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And studies of adding clonidine to a serotonergic medication have had mixed results in treatmentresistant OCD and the side effects usually are limiting. Older Antidepressants Sometimes older antidepressants are added to an SSRI to boost anti-obsessional effects. Trazodone has been reported to improve the severity of OCD in some patients when it was added to fluoxetine, although many patients could not tolerate the combination because of sedation. In another study, low doses of clomipramine plus fluoxetine resulted in greater clinical improvement with fewer side effects when compared with clomipramine alone. Other antidepressants such as mirtazepam, nortriptyline, and imipramine are sometimes used. Neuroleptics Anti-psychotic agents also referred to as `neuroleptics' ; are not generally useful for patients with OCD. However, some small studies have shown that the addition of one of these medications to a serotonergic medication resulted in improvement in OCD in some patients who were treatmentresistant to the serotonergic agent alone. If neuroleptic addition is considered, it is important to identify specific `target symptoms' that one is treating. If there is no improvement with the neuroleptic addition after a few months, the neuroleptic should be stopped because there is a risk of irreversible neurological side effects from these types of medications. OCD patients with tic symptoms may be more likely to respond to the addition of a neuroleptic. In addition to several of the older `first generation' anti-psychotic agents, over the last several years a few newer `second generation anti-psychotic medications have become available. The medical literature describes a few reports examining the effects of these second generation neuroleptics Risperdal, Zyprexa, Seroquel, Geodon ; , suggesting that these medications may have potential utility as augmenting agents for some patients with OCD. One benefit of these newer anti-psychotic agents is the reduced risk of long-term neurological side effects. It is, however, important to be taking a SSRI prior to starting one of these drugs because they are known to worsen OCD or even bring it out when used alone. It is important to monitor weight gain with these drugs especially Zyprexw ; and to change medication if this becomes a clinically significant problem. Depression Persists Despite Improvement In OCD In patients whose OCD responds well to medication and CBT, but who remain depressed, the addition of a second drug to a SSRI may improve mood, often quickly and dramatically. In our experience, the most effective augmenter for this situation is Wellbutrin bupropion ; , but other agents like lithium, Cytomel, pindolol, and the other antidepressants are sometimes effective!
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H Pylori Infection Should Be Treated 4-8 TREATING HELICOBACTER PYLORI INFECTION IN PRIMARY CARE PATIENTS WITH UNINVESTIGATED DYSPEPSIA Dyspepsia is one of the most common conditions presenting to primary care. Most patients are not investigated and the cause is usually not known. Primary care clinicians are comfortable treating patients without an initial diagnosis and prescribe up to 2.5 courses of empirical drugs before referring for investigation. The majority of investigations are normal and the diagnosis is functional dyspepsia. A suggested strategy for managing uninvestigated dyspepsia is to screen patients under age 50 with a noninvasive test for H pylori and to eradicate the infection in those with positive results. This study determined whether a non-invasive H pylori "test and treat" strategy for primary care adult patients of any age with uninvestigated dyspepsia would result in improvement or cure of dyspepsia. Conclusion: A "test and treat" strategy resulted in significant symptomatic benefit. STUDY 1. Randomized, placebo-controlled trial entered 294 patients with dyspepsia. All had a positive H pylori.
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Associated with capacity increases for certain growth and new products, and higher inventory losses. These declines in gross margin were partially offset by favorable changes in product mix due to growth in sales of other higher margin products, such as Zyprexa, Gemzar, Evista, and diabetes care products, and favorable manufacturing throughput from increased volume of product manufactured. Operating expenses decreased 1 percent in 2002. Research and development expenses decreased 4 percent, to $2.15 billion, due primarily to lower late-stage clinical-trial costs as more products were awaiting regulatory approval. Despite the decline, we invested approximately 19 percent of our sales in research and development efforts in 2002. Marketing and administrative expenses remained essentially flat compared with 2001 despite the continued expansion of our worldwide sales force and increased marketing efforts in support of our growth products and upcoming product launches. Operating expenses were also reduced due to lower incentive compensation expenses, reimbursement from collaboration partners, and cost containment, none of which were individually material. During 2002, we expensed $84.0 million for acquired inprocess research and development costs related to the exenatide collaboration arrangement with Amylin. Exenatide is in the development phase and no alternative future uses were identified. Net other income for 2002 was $293.7 million, an increase of $13.0 million. The increase was primarily due to a combination of income recognized from upfront and milestone payments from Quintiles Transnational Corp. Quintiles ; as part of a Cymbalta commercialization agreement and income recognized from InterMune, Inc., related to out-licensing oritavancin in 2001, offset primarily by lower interest income due to lower interest rates. Interest expense for 2002 decreased $112.0 million, to $79.7 million, primarily due to lower variable interest rates paid on our debt. The effective tax rate for 2002 was 21.7 percent compared with 20.7 percent for 2001. See Note 11 to the consolidated financial statements for additional information.
