Saturday, March 2, 2013

Deficiencies of the FDA in evaluating generic formulations: addressing narrow therapeutic index drugs

http://www.ncbi.nlm.nih.gov/pubmed/23356099


 2012;38(4):667-89.

Deficiencies of the FDA in evaluating generic formulations: addressing narrow therapeutic index drugs.

Source

Institute of Health Law Studies, California Western School of Law, USA.

Abstract

Generic drugs represent a significant portion of the medical arsenal in treating disease. As copies of originator drugs, these drugs have been permitted abbreviated approval under the Hatch-Waxman Act. Yet with the current cost focus upon generic formulations, potential safety issues with generics have arisen. Although there is an established criterion of "bioequivalence" that generic formulations must demonstrate, narrow-therapeutic index drugs for sensitive clinical circumstances such as epilepsy, antiplatelet therapies, and mental health treatments may require different regulatory treatment than other generic drugs. Further, in these circumstances, differences in generic formulations may lead to adverse clinical outcomes due to less stringent bioequivalence tolerances. Yet there is no mandate for comparison between different generic formulations. Countries outside the United States advocate for narrowing tolerance ranges for these high risk health situations and the drugs for their treatment. We argue in this paper that additional patient safety matters must be taken into account for narrow therapeutic disease drugs, and regulatory bodies should emphasize greater tightness in bioequivalence before these narrow-therapeutic drug generic formulations are approved.

"EMTALA served as a policy detour that may have misled the public into believing the problem of health care access had largely been solved"

http://www.ncbi.nlm.nih.gov/pubmed/23423410


 2013 Feb 20;309(7):665-6. doi: 10.1001/jama.2012.96863.

Policy responses to demand for health care access: from the individual to the population.

Source

Robert Wood Johnson Foundation Clinical Scholars Program, University of Michigan, 2800 Plymouth Rd, Bldg 10, Room G016, Ann Arbor, MI, USA. vickeryk@med.umich.edu



Current debate and disagreements regarding health care obscure strong public sentiment calling for reform of the US health care system. Public support for the 2010 Patient Protection and Affordable Care Act (ACA) is split nearly perfectly along party lines, with recent polls indicating that 45% of Americans favor the law and 40% oppose it.1
A generation ago, Congress reacted to public demand for reform by passing the Emergency Medical Treatment and Active Labor Act (EMTALA), signed into law by President Ronald Reagan in 1986. EMTALA was timely legislation, intended by Congress to impart a social contract between the health care–seeking public and a US health care system that the public progressively distrusted. In reality, EMTALA served as a policy detour that may have misled the public into believing the problem of health care access had largely been solved. As President George W. Bush explained in 2007, “[P]eople have access to health care in America. After all, you just go to an emergency room.”2

Overdiagnosis in screening mammography in Denmark: population based cohort study

http://www.ncbi.nlm.nih.gov/pubmed/23444414

 2013 Feb 26;346:f1064. doi: 10.1136/bmj.f1064.

Overdiagnosis in screening mammography in Denmark: population based cohort study.

Source

Department of Public Health, University of Copenhagen, Ă˜stre Farimagsgade 5, DK 1014 Copenhagen K, Denmark.

Abstract

OBJECTIVE:

To use data from two longstanding, population based screening programmes to study overdiagnosis in screening mammography.

DESIGN:

Population based cohort study.

SETTING:

Copenhagen municipality (from 1991) and Funen County (from 1993), Denmark.

PARTICIPANTS:

57 763 women targeted by organised screening, aged 56-69 when the screening programmes started, and followed up to 2009.

MAIN OUTCOME MEASURES:

Overdiagnosis of breast cancer in women targeted by screening, assessed by relative risks compared with historical control groups from screening regions, national control groups from non-screening regions, and historical national control groups.

