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Dr. Margaret Foti, PhD, MD, CEO of AACR Honored by Oncology Nursing Society for dedication to improving cancer careReporter: Stephen J. Williams, PhD
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Archive for the ‘Healthcare Reform’ Category
Dr. Margaret Foti, PhD, MD, CEO of AACR Honored by Oncology Nursing Society for dedication to improving cancer care
Posted in Accountable Care Organizations, Cancer - General, Cancer and Current Therapeutics, Health Economics and Outcomes Research, Health Law & Patient Safety, Healthcare Reform, Patient Experience: Personal Memories of Invasive Medical Intervantion, tagged #endcancer, AACR, Cancer - General, cancer patient management, Nursing contribution to healthcare, oncology nursing on April 28, 2016| Leave a Comment »
Problem of Science Doctorate Programs
Posted in Curation, Disease Biology, Evolutionary cognition, Explanatory, Federal Budget Appropriations, Health Economics and Outcomes Research, HealthCare IT, Healthcare Reform, Historical relevance, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, Interviews with Scientific Leaders, Investment in Technological Breakthrough, Materials Science & Engineering, Medical Devices R&D Investment, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Pharmaceutical R&D Investment, Population Health Management, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Scientist: Career considerations, Technology Advance Assessment of, Technology Capital Expenses, tagged doctorate and postdoctoral reseach on April 12, 2016| Leave a Comment »
Problem of Science Doctorate Programs
Larry H. Bernstein, MD, FCAP, Curator
LPBI
WordCloud Image Produced by Adam Tubman
| The Problem in Biomedical Education
Henry Bourne (UCSF) |
Dr. Henry Bourne has trained graduate students and postdocs at UCSF for over 40 years. In his iBiology talk, he discusses the imminent need for change in graduate education. With time to degrees getting longer, the biomedical community needs to create experimental graduate programs to find more effective and low cost ways to train future scientists and run successful laboratories. If we don’t start looking for solutions, the future of the biomedical enterprise will grow increasingly unstable.
Watch Henry Bourne’s iBioMagazine: The Problem in Biomedical Education
Henry Bourne is Professor Emeritus and former chair of the Department of Pharmacology at the University of California – San Francisco. His research focused on trimeric G-proteins, G-protein coupled receptors, and the cellular signals responsible for polarity and direction-finding of human leukocytes. He is the author of several books including a memoir, Ambition and Delight, and has written extensively about graduate training and biomedical workforce issues. Now Dr. Bourne’s research focuses on the organization and founding of US biomedical research in the early 20th century.
Related Talks
- Shirley Tilghman: The Malthusian Dilemma in Biomedical Research
- Bruce Alberts, Marc Kirschner, Shirley Tilghman, Harold Varmus iBioMagazine: Rescuing US Biomedical Research
- Kristin Krukenberg, Sarah Mazzilli, Gary McDowell, Jessica Polka iBioMagazine: Shaping the Future of Research
- Jon Lorsch iBioMagazine: Lab Size: Is Bigger Better?
- Gregory Petsko iBioMagazine: The Post-doctoral Situation
- Watch his archived Q&A on postdocs and the biomedical workforce
ER User for Heart Failure: A Different Reality for Pennsylvania’s Geisinger Health System – A Record of Care Integration and Coordination
Posted in Health Economics and Outcomes Research, Health Law & Patient Safety, HealthCare IT, Healthcare Reform on March 24, 2016| Leave a Comment »
ER User for Heart Failure: A Different Reality for Pennsylvania’s Geisinger Health System – A Record of Care Integration and Coordination
Reporter: Aviva Lev-Ari, PhD, RN
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3. Geisinger’s integrated approach slashes ER use for heart failure Thursday, March 24, 2016 | By Zack Budryk Fully-integrated care is the wave of the future in healthcare, and one health system has used it to cut emergency room visits and improve medication management for heart failure patients, according to a blog post at NEJM Catalyst. Leaders at Danville, Pennsylvania’s Geisinger Health System sought to build on the system’s record of care integration and coordination to address emergency and inpatient care for heart failure patients, write Geisinger’s Sanjay Doddamani, M.D., Janet F. Tomcavage, R.N., and John B. Bulger. Nearly 5 million patients in the United States have heart failure and it costs the healthcare system $32 billion per year, according to the article. The organization began to consider every unplanned admission for acute heart failure that required only diuretic therapy for treatment as a sentinel event. From there, system leaders developed a central urgent heart failure clinic, offering onsite review of each patient’s care plan, coordination between nurse navigators and community nurse case managers, and medication management. Each team member coordinates care according to a methodical assessment and care algorithm, communicating face-to-face, through electronic medical records, by phone and in monthly meetings. When team members communicate with this kind of regularity, it lessens the risk of care and communication gaps, according to the post. These multidisciplinary teams include nurse navigators, nurse case managers and pharmacists, all of whom operate in their distinct spheres while each serving the broader aim of integrated care. Preliminary metrics indicate Geisinger’s approach is bearing fruit, according to the post. Last year, it saved the