From Vilnius U-Lithuania: RE: "the characteristics of donors' participation in European biobanks as reflected in the consent documents"

Sci Eng Ethics. 2013 Oct 18. [Epub ahead of print]

'Mirroring' the Ethics of Biobanking: What Analysis of Consent Documents Can Tell Us?

Jurate S, Zivile V, Eugenijus G.

Source

Department of Medical History and Ethics, Vilnius University, M.K. Ciurlionio St. 21/27, 03101, Vilnius, Lithuania, jurate.serepkaite@gmail.com.

Abstract

Biobanks have been recognized as a key research infrastructure and how to approach ethical questions has been a topic of discussion for at least a decade by now. This article explores the characteristics of donors' participation in European biobanks as reflected in the consent documents of a selection of different biobanks from various European countries. The primary aim of this study is to understand how donors are informed about their participation in biobanking. Also the paper discusses what the most important thematic issues of information are to be given to the biobank participants and how this information should be presented in the consent documents. For these purposes, we analyse consent documents from 14 biobanks in 11 countries for six ethically relevant issues: (1) model of consent, (2) scope of future research, (3) access to medical data, (4) feedback to the participants, (5) consent withdrawal, and (6) role of research ethics committee. In order to compare different trends of informing donors of human biological material and medical data, we interpret the six analysed issues in the context of respect to donor's autonomy paradigm. Although the results of the paper reflect the heterogeneity of biobank consent document policies applied in different European countries, we uncovered some trends and suggested several examples of good practices to balance the interests of the donors with those of the researchers and future patients.

Tim Mackey and Bryan Liang: "Effective global "eHealth Governance" focused on cybercrime is needed in order to effectively combat illicit online pharmacies."

Global Health. 2013 Oct 16;9(1):45. [Epub ahead of print]

Pharmaceutical digital marketing and governance: illicit actors and challenges to global patient safety and public health.

Mackey TK, Liang BA.

Abstract

BACKGROUND:

Digital forms of direct-to-consumer pharmaceutical marketing (eDTCA) have globalized in an era of free and open information exchange. Yet, the unregulated expansion of eDTCA has resulted in unaddressed global public health threats. Specifically, illicit online pharmacies are engaged in the sale of purportedly safe, legitimate product that may in fact be counterfeit or substandard. These cybercriminal actors exploit available eDTCA mediums over the Internet to market their suspect products globally. Despite these risks, a detailed assessment of the public health, patient safety, and cybersecurity threats and governance mechanisms to address them has not been conducted.

DISCUSSION:

Illicit online pharmacies represent a significant global public health and patient safety risk. Existing governance mechanisms are insufficient and include lack of adequate adoption in national regulation, ineffective voluntary governance mechanisms, and uneven global law enforcement efforts that have allowed proliferation of these cybercriminals on the web. In order to effectively address this multistakeholder threat, inclusive global governance strategies that engage the information technology, law enforcement and public health sectors should be established.

SUMMARY:

Effective global "eHealth Governance" focused on cybercrime is needed in order to effectively combat illicit online pharmacies. This includes building upon existing Internet governance structures and coordinating partnership between the UN Office of Drugs and Crime that leads the global fight against transnational organized crime and the Internet Governance Forum that is shaping the future of Internet governance. Through a UNODC-IGF governance mechanism, investigation, detection and coordination of activities against illicit online pharmacies and their misuse of eDTCA can commence.

Hear Res. 2013 Aug;302:96-106. doi: 10.1016/j.heares.2013.05.007. Epub 2013 May 25.

'Ecstasy' enhances noise-induced hearing loss.

Church MW, Zhang JS, Langford MM, Perrine SA.

