Do patents impede the provision of genetic tests in Australia?

2013 ◽  
Vol 37 (3) ◽  
pp. 281 ◽  
Author(s):  
Dianne Nicol ◽  
John Liddicoat
Keyword(s):  
Breast Cancer ◽  
Health Policy ◽  
Genetic Testing ◽  
Evidence Base ◽  
Public Hospitals ◽  
Law Reform ◽  
Genetic Tests ◽  
The Future ◽  
Patent Enforcement ◽  
The Impact

Objective. Health policy and law reform agencies lack a sound evidence base of the impacts of patents on innovation and access to healthcare to assist them in their deliberations. This paper reports the results of a survey of managers of Australian genetic testing laboratories that asked a series of questions relating to the tests they perform, whether they pay to access patented inventions and whether they have received notifications from patent holders about patents associated with particular tests. Results. Some diagnostics facilities are exposed to patent costs, but they are all located in the private sector. No public hospitals reported paying licence fees or royalties beyond those included in the price of commercial test kits. Some respondents reported having received enforcement notices from patent holders, but almost all related to the widely known breast cancer-associated patents. Respondents were also asked for their views on the most effective mechanisms to protect their ability to provide genetic tests now and in the future. Going to the media, paying licence fees, ignoring patent rights and relying on the government to take action were widely seen as most effective. Litigation and applications for compulsory licences were seen as some of the least effective mechanisms. Conclusion. These results provide an evidence base for development of health policy and law reform. What is known about the topic? The impact of patents on the delivery of genetic testing services remains unclear in Australia. What does this paper add? The survey reported in this paper suggests that, aside from well-known enforcement actions relating to the breast cancer associated patents, there is little evidence that providers of genetic testing services are being exposed to aggressive patent-enforcement practices. What are the implications for practitioners? Although patent-enforcement actions may increase in the future, a range of strategies are available to providers of testing services to protect them against adverse consequences of such actions. There are ongoing law reform activities aimed at improving these strategies.

scholarly journals Impact of Comorbidities on Quality Of Life in Breast Cancer Patients

2016 ◽  
Vol 01 (04) ◽  
pp. 025-028
Author(s):  
Monica Irukulla ◽  
Rama Vaghmare ◽  
Deepa Joseph ◽  
Syed Ahmed ◽  
Jyothi Jonnadula ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Patients ◽  
Physical Functioning ◽  
Bodily Pain ◽  
Evidence Base ◽  
Breast Cancer Patients ◽  
Co Morbidity ◽  
The Impact

AbstractIntroduction: Comorbidities are common among cancer patients and with an aging population are becoming more prevalent. These can potentially affect the stage at diagnosis, treatment and outcomes of people with cancer. Despite the intimate relationship between comorbidity and cancer, there is limited consensus on how to record, interpret or manage comorbidities in the context of cancer. Addressing the impact of comorbid conditions in cancer patients warrants improvement in the evidence base from which to make treatment decisions for those with comorbidities.Methods: In this prospective study, 64 patients with breast cancer, underwent QOL assessment using FACT –B questionnaire at three time points- pre-radiation and three and six months post radiation.Results: 29(46%) patients had comorbidities of which 23 (35%) had cardiovascular comorbidities and 6 had other comorbidities. The co-morbidities were negatively associated with multiple domains of quality of life, including physical functioning, general health, bodily pain. Patients with diabetes and hypertension had significantly lower scores in physical functioning in comparison to patients without diabetes and hypertension, but improved after treatment. In majority of patients the overall scores were less in patients with co-morbidities compared to patients without any co-morbidity.Conclusion: Comorbidities can significantly affect the quality of life in patients with comorbidities. Hence greater research into the QOL issues for better patient care and symptom management especially during the transitioning phase from active care to follow up will help clinicians improve the quality of care and interdisciplinary co-ordination.

Rates of appropriate genetic testing referral for breast cancer patients treated in a multidisciplinary cancer care setting.