system $240,000 in ED visits, with 28 percent of hospitalized heart failure patients avoiding emergency care. The system is still crunching the numbers on medication management, but thus far, monitoring of renal function and potassium is up from 41 percent to 80 percent. To learn more: – read the post Related Articles: Why Geisinger’s care coordination strategies are a model for the US 4 steps to an integrated approach to population health management Geisinger researchers share framework for putting a learning health system into practice Geisinger’s Nicholas Marko: Early EMR adoption has propelled innovation [Q&A] Health systems move to solve data exchange problems on their own Lack of standard data model poses hindrance to PCORI ‘network of networks’ Why a learning health system is important for patient care ONC unveils Interoperability Roadmap for public comment PCORI announces $150.7 million in Phase II funding for ‘network of networks’ |
SOURCE
From: FierceHealthcare <editors@fiercehealthcare.com>
Reply-To: <editors@fiercehealthcare.com>
Date: Thursday, March 24, 2016 at 2:53 PM
To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>
Subject: | 03.24.16 | Geisinger’s integrated care model slashes ER use
Healthcare conglomeration to access Big Data and lower costs
Posted in Artificial Intelligence - Breakthroughs in Theories and Technologies, Big Data, BioTechnology - Venture Creation, Clinical & Translational, Clinical Diagnostics, Computational Biology/Systems and Bioinformatics, Diagnostics and Lab Tests, Digital HealthCare – biotech & internet joint ventures, Drug Toxicity, Electronic Health Record, HealthCare IT, Healthcare Reform, Intelligent Information Systems, Technology Advance Assessment of, tagged Consolidated data sources, Electronic Medical Record (EMR) on January 13, 2016| Leave a Comment »
Healthcare conglomeration to access Big Data and lower costs
Curator: Larry H. Bernstein, MD, FCAP
UPDATED on 3/17/2019
Medicare Advantage plans may be driving up quality of care in terms of preventive treatment for coronary artery disease patients, but that has had little impact on outcomes compared with fee-for-service Medicare, researchers reported in JAMA Cardiology.
The expected benefits are not as easily realized as anticipated. The problem of access to data sources is not as difficult as the content needed for evaluation.
DARK DAILY DARK DAILY info@darkreport.com
January 13, 2016
Recently-announced partnerships want to use big data to improve patient outcomes and lower costs; clinical laboratory test data will have a major role in these efforts
In the race to use healthcare big data to improve patient outcomes, several companies are using acquisitions and joint ventures to beef up and gain access to bigger pools of data. Pathologists and clinical laboratory managers have an interest in this trend, because medical laboratory test data will be a large proportion of the information that resides in these huge healthcare databases.
For health systems that want to be players in the healthcare big data market, one strategy is to do arisk-sharing venture with third-party care-management companies. This allows the health systems to leverage their extensive amounts of patient data while benefiting from the expertise of their venture partners.
Cardinal Health Acquires 71% Interest in naviHealth
One company that wants to work with hospitals and health systems in these types of arrangements is Cardinal Health. It recently acquired a 71% interest in Nashville-based naviHealth. This company partners with health plans, health systems, physicians, and post-acute providers to manage the entire continuum of post-acute care (PAC), according to a news release on the naviHealth website. NaviHealth’s business model involves sharing the financial risk with its clients and leveraging big data to predict best outcomes and lower costs.
“We created an economic model to take on the entire post-acute-care episode,” declared naviHealth CEO and President Clay Richards in a company news release. “It’s leveraging the technology and analytics to create individual care protocols.”
“The most basic, and the most important, thing is … they [Cardinal Health] share the same core values as we do, which is to be on the right side of healthcare,” naviHealth CEO Clay Richards told The Tennessean. “It’s about how you deliver better outcomes for patients with lower costs: How do you solve the problems [with growing costs]? That’s what we and Cardinal define as being on the right side of healthcare.” (Caption and image copyright: The Tennessean.)
Provider Investments Signal Continuation of Trend
Cardinal Health intends to combine its ability to reduce costs while providing effective care with naviHealth’s evidence-based, personalized post-acute-care plans. This is one approach to harness the power of big data to improve patient care. One goal is focus this expertise on post-acute care, which is one of Medicare’s quality measures.
Patients and their families often are unsure of what to expect after being discharged. And, according to an article published in Kaiser Health News, a 2013 Institutes of Medicine (IOM) report noted a link between the quality of post-acute care and healthcare spending following the discharge of Medicare patients.
However, maximizing the use of healthcare big data requires the participation of multiple stakeholders. Information scientists, hospital administrators, software developers, insurers, clinicians, and patients themselves must all perform a role in order for big data to reach its full potential. No single sector will be able to bring the benefits of big data to fruition; rather collaboration and partnerships will be necessary.
