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Sunday, March 18, 2012

American College of Rheumatology: Patient Education - Fibromyalgia



Patient Education - Fibromyalgia

Faculty of Health Science - News - New Blood Test for Early Cancer Detection Developed by Ben-Gurion University of the Negev Researchers



Faculty of Health Science - News - Cancer_detection


New Blood Test for Early Cancer Detection Developed by Ben-Gurion University of the Negev Researchers



90 Percent Detection Rate in Clinical Tests for Multiple Types of Cancers
A simple blood test is being developed by researchers at Ben-Gurion University of the Negev (BGU) and Soroka University Medical Center in Beer-Sheva, Israel that may provide early detection of many types of cancer.
Prof. Joseph Kapelushnik of BGU’s Faculty of Health Sciences and his team developed a device that illuminates cancer cells with less than a teaspoon of blood. The test uses infrared light to detect miniscule changes in the blood of a person who has a cancerous growth somewhere, even before the disease has spread. Various molecules released into the bloodstream cause it to absorb infrared light slightly differently compared to that of healthy people.  
In the latest clinical trial with 200 patients and a control group, the test identified specific cancers in 90 percent of the patients and found other types of cancer, as well.  The researchers are focused on detection of common cancers, such as lung and ovarian cancer. 
Doctors believe that it is critical to increase cancer detection in early stages to prevent the need for long, difficult and costly treatments in more advanced stages.
“This is still research in the early stages of clinical trials,” clarifies Prof. Joseph Kapelushnik, who is also head of the Department of Pediatric Hemato-Oncology at Soroka hospital. 
“But the purpose is to develop an efficient, cheap and simple method to detect as many types of cancers as possible. We want to be able to detect cancer while a patient is still feeling good, before it has a chance to metastasize, meaning fewer treatments, less suffering and many more lives saved.”
More clinical trials will be conducted in the next 18 months.
Publish date: 26/02/2012

Seth's Blog: The ironic truth about sincerity



Seth's Blog: The ironic truth about sincerity:

No one cares how much you care.
That salesperson who will surely die if he doesn't close this sale, that painter who is sweating blood to get her idea on the canvas, that student who just pulled an all-nighter...
In fact, we're hyper alert to the appearance of caring. We want to do business with people who appear to care, who appear to bring care and passion and dedication to their work. If the work expresses caring, if you consistently and professionally deliver on that expression, we're sold.
The truth is that it's what we perceive that matters, not what you bring to the table. If you care but your work doesn't show it, you've failed. If you care so much that you're unable to bring quality, efficiency and discernment to your work, we'll walk away from it.
And the irony? The best, most reliable way to appear to care when it matters--is to care.

Saturday, March 17, 2012

WSJ to Biotech: "You're All Going To Die." Thanks - Now Let's Keep Fighting. - Forbes (worth reading)



WSJ to Biotech: "You're All Going To Die." Thanks - Now Let's Keep Fighting. - Forbes

"Friday’s WSJ features a brutally – I mean brutally — frank article about the dismal state of biotech financing.  There are few revelations (certainly not for those readers of this column who I know follow the space closely), and unfortunately, few patches of sunlight.   This clip from Play It Again, Sam pretty much captures the tone.
The crisis in financing is having a chilling effect on biomedical innovation.  As discussed in my last column, the main problem in our industry is that the sheer cost of drug development has become almost prohibitively expensive, effectively pricing almost everyone but the largest companies out of the market............"

"..........In the land of digital health, I also worry that there are a lot of developers who I don’t think really understand the gravitas of illness and disease.  For many of these folks, wellness is best envisioned as a fun and entertaining diversion, one that should be pursued with enthusiasm and characterized by delight.  Yet this whole idea of “gamefication” – while obviously both popular and fundable – doesn’t really connect with so much of what I’ve seen as a physician (and you don’t have to be a physician to understand the distinction – clearly, Jamie Heywood is an it-getter).
Perhaps when you’re 22, wellness is a game, but for most of the patients I recall in internal medicine, it really was anything but; patients have very serious, often existential concerns about their health, and about their ability to work and to provide.  What these patients want, expect, and deserve is serious engagement – and not some dipshit app........."

ICGC Data Portal - search using MSH2 gene as an example



ICGC Data Portal (search results MSH2)

United States - Ovarian Cancer | International Cancer Genome Consortium



United States - Ovarian Cancer | International Cancer Genome Consortium

Project Summary
The National Cancer Institute and the National Human Genome Research Institute launched The Cancer Genome Atlas program to create a comprehensive atlas of the genomic changes involved in more than 20 common types of cancer. This large-scale, high-throughput effort is being carried out by a network of more than 100 researchers at many organizations across the Unitred States. The overarching goal of TCGA is to further scientific understanding of the genomic changes in cancer, thereby improving the ability to diagnose, treat and prevent this devastating disease. All data generated by the TCGA research network are made rapidly available to the research community through the TCGA Data Portal.

Principal Investigators
TCGA Program Directors: Kenna Shaw, Ph.D., (NCI) and Brad Ozenberger, Ph.D., (NHGRI)
Biospecimen Core Resources (BCRs)
Julie Gastier-Foster, Ph.D.
Robert Penny, M.D., Ph.D.
Genome Characterization Centers (GCCs)
Stephen Baylin, M.D.
Rui Chen, Ph.D.
Lynda Chin, M.D.
Stacey Gabriel, Ph.D
Richard Gibbs, M.D, Ph.D.
Neil Hayes, M.D., M.P.H.
Raju Kucherlapati, Ph.D.
Peter Laird, Ph.D.
Jason Lieb, Ph.D.
Marco Marra, Ph.D.
Matthew Meyerson, M.D., Ph.D.
Chuck Perou, Ph.D.
Jonathan Seidman, Ph.D
David Wheeler, Ph.D.
Genome Sequencing Centers (GSCs)
Richard Gibbs, Ph.D.
Eric Lander, Ph.D.
Richard Wilson, Ph.D.
Data Coordinating Center (DCC)
John Greene, Ph.D., Project Director
Genome Data Analysis Centers (GDACs)
Christopher Benz, M.D
Lynda Chin, M.D.
Gaddy Getz, Ph.D.
David Haussler, Ph.D.
Neil Hayes, M.D., M.P.H.
Marc Ladanyi, M.D
Gordon Mills, M.D., Ph.D.
Chris Sander, Ph.D.
Ilya Shmulevich, Ph.D.
Terrence Speed, Ph.D.
Paul Spellman, Ph.D.
John Weinstein, M.D., Ph.D.
W.K. Alfred Yung, M.D.
Wei Zhang, Ph.D.

