Target Health is a Microsoft Silver Partner

 

 

As a leading provider of software products to support the paperless clinical trial, Target Health is pleased to announce that it is now a Microsoft Silver partner. Earning a silver competency allows Target Health to distinguish its business by placing it among the top 5% of Microsoft partners worldwide. By being a partner, Target Health will have access to:

 

  1. The latest internal-use software
  2. Business modeling tools and roadmaps
  3. Marketing campaigns
  4. Deep technical support and advisory services

 

Our software tools include:

 

  1. 1.   Target e*CRF® (EDC Made Simple)
  2. 2.   Target e*CTMS®
  3. 3.   Target Document®
  4. 4.   Target e*Pharmacovigilance®
  5. 5.   Target Encoder®
  6. 6.   Target Monitoring Reports™
  7. 7.   Target Newsletter®
  8. 8.   Target e*CTR® (electronic medical record for clinical trials)

 

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

Clear Brain Plaques with This Nutrient

 

Salmon fillet with baby spinach, mushrooms and sun-dried tomatoes

 

 

If your mother gave you vitamin D-rich cod 1) ___ oil when you were a child, she may have been way ahead of her time.

 

Posted this past week on the website of Mehmet Oz MD and Michael Roizen MD, was a new animal study from Japan, which suggests that vitamin D may help clear the brain of amyloid beta, a toxic protein-like compound that accumulates in the 2) ___ of Alzheimer’s patients. The animal study validates the results of a previous study done in human Alzheimer’s patients. In the human study, vitamin D together with curcumin – a chemical found in turmeric spice – appeared to stimulate the immune system in a way that helped clear the brain of toxic 3) ___ beta.

 

But this new animal research suggests that vitamin D alone may be able to do that job nicely. Even more amazing, the lab animals that received vitamin D were able to remove a significant amount of amyloid beta buildup in their brains, literally overnight. It seems the vitamin may somehow regulate production of transporter proteins that ferry amyloid 4) ___ across the blood-brain barrier and out of the brain.

 

In addition, another study done during flu season shows that people who had higher blood levels of vitamin 5) ___ were half as likely to get hit with the bug – or any other viral infection of the respiratory tract, for that matter. Not only were the high D level people, in the study, less likely to get 6) ___ compared with people who had lower D levels, but the high-D group also tended to be out of commission for fewer days when they did get hit. Of course, washing your hands frequently and living a healthy lifestyle are still the cornerstones of flu avoidance. But it’s nice to know that a D supplement could act as positive reinforcement. Researchers aren’t totally sure why D helps, but it could be that the nutrient’s inflammation-suppressing powers help reduce the severity of infections.

 

Many grown-ups lack vitamin D – especially in the 7) ___ months. Foods high in Vitamin D are: Cod liver oil, fortified milk, salmon, tuna, mackerel, & sardines, eggs, beef liver, fortified orange juice. Mushrooms are the only veggies with Vitamin D. According to Oz and Roizen, If you take Vitamin D supplements make sure it is Vitamin D3 and not D2. Vitamin D3 binds with calcium for proper absorption. Humans cannot digest calcium without adequate amounts of Vitamin D3. Aim for 1,000 IU of vitamin D3 per day and include what’s in your multi, your calcium-D3- magnesium tablet, your D-fortified milk or other fortified foods. Yes, we’ve seen the Internet buzz about taking super-high doses on your own. Don’t do it. The Institute of Medicine says over 4,000 IU per day can be 8) ___. Superpills packing 10,000 IU should only be taken under medical supervision, usually by those who don’t absorb it well or who need a special regimen.

 

ANSWERS: 1) liver; 2) brains; 3) amyloid; 4) beta; 5) D; 6) sick; 7) winter. 8) harmful

Joseph Lister, 1st Baron Lister

 

Joseph Lister MD, photo taken 1912

 

 

Because of the recent outbreak of Listeria in cantaloupes, these last weeks, we present the physician whose name was bestowed upon this pathogenic bacteria, Joseph Lister, 1st Baron Lister OM, FRS, PC (5 April 1827 – 10 February 1912). Lister was a British surgeon and a pioneer of antiseptic surgery, who promoted the idea of sterile surgery. Lister successfully introduced carbolic acid (now known as phenol) to sterilize surgical instruments and to clean wounds, which led to reducing post-operative infections and made surgery safer for patients.

