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AFTL Women’s Caucus Journal Article
November/December 2004
“VIOXX: ONCE AGAIN WE LEARN THAT NEITHER MANUFACTURERS NOR THE
FDA LOOK OUT FOR THE AMERICAN PUBLIC”
by Virginia M. Buchanan, Levin, Papantonio, et al Vioxx, a Cox-2 inhibitor non-steroidal anti- risks of Vioxx. Specifically, the FDA said the company inflammatory medication, was rushed to approval by the was engaging in promotional practices to minimize the FDA in 1999. It became available for use on an unlimited potential cardiovascular effects of the drug. Merck had basis in May of 1999. Since that time, Merck, the drug’s undertaken a campaign to downplay the results of the manufacturer, has spent over half a billion dollars VIGOR study and misstated the effects of Naproxen on promoting and marketing the drug, including direct advertising to consumers. Vioxx was initially offered as apain relieving medication for chronic pain. It was also Rather than looking at the long term effects on patients marketed as a pain reliever for juvenile rheumatoid using Vioxx, Merck directed its efforts to expanding the arthritis sufferers, including children over the age of 2.1 use of the drug. Merck wanted to get approval for the use Vioxx was prescribed to millions of patients, and sales of of Vioxx to prevent recurrent colon polyps.4 During the Vioxx in 2003 were just under $2.5 billion. Vioxx was one course of the research, known as the APPROVe study, researchers were alarmed to see the number of heart of the fastest growing and largest performers of Merck’s attacks and strokes which occurred among the patients.
pharmaceutical products. Some estimate that Vioxx was The results were so stunning, the study was halted. The one of the top 10 selling drugs in the world in 2003.
results of the APPROVe study, together with an analysis done by an FDA researcher, Dr. David Graham, confirmed Although Vioxx was never offered as a medication with the suspicion that Vioxx poses significant cardiovascular life-saving propensities, the FDA approved a fast track application process for Vioxx with the justification thatVioxx would offer relief to millions of sufferers of chronic These two events caused Merck to voluntarily withdraw pain. At that time, there were representations by Merck the drug from the market on September 30, 2004.
that Vioxx would not cause gastrointestinal complica-tions, including ulcers and bleeding, that were seen in The public statements about it being a voluntary with- other over-the-counter non-steroidal medications.2 Vioxx drawal are questionable. Based upon reports and infor- was the first NSAID, selective, Cox-2 inhibitor, so Merck mation from FDA researcher Dr. Graham, it appears that was able to quickly gain a large market. Merck was the safety and efficacy of Vioxx were challenged almost unable to demonstrate at that time, or at any time, the from the beginning, from within the FDA. The concerns superiority of VIOXX as a pain relieving agent.
were ridiculed and rejected. However, with the results ofthe most recent study and the analysis done by the FDA, In a post-marketing study, known as the VIGOR study, a the FDA could no longer turn a blind eye to the impact of number of patients were given Naproxen, while others Vioxx on patients. The FDA had effectively shirked its were given Vioxx.3 The studies showed that there were responsibility up to the point of the most recent disclo- more than double the number of cardiovascular events in sures. Given its hands-off approach with Merck, it is patients taking Vioxx than Naproxen. At that time, unclear what the FDA would have done had the medica- members of the international medical community, tion not been voluntarily withdrawn by the manufacturer.
including Dr. E. J. Topal from the Cleveland ClinicFoundation and Dr. James Wright from the University of One can surmise that the evidence must be overwhelm- British Columbia, called for further testing of Vioxx, to ing for Merck to withdraw a drug that generated a sub- specifically assess cardiovascular effects. Neither the stantial portion of its profits and for which they had FDA nor Merck took any action to follow-up on the committed such an extensive and elaborate marketing concerns that Vioxx could in some way be related to the campaign. The Wall Street Journal has reported that increase in heart attacks and stroke as seen in the there was substantial evidence known to Merck and VIGOR study. Neither the FDA nor Merck heeded the acknowledged by its leading VIOXX researcher that the admonition of the medical experts that the safety of evidence was clear that there were some cardiovascular Merck blindly ignored the information published in the Sadly, the limited ability and commitment on the part of the FDA to regulate pharmaceutical companies are clear various studies of Cox-2, NSAIDS, each time criticizing in this instance. Chronic pain can admittedly be a some aspect of the conclusions. Merck instead went to significant problem for those who suffer from such a great lengths to both increase its marketing budget and condition. However, VIOXX was broadly marketed to continue its representations that Vioxx was safe and virtually all people with chronic pain, without regard to efficacious for the control of pain.
severity of the problem, and certainly without full disclo- sure of risks. Merck was all too willing to take advantage In September, 2001, the FDA made some effort to reign inMerck’s overzealous marketing efforts. The FDA admon- ished Merck about misinforming physicians about the of the complacent, deferential attitude of the FDA. Thedrug has been marketed very aggressively since 1999, and its withdrawal at the end of the third quarter of 2004leaves many Vioxx users and surviving family members questioning whether their strokes or heart attacks werethe result of VIOXX use.
Strokes and heart attacks are disabling and sometimes deadly conditions. The cost of care, loss of earnings andservices to the community caused by stroke and heartattack on an annual basis are enormous.
More than 300 cases have been filed so far for what isbelieved to be adverse affects of Vioxx. As more discov-ery is completed, more will become known about just howmuch Merck knew about its drug. In addition, its specificmarketing goals and conduct will be identified through itsinternal documents. Merck will undoubtedly assert aproprietary interest in its documents, and the public willmost likely never know the actual corporate philosophiesabout Vioxx. Based upon what has been publicallydisplayed, though, it appears clear that Merck wanted tomake sales at all costs. That cost may have been theloss of health and life for many.
Dr. Topol has called for a congressional inquiry into whatMerck and the FDA have done.6 It would benefit many ifthe challenge is accepted by Congress. This is a problemwhich must be fixed.
____________ 1See Vioxx packaging indications for use.
2“The double-edged sword of Cox-2 selective NSAIDS.” J. M. Wright, CMAJ, Nov. 12, 2002; 167 (10).
3The results of the VIGOR study for Vioxx gastrointestinal outcomes research were released inMarch, 2000.
4Interestingly, the APPROVe study seems to fit into what was outlined in a Wall Street Journal articlepublished on November 1, 2004; the article discussesinternal emails and documents of Merck and whatappears to be a concerted effort by Merck to designstudies which would de-emphasize the cardiovascularrisks of VIOXX.
5The FDA researchers worked in conjunction with Kaiser Permente in evaluating medical records of 1,300patients.
6Failing the Public Health–Rofecoxib, Merck and the FDA” E. J. Topol; N. England J. Med., 21 Oct. 2004;351(17): 1707-9.

Source: http://old.floridajusticeassociation.org/images/uploads/1106746764WCnovDec04.pdf

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