Source

Department of Otolaryngology & Head Neck Surgery, Wayne State University School of Medicine, Detroit, MI 48201, USA. mchurch@med.wayne.edu

Abstract

'Ecstasy' or 3,4-methylenedioxy-N-methamphetamine (MDMA) is an amphetamine abused for its euphoric, empathogenic, hallucinatory, and stimulant effects. It is also used to treat certain psychiatric disorders. Common settings for Ecstasy use are nightclubs and "rave" parties where participants consume MDMA and dance to loud music. One concern with the club setting is that exposure to loud sounds can cause permanent sensorineural hearing loss. Another concern is that consumption of MDMA may enhance such hearing loss. Whereas this latter possibility has not been investigated, this study tested the hypothesis that MDMA enhances noise-induced hearing loss (NIHL) by exposing rats to either MDMA, noise trauma, both MDMA and noise, or neither treatment. MDMA was given in a binge pattern of 5 mg/kg per intraperitoneal injections every 2 h for a total of four injections to animals in the two MDMA-treated groups (MDMA-only and Noise + MDMA). Saline injections were given to the animals in the two non-MDMA groups (Control and Noise-only). Following the final injection, noise trauma was induced by a 10 kHz tone at 120 dB SPL for 1 h to animals in the two noise trauma-treated groups (Noise-only and Noise + MDMA). Hearing loss was assessed by the auditory brainstem response (ABR) and cochlear histology. Results showed that MDMA enhanced NIHL compared to Noise-only and that MDMA alone caused no hearing loss. This implies that "clubbers" and "rave-goers" are exacerbating the amount of NIHL when they consume MDMA and listen to loud sounds. In contrast to earlier reports, the present study found that MDMA by itself caused no changes in the click-evoked ABR's wave latencies or amplitudes.

“Do we want the state to fund water infrastructure like we have funded research and commercialization with CPRIT? Do we want state government handing out sweetheart loans based on political connections instead of economic realities?"

PROPOSITION 6 UNNECESSARILY EXPANDS STATE GOVERNMENT INTO INVESTMENT BANKING, REPLACING THE FREE MARKET

Read more:The Gilmer Mirror - PROPOSITION 6 UNNECESSARILY EXPANDS STATE GOVERNMENT INTO INVESTMENT BANKING REPLACING THE FREE MARKET

"everyone is getting fatter"

5 Frightening Facts About Obesity In The US

KELLY DICKERSON OCT. 18, 2013

Read more: http://www.businessinsider.com/cdc-american-obesity-rates-2013-10#ixzz2i88BYjPa

"'Negative results' now account for only 14% of published papers, down from 30% in 1990. Yet knowing what is false is as important to science as knowing what is true."

How science goes wrong

Scientific research has changed the world. Now it needs to change itself

Oct 19th 2013

"Conversely, failures to prove a hypothesis are rarely even offered for publication, let alone accepted. “Negative results” now account for only 14% of published papers, down from 30% in 1990. Yet knowing what is false is as important to science as knowing what is true. The failure to report failures means that researchers waste money and effort exploring blind alleys already investigated by other scientists."

Jackie Fox's Excellent "The 10 Commandments of Breast Cancer"

The 10 Commandments of Breast Cancer

Res Social Adm Pharm. 2013 Oct 9. pii: S1551-7411(13)00152-6. doi: 10.1016/j.sapharm.2013.08.002. [Epub ahead of print]

Prescription drug coupons: Evolution and need for regulation in direct-to-consumer advertising.

Mackey TK, Yagi N, Liang BA.

Source

Institute of Health Law Studies, California Western School of Law, USA; San Diego Center for Patient Safety, University of California, San Diego School of Medicine, USA; Department of Anesthesiology, University of California, San Diego School of Medicine, USA. Electronic address: tmackey@ucsd.edu.

Abstract

Pharmaceutical marketing in the United States had undergone a shift from largely exclusively targeting physicians to considerable efforts in targeting patients through various forms of direct-to-consumer advertising ("DTCA"). This includes the use of DTCA in prescription drug coupons ("PDCs"), a new form of DTCA that offers discounts and rebates directly to consumers to lower costs of drug purchasing. Our examination of PDCs reveals that the use and types of PDC programs is expanding and includes promotion of the vast majority of top grossing pharmaceuticals. However, controversy regarding this emerging form of DTCA has given rise to health policy concerns about their overall impact on prescription drug expenditures for consumers, payers, and the health care system, and whether they lead to optimal long-term utilization of pharmaceuticals. In response to these concerns and the growing popularity of PDCs, what we propose here are clearer regulation and regulatory guidance for PDC DTCA use. This would include review for appropriate disclosure of marketing claims, increased transparency in PDC use for pharmaceutical pricing, and leveraging potential positive benefits of PDC use for vulnerable or underserved patient populations.

