Tuesday, March 31, 2015

Kamakahi vs. ASRM and the future of compensation for human eggs

 2015 Mar 26. pii: S0002-9378(15)00327-0. doi: 10.1016/j.ajog.2015.03.046. [Epub ahead of print]

Kamakahi vs. ASRM and the future of compensation for human eggs.

Author information

  • 1Professor of Clinical Psychiatry, Director, Masters of Bioethics Program, Columbia University. Electronic address: rlk2@columbia.edu.
  • 2Professor Obstetrics & Gynecology, Chief, Division of Reproductive Endocrinology, Columbia University, College of Physicians & Surgeons.

Abstract

A recent lawsuit, alleging that the American Society for Reproductive Medicine (ASRM) engages in price fixing by capping the amount of compensation paid for human oocytes, has several critical ethical and policy implications that have received relatively little attention. ASRM has argued that ceilings on donor compensation prevent enticement, exploitation, and oocyte commodification. Critics counter that low donor compensation decreases supply, since fewer women are then interested in donating, which then increases prices for the service that physicians - not donors - accrue; and that ethical goals can be better achieved through enhanced informed consent, hiring egg donor advocates and better counseling and screening. Yet if compensation caps are removed, questions emerge concerning what the oocyte market would then look like. Informed consent is an imperfect process. Beyond the legal and economic questions of whether ASRM violates the Sherman Anti-trust Act also lie crucial questions of whether human eggs should be viewed as other products. We argue that human eggs differ from other, factory-produced goods, and should command moral respect. Although eggs (or embryos) are not equivalent to human beings, they deserve special consideration, because of their potential for human life, and thus have a different moral status. ASRM's current guidelines appear to address, even if imperfectly, ethical challenges related to egg procurement for infertility treatment. Given public concerns about oocyte commodification and ASRM's wariness of government regulations, existing guidelines may represent a compromise - aiding patients who seek eggs, while simultaneously trying to avoid undue influence, exploitation and eugenics. Though the ultimate outcome of this lawsuit remains unclear, policy makers, providers, lawyers, judges and others should attend seriously to these issues. Alternatives to current ASRM guidelines may be possible - e.g., raising the current caps to, say, $12,000 or $15,000, potentially increasing donation, while still avoiding certain ethical difficulties - and warrant close consideration. These complex conflictingethical issues deserve more attention than they have received, since they affect key aspects of clinical practice and the lives of countless patients.

"Cancer biomarker testing is now a mainstay of 21st century pathology practice..."

Philip T. CagleMD; Randall J. OlsenMD, PhD; Bryce P. PortierMD, PhD; Hidehiro TakeiMD; David W. BernardMD, PhD
From the Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas


"Cancer biomarker testing is now a mainstay of 21st century pathology practice, embracing the pathologist’s role in patient selection for specific targeted therapies. Pathologists, oncologists, and others require direction in adapting to this new ever-evolving paradigm."

Lynette Sholl: Biomarkers in Lung Adenocarcinoma: A Decade of Progress

Lynette M. ShollMD
From the Department of Pathology, Brigham and Women's Hospital, and Harvard Medical School, Harvard University, Boston, Massachusetts.
Context.— The analysis of molecular biomarkers in lung adenocarcinoma (ACA) is now a central component of pathologic diagnosis and oncologic care. The identification of an EGFR mutation or ALK rearrangement in advanced-stage lung ACA will dictate a change in first-line treatment from standard chemotherapy to targeted inhibition of these oncogenic alterations. Viable approaches to therapeutic targeting of KRAS-mutated ACA are now under investigation, raising the possibility that this too will become an important predictive marker in this tumor type. The recognized array of less common oncogenic alterations in lung ACA, including in the ROS1RETBRAF, and ERBB2 genes, is growing rapidly. The therapeutic implications of these findings are, in many cases, still under investigation.
Objective.— To focus on the major molecular biomarkers in lung ACA, recommended testing strategies, the implications for targeted therapies, and the mechanisms that drive development of resistance.
Data Sources.— Our current understanding of predictive and prognostic markers in lung ACA is derived from a decade of technical advances, clinical trials, and epidemiologic studies. Many of the newest discoveries have emerged from application of high-throughput next-generation sequencing and gene expression analyses in clinically and pathologically defined cohorts of human lung tumors.
Conclusions.— Best practices require a solid understanding of relevant biomarkers for diagnosis and treatment of patients with lung ACA.