Other Collaborations and Alliances Target Healthcare Big Data
Two other organizations engaged in a similar collaboration are the Mayo Clinic andOptum360, a revenue management services company that focuses on simplifying and streamlining the revenue cycle process. In a press release, the companies announced that they were partnering to “develop new revenue management services capabilities aimed at improving patient experiences and satisfaction while reducing administrative costs for healthcare providers.” (See Dark Daily, “When It Comes to Mining Healthcare Big Data, Including Medical Laboratory Test Results, Optum Labs Is the Company to Watch,” December 14, 2015.)
In order to accomplish this, Mayo will have to share its revenue cycle management (RCM) data with Optum360, which will use the data to devise improved revenue cycle processes and systems.
“What we’re trying to find out, if we can, is what does healthcare cost, and what of that spend really adds value to a patient’s outcome over time, especially with these high-impact diseases,” stated Mayo Clinic President and CEO John Noseworthy, MD, in a story published by the Star Tribune. He was referencing another big data project Mayo is engaged in with UnitedHealth Group. “Ultimately, we as a country have to figure this out, so people can have access to high-quality care and it doesn’t bankrupt them or the country.”
Mayo Clinic President and CEO John Noseworthy, MD, believes big data may be the key to transforming healthcare costs by informing clinical decision-making and altering patient outcomes. (Photo copyright: Mayo Clinic.)
Another interesting healthcare big data partnership is the Pittsburgh Health Data Alliance (The Alliance). It involves a collaboration between Carnegie Mellon University (CMU), the University of Pittsburgh (PITT), and the University of Pittsburgh Medical Center (UPMC). The aim of The Alliance is to take raw data from wearable devices, insurance records, medical appointments, as well as other common sources, and develop ways to improve the health of individuals and the wider community.
The common thread among all these collaborative efforts is a desire to improve outcomes while reducing costs. This is the promise of healthcare big data. And no matter which direction the effort takes, clinical laboratories, which generate a vast amount of critical health data, are in a good position to play important roles involving the contribution of lab test data and identifying ways to use healthcare big data projects to improve patient care.
—Dava Stewart
Measuring generic medicine performance
Posted in Pharmaceutical Analytics, Pharmacodynamics and Pharmacokinetics, Pharmacologic toxicities, Population Health Management, Prescription Drugs Costs, tagged generic drugs, off-patent on December 18, 2015| Leave a Comment »
Measuring generic medicine performance
Larry H. Bernstein, MD, FCAP, Curator
UPDATED 11/07/2025
The Global Generic Drugs Market in 2025. Valued at USD 437.2 billion in 2024, is set to grow at a 6.3% CAGR till 2033—and India stands at the heart of this transformation. From Sun Pharma, Aurobindo, Cipla, and Dr. Reddy’s to a new wave of biotech-driven manufacturers, India continues to power global access to affordable, high-quality medicines. With innovation in APIs, biosimilars, and complex generics, India isn’t just the “pharmacy of the world” – it’s shaping the future of equitable healthcare.
Measuring performance in off-patent drug markets
Category: Abstracted Scientific Content
Author(s): GaBI Journal Editor
GaBi 2015; 4(4). http://gabi-journal.net/issues/vol-4-2015-issue-4
Generic medicines can play a role in curbing rising pharmaceutical costs, and therefore the cornerstone of key policies within Organisation for Economic Co-operation and Development (OECD) countries has been to promote the wider use of generics after patent expiry or loss of market exclusivity of originator drugs. At patent expiry however, prices and market share of different generics in different countries vary significantly [1, 2] compared with branded originator drugs. Studies examining the effect of generics entry on originator prices and market share have produced contradictory results [3, 4].
In an attempt to address the key concerns of decision makers about the performance of generic policies, Kanavos [5] has developed a methodological framework comprising five indicators (independent of policy mix) that can be used as a benchmark for evaluating generic policy in non-tendering settings once originators lose exclusivity. These indicators are: (1) generic drug availability after patent expiry; (2) delay in time to generic entry; (3) number of generic competitors; (4) price development of originators and generics after loss of exclusivity; and (5) evolution of generic volume market share.
Kanavos [5] proposes a number of metrics to assess the performance of each of the indicators over time. For generic drug availability, the metrics include: (1) the share of total molecules studied in each country, with generic entry within the first 12 and 24 months after patent expiry; (2) the proportion of total sales facing generic entry within the same time-frame; and (3) the proportion of sales facing generic entry in the top and bottom decile of each market by sales, 12 and 24 months after patent expiry.
Intercontinental Medical Statistics data (last quarter of 1998 to the last quarter of 2010) for 101 molecules that had lost patent protection in 12 EU countries were analysed to test and measure the performance of the indicators. Countries were divided into three tiers according to perceived strength of their generic policies. The aim was to understand the drivers behind generic entry and competition in each country, and to identify any associated changes in prices, sales and market share over time after the originator patent had expired.
The empirical analysis carried out by Kanavos [5] confirms the hypothesis that different regulatory policies produce diverse outcomes. Some general predictions were confirmed, and the expected effects of individual policies were questioned.
