases of carbapenem-resistant infection. The problem is most common in the Northeast, particularly in hospitals in New York City, officials said. Nationwide, about 4% of short-stay hospitals reported such infections in the first half of 2012, but the rate was much higher – 18% – among long-term acute-care hospitals, which treat people who need ventilators for a long time or who have other 7) ___ problems.

 

The disease centers recommended a variety of ways to try to stop the infections from spreading. The advice includes the usual call for ruthless scrubbing of all surfaces and relentless 8) ___. But hospitals are also urged to find out whether patients are infected, isolate those who are, and assign dedicated-care teams and equipment to infected people only, to avoid spreading the 9) ___ to others. Catheters and intravenous lines should be removed as quickly as possible, because they can be avenues of 10) ___, and doctors should prescribe antibiotics only when they are truly needed. Health officials also urge patients and their loved ones to insist that medical personnel wash their hands before touching a 11) ___. Source: The New York Times, March 7, 2013, by Denise Grady

 

ANSWERS: antibiotics; 2) gut; 3) death; 4) Centers for Disease Control and Prevention; 5) hospitals; 6) National Institutes of Health; 7) chronic; 8) handwashing; 9) bacteria; 10) infection; 11) patient

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Germ Theory

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Romans came up with one of the best and most sophisticated medical systems of the ancient world. The science of medicine and the human body was slowly evolving.

 

The earliest mention of germ theory was in the first century BCE, by a highly educated Roman named Marcus Terentius Varro, in his document, De Re Rustica, where he writes about tiny animals causing disease. Here is a short translation: “Precautions must also be taken in the neighborhood of swamps, both for the reasons given, and because there are bred certain minute creatures which cannot be seen by the eyes, which float in the air and enter the body through the mouth and nose and there cause serious diseases.” It’s interesting that in the same document with the sophisticated notion of airborn “minute creatures,” Varro also prescribes the following for foot pain: “when a man’s feet begin to hurt he may be cured if he will actively think of you, the physician: ‘I am thinking of you, cure my feet. The pain go in the ground, and may my feet be sound.’He bids you chant this thrice nine times, touch the ground, spit on it, and be fasting while you chant.” Here is clear evidence that scientific intellectual progress is not linear, but comes in sputters and spurts, interspersed with superstition and magical thinking.

 

Roman medical theories were sometimes very close to what we know today. Marcus Terentius Varro (116 BCE – 27 BCE) believed disease was caused by miniature creatures too small for the naked eye to see (bacteria and viruses are too small to see). Others were still looking up at the sky – Crinas of Massilia was sure that our illnesses were caused by the stars. Lucius Junius Moderatus Columella (CE 4 – circa CE 70), an agricultural writer, thought diseases came from swamp vapors. Many of these beliefs prevailed until a couple of hundred years ago.

 

Roman surgeons, most of whom got their practical experience on the battlefield, carried a tool kit which contained arrow extractors, catheters, scalpels and forceps. They used to sterilize their equipment in boiling water before usage. Surgical procedures were performed using opium and scopolamine as painkillers, and acid vinegar (acetum) to clean up wounds. They did not have what we would consider as effective anesthetics for complicated surgical procedures; it is doubtful they carried out surgical operations deep inside the body.

 

Unlike the Greeks who would place their patients in temples in the hope that the gods might help cure them, the Romans had purpose-built hospitals where patients could rest and have a much better chance of recovering. In hospital settings, doctors were able to observe sick patients, instead of depending on supernatural forces to perform miracles. By not allowing doctors to dissect corpses, Roman doctors were rather limited in human anatomy research. Even though some of their progress was undermined by initially rejecting Greek ideas about medicine, they made great progress in trying to understand what causes diseases, and then finding ways of preventing them.

 

Roman physicians were strongly influenced by what the Greeks used to do, and would carry out a thorough physical exam of the patient. Many of their treatments were also influenced by Greek practices. Roman diagnosis and treatment of patients consisted of a combination of Greek medicine and some local practices. They did have a wide range of herbal medicines and other remedies: Willow was used as an antiseptic and fennel for many other illnesses. Galen said that opposites would often cure patients. For a cold he would give the patient hot pepper. If a patient had a fever, he advised doctors to use cucumber.

