Health Economic Benefits Research Articles

Cost effectiveness of palivizumab for RSV prevention in high-risk children in the Netherlands

Background: Respiratory syncytial virus (RSV) is a common pathogen that is the leading cause of lower respiratory tract infections in young children. High-risk children are at risk of severe infection, which may require hospitalisation. RSV is also associated with a high risk for respiratory morbidity and mortality, which may have long-term clinical and economic consequences.Objective: To assess the cost effectiveness of palivizumab, a humanised monoclonal antibody, used as prevention against severe respiratory syncytial virus (RSV) infection requiring hospitalisation, in the indication of preterm infants and infants with preterm/bronchopulmonary dysplasia and in the second indication of children with congenital heart disease in the Dutch healthcare setting.Methods: A decision-tree model was used to estimate the cost effectiveness of palivizumab, used as a preventative treatment against severe respiratory syncytial virus (RSV) infection, in high-risk groups of children in the Netherlands. The analysis was based on a lifetime follow-up period in order to capture the impact of palivizumab on long-term morbidity and mortality resulting from an RSV infection. Data sources included published literature, the palivizumab pivotal trials, official price/tariff lists and national population statistics. The study was conducted from the perspective of society in the Netherlands.Results: The use of palivizumab results in undiscounted incremental cost-effectiveness ratios of €12,728/QALY and €4,256/QALY in the in preterm/bronchopulmonary dysplasia and congenital heart disease indications, respectively. Inclusion of indirect costs leads to even more favourable cost-effectiveness outcomes. The study is limited by a number of conservative assumptions. It was assumed that palivizumab only affects the occurrence of RSV hospitalisation and does not influence the severity of the RSV infection. Another assumption was that international clinical trial data and data on utilities could be applied to the Dutch healthcare setting.Conclusion: Palivizumab provides cost-effective prophylaxis against RSV in high-risk infants. The use of palivizumab in these children results in positive short- and long-term health-economic benefits.

An estimation of the long‐term clinical and economic benefits of insulin lispro in Type 1 diabetes in the UK

AimsTo determine the long-term health economic benefits associated with lispro vs. regular human insulin (RHI) in UK Type 1 diabetic (T1DM) patients using the previously published and validated CORE Diabetes Model.MethodsA literature review designed to capture clinical benefits associated with lispro and T1DM cohort characteristics specific to UK was undertaken. Clinical benefits were derived from a Cochrane meta-analysis. The estimated difference (weighted mean) in glycated haemoglobin (HbA1c) was −0.1% (95% confidence interval −0.2 to 0.0%) for lispro vs. RHI. Severe hypoglycaemia rates for lispro and RHI were 21.8 and 46.1 events per 100 patient years, respectively. Costs and disutilities were accounted for severe hypoglycaemia rates. All costs were accounted in 2007 £UK from a National Health Service (NHS) perspective. Future costs and clinical benefits were discounted at 3.5% annually.ResultsIn the base-case analysis, lispro was projected to be dominant compared with RHI. Lispro was associated with improvements in quality-adjusted life expectancy (QALE) of approximately 0.10 quality-adjusted life years (QALYs) vs. RHI (7.60 vs. 7.50 QALYs). Lifetime direct medical costs per patient were lower with lispro treatment, £70 576 vs. £72 529. Severe hypoglycaemia rates were the key driver in terms of differences in QALE and lifetime costs. Sensitivity analyses with assumptions around time horizon, discounting rates and benefits in terms of glycaemic control or hypoglycaemic event rates revealed that lispro remained dominant.ConclusionsOur findings suggest that lispro is likely to improve QALE, reduce frequency of diabetes-related complications and lifetime medical costs compared with RHI.

