A ruling from a texas judge coming as soon as monday is expected to undercut the legal foundation for all 1000 vioxx cases brought against merck & co by texas plaintiffs, providing a potentially significant boon to merck's defense.
The company has directors and officers insurance coverage applicable to the vioxx securities lawsuits and vioxx derivative lawsuits with stated upper limits of approximately $190 million.
Merck had sponsored a three-year, 2, 600-patient randomized trial to see whether vioxx, like celebrex, could claim that it protects against the recurrence of colon polyps, which can become cancerous.
Another approach to evaluating the involvement of various nuclei in primed reinstatement has been to use microdialysis to measure changes in neurotransmitter release during primed reinstatement or to microinject neurotransmitter antagonists to inhibit reinstatement. These studies have identified two major features 11-16 ; . Dopamine release in the prefrontal cortex mediates cocaine-primed reinstatement, while dopamine release in the basolateral amygdala mediates cue-primed reinstatement. In contrast, involvement of dopamine release into the nucleus accumbens has been inconsistently demonstrated in either cue- or drug-primed reinstatement. Although the role of dopamine release into the accumbens is not clear, glutamate release into the core of the nucleus accumbens appears critical to both cue- and drug-primed reinstatement, because vioxx trial.
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Two drugs the heavily promoted Vooxx and Celebrex accounted for 9.2 percent of the entire increase in prescription drug sales in the year 2000 and a total of $3.5 billion in sales. It is unlikely that the health-care system received full value for this money, given the evidence that these drugs are no more effective than overthe-counter ibuprofen i.e., Advil ; at reducing pain and inflammation and are only slightly less likely to cause ulcers.44 Percentage of 2001 U.S. Sales for Top Five Drugs at Pharmaceutical Companies and
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Ease management is prevention and education as a method to reduce health care costs and improve patient outcomes Results of Comprehensive Management Unfortunately, there are few investigations of the effectiveness of comprehensive management with COPD patients, whereas these principles have been more widely and successfully applied with asthma patients. Collaborative self-management programs that have been investigated have not always included all the key components in Table 4, and the role of the physician in these programs has not always been clearly defined. Gallefoss et al have reported extensively on the results of their "self-management" program for patients with respiratory disease.2225 Their studies have compared results in 78 patients with asthma and 62 COPD patients randomized to receive self-management or standard care. Their self-management program includes an educational brochure about the disease, two 2-hour education sessions with a nurse or physiotherapist, and an individual treatment plan for each patient.25 Outcomes have been assessed for 1 year following the intervention. These investigators have shown this program increases inhaled steroid use among asthma patients but not among COPD patients.25 Rescue, as-needed agonist use for control of dyspnea was reduced among COPD patients but not among asthma patients. Physician visits and patient absences from work were reduced among both COPD and asthma patients. The self-management plan was found to reduce costs with COPD patients, because of reduced physician visits and reduced use of asneeded bronchodilators.23 Quality of life was improved among asthma patients but not among COPD patients.22 Bourbeau et al explored the efficacy of a self-management program on COPD hospitalizations.26 In this controlled, randomized multicenter trial, 191 COPD patients who had at least 1 hospitalization in the previous year were enrolled from 7 hospitals. Mean post-bronchodilator FEV1 was 45% of predicted, and mean patient age was 69.5 years. The self-management program consisted of weekly in-home education for 7 8 weeks, using written workbook education modules, which include an action plan for exacerbations, customized for each patient by the physician, and a supervised exercise session. Patients were encouraged to exercise at least 3 times a week thereafter. Compared to the patients receiving usual care, patients in the self-management group had 40% fewer hospital admissions for COPD exacerbations and 57% fewer admissions for other medical problems in the subsequent 12 months. The patients who participated in the self-management program had fewer emergency room visits and better quality of life, as assessed by the impact scale of the St George's Respiratory Questionnaire. The National Jewish Medical and Research Center has developed a disease management program for COPD patients. Their outcomes are available on their Web site and show reductions in 6-month health care utilization, including a 77% reduction in missed work days and a 56% reduction in hospitalizations.27 Summary Therapies for COPD can be effective and improve outcomes only if they are actually used by patients. Health care practitioners should recognize the complexity of prescribed treatments and routinely utilize strategies to promote patient adherence. The principles of collaborative self-management, with the patient and all health care providers working in concert toward clearly defined goals, should be routinely incorporated into patient care. Although the principles of collaborative self-management may seen logical, reasonable, and self-evident, additional research on their long-term effectiveness is needed. The goals of collaborative self-management may be fostered by disease management programs, which can assist in improving patient outcomes.