Australia - Ovarian Cancer | International Cancer Genome Consortium



Australia - Ovarian Cancer | International Cancer Genome Consortium

 

Project Summary
The primary aims sequence largely paired primary and recurrent ovarian tumors primarily drawn from a population based cohort study, the Australian Ovarian Cancer Study. The studies will define the somatic genomic abnormalities in primary ovarian tumours and insights into the molecular drivers of primary and acquired platinum resistance.

Principal Investigators
Institute for Molecular Bioscience
• Sean M. Grimmond (overall lead)
• David Miller
• Conrad Leonard
• Nicola Waddell
• Peter Wilson
• John V. Pearson
• Karin Kassahn
Peter MacCallum Cancer Centre
• David Bowtell (ovarian cancer lead)
• Dariush Etemadmoghadam
Westmead Millennium Institute for Medical Research
• Anna de Fazio
Queensland Institute for Medical Research
• Adèle Green
• Georgia Chenevix-Trench
• Penelope Webb
• David Whiteman
• David Purdie

March 15th update: Version 8 ICGC data protal (updates)International Cancer Genome Consortium



International Cancer Genome Consortium

 ICGC Goal: To obtain a comprehensive description of genomic, transcriptomic and epigenomic changes in 50 different tumor types and/or subtypes which are of clinical and societal importance across the globe

  • 15/March/2012 - The ICGC Data Coordination Center (DCC) is pleased to announce the release of Version 8 of the ICGC data portal.

    This update includes first data releases from France’s Liver Cancer project, Germany’s Pediatric Brain Cancer project, and the United Kingdom’s Myelodysplastic Syndrome Project. Also included are new submissions from the Australian Pancreatic Cancer project, the Canadian Pancreatic Cancer project, the Japanese Liver Cancer project, and the United Kingdom Breast Cancer (Triple Negative) project.

    This data adds to previous data releases from the Chinese Gastric Cancer project, the Spanish Chronic Lymphocytic Leukemia project and submissions from The Cancer Genome Atlas in the United States, which has contributed information on about 10 types of cancer affecting the blood, brain, breast, colon, kidney, lung, ovaries, rectum, stomach and uterus.

    In total, 600 newly-available cancer datasets are provided in this release, with the ICGC data portal now containing data from 3,561 cancer genomes.

Updates

  • Currently, the ICGC has received commitments from funding organizations in Asia, Australia, Europe and North America for 47 project teams in 15 jurisdictions to study over 21,000 tumor genomes. Projects that are currently funded are examining tumors affecting the bladder, blood, bone, brain, breast, cervix, colon, head and neck, kidney, liver, lung, oral cavity, ovary, pancreas, prostate, rectum, skin, soft tissues, stomach, thyroid and uterus. Over time, additional nations and organizations are anticipated to join the ICGC. The genomic analyses of tumors conducted by ICGC members in Australia and Canada (pancreatic cancer), China (gastric cancer), France (liver cancer), Germany (brain cancer), Japan (liver cancer), Spain (blood cancer), the UK (blood, breast, lung and skin cancer) and the USA (blood, brain, breast, colon, kidney, lung, ovarian, rectal, stomach and uterine cancer) are now available through the Data Coordination Center housed on the ICGC website at www.icgc.org.

abstract: Phase I trial of intraperitoneal pemetrexed, cisplatin, and paclitaxel in optimally debulked ovarian cancer.



Phase I trial of intraperitoneal pemetrexed, cisplatin, and paclitaxel in optimally debulked ovarian cancer.


Abstract

PURPOSE:

This phase I trial evaluated intraperitoneal (IP) pemetrexed, cisplatin, and paclitaxel in optimally debulked ovarian cancer.

The (U.S.) overnment’s Assault on Women’s Health | e-Patients.net



The Government’s Assault on Women’s Health | e-Patients.net

"I’m a little confused… I’m not sure where the U.S. Constitution guaranteed the government’s right to interfere with the doctor/patient relationship. Nowhere in this historic document could I find anything about the government’s right to dictate how women’s health and reproductive health (but not men’s) are areas appropriate to government interference. (You won’t find it in any state’s Constitution either.)
Yet that’s not stopping government intervention into the doctor-patient relationship from state to state, completely oblivious to the lack of jurisdiction to interfere in this professional relationship. Imagine if the government started wanting to regulate how people practiced their faith?......"

abstract: Does Significant Medical Comorbidity Negate the Benefit of Up-front Cytoreduction in Advanced Ovarian Cancer?



Does Significant Medical Comorbidity Negate the Benefit of Up-front Cytoreduction in Advanced Ovarian Cancer?

Background:
The objective of the study was to determine if initial surgery (IS) or initial chemotherapy (IC) affects rates of optimal surgery and survival in a population with significant medical comorbidities.

Conclusions:
The achievement of optimal cytoreduction continues to be a significant predictor of survival, regardless of treatment approach. Patients selected for IS and in whom optimal cytoreduction was achieved had improvements in both progression-free survival and overall survival. However, the differences could not be explained by surgical effort alone as diabetes was independently associated with mortality.

Fifth Lilly Oncology on Canvas Art Competition Invites All Touched by Cancer to... -- U.S./deadline June 29th



Fifth Lilly Oncology on Canvas Art Competition Invites All Touched by Cancer to... -- INDIANAPOLIS, Feb. 9, 2012 /PRNewswire/ --

INDIANAPOLIS, Feb. 9, 2012 /PRNewswire/ --

Get your canvases, paintbrushes and cameras ready -- the subject is cancer and you are the storyteller. Lilly Oncology and the National Coalition for Cancer Survivorship (NCCS) today announced the launch of the 2012 Lilly Oncology On Canvas: Expressions of a Cancer Journey Art Competition and Exhibition. The biennial competition invites individuals from the United States and Puerto Rico, who were diagnosed with any type of cancer -- as well as their families, friends, caregivers and healthcare providers -- to express, through art and narrative, the life-affirming changes that give their cancer journeys meaning. Entries must be postmarked by June 29, 2012

abstract: Patient Selection for Oncology Phase I Trials: A Multi-Institutional Study of Prognostic Factors [Phase I and Clinical Pharmacology]



Patient Selection for Oncology Phase I Trials: A Multi-Institutional Study of Prognostic Factors [Phase I and Clinical Pharmacology]:

Purpose
The appropriate selection of patients for early clinical trials presents a major challenge. Previous analyses focusing on this problem were limited by small size and by interpractice heterogeneity. This study aims to define prognostic factors to guide risk-benefit assessments by using a large patient database from multiple phase I trials.