Limitation of care orders in patients with a diagnosis of dementia

 2015 Mar 25. pii: S0300-9572(15)00129-X. doi: 10.1016/j.resuscitation.2015.03.014. [Epub ahead of print]

Limitation of care orders in patients with a diagnosis of dementia.

Author information

  • 1Department of Forensic Medicine, Monash University, and Ballarat Health Service, Ballarat Victoria Australia; Ballarat Health Services Ballarat 3350 Australia. Electronic address: joseph.ibrahim@monash.edu.
  • 2Ballarat Health Services Ballarat 3350 Australia.
  • 3Australian Centre for Evidence Based Aged Care Faculty of Health Sciences, La Trobe University 3086.
  • 4Office of the Public Advocate, 1/204 Lygon Street, Carlton VIC 3053.

Abstract

The prevalence of dementia is growing with an ageing population. Most persons with dementia die of acute illness and many are hospitalised at the end of life. In the acute hospital setting, limitation of care orders (LCOs) such as Do Not Attempt CPR and Physician Orders For Life Sustaining Treatment (POLST), appear to be underused in patients with dementia. These patients receive the same aggressive life-prolonging therapies as any other patient, despite drastically higher mortality. However, limitation of care orders in patients with dementia is not addressed by current guidelines or policies. Systems and processes for obtaining and documenting LCO need improvement at the individual, organisational and societal level. The issue is controversial amongst the public and poorly understood by clinicians. Balanced and empathetic decision-making requires an individualised approach and recognition of the complexities (legal, ethical and clinical) of this issue. We examine the domains of: (a) treatment effectiveness, (b) burden of care and quality of life (c) patient autonomy and capacity.

The 2015 Physician Quality Reporting System Reflects Pathologists' Role in Lung Cancer Biomarker Testing

Philip T. CagleMD; Timothy Craig AllenMD, JD
From the Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas (Dr Cagle);
and the Department of Pathology, University of Texas Medical Branch, Galveston (Dr Allen).

The Essential Role of Pathologists in Health Care and Health Policy

 2015 Apr;139(4):441-444.

The Essential Role of Pathologists in Health Care and Health Policy.

Author information

  • 1From the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota (Drs Romano and Blessing); and the Department of Pathology, University of Texas Medical Branch, Galveston, Texas (Dr Allen).

Learning From New York City: A Case Study of Public Health Policy Practice in the Bloomberg Administration

 2015 Mar 27. [Epub ahead of print]

Learning From New York City: A Case Study of Public Health Policy Practice in the Bloomberg Administration.

Author information

  • 1Georgia Institute of Technology, School of Public Policy, Atlanta (Dr Isett); and Department of Health Policy and Management, Mailman School of Public Health, Columbia University, New York (Dr Laugesen and Mr Cloud).

Abstract

OBJECTIVES:

To ascertain any lessons learned about how public health reforms undertaken in New York City during the Bloomberg Administration were shepherded through the public policy and administration gauntlet. The question is, how feasible is this approach and would it work outside of New York City?

DESIGN/SETTING/PARTICIPANTS:

Using a theoretically grounded case study approach, 3 initiatives were examined that were proposed and/or implemented during a 10-year period of the Mayoralty of Michael Bloomberg (2002-2011): transfats restrictions, clean bus transportation policies, and a sugar-sweetened beverages tax (as a counterfactual). The investigation began by performing a comprehensive public documents search and was followed with interviews of 27 individuals involved in the selected policy initiatives. Interviews were coded in Nvivo using an iterative, grounded methodology.

