Target Health in Wikipedia

Target Health in Top 30 CROs After “Big 10”

 

Target Health has been listed in alphabetical order, in Wikipedia as one of the top 30 CROs after the so-called “Big 10.” Congratulations to the best professional team in the industry.

 

Annual DIA Meeting – PhiladelphiaJune 25– 28, 2012

 

Target Health will again be exhibiting at the annual meeting of the Drug Information Association being held in Philadelphia this year. Visit us at Booth 2542.

 

On Tuesday 26 June, please also attend the Forum entitled: “Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials.” The forum will present data collected from the Clinical Trials Transformation Initiative (CTTI) survey on clinical trial monitoring and auditing practices used by organizations to address regulatory requirements, provide a rationale for the re-evaluation of these practices, and summarize new industry trends in the areas of monitoring and auditing of clinical trials.

 

Forum participants include:

 

1. Joan Harley, BSN, RN, Training Consultant and eLearning Developer, Training Extension, Division of Pastor Consulting, Inc

2. Cynthia Kleppinger, MD, Senior Medical Officer, Office of Scientific Investigations, CDER, FDA

3. Cynthia R. Zacharias, Executive Director, Clinical Operations-Americas, Celgene Corporation

4. Jennifer K. Giangrande, PharmD, Senior Regional Manager, Hoffmann-La Roche Inc.

5. Jules T. Mitchel, MBA, PhD, President, Target Health Inc.

 

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

QUIZ

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Getting to Know What’s in the ACA

 

 

In late March of 1) ___, the U.S. Congress finished passing the Patient Protection and Affordable Care Act (H.R. 3590) and the Health Care and Education Reconciliation Act of 2010 (H.R. 4872). Soon after, President Obama signed these pieces of legislation into law, creating Public Law 111-148 (the Patient Protection and Affordable Care Act) and Public Law 111-152 (the Health Care and Education Reconciliation Act of 2010). Together, these laws are commonly known as the 2) ___ ___ ___ (ACA). These laws will result in significant reform of our nation’s health care system, including extending health care coverage to many more 3) ___ of Americans.

 

The changes in the new laws do not all happen immediately, but will take effect over a period of years, through 4) ___.

 

Over the past decade, health insurance costs for employers who provide insurance to their workers increased by 5) ___. Losses due to productivity and absenteeism related to health are estimated to be more than 6) $___ annually. America spends more than 7) ___ of GDP on health care, far more than our competitor nations. Health reform will help reduce these costs and put businesses on a stronger financial footing.

 

In May 2012, the Department of Health and Human Services (HHS) released the latest step towards expanding community living with the final rule creating the Community First Choice (CFC) Option. Thanks to the new health care law, CFC gives States additional resources to make community living a first choice, and leave 8) ___ homes and institutions as a fall back option. Under CFC, States can receive a six percentage point increase in federal matching funds for providing community-based attendant services and supports to people with Medicaid.

 

The Affordable Care Act helps all Americans, including people with 9) ___ and seniors, live at home with the supports they need, rather than in nursing homes or other institutions, and participate in communities that value their contributions. Recently announced are grants, made possible by the Affordable Care Act to support 398 renovation and construction projects at Community Health Centers nationwide. These projects will help Community Health Centers serve nearly 900,000 more patients. And these grants are just one of the ways the new health care law is making Community Health Centers stronger. The health care law has already supported 190 construction and renovation projects at health centers and the creation of 67 new health center sites across the country.

 

Since the beginning of 2009, employment at health centers nationwide has increased by 10) ___. Affordable Care Act and the Recovery Act are enabling, community health centers to serve nearly 11) ___ additional patients today.