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Clinical studies have indicated that patients taking vioxx on a regular basis for an extended period of time may be at risk for injuries such as strokes and heart attack.
Ple worldwide. This form of diabetes occurs when the body does not make enough insulin or cannot effectively use what it manages to produce. Avandia, or rosiglitazone, helps sensitize the body to insulin and was considered a breakthrough medication for bloodsugar control. It also is combined with metformin and sold as Avandamet. Only one other drug like it - pioglitazone, sold as Actos and Actoplus Met by Takeda Pharmaceuticals - is sold in the United States. Avandia had total U.S. sales of $2.2 billion in 2006, slightly trailing $2.6 billion for Actos, according to IMS Health, a healthcare information company. About 13 million Avandia prescriptions were filled in the U.S. last year. A one-month supply of Avandia sells for between $90 and $170. GlaxoSmithKline also has been testing Avandia to try to prevent diabetes in those at high risk of it, and, in separate studies, to prevent Alzheimer's disease. However, the new analysis casts a pall on its prospects for prevention as well as treatment, many specialists said. The study was led by Dr. Steven Nissen and statistician Kathy Wolski at the Cleveland Clinic. Nissen accepts no personal fees for consulting for any drug makers. While the analysis doesn't spell out the actual the rate of heart attacks among Avandia users, the 43 percent excess risk is in line with what a similar analysis found for lower doses of Viocx use, Nissen said. Another context for that number: Heart attack risks are lowered about 25 percent by cholesterol-reducing statin drugs - ample reason to prescribe them. The Avandia studies Nissen analyzed were not designed to look for heart risks and many of them were so short - some only 24 weeks - that risks may only appear over the longer term, he said. Dr. David Nathan, chief of diabetes care at Massachusetts General Hospital, agreed and
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The study did indicate, though, that more vioxx patients had suffered heart attacks and
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It's like telling kids today that it's normal for you to experiment with various drugs when it's not, for example, san antonio vioxx attorney.
Recommended exercises & some anti-inflammatory meds like vioxx & celebrex but they never came close to suppressing and zestril.
DiMasi and Paquette make some circumstantial comments on clinical importance. They point out that these are based on FDA's rating system, but as they point out, that system is a tool for managing FDA's workflow, rather than a definitive assessment of clinical safety, efficacy, and other factors DiMasi and Paquette, 2004 ; . 16 There are of course other factors that exert pressure to restrict use to approved indications, e.g., matters of liability and reimbursement. 17 Recent news has made it clear that NIH already has the power to conduct studies: on December 17, 2004 NIH announced that it was suspending a trial with VioxxTM that was being conducted by NCI NIH, 2004 ; . This has led to Merck's withdrawing Vi0xx from the market and to reviews of the entire class of COX-2 inhibitors by multiple agencies. 18 See the websites for Drugs for Neglected Diseases initiative : dndi ; and OneWorld Health : oneworldhealth ; . Of course efforts by governments, agencies of the United Nations, companies, and foundations to subsidize drug distribution in the developing world indirectly encourage needs-driven drug development. In effect many of these initiatives expand markets for drugs. For example, the Clinton Foundation is partnered with a number of governments and agencies to purchase at greatly reduced prices medication for the treatment of HIV Aids McNeil, 2005 ; . 19 This year, 2005, is the 25th anniversary of Terry Fox's Marathon of Hope, which was an attempt by a one-legged man to hop run across Canada from the Atlantic to the Pacific in an effort to raise money for cancer research. Fox had lost his leg to cancer, and subsequently, his life at the age of 26. His marathon was cut short because of a recurrence when he had gone 3300 km. Someone suffering from his condition today would have a much greater chance of keeping his leg and of surviving. No doubt that improvement owes a great deal to basic research, which Fox helped fund by raising hundreds million dollars, but the contemporary drug development and regulatory systems deserve some credit for such advances. 20 "Well regulated" includes both expanding some requirements and introducing new ones. Examples include the need for more complete and timely disclosure of information about ongoing clinical trials and of results.