Ten years single surgeon experience with botulinum toxin in the urinary tract; clinical observations and research discovery

This review details a single surgeon's 10-year experience with botulinum toxin (BoNT) for lower urinary tract symptoms (LUTS). Review of author's published clinical and research experience with BoNT in the prostate, bladder and urethral sphincter. Key observations include that an approximate 90% decrease is needed for bladder augmentation and reconstruction. Detrusor compliance and vesicoureteral reflux improved in over 50% of patients. Submucosal and trigone injection had similar efficacy with low rate of retention that can benefit patients with sensory urgency. No case of clinical vesicoureteral reflux has been noted with trigone injection technique. Dose of less than 200 U are clinically beneficial with duration of efficacy increasing with subsequent BoNT injection that may result in improved health economics benefits. Symptom improvement commonly lasts no less than 12 months with prostate injection. Experiment evidences that BoNT blocks sensory neurotransmitter release that has correlated with benefits seen in patients with bladder pain and abacterial prostatitis. Similar efficacy is observed in refractory overactive bladder as with neurogenic and idiopathic detrusor overactivity. BoNT is promising for a variety of LUTS in author's personal experience over the past 10 years with research that advanced our understanding of BoNT mechanisms of action in the sensory nerves and prostate gland. International multicenter randomized trials for bladder and prostate indications are currently ongoing seeking regulatory approval.

Health-economic benefits of memantine treatment: Translating symptomatic effects into cost savings

Health-economic benefits of memantine treatment: Translating symptomatic effects into cost savings

Comparison of high specificity with standard versions of a quantitative latex D-dimer test in the assessment of community pulmonary embolism: HaemosIL D-dimer HS and Pulmonary Embolism

Background D-dimer assays are sensitive but have poor specificity. False positive results lead to extra imaging and hospital admissions. Objectives To make a pilot comparison of the diagnostic accuracy of the standard quantitative latex HemosIL D-dimer assay with a newer HemosIL D-dimer HS version designed to have improved specificity. Patients / Methods Consecutive patients presenting from the community to an Emergency Department that were investigated for suspected pulmonary embolism using a D-dimer test were included in the study. Standard and D-dimer HS tests were performed. Pulmonary Embolism was diagnosed on the basis of imaging studies or post-mortem at any time from presentation to 90 days thereafter. Results The prevalence of Pulmonary Embolism was 4.5% (18/402). The sensitivity, specificity, negative predictive value, and positive predictive value for the standard quantitative D-dimer test was 100% (81.5 – 100.0), 49.2% (44.1 – 54.3),100% (98.1 – 100.0), and 8.5% (5.1 – 13.0), respectively, and 100% (81.5 – 100.0), 58.3% (53.2 – 63.3),100% (98.4 – 100.0), and 10.1% (6.1 – 15.5), for the D-dimer HS test. There were 35 (16%) fewer ‘false positives’ using the D-dimer HS assay compared with the standard assay. Conclusions D-dimer HS has superior specificity to the standard quantitative D-dimer test without any loss of sensitivity. The generation of fewer false positive results should lead to less unnecessary diagnostic imaging; the use of which is associated with increased hospital admissions and length of stay. The HS assay may therefore have significant health economic benefits.

Chronic kidney disease Markov model comparing paricalcitol to calcitriol for secondary hyperparathyroidism: a US perspective

ABSTRACTObjective: The objective of this study was to determine the cost effectiveness of paricalcitol versus calcitriol for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease in the United States setting.Methods: A Markov process model was developed employing data sources from the published literature, paricalcitol clinical trials and observational studies, official US price/tariff lists and national population statistics. The comparator was calcitriol, a non-selective vitamin D receptor activator (VDRA) medication. The primary perspective of the study was that of the third-party payer in the US. The efficacy outcomes (reduction in secondary hyperparathyroidism (SHPT), reduction in proteinuria, complications and mortality) were extrapolated to: number of life-years gained (LYG) and number of quality-adjusted life-years (QALYs). Clinical and economic outcomes were discounted at 3.5%.Results: The reference case analysis was a 10-year time horizon based on a comparison of paricalcitol with calcitriol, which is started in chronic kidney disease (CKD) stage 3 and continued in CKD stage 4 and CKD stage 5. The use of paricalcitol leads to a cost saving of US$1941. The inclusion of indirect costs leads to a cost saving of US$2528. The use of paricalcitol leads to an increase in life-years gained (0.47 years) and a gain in QALYs (0.43). The use of paricalcitol results in a dominant outcome from the perspective of the third-party payer, as well as from the societal perspective. One-way sensitivity analyses and probabilistic sensitivity analyses confirmed the robustness of the model.Conclusion: This model showed that the favorable clinical benefit of paricalcitol results in positive short and long-term health economic benefits. This study suggests that the use of paricalcitol in patients with early chronic kidney disease may be cost-effective from the third-party payer perspective in the US versus calcitriol. Additional comparative studies are necessary to validate these results.