 

The new health care law strengthens 12) ___ and wellness efforts around the country and expands investments in primary care programs in which nurses play a vital role. Currently, 16,000 nurses work at community health centers providing primary and preventive care – including oral and behavioral health care – to about 20 million patients at more than 8,500 sites. Because of the efforts of the ACA to expand the health center programs, health centers have added about 3,000 nursing positions, including 800 in advanced practice. The National Health Service Corps (NHSC) places primary care providers in underserved urban and rural areas for at least 13) ___ years in exchange for scholarships and for paying down their student loans. The health care law allocated $1.5 billion over five years to grow the NHSC. The number of nurse practitioners in the NHSC has more than doubled to 1,750, since 2009. New in 2012, the State Loan Repayment Program has expanded State-run programs to include registered nurses. The Nursing Education Loan Repayment Program budget has more than doubled. Under this program, RNs and nurse practitioners who work for two years in a facility with a critical nursing shortage can get 14) ___ % of their school debt paid. Under the Graduate Nurse Education Demonstration, a new Affordable Care Act initiative, CMS will provide up to $200 million over four years to cover the costs of clinical training for advanced practice registered nurses to hospitals working with nursing schools.

 

The ACA recognizes that many self-employed individuals often can’t get health insurance because of a preexisting condition. To rectify this problem, a temporary national Preexisting Condition Insurance Plan (PCIP) was established in July, 2010 and provides up to $5 billion in federal funding to cover those who have been denied coverage due to preexisting conditions. The Affordable Care Act allows the self-employed who have been uninsured for at least six months to get coverage through their state’s temporary high-risk pool. It includes limits on premiums, caps on cost-sharing and making premium subsidies available to individuals based on income eligibility. Once a complete ban on the denial of health insurance due to a preexisting condition takes place in 15) ___, self-employed Americans will have even more options when choosing coverage.

 

ANSWERS: 1) 2010; 2) Affordable Care Act; 3) millions; 4) 2019; 5) 113 percent; 6) $250 billion; 7) 17%; 8) nursing; 9) disabilities; 10) 15 percent; 11) 3 million; 12) prevention; 13) two; 14) 60%; 15) 2014

The Commonwealth Fund

 

1931 Portrait of Commonwealth Fund Founder, Anna M. Richardson Harkness (1837 – 1926), who was an American philanthropist

 

 

The Commonwealth Fund, one of the first foundations to be established by a woman, was founded in 1918 with an endowment of almost $10 million by Anna M. Harkness. The widow of Stephen V. Harkness, a principal investor in Standard Oil, Mrs. Harkness wanted to “do something for the welfare of mankind.” Anna’s son, Edward Stephen Harkness, became the Commonwealth Fund’s first president and hired a staff of people to help him build the foundation. Edward Harkness possessed a “passionate commitment to social reform” and was “determined to improve health and health services for Americans.” Through additional gifts and bequests between 1918 and 1959, the Harkness family’s total contribution to the Fund’s endowment amounted to more than $53 million. Today, the Commonwealth Fund’s endowment stands at almost $700 million.

 

According to the Rockefeller Archive Center, The Commonwealth Fund’s “early grants supported a variety of programs while generally promoting welfare, especially child welfare.” Over the years, it has given support to medical schools and to the building of hospitals and clinics. In New York City, the Commonwealth Fund was a major contributor to the building of Columbia-Presbyterian Medical Center of the College of Physicians and Surgeons and Presbyterian Hospital at Columbia University in 1922. By the mid-1920s the chief interest of the foundation had become public health, including mental hygiene, community health, rural hospitals, medical research, and medical education. Other grant areas included war relief, educational and legal research, and international medical fellowships.

 

In 1925, the Commonwealth Fund launched its international program of fellowships called The Commonwealth Fund Fellowships (now the Harkness Fellowships). Until the 1990s, the fellowship was open to scholars of all academic disciplines, and included many who went on to excel in science, the arts and business. From the late 1920s through the 1940s, the Commonwealth Fund supported the construction of rural hospitals, paving the way for the Hill-Burton Act in 1946. Following World War II, the foundation supported the development of new medical schools in the United States in an effort to address doctor shortages and meet the needs of communities lacking health care services. Other achievements include the Rochester Regional Hospital Council and the development of the Nurse Practitioner and Physician Assistant professions.