Patients and Methods
Data were collected from 2,182 eligible patients treated in phase I trials between 2005 and 2007 in 14 European institutions. We derived and validated independent prognostic factors for 90-day mortality by using multivariate logistic regression analysis.

Results
The 90-day mortality was 16.5% with a drug-related death rate of 0.4%. Trial discontinuation within 3 weeks occurred in 14% of patients primarily because of disease progression. Eight different prognostic variables for 90-day mortality were validated: performance status (PS), albumin, lactate dehydrogenase, alkaline phosphatase, number of metastatic sites, clinical tumor growth rate, lymphocytes, and WBC. Two different models of prognostic scores for 90-day mortality were generated by using these factors, including or excluding PS; both achieved specificities of more than 85% and sensitivities of approximately 50% when using a score cutoff of 5 or higher. These models were not superior to the previously published Royal Marsden Hospital score in their ability to predict 90-day mortality.

Conclusion
Patient selection using any of these prognostic scores will reduce non–drug-related 90-day mortality among patients enrolled in phase I trials by 50%. However, this can be achieved only by an overall reduction in recruitment to phase I studies of 20%, more than half of whom would in fact have survived beyond 90 days.

abstract: (Lynch Syndrome) Colorectal and Other Cancer Risks for Carriers and Noncarriers From Families With a DNA Mismatch Repair Gene Mutation: A Prospective Cohort Study [Epidemiology] multi-national study



 Blogger's Note: some stats deleted for ease of reading, see abstract (or paid subscription for full details; interesting stat on female breast cancer


Colorectal and Other Cancer Risks for Carriers and Noncarriers From Families With a DNA Mismatch Repair Gene Mutation: A Prospective Cohort Study [Epidemiology]:

Purpose
To determine whether cancer risks for carriers and noncarriers from families with a mismatch repair (MMR) gene mutation are increased above the risks of the general population.

Patients and Methods
We prospectively followed a cohort of 446 unaffected carriers of an MMR gene mutation (MLH1, n = 161; MSH2, n = 222; MSH6, n = 47; and PMS2, n = 16) and 1,029 their unaffected relatives who did not carry a mutation every 5 years at recruitment centers of the Colon Cancer Family Registry. For comparison of cancer risk with the general population, we estimated country-, age-, and sex-specific standardized incidence ratios (SIRs) of cancer for carriers and noncarriers.
Results
Over a median follow-up of 5 years, mutation carriers had an increased risk of

colorectal cancer (20.48),
endometrial cancer (30.62),  
ovarian cancer (18.81),
renal cancer (11.22),
pancreatic cancer ( 10.68), 
gastric cancer (9.78),  
urinary bladder cancer (9.51), and  
female breast cancer ( 3.95;).

We found no evidence of their noncarrier relatives having an increased risk of any cancer, including CRC (1.02).

Conclusion 
 We confirmed that carriers of an MMR gene mutation were at increased risk of a wide variety of cancers, including some cancers not previously recognized as being a result of MMR mutations, and found no evidence of an increased risk of cancer for their noncarrier relatives.

JCO abstract: Understanding Patients' Attitudes Toward Communication About the Cost of Cancer Care



 Blogger's Note: semantics - 'most'/'majority' requires language editing eg. majority 68%, most 59% (language bias?)

Understanding Patients' Attitudes Toward Communication About the Cost of Cancer Care

Abstract
Purpose: Recent publications have promoted physician-patient communication on cost as a means of decreasing overall spending and minimizing patients' financial burden in oncology. No study has assessed patients' perspectives on cost communication in oncology......

Results: Of the 771 patients approached, 256 responded (response rate, 33%). Most (68%) preferred to know about out-of-pocket costs before treatment. A majority (59%) wanted their physician to discuss these costs with them. Although 76% reported feeling comfortable discussing cost with their physician, 74% were amenable to discussing cost with someone other than their physician. Most patients did not consider out-of-pocket costs (57%) or the health care costs of the country (61%) in their decision making, nor did they believe their physician should (55%). Patients receiving active chemotherapy were less likely to want to discuss out-of-pocket costs with their physician (P = .035). 

Conclusion: Patients' comfort with and desire to discuss cancer costs exceed that of oncologists, suggesting a need to educate oncologists on this important topic. A patient's desire to understand treatment-associated cost does not equate with a desire for cost to influence medical decision making.

Caveat Oncologist: Clinical Findings and Consequences of Distributing Counterfeit Erythropoietin in the United States (Florida)



Caveat Oncologist: Clinical Findings and Consequences of Distributing Counterfeit Erythropoietin in the United States [Original Contributions]:

Purpose:
Counterfeit pharmaceuticals pose risks domestically. Because of their cost, cancer pharmaceuticals are vulnerable. We review findings from a domestic counterfeiting episode involving erythropoietin and outline anticounterfeiting recommendations for policy makers, patients, and health care professionals.

Countering the Misincentivization of Cancer Medicine by Real-Time Personal Professional Education (febrile neutropenia medications)



Countering the Misincentivization of Cancer Medicine by Real-Time Personal Professional Education [Cancer Center Business Summit]:

Purpose:
In the United States, public and private payer misincentivization of medical care and the invisibility of costs to the consumers of that care have conspired to create unsustainable growth in health care expenditure that undermines our economy, diminishes our productivity, and limits our international competitiveness. Cancer medicine provides a small yet salient example. On average, Medicare reimburses oncologists 6% above the average acquisition price for essential anticancer agents and supportive therapies. The costs of these agents vary across a stunning five orders of magnitude, from a few dollars to more than $400,000 per course of treatment. The profitability to providers varies across approximately four orders of magnitude, from cents to thousands of dollars per treatment. National guidelines (National Comprehensive Cancer Network [NCCN], American Society of Clinical Oncology [ASCO]) help providers select the most effective therapies without regard for cost.

Methods:
We created an oncologist-to-oncologist professional education program to help cancer physicians optimally use expensive long-acting white blood cell growth factors, in accordance with these national guidelines.

abstract: Factors Associated With Pain Among Ambulatory Patients With Cancer With Advanced Disease at a Comprehensive Cancer Center (Center for Patient Safety, Dana-Farber Cancer Institute)



Factors Associated With Pain Among Ambulatory Patients With Cancer With Advanced Disease at a Comprehensive Cancer Center

Conclusion:
Younger age, minority race, and recent onset of advanced disease are associated with severe pain among patients with cancer. Recognizing these high-risk groups could inform targeted interventions to address pain care in ambulatory patients with advanced cancer.

