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| yusgeTsm | Date: Joi, 2013-07-04, 6:51 PM | Message # 812 |
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| It is difficult to say what should be done to somehow contribute to even a slight improvement in the world order, and we are talking generally about ecology. Although, of course, do not say that if you try a bit, do not we find a solution, which is no problem which will cause the planet we inhabit will be a lot more welcoming. Take into account that even to the most benefit from these new technologies, which are also highly environmentally friendly. Currently places a strong emphasis on the fact that just all kinds of technologies are more environmentally friendly.
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| ledzereflug | Date: Vineri, 2013-07-05, 10:54 PM | Message # 813 |
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| 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
One must, of course, weigh any observed drug-associated risk against clinical benefits, so it's appropriate to consider the possibility that certain offsetting benefits of azithromycin may not have been reflected in the risk data analyzed by Ray et al. For example, other studies have suggested that macrolides have an advantage over other antibacterial agents in terms of overall survival from community-acquired pneumonia. In a recent Canadian observational study, researchers followed 2973 outpatients with community-acquired pneumonia and found significantly lower 30-day mortality among patients receiving macrolides than among those receiving fluoroquinolones (adjusted odds ratio, 0.28; 95% CI, 0.09 to 0.86).2 A recent meta-analysis of observational studies showed a statistically significant 25% difference in mortality among hospitalized patients with community-acquired pneumonia favoring macrolides over nonmacrolide antibacterials.3 Such findings, which must be considered with due regard for the limits of observational studies, do not necessarily contradict the results of Ray et al. Past the 5-day period of risk of azithromycin-associated cardiovascular death, the drug might reduce the longer-term (e.g., more-than-30-day) rate of death due to pneumonia. Pneumonia was an uncommon indication among the Tennessee Medicaid patients treated with azithromycin.
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.
Analysis of the data submitted in support of recent applications for marketing authorization shows that the current regulatory environment has ensured reasonable representation of “younger old” patients, but drug-usage patterns reveal a high prevalence of use in “older old” patients (see graphThe Example of Cardiovascular Drugs: Percentages of All Patients in a Given Age Group Treated with Cardiovascular Drugs (Italy) versus Percentages in Each Age Group Included in Cardiovascular Drug Trials (Globally).). Patients who are 75 years old or older often present a complex picture involving coexisting conditions and frailty: they are the fastest-growing demographic group but are largely underrepresented in clinical trials given their disproportionately high actual use of drugs. This imbalance will make it increasingly difficult and potentially inappropriate to extrapolate data to these patients.2 Though trials are less likely to set unjustified age limits than they were a few decades ago, this improvement must be considered in the context of a rapidly aging population and the continued widespread use of exclusion criteria based on coexisting conditions. Corrective efforts must be maintained to ensure that a representative population of patients covering the entire age range is studied in the preauthorization phase, in accordance with international guidelines.3
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.
The NIH is committed to ensuring that prospective research participants — and the people who speak for and love them — are given clear, complete, and accurate information about the risks and benefits of participating in research. We are strongly committed to supporting critical research studies like SUPPORT, which inform clinical care by providing rigorous evidence for use in daily practice. This controversy has alarmed some of the parents of infants who were in the study, confused the biomedical research community, and befuddled IRBs. Several other studies seeking new insights to improve care for these vulnerable infants have been put on hold as the field tries to understand the OHRP findings.
Although population aging is a mark of the success of public health policies, it also challenges the established way of implementing such policies. In the case of the European Medicines Agency (EMA), it has prompted an analysis of whether the regulatory system is adapted to taking the needs of older people into account in the development, approval, and use of medications.
Chronologic age alone is inadequate for characterizing the population enrolled in a clinical trial. Frailty is a predictor of clinical outcomes,4 and the reduction of frailty has benefits for individuals and society. The EMA is exploring the possibility of reaching a consensus on an operational definition of frailty and tools for evaluating it that could be used for clinical research and to guide therapeutic decisions.
In the Federal District Court in Boston a few days later, GSK pleaded guilty to two criminal counts for sales of misbranded Paxil (paroxetine) and Wellbutrin (bupropion). These drugs are considered misbranded when they are promoted for indications for which they have not been approved by the Food and Drug Administration — the practice commonly known as off-label promotion. Providers cannot be reimbursed for misbranded drugs under federal and state rules. GSK also pleaded guilty to a third crime, failing to report safety data related to Avandia (rosiglitazone). Failing to report safety data violates the Food, Drug, and Cosmetic Act and leads to serious questions about whether clinicians are basing their decisions on the best evidence. GSK also settled related civil liabilities for these and other drugs.