 

Dr. Georgios Papanikolaou’s Commonwealth Fund-supported research in the 1940s pioneered the Pap test as the basic technique for detecting cervical cancer. Refinement of cardiac catheterization into routine treatment resulted in a 1956 Nobel Prize for the Fund-supported researchers.

 

In the 1960s and early 1970s, the organization focused on developing urban health care systems, and in the late 1970s, worked to improve medical school curricula. In the 1980s, the Commonwealth Fund played a prominent role in the development of the patient-centered care movement and helped draw attention to the needs of older Americans.

 

The Program on Health System Quality and Efficiency focuses on greater coordination and accountability among all those involved in the delivery of health care. One project of note is State Action on Avoidable Rehospitalizations(STAAR), run by the Institute for Healthcare Improvement (IHI) with Commonwealth Fund support since 2009. To date nearly 150 STAAR hospitals in three states have joined more than 500 community-based partners such as nursing homes in the push to improve care transitions. The program also operates WhyNottheBest.org, an online resource for health professionals that enables them to track performance across hospitals and regions.

 

The Program on Patient-Centered Coordinated Care sponsors activities aimed at improving the quality of primary health care in the United States, including efforts to make care more centered around the needs and preferences of patients and their families. In April 2008, The Commonwealth Fund launched the five-year Safety Net Medical Home Initiative to support the transformation of 65 primary care clinics serving low-income and uninsured people into patient-centered medical homes.

 

The Picker/Commonwealth Fund Program on Long-Term Care Quality Improvement aims to 1) raise the quality of post acute and long-term care services and supports, and 2) improve care transitions for patients by integrating these services with the other care that they receive. The program supports Advancing Excellence in America’s Nursing Homes, a national, voluntary quality improvement campaign in which half of all U.S. nursing homes participate.

 

The Program on Vulnerable Populations is designed to ensure that low-income, uninsured, and other minority populations are able to obtain care from health systems capable of meeting their special needs. This program includes the Mongan Commonwealth Fund Fellowship Program (formerly the Commonwealth Fund/Harvard University Fellowship in Minority Health Policy), a Harvard Medical School-based fellowship that develops physician leaders.

 

The Program on Affordable Health Insurance envisions an equitable and efficient system of health coverage that makes comprehensive, continuous, and affordable coverage available to all Americans. Its Biennial Health Insurance Survey has enabled researchers to examine the effects of the recent severe economic recession on insurance coverage, as well as to assess changes in coverage, access to care, and medical bill problems over a decade. It also helped identify the problem of the underinsured, which are people with health insurance but high medical expenses relative to income. The survey found that between 2003 and 2010, the number of underinsured rose from 16 million to 29 million. The program also conducts surveys of young adults, which, prior to the Affordable Care Act, have found they delay care because of lack of coverage.

 

The Commonwealth Fund gathers and disseminates evidence of excellence in health care from across the country and the world to show what it is possible to achieve, and to stimulate health care providers, policymakers, and stakeholders to take action to improve performance. Since 2006, The Commonwealth Fund and its Commission on a High Performance Health System have tracked the performance of U.S. health care through a series of national, state, and regional scorecards.

 

The Commonwealth Fund is currently funding, research to determine the efficacy of the Affordable Care Act (ACA). So far, the ACA will offer Americans better healthcare for less, beginning in 2014.

 

Harkness House, 1 East 75th Street in Manhattan, built in 1908

Sigmoidoscopy Reduces Colorectal Cancer Rates

 

Sigmoidoscopy involves examination of the lower colon using a thin, flexible tube-like instrument, called a sigmoidoscope. Sigmoidoscopy has fewer side effects, requires less bowel preparation, and poses a lower risk of bowel perforation (an uncommon event, when the screening instrument pokes a hole in the intestine) than colonoscopy, in which a similarly flexible, but longer, tube is used to view the entire colon. Colorectal cancer is the second-leading cause of cancer-related death in the United States. Previous studies have shown shown that colorectal cancer incidence and mortality can be reduced with a number of screening methods, including fecal occult blood testing (FOBT). However, flexible sigmoidoscopy and colonoscopy are more sensitive than FOBT for detecting polyps that may lead to colorectal cancer. Removal of pre-cancerous polyps, which can be done during sigmoidoscopy or colonoscopy, reduces colorectal cancer risk.

