Don’t dismiss conflict-of-interest concerns in IVF, they have a basis

It’s estimated over 5 million children have been born worldwide as a result of assisted reproductive technology treatments. Assisted reproductive technology, an umbrella term that includes in vitro fertilisation (IVF), is a highly profitable global industry, and fertility clinics are increasingly regarded as an attractive investment option. In 2014, two major IVF clinics - Virtus and Monash IVF — floated on the stock exchange. Excited financial analysts observed at the time that: people will pay almost anything to have a baby. Over the past 12 months, there have been numerous critical media analyses of the IVF industry in Australia, including Monday night’s ABC Four Corners program, The Baby Business. The episode suggested IVF doctors are recommending treatments that are expensive, unsafe and likely to be futile. The following morning the Fertility Society of Australia rejected these assertions, saying: Four Corners presented no evidence to support these claims. One of the claims made in the program was that IVF doctors have a financial incentive to treat women with the more invasive practice of IVF. The program suggested this financial incentive conflicts with the doctor’s duty of care towards the patient. Four Corners highlighted the conflicted nature of commercialised IVF, where some IVF doctors are more concerned about their own interests (making money for themselves or their clinics) than they are about their patients. Not surprisingly, the Fertility Society of Australia strongly denied such conflicts of interest exist. It argued that the profession is both highly ethical and highly regulated

Assessment of proximal pulmonary arterial stiffness using magnetic resonance imaging:effects of technique, age and exercise

INTRODUCTION: To compare the reproducibility of pulmonary pulse wave velocity (PWV) techniques, and the effects of age and exercise on these. METHODS: 10 young healthy volunteers (YHV) and 20 older healthy volunteers (OHV) with no cardiac or lung condition were recruited. High temporal resolution phase contrast sequences were performed through the main pulmonary arteries (MPAs), right pulmonary arteries (RPAs) and left pulmonary arteries (LPAs), while high spatial resolution sequences were obtained through the MPA. YHV underwent 2 MRIs 6 months apart with the sequences repeated during exercise. OHV underwent an MRI scan with on-table repetition. PWV was calculated using the transit time (TT) and flow area techniques (QA). 3 methods for calculating QA PWV were compared. RESULTS: PWV did not differ between the two age groups (YHV 2.4±0.3/ms, OHV 2.9±0.2/ms, p=0.1). Using a high temporal resolution sequence through the RPA using the QA accounting for wave reflections yielded consistently better within-scan, interscan, intraobserver and interobserver reproducibility. Exercise did not result in a change in either TT PWV (mean (95% CI) of the differences: −0.42 (−1.2 to 0.4), p=0.24) or QA PWV (mean (95% CI) of the differences: 0.10 (−0.5 to 0.9), p=0.49) despite a significant rise in heart rate (65±2 to 87±3, p<0.0001), blood pressure (113/68 to 130/84, p<0.0001) and cardiac output (5.4±0.4 to 6.7±0.6 L/min, p=0.004). CONCLUSIONS: QA PWV performed through the RPA using a high temporal resolution sequence accounting for wave reflections yields the most reproducible measurements of pulmonary PWV

Deriving and critiquing an empirically-based framework for pharmaceutical ethics.

Background: The pharmaceutical industry has been responsible for major medical advances, but the industry has also been heavily criticized. Such criticisms, and associated regulatory responses, are no doubt often warranted, but do not provide a framework for those who wish to reason systematically about the moral dimensions of drug development. We set out to develop such a framework using Beauchamp and Childress’s “four principles” as organizing categories. Methods: We conducted a qualitative interview study of people working in the “medical affairs” departments of pharmaceutical companies to determine: (1) whether our data could meaningfully be organized under the headings of “autonomy,” “beneficence,” “nonmaleficence,” and “justice”; (2) how principles might be expressed in this particular commercial setting; and (3) if these principles are expressed, whether and how competing principles are balanced. We then critiqued these findings using existing normative theory. Results: Our interviews demonstrated that three of Beauchamp and Childress’ four principles were salient to our participants: beneficence, non-maleficence, and justice. Within each of these principles, participants had two broad ethical orientations: an altruistic public focus (“other-ness”) and a commitment to their companies (“firm-ness”). Our participants also demonstrated efforts to balance these principles and highlighted the importance of phronesis (or practical wisdom) in balancing and enacting principles. Notably, however, our participants did not spontaneously emphasize the importance of autonomy. Conclusions: It is possible to use qualitative empirical research, together with normative analysis, to derive a framework for pharmaceutical ethics. We suggest that our framework would be useful for those who wish to reason ethically within, or in collaboration with, the pharmaceutical industry. Keywords: Empirical ethics, principle-based ethics, pharmaceutical industry, pharmaceutical ethics, qualitative researchNHMRC Career Development Fellowship APP106356

