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Official websites use. Share sensitive information only on official, secure websites. Competing Interests: The authors have declared that no competing interests exist. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. This study updates the cost-effectiveness analysis of this novel therapy using data from a new phase 3 trial, including the incremental cost-effectiveness of the more intensive phase 3 regimen compared with the shorter phase 2 regimen. Inputs were based on trial results and published literature. The primary outcome was assessed 8 weeks after the final experimental session. Patients received three minute preparatory psychotherapy sessions, three 8-hour active MDMA or placebo sessions, and nine minute integrative psychotherapy sessions. We reported results from the U. Costs were adjusted to U. A third MDMA session generates additional medical savings and health benefits compared with a two-session regimen. PTSD is also associated with a wide range of comorbid health conditions. In addition to the direct human toll, PTSD imposes a large economic burden on the country in added health care costs \[ 2 \] lower productivity, and higher rates of unemployment \[ 3 \]. The need for more effective treatments is widely acknowledged. Six phase 2 randomized, placebo-controlled, multi-site clinical trials sponsored by the Multidisciplinary Association for Psychedelic Studies MAPS , tested the safety and efficacy of a novel therapy assisted by 3,4-methylenedioxymethamphetamine MDMA. An additional portion exhibited clinically significant improvement, though still met criteria for PTSD. Payers would break even in a little over three years \[ 7 \]. Cost-effectiveness is important in the coverage deliberations of third party payers, both private insurers and governmental payers such as the Veterans Administration, Medicare, and Medicaid. In view of the likely approval by the U. By reassessing cost-effectiveness, this article is intended to support the insurance and policy planning process. We adapted a previously published decision analytic model to portray clinical benefits, MDMA-AT costs, and net medical costs in a hypothetical cohort of 1, patients reflecting the distribution by PTSD severity of 90 patients treated in the MAPS-sponsored randomized, placebo-controlled, multi-site phase 3 trial, enrolled between November and May, \[ 8 \]. Patients were portrayed in a Markov process as asymptomatic, or suffering from mild, moderate, severe, or extreme PTSD. Mortality by PTSD severity category and medical costs were estimated from published literature. Model input values are summarized in Table 1. PTSD severity of all subjects was severe or extreme at baseline. The mean age was Females constituted These patients had received a heterogeneous mix of treatments for PTSD prior to enrollment in the trial. With regard to non-pharmacological interventions, Only 2. Following recruitment, randomization, and three non-drug minute therapy sessions, participants received blinded doses of an inert placebo or active doses of MDMA. Three minute psychotherapeutic integration sessions were providing following each experimental session. The first was provided on the morning after the experimental session and the remaining two were provided over the following three to four weeks. All sessions were conducted with two therapists formally trained in psychedelic-assisted psychotherapy. Further details on the protocol are provided elsewhere \[ 8 \]. Because the control condition does not represent a feasible treatment option, we modeled the costs and benefits of the active treatment group after receiving MDMA-AT with the same group at baseline assuming no change in their treatment. Other key features of the model are described in the earlier publication \[ 7 \] and summarized here:. Patients transitioned to death according to the relative risk of mortality by severity category. Thus, the intervention effect is captured as the difference between baseline and follow-up in the distribution of patients by severity categories. This approach comports with a follow-up study of 19 subjects who completed the phase 2 trials and showed a modest, statistically insignificant improvement in PTSD at No improvement or remission is also consistent with the stable clinical status of the patients in this trial who suffered from PTSD for an average of The EQ-5D-5L EuroQol questionnaire was administered to the phase 3 but not phase 2 trial participants, and scores were converted to utilities as used in QALY assessments according to the methods outlined in a study designed specifically to convert EQ-5D-5L scores from the United States into utility measures \[ 15 \]. Adverse events associated with the trial were transient \[ 8 \] and are not reflected in the current analysis. Using micro-costing to obtain service delivery costs, Current Procedural Terminology codes were assigned to each MDMA-AT activity and costed according to the average in-provider-network cost in eight metropolitan areas provided by FAIR Health Consumer \[ 16 \] or by Medicare allowable reimbursement \[ 17 \]. Details are provided in eMethods B. PTSD is associated with higher mental health and general medical care costs, and costs increase with severity \[ 18 \]. By applying the medical care component of the Consumer Price Index CPI for \[ 19 \], we updated our previous estimate of all-cause medical costs borne by U. Our treatment of relative mortality risk, analytic time horizons, and the specification of outcomes are unchanged from the previous analysis and are summarized here: Using the age-specific background U. The base-case analysis projects costs and health consequences to 30 years. We also report on results at 1 and 10 years and find the duration of benefits at which net payer costs break-even. In scenarios that do not generate net savings, we calculate the cost per QALY gained. We conducted one-way and multi-way sensitivity analyses to assess variation in findings given parameter value uncertainty. For probabilistic, multi-way sensitivity analyses, we ran 10, Monte Carlo simulations with beta distributions specified for probabilities, gamma distributions for costs, and lognormal distributions for relative risks. We specified distribution parameters such that