Lynch Syndrome: Don't Miss It (Transcript including slides))



Blogger's Opinion/Note:
guidelines indicate varying ages of screening depending on organ assuming there are screening mechanisms (eg. ovarian cancer has no screening for the general population however increased surveillance is possible for those at high risk,  albeit, ineffective; generally 25 yrs +;  'averages' are not helpful and therefore the urging of family history taking by primary/family care physicians, see NCCN guidelines for Lynch Syndrome which includes gene-specific details (eg. MLH1, MSH2/6, PMS2.....)

Lynch Syndrome: Don't Miss It (Transcript)

Clinical Implications

"Lynch syndrome is a genetic defect that has significant implications on the clinical side. A patient whose genetic testing is positive for Lynch syndrome has a likelihood of developing colon cancer that approaches 70% over his or her lifetime. The risk for uterine cancer is similar or a bit higher, and the risk for ovarian cancer is13%-15%. Almost certainly, these patients will have some type of cancer during their lifetime.

Metachronous cancers occur in 7%-10% of patients with Lynch syndrome. These patients present with one cancer, and typically in the course of a short period of time, another cancer develops. In patients with Lynch syndrome who have colon cancer, if you don't perform a subtotal colectomy because you didn't recognize that it was Lynch syndrome, the likelihood that the patient will develop a repeat colon cancer over 30 years (even in patients who are being screened) approaches 65%. This is not uncommon. A lot of these diagnoses are missed, and a secondary cancer develops."

"You need to start thinking about syndromic cancers because the relative risk is quite high. You need to be thinking about this in patients with early cancers -- not just colon cancer, but in uterine cancer and ovarian cancer as well." (Blogger's Note: and others including pancreatic, stomach, ureter, renal, bilary tract, gallbladder.....see slides)

" If you look at colon cancer in Lynch syndrome, the average age of onset is earlier (45 years) and some patients may be in their 20s. For sporadic uterine cancer, the average age is approximately 60 years, but in Lynch syndrome, it is shifted by a decade, to 50 years. When you see these cancers in a younger patient, the bell should go off and you should start thinking about Lynch syndrome and doing the appropriate testing."

"It is important to think about extracolonic cancers in these patients and to start to put the dots together because we are missing the boat on a lot of these syndromic cancers. It's not a zebra; it's 2%-3% of the patients who are presenting with cancer. We need to think outside the box. Even if you are not a gastroenterologist, include the colon when you see syndromic related cancers of the uterus, ovary, small bowel, or stomach."

Future Science - abstract: Targeted cancer therapy: giving histone deacetylase inhibitors



Future Science - Future Medicinal Chemistry - 4(4):505 - Summary

Review
Abstract

Targeted cancer therapy: giving histone deacetylase inhibitors


"Histone deacetylase inhibitors (HDACis) have now emerged as a powerful new class of small-molecule therapeutics acting through the regulation of the acetylation states of histone proteins (a form of epigenetic modulation) and other non-histone protein targets. Over 490 clinical trials have been initiated in the last 10 years, culminating in the approval of two structurally distinct HDACis – SAHA (vorinostat, Zolinza™) and FK228 (romidepsin, Istodax™). 

However, the current HDACis have serious limitations, including ineffectively low concentrations in solid tumors and cardiac toxicity, which is hindering their progress in the clinic. Herein, we review the primary paradigms being pursued to overcome these hindrances, including HDAC isoform selectivity, localized administration, and targeting cap groups to achieve selective tissue and cell type distribution."

Future Science - Abstract: EGFR/HER-targeted therapeutics in ovarian cancer



Blogger's Note: this is a subscription based ($$$) journal

Future Science - Future Medicinal Chemistry - 4(4):447 - Summary


Review

EGFR/HER-targeted therapeutics in ovarian cancer

"Despite decades of research and evolving treatment modalities, survival among patients with epithelial ovarian cancer has improved only incrementally.
During this same period, the development of biologically targeted therapeutics has improved survival for patients with diverse malignancies.
Many of these new drugs target the human epidermal growth factor receptor (EGFR/HER/ErbB) family of tyrosine kinases, which play a major role in the etiology and progression of many carcinomas, including epithelial ovarian cancer. While several HER-targeted therapeutics are US FDA approved for the treatment of various malignancies, none have gained approval for the treatment of ovarian cancer.
Here, we review the published literature on HER-targeted therapeutics for the treatment of ovarian cancer, including novel HER-targeted therapeutics in various stages of clinical development, as well as the challenges that have limited the use of these inhibitors in clinical settings."

Cochrane Review: Adjuvant (post-surgery) chemotherapy for early stage epithelial ovarian cancer (abstract)



Adjuvant (post-surgery) chemotherapy for early stage epithelial ovarian cancer [Cochrane Database Syst Rev. 2012]


Cochrane Database Syst Rev. 2012 Mar 14;3:CD004706.

Adjuvant (post-surgery) chemotherapy for early stage epithelial ovarian cancer.

Abstract

BACKGROUND:

Epithelial ovarian cancer is diagnosed in 4500 women in the UK each year of whom 1700 will ultimately die of their disease.Of all cases 10% to 15% are diagnosed early when there is still a good possibility of cure. The treatment of early stage disease involves surgery to remove disease often followed by chemotherapy. The largest clinical trials of this adjuvant therapy show an overall survival (OS) advantage with adjuvant platinum-based chemotherapy but the precise role of this treatment in subgroups of women with differing prognoses needs to be defined.

OBJECTIVES:

To systematically review the evidence for adjuvant chemotherapy in early stage epithelial ovarian cancer to determine firstly whether there is a survival advantage of this treatment over the policy of observation following surgery with chemotherapy reserved for treatment of disease recurrence, and secondly to determine if clinical subgroups of differing prognosis based on histological sub-type, or completeness of surgical staging, have more or less to gain from chemotherapy following initial surgery.

SELECTION CRITERIA:

We selected randomised clinical trials that met the inclusion criteria set out based on the populations, interventions, comparisons and outcome measures.

