Friday, March 16, 2012
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.
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
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).
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.
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.
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 | 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
Released: 3/16/2012 12:20 PM EDT
Source: Johns Hopkins Medicine
Source: Johns Hopkins Medicine
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:
Cochrane Web Team
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.
AbstractMore 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.
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/ --
".....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.
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
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.
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.
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.
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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
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.