Nutr Res Pract. 2013 Oct;7(5):400-8. doi: 10.4162/nrp.2013.7.5.400. Epub 2013 Oct 1.

Maternal and grandmaternal obesity and environmental factors as determinants of daughter's obesity.

Shin MN, Lee KH, Lee HS, Sasaki S, Oh HY, Lyu ES, Kim MK.

Source

Department of Food and Nutrition, Pukyung National University, Busan 608-737, Korea.

Abstract

Obesity may be the consequence of various environmental or genetic factors, which may be highly correlated with each other. We aimed to examine whether grandmaternal and maternal obesity and environmental risk factors are related to obesity in daughters. Daughters (n = 182) recruited from female students, their mothers (n = 147) and their grandmothers (n = 67) were included in this study. Multivariable logistic regression was used to analyze the association between the daughter's obesity and maternal, grandmaternal, and environmental factors. Maternal heights of 161-175cm (OD: 8.48, 95% CI: 3.61-19.93) and 156-160 cm (2.37, 1.14-4.91) showed positive associations with a higher height of daughter, compared to those of 149-155 cm. Mothers receiving a university or a higher education had a significant OR (3.82, 1.27-11.50) for a higher height of daughter compared to those having a low education (elementary school). Mother having the heaviest weight at current time (59-80 kg, 3.78, 1.73-8.28) and the heaviest weight at 20 years of age (51-65 kg, 3.17, 1.53-6.55) had significant associations with a higher height of daughters, compared to those having the lightest weight at the same times. There was no association between the height, weight, and BMI of daughters and the characteristics and education of her grandmothers. In conclusion, although genetic factors appear to influence the daughter's height more than environmental factors, the daughter's weight appears to be more strongly associated with individual factors than the genetic factors.

Blood Press Monit. 2013 Oct 14. [Epub ahead of print]

Early morning hypertension: a narrative review.

Hoshide S, Kario K.

Source

Department of Cardiology, Jichi Medical University School of Medicine, Tochigi, Japan.

Abstract

Early morning hypertension has attracted more attention because of the close relationship between blood pressure levels in the early morning and cardiovascular risk. However, there are some unsolved issues on early morning hypertension. First, is early morning hypertension more special than other hypertension evaluated by other blood pressure indices? Second, the concept of early morning hypertension and morning blood pressure surge is sometimes discussed in the same context. Finally, is there any benefit in reducing early morning hypertension independent of a reduction in any other blood pressure index? Here, we review the remaining unsolved issues on early morning hypertension.

Zombie allusions: They just keep on coming-ivy league

'Zombie Car' abandoned in China street, overgrown with ivy

"In China, abandoned cars are known colloquially as “jiangshiche,” or “zombie cars.” But the Huayang example, hidden almost completely by leaves, quickly became the most famous zombie car in China, with pictures circulated on social media.

Police tried to remove the vines, but they were so thick and thorny that it was decided the vehicle should be towed away with the green foliage in place – a bizarre sight for other drivers."

Nature. 2013 Oct 17;502(7471):317-20. doi: 10.1038/nature12564.

Criteria for the use of omics-based predictors in clinical trials.

McShane LM, Cavenagh MM, Lively TG, Eberhard DA, Bigbee WL, Williams PM, Mesirov JP, Polley MY, Kim KY, Tricoli JV, Taylor JM, Shuman DJ, Simon RM,Doroshow JH, Conley BA.

Source

Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA. mcshanel@ctep.nci.nih.gov

Abstract

The US National Cancer Institute (NCI), in collaboration with scientists representing multiple areas of expertise relevant to 'omics'-based test development, has developed a checklist of criteria that can be used to determine the readiness of omics-based tests for guiding patient care in clinical trials. The checklist criteria cover issues relating to specimens, assays, mathematical modelling, clinical trial design, and ethical, legal and regulatory aspects. Funding bodies and journals are encouraged to consider the checklist, which they may find useful for assessing study quality and evidence strength. The checklist will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests will be used to guide therapy.

From NIH: The ethics of peer review in bioethics

J Med Ethics. 2013 Oct 16. doi: 10.1136/medethics-2013-101364. [Epub ahead of print]

The ethics of peer review in bioethics.