 

Lister came from a prosperous Quaker home in Upton, Essex, a son of Joseph Jackson Lister, the pioneer of the compound microscope. He attended the University of London, one of only a few institutions which were open to Quakers at that time. He initially studied the Arts, but graduated with honors as Bachelor of Medicine and entered the Royal College of Surgeons at the age of 26. In 1854, Lister became both first assistant to and friend of surgeon James Syme at the University of Edinburgh, Edinburgh Royal Infirmary in Scotland. In 1867, Lister discovered the use of carbolic acid as an antiseptic, such that it became the first widely used antiseptic in surgery. He subsequently left the Quakers, joined the Scottish Episcopal Church and eventually married Syme’s daughter Agnes.  On their honeymoon, they spent 3 months visiting leading medical institutes (hospitals and universities) in France and Germany. By this time Agnes was enamored of medical research, and was Lister’s partner in the laboratory for the rest of her life.

 

Joseph Lister

 

 

Until Lister’s studies of surgery most people believed that chemical damage from exposure to bad air (“miasma”) was responsible for infections in wounds. Hospital wards were occasionally aired out at midday as a precaution against the spread of infection via miasma, but facilities for washing hands or a patient’s wounds were not available. A surgeon was not required to wash his hands before seeing a patient because such practices were not considered necessary to avoid infection. Despite the work of Ignaz Semmelweis and Oliver Wendell Holmes, hospitals practiced surgery under unsanitary conditions.

 

While he was a professor of surgery at the University of Glasgow, Lister became aware of a paper published by the French chemist Louis Pasteur, showing that rotting and fermentation could occur under anaerobic conditions if micro-organisms were present. Pasteur suggested three methods to eliminate the micro-organisms responsible for gangrene: filtration, exposure to heat, or exposure to chemical solutions. Lister confirmed Pasteur’s conclusions with his own experiments and decided to use his findings to develop antiseptic techniques for wounds. As the first two methods suggested by Pasteur were inappropriate for the treatment of human tissue, Lister experimented with the third.

 

Friedlieb Runge (1797-1867) discovered creosote, which later was processed into carbolic acid. Although Runge had no understanding of how decomposition occurred, the chemical he invented was widely used to prevent it. The chemical had been used to treat the wood used for railway ties and ships since it protected the wood from rotting. Later, it was used for treating sewage in England, Belgium and Holland. The same chemical was also used to fight parasites and reduce the odors during cholera and cattle plague.

 

Therefore, Lister tested the results of spraying instruments, the surgical incisions, and dressings with a solution of it. Lister found that carbolic acid solution swabbed on wounds remarkably reduced the incidence of gangrene. In August 1865, Lister discovered the antiseptic properties of carbolic acid by applying a piece of lint dipped in the solution onto the wound of an eleven year old boy at Glasgow Infirmary, who had sustained a compound fracture after a cart wheel has passed over his leg. After four days, he renewed the pad and discovered that no infection had developed, and after a total of six weeks he was amazed to discover that the boy’s bones had fused back together, without the danger of suppuration. He subsequently published a series of articles on the Antiseptic Principle of the Practice of Surgery describing this procedure in The British Medical Journal.

 

Lister also noticed that midwife-delivered babies had a lower mortality rate than surgeon-delivered babies, correctly attributing this difference to the fact that midwives tended to wash their hands more often than surgeons, and that surgeons often would go directly from one surgery, such as draining an abscess, to delivering a baby. He instructed surgeons under his responsibility to wear clean gloves and wash their hands before and after operations with 5% carbolic acid solutions. Instruments were also washed in the same solution and assistants sprayed the solution in the operating theatre. One of his additional suggestions was to stop using porous natural materials in manufacturing the handles of medical instruments.