Tier 1 countries (Denmark, Germany, The Netherlands and the UK), for example, had high levels of generic prescribing and substitution, consistently less time delay to generic entry, higher numbers of generic competitors, faster price declines and higher generic volume shares compared with Tier III countries (Greece, Italy and Portugal), which showed opposite trends; these countries implemented price capping on generics and had fewer incentives for generic prescribing. Tier II countries (Austria, Finland, France, Spain and Sweden) had moderate levels of generic prescribing and used price reduction strategies.
Price reductions in some countries implementing supply-side measures, such as price capping or linking generic price to the originator price as done in Greece, Italy and France, were significantly slower over time than seen in countries that did not have these controls, such as Denmark, Germany, The Netherlands and the UK; countries with no such controls had the shortest delay in time to generic entry and the highest rate of generic penetration.
Kanavos [5] questions the extent to which reference pricing facilitates faster and more extensive generic competition after patent expiry. In Sweden and the UK, which do not have international reference pricing (IRP), delays to generics entry are shorter compared with countries that have IRP. The UK’s open-market pricing system for post-patent drugs allows price competition to be achieved quickly after patent expiry, and the decreases in the price of both generic and originator drugs 12 and 24 months after patient expiry are relatively large. Other reasons accounting for the speed of competition in the UK include implementation of attempts to teach medical students the cost-saving benefits of generic products, and implementation of mandatory International Nonproprietary Names (INN) prescribing.
Germany, in contrast, has an established IRP system but a more competitive market compared with the UK. An association, however, was identified between the use of reference pricing and a pattern of high prices for originator drugs and continually decreasing prices for originator drugs after patent expiry. The volume share for generics 24 months after originator patent expiry is large in Germany. Greece is an outlier; although it has implemented a reference pricing system, this has not been reinforced with INN prescribing or mandatory generic substitution that could increase generic uptake.
Another question addressed by Kanavos [5] is the effect of the introduction of generic drugs on the prices of originators whose patents have expired. In most cases, prices of originator drugs were found to decline in response to generic entry. Paradoxically, in Germany and Denmark, prices of originator drugs in fact increased [6, 7]. The opposite has been observed in Greece, where prices of off-patent originators that do not face generic entry generally decreased although in some cases they increased. This suggests that generic competition and availability of generics are important determinants of price reductions of off-patient originator brands, since in their absence the price of these products can increase.
Countries that have strong demand-side policies, e.g. mandatory or strongly encouraged INN prescribing, have a higher degree of generic penetration after patent expiry and lower time delays to generic entry compared with countries that do not encourage these policies. The effect of generic pricing and substitution, however, may be related to the specific components of the policies, i.e. whether physicians or patients are permitted to overrule generic substitution and whether pharmacists are offered incentives or disincentives to dispense generic over branded products, as well as the price difference between originator brand and generic.
Although the author acknowledges some limitations to the study, he suggests that the broad conclusions and specific findings have important policy implications. He believes that further research is needed to identify the most effective policy mix that will maximize generic entry and penetrations and lead to greater expenditure optimization by health insurers.
Poverty and the American Dream
Posted in Child and Adolescent Psychiatry, Cognition, Curation, Empathy, Health Economics and Outcomes Research, Healthcare Reform, tagged Brookings report, child development, personal safety, poverty, Public health, safety net, security on December 12, 2015| Leave a Comment »
Poverty and the American Dream
Larry H. Bernstein, MD, FCAP, Curator
LPBI
Brookings Institute: Poverty Report
Chapter 1:
Introduction
In 1931, the writer James Truslow Adams coined the term “The American Dream.” His definition holds up well today. The dream, he said, is of a land in which: life should be better and richer and fuller for everyone, with opportunity for each according to ability or achievement. It is a difficult dream for the European upper classes to interpret adequately, and too many of us ourselves have grown weary and mistrustful of it. It is not a dream of motor cars and high wages merely, but a dream of social order in which each man and each woman shall be able to attain to the fullest stature of which they are … capable, and be recognized by others for what they are, regardless of the fortuitous circumstances of birth or position.1
Today, many Americans fear that our country is no longer a land of opportunity. Although social mobility overall seems not to have decreased in recent decades,2 there is evidence that it is lower in America than in many other advanced economies.3 Scholars on both the left and the right are also increasingly worried that children growing up today in lower-income families have fewer social supports and pathways into the middle class than in past generations. As Robert Putnam showed in his recent book Our Kids, 4 children from wellto-do families today enjoy more material, emotional, and educational support than ever before, but children from low-income families often grow up in homes, schools, and communities that are in disarray. Charles Murray reached similar conclusions in Coming Apart. 5
The trends aren’t entirely bleak, and poor children today are better off in several ways than they were a few decades ago. They have better access to healthcare, fewer of them are born to teen mothers, their parents have more education, they are exposed to fewer environmental toxins and violence, and fewer live in foster care. We should celebrate these advances. But the circumstances and outcomes of upper-income children have improved even more rapidly, leading to ever-widening inequality in the human and financial resources that boost child development. And on a few important factors, such as family stability, the circumstances of poor children have gotten worse.
