Depression’s Criteria May Be Changed to Include Grieving - When does a broken heart become a diagnosis? NYTimes.com

"In a bitter skirmish over the definition of depression, a new report contends that a proposed change to the diagnosis would characterize grieving as a disorder and greatly increase the number of people treated for it.

The criteria for depression are being reviewed by the American Psychiatric Association, which is finishing work on the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders, or D.S.M., the first since 1994. The manual is the standard reference for the field, shaping treatment and insurance decisions, and its revisions will affect the lives of millions of people for years to come......"

Expanding the Definition of Depression - Does grieving over a loved one constitute full-blown depression? NYTimes.com

Medical News: BRCA Mutations Also Play Good Role in Ovarian Cancer - in Oncology/Hematology, Ovarian Cancer from MedPage Today

Action Points

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• A pooled analysis of 26 observational studies found that five-year survival was significantly improved for invasive epithelial ovarian cancer patients carrying BRCA1 or BRCA2 mutations compared with noncarriers.



• Note that data on treatment differences among the heterogeneous population were not available, there were missing data, and procedures for screening for the mutations differed among the studies.

abstract: Intracranial hemorrhage in patients with cancer treated with bevacizumab (Avastin) : the Memorial Sloan-Kettering experience

Background: Bevacizumab is a monoclonal antibody targeting vascular endothelial growth factor approved for recurrent glioblastoma (GBM), metastatic breast, colorectal and non-small-cell lung cancers (NSCLC). There has been a potentially increased risk of intracranial hemorrhage (ICH) in patients receiving bevacizumab.

Methods: We retrospectively identified patients with ICH who received bevacizumab between 1 January 2001 and 10 January 2009.

Results: We identified 1024 patients with ICH, 4191 patients who received bevacizumab and 12 (0.3%) who met both our criteria. There were eight women and four men with a median age of 66 years. Primary cancers were ovarian (n = 3), NSCLC (n = 3), colon (n = 1), angiosarcoma (n = 1) and GBM (n = 4). Intracranial tumors were present in 9 of the 12 patients; the remaining three (25%) had no evidence of intracranial pathology. Two hundred and fifty-seven patients with these same primary pathologies and brain tumors were treated with bevacizumab; ICH was seen in nine (3.7%), which was comparable to the 3.6% frequency seen in comparable patients not receiving bevacizumab.

Conclusions: ICH with bevacizumab treatment in this population is rare and does not appear to increase its frequency over the baseline rate of ICH in a comparable population. Most bevacizumab-related ICH occurs into central nervous system tumors but spontaneous hemorrhages were seen.

abstract: Weekly paclitaxel as a single agent or in combination with carboplatin or weekly topotecan in patients with resistant ovarian cancer: the CARTAXHY randomized phase II trial (GINECO)

Conclusions: Combination chemotherapy in platinum-resistant ROC (recurrent ovarian cancer) was more toxic than weekly paclitaxel and did not significantly prolong PFS.

open access: Cancer of unknown primary (CPU) : progress in the search for improved and rapid diagnosis leading toward superior patient outcomes

Abstract

This paper explores the enigma of cancer of unknown primary (CUP) in relation to rapidly improving molecular diagnostic approaches. It is based on the first global collaboration meeting on improving research and clinical outcomes in CUP organized by the CUP Foundation........All patients with CUP could thus be appropriately managed without the constant uncertainty that has previously severely hampered patient care and optimal outcomes. The longer-term objective is to understand the biology of highly metastatic disease, leading to the development of future global therapeutic programs. Current clinical studies, such as CUP-ONE, will address some of these issues.

introduction

definition, epidemiology, biology, and prognosis

diagnostic approaches to CUP

pathologic evaluation

clinical evaluation

molecular profiling and classification of human cancers

new technologies in practice

conclusion

 

"....Several of the favorable subsets of CUP patients seem to mimic the clinical and pathologic features of particular known metastatic cancers. These include ..............; peritoneal serous adenocarcinoma (ovarian primary) ........" 

Table 1.    Favorable prognostic subsets of patients with unknown primary cancer recognized by clinical and pathologic features in the last three decades

 

Letters (2)/Response: BRCA1 and BRCA2 Mutations in Ovarian Cancer, January 25, 2012 — JAMA

Blogger's Note: to view full response subscription req'd ($$$)

Letter #1
Letter #2
Author Response

open access: PLoS Medicine: Challenging Medical Ghostwriting in US Courts - eg. ethics, legal liabilities, patient harm.....

Introduction

"Complaints about the ethics of medical ghostwriting have increased in the last decade, but little has changed [1]–[14]....."

Summary Points

• Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.
• In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
• For example, when an injured patient's physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.
• In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.
• Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.
• Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud.