 

Lister left Glasgow in 1869, returning to Edinburgh as successor to Syme as Professor of Surgery at the University of Edinburgh, and continued to develop improved methods of antisepsis and asepsis. His fame had spread by then, and audiences of 400 often came to hear him lecture. As the germ theory of disease became more widely accepted, it was realized that infection could be better avoided by preventing bacteria from getting into wounds in the first place. This led to the rise of sterile surgery. Some consider Lister “the father of modern antisepsis”. In 1879 Listerine mouthwash was named after him for his work in antisepsis. Also named in his honor is the bacterial genus Listeria, typified by the food-borne pathogen Listeria monocytogenes.

 

Lister moved from Scotland to King’s College Hospital, in London, and became the second man in England to operate on a brain tumor. He also developed a method of repairing kneecaps with metal wire and improved the technique of mastectomy. His discoveries were greatly praised and in 1883 he was created a Baronet, of Park Crescent in the Parish of St Marylebone in the County of Middlesex. In 1897 he was further honored when he was raised to the peerage as Baron Lister, of Lyme Regis in the County of Dorset.He also became one of the twelve original members of the Order of Merit and a Privy Councilor in the Coronation Honors in 1902.

 

Lister retired from practice after his wife, who had long helped him in research, died in 1892 in Italy, during one of the few holidays they allowed themselves. Studying and writing lost appeal for him and he sank into religious melancholy. Despite suffering a stroke, he still came into the public light from time to time.

 

Edward VII came down with appendicitis two days before his coronation. Like all internal surgery at the time, the appendectomy needed by the King still posed an extremely high risk of death by post-operational infection, and surgeons did not dare operate without consulting Britain’s leading surgical authority. Lister obligingly advised them in the latest antiseptic surgical methods (which they followed to the letter), and the King survived, later telling Lister, “I know that if it had not been for you and your work, I wouldn’t be sitting here today.”

 

Lister died on 10 February 1912 at his country home in Walmer, Kent at the age of 84.

 

Lister is one of the two surgeons in the United Kingdom who have the honor of having a public monument in London, Lister’s stands in Portland Place (the other surgeon is John Hunter). There is a statue of Lister in Kelvingrove Park, Glasgow, celebrating his links with the city. A building at Glasgow Royal Infirmary which houses cytopathology, microbiology and pathology departments was named in his honor to recognize his work at the hospital.

 

Finally, the Discovery Expedition of 1901–04 named the highest point in the Royal Society Range, Antarctica, Mount Lister.

Imaging Of Traumatic Brain Injury Patients

 

 

Target Health is very pleased to announce that it is providing regulatory (IND approved), protocol writing and data management services for a Department of Defense project to treat patients, including wounded warriors, with traumatic brain injury (TBI).

 

According to the NIH, researchers have a new weapon in their arsenal to diagnose and treat TBI and post-traumatic stress disorder (PTSD) among military service members and civilians. The National Institutes of Health Clinical Center began imaging patients last week on a first-of-its-kind, whole-body simultaneous positron emission topography (PET) and magnetic resonance imaging (MRI) device. The Biograph mMR offers a more complete picture of abnormal metabolic activity in a shorter time frame than separate MRI and PET scans, two tests many patients undergo.

 

The purchase of the Biograph mMR was made possible through the Center for Neuroscience and Regenerative Medicine (CNRM), a Department of Defense-funded collaboration between the NIH and the Uniformed Services University of the Health Sciences. The CNRM carries out research in TBI and PTSD that would benefit servicemen and women at Walter Reed National Navy Medical Center, near the NIH campus in Bethesda, Md. Researchers at the NIH Clinical Center will also use the Biograph mMR in studies with patients with other brain disorders, cardiovascular disease, and cancer.

