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189Forêt en Fête 2012 : les trésors de nos forêts

le 16/05/2012 à 9:36 par Etienne - Vosges

A la Communauté de Communes du Canton de Brouvelieures, avec les organisateurs de la manifestation "forêt en fête" nous avons présenté officiellement l'affiche et le programme de Forêt en Fête 2012 dont le thème cette année porte sur les "Trésors de nos Forêts". Comme l'année dernière, le dessinateur Hughes Fertin s'est attelé à la confection du graphisme de l'affiche reconnaissable entre toutes et mettant en avant les ressources procurées par les forêts des massifs vosgiens: bois d'oeuvre, petits fruits, champignons, nature remarquable,... Tout autant de trésors que les 3 jours de la manifestation mettront à l'honneur. Cela démarrera sur les chapeaux de roues avec la soirée-concert organisée au Haut-Fer de Brouaumont par l'association SEMER: le duo d'accordéonistes EXPIRE mettra assurément l'ambiance! Les samedi et Dimanche, le Moulin de Frémifontaine accueillera toute la journée les artisans, producteurs locaux et les animations sur la filière bois/forêt chère à ce canton . La soirée du samedi se déroulera à la salle de Domfaing avec un concert de Taenn, musique celtique entre Bretagne et Irlande.

Mobilisant de nombreux bénévoles sans qui rien ne serait possible, "forêt en fête" valorise l'atout principal de notre territoire, à savoir la forêt, qui fait nos paysages, une bonne part de notre activité économique, mais aussi notre attractivité touristique et de loisirs. Ce grand rendez-vous annuel qui a reçu plus de 1 000 visiteurs l'an passé est un moment familial et ludique pour tous et en accès libre.

la Communauté de Communes réalise cette animation en partenariat avec les associations, les entreprises du canton  qui en est déjà à sa troisième édition ! Rendez-vous les 1er, 2 et 3 Juin en vallée de la Mortagne !!