 

The Romans believed in public health, that is, maintaining the whole community in good health. Today, this involves preventing the spread of disease, vaccination programs, promoting healthy lifestyles and good eating habits, building hospitals, providing clean water for people to drink and wash themselves, etc. The Romans, unlike the Greeks and Egyptians, were strong believers in public health. They knew that hygiene was vital to prevent the spread of diseases. They promoted facilities for personal hygiene in a big way by building public baths, toilets and sewage systems. Although their focus was on maintaining a motivated and healthy army, their citizens also benefited. There were nine public baths in Rome alone. Each one had pools of varying temperatures. Some of them had gyms and massage rooms. Government inspectors enforced high hygiene standards vigorously. The sewage system in Rome was so advanced, that nothing like it was built again until the late 17th century AD. Despite their impressive projects which helped improve public health, they were not yet aware of the association of germs with diseases.

 

Hospitals started in Ancient Rome. The first ones were built to treat soldiers and veterans. The Romans were also superb engineers and built several aqueducts to supply people with water. They took the advice of Marcus Varro and were careful to place army barracks well away from swamps. If marshes got in the way, they would drain them. The Romans were aware of the link between swamps and mosquitoes and the diseases they could transmit to humans.

 

Perhaps the overarching medical advance of the 19th century, certainly the most spectacular, was the conclusive demonstration that certain diseases, as well as the infection of surgical wounds, were directly caused by minute living organisms. This discovery changed the whole face of pathology and effected a complete revolution in the practice of surgery. The idea that disease was caused by entry into the body of imperceptible particles was of ancient date. It had been expressed by the Roman encyclopedist, Marco Varro as early as 100 BCE, by Fracastoro in 1546, by Athanasius Kircher and Pierre Borel. Girolamo Fracastoro proposed in 1546 that epidemic diseases are caused by transferable seed-like entities that transmit infection by direct or indirect contact, or even without contact over long distances.

 

The Italian physician Francesco Redi provided early evidence against spontaneous generation. He devised an experiment in 1668 in which he used three jars. He placed a meatloaf and egg in each of the three jars. He had one of the jars open, another one tightly sealed, and the last one covered with gauze. After a few days, he observed that the meat loaf in the open jar was covered by maggots, and the jar covered with gauze had maggots on the surface of the gauze. However, the tightly sealed jar had no maggots inside or outside it. He also noticed that the maggots were found only on surfaces that were accessible by flies. From this he concluded that spontaneous generation is not a plausible theory.

 

Microorganisms were first directly observed by Anton van Leeuwenhoek, who was an early pioneer in microbiology. Building on Leeuwenhoek’s work, physician Nicolas Andry argued in 1700 that microorganisms he called “worms” were responsible for smallpox and other diseases.

 

1.         Agostino Bassi

The Italian Agostino Bassi was the first person to prove that a disease was caused by a microorganism when he conducted a series of experiments between 1808 and 1813, demonstrating that a “vegetable parasite” caused a disease in silkworms known as calcinaccio. This disease was devastating the French silk industry at the time. The “vegetable parasite” is now known to be a fungus pathogenic to insects called Beauveria bassiana (named after Bassi).

 

2.         Ignaz Semmelweis

Ignaz Semmelweis was an obstetrician working at the Vienna General Hospital (Allgemeines Krankenhaus) in 1847, when he noticed the dramatically high incidence of death from puerperal fever among women who delivered at the hospital with the help of the doctors and medical students. Births attended by the midwives were relatively safe. Investigating further, Semmelweis made the connection between puerperal fever and examinations of delivering women by doctors, and further realized that these physicians had usually come directly from autopsies. Asserting that puerperal fever was a contagious disease and that matter from autopsies were implicated in its development, Semmelweis made doctors wash their hands with chlorinated lime water before examining pregnant women, thereby reducing mortality from childbirth from 18% to 2.2% at his hospital. Nevertheless, he and his theories were at first rejected by most of the Viennese medical establishment.