Asthma management and asthma control in São Paulo, Brazil and Uppsala, Sweden: a questionnaire‐based comparison

The Global Initiative Against Asthma (GINA) was developed to meet the global challenge of asthma. GINA has been adopted in most countries and comparison of asthma management in different parts of the world may be of help when assessing the global dissemination of the guideline. The overall goals in GINA include that asthma patients should be free of symptoms, acute asthma attacks and activity limitations. The aim of the present study was to compare asthma management and asthma control in São Paulo, Brazil and Uppsala, Sweden. Information was collected from asthmatics in São Paulo and Uppsala with a questionnaire. The questionnaire dealt with the following issues: symptoms, smoking, self-management, hospital visits, effect on school/work and medication. The São Paulo patients were more likely to have uncontrolled asthma (36% vs 13%, P < 0.001), having made emergency room visits (57% vs 29%, P < 0.001) and having lost days at school or work because of their asthma (46% vs 28%, P = 0.03) than the asthmatics from Uppsala. There were no difference in the use of inhaled corticosteroids, but the Brazilian patients were more likely to be using theophylline (18% vs 1%, P = 0.001) and less likely to be using long-acting beta-2 agonists (18% vs 37%, P < 0.001). We conclude that the level of asthma control was lower among the patients from São Paulo than Uppsala. Few of the patients in either city reached the goals set up by GINA. Improved asthma management may therefore lead to health-economic benefits in both locations.

PUK9 HEALTH ECONOMIC EVALUATION OF PARICALCITOL COMPARED TO NON-SELECTIVE VITAMIN D RECEPTOR ACTIVATOR FORTHETREATMENT OF SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE PATIENTS: US PERSPECTIVE

HEALTH ECONOMIC EVALUATION OF PARICALCITOL COMPARED TO NON-SELECTIVE VITAMN D RECEPTOR ACTIVATOR FOR THE TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE PATIENTS: US PERSPECTIVE Mark Nuijten, Dennis L. Andress, Steven E. Marx, Raimund Sterz (1) Ars Accessus Medica, Erasmus University, Rotterdam, The Netherlands, (2) Abbott, Abbott Park, IL, USA, The objective of this study was to determine the health economic impact of paricalcitol versus standard non-selective Vitamin D receptor activators (VDRA) treatment for secondary hyperparathyroidism in patients with chronic kidney disease (CKD) in the US. A Markov process model was developed employing data sources from the published literature, paricalcitol clinical trials, and national population statistics. The comparator was calcitriol, a non-selective VDRA medication. The primary perspective of the study was that of the third party payor. The outcomes in the paricalcitol clinical trials and observational studies (reduction SHPT, reduction proteinuria, complications and mortality) were extrapolated to number of life years gained (LYG) and number of qua lity-adjusted life-years (QALYs). Clinical and economic outcomes were discounted at 3.5%. The base case analysis is based on a 10-years time horizon and is based on a comparison of paricalcitol with a non-selective VDRA, which is started in CKD 3 and continued in CKD 4 and CKD 5. The use of paricalcitol leads to a reduction in medical cost of $2,528 and an increase in LYG (0.47 years) and a gain in QALYs (0.43). Consequently the use of paricalcitol result is a dominant strategy, costing less and more effective, from the primary perspective of the US third party payor. The incremental cost-effectiveness ratio remained dominant from the perspective of the society after inclusion of indirect costs. One-way sensitivity analyses and probabilistic sensitivity analyses confirmed the robustness of the model. The results showed that the favorable clinical benefit of paricalcitol results in positive health economic benefits in CKD Stages 3, 4 & 5. This study suggests that the use of paricalcitol in patients with early CKD may be cost-effective from a third party payor perspective when compared to standard non-selective VDRA medication.