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After 17 months of hearings, in which pharmaceutical executives were openly berated for profiteering and doctors were portrayed as dupes of pharmaceutical companies' marketing departments, Kefauver presented his bill, S.1552. Perhaps its least controversial components were its calls for ensuring that the FDA review claims of efficacy before drug approval, monitor pharmaceutical advertising, and ensure that all drugs had readable generic names. More radically, Kefauver proposed completely overhauling the relationship between patents and therapeutic innovation. First, he proposed a compulsory licensing provision so that all important new drugs would generate competitive markets after 3 years. Second, and more controversial still, Kefauver wanted to eliminate “me-too drugs” and “molecular modifications” by insisting that a new drug be granted a patent only if it produced a therapeutic effect “significantly greater than that of the drug before modification.”1 Proving that a drug worked, according to Kefauver, was not enough: he wanted proof that a drug worked better than its predecessors. In contemporary terms, he wanted to know its comparative effectiveness.
These numbers may not fully capture the reasons why a device reaches the market more quickly in one country than in another and do not reflect experiences with all innovative, high-risk devices. However, unless one uses equivalent standards in terms of the level of risk, the start and end points of the process, and the key end point of market access, accurate comparisons cannot be made.
The GSK corporate integrity agreement does include some provisions that attempt to change corporate culture. First, GSK must revise its compensation systems to “ensure that financial incentives do not inappropriately motivate” sales representatives; these changes include new restrictions on compensation for off-label promotion. GSK has now implemented a program to eliminate incentive-based compensation for sales representatives based on “territory/individual level sales goals,” which will alter the financial incentives for sales representatives who meet with physicians. Second, GSK senior executives and other employees who are paid bonuses and other compensation may in the future be asked to repay those amounts if certain types of fraudulent behavior occur that violate the corporate integrity agreement. As has been noted in the financial press, this requirement does nothing to recoup several substantial recent bonuses given to senior management at such firms,2 but it does make it more difficult to repeat the practice, at least at GSK. Third, in view of the serious questions about failure to report negative data related to Avandia's safety, GSK must commit itself to “research and publication practices” designed to make more clinical trial information available to clinicians and regulators. These commitments have several disturbing exceptions: GSK will “generally” seek publication for research results, and summaries of clinical trial data will be posted on a clinical study register “with rare exception.” These are but partial steps toward transparency.
Inappropriate formulations and packaging may contribute to low adherence, medication errors, and safety and efficacy problems. Additional considerations for a largely elderly population will include the need for easy administration, possible dose reduction, the effects of visual and motor impairment, and the likelihood of polypharmacy. If appropriate, protocols should be designed for evaluating patients' ability to manage their own medications. Regulators should also look favorably on nondrug technologies such as information and communication technology systems for monitoring adherence or clinical signs.
Kefauver's bill met strong resistance as it made its way through the Subcommittee on Antitrust and Monopoly.2 The American Medical Association firmly opposed the regulation of efficacy by a government agency, arguing that “the only possible final determination as to the efficacy and ultimate use of a drug is the extensive clinical use of that drug by large numbers of the medical profession over a long period of time.”3 The editors of the Journal, on the other hand, supported the efficacy provision and the expansion of generic drug names but opposed the patent provisions (considering them an “arbitrary discrimination” against the pharmaceutical industry) and the comparative effectiveness provisions (considering “proof of superiority” necessary only if superiority was actually being “claimed by the manufacturer”).4 The pharmaceutical industry amplified such concerns about comparative effectiveness, arguing that any a priori determination of which medicines were “me-too” and which were true innovations would be arbitrary. Efficacy was hard enough to prove, they suggested; proving comparative efficacy would be “completely impracticable.”3
It's important to provide adequate information to patients and prescribers. That's impossible if there are no good data, but sometimes data included in a drug-development dossier are not adequately reflected in the approval documents. There must be greater focus on the package insert, the regulatory document most widely referred to by the public, which must do a better job of explaining how to take the medication, whether dosage adjustments are advised for older patients, and what is known about use with concomitant medications.
In a 2012 observational study involving Tennessee Medicaid patients, Ray et al.1 quantified the risk of death from cardiovascular causes associated with azithromycin as compared with other antibacterial drugs or nonuse. The study showed that the risks of death, both from any cause and from cardiovascular causes, associated with azithromycin were greater than those associated with amoxicillin. For every 21,000 outpatient prescriptions written for azithromycin, one cardiovascular death occurred in excess of those observed with the same number of amoxicillin prescriptions. The excess risk over amoxicillin varied considerably according to cardiovascular risk factors; the researchers estimated that there was one excess cardiovascular death per 4100 prescriptions among patients at high cardiovascular risk but less than one per 100,000 among patients with lower cardiovascular risk.
Within a year after gaining approval at the end of 2006, Budeprion XL 300 mg became the subject of intense media coverage describing adverse events in patients being treated for major depressive disorder who had switched to the generic drug from Wellbutrin XL. Approval of Budeprion XL 300 mg was based on the results of a bioequivalence study of Budeprion XL 150 mg and Wellbutrin XL 150 mg, which were extrapolated to the 300-mg product. Our new data provide direct comparative pharmacokinetic analyses of the 300-mg products.
For both private and public systems in the United States, the pathway to patient access to a device starts with the submission of an application to the FDA. The FDA reviews innovative, high-risk devices for safety and effectiveness (clinical benefit) under the premarket approval (PMA) process, and information on the duration of reviews is publicly available. In fiscal year 2011, the FDA approved 40 applications for PMA. The average review time was 13.1 months, with 8.4 months attributed to FDA review time, and 4.7 months to the time the agency waits for the sponsor to address deficiencies in the application (“sponsor time”).3 CMS provides reimbursement for the majority of devices when they earn FDA approval. For a limited number of devices each year, however, CMS conducts a national coverage determination in response to external requests for validation or for devices that have limited or conflicting evidence of clinical benefit. This process averaged 8.6 months over the past 5 fiscal years.4 Although it is difficult to obtain data on how long private insurers take to make coverage decisions, anecdotal information from private insurers suggests that decisions are made within a few weeks to a few months after FDA approval, depending on the amount and quality of evidence of clinical benefit.
