נושא : תחליף טבעי לריטלין בשם ריטלקס שלום
יש לי ילד בן 7 שאובחן ADHD לפני כשנה ומאז מטופל בריטלין.
מאז אינני שקט ואני מחפש בנרות תחליף טבעי.
האם למישהו יש נסיון עם התחליף ריטלקס?
לא ממש שמעו עליו ואין יותר מדי ביקורות ברשת
נושא : ריטלקס בתגובה ל: תחליף טבעי לריטלין בשם ריטלקס - גל
האמת ניסיתי ולא ראיתי תוצאות בכלל.. - כל כך קוויתי !
אחרי הרבה ניסויים ב"תרופות" טבעיות, הומפאתיה , שיטת אלבויים, ריפוי בעיסוק, הוראה מתקנת זהו התייאשתי ואני בדרך לנסות ריטלין
למה אתה לא לא שקט עם הריטלין?
נושא : תחליף טבעי לריטלין בשם ריטלקס בתגובה ל: ריטלקס - evaeva
אני לא שקט כי את תופעות הלוואי המידיות אני רואה ביום יום כגון חוסר תאבון, קשיי הרדמות, וכולי.
מה שהכי מטריד אותי זה ההשפעה של הריטלין לאחר 10 - 20 שנה.
אני חושש לגבי נזקים תמידיים בעתיד שלא ניתן יהיה לתקן.
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נושא : minoxidil finasteride hormone An important finding of the study was a reduced incidence of ROP in the lower oxygen-saturation range. However, contrary to what was known at the time, the study also showed a slightly but significantly increased incidence of death вЂ” 19.9% versus 16.2% (P=0.04) вЂ” among infants assigned to the lower as compared with the upper range. As a result, last year the AAP amended its guidelines, citing SUPPORT, and physicians treating very premature infants are starting to use higher saturation rates to reduce the risk of death, even with the potentially higher risk of ROP at these levels. Studies such as SUPPORT that compare two alternatives, both within current standard clinical practice, often lead to critical improvements in medical care.
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.
Renewed attention to comparative effectiveness research in the 21st century illustrates the consequences of sidelining Kefauver's initial demand for comparative data for evaluating the promotion of novel therapeutics. By 2000, pharmaceutical expenditures had become one of the fastest-growing parts of the budget of many U.S. states and third-party insurers. But the kind of knowledge required for entry into the U.S. drug market offers consumers and payers little information relevant to choosing between subtly different вЂњme-tooвЂќ drugs within the same therapeutic class вЂ” whose therapeutic effect may or may not be the same. Only in the past decade, through the action of the Reforming States Group, the Drug Effectiveness Review Project, and most recently funding of comparative effectiveness research through the American Recovery and Reinvestment Act, the Affordable Care Act, and now the Patient-Centered Outcomes Research Institute, have we begun to catch up on the vital project of comparing therapeutics so that American consumers and their physicians can make meaningful treatment decisions вЂ” the project that motivated Kefauver's original investigations a half century ago.
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.
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 вЂњthe 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.вЂќ3 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 вЂњarbitrary discriminationвЂќ against the pharmaceutical industry) and the comparative effectiveness provisions (considering вЂњproof of superiorityвЂќ necessary only if superiority was actually being вЂњclaimed by the manufacturerвЂќ).4 The pharmaceutical industry amplified such concerns about comparative effectiveness, arguing that any a priori determination of which medicines were вЂњme-tooвЂќ and which were true innovations would be arbitrary. Efficacy was hard enough to prove, they suggested; proving comparative efficacy would be вЂњcompletely impracticable.вЂќ3
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 вЂ” 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 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.
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.
Regulators must ensure that the development and evaluation of drugs take into account global demographic changes, so that safe and effective drugs reach the patients who ultimately use them.
Once a product is on the market, new safety signals may emerge. Spontaneous reports of adverse reactions can be used to identify patterns of drugвЂ“drug and drugвЂ“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 вЂ” based on its risk profile вЂ” should be designed to fill knowledge gaps, and targeted measures should be used to minimize risk.
On July 2, 2012, the Department of Justice announced the largest settlement ever in a case of health care fraud in the United States. GlaxoSmithKline (GSK) agreed to plead guilty to three criminal counts and settle civil charges brought under various federal statutes; the company will pay a total of 3 billion to the federal government and participating states. Since 2009, the federal government has collected more than 11 billion in such settlements under the False Claims Act.
Second, an accurate comparison of time to market access requires measurement of the total time that elapses between application submission and market access. Previous studies have compared the chronologic dates of application submission and market access, but the date an application is submitted varies from country to country.
Kefauver initially stuck to his guns on issues of compulsory licensing and patents, but his persistence ultimately cost him control of his own bill. In June of 1962, officials from the Kennedy administration and the pharmaceutical industry presented the subcommittee with an alternate bill вЂ” with no regulatory language about patents included. Kefauver cried foul, the Kennedy administration eased off its support, and S.1552 seemed to all observers to be a dead letter. It was only by chance timing that the summer of 1962 also produced a highly visible tragedy (thalidomide), a hero (Frances Kelsey), and enough ensuing public outcry to persuade Kefauver and Kennedy to embrace the gutted bill.
Even when inclusion and exclusion criteria are set adequately, clinicians and ethics review boards often act as gatekeepers in the recruitment process, creating a selection bias by allowing enrollment of only some of the eligible patients. They are particularly likely to exclude the вЂњolder oldвЂќ and patients with coexisting conditions. Again, every effort should be made to gather evidence in these patients during the premarketing period of drug development. Regulatory guidance for these patients is often lacking, and more work is needed to strengthen the guidance on expectations concerning such patients when guidelines are drafted or revised.
In almost every country, the proportion of people over 60 years of age is growing faster than any other age group, as a result of longer life expectancy and declining fertility rates. In Europe, the median age is already the highest in the world, and in 2050 there are projected to be 88.5 million Americans 65 years old or older вЂ” more than double the 40.3 million in the 2010 census.
To compare the United States and Europe fairly on this front, three criteria must be considered: the level of device innovation, equivalent start and end points, and patient access as defined by time to reimbursement. First, we focused on innovative, high-risk devices because in the United States such devices require the strongest evidence of clinical benefit and are the subject of most debates about the relative effectiveness of approval processes in different countries. Furthermore, previous studies have shown that lower-risk devices achieve market access in a similar amount of time in the United States and in Europe.
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.
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 вЂ” one with the oxygen saturation target of 85 to 89%, the other with the target of 91 to 95%.
Another unintended consequence of the amendments was that the new structures of proof changed not only the behavior of the pharmaceutical industry but also the conceptual categories used by biomedical researchers around the world.5 Pharmaceutical research came to be overwhelmingly organized around the placebo-controlled, randomized, controlled trial. Although this system has greatly helped researchers gauge the efficacy of an individual drug, it has also rendered data on comparative efficacy much more difficult вЂ” and much more expensive вЂ” to find or produce.
Each year in the United States, nearly 500,000 infants вЂ” 1 in every 8 вЂ” 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.
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