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Who can be prescribed olanzapine? Olanzapine brand name, Zyp5exa ; may be prescribed for people with schizophrenia and related psychoses. How long before it starts to work? People being treated with olanzapine may see some bene ts within six weeks of starting to take it. If it is not helping, then the doctor may consider adjusting the dose or replacing it with a different antipsychotic medication. What are possible side-effects? Some people taking olanzapine may experience blurred vision, weight gain, sleepiness, increased appetite, dizziness, low blood pressure, dry mouth or constipation. What can be done about these side-effects? Some of these side-effects, such as sleepiness, may decrease over time, while others may be helped by the doctor reducing the dose prescribed. Problems with weight gain can be helped by a careful diet and regular exercise and
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Who is Jim Gottstein? He is President and CEO of PsychRights. See : psychrights What are the Zyp4exa Papers? They are crucial documents in the fight to hold Eli Lilly accountable for hiding harm caused by Zypreca and their illegal marketing of it. What is the problem? Jim Gottstein, in his effort to hold Eli Lilly accountable has become embroiled in a legal battle with this pharmaceutical giant. 2005 Revenues: 14.6 Billion ; Jim Gottstein faces financially ruinous sanctions in his attempt to protect and inform the public. What can you do? Below are background information and possible actions you can take. Background. Jim obtained the Zyprfxa Papers by subpoenaing Dr. David Egilman as provided in the Protective Order in a case where he served as an expert witness. An expert in Public Health, Dr. Egilman had been retained by a plaintiff's law firm in the massive litigation over Zyprexa causing diabetes and other metabolic disease. When Jim received the papers, he released them to New York Times reporter Alex Berenson and others. As reported in the New York Times, the Zyprexa Papers prove Lilly hid the dangers of Zyprexa, downplayed its risks to doctors, and illegally marketed it to primary care physicians and the nursing home industry for non-FDA-approved uses. Not reported by the Times is that Zyprexa is also being illegally marketed for administration to children, especially those who have been taken away from their families. As a result of what was revealed in the Zyprexa Papers, the New York Times has called for a Congressional Investigation into Lilly's practices. On February 13, 2007, in spite of inviting a Congressional Investigation, Judge Weinstein erroneously concluded in very harsh terms that Jim had conspired with Dr. Egilman and Mr. Berenson to violate the Protective Order that had kept them secret, and ordered the Zyprexa Papers be returned by Jim and certain other people. This decision has set Jim up for financially ruinous contempt of court sanctions and potential action against his license to practice law. If you want to be a part of the efforts to hold Eli Lilly accountable and support Jim, the following are things you can do: Congressional Investigation Contact Congress, encouraging them to subpoena the Zyprexa Papers, and investigate Lilly and other companies' illegal marketing practices promoting off-label uses of psychiatric medications, especially on children and the elderly. The following Committees and their members can be contacted. Members and contact information for each committee can be found on the listed websites. It doesn't hurt to contact all members of these committees, but members of Congress are most responsive to people from their districts. The House Committee on Oversight and Government Reform has requested Eli Lilly produce documents pertaining to the issue. : psychrights Issues ZPapers 3-1-07RepWaxmanLtr . This can be the beginning of an investigation. Committee website: : oversight.house.gov . The House Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce is currently holding hearings on the FDA, where the topic of Zyprexa has been raised. : energycommerce.house.gov Subcommittees ovin.shtml The Senate Committee on Health, Education, Labor & Pensions has jurisdiction over this issue. : help nate.gov Health index The issue of documents being kept secret in settlements, including the Zyprexa Papers, has been raised in the Senate Judiciary Committee. : judiciary nate.gov.