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By Evan L. Siegel, MD, FACR This is an exciting time for patients with Rheumatoid Arthritis and the physicians who treat them. After a decade marked by a dearth of any truly new therapies for this potentially disabling disease, a variety of new and exciting therapies have arrived. These new treatments represent both an evolution and a revolution in the way we think about the therapy of RA. The new and upcoming arsenal of medications has begun to address the dually vexing deficiencies of current therapies--a less than adequate degree of efficacy and a greater than acceptable degree of toxicity. In general, Rheumatologists separate the therapies of Rheumatoid Arthritis into two categories. The first is anti-inflammatory therapy, meant to decrease inflammation and pain. This category includes medicines like aspirin and Ibuprofen. The second category is a group of medicines called Disease Modifying agents, or Remission Inducing agents, meant to slow the progression of the disease. These include drugs such as Methotrexate, Hydroxychloroquine, and gold. Major innovations have drastically improved our options in both of these categories. In a prior issue of Rheumors the new drugs in the anti-inflammatory group, known as "Cox 2 Inhibitors" were discussed. Briefly, these are a new generation of non-steroidal anti-inflammatory drugs NSAIDs ; that are special because of significantly lower toxicity than the older drugs. NSAIDs have long been known to function through the inhibition of an enzyme called Cyclooxygenase COX ; . This inhibition prevents the production of chemicals called prostaglandins, some of which are very important in promoting inflammation and causing pain. However, other prostaglandins also produced by COX are essential in the maintenance of normal bodily functions. They protect the stomach lining, allow cells called platelets to prevent excessive bleeding, and maintain adequate blood flow to the kidneys, among others. Older NSAIDs block the production of both types of prostaglandins. This allowed for effective blockade of pain and inflammation, but also promoted the serious side effects such as stomach ulcers, bruising and bleeding, and kidney failure. Relatively recent research revealed that Cyclooxygenase actually exists in two forms, COX-1 and COX-2. COX-1 is responsible for producing the "housekeeping" prostaglandins, which are responsible for normal bodily functions. COX-2 is responsible for producing the prostaglandins associated with inflammation and pain. The new generation of NSAIDs selectively inhibits COX-2 and its products, leaving COX-1 available to continue to produce the helpful prostaglandins. Drugs already on the market in this category include Celebrex and Vioxx, with a few others already in the pipeline. It is important to realize that these drugs are not necessarily more effective in reducing pain or inflammation than older drugs, but do appear to be safer particularly with respect to.
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A: viosx has been linked to possible cardiovascular complications, including blood clots, heart attacks and strokes, and to kidney failure.
Posted by admin on: friday 26 july : 48 we are currently evaluating cases involving users of vixx or celebrex who have suffered a heart attack or stroke while taking these medications and
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Hundreds of lawsuits filed against merck, blaming its painkiller vioxs for deaths and injuries, will be consolidated in a federal court in new orleans.
Are there any negatives due to age for taking seasonale or skipping the sugar pills of regular birth control pills, because vioxx 25 mg.
Medical and nutritional treatment for severely malnourished children and infants in the stabilisation centre should be carried out according to standard WHO protocols for phase 1 inpatient care. This section should therefore be used alongside and warfarin.