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 45-45 ◽  
Author(s):  
Caitlin Laurel Gomez ◽  
Nicole Ann Dawson ◽  
Robyn Lynn Dvorak ◽  
Nova Foster ◽  
Anne Hoyt ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Genetic Testing ◽  
Family History ◽  
Genetic Counselor ◽  
Newly Diagnosed ◽  
Breast Cancer Patients ◽  
Breast Clinic ◽  
Jewish Ancestry ◽  
The Impact ◽  
Genetics Referral

45 Background: Approximately 5% to 10% of women diagnosed with breast cancer have a genetic predisposition, which can affect management recommendations. The National Comprehensive Cancer Network (NCCN) has established guidelines for genetics referral and testing, however recent publications have indicated low rates of family history documentation and appropriate genetics referral. We sought to assess the impact of standardized family history documentation on rates of appropriate genetics referral in a multidisciplinary breast clinic (MDC) setting. Methods: In advance of MDC consultation, women with newly diagnosed breast cancer complete an intake questionnaire which includes documentation of Ashkenazi Jewish ancestry along with a thorough family history. We retrospectively analyzed family history documentation to inform eligibility for genetic testing and rates of appropriate genetics referral. Results: Between June 2012 and April 2014, 202 women with newly diagnosed, nonmetastatic breast cancer were seen in MDC. We noted 100% compliance with family history documentation. Per NCCN Guidelines, genetic testing was indicated in 52% (106 patients), of which 77% were appropriately referred to a genetic counselor for evaluation. All patients who met criteria based on personal history factors including age ≤ 45, triple-negative disease under age 60, or two or more breast primaries under age 50 were appropriately referred. Patients who were eligible but not referred ranged in age from 46 to 93 and were eligible for testing based on Ashkenzi Jewish ancestry (3 patients) or family history factors including a relative with ovarian cancer (3 patients), ≥2 relatives with breast cancer (5 patients), or a relative with breast cancer < age 50 (7 patients). Conclusions: Compared with recently published national averages, rates of appropriate family history documentation and genetic testing referrals are significantly higher in our MDC setting. However, this analysis has identified significant opportunity for improvement via identification of overlooked referral indications. Initiatives are underway to improve future compliance.

scholarly journals Substantial Reduction in Adjuvant Chemotherapy With the Use of the 21-Gene Test to Manage Early Breast Cancer in a Public Hospital in Brazil

2021 ◽  
pp. 1003-1011
Author(s):  
André Mattar ◽  
Guilherme R. Fonseca ◽  
Murilo B. A. Romão ◽  
Jorge Y. Shida ◽  
Vilmar M. de Oliveira ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Substantial Reduction ◽  
Recurrence Score ◽  
Treatment Recommendations ◽  
Public Hospitals ◽  
Test Results ◽  
Node Positive ◽  
Gene Testing ◽  
Gene Test ◽  
The Impact

PURPOSE We evaluated the impact of 21-gene test results on treatment decisions for patients with early-stage breast cancer treated under the public health care system in Brazil, Sistema Único de Saúde. METHODS Eligible patients treated at Hospital Pérola Byington and Santa Casa de Misericórdia de São Paulo in Brazil were required to have the following characteristics: postsurgery with hormone receptor–positive, human epidermal growth factor 2–negative, node-negative and node-positive, and T1/T2 breast cancer and patients with these characteristics were candidates for adjuvant systemic therapy. Treatment recommendations, chemotherapy plus hormonal therapy (CT + HT) or HT alone, were captured before and after 21-gene test results. RESULTS From August 2018 to April 2019, 179 women were enrolled. The mean age was 58 years (29-86 years), 135 (76%) were postmenopausal, and 58 (32%) had node-positive breast cancer. Most patients (61%) had a tumor > 2 cm, including 7% with tumors > 4 cm. Using Recurrence Score (RS) result cut points on the basis of the TAILORx trial, 40 (22%) had RS 0-10, 91 (51%) had RS 11-25, and 48 (27%) had RS 26-100. Before 21-gene testing, 162 of 179 (91%) patients were recommended for CT. After testing, 117 of 179 patients (65%) had changes in CT recommendation: 112 (63%) who were initially recommended CT received HT alone and five (3%) who were initially recommended HT alone received CT + HT. After 21-gene testing, 99% of physicians reported strong confidence in their treatment recommendations. CONCLUSION The change in clinical practice at these public hospitals was greater than expected: 66% of initial treatment recommendations were changed to omit CT with 21-gene test results. Clinicopathologic features did not correlate well with 21-gene test results and did not adequately identify those most likely to benefit from CT.