RESULTS:

Using a theoretical lens, the case study illustrates that the multifaceted role of leadership was not confined to the executives in the City or the Agency. Instead, leadership extended to other administrative officials within the agency and the Board of Health. Second, New York City used reorganization and coordinative mechanisms strategically to ensure achievement of their goals. This included creation of new departments/bureaus and coordinating structures across the City. Evidence of the explicit use of incentives, as initially anticipated from the theoretical framework, was not found.

CONCLUSIONS:

While some aspects of this case study are unique to the context of New York City, 2 approaches used in New York City are feasible for other jurisdictions: harnessing the full scope and breadth of authority of the agency and its associated boards and commissions, and remobilizing existing workforce to explicitly focus on and coordinate targeted policies for issues of concern. Questions for further consideration are posed at the conclusion of the article.

Friday, March 27, 2015

The whispering disease

The whispering disease

Dr Reenu Jain, March 28, 2015

"There is no easy or reliable way to test for ovarian cancer if a woman has no symptoms. However, there are two ways to screen for ovarian cancer during a routine gynaecologic check up. One is a blood test for elevated levels of a protein called CA-125. The other is an ultrasound of the ovaries. If suspected, surgery should be performed by a gynaecologic oncologist, a specialist trained in cancers of the female reproductive system. The goal is to remove as much of the cancer as possible. Ovarian cancer is not “silent” but women must “listen” to their bodies in order to recognise the signs of the disease that whispers."

Progress in Human Embryonic Stem Cell Research in the United States between 2001 and 2010

 2015 Mar 26;10(3):e0120052. doi: 10.1371/journal.pone.0120052.

Progress in Human Embryonic Stem Cell Research in the United States between 2001 and 2010.

Author information

  • 1London Business School, London, United Kingdom; Rotman School of Management, University of Toronto, Toronto, Canada.
  • 2Rotman School of Management, University of Toronto, Toronto, Canada; Munk School of Global Affairs, University of Toronto, Toronto, Canada.
  • 3Rotman School of Management, University of Toronto, Toronto, Canada; Asia Pacific Foundation of Canada, Vancouver, Canada.
  • 4Rotman School of Management, University of Toronto, Toronto, Canada.
  • 5Sandra Rotman Centre, University of Toronto and University Health Network, Toronto, Canada; Dalla Lana School of Public Health and Dept. of Surgery, University of Toronto, Toronto, Canada; Stellenbosch Institute for Advanced Study, Wallenberg Research Centre, University of Stellenbosch, Stellenbosch, South Africa.

Abstract

On August 9th, 2001, the federal government of the United States announced a policy restricting federal funds available for research on human embryonic stem cell (hESCs) out of concern for the "vast ethical mine fields" associated with the creation of embryos for research purposes. Until the policy was repealed on March 9th, 2009, no U.S. federal funds were available for research on hESCs extracted after August 9, 2001, and only limited federal funds were available for research on a subset of hESC lines that had previously been extracted. This paper analyzes how the 2001 U.S. federal funding restrictions influenced the quantity and geography of peer-reviewed journal publications on hESC. The primary finding is that the 2001 policy did not have a significant aggregate effect on hESC research in the U.S. After a brief lag in early 2000s, U.S. hESC research maintained pace with other areas of stem cell and genetic research. The policy had several other consequences. First, it was tied to increased hESC research funding within the U.S. at the state level, leading to concentration of related activities in a relatively small number of states. Second, it stimulated increased collaborative research between US-based scientists and those in countries with flexible policies toward hESC research (including Canada, the U.K., Israel, China, Spain, and South Korea). Third, it encouraged independent hESC research in countries without restrictions.

The Texas Cattle Trail to Nebraska and James Cook's Description of Life on the Texas Cattle Trail

The Texas Cattle Trail to Nebraska

and

James Cook's Description of Life on the Texas Cattle Trail

Thursday, March 26, 2015

"On Thursday, the House touched the third rail. Lawmakers didn’t punt."

