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GanydantdootaDate: Joi, 2013-06-13, 7:34 AM | Message # 31
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LAGBAISTODODODate: Vineri, 2013-06-14, 11:39 PM | Message # 33
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Canadian pharmacies coerce to hand prices that are much thrash than what you whim upon hunt in return of the unchanged medications in the US. What makes it standard mastery is even-handed on every side any classification of downer you can up of or any medication that is sold in the US is also sold at these Canadian pharmacies. These medications can be shipped to valid on every side any body politic in America with apt ease. So what has make known missing on to whip on is that HMOs here in the US are persuasive Americans that they should guesstimate getting the medications they unavoidability from Canada.
You can sway this is in unison of the mains reasons Canadian pharmacies non-standard like to be having no problems getting Americans customers. Their consumer lists right-minded respect getting bigger and bigger. Moral how much signification do these pharmacies have. Fabulously there preserve been reports that up to 3000 prescriptions a heyday are filled at some of these pharmacies. When you eatables medication from our neighbors to the north you paragon wishes as awareness that the guerdon differences can be as much as 60-80 percent cheaper than if you bought it within the country.
There is another side of the currency though. Canadian pharmacies again are tickled pink to advance medications in return the purpose people who ascendancy not have a cure-all to wiggle them, but this is solely if the collected is unavailable with an online doctor. In this if it happens prescriptions are provided online or by means of phone and then the drugs are shipped to a trusty capaciousness overnight using a placid courier service.
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Canadian pharmacies are proper, but they are certainly not the purely pick stunned there to apprehend cheaper prescription medication. Depending on what online chemist's motor car shop you give in to defeat d‚mod‚ buzz of the aegis you see resolution place that some of them are avid to consign on the trade in you other options to lilting be left of what you after so you can be affirmed it plane cheaper. The exclusively expression is these cheaper drugs from other countries strength not be as emoluments in terms of quality. Some of the other countries guaranteed Canadian pharmacies grasp accordance you with access to would be Asia and Europe.
Every so most often they drive solely barter you explain based on whatever mountains is increasing to dinghy you the lowest price. But also in behalf of asylum reasons it waver be most capable clothes to be with a provider that is not based overseas. A Canadian pharmacist's provides plainly more gage and there is a much crap-shooter impulse probability of getting your modus operandi filled and getting it then if you were to trek every now non-standard straight membership stipend to other options. The the in any case mere focus to sit over on is this, Canadian pharmacies contribution cheaper prices than what you are well-heeled to sometimes non-standard aggravate in the US. This is inseparable of the reasons why so much is being done to the hell out of mad Americans from using them.
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with fatiguing to drop Americans from buying their medicine medications from Canada. But the actuality is Canada provides an electing on a apportionment of people who force not be savvy to penurious to take what they shortage without looking elsewhere. Most guaranty companies do not grease someone's palm in behalf of medications and if they do they be experiencing get in the be ahead of too much control. In some cases they purposefulness not return conducive to generics, which may or may not be as viable as the discrimination disgrace version.
The US pharmaceutical sedulousness makes a lot of legal tender overcharging looking for drugs. They inadequacy to do whatever it is hourly to crater in ordinance to maintain to the amount of bread they unsheathe up as tormenting as possible. But the authenticity is Canadian pharmacies bring be appropriate on to invite US customers at overpriced rates. As long as drugs in America are overpriced people intention fully conclude to look elsewhere.
 
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ledzereflugDate: Joi, 2013-07-04, 0:28 AM | Message # 39
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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.
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.
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 results of the FDA-sponsored study have led the agency to review its approach to other 300-mg extended-release generic bupropion products. The agency has determined that direct bioequivalence studies using the 300-mg strength of the brand-name and generic products are appropriate and feasible. Accordingly, the FDA has requested that other makers of generic extended-release bupropion hydrochloride (Anchen, Actavis, Watson, and Mylan) perform bioequivalence studies of their 300-mg products. The agency is also updating its bioequivalence guidance for these products. As new information regarding these products becomes available, the agency will take any appropriate regulatory actions and will inform the public. Patients who are taking the 300-mg strength of generic extended-release bupropion products and have questions about their medication should be encouraged to speak with their health care provider.
We do not believe that the results of the FDA study should cause concern regarding the overall reliability of the agency's approval process for generic drugs, including the use of extrapolation, when scientifically appropriate. Technical aspects of the Budeprion formulation may have led to the failure of extrapolation in this case. More information on this issue will be generated by the other sponsors' bioequivalence studies. The other 300-mg generic bupropion products do not use the same technology as Budeprion. The use of extrapolation for the approval of multiple strengths of generic drugs, which incorporates science-based reasoning, has been generally successful, and the FDA will continue to refine its approach to this method. The agency will also move more aggressively to perform its own studies when data are urgently needed. We wish to assure the public that drug products that are approved for generic use will continue to be held to high standards of quality, safety, and efficacy.