The Burden of Testosterone Deficiency Syndrome in Adult Men: Economic and Quality-of-Life Impact

Testosterone deficiency syndrome (TDS) causes a wide range of symptoms that can lead to significant morbidity. Preliminary evidence has also linked TDS with premature mortality and with a number of comorbid diseases including diabetes and metabolic syndrome. Such associations can lead to substantial economic and quality-of-life implications, the magnitude of which remains largely unknown. To review the economic and quality-of-life consequences of a largely untreated condition and to consider the likely health economic benefits of testosterone treatment. A systematic review of four main areas: epidemiological evidence of the magnitude of TDS, estimates of cost of illness, impact on quality-of-life, and cost-effectiveness of testosterone treatment. Review of peer-reviewed literature. The lack of clear universally accepted diagnostic criteria and the uncertainty surrounding the link between TDS and some of its consequences complicate the estimation of the burden of illness of TDS. Consequences of TDS that potentially lead to increased economic burden include depression, sexual dysfunction, mild cognitive impairment, osteoporosis, cardiovascular disease, and mortality. However, although good evidence exists demonstrating an association between TDS and sexual dysfunction and cognitive impairment, evidence is less strong for depression, the incidence of fractures and mortality, and highly controversial for cardiovascular disease. The consequences that are likely to impact on patients' quality of life include sexual function, energy levels, body composition, mood, and cognitive function. Understanding the burden is only the first step decision makers need to take to decide whether to allocate scarce resources to treat the condition. To make informed decisions on when and who to treat information is also needed on the cost-effectiveness of available treatments. Such data would highlight the benefits of treatment of TDS to physicians, patients, and to society as a whole.

Prophylactic HPV vaccines

The HPV L1 VLP vaccines are immensely important developments in public health and the benefits that they promise are immense, offering the opportunity to prevent, in the long term, 80% of cervical cancers, 60% of vulval cancers and 80% of anal cancers in women. In the short to medium term they will prevent at least 90% of genital warts and have a major impact on the incidence of high grade CIN, thus reducing the number of women who have to undergo LEEP and LLETZ. The health economic benefits will be substantial but the overwhelming benefit is the major improvement for human health and well-being. (

Efficient computation of partial expected value of sample information using Bayesian approximation

We describe a novel process for transforming the efficiency of partial expected value of sample information (EVSI) computation in decision models. Traditional EVSI computation begins with Monte Carlo sampling to produce new simulated data-sets with a specified sample size. Each data-set is synthesised with prior information to give posterior distributions for model parameters, either via analytic formulae or a further Markov Chain Monte Carlo (MCMC) simulation. A further ’inner level’ Monte Carlo sampling then quantifies the effect of the simulated data on the decision. This paper describes a novel form of Bayesian Laplace approximation, which can be replace both the Bayesian updating and the inner Monte Carlo sampling to compute the posterior expectation of a function. We compare the accuracy of EVSI estimates in two case study cost-effectiveness models using 1st and 2nd order versions of our approximation formula, the approximation of Tierney and Kadane, and traditional Monte Carlo. Computational efficiency gains depend on the complexity of the net benefit functions, the number of inner level Monte Carlo samples used, and the requirement or otherwise for MCMC methods to produce the posterior distributions. This methodology provides a new and valuable approach for EVSI computation in health economic decision models and potential wider benefits in many fields requiring Bayesian approximation.