 

According to an article published online in the New England Journal of Medicine (21 May 2012), flexible sigmoidoscopy, a screening test for colorectal cancer that is less invasive and has fewer side effects than colonoscopy, is effective in reducing the rates of new cases and deaths due to colorectal cancer. In a study that spanned almost 20 years, it was found that overall colorectal cancer mortality (deaths) was reduced by 26% and incidence (new cases) was reduced by 21% as a result of screening with sigmoidoscopy.

 

For the study, from 1993 to 2001, a total of 154,900 men and women aged 55 through 74 were randomly assigned to receive flexible sigmoidoscopy screening or usual care as part of The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. The PLCO trial is a large population based randomized trial designed and sponsored by the National Cancer Institute (NCI) to determine the effects of screening on cancer-related mortality and secondary endpoints in men and women aged 55 to 74. The screening component of the trial was completed in 2006.

 

People in the usual care group (i.e. control group) only received screening if they asked for it, or if their physician recommended it. Participants assigned to the flexible sigmoidoscopy group were screened once on entering the study (baseline) and again three years to five years later. The participants were followed for approximately 12 years to collect data on cancer diagnoses and deaths.

 

The study compared overall colorectal cancer mortality and incidence in the two groups, and also analyzed incidence and mortality according to the location of the cancers that developed. Cancers located from the rectum through a bend in the colon called the splenic flexure were defined as distal, and those in the transverse colon to the cecum were defined as proximal. Although flexible sigmoidoscopy examines only the rectum and sigmoid colon, participants with a suspicious finding were referred for a follow-up colonoscopy, in which both the distal and proximal regions of the colon would be examined.

 

Results showed that after an average of nearly 12 years, participants in the screening group had a 21% lower incidence of colorectal cancer overall and a 26% lower rate of colorectal cancer mortality than participants in the usual care group. The incidence of distal colorectal cancer was reduced by 29%, and mortality from distal colorectal cancer was reduced by 50%, in the screening group. While there was no statistically significant decline in deaths from proximal colorectal cancer, the incidence of proximal colorectal cancer was reduced by 14% in the screening group.

 

Screening by sigmoidoscopy detected 24% of the colorectal cancers that were diagnosed in the screening group. Another 60% were detected by symptoms or by screening performed outside of the PLCO protocol or were found more than one year after a screening exam – the cutoff for defining a cancer as screen detected – in participants who had at least one screening exam, and the remaining 16% developed in participants assigned to the screening group who never actually underwent screening. Of the colorectal cancers that were detected by screening, nearly 83% were found in the distal colon, whereas distal colorectal cancers made up about 53% of the cancers in people in the screening group who were never screened and about 32% of cancers in people who underwent screening but whose cancers were not detected by screening. Cancers detected by screening were more likely to be early stage (75% were stage I or II) than cancers that weren’t detected by screening (51% were stage I or II).

 

Screening was associated with reductions in incidence and mortality for all stages of distal colorectal cancer. However, in the proximal colon, reductions in incidence were only seen in stages I, II, and III, and there was no impact on proximal colorectal cancer mortality. The authors estimated that if they had used colonoscopy rather than sigmoidoscopy in this study, they would have identified 16% more cancers, two-thirds of which would have been proximal cancers. However, they were not able to determine what effect that may have had on proximal colorectal cancer mortality. Sigmoidoscopy has never been directly compared to colonoscopy in a definitive clinical trial.

 

False-positive sigmoidoscopy results were observed in 20% of men and 13% of women in the screening group, but some of these false positives could have been the result of false-negative colonoscopies done to follow up on suspicious sigmoidoscopy findings. Approximately 22% of people in the screening group were sent for follow-up colonoscopies during the screening phase of the trial.