Wendler D, Miller F.

Source

Department of Bioethics, NIH Clinical Center, , Bethesda, Maryland, USA.

Abstract

A good deal has been written on the ethics of peer review, especially in the scientific and medical literatures. In contrast, we are unaware of any articles on the ethics of peer review in bioethics. Recognising this gap, we evaluate the extant proposals regarding ethical standards for peer review in general and consider how they apply to bioethics. We argue that scholars have an obligation to perform peer review based on the extent to which they personally benefit from the peer review process. We also argue, contrary to existing proposals and guidelines, that it can be appropriate for peer reviewers to benefit in their own scholarship from the manuscripts they review. With respect to bioethics in particular, we endorse double-blind review and suggest several ways in which the peer review process might be improved.

"...THC and related compounds could potentially usurp normal adolescent neurodevelopment, shifting the brain's developmental trajectory toward a disease-vulnerable state, predisposing early cannabis users to motivational, affective, and psychotic disorders."

Front Psychiatry. 2013 Oct 14;4:129.

Cannabis Use during Adolescent Development: Susceptibility to Psychiatric Illness.

Chadwick B, Miller ML, Hurd YL.

Source

Fishberg Department of Neuroscience, Friedman Brain Institute, Icahn School of Medicine at Mount Sinai , New York, NY , USA.

Abstract

Cannabis use is increasingly pervasive among adolescents today, even more common than cigarette smoking. The evolving policy surrounding the legalization of cannabis reaffirms the need to understand the relationship between cannabis exposure early in life and psychiatric illnesses. cannabis contains psychoactive components, notably Δ⁹-tetrahydrocannabinol (THC), that interfere with the brain's endogenous endocannabinoid system, which is critically involved in both pre- and post-natal neurodevelopment. Consequently, THC and related compounds could potentially usurp normal adolescent neurodevelopment, shifting the brain's developmental trajectory toward a disease-vulnerable state, predisposing early cannabis users to motivational, affective, and psychotic disorders. Numerous human studies, including prospective longitudinal studies, demonstrate that early cannabis use is associated with major depressive disorder and drug addiction. A strong association between schizophrenia and cannabis use is also apparent, especially when considering genetic factors that interact with this environmental exposure. These human studies set a foundation for carefully controlled animal studies which demonstrate similar patterns following early cannabinoid exposure. Given the vulnerable nature of adolescent neurodevelopment and the persistent changes that follow early cannabis exposure, the experimental findings outlined should be carefully considered by policymakers. In order to fully address the growing issues of psychiatric illnesses and to ensure a healthy future, measures should be taken to reduce cannabis use among teens.

"We must now focus on modernizing the tumour board to reflect current medical care realities..."

Nat Rev Clin Oncol. 2013 Oct;10(10):552-4. doi: 10.1038/nrclinonc.2013.159. Epub 2013 Aug 27.

Innovation: Tumour board-introducing real time to oncology management.

Allen TC, Liang BA.

"Over a decade ago, Petty and Vetto⁷ acknowledged “[t]here is little solid evidence to support the belief that tumour conferences directly impact the care patients receive.” Furthermore, work of Keating et al.⁸ observed only weak associations between multidisciplinary tumour board and measures of use, quality and survival. Blayney⁹ critically concluded that “huddles, lab meetings, cooperative group meetings, or attending physician rounds don't get the job done.” Ultimately, tumour board do not influence the quality of cancer care, which is their intended purpose.¹⁰ Despite these noted challenges, traditional perspectives die hard. We must now focus on modernizing the tumour board to reflect current medical care realities, address the limited effectiveness of the current paradigm and include the need for patient integration into a real-time decision-making process."

Oh, great: "For those too young to remember the Cold War but old enough to be trapped by the Great Recession, Marxism holds new appeal"

A Generation of Intellectuals Shaped by 2008 Crash Rescues Marx From History’s Dustbin

For those too young to remember the Cold War but old enough to be trapped by the Great Recession, Marxism holds new appeal

By Michelle Goldberg|October 14, 2013

"In the United States, of course, Marxism remains an intellectual current rather than a mass movement. Certainly, millennials are famously progressive; a much-discussed 2011 Pew pollfound that 49 percent of people between 18 and 29 had a favorable view of socialism, while only 46 percent felt positively about capitalism. It’s hard to say exactly what this means—it’s not as if young people are sending Das Kapital racing up the best-seller lists or reconstituting communist cells. Still, it’s been decades since so many young thinkers have been so engaged in imagining a social order not governed by the imperatives of the market.