Finally, these types of fraud are hard to detect from the outside. Internal documents are often critical to these cases. Most of the time, these documents are provided by internal whistleblowers. In a recent survey, researchers identified several ways in which the whistleblower provisions of the False Claims Act could be strengthened to encourage whistleblowers to come forward and to protect them from retaliation.5 Whistleblowers should be encouraged, not punished for their testimony.
The long delay between the approval of Budeprion XL 300 mg in late 2006 and the appearance of the bioequivalence results reported here, during which the product remained listed by the FDA as a generic substitute for Wellbutrin XL 300 mg, is problematic. Because of the risk of seizure associated with high doses of bupropion, the agency initially took a conservative approach to trial design. Today, the FDA has greater understanding of the risk of seizure with bupropion. At the time of the sponsor's 2007 study, some critics considered its design to be flawed. The results of the recent study by the FDA show that a design entailing the enrollment of a more accessible trial population might well have brought the bioequivalence data to light sooner. In retrospect, the conservative approach did not provide the right conclusions regarding therapeutic equivalence in a timely manner.
The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), carried out at more than 20 sites between 2004 and 2009, sought to identify, in infants born very prematurely at 24 to 27 weeks' gestation, the oxygen-saturation level within the range considered the standard of care that would minimize the risk of retinopathy of prematurity (ROP), a complication of oxygen therapy that can result in vision loss.2 When the study began, targeting an oxygen-saturation range of 85 to 95% was becoming standard clinical practice, and the American Academy of Pediatrics (AAP) later recommended this range in its 2007 guidelines. The SUPPORT researchers and institutional review boards (IRBs), practicing clinicians, and the AAP had no scientific evidence to expect a difference in mortality between the two treatment groups in SUPPORT — one with the oxygen saturation target of 85 to 89%, the other with the target of 91 to 95%.
These measures can certainly be improved. For one thing, though all these provisions seem advisable, they are imposed only under a corporate integrity agreement, as opposed to official regulations, and expire in 5 years. Legislative reformers should consider whether the entire industry should be regulated on a level playing field, as opposed to through piecemeal agreements. In addition, individuals must be held responsible in appropriate circumstances. Models might include federal tax law, under which directors and officers of nonprofit corporations cannot be indemnified against fines imposed on them as individuals for particularly egregious violations.3 Key leaders can also be excluded from participation in federal health programs. The academic researchers involved in the controversy regarding the safety data for Avandia has thus far escaped sanctions as well.4
Fifty years ago this month, President John F. Kennedy signed into law the Kefauver–Harris Amendments to the Federal Food, Drug, and Cosmetic Act (see photoPresident John F. Kennedy Signing the 1962 Kefauver–Harris Amendments.). With the stroke of a pen, a threadbare Food and Drug Administration (FDA) was given the authority to require proof of efficacy (rather than just safety) before approving a new drug — a move that laid the groundwork for the phased system of clinical trials that has since served as the infrastructure for the production of knowledge about therapeutics in this country. We often remember the Kefauver–Harris Amendments for the thalidomide scandal that drove their passage in 1962. But there is much we have collectively forgotten about Senator Estes Kefauver (D-TN) and his hearings on administered prices in the drug industry. Many parts of the bill left on Congress's cutting-room floor in 1962 — and left out of our memories since — have not disappeared but continue to confront those who would ensure access to innovative, safe, efficacious, and affordable therapeutics.
The Food and Drug Administration (FDA) has completed a head-to-head bioequivalence study of single doses of the generic drug Budeprion XL 300 mg (extended-release bupropion hydrochloride, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals) and the brand-name drug Wellbutrin XL 300 mg (Biovail). The agency has concluded that Budeprion XL 300 mg cannot be considered therapeutically equivalent to the brand-name product. We at the FDA are therefore changing our bioequivalence recommendations for extended-release bupropion products and have asked other manufacturers of 300-mg extended-release bupropion products to conduct additional bioequivalence studies.
After the approval of Budeprion XL, the Tmax disparity between Budeprion XL 150 mg and Wellbutrin XL 150 mg remained a source of concern. This concern, along with the reports that began surfacing after initial marketing of Budeprion XL 300 mg, prompted the FDA to recommend, in November 2007, that the sponsor conduct a clinical comparison with the 300-mg product. The FDA believed that the most appropriate population for this study would be patients who had reported a lack of efficacy or unwanted side effects after switching from Wellbutrin XL 300 mg to Budeprion XL 300 mg; the protocol therefore stipulated the enrollment of such patients. By early 2008, the sponsor had begun preparing to conduct the recommended study. Unfortunately, the study was terminated because of an inability to enroll a sufficient number of patients who met the entry criteria.
In Europe, by contrast, most of the 27 member countries of the European Union (EU) have publicly financed health care systems; such systems cover approximately four fifths of the populations of the four largest device markets. All EU countries require devices to first obtain a Conformité Européenne (CE) marking, which refers to a symbol shown on products that indicates market approval throughout the EU. The CE marking process is conducted by for-profit, third-party “notified bodies” that have been accredited by a member country to assess device safety and performance but do not evaluate effectiveness (which requires more clinical data). Although publicly available data are limited, anecdotal information from notified bodies suggests that the process takes 1 to 3 months, excluding sponsor time.
In 2011, approximately 40.3 million people in the United States (roughly one eighth of the population) received an outpatient prescription for the macrolide azithromycin, according to IMS Health. During that year, we at the Food and Drug Administration (FDA) reviewed the labels of azithromycin and other approved macrolide antibacterials in view of cardiovascular risks that had become evident from published studies and reports emerging through postmarketing surveillance. On the basis of its review, the FDA approved revisions to azithromycin product labels regarding risks of QT-interval prolongation and the associated ventricular arrhythmia torsades de pointes. The revised labels advise against using azithromycin in patients with known risk factors such as QT-interval prolongation, hypokalemia, hypomagnesemia, bradycardia, or use of certain antiarrhythmic agents, including class IA (e.g., quinidine and procainamide) and class III (e.g., dofetilide, amiodarone, and sotalol) — drugs that can prolong the QT interval. In March 2013, the FDA announced that azithromycin labels had been further revised to reflect the results of a clinical study showing that azithromycin can prolong the corrected QT interval.
A 400-Gram Female Infant Delivered at 24 and 4/7 Weeks.
To further illustrate this point, we compared the time to approval for five innovative, high-risk medical devices available in France, Italy, and the United States (see tableComparison of Time to Market Access for Five Innovative Devices in France, Italy, and the United States.). These case studies indicate that the average time to market access for these devices was 26.3 months in France, 30.8 months in Italy, and 15.3 months in the United States.

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