Saturday, June 25, 2016

Ethical considerations and challenges in first-in-human research

 2016 Jun 6. pii: S1931-5244(16)30066-4. doi: 10.1016/j.trsl.2016.05.006. [Epub ahead of print]

Ethical considerations and challenges in first-in-human research.

Author information

  • 1Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Japan; Leading Program, Graduate School of Biomedical Sciences, Nagasaki University, Japan.
  • 2Chulabhon International College of Medicine, Thammasat University, Thailand.
  • 3Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Japan. Electronic address: karbwangj@nagasaki-u.ac.jp.

Abstract

First-in-human (FIH) research is a translational process to move a new potential therapy from bench to bedside. Major ethical challenges of an FIH trial arise because of the indeterminate nature of the risks involved and the controversial risk-benefit justification. Severe adverse events and death of subjects who participated in FIH research in the past have led to an increased attention on ethical considerations in the design and conduct of such research. Furthermore, novel therapies in the current decade, such as molecular-targeted, gene transfer, and pluripotent stem cells therapies, have led to numerous emerging ethical challenges or different ethical assessment and justification frameworks for FIH research. This article presents, discusses, and interlinks ethical considerations and challenges in FIH research through a review of related ethical principles and their application to each ethical issue with given examples. Possible solutions to address each ethical challenge are presented. The scope of this article focuses on 4 major ethical issues in FIH research: risk-benefit assessment and justification for the conduct of research, selection of a suitable target population, informed consent, and conflict of interest.

PHILADELPHIA BECOMES FIRST MAJOR CITY TO APPROVE TAX ON SODA

PHILADELPHIA BECOMES FIRST MAJOR CITY TO APPROVE TAX ON SODA


"With the exception of baby formula, products that contain more than 50 percent milk, fruit and vegetable juice, the law lists “non-100%-fruit drinks; flavoured water; energy drinks; pre-sweetened coffee or tea; and non-alcoholic beverages intended to be mixed into an alcoholic drink,” as taxable products. It will go into effect on Jan. 1, 2017.

“The tax will be levied on distributors. Only time will tell how much will trickle down to consumers. The tax could add up to 18 cents to the cost of a 12-ounce can, $1 to the cost of a 2-liter container, and $2.16 to the cost of a 12-pack,” Philly.com explains."

"These sorts of tribal affiliations cause problems, obviously, which is why elites were so eager to tamp them down. Unfortunately, they are also what glues polities together, and makes people willing to sacrifice for them."

'Citizens of the World'? Nice Thought, But ...

915
By

"If you cannot see your fellow students, or colleagues, as engaged in a common and intrinsically human search for knowledge — maybe even wisdom — then you will have no incentive to cross the boundaries of race, gender, or culture."

Renewing the University


"If you cannot see your fellow students, or colleagues, as engaged in a common and intrinsically human search for knowledge — maybe even wisdom — then you will have no incentive to cross the boundaries of race, gender, or culture. You will in the end have no incentive to cross the boundaries of your narrow little self. You may occasionally speak the language of "alliance," but you will define your allies as those who obey your demands. And, in times of conflict, it will be characteristic of your stance toward the world to make demands.
This is a way to live. But it is not a good way to live, and it exacts a heavy toll on everyone involved — especially the students, who postpone beyond any reasonable point that vital achievement Richard Rodriguez described: becoming "assimilated into public society" in such a way as to make possible "the achievement of public individuality." If our young people are going to see that there are less confrontational alternatives, something other than zero-sum games, they will need instruction in the humanities. Some of us are prepared to give it."

Preanalytic Variables in Cytology: Lessons Learned From Next-Generation Sequencing—The MD Anderson Experience