The reason why is obvious enough. “Now everything is falling apart,” says Doug Henwood, publisher of the Left Business Observer and mentor to several among the new Marxist thinkers. “Not even the most energetic apologists can say things are going well. The basic premises of American life, about upward mobility and all that, it all seems like a cruel joke now.”

Meanwhile, the end of the Cold War has freed people—especially those too young to remember it—to revisit Marxist ideas without worrying that they’re justifying existing repressive regimes."

PLoS One. 2011;6(12):e28964. doi: 10.1371/journal.pone.0028964. Epub 2011 Dec 14.

The predatory ecology of Deinonychus and the origin of flapping in birds.

Fowler DW, Freedman EA, Scannella JB, Kambic RE.

Source

Museum of the Rockies and Department of Earth Sciences, Montana State University, Bozeman, Montana, United States of America. df9465@yahoo.co.uk

Abstract

Most non-avian theropod dinosaurs are characterized by fearsome serrated teeth and sharp recurved claws. Interpretation of theropod predatory ecology is typically based on functional morphological analysis of these and other physical features. The notorious hypertrophied 'killing claw' on pedal digit (D) II of the maniraptoran theropod Deinonychus (Paraves: Dromaeosauridae) is hypothesized to have been a predatory adaptation for slashing or climbing, leading to the suggestion that Deinonychus and other dromaeosaurids were cursorial predators specialized for actively attacking and killing prey several times larger than themselves. However, this hypothesis is problematic as extant animals that possess similarly hypertrophied claws do not use them to slash or climb up prey. Here we offer an alternative interpretation: that the hypertrophied D-II claw of dromaeosaurids was functionally analogous to the enlarged talon also found on D-II of extant Accipitridae (hawks and eagles; one family of the birds commonly known as "raptors"). Here, the talon is used to maintain grip on prey of subequal body size to the predator, while the victim is pinned down by the body weight of the raptor and dismembered by the beak. The foot of Deinonychus exhibits morphology consistent with a grasping function, supportive of the prey immobilisation behavior model. Opposite morphological trends within Deinonychosauria (Dromaeosauridae + Troodontidae) are indicative of ecological separation. Placed in context of avian evolution, the grasping foot of Deinonychus and other terrestrial predatory paravians is hypothesized to have been an exaptation for the grasping foot of arboreal perching birds. Here we also describe "stability flapping", a novel behaviour executed for positioning and stability during the initial stages of prey immobilisation, which may have been pivotal to the evolution of the flapping stroke. These findings overhaul our perception of predatory dinosaurs and highlight the role of exaptation in the evolution of novel structures and behaviours.

From U Barcelona: How does morality work in the brain?

Front Integr Neurosci. 2013 Sep 12;7:65.

How does morality work in the brain? A functional and structural perspective of moral behavior.

Pascual L, Rodrigues P, Gallardo-Pujol D.

Source

Department of Personality, University of Barcelona Barcelona, Spain.

Abstract

Neural underpinnings of morality are not yet well understood. Researchers in moral neuroscience have tried to find specific structures and processes that shed light on how morality works. Here, we review the main brain areas that have been associated with morality at both structural and functional levels and speculate about how it can be studied. Orbital and ventromedial prefrontal cortices are implicated in emotionally-driven moral decisions, while dorsolateral prefrontal cortex appears to moderate its response. These competing processes may be mediated by the anterior cingulate cortex. Parietal and temporal structures play important roles in the attribution of others' beliefs and intentions. The insular cortex is engaged during empathic processes. Other regions seem to play a more complementary role in morality. Morality is supported not by a single brain circuitry or structure, but by several circuits overlapping with other complex processes. The identification of the core features of morality and moral-related processes is needed. Neuroscience can provide meaningful insights in order to delineate the boundaries of morality in conjunction with moral psychology.