House Passes SGR Deal in Big, Bipartisan Fashion





"On Thursday, the House touched the third rail. Lawmakers didn’t punt. They didn’t kick the can down the road. And they were bigger than the clich├ęs that have come to describe the predictable patterns of Congress.
In a bipartisan vote, 392-37, House lawmakers passed a bill to end the “sustainable growth rate” used to calculate doctor’s payments for Medicare. After extending the program 17 times with only partial offsets, the House sent a bill to the Senate that would eliminate the need for patches and would pay for at least some of it by changing how much wealthy seniors pay for their Medicare prescriptions and doctors visits, and by instituting a $147 deductible for supplemental Medicare coverage (Medigap)."

A Game Theoretic Framework for Analyzing Re-Identification Risk

 2015 Mar 25;10(3):e0120592. doi: 10.1371/journal.pone.0120592.

A Game Theoretic Framework for Analyzing Re-Identification Risk.

Author information

  • 1Department of Electrical Engineering and Computer Science, Vanderbilt University, Nashville, Tennessee, United States of America.
  • 2Center for Biomedical Ethics and Society, Vanderbilt University, Tennessee, United States of America.
  • 3Department of Computer Science, University of Texas at Dallas, Richardson, Texas, United States of America.
  • 4Department of Biomedical Informatics, Vanderbilt University, Nashville, Tennessee, United States of America.

Abstract

Given the potential wealth of insights in personal data the big databases can provide, many organizations aim to share data while protecting privacy by sharing de-identified data, but are concerned because various demonstrations show such data can be re-identified. Yet these investigations focus on how attacks can be perpetrated, not the likelihood they will be realized. This paper introduces a game theoretic framework that enables a publisher to balance re-identification risk with the value of sharing data, leveraging a natural assumption that a recipient only attempts re-identification if its potential gains outweigh the costs. We apply the framework to a real case study, where the value of the data to the publisher is the actual grant funding dollar amounts from a national sponsor and the re-identification gain of the recipient is the fine paid to a regulator for violation of federal privacy rules. There are three notable findings: 1) it is possible to achieve zero risk, in that the recipient never gains from re-identification, while sharing almost as much data as the optimal solution that allows for a small amount of risk; 2) the zero-risk solution enables sharing much more data than a commonly invoked de-identification policy of the U.S. Health Insurance Portability and Accountability Act (HIPAA); and 3) a sensitivity analysis demonstrates these findings are robust to order-of-magnitude changes in player losses and gains. In combination, these findings provide support that such a framework can enable pragmatic policy decisions about de-identified data sharing.

Food and Drug Administration approval of laboratory tests

 2013 Jan;137(1):13-8. doi: 10.5858/arpa.2012-0077-ED.

Food and Drug Administration approval of laboratory tests.




 2013 Nov;137(11):1543-4. doi: 10.5858/arpa.2013-0020-ED. Epub 2013 Mar 15.

US Food and Drug Administration-approved laboratory tests after Caronia.

"The FDA last year finalized its companion diagnostics guidance, in which the agency reaffirmed its preference for simultaneous development of a drug alongside its companion diagnostic..."

At CDx Harmonization Meeting, Drugmakers Take First Step At Exploring Test Differences

Access to controlled medicines for palliative care in India: gains and challenges

 2015 Mar 23;-(-):1-6. [Epub ahead of print]

Access to controlled medicines for palliative care in India: gains and challenges.

Author information

  • 1Independent Researcher in Global Health,Bioethics and Programme Evaluation, C-5, Mantri Avenue-I, Panchavati, Pashan Rd, Pune, Maharashtra, 411 008 India.

Abstract

It was in the early 1990s that an appeal was made, both in India and globally, for access to palliative care to be treated as a human rights issue. Over the past few years, India has witnessed robust advocacy efforts which push for the consideration of palliative care and pain management as a human right. Central to this paper is India's Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985: its genesis, its critique, and the amendments aimed at enhancing access to the NDPS for medical care and research. I refer to the advocacy efforts in India, particularly the most recent ones, which led to the amendments to the NDPS Act, 1985 in February 2014; and the contribution of the global and local human rights discourse on palliative care to these efforts. This I situate in the overall status of palliative care in India. Towards the end, I briefly set out the agenda that should be pursued in the coming years to enhance access to controlled medicines for pain management and palliative care.