Study Shows How Immune Cells Change Wiring of the Developing Mouse Brain

 

 

As the brain develops, it goes through dynamic changes to refine its circuitry, trimming away the synaptic connections that do not have a lot of activity, and preserving the stronger, more active synapses. This period, known as synaptic pruning, is a key part of normal brain development. To date, there has not been a clear understanding of how these synapses are selected, targeted and then pruned. However, precise elimination of unused synapses and strengthening those that are most needed is essential for normal brain function. Many childhood disorders, such as amblyopia (a loss of vision in one eye that can occur when the eyes are misaligned), various forms of mental retardation, epilepsy and autism are thought to be due to abnormal brain development.

 

Microglia originate in the bone marrow and transform into an activated state to defend the body against infections. Activated microglia are also found in other disease states, ranging from stroke to Alzheimer’s disease. It is not always clear, however, if these cells cause degeneration of brain cells, or if they are part of the brain’s recovery process. In more recent years, it has been reported that activated microglia are also present in the normal brain. Additionally, during the most robust synaptic pruning periods there is an increased number of activated microglia present and clustered around synapses.

 

Microglia can prune the billions of tiny connections (or synapses) between neurons. Neurons are the brain cells that transmit information through electric and chemical signals. An article published online in the journal Neuron (24 May 2012), showed how microglia target and remove unused connections between brain cells during normal development in the mouse brain. This new research demonstrates that microglia respond to neuronal activity to select synapses to prune, and shows how this pruning relies on an immune response pathway — the complement system — to eliminate synapses in the way that bacterial cells or other pathogenic debris are eliminated.

 

The study visual system in mice to study synaptic pruning, a model that undergoes robust change and remodeling during development and which has circuitry that is well-defined and easy to manipulate. When neurons that project from the eye into an area of the brain called the lateral geniculate nucleus, or LGN were labeled, it was found that reactive microglia contained portions of the synapses from the labeled neurons. It was also observed that these labeled pieces of synaptic material were specifically found inside the microglia’s lysosomes — compartments responsible for digesting foreign particles.

 

The authors then investigated if the amount of neuronal activity at a synapse determines whether microglia target it for removal. To evaluate this, the authors used a drug to increase activity in the neurons projecting from one eye and saw less pruning of synapses in the corresponding brain region, as compared to the untreated eye. When a drug was used to reduce activity, this resulted in more pruning compared to the untreated eye. The authors hypothesized that microglia select a synapse for removal based on the synapse’s level of activity. From a clinical perspective, this may be directly relevant to amblyopia, a loss of vision in one eye that can occur when the eyes are misaligned. Children with amblyopia will preferentially use one eye and vision in the less used eye deteriorates due loss of synapses and cells in the LGN.

 

The authors noted that the study has elucidated the role of microglia in the normal brain and supports further investigations into the role of microglia in brain disease.

Aspirin for Preventing the Recurrence of Venous Thromboembolism

 

 

About 20% of patients with unprovoked venous thromboembolism have a recurrence within 2 years after the withdrawal of oral anticoagulant therapy. Extending anticoagulation prevents recurrences but is associated with increased bleeding. As a result, a study published in the New England Journal of Medicine (2012; 366:1959-1967) was performed to evaluate the benefit of aspirin for the prevention of recurrent venous thromboembolism is unknown.

 

The investigation was a multicenter, investigator-initiated, double-blind study, in patients with first-ever unprovoked venous thromboembolism who had completed 6 to 18 months of oral anticoagulant treatment. Patients were randomly assigned to aspirin, 100 mg daily, or placebo for 2 years, with the option of extending the study treatment. The primary efficacy outcome was recurrence of venous thromboembolism, and major bleeding was the primary safety outcome.

 

Venous thromboembolism recurred in 28 of the 205 patients who received aspirin and in 43 of the 197 patients who received placebo (6.6% vs. 11.2% per year; median study period, 24.6 months). During a median treatment period of 23.9 months, 23 patients taking aspirin and 39 taking placebo had a recurrence (5.9% vs. 11.0% per year). One patient in each treatment group had a major bleeding episode. Adverse events were similar in the two groups.

 

According to the authors, aspirin reduced the risk of recurrence when given to patients with unprovoked venous thromboembolism who had discontinued anticoagulant treatment, with no apparent increase in the risk of major bleeding.