Sinchita Roy-Chowdhuri MD, PhDJohn Stewart MD, PhD

Reprints: Sinchita Roy-Chowdhuri, MD, PhD, Department of Pathology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 85, Houston, TX 77030 (email: ).
Context.—As our understanding of genomic alterations underlying solid tumor malignancies continues to evolve, molecular testing of tumor samples is increasingly used to guide therapeutic management. Next-generation sequencing (NGS) provides a novel platform for the simultaneous screening of multiple genes using small amounts of DNA. Several recent studies have described NGS mutational analysis using cytologic specimens. The cytopathologist's role in specimen assessment and triaging is critical to effectively implementing NGS in routine cytology practice.
Objectives.—To review the NGS experience and a variety of preanalytic factors that affect NGS success rates of cytologic specimens at our institution.
Data Sources.—To evaluate cytology specimen adequacy rates for NGS, we reviewed a 14-month period of image-guided fine-needle aspiration and core needle biopsies, used for testing. In addition, we reviewed data from our previously published studies to evaluate preanalytic factors affecting NGS success in these specimens.
Conclusions.—Identifying factors that affect NGS success rates in cytology specimens is crucial for a better understanding of specimen adequacy requirements and for proper use of limited-volume tissue samples. In our practice, which uses direct smears as well as cell block sections, NGS success rates in core needle biopsy and fine-needle aspiration samples are comparable. The chance of successful testing is further increased by procuring concurrent fine-needle aspiration and core needle biopsy samples. The type of glass slides used for direct smears and the method of tissue extraction affect our DNA yield. Validating a DNA input for cytology samples that is lower than that recommended by the manufacturer has significantly increased our NGS success rate.

Thursday, June 23, 2016

"After three years as a resident physician in pathology, I'd grown accustomed to seeing cancer. In fact, I see it every day. But this was different: These were just kids."

Spending a month with children's cancer


Chicago Tribune





"After three years as a resident physician in pathology, I'd grown accustomed to seeing cancer. In fact, I see it every day. But this was different: These were just kids.

Kids with leukemia. Kids with osteosarcoma. Kids with Wilms' tumor of the kidney. Kids with melanoma. The youngest kid diagnosed with cancer was just 3 days old."

Sunday, June 12, 2016

Will obesity reverse the life span gains made over decades of health triumphs?

Will obesity reverse the life span gains made over decades of health triumphs?

AMERICANS HAD BEEN LIVING LONGER, BUT WEIGHT EPIDEMIC IS REVERSING THE TREND
"In one year alone, deaths from stroke ticked up 4 percent, chronic liver disease deaths jumped 3 percent and deaths attributed to heart disease and to diabetes rose by 1 percent each, according to the Centers for Disease Control and Prevention. Deaths because of Alzheimer’s disease, which has been linked to midlife obesity, rose 19 percent over the year before."



Graduated responsibility for pathology residents: no time for half measures

 2013 Apr;137(4):457-61. doi: 10.5858/arpa.2012-0161-ED.

Graduated responsibility for pathology residents: no time for half measures.

The Fattest States In America

The Fattest States In America

"According to The State of Obesity study, rates of obesity now exceed 35% in three states (Arkansas, West Virginia and Mississippi), 22 states have rates above 30%, 45 states are above 25%, and every state is above 20%. Arkansas has the highest adult obesity rate at 35.9%, while Colorado has the lowest at 21.3%. The data show that 23 of 25 states with the highest rates of obesity are in the South and Midwest."



Read more: The Fattest States In America - 24/7 Wall St. http://247wallst.com/healthcare-economy/2016/06/12/the-fattest-states-in-america-2/#ixzz4BNJWaXeD
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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).

Saturday, June 11, 2016

FDA Has Strong Words for Cancer Drug Developers

FDA Has Strong Words for Cancer Drug Developers

 

"In the end, patients may benefit from lower costs if Merck and Bristol-Myers face more rivals in the marketplace. Both Keytruda and Opdivo have a U.S. list price of about $150,000 per year.

If combinations of expensive therapies become the norm, drugmakers could theoretically keep prices lower by mixing their own treatments rather than seeking permission from a rival."

"Stalin needed terror to master a country brutalized by his program of factory building and collectivism..."

Stalin’s Curse

As Joshua Rubenstein’s new ‘The Last Days of Stalin’ makes clear, an empire that sows fear reaps it

“Eating fat does not make you fat.”

Report Says UK Government Is Pushing Obesity Epidemic

Forty Percent Of US Women, 17 Percent Of Teenagers Are Obese: CDC

Is sugar really bad for you?

Is sugar really bad for you?

Many nutrition experts say that sugar in moderation is fine for most people but in excess it can lead to metabolic problems beyond its effects on weight gain

Anahad O'connor 

Battle of Tarakan 1-25 May 1945

Borneo Campaign

11 Apr 1945 - 15 Aug 1945

Contributor: 
Battle of Tarakan
1-25 May 1945

"Tarakan was a small island located in the northeastern corner of Borneo. The town and its oil fields were primary objectives when the Japanese invaded in 1942, and again was deemed important when it came for the Allies to invade Borneo. Although its 350,000 barrels per month production could no longer reach Japan due to the Allied occupation of the Philippines (oil so pure that the Japanese could pump them directly into warships without refining, some claimed), Operation Oboe One still provided key airfields that the Allies could use to aid the upcoming campaign against Borneo. The Allies, of course, could use the additional oil production capability that the oil fields could provide."