Wednesday, March 25, 2015

Pathologists and medical error disclosure: don't wait for an invitation

 2015 Feb;139(2):163-4. doi: 10.5858/arpa.2014-0136-ED.

Pathologists and medical error disclosure: don't wait for an invitation.

Author information

  • 1From the Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas (Dr Cohen); and the Department of Pathology, University of Texas Medical Branch, Galveston (Dr Allen).

Understanding your Pathology Report: A Patient's Story

Understanding your Pathology Report: A Patient's Story

How Obesity Became a Disease

How Obesity Became a Disease

And, as a consequence, how weight loss became an industry

Tuesday, March 24, 2015

Angelina Jolie Pitt: Diary of a Surgery

Angelina Jolie Pitt: Diary of a Surgery



"Then two weeks ago I got a call from my doctor with blood-test results. “Your CA-125 is normal,” he said. I breathed a sigh of relief. That test measures the amount of the protein CA-125 in the blood, and is used to monitor ovarian cancer. I have it every year because of my family history.
But that wasn’t all. He went on. “There are a number of inflammatory markers that are elevated, and taken together they could be a sign of early cancer.” I took a pause. “CA-125 has a 50 to 75 percent chance of missing ovarian cancer at early stages,” he said. He wanted me to see the surgeon immediately to check my ovaries."

Monday, March 23, 2015

Who speaks for whom? Health humanities and the ethics of representation

 2015 Mar 20. pii: medhum-2014-010642. doi: 10.1136/medhum-2014-010642. [Epub ahead of print]

Who speaks for whom? Health humanities and the ethics of representation.

Abstract

The medical or health humanities are in essence a form of advocacy, a means of addressing a problem of underrepresentation. They focus on suffering, rather than pathology, and on sociocultural understandings of illness and disability, rather than a narrow biomedical perspective. The health humanities thus analyse and attempt to recalibrate the power imbalance in healthcare. This article reviews health humanities scholarship that addresses underrepresentation through the analysis of illness and disability narratives. It examines the ethics of representation by exploring how literary representation functions, its aesthetic as well as political dimensions, and how it operates as a relay mechanism for power. The mechanism of representation is further explored through a reading of Eli Clare's narrative Exile and Pride. Donna Haraway's notion of articulations is proposed as a tool for a more ethical approach to representation. The article suggests that transparency about the power health humanities scholars stand to gain through representation may contribute to a more ethical health humanities practice.

Saturday, March 14, 2015

Prison program aims to turn criminals into coders

Prison program aims to turn criminals into coders


"Almost every week there's epiphanies," Redlitz said. "And most of the guys in here, they've never touched a computer before. They are progressing beyond our expectations."

RIP: Screening tests?

 2015 Feb;44(1):264-77. doi: 10.1093/ije/dyu140. Epub 2015 Jan 15.

Does screening for disease save lives in asymptomatic adults? Systematic review of meta-analyses and randomized trials.

Author information

  • 1Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA and Department of Statistics, Stanford University School of Humanities and Sciences, Stanford, CA, USA.
  • 2Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA and Department of Statistics, Stanford University School of Humanities and Sciences, Stanford, CA, USA Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA and Department of Statistics, Stanford University School of Humanities and Sciences, Stanford, CA, USA Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA and Department of Statistics, Stanford University School of Humanities and Sciences, Stanford, CA, USA jioannid@stanford.edu.

Abstract

BACKGROUND:

Several popular screening tests, such as mammography and prostate-specific antigen, have met with wide controversy and/or have lost their endorsement recently. We systematically evaluated evidence from randomized controlled trials (RCTs) as to whether screening decreasesmortality from diseases where death is a common outcome.