387 PUBLICATION Potential health economic benefits of adjuvant (A) trastuzumab (H) therapy of node-positive (N+) her-2+breast cancer (BC)

Steven L. Lansman, MD, PhD, Westchester Medical Center, Valhalla, NY.Wilson Y. Szeto, MD, Hospital of the University of Pennsylvania, Philadelphia, Pa; Giampiero Esposito, MD, Department of Cardiovascular Disease, Cliniche Humanitas, Gavazzeni, Bergamo, Italy; Niels Rahe-Meyer, MD, Clinic for Anesthesiology and Intensive Care Medicine, Franziskus Hospital Bielefeld, Germany; Ourania Preventza, MD, Division of Cardiothoracic Surgery, Department of Surgery, Baylor College of Medicine, Texas Heart Institute at St. Luke's Episcopal Hospital, Houston, Texas; Eric E. Roselli, MD, Cleveland Clinic, Cleveland, Ohio; G. Chad Hughes, MD, Duke University, Durham, NC; Toru Kuratani, MD, Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan; Santi Trimarchi, MD, Thoracic Aortic Research Center, IRCCS Policlinico San Donato, Milano, Italy; Marco Di Eusanio, MD, Departments of Cardiac Surgery, S. Orsola-Malpihgi Hospital, Bologna, Italy.

Risk‐cost‐benefit analysis of atrazine in drinking water from agricultural activities and policy implications

This study provides an improved methodology for investigating the trade‐offs between the health risks and economic benefits of using atrazine in the agricultural sector by incorporating public attitude to pesticide management in the analysis. Regression models are developed to predict finished water atrazine concentration in high‐risk community water supplies in the United States. The predicted finished water atrazine concentrations are then used in a health risk assessment. The computed health risks are compared with the total economic surplus in the U.S. corn market for different atrazine application rates using estimated demand and supply functions developed in this work. Analysis of different scenarios with consumer price premiums for chemical‐free and reduced‐chemical corn indicate that if the society is willing to pay a price premium, risks can be reduced without a large reduction in the total economic surplus and net benefits may be higher. The results also show that this methodology provides an improved scientific framework for future decision making and policy evaluation in pesticide management.

Natural history and screening model for high‐risk human papillomavirus infection, neoplasia and cervical cancer in the Netherlands

A simulation model is presented that assumes that persistent infection with high-risk human papillomavirus (hrHPV) is a necessary cause of cervical cancer. For the estimation of the model parameters, data of recent Dutch follow-up studies were reanalyzed. The predicted incidences of cervical cancer, cervical intraepithelial neoplasia (CIN1, CIN2 and CIN3) and abnormal cytology were validated with nationwide figures and population-based screening results. The model predicted a lifetime risk for cervical cancer of 2.9% with a peak at age 48 years. The predicted lifetime risk dropped to 0.4% when attending cervical screening. For women who were not hrHPV infected at 30 years, the lifetime risk was 1.6%. Sensitivity analyses were performed to check natural history assumptions that were only weakly identified from available data sets. The incidence of CIN3 observed with screening appeared a useful clinical end point as the predicted incidence was robust against changes in the sensitivity of cervical cytology and the duration to CIN3. The model can be used to study the health-economic benefits that can be achieved in nationwide screening when including an hrHPV test.

Immunotherapy with autologous tumor cell-BCG vaccine in patients with colon cancer: a prospective study of medical and economic benefits

