Wednesday, March 28, 2012
Consumer Reports targets medical devices' safety - latimes.com
Blogger's Note: search blog for other posts regarding 'surgical mesh' issues/concerns
Consumer Reports targets medical devices' safety - latimes.com
"In a report issued Wednesday the consumer magazine also expressed concerns about risks related to surgical mesh, metal hips and certain cardiac devices. It highlighted how the federal government allows some products to be sold with little or no advance safety testing......
reposted from Jan 2012 - worth reading - Editorial Commentary - Maurie Markman - Clinical Oncology News - Meaningful Responses To ‘We-Know-the-Answer’ Syndrome
".... The following three examples, all drawn from the field of epithelial ovarian cancer management, illustrate the dangers of simply accepting conventional wisdom, and in my opinion, serve as excellent examples of the importance of critical thinking when evaluating this type of proclamation...." (3 examples )
"Similar examples can be found in all areas of clinical oncology where conventional wisdom and “expert opinion” have inappropriately trumped the essential process of critical thinking. Unfortunately, this is not surprising: Critical thinking often is quite difficult, particularly when the outcome rejects a strong belief in some particular conventional wisdom that has been passed on by “senior leaders” or “experts in a field.”"
"....... Stressing the dangers of nonrigorously tested, overly simplistic or nonbiologically based beliefs often is not the way to win popularity contests among your peers (or within professional organizations), who may accept the conventional wisdom as being factually correct. But for those who appropriately, and even courageously, refuse to be swept up by the superficial allure and comfort of conventional wisdom, who understand that genuine progress in oncologic outcomes demands constant inquiry into our existing interpretations of biological systems and current medical practice, it is important to remember it is our patients who are the beneficiaries of our efforts........"
abstract: Harmony in drug regulation, but who's calling the tune? An examination of regulatory harmonization in health Canada [Int J Health Serv. 2012] (eg. safety, influences, industry...)
Blogger's Note: the current federal (conservative) government is known widely for its lack of transparency (past and present), Health Canada, obviously, falls within federal mandates
Harmony in drug regulation, but who's call... [Int J Health Serv. 2012] - PubMed - NCBI
Int J Health Serv. 2012;42(1):119-36.
Source
School of Health Policy and Management, York University, Toronto, ON, Canada. jlexchin@yorku.caAbstract
Harmonizing standards on drug regulation makes sense, but it must protect safety, ensure that only drugs that are truly effective are marketed, and protect a country's ability to act independently. The main driving force behind international harmonization is the International Conference on Harmonization (ICH). When it comes to safety, the ICH has been harmonizing to the lowest common denominator. Examples of harmonization indicate that industry priorities have influenced the direction that Health Canada has taken. Harmonization is also intimately tied in with the policy of smart regulation, changing regulations in a way that enhances the climate for investment. Canada has introduced user fees in concert with other countries, but there are concerns that these may compromise safety standards. When it comes to transparency, Health Canada has chosen to adopt the more restrictive European Union model rather than the more open process used by the United States. Finally, there are a number of areas in which Health Canada has chosen not to harmonize, and in each case the decision is in the direction of lower safety standards. Harmonization could be of benefit to Canada, but the evidence to date suggests that Health Canada been harmonizing down rather than up.Clinical Oncology News - Zoledronic Acid Debate in Breast Cancer Continues
Clinical Oncology News - Zoledronic Acid Debate in Breast Cancer Continues
San Antonio—Long-term results of the ABCSG-12 trial and subanalyses of two recently presented Phase III trials provide further evidence that bisphosphonates can improve survival in breast cancer patients with low estrogen levels. The results of the studies, presented at the recent San Antonio Breast Cancer Symposium (SABCS), have convinced some doctors of the low estrogen hypothesis, but for others the water is still very murky.....
Weighing the Evidence
In recent years, some oncologists have been prescribing bisphosphonates off-label to treat breast cancer, and the new studies may sway more doctors to do so.
“The anticancer effects of adjuvant zoledronic acid are now well established in endocrine-responsive patients,” said Dr. Gnant.
Dr. Paterson added that “inhibition of osteoclast function with bisphosphonates has an effect on cancer growth in older women, and little effect in premenopausal women.”
For other doctors, however, the jury is still out. “Subanalyses are suspect,” said Dr. Vogl. “This is interesting, but we need to study it some more. But if they study it some more, Novartis will have lost its patent protection by the time that study comes out. Novartis has some interest in it [being approved] now.”
Dr. Paterson is a consultant for GlaxoSmithKline, Amgen, Roche and Nicomed and has received a grant for a clinical trial involving denosumab. Dr. Gnant disclosed relationships with AstraZeneca, Novartis, Pfizer, Sanofi, Roche, Schering and Amgen. Dr. Möbus disclosed relationships with Amgen, Novartis and Roche. Dr. de Boer disclosed a relationship with Novartis. Drs. Ingle and Dr. Vogl have no relevant disclosures.
Seth's Blog: Why isn't it better?
Seth's Blog: Why isn't it better?