The reasons for the increasing gaps between childhoods in different social classes are many and intertwined, including: the loss of manufacturing jobs, stagnating wages for workers without a college degree, labor-saving technological changes, changing relationships between workers and management, the increasing importance of education and training in a post-industrial economy, a less energetic civil society, high rates of incarceration, weaker attachment to the labor force among less-educated men, and the rising prevalence of single-parent families among the less-educated.
The poor prospects for children born into poor families are an urgent national concern. This state of affairs contradicts our country’s founding ideals. It weakens the promise that inspired so many immigrants to uproot themselves from everything familiar to seek freedom, self-determination, and better lives for their children in America. It holds particularly grave implications for the well being of blacks and for the future of racial equality so courageously fought for over the course of generations.
At its best, the American credo of freedom and individual initiative has been uniquely able to unleash the energy and imagination of its citizens, inspiring them, as Adams put it, “to attain to the fullest stature of which they are capable.”6 For many American families—including many low-income families—that dream is still possible. But large numbers of children live in disadvantaged and often chaotic homes and communities, attend schools that don’t prepare them to navigate an increasingly complex economy, and have parents (often a single parent) who work in low-wage jobs with variable and uncertain hours. The massive waste and loss of this human potential costs the United States in economic terms, and it is a tragedy in human terms. Most Americans would agree that we can do better.
The political difficulty arises when we turn to solutions. Most new ideas for helping the poor are controversial and expensive, and when one political party offers a proposal, the other party usually disagrees with its premises or specifics. The parties often have deep philosophical differences, but research also shows that the mere fact that one party proposes an idea can motivate partisans on the other side to dismiss it.7 And yet, points of agreement are emerging that could serve as a foundation for consensus. Most Americans and their political representatives tend to agree on several key points.
- First, for able-bodied Americans, it is far better to earn money than to depend on public assistance, although economic conditions sometimes prevent people from becoming self-sufficient.
- Second, children are on average better off growing up with two parents committed to each other for the long term, an arrangement most likely to occur within the context of marriage.
- And third, our schools don’t adequately prepare the young for the economic and social environment in which they must make their way.
THE AEI-BROOKINGS WORKING GROUP
Our report has three distinctive features.
- the diversity of our perspectives and experiences. We share an intense belief that poverty and opportunity are profoundly consequential and that our nation’s future prosperity and our common humanity compel us to work together to find credible strategies to reduce poverty and increase economic mobility.
- we consider three major domains of life simultaneously: family, work, and education. they are highly interconnected. Improving family stability helps children succeed in school; improving the fit between schools and jobs helps teenagers transition into the labor force; when young people can find work that pays well, they create more stable families, and the cycle continues.
- it is grounded in values—the three broadly shared American values of opportunity, responsibility, and security. Focusing on these shared values has made it easier for us to work together and find many points of agreement.
OPPORTUNITY The concept of “opportunity” draws nearly universal support among Americans, and it’s the core concept of the American Dream. We endorse Truslow Adams’ definition of opportunity as the state of affairs when “each man and each woman shall be able to attain to the fullest stature of which they are capable,” regardless of the circumstances of their birth.8
RESPONSIBILITY America is a free society, but freedom comes with responsibilities. Responsibility is the state of being accountable for things over which one has control, or has a duty of care. Family life is a network of mutual responsibilities. So is work life. So is democratic citizenship.
The values of responsibility and opportunity are closely linked in the American mind. We can see the link in a line from President Clinton’s 1993 Labor Day speech that has had bipartisan resonance: We’ll think of the faith of our parents that was instilled in us here in America, the idea that if you work hard and play by the rules, you’ll be rewarded with a good life for yourself and a better chance for your children.10 The converse of this assertion is that if you fail to be responsible—if you don’t work hard or don’t play by the rules, then you aren’t entitled to a reward. These linked values of responsibility and opportunity were the linchpins of the bipartisan welfare reform law of 1996—whose official name included both “Personal Responsibility” and “Opportunity.”11
SECURITY Despite our best efforts to care for ourselves, we all know that life sometimes resembles a lottery. The central idea of insurance is that we are all better off pooling some of the risks of life, and hoping that we never get to recover our insurance premiums.
Friedrich Hayek, an economist who was wary of collectivism in most forms and who is widely admired by conservatives, endorsed the value of security in 1944 in this famous passage from The Road to Serfdom: There is no reason why, in a society which has reached the general level of wealth ours has . . . should not be guaranteed to all . . . some minimum of food, shelter and clothing, sufficient to preserve health. Nor is there any reason why the state should not help to organize a comprehensive system of social insurance in providing for those common hazards of life against which few can make adequate provision.12
Several decades of research show that increasing security for children can better prepare them to break the cycle of poverty and grow up to be more responsible adults. A child’s brain is highly malleable. In the early years, when it is growing rapidly, the young brain responds to cues about the kind of environment that surrounds it. When children are raised in a chaotic and unpredictable environment, they become more attracted to immediate rewards, rather than larger but more distant rewards.13 Although children have great resilience and the capacity to overcome their early environment, some children—especially if they don’t have the benefit of interventions that reduce the stress to which they are exposed—are overwhelmed by early stress and trauma and suffer permanent damage.16
Conversely, when children are raised in more stable and predictable environments, they are more likely to learn that it pays to defer gratification and reap larger rewards in the future. Low stress, high predictability, and strong, stable relationships with caring adults all help children become measurably better at self-regulating, delaying gratification, and controlling their impulses.17 If we want adult citizens who can exercise responsibility, we should do as much as we can to improve the security of childhood, especially among the poor.