From U Kentucky: Self-collecting a cervico-vaginal specimen for cervical cancer screening: An exploratory study of acceptability among medically underserved women in rural Appalachia

Gynecol Oncol. 2013 Oct 11. pii: S0090-8258(13)01253-5. doi: 10.1016/j.ygyno.2013.10.008. [Epub ahead of print]

Self-collecting a cervico-vaginal specimen for cervical cancer screening: An exploratory study of acceptability among medically underserved women in rural appalachia.

Vanderpool RC, Jones MG, Stradtman LR, Smith JS, Crosby RA.

Source

Department of Health Behavior, University of Kentucky College of Public Health, Lexington, KY, USA. Electronic address: robin@kcr.uky.edu.

Abstract

OBJECTIVE:

Innovative screening methods such as self-testing for human papillomavirus (HPV) may alleviate barriers to cervical cancer screening. The purpose of this exploratory study was to determine whether Appalachian Kentucky women would be amenable to self-collecting a cervico-vaginal specimen for HPV testing.

METHODS:

Women aged 30-64 who were overdue for guideline-recommended cervical cancer screening were recruited from a primary care clinic in southeastern Kentucky. The women were asked to self-collect a specimen, using a cervico-vaginal brush, based on verbal and printed directions provided by a research nurse. All study participants, regardless of laboratory-confirmed HPV status, received the same counseling on the importance of cervical cancer screening and offered navigation to follow-up Pap testing at the local health department.

RESULTS:

Thirty-one women were approached and recruited to participate in the study, indicating a 100% acceptance rate of HPV self-testing. Of the 31 women, 26 tested negative for high-risk HPV and five tested positive. All of the women with negative results declined nurse navigation to Pap testing, whereas four of the five women with positive results accepted nurse navigation and received subsequent Pap smear screenings (all results were normal).

CONCLUSIONS:

Among this sample of Appalachian Kentucky women, self-collecting a cervico-vaginal specimen for HPV testing was highly acceptable. This exploratory study provides impetus for larger studies among high-risk, medically underserved women in rural communities. Tailoring alternative cancer screening strategies to meet the complex needs of rural women is likely to lead to reductions in cervical cancer incidence and mortality among this vulnerable population.

Behav Brain Sci. 2013 Oct;36(5):490-491.

What about politics and culture?

Güss CD.

Source

Department of Psychology, University of North Florida, Jacksonville, FL 32224; Research Fellow, Alexander von Humboldt Foundation, 53173 Bonn, Germany. dguess@unf.edu https://www.unf.edu/coas/psychology/C__Dominik_Guess.aspx.

"Given Van de Vliert's impressive dataset and prognoses, I will discuss three limitations. First, the evolutionary argument does not adequately take into account how political changes influence freedoms. Second, the operationalizations of needs and freedoms are limited and questionable. Third, a direct relationship between climate, monetary resources, and psychological variables is a simplification neglecting various intervening variables."

Can a doctor refuse a person in need of urgent medical attention?

Aust Fam Physician. 2013 Oct;42(10):746-748.

Duty of care or a matter of conduct - Can a doctor refuse a person in need of urgent medical attention?

Dean J, Mahar P, Loh E, Ludlow K.

Source

is a medical student in the Faculty of Medicine, Nursing & Health Sciences, and a law student in the Faculty of Law, Monash University, Melbourne, Victoria.

Abstract

BACKGROUND:

Medical practitioners may have their particular skills called upon outside a direct professional context. The responsibilities of medical practitioners outside their defined scope of clinical practice may not be clear to all clinicians.

OBJECTIVE:

To consider the possible legal consequences of a doctor refusing to assist a person in need of urgent medical attention both in terms of medical negligence and professional misconduct.

DISCUSSION:

Where an established clinical relationship does not exist, and a doctor does not wish to render aid, three particular scenarios may arise. A doctor may actively deny being a doctor, passively avoid identifying themselves as a doctor or acknowledge being a doctor, but refuse to render assistance. Aside from any ethical issues, how a doctor chooses to act and represent themselves may lead to different legal ramifications. There exists significant variation in state provisions relating to legal obligations to render aid, which may benefit from review and revision at a national level.

J Med Ethics. 2013 Nov;39(11):672-674. doi: 10.1136/medethics-2013-101815.

Medical humanities: lineage, excursionary sketch and rationale.