 

3.         John Snow

John Snow was a skeptic of the then-dominant miasma theory. The germ theory of disease had not yet been developed, so Snow did not understand the mechanism by which the disease was transmitted. He first published his theory in an 1849 essay On the Mode of Communication of Cholera. Despite continuing reports, he was awarded 30,000 French francs for this work by the Institut de France. In 1855 he published a second edition of his article, documenting his more elaborate investigation of the effect of the water supply in the Soho, London epidemic of 1854. By talking to local residents, he identified the source of the outbreak as the public water pump on Broad Street (now Broadwick Street). Although Snow’s chemical and microscope examination of a water sample from the Broad Street pump did not conclusively prove its danger, his studies of the pattern of the disease were convincing enough to persuade the local council to disable the well pump by removing its handle. This action has been commonly credited as ending the outbreak, but Snow observed that the epidemic may have already been in rapid decline. Snow later used a dot map to illustrate the cluster of cholera cases around the pump. He also used statistics to illustrate the connection between the quality of the water source and cholera cases. He showed that the Southwark and Vauxhall Waterworks Company was taking water from sewage-polluted sections of the Thames and delivering the water to homes, leading to an increased incidence of cholera. Snow’s study was a major event in the history of public health and geography. It is regarded as one of the founding events of the science of epidemiology.

 

Later, researchers discovered that this public well had been dug only three feet from an old cesspit, which had begun to leak fecal bacteria. The diapers of a baby, who had contracted cholera from another source, had been washed into this cesspit. Its opening was originally under a nearby house, which had been rebuilt farther away after a fire. The city had widened the street and the cesspit was lost. It was common at the time to have a cesspit under most homes. Most families tried to have their raw sewage collected and dumped in the Thames to prevent their cesspit from filling faster than the sewage could decompose into the soil.

 

After the cholera epidemic had subsided, government officials replaced the handle on the Broad Street pump. They had responded only to the urgent threat posed to the population, and afterward they rejected Snow’s theory. To accept his proposal would have meant indirectly accepting the oral-fecal method transmission of disease, which was too unpleasant for most of the public to contemplate.

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Louis Pasteur in his laboratory, painting by A. Edelfeldt in 1885

 

4.         Louis Pasteur

The more formal experiments on the relationship between germ and disease were conducted by Louis Pasteur between 1860 and 1864. He discovered the pathology of the puerperal fever and the pyogenic vibrio in the blood, and suggest using boric acid to kill these micro-organisms before and after confinement. Louis Pasteur further demonstrated between 1860 and 1864 that fermentation and the growth of microorganisms in nutrient broths did not proceed by spontaneous generation. He exposed freshly boiled broth to air in vessels that contained a filter to stop all particles passing through to the growth medium: and even with no filter at all, with air being admitted via a long tortuous tube that would not pass dust particles. Nothing grew in the broths, therefore the living organisms that grew in such broths came from outside, as spores on dust, rather than being generated within the broth. Abraham Groves developed aseptic surgery techniques in the 1870s because he considered surgical infections to be transmitted by fluids as he knew typhoid was spread. Pasteur discovered that another serious disease of silkworms, pebrine, was caused by a small microscopic organism now known as Nosema bombycis (1870). Pasteur saved the silk industry in France by developing a method to screen silkworms eggs for those that are not infected, a method that is still used today to control this and other silkworm diseases

.

5.         Robert Koch

Robert Koch is known for developing four basic criteria (known as Koch’s Postulates) for demonstrating, in a scientifically sound manner, that a disease is caused by a particular organism. These postulates grew out of his seminal work with the anthrax using purified cultures of the pathogen that had been isolated from diseased animals. Koch’s postulates were developed in the 19th century as general guidelines to identify pathogens that could be isolated with the techniques of the day. Even in Koch’s time, it was recognized that some infectious agents were clearly responsible for disease even though they did not fulfill all of the postulates. Attempts to rigidly apply Koch’s postulates to the diagnosis of viral diseases in the late 19th century, at a time when viruses could not be seen or isolated in culture, may have impeded the early development of the field of virology. Currently, a number of infectious agents are accepted as the cause of disease despite their not fulfilling all of Koch’s postulates. Therefore, while Koch’s postulates retain historical importance and continue to inform the approach to microbiologic diagnosis, fulfillment of all four postulates is not required to demonstrate causality. Koch’s postulates have also influenced scientists who examine microbial pathogenesis from a molecular point of view. In the 1980s, a molecular version of Koch’s postulates was developed to guide the identification of microbial genes encoding virulence factors.