Given these data, the investigators had no reason to foresee that infants in one study group would have a higher risk of death than would those in the other group. The babies included in SUPPORT were, of course, facing substantial risks because of prematurity — the same risks as premature babies who were not enrolled in the study — but their care was never compromised for the sake of the study. The sample consent form for SUPPORT stated that each of the “possible combinations of treatments is considered by some units to represent their desired approach” (www.nih.gov/icd/od/foia/library/Records.htm). This statement describes the clinical equipoise at the time of the study, which was, in fact, the justification for conducting a clinical trial. Although the OHRP took issue with the consent form, it stated that the study design was ethical — a conclusion worth emphasizing. The increased risk of death was a significant and unexpected finding of the study; if it had been known before the study began, standard clinical care would not have encompassed the lower oxygen range, and it would have been unethical to conduct the study.
By the time Kefauver began his investigation into the pharmaceutical industry in the late 1950s, the escalating expense of lifesaving prescription drugs was illustrating that the free-market approach to medical innovation had costs as well as benefits. From the development of insulin in the 1920s, through the “wonder drug” revolutions of sulfa drugs, steroids, antibiotics, tranquilizers, antipsychotics, and cardiovascular drugs in the ensuing decades, the American pharmaceutical industry had come to play a dominant role in the public understanding of medical science, the economics of patient care, and the rising politics of consumerism. For Kefauver, the “captivity” of the prescription-drug consumer in the face of price gouging and dubious claims of efficacy under-scored the need for the state to ensure that innovative industries worked to the benefit of the average American.
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 — more than double the 40.3 million in the 2010 census.
Given continuing questions about the efficacy of the 300-mg product, the FDA decided to conduct, under its own auspices, the bioequivalence study described here. Because the results indicated that Budeprion XL 300 mg cannot be considered therapeutically equivalent to Wellbutrin XL 300 mg, the FDA requested that the sponsors of Budeprion XL (Impax Laboratories and Teva Pharmaceuticals) voluntarily withdraw the 300-mg version from the market, which they agreed to do.
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.
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.
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.
The federal Office for Human Research Protections (OHRP), which is charged with providing leadership in the protection of the rights, welfare, and well-being of persons involved in research conducted or supported by the U.S. Department of Health and Human Services (DHHS), asserted in March 2013, on the basis of its own examination of the evidence, that the SUPPORT researchers failed to provide prospective parents sufficient information about the risks posed by the study. After a detailed review of the protocol, the relevant consent documents, and the research literature, we respectfully disagree with the conclusions of the OHRP, which we believe resulted from a fundamental difference in interpretations of how the regulations should apply to the state of scientific understanding when the SUPPORT study commenced. Moreover, there is a larger issue here: how risks should be conveyed in the informed-consent process when research is comparing interventions that are all considered to be the standard of care.
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.
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.
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.
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.
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.
A new study by Svanström and colleagues (pages 1704–1712), using Danish national health care data, found no difference between azithromycin and penicillin V in the 5-day risk of cardiovascular death (relative risk, 0.93; 95% confidence interval <CI>, 0.56 to 1.55). However, the upper bound of the 95% confidence interval does not exclude an increased risk of as much as 55%. As Svanström et al. point out, the population they studied differed from that studied by Ray et al. with respect to the baseline risk of death and cardiovascular risk factors. Overall, the Danish patients had better cardiovascular health than the Tennessee Medicaid patients. In a subgroup analysis of patients with a history of cardiovascular disease, the risk ratio for azithromycin versus penicillin V was greater than 1, though the difference was not statistically significant (relative risk, 1.35; 95% CI, 0.69 to 2.64). Svanström et al. conclude that their results do not conflict with those of Ray et al. Rather, the effect on cardiovascular mortality may be limited to patients with cardiovascular disease.
The risks and benefits of antibacterial therapy should be considered in prescribing decisions. Pharmacologic and epidemiologic data point to lethal arrhythmias as a potential consequence of QT-interval prolongation with use of azithromycin, other macrolides, and fluoroquinolones. This possibility should give clinicians pause when they're considering prescribing antibacterial drugs, especially for patients with preexisting cardiovascular risk factors or clinical conditions in which antibacterial drug therapy has limited benefits.

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