MAIN RESULTS:

Five randomised controlled trials (RCTs), enrolling 1277 women, with a median follow-up of 46 to 121 months, met the inclusion criteria. Four trials were included in the meta-analyses and we considered them to be at a low risk of bias. Meta-analysis of five-year data from three trials indicated that women who received adjuvant platinum-based chemotherapy had better overall survival (OS) than those who did not (1008 women; hazard ratio (HR) 0.71; 95% confidence interval (CI) 0.53 to 0.93). Likewise, meta-analysis of five-year data from four trials indicated that women who received adjuvant chemotherapy had better progression-free survival (PFS) than those who did not (1170 women; HR 0.67; 95% CI 0.53 to 0.84). The trials included in these meta-analyses gave consistent estimates of the effects of chemotherapy. In addition, these findings were robust over time (10-year PFS: two trials, 925 women; HR 0.67; 95% CI 0.54 to 0.84).
Subgroup analysis suggested that women who had optimal surgical staging of their disease were unlikely to benefit from adjuvant chemotherapy (HR for OS 1.22; 95% CI 0.63 to 2.37; two trials, 234 women) whereas those who had sub-optimal staging did (HR for OS 0.63; 95% CI 0.46 to 0.85; two trials, 772 women). One trial showed a benefit from adjuvant chemotherapy among women at high risk (HR for OS 0.48; 95% CI 0.32 to 0.72) but not among those at low/medium risk (HR for OS 0.95; 95% CI 0.54 to 1.66).
However, these subgroup findings could be due to chance and should be interpreted with caution.

AUTHORS' CONCLUSIONS:

Adjuvant platinum-based chemotherapy is effective in prolonging the survival of the majority of patients who are assessed as having early (FIGO stage I/IIa) epithelial ovarian cancer. However, it may be withheld from women in whom there is well-differentiated encapsulated unilateral disease (stage 1a grade 1) or those with comprehensively staged Ib, well or moderately differentiated (grade 1/2) disease. Others with unstaged early disease or those with poorly differentiated tumours should be offered chemotherapy.

A pragmatic approach may be necessary in clinical settings where optimal staging is not normally performed/achieved. In such settings, adjuvant chemotherapy may be withheld from those with encapsulated stage Ia grade 1 serous and endometrioid carcinoma and offered to all others with early stage disease.

Friday, March 16, 2012

Current Drug Shortages: Paclitaxel (Taxol) Injection (updated)



Current Drug Shortages: Paclitaxel Injection (updated):

Hospira product 30 mg/5 mL vial (NDC 0409-0342-09): ample levels of inventory to support market demand. Product 300 mg/50 mL vial (NDC 0409-0342-50): ample levels of inventory to support market demand. Product 100 mg/16.7 mL vial (NDC 0409-0342-22): next delivery April. Please check with your wholesaler for available inventory. Teva has 30 mg/ 5 ml vial on backorder until April 2012. All other presentations are available with ample inventory.

press release: Association for Psychological Science - Checking off symptoms online affects our perceptions of risk (student study)



Checking off symptoms online affects our perceptions of risk

"You've been feeling under the weather. You Google your symptoms. A half-hour later, you're convinced it's nothing serious—or afraid you have cancer. More than 60 percent of Americans get their health information online, and a majority of those decide whether to see a doctor based on what they find. "Wow, this is an era of self-diagnosis," thought Arizona State University psychologist Virginia Kwan, learning that statistic. How might information accessed online affect individual health decisions?....."

MBCC: PARP Inhibitors for Breast Cancer—Which Subpopulation to Target? - Cancer Network (BRCA, triple-negative breast...)



MBCC: PARP Inhibitors for Breast Cancer—Which Subpopulation to Target? - Cancer Network

"Speaking at the 29th Annual Miami Breast Cancer Conference, Jorge S. Reis-Filho, PhD, MD, professor of medical pathology at the Institute of Cancer Research in London, England, described the rationale of applying poly (ADP-ribose) polymerase inhibitors (PARP) to breast cancer patients.

Tumors that have a loss of function in DNA-repair genes such as BRCA1 and BRCA2, and homologous recombination, as Dr. Joyce O'Shaughnessy described during her session on emerging triple-negative breast cancer therapies, may be particularly sensitive to PARP inhibitors.

Reis-Filho highlighted that sequencing tumors may not be enough to characterize whether tumors have intact DNA-repair pathways—tumors also have epigenetic changes that regulate homologous recombination......"

Editorial: Clinical Trials in Elderly Ovarian Cancer Patients – Does It Make Sense? (Germany)



Editorial: Clinical trials in elderly ovarian cancer Patients - Does It Make Sense?

 "Clinical research needs clinical trials, new and generally
applicable knowledge can only be acquired if the young and
the old participate in clinical trials."

abstract: Treatment of Elderly Ovarian Cancer Patients in the Context of Controlled Clinical Trials: A Joint Analysis of the AGO Germany Experience



Treatment of Elderly Ovarian Cancer Patients in the Context of Controlled Clinical Trials: A Joint Analysis of the AGO Germany Experience

Summary
 
Background:

Age remains a negative prognostic factor in ovarian cancer (OC). 3 separate analyses by the AGO (Arbeitsgemeinschaft Gynaekologische Onkologie) give insight into the treatment of elderly patients (EPs) in the context of controlled clinical trials (CCTs).

Methods:
1 retrospective study evaluated the reasons for non-enrolment into CCTs of patients with advanced OC in AGO centers. 2 other exploratory age-specific analyses of a phase III trial in advanced OC treated with platinum/ paclitaxel evaluated (1) feasibility, toxicity and quality of life (QoL) and (2) the clinical outcome.  

Results: 
Non-study patients were significantly older (66.7 vs. 57.2 years). Reasons for non-enrolment were predominantly predefined exclusion criteria, numeric age, and the patient’s decision. The phase III trial confirmed an under-representation of EPs. Cycle delivery was significantly lower and discontinuation more frequent in EPs than in younger patients (YPs), although QoL, toxicity, cycle delays, and dose reductions were comparable. Delivery of cycles was prognostically significant in EPs but not YPs. The survival advantage of YPs remained significant even in completely debulked patients.

Conclusion:
There is some kind of investigator reservation for the treatment of EPs, which not only applies for the enrolment into clinical trials but also for the treatment, even under CCT conditions, with impact on outcome.

David Payne: Playing the sepsis game "SEPTRIS" educational game| BMJ



David Payne: Playing the sepsis game | BMJ

There are 1.1m cases of sepsis each year in the US, costing $17bn to treat and accounting for 17% of hospital mortality.