Koch’s postulates are the following:

  1. The microorganism must be found in abundance in all organisms suffering from the disease, but should not be found in healthy organisms.
  2. The microorganism must be isolated from a diseased organism and grown in pure culture.
  3. The cultured microorganism should cause disease when introduced into a healthy organism.
  4. The microorganism must be reisolated from the inoculated, diseased experimental host and identified as being identical to the original specific causative agent.

 

However, Koch abandoned the universalist requirement of the first postulate altogether when he discovered asymptomatic carriers of cholera and, later, of typhoid fever.

Asymptomatic or subclinical infection carriers are now known to be a common feature of many infectious diseases, especially viruses such as polio, herpes simplex, HIV, and hepatitis C. As a specific example, all doctors and virologists agree that poliovirus causes paralysis in just a few infected subjects, and the success of the polio vaccine in preventing disease supports the conviction that the poliovirus is the causative agent.

 

The third postulate specifies “should”, not “must”, because as Koch himself proved in regard to both tuberculosis and cholera, not all organisms exposed to an infectious agent will acquire the infection. Noninfection may be due to such factors as general health and proper immune functioning; acquired immunity from previous exposure or vaccination; or genetic immunity, as with the resistance to malaria conferred by possessing at least one sickle cell allele. The second postulate may also be suspended for certain microorganisms or entities that cannot (at the present time) be grown in pure culture, such as prions responsible for Creutzfeldt–Jakob disease. In summary, a body of evidence that satisfies Koch’s postulates is sufficient but not necessary to establish causation.

 

Sanitation

In the 1870s, Joseph Lister was instrumental in developing practical applications of the germ theory of disease with respect to sanitation in medical settings and aseptic surgical techniques – partly through the use of carbolic acid (phenol) as an antiseptic. Simultaneous innovations in medical sanitation were developed independently by Ignaz Semmelweis. The full implications of germ theory for medical practice were not immediately apparent after it was proven; surgeons operated without masks or head coverings as late as the 1890s.

 

In 1928, however, the Germ Theory got a power boost. Dr. Alexander Fleming, a British scientist, accidentally discovered that his cultures were being destroyed by a certain mold. For the next 14 years, scientists in England and America were successful in isolating and testing penicillin, in secret. However, in 1942 a fire at The Cocoanut Grove, Boston’s oldest nightclub, killed and injured hundreds of people. Penicillin was rushed to Boston in time to prevent infection from burns in hundreds of patients. The news exploded, and the race to mass-produce penicillin, the Wonder Drug, was on. By 1944, all American military requirements for penicillin could be met. Merck to the rescue.

 

In his early research to formulate penicillin, Sir Alexander Fleming knew very well about the way living things could change or adapt when stressful substances were added. He knew, perhaps better than anyone, the dangers of resistance from overuse of penicillin, and warned against that overuse from the very beginning, as expressed in an interview Fleming gave to the New York Times in 1945: “The greatest possibility of evil in self-medication is the use of too-small doses, so that instead of clearing up infection the microbes are educated to resist penicillin.”

 

Today we do have the problem of drug resistant bacteria. Antibiotic resistance will be one of the biggest health challenges of the 21st century.

Possible Role of Climate in Influenza Transmission

 

Human influenza infections exhibit a strong seasonal cycle in temperate regions, and laboratory experiments suggest that low specific humidity facilitates the airborne survival and transmission of the virus in temperate regions. Specific humidity is the ratio of water vapor to dry air in a particular body of air while relative humidity – commonly used in weather forecasts – the amount of water vapor in the air relative to its capacity to hold water vapor, is primarily a function of temperature. Data from animal studies indicate low temperature and humidity increase the duration of the virus’s reproduction and expulsion in infected organisms and virus stability in the environment, increasing the probability of transmission through coughing, sneezing or breathing. In contrast, high temperature seems to block airborne transmission.

 

According to an epidemiological study published in PLoS Pathogens, 2 types of environmental conditions — cold-dry and humid-rainy — are associated with seasonal influenza epidemics,. The paper presents a simple climate-based model that maps influenza activity globally and accounts for the diverse range of seasonal patterns observed across temperate, subtropical and tropical regions.