scholarly journals The impact of COVID-19 on and recommendations for breast cancer care: the Singapore experience

2020 ◽  
Vol 27 (9) ◽  
pp. R307-R327 ◽  
Author(s):  
Jack Junjie Chan ◽  
Yirong Sim ◽  
Samuel Guan Wei Ow ◽  
Joline Si Jing Lim ◽  
Grace Kusumawidjaja ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Evidence Base ◽  
Healthcare Sector ◽  
Public Healthcare ◽  
Global Public Health ◽  
Medical Systems ◽  
Outbreak Response ◽  
Cancer Management ◽  
Breast Cancer Management ◽  
The Impact

The ensuing COVID-19 pandemic poses unprecedented and daunting challenges to the routine delivery of oncological and supportive care to patients with breast cancer. Considerations include the infective risk of patients who are inherently immunosuppressed from their malignancy and therapies, long-term oncological outcomes from the treatment decisions undertaken during this extraordinary period, and diverted healthcare resources to support a coordinated whole-of-society outbreak response. In this review, we chronicle the repercussions of the COVID-19 outbreak on breast cancer management in Singapore and describe our approach to triaging and prioritising care of breast tumours. We further propose adaptations to established clinical processes and practices across the different specialties involved in breast oncology, with references to the relevant evidence base or expert consensus guidelines. These recommendations have been developed within the unique context of Singapore’s public healthcare sector. They can serve as a resource to guide breast cancer management for future contingencies in this city-state, while certain elements therein may be extrapolatable to other medical systems during this global public health emergency.

Revised standards of proficiencies for midwives: an opportunity to influence childhood health?

2020 ◽  
Vol 28 (3) ◽  
pp. 150-154
Author(s):  
Samantha Meegan
Keyword(s):  
Public Health ◽  
Child Development ◽  
Evidence Base ◽  
Early Child Development ◽  
Childhood Health ◽  
Early Child ◽  
The Public ◽  
The Future ◽  
The Uk ◽  
The Impact

The first 1 000 days of life are critical during early child development, yet the significance of this time and the impact on childhood health have only recently been recognised within the UK. In early 2020, the Nursing and Midwifery Council (NMC) released revised standards of proficiency for midwives. These draw on the evidence-base generated by recent research developments within public health, providing the first update of midwifery standards for a decade. This article critically explores the main aspects within the NMC's future midwife proficiencies that relate to the public health component of the midwifery role, and will examine how these factors can equip midwives of the future to support women, their babies and families within the fundamental early days of life.

Using the Impact of Event Scale to Evaluate Distress in the Context of Genetic Testing for Breast Cancer Susceptibility

2006 ◽  
Vol 98 (3) ◽  
pp. 873-881 ◽  
Author(s):  
Michel Dorval ◽  
Mélanie Drolet ◽  
Mélanie LeBlanc ◽  
Elizabeth Maunsell ◽  
Michel J. Dugas ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Genetic Testing ◽  
Cancer Susceptibility ◽  
Breast Cancer Susceptibility ◽  
Impact Of Event Scale ◽  
Event Scale ◽  
The Impact

scholarly journals Gaps in Incorporating Germline Genetic Testing Into Treatment Decision-Making for Early-Stage Breast Cancer