Table 3. Hematologic toxicities and associated supportive care in patients with advanced ovarian cancer stratified by treatment arm and toxicity grade * NCI CTC grade, % TC arm Toxicity Hemoglobin Platelets Transfusion pRBCs Leukocytes Neutrophils Febrile neutropenia Supportive care: antibiotics Supportive care: GCSF Set C P C 2209 388 2193 0 29.1 9.0 71.9 - - 22.6 16.0 12.9 - - 2 20.1 44.3 - - 29.3 38.7 12.8 - - 3 1.3 5.4 - - 0.3 1.5 5.0 0.0 0.0 - - N 2095 382 2082 0 33.6 14.7 93.4 PT arm 1 49.5 44.2 - - 23.3 25.1 10.6 - - 2 16.1 37.2 - - 17.3 32.7 9.8 - - 3 0.8 3.9 0.0 0.0 0.0 0.0 - - 0.0 0.3 2.3 7.0 0.0 0.0 - - Difference in the proportions of patients with grades 3 4 toxicity, % E -0.6 -2.0 -2.9 -11.8 -2.9 -7.7 -8.1 -21.2 -8.7 -14.9 -0.9 -4.3 0.4 2.7 -4.2 -9.8 95% CI -1.3 to 0.0 -5.1 to 1.1 -3.6 to -2.1 -15.3 to -8.4 -4.2 to -1.6 -12.7 to -2.8 -9.6 to -6.6 -26.8 to -15.6 -10.8 to -6.5 -21.4 to -8.5 -1.6 to -0.3 -7.6 to -1.1 -0.5 to 1.3 -1.2 to 6.6 -5.5 to -3.0 -13.9 to -5.7.
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Is accelerated when ERT HRT is discontinued.12, 13 Therefore, estrogen may simply postpone the rapid bone loss associated with menopause. This is a very important point when counseling patients about ERT HRT compliance and the long-term prevention of osteoporosis. Unlike other pharmacologic therapies for osteoporosis, estrogen is not FDAapproved for the treatment of osteoporosis. These other therapies have demonstrated their sustained ability to safely reduce hip and or vertebral fractures in osteoporotic postmenopausal women, with or without existing vertebral fractures, through large, long-term, randomized double-blind placebo-controlled trials. Until recently, the vast majority of studies demonstrating that postmenopausal women not on ERT HRT had a higher number of fractures than an aged matched cohort of women on ERT HRT were only case-control or cohort designs. Several critics argued that the estrogen benefits observed in these studies were due to "Healthy User Bias; " the observation that postmenopausal women on ERT HRT tend to be healthier i.e., nonsmokers, exercised more ; than their agematched cohorts not taking estrogen.14 The WHI and other recent clinical trials have finally demonstrated that estrogen significantly reduces fractures among osteoporotic postmenopausal women in a prospective, randomized fashion.1, 15, 16 The WHI is the first trial with definitive data supporting the ability of postmenopausal hormones to prevent fractures at the hip and other sites. Table 1 ; However, it is unlikely that estrogen will receive the added indication for osteoporosis treatment, based solely on these recent studies, given their design limitations and the FDA's recent response to the WHI's adverse findings.17.
Stock market valuation of R&D Role of Contagion Shocks By Aiyaswami Prasad1 Abstract We investigate the nature and contagion effects of unanticipated shocks in hi-tech R&D intensive industries and evaluate their impact on firm value and R&D expenditure. The contagion effects of such unexpected shocks in R&D intensive industries have not been studied so far to our knowledge. We find that such shocks are frequent in all hi-tech industries and the financial and trade reports claim that such shocks have industry wide contagion effects which adversely affect R&D. We formulate a model to explain the nature of these shocks based on herd behavior and information asymmetry. Our model predicts that such shocks will be frequent and the contagion effects will be local to a specific group of firms in the industry. The model further suggests that such shocks adversely affect subsequent R&D expenditure of the firm and the adverse impact is in proportion to the R&D intensity. We draw testable hypotheses from our model in the context of pharmaceutical industry. We empirically test our hypotheses on pharmaceutical industry and use the recent withdrawal of Vi0xx by Merck as the unanticipated shock. The empirical tests support our model. Our model and findings have important policy implications for the R&D intensive industries. We find support for previous recommendations in the literature to bring about a simplified legal framework and foster industry alliances to enhance R&D.
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| Vioxx for menPregnancy: chlordiazepoxide information on the drug vioxx and diazepam have been reported to increase the chance information on the drug vioxx of birth defects when used during the first 3 information on the drug vioxx months of pregnancy.
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