the central tendencies approximate those reported in the source literature when such information was available. Variables included in the simulations were MDMA-AT cost, health care costs, relative mortality risk and utilities, mean patient age and the discount rate. Finally, we calculated an ICER comparing the cost and health consequences of the less intensive and less costly phase 2 protocol featuring two MDMA sessions per patient, with the more intensive phase 3 protocol which includes three MDMA sessions. The remaining 9. See Fig 1. Undiscounted; 3. In one-way sensitivity analyses, net costs are importantly affected by the mean age of the patient cohort, followed by the cost of treating severe and extreme PTSD, and by the relative mortality risk associated with severe and extreme PTSD. See Fig 2. Fig 3 shows the results of a 10, iteration Monte Carlo scenario analysis which, in addition to variation in the other variables shown in Table 1 , allows for annual risk of progression to the next more severe category of PTSD to range from 0. In each of the longer analytic time horizons, the comparative benefits of the phase 3 protocol become progressively greater, and is the dominant option. See Table 3. To facilitate comparisons, QALYs reflect the same utility values for PTSD used in the present study rather than the values used in the analysis based on the pooled phase 2 results Marseille ; 2. This study of the cost-effectiveness of MDMA-AT provided to severely-affected PTSD patients using recently-published phase 3 trial data strengthens the broad conclusion of an earlier article based on pooled phase 2 data: Access to MDMA-AT by this group of patients would save the health care system money while generating substantial health benefits \[ 7 \]. The results of the two studies vary in consequential ways. Most importantly, the clinical benefit of the phase 3 trial surpassed that of the phase 2 trials: At the primary endpoint, The number of averted deaths is also higher in the current study, However, the overall estimated health benefits over 30 years measured in QALYs was higher in the previous study, 5, versus 4, This paradoxical-seeming result is due to the improved methods of measuring health-related utility employed in the current study. In the previous analysis, based on the phase 2 results , the best available estimates of utility associated with PTSD were not well-stratified by severity, and were derived from disparate and thus imperfectly-applicable study populations. In the phase 3 trial, by contrast, the EQ-5D-5L survey was administered to participants, and we were able to derive utility estimates using a consistently-applied method in the most directly-relevant patient population. This improved method yielded a different result. Specifically, the utilities associated with less severe PTSD were lower. For example, the difference between mild and extreme PTSD in the earlier study was 0. In the current study the difference is 0. Thus, all else equal, fewer added QALYs are associated with the transition from more severe to less severe PTSD in the context of the current phase 3 study. It is likely that the addition of a third MDMA session is responsible for the greater efficacy seen in the phase 3 trial. Evidence for this can be seen in the large drop in CAPS-5 scores between sessions 2 and 3, from We see a similar proportionate decrease in CAPS-IV scores in the pooled phase 2 analysis among subjects who received a third MDMA session, though this was not a primary outcome due to the cross-over design and lack of control group for the third session \[ 20 \]. Finally, early evidence of enhanced benefit with three MDMA sessions was noted in a small randomized pilot study in which a statistically significant difference in CAPS scores was found between MDMA sessions 2 and 3 \[ 21 \]. Taken together, these findings provide substantial evidence of the incremental benefit and the favorable ICER of the three-session regimen. The phase 3 trial utilized a centralized assessment core. The dynamic between a participant and study team is complex; thus, the use of a centralized pool of assessors across all phase 3 study sites may have removed subtle biases present in the phase 2 data. An additional strength of this study is the estimation of utilities using EQ-5D-5L data drawn directly from the trial subjects. The sensitivity and scenario analyses may also reinforce confidence in the validity of these findings. Similarly, data are not yet available on the durability of MDMA benefits beyond 3. The demographic composition of the trial patients is weighted toward better-educated and white people. Just as caution should be exercised in extending the effectiveness results to the general U. It reinforces and extends earlier findings that this intervention is likely to save lives and reduce morbidity in patients with severe, chronic PTSD, while reducing health care costs. The results of a second MAPS-sponsored phase 3 trial are expected by mid However, broad access and therefore public health impact will depend on the willingness of private and public health care payers to make MDMA-AT available as a benefit to their members. The evidence that they can do so with confidence is now compelling. All of the cost data are publicly available from the sources mentioned in the article. The outcomes data that are not immediately available via published literature are patient-level CAPS score data that we used to classify trial subjects by PTSD severity categories. The data that support the findings of this study are available from the sponsor MAPS. However, restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Dec 20 PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone plos. A rebuttal letter that responds to each point raised by the academic editor and reviewer s. You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. In addition to carefully revising your manuscript based on reviewer comments, please consider the following:. Kindly ensure that your abstract provides the following information: Perspective of the analysis, the country you are estimating the cost-effectiveness from, time horizon you mentioned multiple, which time horizon was used for the base case analysis? I see 30 years was used in sensitivity analyses and I am assuming that was the horizon for your base case , discounting rate used, and cost year are cost estimates based on dollar value as indicated in the main manuscript? In table 1, under the column named 'Value,' consider clarifying what you are reporting in parenthesis as some readers without hands-on experience with modeling cost-effectiveness can get confused. All acronyms in tables or figures should be defined in a table footnote or figure legend caption. Your QALY estimates look too high. Is it common in PTSD treatments? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception please refer to the Data Availability Statement in the manuscript PDF file. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e. PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. Please upload your review as an attachment if it exceeds 20, characters. Reviewer 1: This updated cost-effectiveness analysis expands upon a previously published study demonstrating that MDMA-AT is not only clinically beneficial for people suffering from severe PTSD but also cost-saving from a payer's perspective. The manuscript is written in a clear and concise manner and it was relatively easy to follow the methods and modelling techniques which are also described in detail in the prior related publication. Table 3 appears to be missing footnotes; should clarify that net cost is savings in red in brackets? What are the limitations of comparing the different methods to measure health-related utility i. Line I was not able to locate the data you were specifying about the 0. I understand it is not shown, and the sentence above it is more significant to the message. I see the figure- But I believe it is implied. Just because it is mentioned again in the conclusion, perhaps another figure or table? Or further explanation for the calculation? Overall, well constructed work and analysis. PLOS authors have the option to publish the peer review history of their article what does this mean? If published, this will include your full peer review and any attached files. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Please log into your account, locate the manuscript record, and check for the action link 'View Attachments'. If this link does not appear, there are no attachment files. To use PACE, you must first register as a user. Registration is free. Please note that Supporting Information files do not need this step. We believe that the article is stronger now as a result of this review process. Each comment is listed below with a description of our corresponding revision. Response: Agree. In addition to the items mentioned above, we re-ordered the sentences in the Methods section of the Abstract so that it flows more logically now. Response: I think that the perceived problem is that these results are for patients. The scale is arbitrary but is often used in CEAs. I mentioned the patients more prominently in the title of Table 3 now. This updated cost-effectiveness analysis expands upon a previously published study demonstrating that MDMA-AT is not only clinically beneficial for people suffering from severe PTSD but also cost-saving from a payer's perspective. As noted in the manuscript, limited existing data on long-term benefits suggests stable and even improving outcomes to 3. The clinical course after that is unknown, but there is no reason to suspect dramatic deterioration of benefit after that time. This scenario is intended to add another illustration of the insensitivity of our results to assumptions about the duration of benefits. For example, for 1, patients, 10 years after the trial, under base-case assumptions, patients would be asymptomatic and 22 would have extreme PTSD. To reinforce just how robust this finding is we added this sentence at around line in the Discussion. Response: Good catch — thanks. In the previous analysis, the best available estimates of utility associated with PTSD were not well-stratified by severity, and were derived from disparate study populations. The phase 3 trial included the EQ-5D-5L survey, and we were able to derive utility estimates using standard methods. However, the utilities associated with less severe PTSD were lower using this more accurate method. For example, we assigned a utility of 1. In the previous analysis based on the phase 2 results , the best available estimates of utility associated with PTSD were not well-stratified by severity, and were derived from disparate and thus imperfectly-applicable study populations. Response: We don't think so. First, the long-term 3. While it is encouraging, it cannot be considered definitive. Second, we can think of no reason that the more favorable results from the three-MDMA-session phase 3 trial regimen should be less durable than the results from the less intensive two-MDMA-session phase 2 trials. To emphasize this point, we changed lines to read as follows. To be clear, we do not mention the 0. An invoice for payment will follow shortly after the formal acceptance. If you have any billing related questions, please contact our Author Billing department directly at authorbilling plos. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress plos. Updated cost-effectiveness of MDMA-assisted therapy for the treatment of posttraumatic stress disorder in the United States: Findings from a phase 3 trial. Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. For more information please contact onepress plos. This section collects any data citations, data availability statements, or supplementary materials included in this article. As a library, NLM provides access to scientific literature. PLoS One. Find articles by Elliot Marseille. Find articles by Jennifer M Mitchell. Find articles by James G Kahn. Ismaeel Yunusa : Editor. Received Jun 7; Accepted Jan 14; Collection date This article has been corrected. See PLoS One. Mild 0. Background mortality 0. Open in a new tab. Click here for additional data file. Find articles by Ismaeel Yunusa. Roles Ismaeel Yunusa : Academic Editor. PMC Copyright notice. Associated Data. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. Test kits, nuclear stress test, carotid ultrasound, pharmacy. Calculated from EQ-5D-5L data collected in the phase 3 trial. Intervention and future medical care costs. Health benefits. Deaths averted 2.

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