Doctors at Stanford University in Palo Alto, California wanted to help their fellow physicians to recognise and treat it, but instead of producing a paper or video, devised a game.


Septris is a case–based interactive tool that shows up to eight patients’ avatar slowly descending a screen as their condition deteriorates. You can download it here. There is also a YouTube demo.

If a doctor decides on an appropriate course of action, the avatar bumps up the page, ultimately ending at the top if their life is saved.
Lisa Shieh, medical director for quality at Stanford, told delegates attending the spring conference of HighWire Press, the university’s web hosting service for scholarly publishers: “Doctors are inherently competitive and we wanted something challenging that doctors can play anytime, with bonus points for saving lives.”

Public Disclosure of Hospital Infection Rates Vary by State (surgical site infections) - patients “walking in blind”



Public Disclosure of Hospital Infection Rates Vary by State


Public Disclosure of Hospital Infection Rates Vary by State

Released: 3/16/2012 12:20 PM EDT
Source: Johns Hopkins Medicine
 
--Johns Hopkins study finds patients “walking in blind” with little access to quality and outcomes data

Newswise — Only 21 states require public reporting of hospital data on surgical site infections and, even when disclosure is mandated, the information is often not easily accessible to patients who could use it to make decisions about their medical care, according to new Johns Hopkins research.
The research findings suggest that a haphazard, state-by-state system for reporting these critical measures of health care quality isn’t working and that only national guidelines governing disclosure can paint a clear picture of how well hospitals are doing at preventing patient harm, the researchers say.
Reporting accurate data on measures such as rates of surgical site infections can be an inexpensive way to actually reduce them, the authors note in their study published online in the Journal for Healthcare Quality.
When patients have access to this information and use it to take their business to hospitals with lower infection rates for select operations, the researchers say, hospitals with higher infection rates will have financial and reputational incentives to quickly find ways to do better.
A lot of information is not available to the public and, if it were, hospitals would be motivated to improve,” says study leader Martin Makary, M.D., M.P.H., an associate professor of surgery at the Johns Hopkins University School of Medicine. “Right now, a hospital can have high complication rates, high readmission rates and high infection rates, but because patients can’t look up this information, they’re essentially walking in blind.”
One example of the impact of such transparency occurred in New York State two decades ago, Makary said. Rates of mortality from coronary artery bypass surgery varied widely among hospitals before the state began requiring public reporting of death rates from the procedure. Four years into mandatory reporting requirements, average hospital death rates from the operation fell by 41 percent. Makary says he thinks one reason for the precipitous drop is that “poorly performing hospitals had an incentive to look better to consumers making health care decisions.”
Researchers estimate that surgical site infections occur in up to 25 percent of patients after major surgical procedures and are estimated to cause more than 8,000 deaths a year. The occurrence of a surgical site infection is increasingly recognized to be largely preventable and, as a result, rates are being used as a surrogate measure of broader health care quality.
The Centers for Medicare and Medicaid Services recently announced that hospitals must soon report surgical site infection rates for select procedures. Failing to meet benchmarks will result in financial penalties. But Makary says that the new requirement covers only a small number of procedures and wider reporting of complications will initially be voluntary. Makary says Medicare needs to quickly expand the program and speed up the transition to uniform public reporting for all hospitals.
In the new study, Makary and his colleagues found that, as of September 2010, 29 states had no laws regarding the monitoring and reporting of surgical site infections. Of the 21 that did have such laws, only eight made the data publicly available in an easy-to-access format.
Even then, he said, the data shared are limited, covering between two and seven procedures. Seven of the eight states reported surgical site infection rates following coronary artery bypass graft procedures, six did so for knee or hip replacement surgeries, and two reported rates after colon surgery, which nationally has the highest rates of surgical site infections. Only one state, Ohio, reported rates after gallbladder surgery, among the most common surgical procedures in the United States. The average time lag between collection and publication of data was six months, with a range of two to 11 months.
Makary also says that states don’t always specify how data are to be collected, resulting in lack of uniform reporting that can make comparisons impossible. The lack of national standards, he says, may also disadvantage hospitals that are better at collecting information, because their rates may appear higher than those at hospitals that don’t look as rigorously for infection cases.
“It is important to use a common method or at a minimum ensure common parameters, inputs and definitions are used,” he says. “Without that, it is difficult for consumers, payers or regulators to compare infections within or across states. Unless we are comparing apples to apples, public disclosure has the potential to mislead patients instead of help them.”

Colloquium registration, abstract and workshop submission now open - conference Sept 30-Oct 3 Auckland, New Zealand



Colloquium registration, abstract and workshop submission now open:

Registration for the 20th Cochrane Colloquium is now open, and submissions for abstracts and workshops are being accepted. This year's Colloquium will be held in Auckland, New Zealand, 30 September to 3 October 2012.

Important upcoming deadlines to note:
Abstract and workshop submission: Thursday, 19 April
Early registration: Thursday, 12 July

Please check the main Colloquium website regularly for updates and general information.
External link for more information: 
Contributor's Information
Contributor's name: 
Cochrane Web Team
Email address: 
web@cochrane.org

abstract: Minireview: Human Ovarian Cancer: Biology, Current Management, and Paths to Personalizing Therapy. March 13th



Minireview: Human Ovarian Cancer: Biology, Current Management, and Paths to Personalizing Therapy  [Endocrinology. 2012] - PubMed - NCBI

Endocrinology. 2012 Mar 13. [Epub ahead of print]

Minireview: Human Ovarian Cancer: Biology, Current Management, and Paths to Personalizing Therapy.


Abstract

More than 90% of ovarian cancers have been thought to arise from epithelial cells that cover the ovarian surface or, more frequently, line subserosal cysts. Recent studies suggest that histologically similar cancers can arise from the fimbriae of Fallopian tubes and from deposits of endometriosis. Different histotypes are observed that resemble epithelial cells from the normal Fallopian tube (serous), endometrium (endometrioid), cervical glands (mucinous), and vaginal rests (clear cell) and that share expression of relevant HOX genes which drive normal gynecological differentiation. Two groups of epithelial ovarian cancers have been distinguished: type I low-grade cancers that present in early stage, grow slowly, and resist conventional chemotherapy but may respond to hormonal manipulation; and type II high-grade cancers that are generally diagnosed in advanced stage and grow aggressively but respond to chemotherapy. Type I cancers have wild-type p53 and BRCA1/2, but have frequent mutations of Ras and Raf as well as expression of IGFR and activation of the phosphatidylinositol-3-kinase (PI3K) pathway. Virtually all type II cancers have mutations of p53, and almost half have mutation or dysfunction of BRCA1/2, but other mutations are rare, and oncogenesis appears to be driven by amplification of several growth-regulatory genes that activate the Ras/MAPK and PI3K pathways. Cytoreductive surgery and combination chemotherapy with platinum compounds and taxanes have improved 5-yr survival, but less than 40% of all stages can be cured. Novel therapies are being developed that target high-grade serous cancer cells with PI3Kness or BRCAness as well as the tumor vasculature. Both in silico and animal models are needed that more closely resemble type I and type II cancers to facilitate the identification of novel targets and to predict response to combinations of new agents.