 

The new device makes patient care swifter and safer. The faster turnaround time and more comprehensive results will help diagnose patients at an earlier stage of disease, leading to better outcomes. Additionally, traditional PET scanners combine computed tomography imaging, which uses radiation, while the MRI and PET technology of the new Biograph mMR does not. The risk of exposure to low doses of medical radiation from diagnostic medical-imaging tests is not known, but very high radiation doses have the potential to cause cancer.

 

The CNRM works to develop innovative approaches to diagnosis and intervene for the prevention of long-term consequences resulting from TBI. Under the CNRM Diagnostics and Imaging Program, researchers characterize each patient’s injury to optimize diagnosis and inform the plan of treatment from among the available options.

Gene Variant Connects Response to Asthma Drugs

 

Asthma is a complex inflammatory disease that affects over 22 million people in the US and roughly 300 million people worldwide. Many factors can influence how severely the disease affects people and how well they respond to treatments. Poor response to inhaled corticosteroids (ICS) often runs in families, suggesting that genetics plays a role in how people respond to asthma treatments.

 

According to an article published online in the New England Journal of Medicine (26 September 2011), a genetic variant may explain why some people with asthma do not respond well to ICSs, the most widely prescribed medicine for long-term asthma control. The study found that asthma patients who have two copies of a specific gene variant responded only one-third as well to steroid inhalers as those with two copies of the regular gene. This genome-wide association study analyzed data from over 1,000 people enrolled in five separate clinical trials that studied different steroid treatments for asthma.

 

The study first conducted a genome-wide scan of the DNA of children enrolled in the Childhood Asthma Management Program and of their parents. The genomic scan uncovered a variant in a gene called GLCCI1 that appeared to be associated with poor ICS response. This association was then verified in 935 additional people with asthma, both children and adults, enrolled in four independent ICS studies. Since most of the participants in these studies were white, the results may not be applicable to persons of other ethnicities.

 

Results showed that people carrying two copies of the GLCCI1 variant were more than twice as likely to respond poorly to ICS treatment as participants with two copies of the regular GLCCI1 gene. Those who responded poorly had an average of one-third the level of lung improvement following inhaler treatment as did people with two regular copies of the gene. About 1 in 6 study participants had two copies of the GLCCI1 variant.

 

According to the authors, more studies will be needed to understand how GLCCI1 operates in the lungs and to explore whether it contributes to response in patients of other ethnic groups.

Alcohol Consumption at Midlife and Successful Ageing in Women

 

Throughout history, there have been arguments about the risks and benefits of beer, wine, and spirits. It is clear that excessive alcohol use-heavy drinking (an average of more than two drinks per day for men or more than one drink per day for women; in the US, a “drink” is defined as 15 g of alcohol or, roughly speaking, a can of beer or a small glass of wine) or binge drinking (five or more drinks on a single occasion for men; 4 or more drinks at one time for women) – is harmful. Excessive drinking causes liver damage and increases the risk of developing some types of cancer. It also contributes to depression and violence, interferes with relationships, and is often implicated in fatal traffic accidents. However, in contrast to these and other harms associated with excessive alcohol use, moderate alcohol consumption seems to reduce the risk of specific diseases such as heart disease, stroke, and cognitive decline (deterioration in learning, reasoning, and perception).

 

While observational studies have documented inverse associations between moderate alcohol consumption and risk of premature death, it is largely unknown whether moderate alcohol intake is also associated with overall health and well-being among populations who have survived to older age. As a result, a study published in PLoS Medicine (September 2011), was performed to prospectively examine alcohol use at midlife in relation to successful ageing in a cohort of US women.