RESULTS:

In total, 3279 invasive breast carcinomas and ductal carcinomas in situ occurred. The start of screening led to prevalence peaks in breastcancer incidence: relative risk 2.06 (95% confidence interval 1.64 to 2.59) for Copenhagen and 1.84 (1.46 to 2.32) for Funen. During subsequentscreening rounds, relative risks were slightly above unity: 1.04 (0.85 to 1.27) for Copenhagen and 1.14 (0.98 to 1.32) for Funen. A compensatory dip was seen after the end of invitation to screening: relative risk 0.80 (0.65 to 0.98) for Copenhagen and 0.67 (0.55 to 0.81) for Funen during the first four years. The relative risk of breast cancer accumulated over the entire follow-up period was 1.06 (0.90 to 1.25) for Copenhagen and 1.01 (0.93 to 1.10) for Funen. Relative risks for participants corrected for selection bias were estimated to be 1.08 for Copenhagen and 1.02 for Funen; for participants followed for at least eight years after the end of screening, they were 1.05 and 1.01. A pooled estimate gave 1.040 (0.99 to 1.09) for all targeted women and 1.023 (0.97 to 1.08) for targeted women followed for at least eight years after the end of screening.

CONCLUSIONS:

On the basis of combined data from the two screening programmes, this study indicated that overdiagnosis most likely amounted to 2.3% (95% confidence interval -3% to 8%) in targeted women. Among participants, it was most likely 1-5%. At least eight years after the end ofscreening were needed to compensate for the excess incidence during screening.

From Emory U: In Their Own Words: Romantic Relationships and the Sexual Health of Young African American Women

http://www.ncbi.nlm.nih.gov/pubmed/23450883


 2013 Mar;128(Suppl 1):33-42.

In Their Own Words: Romantic Relationships and the Sexual Health of Young African American Women.

Source

Emory University, Rollins School of Public Health, Atlanta, GA.

Abstract

OBJECTIVE:

We assessed young African American women's understanding of "dual protection" (DP) (i.e., strategies that simultaneously protect against unintended pregnancies and sexually transmitted diseases [STDs]) and how relationship factors influence their use of DP methods.

METHODS:

We conducted 10 focus groups with African American women (n=51) aged 15-24 years in Atlanta, Georgia, to identify barriers to and facilitators of their DP use. Focus group participants also completed a brief self-administered questionnaire that assessed demographics and sexual behaviors. We analyzed focus group data by theme: relationships, planning for sex, pregnancy intentions, STD worries, the trade-off between pregnancy and STDs, attitudes toward condoms and contraceptives, and understanding of DP.

RESULTS:

From the questionnaire, 51% of participants reported that an STD would be the "worst thing that could happen," and 26% reported that being pregnant would be "terrible." Focus group data suggested that most participants understood what DP was but thought it was not always feasible. Relationship factors (e.g., trust, intimacy, length of relationship, and centrality) affected pregnancy intentions, STD concerns, and use of DP. Social influences (e.g., parents) and pregnancy and STD history also affected attitudes about pregnancy, STDs, and relationships.

CONCLUSIONS:

Although participants identified risks associated with sex, a complex web of social and relationship factors influenced the extent to which they engaged in protective behavior. The extent to which relationship factors influence DP may reflect developmental tasks of adolescence and should be considered in any program promoting sexual health among young African American women.

How should Australia regulate voluntary euthanasia and assisted suicide?

http://www.ncbi.nlm.nih.gov/pubmed/23431857


 2012 Dec;20(2):410-38.

How should Australia regulate voluntary euthanasia and assisted suicide?

Source

Health Law Research Centre, Faculty of Law, Queensland University of Technology. bp.white@qut.edu.au

Abstract

This article invites consideration of how Australia should regulate voluntary euthanasia and assisted suicide. It attempts to pose this question as neutrally as possible, acknowledging that both prohibition and legalisation of such conduct involve decisions about regulation. It begins by charting the wider field of law at the end of life, before considering the repeated, but ultimately unsuccessful, attempts at law reform in Australia. The situation in Australia is contrasted with permissive jurisdictions overseas where voluntary euthanasia and/or assisted suicide are lawful. The authors consider the arguments for and against legalisation of such conduct along with the available empirical evidence as to what happens in practice both in Australia and overseas. The article concludes by outlining a framework for deliberating on how Australia should regulate voluntary euthanasia and assisted suicide. It asks a threshold question of whether such conduct should be criminal acts (as they presently are), the answer to which then leads to a range of possible regulatory options.