Why isn't it better?
- Perhaps you don't know enough
- Perhaps you don't care enough, or
- Perhaps you're unable to execute because of committees, the status quo and fear
The combination of fear and ignorance (two sides of the same coin) can be paralyzing
UK - Quality of Life and Experience of Care in Women With Metastatic Breast Cancer: A Cross-Sectional Survey
Blogger's Comment: read prior post on 'symptom clusters'
Journal of Pain and Symptom Management - Quality of Life and Experience of Care in Women With Metastatic Breast Cancer: A Cross-Sectional Survey
Conclusion
Despite
improvements in treatment and survival of women with metastatic breast
cancer, this group reports high symptom burden and dissatisfaction with
elements of their care, indicating that alternative models of service
delivery should be explored.
ScienceDirect.com - Journal of Pain and Symptom Management - Talking About End-of-Life Preferences With Advanced Cancer Patients: Factors Influencing Feasibility
ScienceDirect.com - Journal of Pain and Symptom Management - Talking About End-of-Life Preferences With Advanced Cancer Patients: Factors Influencing Feasibility
Conclusion
Results
indicate that discussing end-of-life preferences in an earlier disease
phase, such as in the OU (outpatient) setting, could be preferable but that its
accomplishment in this setting may be more difficult, mainly as a result
of organizational reasons. This observation could indicate that the
system is not yet ready to offer patients such an opportunity and
although communication on these sensitive issues cannot be reduced to a
procedure, the ELPI can become a useful tool to help physicians in
accomplishing this difficult task.
abstract: All’s Well That Ends Well? Quality of Life and Physical Symptom Clusters in Long-Term Cancer Survivors Across Cancer Types (Australia/Canada)
Blogger's Note: search blog for other posts on 'symptom cluster' research, note that the abstract does not discuss the current status of the 5/6 year survivors (eg. in treatment, type/s of treatments, # prior treatments, stage.....
Blogger's Opinion: short answer - no, back to the 'drawing' board on this one
abstract: "Cancer patients also will welcome the news that only a minority of five-year survivors experience long-term and late effects."
All’s Well That Ends Well? Quality of Life and Physical Symptom Clusters in Long-Term Cancer Survivors Across Cancer Types:
Publication year: 2012
Source: Journal of Pain and Symptom Management, Volume 43, Issue 4
Context
Little is known about the presentation of multiple concurrent symptoms (symptom clusters) in long-term cancer survivors, with few studies adequately powered to compare quality of life (QoL) and symptom presentation by cancer type.
Objectives
This research aimed to 1) assess patient-reported QoL and 2) identify clusters of cancer-related physical symptoms by cancer type among long-term breast, prostate, colorectal, and melanoma cancer survivors.
Methods
A population-based cross-sectional sample of 863 adult cancer survivors five to six years post-diagnosis completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), assessing global QoL and frequency of presentation of cancer-related physical symptoms.
Results
Long-term survivors reported higher levels of global QoL than 1) the general population (age-adjusted mean=79.4 vs. 71.1, small clinical difference) and 2) cancer patients early in the care trajectory (age-adjusted mean=77.1 vs. 61.3, moderate clinical difference). The majority (71%) did not report any cancer-related physical symptoms; 18% reported multiple (two or more) symptoms in the past month. Factor analysis found that cognitive functioning, fatigue, insomnia, pain, dyspnea, appetite loss, constipation, diarrhea, nausea, and vomiting formed a cluster (α =0.48). No symptom clusters were identified that were specific to just one cancer type. However, individual symptoms (including diarrhea, pain, constipation, and insomnia) modestly discriminated between cancer types.
Conclusion
Contrary to expectations, no symptom clusters specific to one type of cancer were identified and survivors reported few cancer-related symptoms and high QoL. These results convey a strong “good news” message, providing health professionals with a sound foundation for making encouraging predictions about their patients’ long-term physical recovery after cancer. Cancer patients also will welcome the news that only a minority of five-year survivors experience long-term and late effects.
abstract - Journal of Pain and Symptom Management - A Spicamycin Derivative (KRN5500) Provides Neuropathic Pain Relief in Patients With Advanced Cancer: A Placebo-Controlled, Proof-of-Concept Trial
ScienceDirect.com - Journal of Pain and Symptom Management - A Spicamycin Derivative (KRN5500) Provides Neuropathic Pain Relief in Patients With Advanced Cancer: A Placebo-Controlled, Proof-of-Concept Trial
Conclusion
This
proof-of-concept study for KRN5500 in patients with advanced cancer and
any type of neuropathic pain found gastrointestinal adverse events to
be the predominant safety concern. The results also provided the first
indication of clinical and statistical efficacy in reducing pain
intensity.
Evidence-based Guideline Recommendations on the use of Positron Emission Tomography Imaging in Colorectal Cancer (Ontario provincial Gastrointestinal Disease Site Group)
Blogger's Note: updated to 2010
Evidence-based Guideline Recommendations on the use of Positron Emission Tomography Imaging in Colorectal Cancer
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