Hurwitz B.

Abstract

Medical Humanities the journal started life in 2000 as a special edition of the JME. However, the intellectual taproots of the medical humanities as a field of enquiry can be traced to two developments: calls made in the 1920s for the development of multidisciplinary perspectives on the sciences that shed historical light on their assumptions, methods and practices; refusals to assimilate all medical phenomena to a biomedical worldview. Medical humanities the term stems from a desire to situate the significance of medicine as a product of culture. But despite growing usage over half a century the term defies a unifying encapsulation and continues to conjure up a multitude of discourse communities, including scholars working at the interfaces of health and humanities, arts and health, and medical education and bioethics. The field is intellectually capacious and polymorphous, forming and reforming around critical new research questions and teaching tasks spanning disciplines.

"The jury in federal court found that the SEC failed to prove several key elements of its case..."

http://bigstory.ap.org/photo/mark-cuban-35

SEC sued Mark Cuban in 2007. Jury cleared him in 3 1/2 hours.

Texas Federal Jury Clears Mark Cuban in Insider-Trading Lawsuit

 Dallas attorney Thomas M. Melsheimer of Fish & Richardson served as Mr. Cuban's lead counsel during the three-week trial before Chief Judge Sidney Fitzwater in the U.S. District Court for the Northern District of Texas. Mr. Cuban also was represented by Stephen A. Best of Brown Rudnick in Washington, D.C.; Christopher J. Clark of Latham & Watkins in New York; Lyle Roberts and George Anhang of Cooley LLP in Washington, D.C.; and Scott C. Thomas and Natalie L. Arbaugh from the Dallas office of Fish.

 

 

Obstet Gynecol. 2013 Oct 7. [Epub ahead of print]

Exclusion of Pregnant Women From Industry-Sponsored Clinical Trials.

Shields KE, Lyerly AD.

Source

Office of Ethics, Merck, Whitehouse Station, New Jersey; and the Department of Social Medicine and the Center for Bioethics, University of North Carolina, Chapel Hill, North Carolina.

Abstract

OBJECTIVE::

The lack of human data available to inform evidence-based treatment for illness during pregnancy has led to calls for greater inclusion of pregnant women in research, but the extent of their current representation is poorly characterized. Our objective was to measure the current exclusion of pregnant women from industry-sponsored clinical trials as a baseline for future comparison.

METHODS::

We compiled data from studies enrolling women of childbearing potential posted on www.ClinicalTrials.gov between 1 October 2011 and 31 January 2012. The review was limited to open United States-based phase IV interventional studies sponsored by the pharmaceutical industry evaluating treatment of conditions that may be experienced by but are not limited to pregnant women and did not involve a medication classified as potentially teratogenic. If there was no mention of pregnancy in the inclusion or exclusion criteria, we contacted a study representative to confirm that pregnant women could be enrolled.

RESULTS::

Of 558 qualifying industry-sponsored studies, five (1%) were designed specifically for pregnant women. Of 367 phase IV clinical trials with verified inclusion and exclusion criteria, 348 (95%) excluded pregnant women and 19 (5%) did not.

CONCLUSION::

We found the exclusion of pregnant women from industry-sponsored clinical trials to be common practice. Moving beyond reflexive exclusion and developing thoughtful criteria for inclusion of pregnant women in clinical research would likely advance the evidence base to inform treatment decisions during pregnancy and lead to better health outcomes for women and children.

CAP '13 has begun in sunny Orlando!

CAP '13 has begun in sunny Orlando!

From Michael Misialek: Pathologist: Legacy Of A 31-Year-Old Lung Cancer Patient

October 9, 2013 | 1:50 PM | Dr. Michael Misialek

Pathologist: Legacy Of A 31-Year-Old Lung Cancer Patient

"Kevin was also an outspoken advocate for lung cancer, working to erase the stigma that it is a patient’s fault because they smoked. About 15% of lung cancers occur in patients without a smoking history, many of them young like Kevin. It is in this population that the likelihood of finding a mutation that can be targeted is highest. This is the new world of personalized medicine, and as a pathologist I am looking for these mutations.

Kevin’s tumor initially responded well to the drug, but then developed resistance. He lost his battle just days after his marriage."