2017 ◽  
Vol 35 (20) ◽  
pp. 2232-2239 ◽  
Author(s):  
Allison W. Kurian ◽  
Yun Li ◽  
Ann S. Hamilton ◽  
Kevin C. Ward ◽  
Sarah T. Hawley ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Genetic Testing ◽  
Los Angeles ◽  
Early Stage ◽  
Genetic Counselor ◽  
Private Insurance ◽  
Bilateral Mastectomy ◽  
Average Risk ◽  
Pathogenic Mutations ◽  
The Impact

Purpose Genetic testing for breast cancer risk is evolving rapidly, with growing use of multiple-gene panels that can yield uncertain results. However, little is known about the context of such testing or its impact on treatment. Methods A population-based sample of patients with breast cancer diagnosed in 2014 to 2015 and identified by two SEER registries (Georgia and Los Angeles) were surveyed about genetic testing experiences (N = 3,672; response rate, 68%). Responses were merged with SEER data. A patient subgroup at higher pretest risk of pathogenic mutation carriage was defined according to genetic testing guidelines. Patients’ attending surgeons were surveyed about genetic testing and results management. We examined patterns and correlates of genetic counseling and testing and the impact of results on bilateral mastectomy (BLM) use. Results Six hundred sixty-six patients reported genetic testing. Although two thirds of patients were tested before surgical treatment, patients without private insurance more often experienced delays. Approximately half of patients (57% at higher pretest risk, 42% at average risk) discussed results with a genetic counselor. Patients with pathogenic mutations in BRCA1/2 or another gene had the highest rates of BLM (higher risk, 80%; average risk, 85%); however, BLM was also common among patients with genetic variants of uncertain significance (VUS; higher risk, 43%; average risk, 51%). Surgeons’ confidence in discussing testing increased with volume of patients with breast cancer, but many surgeons (higher volume, 24%; lower volume, 50%) managed patients with BRCA1/2 VUS the same as patients with BRCA1/2 pathogenic mutations. Conclusion Many patients with breast cancer are tested without ever seeing a genetic counselor. Half of average-risk patients with VUS undergo BLM, suggesting a limited understanding of results that some surgeons share. These findings emphasize the need to address challenges in personalized communication about genetic testing.

Decision Making Regarding Prophylactic Mastectomy: Stability of Preferences and the Impact of Anticipated Feelings of Regret

2008 ◽  
Vol 26 (14) ◽  
pp. 2358-2363 ◽  
Author(s):  
Sandra van Dijk ◽  
Mariëlle S. van Roosmalen ◽  
Wilma Otten ◽  
Peep F.M. Stalmeier
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Risk Management ◽  
Prophylactic Mastectomy ◽  
Coping Process ◽  
The Future ◽  
Management Preferences ◽  
The Impact ◽  
Stability Of Preferences ◽  
Over Time

Purpose Women who test positive for a BRCA1/2 mutation face difficult choices to manage their breast cancer risk; one of these choices is whether to opt for prophylactic mastectomy. Few data are available about this decision-making process. The current study provides data regarding the stability of risk-management preferences over time and the factors that are associated with these preferences. Patients and Methods We analyzed data from 338 women who opted for breast cancer antigen (BRCA) testing. First, we prospectively assessed preferences of 80 BRCA mutation carriers at five different points in time ranging from 1 week after blood sampling up to 9 months after BRCA-test disclosure. Second, we applied univariate and multivariate regression analyses to examine which medical, sociodemographic, and psychological factors are related to a preference for prophylactic mastectomy. Results Ninety percent of the women already indicated a preference regarding risk management at baseline. Moreover, most women had stable preferences over time. Furthermore, anticipated feelings of regret in case of a hypothetical breast cancer diagnosis in the near future were strongly related to risk-management preference (odds ratio = 8.93; P < .0001). Conclusion Women seem to decide at a relatively early stage about their risk-management preferences. Many of them may be sensitive to the possibility of regret in case of a bad outcome. We discuss whether possible regret in the future is a rational reason for opting for prophylactic mastectomy, or whether it signifies an emotional coping process or strategy in which the future costs are no longer fully considered.

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