These three values guide the rest of our report. We offer a comprehensive plan for reducing poverty and promoting economic opportunity in the United States. In each chapter, we evaluate the best evidence about current approaches and then recommend policies that will increase opportunity, encourage people to take greater responsibility for their own lives, and increase security, especially among lower-income Americans and their children.
In the final chapter, we summarize our recommendations and suggest how the nation can pay for the policies we propose. We also lay out a path by which our recommendations might be carried out, evaluated, and improved, despite America’s political polarization. We have negotiated and compromised to create a plan that we believe is the best way forward. We are all enthusiastic about the final product because we believe it will reduce poverty and increase opportunity in America.
Primary Care Practitioners’ Perspectives
Posted in Healthcare Reform, tagged assessment of healthcare in 2015, primary care physicians on November 25, 2015| Leave a Comment »
Primary Care Practitioners’ Perspectives
Larry H. Bernstein, MD, FCAP, Curator
LPBI
Primary Care Practitioners’ Perspectives on Delivery System Changes
VISUALIZING HEALTH POLICY JAMA Infographic | November 24, 2015
Liz Hamel; Mira Norton, MPH; Anne Jankiewicz; David Rousseau, MPH ; for the Kaiser Family Foundation
JAMA. 2015;314(20):2120. http://dx.doi.org:/10.1001/jama.2015.14715.
This Visualizing Health Policy infographic is based on a survey of primary care clinicians in early 2015 and delves into primary care practitioners’ (PCPs’) perspectives on recent changes to the health care delivery system. While physicians view the increased reliance on nurse practitioners and physician assistants as more negative than positive for their ability to deliver quality care, their opinions are mixed on the effect of accountable care organizations and medical homes. Half of physicians say quality of care is positively affected by the increased use of health information technology; however, similar shares of physicians say quality of care is negatively affected by quality metrics and by financial penalties for unnecessary hospital readmissions. Generally, physicians rate private insurers more highly than public insurers on payment and ease of reimbursement. Nearly half say they are considering early retirement because of health care trends.
ARTICLE INFORMATION
Source: Kaiser Family Foundation analysis. Original data and detailed source information are available athttp://kff.org/JAMA_11-24-2015.
Acknowledgment: Jamie Ryan, MPH, of the Commonwealth Fund contributed to the survey design, analysis, and presentation.
Victoria Hale: Pharmaceutical Pioneer
Posted in Health Economics and Outcomes Research, Healthcare costs and reimbursement, Indigent Nutrition, Personal Health Applications: Tech Innovations serves HealhCare, Pharmaceutical Analytics, Pharmaceutical Discovery, Pharmaceutical Drug Discovery, Pharmaceutical R&D Investment, Population Health Management, Prescription Drugs Costs, Uninsured and Underinsured, tagged drug costs, drug innovation, Pharmaceuticals on October 27, 2015| Leave a Comment »
Victoria Hale: Pharmaceutical Pioneer
Larry H. Bernstein, MD, FCAP, Curator
LPBI
Bringing Life-Saving Medicine to Those Who Can Least Afford It
http://www.genengnews.com/insight-and-intelligence/victoria-hale-pharmaceutical-pioneer/77900545/
The quest for innovative, affordable, and sustainable medical solutions for women has driven Victoria Hale, Ph.D., to start multiple companies. [iStock/© zodebala]
- Three years into working for Genentech, Victoria Hale, Ph.D., faced a pivotal moment. Her career was on track to becoming a high-ranking, well-paid executive in one of the major pharmaceutical companies. Instead, she quit her job to create a whole new model for the way pharmaceuticals are developed.
Prior to Genentech, while working at the FDA, she witnessed an example of what happens to medicines for unprofitable markets. A pharmaceutical company was developing one new drug for two promising indications, one a potential blockbuster and the other an orphan disease. Corporate executives decided to focus on the blockbuster and abandon the orphan disease because it distracted the team from the more profitable indication.
Dr. Hale saw this as a glaring injustice.
“I felt that it was important to make drugs for everyone who needs them, regardless of whatever level they can pay,” she says. “People cannot develop medicines themselves. Experienced, trained professionals are the only ones who know how to do this. There are people who have medicines for any disease here, while 5,000 miles away babies are dying for lack of simple medications.”
Observing the inequities in how drugs were distributed, she asked a fundamental question: “What if we removed the profit requirement? What if we created a nonprofit model for developing pharmaceuticals?”