 

According to the authors, the findings could be used to improve existing current influenza transmission models, and could help target surveillance efforts and optimize the timing of seasonal vaccine delivery. In addition, the model could have a broader application, encouraging researchers to analyze the association between climatic patterns and infectious disease across a wide range of diseases and latitudes.

 

After assessing the role of local climatic variables on virus seasonality in a global sample of study sites, the study found that temperature and specific humidity were the best individual predictors of the months of maximum influenza activity, known as influenza peaks. The research team discovered that in temperate regions, influenza was more common one month after periods of minimum specific humidity. These periods happen to coincide with months of lowest temperature. In contrast, sites that maintained high levels of specific humidity and temperature were generally characterized by influenza epidemics during the most humid and rainy months of the year. The models used predicted the timing of peak influenza activity with 75 to 87% accuracy.

 

To reach these conclusions, the authors used a recently developed global database that provides information on influenza peaks from 1975-2008 for 78 sites worldwide. The study spanned a range of latitude that was between 1 and 60 degrees, with 39% of the sites located in the tropics. Additionally, epidemiological data from nine countries participating in FluNet, the World Health Organization’s global influenza surveillance program, was used to ensure independent validation. The nine countries — including Spain, Tunisia, Senegal, Philippines, Vietnam, Colombia, Paraguay, South Africa and Argentina — were not represented in the original 78-location database and were chosen because each country provided several years of data.

 

According to the authors, though the study offers researchers a new tool in the global effort to track the spread of influenza, climate is only one of several potential drivers of influenza seasonality. As a result, further work should focus on examining the role of population travel and other factors in influenza transmission. More broadly, additional analysis of the link between climate and infectious diseases is needed — particularly for respiratory and intestinal pathogens that display marked seasonality as well as a better understanding of the environmental, demographic and social drivers of infectious disease seasonality.

Seven Genetic Risk Factors Found To Be Associated With Age-related Macular Degeneration (AMD)

 

Age-related macular degeneration (AMD) affects the macula, a region of the retina responsible for central vision. The retina is the layer of light-sensitive tissue in the back of the eye that houses rod and cone photoreceptor cells. Compared with the rest of the retina, the macula is especially dense with cone photoreceptors and is what humans rely on for tasks that require sharp vision, such as reading, driving, and recognizing faces. As AMD progresses, such tasks become more difficult and eventually impossible. Some kinds of AMD are treatable if detected early, but no cure exists. An estimated 2 million Americans have AMD.

 

Scientists have shown that age, diet, and smoking influence a person’s risk of developing AMD. Genetics also plays a strong role. AMD often runs in families and is more common among certain ethnicities, such as people of Asian or European descent.

 

Since the 2005 discovery that certain variations in the gene for complement factor H — a component of the immune system — are associated with major risk for AMD, research groups around the world have conducted genome-wide association studies to identify other loci that affect AMD risk. These studies were made possible by tools developed through the Human Genome Project which mapped human genes, and related projects, such the International HapMap Project, which identified common patterns of genetic variation within the human genome.

 

According to an article published online in the journal Nature Genetics (4 March 2013), seven new regions of the human genome — called loci – have been discovered that are associated with increased risk of AMD. The AMD Gene Consortium, a network of international investigators representing 18 research groups, also confirmed 12 loci identified in previous studies.

 

The study combined data from 18 research groups to increase the power of prior analyses. The analysis included data from more than 17,100 people with the most advanced and severe forms of AMD, which were compared to data from more than 60,000 people without AMD. The 19 loci that were found to be associated with AMD implicate a variety of biological functions, including regulation of the immune system, maintenance of cellular structure, growth and permeability of blood vessels, lipid metabolism, and atherosclerosis.

 

As with other common diseases, such as type 2 diabetes, an individual person’s risk for getting AMD is likely determined not by one but many genes. Further comprehensive DNA analysis of the areas around the 19 loci identified by the AMD Gene Consortium could turn up undiscovered rare genetic variants with a disproportionately large effect on AMD risk. Discovery of such genes could greatly advance scientists’ understanding of AMD pathogenesis and their quest for more effective treatments.