Author Insights: BRCA1 and BRCA2 Gene Mutations Associated With Improved Ovarian Cancer Survival « news@JAMA

"....The pooled analysis of 26 observational studies involving 3879 women with ovarian cancer found 52% of women with a BRCA2 mutation were alive 5 years after diagnoses, as were 44% of women with a BRCA1 mutation........ The researchers noted that the survival advantage seen in women carrying a BRCA1 or BRCA2 mutation could be related to “intrinsic biological differences, their response to therapeutic agents, or both.”"

Conclusion Among patients with invasive EOC, having a germline mutation in BRCA1 or BRCA2 was associated with improved 5-year overall survival. BRCA2 carriers had the best prognosis. 

financial: California University's health unit acquires Nevada Cancer Institute

new website: Peerage of Science (for scientists/peer review))

Peerage of Science…

…is not doing “open peer review”. It provides anonymous peer review, by qualified scientists only. While a Peer can invite anyone to join, the right to access and review work done by others is given only after service administration has verified identity and qualifications (at least one published article where the new Peer is first or corresponding author, in a peer-reviewed international journal).
…is not a “pre-print server” like arXiv.org or Nature Preprints. It is closed to the outside world. It strictly limits access to manuscript under peer review to only editors and those Peers involved in that particular peer review, and does not archive manuscripts to be accessed after peer review.
…is not providing an “alternative publishing model”. It is only concerned with providing better peer review for the benefit of everyone involved, including the publishing companies.
…is not charging fees from scientists.

open access: Journal of Translational Medicine - Supporting the advancement of science: Open access publishing and the role of mandates (the Research Works Act[1])

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

excerpt pdf file:

"In December 2011 the United States House of Representatives introduced a new bill, the Research Works Act (H.R.3699), which if passed could threaten the public’s access to US government funded
research. In a digital age when professional and lay parties alike look more and more to the online environment to keep up to date with developments in their fields, does this bill serve the best
interests of the community? Those in support of the Research Works Act argue that government open access mandates undermine peer-review and take intellectual property from publishers without compensation, however journals like Journal of Translational Medicine show that this is not the case. Journal of Translational Medicine in affiliation with the Society for Immunotherapy of Cancer demonstrates how private and public organisations can work together for the advancement
of science.

Editorial

Journal of Tra nslational Medicine is an open access journal published by BioMed Central that aims to optimise communication between basic and clinical science. Now in its 10th year of publication
the journal is successful in its aim for fostering communication from bench to bedside.
A new bill, the Research Works Act[1], has been introduced in the United States House of Representatives threatening the public’s access to US government funded research and the foundation on which Journal of Translational Medicine was built.

The bill states:

“No Federal agency may adopt, implement, maintain, continue, or otherwise engage in any policy, program, or other activity that:
(1) causes, permits, or authorizes network dissemination of any private-sector research work without the prior consent of the publisher of such work; or (2) requires that any actual or prospective author, or the employer of such an actual or prospective author, assent to network dissemination of a private-sector research work.”

If passed, this bill would force the retraction of the public access policy of the National Institutes of Health[2], who mandate that recipients of their grants must make their published research publically accessible by depositing full-text versions in open access repositories (such as PubMed Central), and prevent similar policies from being introduced by federal agencies in the future.

It is argued [3, 4] that research funded by tax-payers should be made available to the public free of charge so that the tax-payer does not in effect pay twice for the research - first for the research to be done and then to read the results. As much as this may be true, the biggest detriment seems to be to developments in science. Open access to research means the widest possible dissemination of information. Limiting access to a (by comparison) small subset of people with subscriptions can stunt further developments......"

abstract: Balancing repair and tolerance of DNA damage caused by alkylating agents : Nature Reviews Cancer

Blogger's Note: requires subscription ($$$)

Quest Diagnostics Reports Fourth Quarter 2011 Financial Results; Provides Guidance for 2012 -- MADISON, N.J., Jan. 24, 2012 /PRNewswire/ --

press release: InSightec Submits Pre Market Application (PMA) for FDA Approval of ExAblate for Treatment of Painful Bone Metastases | Press Release | Rehab Management

"....ExAblate is the only MRgFUS system with FDA approval, granted in 2004 for uterine fibroids. It also received European CE marking for uterine fibroids, bone metastases, and adenomyosis. Clinical trials are ongoing for brain disorders, including essential tremor and Parkinson's disease, and prostate cancer."

abstract - Current Obstetrics and Gynecology Reports: Ovarian Cancer is an Imported Disease: Fact or Fiction?

Abstract

The cell of origin of ovarian cancer has been long debated. The current paradigm is that epithelial ovarian cancer (EOC) arises from the ovarian surface epithelium (OSE). OSE is composed of flat, nondescript cells more closely resembling the mesothelium lining the peritoneal cavity. In light of various histologic types of ovarian carcinoma (serous, endometrioid, and clear cell carcinoma), which have a Müllerian phenotype, it has been argued that the OSE undergoes a process termed “metaplasia” to account for this profound morphologic transformation.