Disgust made us human

Disgust made us human

Our ancestors reacted to parasites with overwhelming revulsion, wiring the brain for morals, manners, politics and laws

by Kathleen McAuliffe

"When we’re worried about disease, it appears, we’re drawn not just to Mama’s cooking but also to her beliefs about the proper way to conduct ourselves – especially in the social arena. We place our faith in time-honoured practices probably because they seem like a safer bet when our survival is in jeopardy. Now’s not the time to be embracing a new, untested philosophy of life, whispers a voice in the back of your mind."







"...it has been bittersweet for researchers to discover that, actually, our successful campaigns to reduce smoking may play a role in the growing obesity epidemic."

The Surprising Link Between Obesity And A Smoke-Free America

Public health requires a delicate, and sometimes impossible, balance.



"Smoking is just about the worst thing you can do for your health. It can cause cancer pretty much all over your body, tooth and gum loss, stillbirth, premature death, and many other awful things. 
It’s for these reasons that it has been bittersweet for researchers to discover that, actually, our successful campaigns to reduce smoking may play a role in the growing obesity epidemic.
After the 1964 Surgeon General’s report confirmed that, yes, smoking does cause cancer, the number of tobacco-toking Americans rapidly declined. As of 2014, 16 percent of high school students and adults smoked, down from 42.4 percent in 1964.
Obesity, on the other hand, has more than doubled in a similar time period. Two-thirds of adults in America were overweight or obese — 68.6 percent — as of 2012."

Obesity is one of biggest problem in U.S.

Obesity is one of biggest problem in U.S. – Daly City Tech Part


"For the last several years, experts thought the nation’s alarming, decades-long rise in obesity had leveled off"

"But the Centers for Disease Control and Prevention said in a report Thursday that the obesity rate has climbed to nearly 38 percent of adults, up from 32 percent about a decade earlier.”This is a striking finding” and suggests that a situation that was thought to be stable is getting worse, said William Dietz, an obesity expert at George Washington University.
Experts said they had no explanation for why the rate appears to be rising.The report, based primarily on a survey conducted in 2013-14, also found the obesity rate was significantly higher for women, at 38 percent, compared with 34 percent for men. The rates for men and women had been roughly the same for about a decade.
Obesity is considered one of the nation’s leading public health problems. Until the early 1980s, only about 1 in 6 adults was obese, but the rate climbed dramatically until it hit about 1 in 3 around a decade ago."

Friday, June 10, 2016

Predictive genetic testing for neurodegenerative conditions: how should conflicting interests within families be managed?

 2016 Jun 8. pii: medethics-2016-103400. doi: 10.1136/medethics-2016-103400. [Epub ahead of print]

Predictive genetic testing for neurodegenerative conditions: how should conflicting interests within families be managed?

Author information

  • 1Murdoch Childrens Research Institute, Parkville, Victoria, Australia Victorian Clinical Genetics Services, Parkville, Victoria, Australia.
  • 2Victorian Clinical Genetics Services, Parkville, Victoria, Australia.
  • 3Murdoch Childrens Research Institute, Parkville, Victoria, Australia Royal Children's Hospital, Parkville, Victoria, Australia University of Melbourne, Parkville, Victoria, Australia.
  • 4Department of Clinical Genetics, Austin Health, Heidelberg, Victoria, Australia.
  • 5Murdoch Childrens Research Institute, Parkville, Victoria, Australia Victorian Clinical Genetics Services, Parkville, Victoria, Australia University of Melbourne, Parkville, Victoria, Australia Department of Clinical Genetics, Austin Health, Heidelberg, Victoria, Australia.

Abstract

Predictive genetic testing for a neurodegenerative condition in one individual in a family may have implications for other family members, in that it can reveal their genetic status. Herein a complex clinical case is explored where the testing wish of one family member was in direct conflict to that of another. The son of a person at 50% risk of an autosomal dominant neurodegenerative condition requested testing to reveal his genetic status. The main reason for the request was if he had the familial mutation, he and his partner planned to utilise preimplantation genetic diagnosis to prevent his offspring having the condition. His at-risk parent was clear that if they found out they had the mutation, they would commit suicide. We assess the potential benefits and harms from acceding to or denying such a request and present an approach to balancing competing rights of individuals within families at risk of late-onset genetic conditions, where family members have irreconcilable differences with respect to predictive testing. We argue that while it may not be possible to completely avoid harm in these situations, it is important to consider the magnitude of risks, and make every effort to limit the potential for adverse outcomes.