We have completed a multicenter, randomized controlled phase III clinical trial in Stages II and III colon cancer patients with active specific immunotherapy (ASI) using autologous tumor cells with an immunomodulating adjuvant bacillus Callmette-Guérin (BCG) vaccine (OncoVAX ®) in an adjuvant setting. In this study, patients were randomized to receive either OncoVAX ® therapy or no therapy after surgical resection of the primary tumor and stratified by stage of disease. Since the biologic essence of the effective tumor immunotherapy is the presence in the vaccine of a minimum number of viable, metabolically active, autologous tumor cells, the processing of the vaccine product, occurred within 48 h after surgery. Analysis of prognostic benefit in the pivotal phase III trial, with a 5.8 year median follow-up, showed that a beneficial effect of OncoVAX ® is statistically significant for all endpoints including recurrence-free interval, overall survival, and recurrence-free survival in Stage II colon cancer patients. Surgery alone cures approximately 65% of Stage II (Dukes B 2, B 3) colon cancer patients. In the remaining patients, OncoVAX ® in an adjuvant setting, significantly prolongs recurrence-free interval (57.1% relative risk reduction) and significantly improves 5-year overall survival and recurrence-free survival. No statistically significant prognostic benefits were achieved in Stage III (Duke's C 1–C 3) patients. A health economics assessment was performed on these results in Stage II colon cancer patients using disease-free survival and overall survival (for the entire intent-to-treat population). Cost-effectiveness, cost-utility and sensitivity analysis were applied with, cost of life years, recurrence-free life years and quality adjusted life years (QALYs) as the primary endpoints to this analysis. The perspective of the economic analysis was the current direct medical cost established by the health care providers. The introduction of new technologies often leads to additional costs. This report verified that the use of OncoVAX ® for patients with Stage II colon cancer not only has significant prognostic benefit and positive clinical outcomes, but also showed that OncoVAX ® therapy yields impressive health economics benefits.

MORTALITY, MORBIDITY, AND ECONOMIC CONSEQUENCES OF FOSSIL FUEL-RELATED AIR POLLUTION IN THREE LATIN AMERICAN CITIES

ISEE-80 Introduction: Rapidly developing regions often face critical air pollution problems due to the high concentrations of pollutants and the large number of people exposed. Decision-making regarding pollutant emissions, such as greenhouse gases, will affect long-term health through climate change, but also short-term health through more immediate changes in local pollution levels. We investigated the health and related economic benefits of modest changes in fossil for three case study cities in Latin America. Methods: We estimated the air pollutant concentrations of particulate matter and ozone for two “what if” scenarios for each of three case study cities (Mexico City; Santiago, Chile; and São Paulo, Brazil) from 2000 to 2020. The first scenario was based on current patterns of pollution (business-as-usual), whereas the second scenario assumed control policies to lessen ambient pollution emissions, such as those for carbon dioxide, methane, and other greenhouse gases. These concentrations were combined with locally-derived concentration-response functions to estimate the difference in health impacts for the two scenarios. Economic valuation of the difference in health endpoints is used to determine the health-related cost benefit of the lower emissions. Results: This research reveals that additional controls on fossil fuel would have enormous health benefits for Mexico City, São Paulo, and Santiago, averting about 32,000 deaths, 5 million asthma attacks, 200,000 child medical visits, and 50,000 cases of chronic bronchitis in the three cities over the 20 year period. Preliminary results indicate that in the year 2020 alone, the lowered pollution levels would prevent approximately 8,700 children’s medical visits in São Paulo, 80,000 asthma attacks in Mexico City, and 700 chronic bronchitis cases in Santiago. These and related health effects will be monetized to put the health-related economic benefits of lower emissions in perspective. Discussion: This work emphasizes the need for diligence regarding air pollution’s health effects and for attention to the local, short-term benefits of climate change mitigation strategies. This research demonstrates the magnitude of health advantages of modest control policies.

Memantine (Ebixa) in the later stages of dementia.

Memantine is the first agent licensed for the treatment of moderate to severe Alzheimer's disease. It is an N-methyl D-aspartate (NMDA) receptor antagonist which reduces glutamatergic excitotoxicity. Benefits are seen in cognitive, functional and global measures in both outpatients and nursing home residents. Prospective health economic benefits have been reported.