Continuous Sedation Until Death as Physician-Assisted Suicide/Euthanasia

http://www.ncbi.nlm.nih.gov/pubmed/23449365


 2013 Feb 28. [Epub ahead of print]

Continuous Sedation Until Death as Physician-Assisted Suicide/Euthanasia: A Conceptual Analysis.

Source

Cuyahoga Community College, Cleveland, Ohio, USA.

Abstract

A distinction is commonly drawn between continuous sedation until death and physician-assisted suicide/euthanasia. Only the latter is found to involve killing, whereas the former eludes such characterization. I argue that continuous sedation until death is equivalent to physician-assisted suicide/euthanasia in that both involve killing. This is established by first defining and clarifying palliative sedation therapies in general and continuous sedation until death in particular. A case study analysis and a look at current practices are provided. This is followed by a defense of arguments in favor of definitions of death centering on higher brain (neocortical) functioning rather than on whole brain or cardiopulmonary functioning. It is then shown that continuous sedation until death simulates higher brain definitions of death by eliminating consciousness. Appeals to reversibility and double effect fail to establish any distinguishing characteristics between the simulation of death that occurs in continuous sedation until death and the death that occurs as a result of physician-assisted suicide/euthanasia. Concluding remarks clarify the moral ramifications of these findings.

From U Michigan: A systematic review of peer review for scientific manuscripts

http://www.ncbi.nlm.nih.gov/pubmed/23449238


 2012 Mar;7(1):37-44. doi: 10.1007/s11552-012-9392-6. Epub 2012 Feb 1.

A systematic review of peer review for scientific manuscripts.

Source

Section of Plastic Surgery, Department of Surgery, The University of Michigan Health System, 2130 Taubman Center, SPC 5340, 1500 E. Medical Center Drive, Ann Arbor, MI 48109-5340 USA.

Abstract

BACKGROUND:

The usefulness of peer review has been expressed as a method to improve the quality of published work. However, there has been a lack of systematic reviews to date to highlight the essential themes of the peer-review process.

METHODS:

We performed a search of the English language literature published prior to October 2011 using PubMed to identify articles regarding peer review. Inclusion and exclusion criteria were developed a priori. Data were extracted and then analyzed for the prevalence of peer-review themes contained within the literature.

RESULTS:

Of the 941 articles found during our original literature search, 37 were selected for review. The majority were commentary/editorial articles. The themes in our search included the structure and process of the peer-review system, the criteria for papers, ethics, and the different forms of the peer-review process.

CONCLUSIONS:

The criteria for submission will vary, but our systematic review provides a comprehensive overview of what reviewers expect from authors. Our systematic review also highlighted ethical considerations for both authors and reviewers during the peer-review process. Although the topic of peer review is expansive and its process may vary from journal to journal, the understanding of the themes outlined in this paper will help authors recognize how to write a more successful paper. Also, more research must be carried out to establish the efficacy of the different styles of peer review, and it would be presumptuous to draw conclusions until further research is established.

From the Indian J Plastic Surgery: Ethical and legal issues in aesthetic surgery

http://www.ncbi.nlm.nih.gov/pubmed/23450235


 2012 Sep;45(3):547-9. doi: 10.4103/0970-0358.105973.

Ethical and legal issues in aesthetic surgery.

Source

Emeritus Consultant in Plastic Surgery and Head of Aesthetic Surgery Unit, Department of Plastic Surgery Sir Gangaram Hospital, New Delhi, India.

Abstract

Rapid growth and expansion of plastic surgery in general and aesthetic surgery in particular in the past decade has brought in its wake some confusions particularly raising questions for the surgeons conduct towards his colleagues and the patients in the light of ethical requirements. Some thoughts from eminent thinkers form a backdrop to consideration of theories of medical ethics. In this article raging and continuous debates on these subjects have been avoided to maintain the momentum. Apart from the western thoughts, directions from our old scriptures on ethical conduct have been included to accommodate prevelant Indian practices. The confusion created by specialists advertising their abilities directly to the lay public following removal of ethical bars by the American Courts as also latitudes allowed by the General Medical Council of Great Britain have been discussed. The medical fraternity however has its reservations. Unnecessary skirmishes with the law arose in cosmetic surgery from the freedom exercised by the police to file criminal proceedings against attending doctors in the event of a patient's death with or without any evidence of wrong doing. This has now been curtailed in the judgement of the Supreme Court of India[1] where norms have been laid down for such prosecution. This has helped doctors to function without fear of harassment. An effort has been made to state a simple day-to-day routine for an ethical doctor-patient relationship.