The use of data extrapolation for the approval of Budeprion XL 300 mg should be considered in historical context. When applications for generic versions of Wellbutrin XL 300 mg began to come under FDA review in 2005, more than 11 million prescriptions for the brand-name product were being written each year. Programs to develop generic bupropion products, and the requisite bioequivalence studies, were important for addressing the widespread need for the treatment of major depressive disorder. At the same time, the FDA and sponsors recognized that bupropion conferred a dose-related risk of seizures, which the agency believed warranted a conservative approach to bioequivalence testing of bupropion in healthy volunteers. Bioequivalence studies that used only the lower strength (150 mg) reflected this conservative approach.
First, the strategy recognizes that older people are the main users of medications — not a minority or special population (a fundamental difference between the geriatric and pediatric populations). Therefore, legislative and regulatory frameworks must be designed to ensure that the use of newly approved medicines in the intended population is supported by relevant data on the benefit–risk balance. The strategy's second aim is to improve the availability of information to patients and prescribers, to support safer use of 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.
Each year in the United States, nearly 500,000 infants — 1 in every 8 — are born prematurely, before 37 weeks of gestation. Despite substantial advances in their care, premature infants face a daunting array of challenges; they are at high risk for death in infancy and face severe and lifelong health problems if they survive.1 The National Institutes of Health (NIH) has a legal and moral responsibility to do research in partnership with scientists and families to optimize the care of these highly vulnerable infants. In recent weeks, a major public debate has arisen regarding a study designed to do just that. And the ramifications go well beyond this one study: the outcome of this debate could affect how we conduct and communicate about critical research on interventions that are within the standard of care for all diseases and conditions.
Once a product is on the market, new safety signals may emerge. Spontaneous reports of adverse reactions can be used to identify patterns of drug–drug and drug–disease interactions that were not apparent before authorization. Collection of data from all possible sources should be optimized, since adverse reactions in elderly populations are generally underreported. The risk-management plan for a drug — based on its risk profile — should be designed to fill knowledge gaps, and targeted measures should be used to minimize risk.
The study by Ray et al. has limitations that are intrinsic to observational, nonrandomized clinical studies. In particular, nonrandomized studies cannot exclude the possibility that patients receiving a drug under evaluation differ from control patients in some important but undetected way, causing bias in the results. Such confounding may bias comparisons not only between patients receiving antibacterial drugs and those receiving no antibacterials but also between patients receiving different antibacterials. Although Ray et al. used appropriate analytic methods to address potential confounding, we cannot know for certain whether these methods were fully successful. Replication of the authors' results, through analysis of a distinct data set, would provide more confidence in the finding of increased cardiovascular mortality among patients receiving azithromycin.
However, a well-circulated grievance pointed to one unanticipated consequence of the amendments: the new burden of proof appeared to make the process of drug development both more expensive and much longer, leading to increasing drug prices and a “drug lag” in which innovative compounds reached markets in Europe long before they reached the U.S. market. Industry agitation surrounding the “drug lag” finally led to modification of the drug patenting system in the Drug Price Competition and Patent Term Restoration Act of 1984 — through further extension of drug patents. Indirectly, then, Kefauver's amendments ultimately affected both pharmaceutical pricing and patenting — in a manner diametrically opposed to the one he intended.
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%.
The circumstances surrounding the SUPPORT study have unquestionably created controversy in the research community, but the situation has created an opportunity for a better understanding of the scientific and ethical issues that must be addressed when designing such studies in the future. We look forward to working with the OHRP, the research community, and patient advocates to improve the effectiveness and ethical standards of research involving human participants.
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
Depending on patients' frailty and disability status, the desirable outcome and treatment choices might vary: different patients place different values on benefits and risks. Certain adverse events, such as dizziness leading to falls, may be of greater importance in the geriatric population. The design of a clinical trial should consider age-appropriate end points; for older people, functional outcomes may be most important, and an emphasis on such outcomes could lead to reduced costs for health care systems.
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