Cost-Effectiveness of Enoxaparin as Thromboprophylaxis in Acutely Ill Medical Patients in Spain

Objective The objective of this study was to determine the cost-effectiveness of thromboprophylaxis with enoxaparin versus no thromboprophylaxis in patients with acute medical illness in Spain from the society perspective. Methods Markov process analysis techniques were used to model the health economic outcomes. Clinical data were derived mainly from the MEDENOX trial, while health-care utilization was derived from Delphi panels. Results An analysis over the MEDENOX trial period shows that the cost per event avoided is ¤432, while the cost per life saved is ¤1527. The cost per event includes all medical resource utilization costs associated with the event. The lifetime model, which assumes no higher risk for recurrence of venous thromboembolism (VTE) and mortality in asymptomatic patients, shows that the use of enoxaparin leads a cost per event avoided of ¤270 and cost per life-year gained of ¤71. If the lifetime model assumes a higher risk for recurrence of VTE in asymptomatic patients, enoxaparin is dominant over no thromboprophylaxis. Conclusion The results showed that the favorable clinical benefit of enoxaparin as thromboprophylaxis in patients with acute medical illness, which was observed in the MEDENOX trial, results in a positive health economic benefit in both the short term and the long term in the health-care setting of Spain.

You Are What You Eat: Genetically Modified Foods, Integrity, and Society

Thus far, the moral debateconcerning genetically modified foods (GMF) hasfocused on extrinsic consequentialist questionsabout the health effects, environmental impacts,and economic benefits of such foods. Thisextrinsic approach to the morality of GMF isdependent on unsubstantiated empirical claimsand fails to account for the intrinsic moralvalue of food and food choice and theirconnection to the agent's concept of the goodlife. I develop a set of objections to GMFgrounded in the concept of integrity andmaintain that food and food choice can beintimately connected to the agent's personalintegrity. I argue that due to the constitutionof GMF and the manner in which they areproduced, such foods are incompatible with thefundamental values and integrity of certainindividual moral agents or groups. I identifythree types of integrity that are threatened byGMF: religious, consumer, and integrity basedon certain other moral or metaphysical grounds.I maintain that these types of integrity aresufficiently important to provide justificationfor political and societal actions to protectthe interests of those affected. I conclude byproposing specific steps for handling GMFconsistent with the moral principles ofinformed consent, non-maleficence, and respectfor the integrity of all members of society.They include mandatory labeling of GMF, theimplementation of a system for control andregulations concerning such foods, andguaranteed provision of conventional foods.

FSH response-dose can be predicted in ovulation induction for normogonadotropic anovulatory infertility.

To evaluate the ability of a prediction model to identify the individual starting dose of FSH for ovulation induction using a step-down regimen. Retrospective analysis of clinical data in an academic fertility unit. Fifty-six normogonadotropic anovulatory infertile patients who failed to ovulate or conceive with clomiphene citrate were included. They were treated with exogenous gonadotropins with a flexible starting dose for ovulation induction using a step-down regimen. The clinically applied starting dose of exogenous gonadotropins was compared with the calculated response-dose using a previously published prediction model. Patients were arbitrarily divided into three groups according to the day of the first decrease in gonadotropin dose: (a) early step-down (day 3 or earlier); (b) standard step-down (day 4 or later); (c) no step-down. These groups had average starting doses of 28.5 IU (group a) and 13 IU (group b) above the calculated response-dose, and 43 IU (group c) under the calculated response-dose. A significant correlation between day of first step-down and the difference between clinically applied and calculated response-dose was observed (P<0.0001, F-test for ANOVA). The patient group with the best step-down profile for ovulation induction exhibited the closest match between the clinically applied and calculated starting dose of gonadotropins. Therefore, this study provides support for the concept that the individual effective FSH starting dose for gonadotropin induction of ovulation in anovulatory infertile patients can be predicted on the basis of initial screening characteristics, such as body mass index, clomiphene resistance or failure, free IGF-I and FSH. This may result in more effective patient treatment protocols, reduced complication rates and health-economic benefits.