FDA commissioner talks counterfeit drugs (and drug shortages) - CNN.com



FDA commissioner talks counterfeit drugs - CNN.com

Medco Study Finds Many Patients on Newer Oncology Treatments Are at Risk for Drug Interactions - PRNewswire



Medco Study Finds Many Patients on Newer Oncology Treatments Are at Risk for Drug Interactions -- WASHINGTON, March 16, 2012 /PRNewswire/ --

John Crown: Move aside bureaucrats and let us take a lead





".....Professional managers have their place in any institution – but where they set the agenda it is likely to be serving political edicts to balance budgets and meet targets. “That often means the welfare of patients comes second, and also – and this may be an old-fashioned view – I do not think that doctors act solely in their own self-interests. We have higher ethical considerations than other professions.” ...........

John Crown: Move aside bureaucrats and let us take a lead:

Outspoken oncologists, willing to take on ‘the powers that be’, can often play a very helpful role in galvanising administrators and policy makers and pushing the priorities of clinicians higher up the agenda. There are notable such characters around Europe, but one oncologist has taken a bigger step into the realm of politics by becoming a senator in his parliament – from where he is able to directly challenge politicians and bureaucrats with the protection of parliamentary privilege.

Ovarian cancer survival 'lower than the rest of Europe' | Scotland | STV News



Ovarian cancer survival 'lower than the rest of Europe' | Scotland | STV News

Access : Mutation analysis of RAD51D in non-BRCA1|[sol]|2 ovarian and breast cancer families : British Journal of Cancer



Access : Mutation analysis of RAD51D in non-BRCA1|[sol]|2 ovarian and breast cancer families : British Journal of Cancer

Mutation analysis of RAD51D in non-BRCA1/2 ovarian and breast cancer families

Background:

Recent data show that mutations in RAD51D have an aetiological role in ovarian carcinoma, yet mutations do not appear to be associated with an increased risk for breast cancer. We studied ovarian and breast cancer families having at least one woman affected by ovarian carcinoma, to assess the importance of RAD51D mutations in such families.

Methods:

The coding region of the RAD51D gene was analysed in 175 BRCA1/2-negative families with family histories of both ovarian and breast cancer ascertained from two Canadian and two Belgian institutions.

Conclusion:

RAD51D should be included in genetic screening of ovarian cancer families that do not have BRCA1/BRCA2 mutations. We show that mutations are more likely to be found in families with two or more ovarian cancers, or in probands with first-degree relatives with ovarian cancer, and we feel testing should be preferentially offered to affected women from such families.


Reuters: Common medicines may cut cancer drug potency: study



Reuters: Common medicines may cut cancer drug potency: study

abstract: Access to anti-cancer drugs: Many evidence-based treatments are off-label and unfunded by the PBS - Australia



Access to anti-cancer drugs: Many evidence-based treatments are off-label and unfunded by the PBS

 ABSTRACT
Background:  The off-label use of a drug refers to a use outside the terms of its approval by the Therapeutic Goods Administration's (TGA). It is also possible to prescribe unlicensed drugs under the Therapeutic Goods Administration's (TGA) Special Access Scheme. A high rate of off-label prescribing has previously been reported in cancer. Our study aimed to document the disparity between clincial evidence-based guidelines for anti-cancer therapy, product approval, and funding status of these agents within an academic tertiary/quaternary cancer centre.
Method:  All chemotherapy protocols approved for use in our specialist oncology centre were assessed to determine if the drugs were off-label or unlicensed for that indication based upon review of their current product information. The Pharmaceutical Benefits Scheme (PBS) funding status for each protocol was subsequently assessed.
Results:  A total of 448 protocols, containing 82 different drugs, across 15 tumour groups were identified. Overall, 189 (42.2%) of protocols were off-label and 3 (0.7%) were unlicensed. This resulted in all 192 protocols being unfunded by the PBS. Of the 189 off-label protocols, 132 (69.9%) were based on established evidence-based treatment guidelines and a further 39 (20.6%) were based upon phase II or III clinical trial data.
Discussion:  Over 90% of off-label protocols are supported by established treatment guidelines or published peer-reviewed research even though the medications are not approved for that particular use by the TGA. However, these off-label protocols are unfunded by the PBS: this results in a marked inequality of access to appropriate medications for cancer patients across Australia.

Thursday, March 15, 2012

Endocyte jumps on plans for cancer drug candidate - Bioscience Technology (EC145 vs Doxil - re: Doxil drug shortage....)



Endocyte jumps on plans for cancer drug candidate - Bioscience Technology:

The Inquisitr


Endocyte jumps on plans for cancer drug candidate
Bioscience Technology
The study is designed to compare EC145 to the chemotherapy drug Doxil as a treatment for ovarian cancer. Enrollment stopped because of a shortage of Doxil, and the company said Tuesday that the Food and Drug Administration will allow it to import the ...
Endocyte Prepares To Restart Clinical Trials For Experimental Cancer DrugThe Inquisitr
Endocyte to seek European OK for ovarian cancer drugIndianapolis Star
Endocyte to Submit EU Conditional Marketing Authorization Applications for ...MarketWatch (press release)
Wall Street Journal -Indianapolis Business Journal
all 21 news articles »

Dr Len's Blog: More On Dichloroacetate (DCA) In Cancer Treatment including comments



More On Dichloroacetate (DCA) In Cancer Treatment

Cochrane Review - Medscape article: Specialized Care May Boost Cancer Survival - in Oncology/Hematology, Ovarian Cancer



Medical News:Specialized Care May Boost Cancer Survival - in Oncology/Hematology, Ovarian Cancer

Grants.gov - Opportunity Synopsis DOD Ovarian Cancer Outcomes Consortium Development Award posted Mar 15th



Grants.gov - Find Grant Opportunities - Opportunity Synopsis

DoD Ovarian Cancer Outcomes Consortium Development Award

Department of Defense

Synopsis


The synopsis for this grant opportunity is detailed below, following this paragraph. This synopsis contains all of the updates to this document that have been posted as of 03/15/2012 . If updates have been made to the opportunity synopsis, update information is provided below the synopsis. If you would like to receive notifications of changes to the grant opportunity click send me change notification emails . The only thing you need to provide for this service is your email address. No other information is requested.