 

Income Inequality and 30 Day Hospital Readmission Outcomes After Acute Myocardial Infarction, Heart Failure, and Pneumonia

 

Editor’s Note: This article on US Medicare patients was published in the British Medical Journal.

 

According to an article published online in the British Medical Journal (14 February 2013), a retrospective cohort study was performed to examine the association between income inequality and the risk of mortality and readmission within 30 days of hospitalization.

 

This was a retrospective cohort study of Medicare beneficiaries in the United States presenting in acute care hospitals. Patients were aged 65 years and older, and hospitalized in 2006-08 with a principal diagnosis of acute myocardial infarction, heart failure, or pneumonia. Hierarchical, logistic regression models were developed to estimate the association between income inequality (measured at the US state level) and a patient’s risk of mortality and readmission, while sequentially controlling for patient, hospital, other state, and patient socioeconomic characteristics.

 

The main outcome measures were risk of death within 30 days of admission or rehospitalization for any cause within 30 days of discharge. The potential number of excess deaths and readmissions associated with higher levels of inequality in US states in the three highest quarters of income inequality were compared with corresponding data in US states in the lowest quarter.

 

From 2006 to 2008, the study identified 555,962 hospitalizations in 4,348 hospitals for acute myocardial infarction that met criteria for the mortality analysis, 1,092,285 hospitalizations in 4,484 hospitals for heart failure, and 1,146,414 hospitalizations in 4,520 hospitals for pneumonia. The readmission analysis included 553,037 hospitalizations in 4,262 hospitals for acute myocardial infarction, 1,345,909 hospitalizations in 4,494 hospitals for heart failure, and 1,345,909 hospitalizations in 4,524 hospitals for pneumonia.

 

In 2006-08, income inequality in US states (as measured by the average Gini coefficient over three years) varied from 0.41 in Utah to 0.50 in New York. The Gini coefficient is usually defined mathematically based on the Lorenz curve, which plots the proportion of the total income of the population (y axis) that is cumulatively earned by the bottom x% of the population Multilevel models showed no significant association between income inequality and mortality within 30 days of admission for patients with acute myocardial infarction, heart failure, or pneumonia. By contrast, income inequality was associated with rehospitalization (acute myocardial infarction, risk ratio 1.09, heart failure 1.07, and pneumonia 1.09. Further adjustment for individual income and educational achievement did not significantly attenuate these findings. Over the three year period, it was estimated that there was an excess of 7,153 readmissions for acute myocardial infarction, 17,991 for heart failure, and 14,127 for pneumonia, that are associated with inequality levels in US states in the three highest quarters of income inequality, compared with US states in the lowest quarter.

 

According to the authors, among patients hospitalized with acute myocardial infarction, heart failure, and pneumonia, exposure to higher levels of income inequality was associated with increased risk of readmission but not mortality.

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

 

Women’s History Month at FDA

 

 

American women have changed the landscape of scientific health research, medicine, and public health. In commemoration of Women’s History Month at FDA, FDA is highlighting the contributions of a number of pioneering women who made significant and long-lasting contributions to public health during their careers with the FDA. Featured women include:

 

Effie Alberta Read: Pioneer in the Laboratory

One of the few women in the Bureau of Chemistry, she was noted for developing a method to detect adulterated teas.

 

Mattie Rae Spivey Fox: Diet and Nutrition Researcher

Her work in researching the role of trace minerals and toxins in the diet was known around the world.

 

Ruth deForest Lamb: FDA’s First Chief Educational Officer

As FDA’s education officer, she was a strong advocate for consumers and a stronger federal food and drug statute.

 

Mary Engle Pennington: The “Cold Chain” of Food Safety

Head of the Bureau of Chemistry’s Food Research Lab in the first years after passage of the 1906 Pure Food and Drugs Act.

 

This Women’s History Month feature highlights the careers of women in FDA who have inspired their colleagues, advanced their fields, influenced the regulatory process and protected and promoted public health.

 

Mary Engle Pennington and Effie Alberta Read, worked for Chief Chemist Harvey Wiley in the Bureau of Chemistry at the turn of the 20th century, while Jane Henney served as FDA’s first female commissioner at the turn of the 21st century. Each was well-educated, focused, and challenged by their work. Each forthrightly characterized and confronted important scientific, regulatory, or administrative challenges during their years in government service.