Second Opinions: Pathologists' Preventive Medicine

http://www.archivesofpathology.org/doi/pdf/10.5858/arpa.2012-0512-ED


Second Opinions: Pathologists' Preventive Medicine

Timothy Craig Allen MD, JD
From the Department of Pathology, University of Texas Health Science Center at Tyler.

"The testimony of eyewitnesses is notoriously subject to suggestion and to error, frequently with dire effects on the wrongfully accused."

http://www.nybooks.com/articles/archives/2013/feb/21/speak-memory/?pagination=false


Speak, Memory

FEBRUARY 21, 2013

Oliver Sacks


In our present age, descriptions and accusations of childhood abuse have reached almost epidemic proportions. Much is made of so-called recovered memories—memories of experiences so traumatic as to be defensively repressed, and then, with therapy, released from repression. Particularly dark and fantastic forms of this include descriptions of satanic rituals of one sort and another, accompanied often by coercive sexual practices. Lives, and families, have been ruined by such accusations. But it has been shown, in at least some cases, that such descriptions can be insinuated or planted by others. The frequent combination, here, of a suggestible witness (often a child) with an authority figure (perhaps a therapist, a teacher, a social worker, or an investigator) can be particularly powerful.
From the Inquisition and the Salem witch trials to the Soviet trials of the 1930s and Abu Ghraib, varieties of “extreme interrogation,” or outright physical and mental torture, have been used to extract political or religious “confessions.” While such interrogation may be intended to extract information in the first place, its deeper intentions may be to brainwash, to effect a genuine change of mind, to fill it with implanted, self-inculpatory memories, and in this it may be frighteningly successful.5
But it may not take coercive suggestion to affect a person’s memories. The testimony of eyewitnesses is notoriously subject to suggestion and to error, frequently with dire effects on the wrongfully accused.6 With the advent of DNAtesting, it is now possible to find, in many cases, an objective corroboration or refutation of such testimony, and Schacter notes that “a recent analysis of forty cases in which DNA evidence established the innocence of wrongly imprisoned individuals revealed that thirty-six of them (90 percent) involved mistaken eyewitness identification.”



Hungry in Hungary? There's a tax for that.

http://www.nytimes.com/2013/03/03/world/europe/hungary-experiments-with-food-tax-to-coax-healthier-habits.html?pagewanted=all&_r=0


Hungary Tries a Dash of Taxes to Promote Healthier Eating Habits


BUDAPEST — Gizella Beres Devenyi, who works behind the cash register at the delicatessen Zena in a working-class neighborhood here, says it is easy to see Hungary’s new salt tax at work.
...................

Many nutrition experts say that taxation is a powerful tool that has been effective in campaigns to reduce smoking and alcohol consumption. But many questions remain about how to make it work when it comes to changing eating habits.

Should taxation be combined with subsidies making fruits, vegetables and lean meat especially cheap? Will it actually improve diet or simply change it? And who will be affected? The truly overweight? Or the poor?

Friday, March 1, 2013

Zombie allusions: They just keep on coming-furloughed by the sequester

http://www.bizjournals.com/jacksonville/blog/2013/03/omg-its-the-sequestration-zombie.html


Mar 1, 2013, 11:42am EST

OMG, it's the sequestration zombie!


Editor-Jacksonville Business Journal

It’s the awful sequestration calamity that has struck, spreading out from Washington D.C. like a a wave of budget-slashing zombies, slashing every worthwhile government service in sight — and paving the way for another gut-wrenching recession.
Watch out, that policeman over there, he’s not going to be on the beat tomorrow. And that teacher, she’s getting furloughed, and your kids are going to be running wild in homeroom, shooting spitballs all day long.

Bioethics in popular science

http://www.ncbi.nlm.nih.gov/pubmed/23446115


 2013 Feb 28;14(1):10. [Epub ahead of print]

Bioethics in popular science: evaluating the impact of The immortal life of henrietta lacks on the biobank debate.