England's Debate Over Fats And Sugars Shows You Can't Believe Any Health Advice Anymore

England's Debate Over Fats And Sugars Shows You Can't Believe Any Health Advice Anymore

Read on for a dose of dietary nihilism.


CHARLIE SORREL 06.10.16 10:30 AM


"So who should you believe? On the one hand, the official advice is over-conservative, and its insistence on a basis of cheap and filling starchy carbs seems more about feeding a hungry country in times of post-WWI scarcity. On the other hand, while the PHC recommends that we cut out processed and sugary foods in favor of natural fats, fruits and veggies, and proteins, its list of patronsand its advisory board includes Atkins-diet and anti-sugar campaigners.
Really, though, we know what’s good for us. Don’t eat too much of anything, avoid processed foods, prefer fruits and veggies. And of course, don’t stint on the delicious butter."



"Newly released State Department emails help reveal how a major Clinton Foundation donor was placed on a sensitive government intelligence advisory board even though he had no obvious experience in the field..."

How Clinton Donor Got on Sensitive Intelligence Board



  •  
Jun 10, 2016, 6:59 AM ET

"Newly released State Department emails help reveal how a major Clinton Foundation donor was placed on a sensitive government intelligence advisory board even though he had no obvious experience in the field, a decision that appeared to baffle the department’s professional staff.
The emails further reveal how, after inquiries from ABC News, the Clinton staff sought to “protect the name” of the Secretary, “stall” the ABC News reporter and ultimately accept the resignation of the donor just two days later.
Copies of dozens of internal emails were provided to ABC News by the conservative political group Citizens United, which obtained them under the Freedom of Information Act after more the two years of litigation with the government."
HT:MC


Wednesday, June 8, 2016

Getting It Right for Every Child: A National Policy Framework to Promote Children's Well-being in Scotland

 2016 Jun;94(2):334-365. doi: 10.1111/1468-0009.12195.

Getting It Right for Every Child: A National Policy Framework to Promote Children's Well-being in Scotland, United Kingdom.

Author information

  • 1Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling.
  • 2School of Health, Nursing and Midwifery, University of the West of Scotland.
  • 3School of Social Sciences, University of Stirling.

Abstract

POLICY POINTS:

Getting It Right for Every Child (GIRFEC), a landmark policy framework for improving children's well-being in Scotland, United Kingdom, is a practice initiative signifying a distinct way of thinking, an agenda for change, and the future direction of child welfare policy. GIRFEC represents a unique case study of national transformative change within the contexts of children's well-being and universal services and is of relevance to other jurisdictions. Implementation is under way, with an understanding of well-being and the requirement for information sharing enshrined in law. Yet there is scope for interpretation within the legislation and associated guidance. Inherent tensions around intrusion, data gathering, professional roles, and balancing well-being against child protection threaten the effectiveness of the policy if not resolved.

CONTEXT:

Despite persistent health inequalities and intergenerational deprivation, the Scottish government aspires for Scotland to be the best country for children to grow up in. Getting It Right for Every Child (GIRFEC) is a landmark children's policy framework to improve children's well-being via early intervention, universal service provision, and multiagency coordination across organizational boundaries. Placing the child and family "at the center," this approach marks a shift from welfare to well-being, yet there is still a general lack of consensus over how well-being is defined and measured. As an umbrella policy framework with broad reach, GIRFEC represents the current and future direction of children's/familypolicy in Scotland, yet large-scale practice change is required for successful implementation.

METHODS:

This article explores the origins and emergence of GIRFEC and presents a critical analysis of its incremental design, development, and implementation.

FINDINGS:

There is considerable scope for interpretation within the GIRFEC legislation and guidance, most notably around assessment of well-being and the role and remit of those charged with implementation. Tensions have arisen around issues such as professional roles; intrusion, data sharing, and confidentiality; and the balance between supporting well-being and protecting children. Despite the policy's intentions for integration, the service landscape for children and families still remains relatively fragmented.

CONCLUSIONS:

Although the policy has groundbreaking potential, inherent tensions must be resolved and the processes of change carefully managed in order for GIRFEC to be effective. It remains to be seen whether GIRFEC can fulfil the Scottish government's aspirations to reduce inequalities and improve lifelong outcomes for Scotland's children and young people. In terms of both a national children's well-being framework within a universal public service context and a distinct style of policymaking and implementation, the Scottish experience represents a unique case study of whole-country, transformational change and is of relevance to other jurisdictions.