 

Certainly luck played a role in each of their careers, as it does in that of most people, but passion played an even larger role. Ruth Lamb launched an innovative educational campaign to change the federal food and drug statute itself while Mattie Rae Spivey Fox conducted innovative research in the field of nutrition and food fortification. Imogene Gollinger, FDA’s first female investigator, initiated change throughout FDA field operations and Sharon Smith Holston, FDA’s first African American deputy commissioner became a mentor to many aspiring FDA administrators.

 

In the drug field, it would be difficult to overestimate the importance of contributions made to drug and vaccine safety by Ruth Kirschstein who developed tests to protect the public from contaminated polio vaccines, and Frances Kelsey, whose well known refusal to license thalidomide for U.S. sale averted a serious drug crisis. Marion Finkel not only helped write the regulatory requirements for modern clinical drug trials following enactment of the 1962 Drug Amendments, she also helped implement the Orphan Drug Act, making new medicines available for neglected patient populations. Susan Ellenberg refined statistical models during the AIDS epidemic to help speed up critical new drug approvals.

Chicken with Mushrooms and Crème fraîche

 

Dairy Bacteria

 

Crème fraîche (lit. ‘fresh cream’) is a soured cream containing about 28% butterfat and with a pH of around 4.5. It is soured with bacterial culture, but is less sour than U.S.-style sour cream, and has a lower viscosity and a higher fat content. European labeling regulation disallows any ingredients other than cream and bacterial culture.

 

Species Major known function Product
Propionibacterium shermanii Flavor & eye formation Swiss cheese family
Lactobacillus bugaricus

Lactobacillus lactis

Lactobacillus helveticus

Acid and flavor Bulgarian buttermilk, yoghurt, kefir, koumiss, Swiss, Emmental, and Italian cheeses, Crème fraîche*
Lactobacillus acidophilus Acid acidophilus buttermilk
Streptococcus thermophilus Acid Emmental, Cheddar, and Italian cheeses, and yogurt
Streptococcus diacetilactis Acid Sour cream, ripe cream, butter, cheese, buttermilk and starter cultures.
Streptococcus lactis

Streptococcus cremoris

Acid Cultured buttermilk, sour cream, cottage cheese, all types of foreign and domestic cheeses, and starter cultures.
Streptococcus durans

Streptococcus faecalis

Acid and flavor Soft Italian, cheddar, and some Swiss cheeses.
Leuconostoc citrovorum

Leuconostoc dextranicum

Flavor Cultured buttermilk, sour cream, cottage cheese, ripened cream butter, and starter cultures.

 

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Ingredients

 

1/2 cup of artificial bacon bits

1 Tablespoon butter, or substitute Olive or Canola oil

6 boneless, skinless chicken breasts

1 Tablespoon almond flour

1 cup dry white wine or cream sherry

1 cup oyster or cremini mushrooms, thinly sliced

1 garlic clove, minced

1 Onion, chopped well

1/2 cup Crème fraîche, plus extra to serve

4 teaspoons fresh rosemary, chopped

Salt and pepper to your taste

Extra rosemary for garnish

 

Directions

 

1. In a large casserole, saute the chicken and onion, in the butter or oil for about 5 minutes until golden

2. Sprinkle in the 1 Tablespoon of almond flour and turn the chicken pieces in the almond flour, to cover.

3. Gradually stir in the wine and bring to a boil stirring.

4. Add the mushrooms, garlic, Crème fraîche, rosemary, salt and pepper and stir well

5. Cover and simmer gently for 25 minutes or until the chicken is tender

6. Serve the chicken garnished with rosemary in the casserole

 

Or, on individual plates, serve the chicken over a mound of jasmine rice and spoon the mushrooms and gravy over the chicken. Add a dollop of Crème fraîche next to the chicken. Consider making broccoli sautéed in garlic and olive oil, to serve with this chicken. A simple tossed salad and warm rolls would round out this meal.

 

How about serving chilled white Zinfandel wine?

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Cheers! (white Zinfandel is pink)