As someone with a Ph.D. in pharmaceutical chemistry from the University of California San Francisco, Dr. Hale was well aware that bringing a new drug to market can cost in the billions. Her strategy, with a future nonprofit, was to find drugs with patents that had expired or which were not being used because of low profit margins. Even so, getting governmental approval for a new use for an existing drug can cost $50 million.
- Struck a Chord
Nevertheless her vision of creating a nonprofit model for addressing injustices in how drugs are distributed began attracting donors. Her first major fundraising success came when the Gates Foundation provided her with a $4.7 million check for seed money. In the years since, she has been granted $150 million in total for several programs. Other philanthropic organizations have continued to fund her efforts, and, surprisingly, if not amazingly, Dr. Hale was able to find an anonymous donor who provided an $82 million grant to fund low-cost highly effective contraception efforts.
Dr. Hale can point to many examples of how this nonprofit approach has successfully played out in practice. One example is the work that the company she founded in 2000, OneWorld Health, is doing in providing a cure for black fever. This is a disease that has historically infected a million people a year in India leading to 300,000 death annually.
Black fever, or visceral leishmaniasis, is a disease of the poor. A malnourished person may have a compromised immune system, making him or her vulnerable to the parasite that causes leishmaniasis.
“When I was first looking into black fever,” remembers Dr. Hale, “there was a treatment available, but the cost was more than $100, and families faced the choice of going into debt for three generations or allowing the family member to die.”
Dr. Hale learned of an injectable antibiotic, paromomycin, that was apparently effective against the parasite in the laboratory setting. It hadn’t been formally studied in people for use against black fever, and there was no money to continue further research on it, so although a cure existed, it hadn’t been proven and it wasn’t available for those who needed it. However, using her nonprofit approach, Dr. Hale and her colleagues were able to raise the $50 million from the Gates Foundation for clinical trials in India, and succeeded in demonstrating efficacy and safety.
Today, Dr. Hale, who was awarded the 2015 Award for Leadership in Women’s Health Worldwide at the 23rd Annual Congress of the Academy of Women’s Health, and her colleagues are able to produce paromomycin for $10 per treatment. As a result, and combined with other public health interventions, India may soon be free of this scourge.
Another of Dr. Hale’s concerns is unwanted pregnancy. Her organization Medicines360 is able to provide an IUD that has a 40-fold greater success rate than the pill, it lasts for three years, and is sold for $50 each to women who lack adequate insurance. Medicines360 makes it available to family planning clinics that provide services to low-income women. The consequences for women and for society are incalculable.
Like OneWorld Health, Medicines360 is also a new approach to pharmaceuticals. Medicines360 is particularly aimed at pharmaceuticals for women, and it has a unique operating model: it reinvests profits generated through commercial sales revenue and puts these profits into advocacy, education, research, and development. The goal is to provide innovative, affordable, and sustainable medical solutions for women.
For Medicines360, profits aren’t the motive; they’re the means to a mission. Dr. Hale believes that her nonprofit can be a model for other nonprofit pharmaceutical companies and also for hybrid companies that could get part of their funding from philanthropists and part from traditional sources. She already knows that there are young idealistic people who will carry the model forward and who are pushing this agenda.
Doubts about Valeant’s Activity in California
Posted in Health Law & Patient Safety, Pharmaceutical Industry Competitive Intelligence, Population Health Management, Prescription Drugs Costs, tagged pharmaceutical news on October 23, 2015| Leave a Comment »
Doubts about Valeant’s Activity in California
Larry H. Bernstein, MD, FCAP, Curator
LPBI
Documents Raise New Questions About Valeant’s Pharmacy Relationships in California
A key Valeant pharmacy was denied a license in California for making false statements. Months later, people affiliated with it gained an ownership stake in a licensed pharmacy.
Charles Ornstein ProPublica, Oct. 22, 2015
Over the last week, Valeant Pharmaceuticals International, a large drug maker, has seen its stock price plunge amid allegations of questionable dealings with pharmacies.
Now ProPublica has obtained documents showing how people affiliated with Valeant’s main pharmacy used a backdoor approach to gain an ownership stake in California after the pharmacy, Philidor Rx Services, was denied a permit to operate in the state.
Philidor’s license application was denied in May 2014 after the California Board of Pharmacy accused the company and its representatives of making “false statements of fact.” Specifically, the board said Philidor lied when listing the pharmacy’s owners, its accountant and its authorized signatories for financial transactions.
Several months later, a holding company whose chief executive identifies herself onlineas Philidor’s director of pharmacy operations purchased a 10 percent stake in West Wilshire Pharmacy in Los Angeles.
Since last Friday, Valeant’s stock has plummeted almost 40 percent as investors have raised as-yet-unanswered questions about its accounting and business practices, particularly its relationship with so-called specialty pharmacies that generally charge patients lower co-payments than retail pharmacies.
Disclosure of the West Wilshire transaction seems likely to intensify those questions. It’s unclear how it enables Philidor or Valeant to distribute drugs any more easily than a contractual relationship with a California pharmacy would. Calls to Philidor, Valeant and West Wilshire were not returned.