Abstract

BACKGROUND:

The global expansion of biobanks has led to a range of bioethical concerns related to consent, privacy, control, ownership, and disclosure. As an opportunity to engage broader audiences on these concerns, bioethicists have welcomed the commercial success of Rebecca Skloot's 2010 bestselling book The Immortal Life of Henrietta Lacks. To assess the impact of the book on discussion within the media and popular culture more generally, we systematically analyzed the ethics-related themes emphasized in reviews and articles about the book, and in interviews and profiles of Skloot.

METHODS:

We conducted a content analysis of a population of relevant English-language articles and transcripts (n = 125) produced by news organizations and publications in the U.S., Canada, Great Britain/Ireland, and Australia/New Zealand. We scored each article for the emphasis and appearance of 9 ethics-related themes. These were informed consent, welfare of the vulnerable, compensation, scientific progress, control/access, accountability/oversight, privacy, public education, and advocacy.

RESULTS:

The informed consent theme dominated media discussion, with almost 39.2 percent of articles/transcripts featuring the theme as a major focus and 44.8 percent emphasizing the theme as a minor focus. Other prominent themes and frames of reference focused on the welfare of the vulnerable (18.4 percent major emphasis; 36.0 percent minor emphasis), and donor compensation (19.2 percent major; 52.8 percent minor). Ethical themes that comprised a second tier of prominence included those of scientific progress, control/access, and accountability/oversight. The least prominent themes were privacy, public education, and advocacy.

CONCLUSIONS:

The book has been praised as an opportunity to elevate public discussion of bioethics, but such claims should be re-considered. The relatively narrow focus on informed consent in the media discussion generated by Skloot's book may limit the ability of ethicists and advocates to elevate attention to donor control, compensation, patenting, privacy, and other ethical issues. Still, ethicists should view the book and a pending major TV film translation as opportunities to highlight through media outreach, consultation exercises and public forums a broader range of bioethical concerns that would otherwise be under-emphasized in news coverage. Such efforts, however, need to be carefully planned and evaluated.

Jackie Fox's The 10 Commandments of Breast Cancer (applicable for patients with other cancers, too)

http://secondbasedispatch.com/2011/09/21/the-10-commandments-of-breast-cancer/


The 10 Commandments of Breast Cancer

U Chicago Law's Todd Henderson: Voice versus Exit in Health Care Policy

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2167470


Voice versus Exit in Health Care Policy


M. Todd Henderson 


University of Chicago - Law School

2012

Pathology Case Reviews, Vol. 17, No. 4, July/August 2012
University of Chicago Institute for Law & Economics Olin Research Paper No. 613
U of Chicago, Public Law Working Paper No. 402 

Abstract:      
This essay uses the recent controversy over President Obama’s mandate that insurance companies provide generous birth control coverage to explore larger issues about the optimal locus of health care decision making. Mandates may be justified in some instances, but they sacrifice choice and local variation and perhaps lead to worse social outcomes. The key question for policy makers is whether market processes or rule by expert is more likely to strike the right balance of choice and mandate.

Meningitis Deathwatch: 48

http://www.modernhealthcare.com/article/20130301/NEWS/303019959/fda-conducts-surprise-inspections-at-compounding-pharmacies

FDA conducts surprise inspections at compounding pharmacies


By Jaimy Lee
Posted: March 1, 2013 - 7:30 pm ET


The Food and Drug Administration conducted surprise inspections of four national compounding pharmacies that uncovered safety and quality issues at each facility just months after contaminated compounded drugs led to a meningitis outbreak that resulted in 48 deaths. 

The inspected facilities were: AnazaoHealth Corp. in Tampa, Fla.; Chicago-based Central Admixture Pharmacy Services, also referred to as CAPS; Lee Pharmacy in Fort Smith, Ark.; and Pharmedium Services in Cleveland, Miss. None of the companies immediately responded to requests for comment. The effort is part of the FDA's campaign to conduct proactive investigations into pharmacies that undertake high-risk sterile compounding, said Erica Jefferson, an FDA spokeswoman.