Recent molecular and clinicopathologic studies not only have failed to support this hypothesis but also have provided evidence that EOC stems from Müllerian-derived extraovarian cells that involve the ovary secondarily, thereby calling into question the very existence of primary EOC.

This new model of ovarian carcinogenesis proposes that fallopian tube epithelium (benign or malignant) implants on the ovary to give rise to both high-grade and low-grade serous carcinomas, and that endometrial tissue implants on the ovary and produces endometriosis, which can undergo malignant transformation into endometrioid and clear cell carcinoma.

Thus, ultimately EOC is not ovarian in origin but rather is secondary, and it is logical to conclude that the only true primary ovarian neoplasms are germ cell and gonadal stromal tumors analogous to tumors in the testis. If this new model is confirmed, it has profound implications for the early detection and treatment of “ovarian cancer”.

Keywords Ovarian cancer – Pathogenesis – Model – Paradigm – Fallopian tube – Endometriosis – Serous tubal intraepithelial carcinoma – STIC – Serous carcinoma

(U.S.) Medscape: Feds Target Roles of PAs and Nurses for Comparative Research

Clinicians, patients, healthcare organizations, and the general public can weigh in on the proposed agenda and research priorities of PCORI at the agency's Web site or at its National Patient and Stakeholder Dialogue meeting, set for February 27 in Washington, DC. More information about the meeting is available at the PCORI Web site.

Jan 2012 abstract: Long-term follow-up of Jewish women with a BRCA1 and BRCA2 mutation who underwent population genetic screening

Blogger's Note: in this study longterm followup = 2 years

Abstract

There are two mutations in BRCA1 and one in BRCA2, which are present in up to 2.5% of Jewish women. Population genetic testing for Jewish women has been proposed; however, it is unclear how this would impact the uptake of cancer prevention options and psychosocial functioning in women with a positive result. Two thousand and eighty unselected Jewish women were tested for the Jewish BRCA mutations, and 1.1% were positive. Cancer-related distress was measured before testing, and at 1 and 2 years post-testing. Information on uptake of cancer risk reduction options was collected at 2 years. Breast and ovarian cancer risks were estimated using BRCAPRO. Within 2 years of receiving a positive result, 11.1% of women had prophylactic mastectomy, and 89.5% had a prophylactic oophorectomy. The mean breast cancer risk was estimated to be 37.2% at time of testing, compared to 20.9% at 2 years post-testing. The mean ovarian cancer risk was estimated to be 24.5% at time of testing, compared to 7.5% at 2 years following testing. Distress decreased between 1 and 2 years for women with prophylactic mastectomy and oophorectomy (P = 0.02), and for women with prophylactic oophorectomy only (P = 0.04) but not for those with neither surgery. The majority of Jewish women with a BRCA mutation identified through a population screening elected prophylactic oophorectomy, but a few had a prophylactic mastectomy. Uptake of either surgery resulted in decreased distress. Provision of population BRCA testing resulted in reduced risks of breast and ovarian cancers in women with a mutation.

Keywords  BRCA1 – BRCA2 – Breast cancer – Genetic testing – Jewish

BMC Cancer | Full text | Breast cancer patients with lobular cancer more commonly have a father than a mother diagnosed with cancer

Conclusion

We propose that lobular breast cancer is associated with having a father diagnosed with cancer, most commonly prostate carcinoma. Since the association remained after excluding family history of breast cancer, the association seems independent of classical breast cancer heredity. The association with a father diagnosed with cancer also remained after removing prostate cancer, indicating an independence from prostate cancer as well. The reason for this association is genetically unclear, but could involve sex-specific imprinting.

open access - BMC Cancer Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study (protocol/design/Netherlands)

Study protocol

Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study

BMC Cancer 2012, 12:31 doi:10.1186/1471-2407-12-31
Published: 20 January 2012

Abstract (provisional)

Background

Standard treatment of advanced ovarian cancer is surgery and chemotherapy. The goal of surgery is to remove all macroscopic tumour, as the amount of residual tumour is the most important prognostic factor for survival. When removal off all tumour is considered not feasible, neoadjuvant chemotherapy (NACT) in combination with interval debulking surgery (IDS) is performed. Current methods of staging are not always accurate in predicting surgical outcome, since approximately 40% of patients will have more than 1 cm residual tumour after primary debulking surgery (PDS). In this study we aim to assess whether adding laparoscopy to the diagnostic work-up of patients suspected of advanced ovarian carcinoma may prevent unsuccessful PDS for ovarian cancer.

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