Virginia Herold, the executive officer of California’s Board of Pharmacy, said it’s vital that pharmacies and their owners provide truthful information to the board.
“The board spends a lot of time investigating applications to ensure the individuals are who they say they are,” Herold said, though she declined to discuss Philidor specifically because the pharmacy has appealed its license denial. “It is a concern to us when someone misrepresents that.”
Valeant rose to prominence through acquisitions of drugs and companies, including Bausch & Lomb and skin-care company Medicis. It specializes in taking over companies with portfolios of small, sleepy drugs, slashing research and development spending, and raising drug prices aggressively. A bevy of high-profile hedge funds, most prominently Bill Ackman’s Pershing Square Capital Management, have taken big stakes in Valeant.
Increasingly, Valeant and other drug companies are encouraging patients to use specialty pharmacies. They are essentially mail-order pharmacies that help patients and doctors navigate insurance company requirements.
Specialty pharmacies are seen as a reliable distribution channel for expensive drugs, offering patients convenience and lower costs while maximizing insurance reimbursements from those companies that cover the drug. Patients typically pay the same co-payments whether or not their insurers cover the drug.
But investors are concerned that Quebec-based Valeant has not disclosed the full extent of its relationship with Philidor and its network of other pharmacies. They also are concerned about the convoluted ownership structure of the network, which has only grown more confusing with Valeant’s recent disclosures.
Camarillo, Calif.-based R&O Pharmacy filed a lawsuit in federal court against Valeant earlier this month, contending Valeant demanded it pay $69 million for drugs even though “it seems that Valeant has no evidence whatsoever to back up its claims.”
R&O’s complaint postulated two theories to explain Valeant’s actions: “1. Valeant and R&O are victims of a massive fraud perpetuated by third parties; or 2. Valeant is conspiring with other persons or entities to perpetuate a massive fraud against R&O and others.”
The lawsuit was first reported on Monday by a group called the Southern Investigative Reporting Foundation.
During a conference call with analysts on Monday, Valeant said that R&O is one of the specialty pharmacies in its network. Valeant said it shipped approximately $69 million worth of drugs to R&O, which was worth about $25 million to Valeant’s bottom line.
“R&O is improperly holding amounts it received from payers,” Valeant said in a slide presentation.
Valeant also disclosed for the first time Monday that it had a “contractual relationship with Philidor and late last year we purchased an option to acquire Philidor.” Philidor is based in Hatboro, Penn., outside Philadelphia.
Then, on Wednesday, Philidor issued its own statement shedding a little more light on its network. Philidor said it is licensed in 46 states and the District of Columbia. “Philidor has contractual relationships with the affiliated pharmacies, such as R&O Pharmacy, under which we provide those services. Philidor does not currently have a direct equity ownership in R&O Pharmacy or the affiliated pharmacies, but does have a contractual right to acquire the pharmacies now or in the future subject to regulatory approval.”
Neither Valeant nor Philidor made reference to West Wilshire Pharmacy.
ProPublica pieced together some details about what’s gone on in California using documents requested under the state’s Public Records Act and other documents on the state pharmacy board’s website.
Philidor applied for a California license in August 2013, listing Matthew S. Davenport as its chief executive. The board denied the application on May 16, 2014, citing “false statements of fact” and failure to comply with pharmacy laws, among other things.
In a Philidor filing with the federal government in July 2013, it lists Andrew Davenport as its CEO. Andrew Davenport, who is reported to be Matthew Davenport’s brother, also was featured as the pharmacy’s chief executive in an interview posted recently on theFacebook page of a Pennsylvania state senator.
Matthew Davenport is listed as the chief innovation officer of BQ6 Media Group, which bills itself as a “privately held marketing firm specializing in pharmaceutical communications.”
Until last year, West Wilshire was owned entirely by Shahrokh Makhani, a licensed pharmacist. He sold a 10 percent stake in August to a company called Lucena Holdings LLC., which was formed in Delaware but has an address in Ambler, Penn.
Lucena lists Sherri Leon as its chief executive officer. Leon’s LinkedIn page lists her as director of pharmacy operations for Philidor since August 2013.
Also listed as an ownerof Lucena is Gregory W. Blaszczynski. He was Philidor’s bookkeeper, accountant and a signatory on its financial transactions, according to the pharmacy board’s denial of Philidor’s license. Blaszczynski is also listed as chief financial officer of BQ6 Media Group, where Matthew Davenport works.
There are other indications that Philidor and West Wilshire are closely tied. West Wilshire’s online privacy policy mentions Philidor directly. In addition, both companies direct questions to the same toll-free number. West Wilshire’s website is also hosted on an online network that belongs to Philidor.
On Thursday afternoon, Valeant announced that it would hold a conference call Monday to “lay out the facts including allegations made against our company regarding our relationship with Philidor and R&O.”
It said many of the reports to date “contain numerous errors, unsupported speculation and incorrect interpretations of facts and circumstances to the detriment of the shareholders of the company.”
ProPublica reporter Jesse Eisinger contributed to this report.
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