Read more: FDA conducts surprise inspections at compounding pharmacies | Modern Healthcare http://www.modernhealthcare.com/article/20130301/NEWS/303019959#ixzz2MLIOMrXy
?trk=tynt 

Gov. Perry appoints members to CPRIT Oversight Committee

http://www.bizjournals.com/houston/news/2013/03/01/gov-perry-appoints-members-to-cprit.html



Gov. Perry appoints members to CPRIT committee

Reporter-Houston Business Journal
Gov. Rick Perry appointed two members to the Cancer Prevention and Research Institute of Texas Oversight Committee.
Angelos Angelou is founder of Austin-based Angelou Economics and former vice president of economic development for theAustin Chamber of Commerce. He is also a past board member of the International Economic Development Council. Perry appointed Angelou to a term that will expire in January 2019.
A. Gerry Geistweidt is a private practice attorney and a member of the State Bar of Texas and Texas Bar Association. Geistweidt was appointed for a term that will end in January 2015.


Christopher Lasch. Scourge of the elites

http://www.spiked-online.com/site/reviewofbooks_article/13398/

Scourge of the elites
Christopher Lasch was a fearless iconoclast who defied left and right labels. Love him or loathe him, you need to grapple with his ideas if you want to understand today’s big political and moral debates.


In his prime, there was no more incendiary intellectual in America than Christopher Lasch. A prolific historian and social critic, Lasch wrote with erudition and flair about a wide range of topics from the early 1960s until his death in 1994, striving ‘for nothing less than a full understanding of the modern condition’, as a fellow historian put it. Called a ‘Marxist’ and a ‘fascist’ and almost everything else in between, he busted out of the conventional ‘right’ and ‘left’ political boxes. His writings typically aroused angry and emotional responses from his opponents.
........

He was raising a question that continues today: has the decline of the family been liberating for people? He argued no: the family has been unravelling, but alternative arrangements that have emerged in its wake, such as co-habitation, are accommodations to the family’s demise rather than positive and viable forms of commitment.

From Kirtee Raparia and colleagues: Lymphoproliferative Neoplasms of the Lung

http://www.archivesofpathology.org/doi/pdf/10.5858/arpa.2012-0202-RA


Lymphoproliferative Neoplasms of the Lung: A Review

Josette William MD, PhDDaina Variakojis MDAnjana Yeldandi MDKirtee Raparia MD
From the Department of Pathology, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.
Context.—Diagnosis and classification of lymphomas are based on the morphologic, immunologic, and genetic features that the lesional cells share with their normal B and T lymphocyte counterparts. Primary pulmonary lymphomas account for 0.3% of primary lung neoplasms and less than 0.5% of all lymphomas.
Objective.—To describe and summarize the clinical and histopathologic features of the primary pulmonary lymphoma and secondary involvement of the lung by lymphoma.
Data Sources.—Peer-reviewed published literature and personal experience.
Conclusions.—Diagnosis of clonal lymphoid proliferations in the lung has evolved owing to the greater utility of molecular and flow cytometric analysis of tissue. Further studies are needed to best define the clinical and prognostic features, as well as search for targeted therapy for these patients with rare neoplasms.

My take on second opinions of pathology diagnoses

http://www.archivesofpathology.org/doi/pdf/10.5858/arpa.2012-0512-ED


Second Opinions: Pathologists' Preventive Medicine

Timothy Craig Allen MD, JD
From the Department of Pathology, University of Texas Health Science Center at Tyler.



“I believe in reform. I know Bill Powers believes in reform”

http://www.texastribune.org/2013/03/01/lawmakers-prepare-review-university-management-ut/?utm_source=texastribune.org&utm_medium=alerts&utm_campaign=News%20Alert:%20Subscriptions


UT Regents Face Allegations of Meddling



House Higher Education Chairman Dan Branch, R-Dallas, is worried that the 2013 legislative session could become a repeat of 2011, when his agenda was overshadowed by tension between university system regents, academic leaders, and lawmakers over questions of governance and reforms.
The situation became so heated that a special oversight committee was formed to hold public hearings on the way higher education institutions in the state were governed, and how reforms were being implemented.
......................
“I believe in reform. I know Bill Powers believes in reform,” said Lt. Gov. David Dewhurst. “That’s why I’m particularly troubled when I see UT regents going around this man and this administration.”