METHODS:

We searched three sources: United States Preventive Services Task Force (USPSTF), Cochrane Database of Systematic Reviews, and PubMed. We extracted recommendation status, category of evidence and RCT availability on mortality for screening tests for diseases on asymptomatic adults (excluding pregnant women and children) from USPSTF. We identified meta-analyses and individual RCTs on screening andmortality from Cochrane and PubMed.

RESULTS:

We selected 19 diseases (39 tests) out of 50 diseases/disorders for which USPSTF provides screening evaluation. Screening is recommended for 6 diseases (12 tests) out of the 19. We assessed 9 non-overlapping meta-analyses and 48 individual trials for these 19 diseases. Among the results of the meta-analyses, reductions where the 95% confidence intervals (CIs) excluded the null occurred for four disease-specificmortality estimates (ultrasound for abdominal aortic aneurysm in men; mammography for breast cancer; fecal occult blood test and flexible sigmoidoscopy for colorectal cancer) and for none of the all-cause mortality estimates. Among individual RCTs, reductions in disease-specific and all-cause mortality where the 95% CIs excluded the null occurred in 30% and 11% of the estimates, respectively.

CONCLUSIONS:

Among currently available screening tests for diseases where death is a common outcome, reductions in disease-specific mortalityare uncommon and reductions in all-cause mortality are very rare or non-existent.

How Stereotype Threat Affects Healthy Older Adults' Performance on Clinical Assessments of Cognitive Decline: The Key Role of Regulatory Fit

 2015 Mar 8. pii: gbv009. [Epub ahead of print]

How Stereotype Threat Affects Healthy Older Adults' Performance on Clinical Assessments of Cognitive Decline: The Key Role of Regulatory Fit.

Author information

  • 1Department of Psychology, San Francisco State University, California. barber@sfsu.edu.
  • 2Davis School of Gerontology and.
  • 3Department of Psychology, University of Southern California, Los Angeles.

Abstract

OBJECTIVES:

Stereotype threat can impair older adults' performance on clinical assessments for cognitive decline. We examined why this occurs. Based upon the regulatory focus account of stereotype threat, we predicted that the effects of stereotype threat should depend upon the assessments' reward structure. Stereotype threat should be associated with poor performance when the assessment emphasizes gaining correct answers, but not when it emphasizes avoiding mistakes.

METHOD:

Healthy older adults completed a series of mental status examinations. Half of the participants completed these examinations under stereotype threat about their cognitive abilities. Monetary incentives were also manipulated. For half of the participants correct responding led to gains. For the remaining participants incorrect responding/forgetting led to losses.

RESULTS:

Consistent with the regulatory focus account, stereotype threat was associated with poor performance when the mental status examinations had a gains-based structure, but not when they had a losses-based structure.

DISCUSSION:

Older adults respond to stereotype threat by becoming vigilant to avoid the losses that will make them their worst. Researchers and clinicians can capitalize on this motivational change to combat stereotype threat's negative effects. By using a loss-avoidance frame, stereotype threat's negative effects can be attenuated or even eliminated.

Proteomics in pharmaceutical research and development

 2015 Mar 12. doi: 10.1002/prca.201400181. [Epub ahead of print]

Proteomics in pharmaceutical research and development.

Author information

  • 1Translational Technologies and Bioinformatics, Pharmaceutical Sciences, Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche AG, CH-4070, Basel, Switzerland.

Abstract

In the 20 years since its inception, the evolution of proteomics in pharmaceutical industry has mirrored the developments within academia and indeed other industries. From initial enthusiasm and subsequent disappointment in global protein expression profiling, pharma research saw the biggest impact when relating to more focused approaches, such as those exploring the interaction between proteins and drugs. Nowadays, proteomics technologies have been integrated in many areas of pharmaceutical R&D, ranging from the analysis of therapeutic proteins to the monitoring of clinical trials. Here we review the development of proteomics in the drug discovery process, placing it in a historical context as well as reviewing the current status in light of the contributions to this special issue, which reflect some of the diverse demands of the drug and biomarker pipelines.