 

For the study, alcohol consumption was assessed at midlife using a validated food frequency questionnaire. Subsequently, successful ageing was defined in 13,894 Nurses’ Health Study participants who survived to age 70 or older, and whose health status was continuously updated. “Successful ageing” was considered as being free of 11 major chronic diseases and having no major cognitive impairment, physical impairment, or mental health limitations. Analyses were restricted to the 98.1% of participants who were not heavier drinkers (>45 g/d) at midlife. Of all eligible study participants, 1,491 (10.7%) achieved successful ageing. After multivariable adjustment of potential confounders, light-to-moderate alcohol consumption at midlife was associated with modestly increased odds of successful ageing. The odds ratios (1.0 referent) for nondrinkers, were 1.11 for <5.0 g/d, 1.19 for 5.1 to 15.0 g/d, 1.28 for 15.1 to 30.0 g/d, and 1.24 for 30.1–45.0 g/d. Meanwhile, independent of total alcohol intake, participants who drank alcohol at regular patterns throughout the week, rather than on a single occasion, had somewhat better odds of successful ageing; for example, the odds ratios were 1.29 and 1.47 for those drinking 3-4 days and 5-7 days per week in comparison with nondrinkers, respectively, whereas the odds ratio was 1.10 for those drinking only 1-2 days per week.

 

These findings suggest that regular, moderate consumption of alcohol at midlife may be related to a modest increase in overall health among women who survive to older ages. Because this is an observational study, it is possible that the women who drank moderately share other unknown characteristics that are actually responsible for their increased chance of successful ageing. Moreover, because all the study participants were women and most had European ancestry, these findings cannot be applied to men or to other ethnic groups. Nevertheless, these findings provide support for the 2010 US Department of Agriculture dietary guidelines, which state that consumption of up to one alcoholic drink per day for women and up to two alcoholic drinks per day for men may provide health benefits. Importantly, they also suggest that drinking alcohol regularly in moderation rather than occasional heavy drinking may be associated with a greater likelihood of successful ageing.

TARGET HEALTH Inc. excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.

 

 

Consumer Directed Value Based Decisions – Panacea or Trojan Horse

 

By Mark L. Horn MD, MPH, CMO Target Health Inc.

 

 

Is the decision to defer, delay or entirely avoid medical care, a reflection of an informed consumer making a value based choice or a desperate consumer forced to choose among medical care, food, shelter and other necessities?

 

A recent Consumer Reports poll, widely reported in the press suggests it is, at least in part, the latter; our citizens are increasingly skimping on (or entirely skipping) prescribed health care services as a consequence of persistent and increasing economic distress. In addition to medication related issues, e.g. failing to fill prescriptions, splitting pills and using expired medications, patients are postponing doctor visits, recommended tests, and procedures. It is highly likely that among these suggested but ‘declined’ interventions are preventive services designed and acknowledged to detect serious or life-threatening problems at early stages when they can be managed in less invasive and risky (as well as more cost-effective) ways.

 

What is striking about the poll, the behaviors that it captures and the concern it elicits, is that many reformers, among them influential policymakers, seek to inject precisely this sort of price consciousness into consumer directed health care decisions. The fact that the Consumer Reports poll apparently focused upon financially distressed citizens does not alter the reality that, conceptually at least, this is precisely the sort of economically driven, value based consumer behavior that many in leadership positions advocate as the market based ‘cure’ for out of control health spending.

 

The dilemma posed is clear; encouraging financially motivated value based decisions in the utilization of health care services creates risks for the individuals potentially least equipped to judge the real value of the prescribed care. The burden will likely prove heaviest for our most vulnerable citizens. Additionally, and ironically, due to the fact that these individuals may well be insured (sometimes through public programs) for catastrophic care, there are compelling externalities. Specifically, to the extent that avoidance of routine services increases the need for emergency care, individuals’ decisions to defer or delay care (for which they might have been personally financially responsible) creates an exponentially greater financial risk for the broader public…in sum, in addition to the suffering imposed upon our fellow-citizens, this policy may transform a (relatively) small individual financial responsibility into a major societal burden.

 

Should this occur in large numbers of patients, the economic consequences of financially stressed health care consumers making individual decisions about the relative value of their care translates into potentially catastrophic expenditures for the rest of us.

 

The Consumer Reports survey warns us, once again, that we need beware of the “unintended consequences” of well-intentioned policy initiatives. As is always true in health care…First, do no harm.

 

 

 

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Joyce Hays, CEO
Jules T. Mitchel, President