Any inconsistency between the original printed document and the disk or electronic document shall be resolved by giving precedence to the printed document.
Document Type: Grants Notice
Funding Opportunity Number: W81XWH-12-OCRP-OCDA
Opportunity Category: Discretionary
Posted Date: Mar 15, 2012
Creation Date: Mar 15, 2012
Original Closing Date for Applications: Aug 02, 2012   
Current Closing Date for Applications: Aug 02, 2012   
Archive Date: Sep 01, 2012
Funding Instrument Type: Cooperative Agreement
Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 2
Estimated Total Program Funding: $1,280,000
Award Ceiling:
Award Floor:
CFDA Number(s): 12.420  --  Military Medical Research and Development
Cost Sharing or Matching Requirement: No

Eligible Applicants

Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"   
Additional Information on Eligibility:

Agency Name

Dept. of the Army -- USAMRAA

Description

The OCRP Outcomes Consortium Development Award supports a multi-institutional research effort conducted by leading ovarian cancer researchers and consumer advocates that specifically focuses on identifying and understanding predictors of disease outcomes in ovarian cancer patients. This effort will be executed through a two-stage approach using two separate award mechanisms: this FY12 Outcomes Consortium Development Award, which will enable the consortium to lay the groundwork for the research project, including proof of concept, and the FY14 Outcomes Consortium Award, which will support the execution of the full research project.

Link to Full Announcement

If you have difficulty accessing the full announcement electronically, please contact:

301-682-5507; help@cdmrp.org CDMRP Help Desk

Synopsis Modification History

There are currently no modifications for this opportunity.

US drug shortages could continue for years : The Lancet



US drug shortages could continue for years : The Lancet

Arch Intern Med -- Abstract: Intensive Care Unit Bed Availability and Outcomes for Hospitalized Patients With Sudden Clinical Deterioration (Calgary, Alberta)



Arch Intern Med -- Abstract: Intensive Care Unit Bed Availability and Outcomes for Hospitalized Patients With Sudden Clinical Deterioration

ONLINE FIRST Intensive Care Unit Bed Availability and Outcomes for Hospitalized Patients With Sudden Clinical Deterioration

Background  Intensive care unit (ICU) beds, a scarce resource, may require prioritization of admissions when demand exceeds supply. We evaluated the effect of ICU bed availability on processes and outcomes of care for hospitalized patients with sudden clinical deterioration.

Methods  We identified consecutive hospitalized adults in Calgary, Alberta, Canada, with sudden clinical deterioration triggering medical emergency team activation between January 1, 2007, and December 31, 2009. We compared ICU admission rates (within 2 hours of medical emergency team activation), patient goals of care (resuscitative, medical, and comfort), and hospital mortality according to the number of ICU beds available (0, 1, 2, or >2), adjusting for patient, physician, and hospital characteristics (using data from clinical and administrative databases).

Results  The cohort consisted of 3494 patients. Reduced ICU bed availability was associated with a decreased likelihood of patient admission within 2 hours of medical emergency team activation (P = .03) and with an increased likelihood of change in patient goals of care (P < .01). Patients with sudden clinical deterioration when zero ICU beds were available were 33.0% (95% CI, –5.1% to 57.3%) less likely to be admitted to the ICU and 89.6% (95% CI, 24.9% to 188.0%) more likely to have their goals of care changed compared with when more than 2 ICU beds were available. Hospital mortality did not vary significantly by ICU bed availability (P = .82).

Conclusion  Among hospitalized patients with sudden clinical deterioration, we noted a significant association between the number of ICU beds available and ICU admission and patient goals of care but not hospital mortality.

index of abstracts: Gynecologic Oncology | Vol 125, Supplement 1, Pgs S1-S188, (March, 2012) | ScienceDirect.com



Gynecologic Oncology | Vol 125, Supplement 1, Pgs S1-S188, (March, 2012) | ScienceDirect.com


ABSTRACTS PRESENTED FOR THE 43RD ANNUAL MEETING OF THE SOCIETY OF GYNECOLOGIC ONCOLOGY AUSTIN, TX USA, 

(click on pdf for full paper) Gynecologic Oncology Case Reports: A Case of Endometrial Cancer in the Context of a BRCA2 Mutation and Double Heterozygosity for Lynch Syndrome



Gynecologic Oncology Case Reports | Articles in Press | ScienceDirect.com

A Case of Endometrial Cancer in the Context of a BRCA2 Mutation and Double Heterozygosity for Lynch Syndrome


In Press, Accepted Manuscript, Available online 15 March 2012
Ping Gong, Sarah Charles, Norman Rosenblum, Zoe Wang, Agnieszka K. Witkiewicz

Highlights

► Endometrial cancer with BRCA2 mutation and double heterozygosity for Lynch syndrome 
► Loss of MLH1 and PMS2 by immunohistochemical stain 
► MSH1 and MSH6 gene mutations by genomic sequencing

open access: Open science versus commercialization: a modern research conflict?



pdf: Open science versus commercialization: a modern research conflict?

 Open debate

Open science versus commercialization: a modern research c


Abstract (provisional)

Background

Efforts to improve research outcomes have resulted in genomic researchers being confronted with complex and seemingly contradictory instructions about how to perform their tasks. Over the past decade, there has been increasing pressure on university researchers to commercialize their work. Concurrently, they are encouraged to collaborate, share data and disseminate new knowledge quickly (i.e., to adopt an open science model) in order to foster scientific progress, meet humanitarian goals, and to maximize the impact of their research.

Discussion

We present selected guidelines from three countries (Canada, United States, and United Kingdom) situated at the forefront of genomics to illustrate this potential policy conflict. Examining the innovation ecosystem and the messages conveyed by the different policies surveyed, we further investigate the inconsistencies between open science and commercialization policies.

Summary

Commercialization and open science are not necessarily irreconcilable and could instead be envisioned as complementary elements of a more holistic innovation framework. Given the exploratory nature of our study, we wish to point out the need to gather additional evidence on the coexistence of open science and commercialization policies and on its impact, both positive and negative, on genomics academic research.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.