Sedentary Behavior, Physical Activity, and Likelihood of Breast Cancer among Black and White Women: A Report from the Southern Community Cohort Study

Increased physical activity has been shown to be protective for breast cancer although few studies have examined this association in black women. In addition, limited evidence to date indicates that sedentary behavior may be an independent risk factor for breast cancer. We examined sedentary behavior and physical activity in relation to subsequent incident breast cancer in a nested case-control study within 546 cases (374 among black women) and 2,184 matched controls enrolled in the Southern Community Cohort Study. Sedentary and physically active behaviors were assessed via self-report at study baseline (2002–2009) using a validated physical activity questionnaire. Conditional logistic regression was used to estimate mutually adjusted odds ratios (OR) and corresponding 95% confidence intervals (CI) for quartiles of sedentary and physical activity measures in relation to breast cancer risk. Being in the highest versus lowest quartile of total sedentary behavior (≥12 hours/day versus <5.5 hours/day) was associated with increased odds of breast cancer among white women (OR=1.94 [95% CI 1.01–3.70], p for trend=0.1) but not black women (OR=1.23 [95% CI 0.82–1.83], p for trend=0.6) after adjustment for physical activity. After adjustment for sedentary activity, greater physical activity was associated with reduced odds for breast cancer among white women (p for trend=0.03) only. In conclusion, independent of one another, sedentary behavior and physical activity are risk factors for breast cancer among white women. Differences in these associations between black and white women require further investigation. Reducing sedentary behavior and increasing physical activity are potentially independent targets for breast cancer prevention interventions

Toll-like receptor 3 blockade in rhinovirus-induced experimental asthma exacerbations:A Randomized Controlled Study

BACKGROUND: Human rhinoviruses (HRVs) commonly precipitate asthma exacerbations. Toll-like receptor 3, an innate pattern recognition receptor, is triggered by HRV, driving inflammation that can worsen asthma. OBJECTIVE: We sought to evaluate an inhibitory mAb to Toll-like receptor 3, CNTO3157, on experimental HRV-16 inoculation in healthy subjects and asthmatic patients. METHODS: In this double-blind, multicenter, randomized, parallel-group study in North America and Europe, healthy subjects and patients with mild-to-moderate stable asthma received single or multiple doses of CNTO3157 or placebo, respectively, and were then inoculated with HRV-16 within 72 hours. All subjects were monitored for respiratory symptoms, lung function, and nasal viral load. The primary end point was maximal decrease in FEV1 during 10 days after inoculation. RESULTS: In asthmatic patients (n = 63) CNTO3157 provided no protection against FEV1 decrease (least squares mean: CNTO3157 [n = 30] = -7.08% [SE, 8.15%]; placebo [n = 25] = -5.98% [SE, 8.56%]) or symptoms after inoculation. In healthy subjects (n = 12) CNTO3157 versus placebo significantly attenuated upper (P = .03) and lower (P = .02) airway symptom scores, with area-under-the-curve increases of 9.1 (15.1) versus 34.9 (17.6) and 13.0 (18.4) versus 50.4 (25.9) for the CNTO3157 (n = 8) and placebo (n = 4) groups, respectively, after inoculation. All of the severe and 4 of the nonserious asthma exacerbations occurred while receiving CNTO3157. CONCLUSION: In summary, CNTO3157 was ineffective in attenuating the effect of HRV-16 challenge on lung function, asthma control, and symptoms in asthmatic patients but suppressed cold symptoms in healthy subjects. Other approaches, including blockade of multiple pathways or antiviral agents, need to be sought for this high unmet medical need