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

 

 

FDA Asked to Ban Use of Pesticide for Head Lice

 

 

Target Health is pleased to announce that it was instrumental in the approval of the last 2 products approved by FDA for the treatment of head lice.

 

According to report from MedPage Today, published 01 June 01 2012, Congressman Edward Markey (D-Mass.) has called on the FDA to ban the pesticide lindane as a treatment for head lice in children. Lindane is sold as Kwell shampoo and its generic versions. In a letter to FDA Commissioner Margaret Hamburg, Markey pointed out that the EPA banned the pesticide — which has been linked with side effects from skin irritations to seizures — from agricultural use in 2006.

 

Although shampoos with the agent are FDA approved for the indication, the chemical is not listed as an approved therapy on the FDA’s webpage on treating head lice, and the CDC page notes that the FDA doesn’t recommend it as a first-line therapy. Nor does the American Academy of Pediatrics recommend it as a treatment. Instead, the CDC and FDA recommend over-the-counter pyrethrins or prescription malathion or benzyl alcohol lotions.

 

Lindane is an organochlorine insecticide, most of which — including DDT — were banned in the 1960s and 1970s due to their neurotoxic effects. Several groups have also declared it a possible carcinogen, including the International Agency for Research on Cancer (IARC). After EPA banned it from agricultural use, 160 nations also agreed to ban its use, according to Markey’s letter. California even nixed it as a treatment for lice and scabies in 2002 because of its potential effects on children and on the public water supply.

 

Sidney Wolfe, MD, of the consumer and health advocacy group Public Citizen, said his organization first called for a halt of pharmaceutical lindane use 37 years ago.

 

In his letter, Markey asks FDA to address eight issues, including an assessment of the chemical’s long-term effects on children and whether it has had any environmental impact from being poured down drains.

Insidious Debt

 

By Mark L. Horn, MD, MPH, Chief Medical Officer, Target Health Inc.

 

According to the American Medical Association, for graduates of the medical school classes of 2010 carrying educational debt the average burden was slightly more than $150,000 – and that’s before compounding interest kicks in. While student debt overall has recently become an issue, discussed in various venues due to its negative personal and economic impact (less discretionary income = less purchasing power = decreased consumer demand = slowing economy), the impact of medical student debt has specific implications for the health care system justifying a separate analysis.

 

It is simply naive to imagine that graduating from medical school with debt equivalent to a pretty hefty mortgage will not significantly impact one’s career and life choices, and given the impact of the decisions of this specific cohort on future health care delivery the implications of its debt burden are important data points for policy makers to ponder.

 

Among the more obvious concerns is the impact on physician career choices; increased debt will almost certainly deter graduating seniors from seeking primary care positions due to diminished earnings potential. “Life happens”, even to the socially committed, and the legitimate needs of spouses and growing families will inevitably influence decisions and (as the burdens increase) not only at the margins.

 

The context, of course, is a growing consensus about the central role of primary care and the unique role of skilled primary care physicians in rationalizing health care costs while maintaining or even improving quality.

 

According to the AMA, there are impediments for lower income and otherwise diverse candidates to attend medical school, depriving the workforce of needed heterogeneity, and concerns about the mental health of young graduates. Adding considerable financial stress to the background stresses of busy medical practice will likely prove psychologically perilous, at least for some.

 

Informal conversations suggest that there is an array of potentially creative solutions to this problem, especially considering that the individuals involved will possess a vital skill with cost saving potential. This seems a problem with solutions that are potentially ‘win-win’, using a model of service obligations in return for loan forgiveness.

 

Could this be accomplished ‘fairly’, without creating an unfair choice only impacting financially distressed students? For the sake of equity should service be required of all young physicians (including those who could easily pay full freight) in return for a partially subsidized or even free education?

 

Interesting questions these, without easy answers. However, if the promise of increased access inherent in the Affordable Care Act is to be meaningful, adequate numbers of well trained, highly motivated, primary care providers will be needed. It is time to focus on making this happen.