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Several drugs in the pipeline for CNS disorders are expected to make a significant impact on drug trend over the next few years. In 2002, the drug to watch will be Lexapro which is a derivative of , Celexa Lexapro will be indicated for depression, and its manufacturer will aggressively try to . switch Celexa patients to Lexapro before Celexa's patent expires in 2003. Another antidepressant with potential is duloxetine. Duloxetine affects both serotonin and norepinephrine receptors in the brain, unlike SSRIs, which only affect serotonin. Whether this difference results in improved efficacy or safety remains to be seen. Development of atypical antipsychotics continues, with Abilitat and Zomaril the next products expected to be approved in 2002 or 2003. Abilitat is a mixed dopamine receptor agonist antagonist, while Zomaril is a serotonin dopamine antagonist. Both will compete with Zyprexa and Risperdal the current market leaders. , Atomoxetine and pregabalin are drugs expected to have an impact on their respective therapeutic classes. If approved, atomoxetine will be indicated for the treatment of attention-deficit hyperactivity disorder ADHD ; and will be the first non-scheduled product approved for ADHD. Pregabalin is similar to Neurontin but it is expected to have an indication for both epilepsy , and neuropathic pain and
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TRUSOPT Glaucoma drug patent term may be extended due to FDA review delays Fed. Cir. ; , 352 TYKERB Breast cancer drug approved, 280 U ULTRACET Pain drug, generic no infringement Fed. Cir. ; , 105 UNINSURED PERSONS Colo. discounted generics bill approved by Senate, 118; signed, 141 Wash., discounts available to all, 335 UNITED KINGDOM UK ; Dementia drug policy challenged, 341 Efficient prescribing could produce savings for Natl. Health, 557 Generic drug incentives questioned, 731 Hemophilia, U.K. proper venue for blood factor suits 7th Cir. ; , 516 Overpayments for drugs reported, 194 USER FEES Agenda for 2007 to address, 42 Agreement reached between FDA and industry, 60 Clinical trials, fee increase may lead to more FDA staff, 61 Foreign clinical trials and production facilities, fees may fund, 417 Generics, FY2008 FDA budget includes fees, 135; Senate panel approves, 748 Reauthorization --FDA submits revised proposal, 330 --Legislation. See LEGISLATION, FEDERAL, HR 2900, S 1082 Safety, user fee law may have affected, 415 Slow reviews blamed on FDA staffing, 580 UTAH Medicaid --Preferred drug list bill approved by Senate, 118; House approves, 188 --Zyprexa, fraud alleged Utah Dist. Ct. ; , 539 V VACCINES Avian flu vaccine approved, 422 Cervical cancer, Colo. Senate approves mandate, 498 DPT shots blamed for brain disorder, appeal of damages ruling dismissed N.C. Ct. ; , 298 FluMist. See FLUMIST Guidance to increase vaccine supply issued by FDA, 601 Medicare guidance delayed, 445 Mercury-based preservative, design defect claims preempted E.D. Pa. ; , 461 Mo. pharmacists may administer vaccinations, bill signed, 751 Neurological damage blamed on preservative, federal law no bar to suit Ga. Ct. App. ; , 742 Polio vaccine blamed for mesothelioma, widow's claim reinstated Cal. Ct. App. ; , 88 Rotavirus vaccine complications reported by FDA, 167 Tenn. liability limits approved, 446 VALTREX Herpes drug, generic, In Brief, 121; generic approved, 143 VERMONT Data mining, medical privacy bill signed, 624 Marketing, Biogen Idec to file disclosures, 65 VIAGRA AIDS group challenges ads Cal. Super. Ct. ; , 82 and
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Written for these drugs. For example, while cancer-fighting drugs averaged $135 per prescription in fiscal 2004, foster children received only 52 prescriptions for these drugs. The four drug categories with the highest average price per prescription--immunosuppressants, urology, cancer and endocrinology-related drugs--include some of the most expensive medicines. For example, the very expensive immunosuppressant drug Cytogam, which is used to treat patients who receive organ transplants, cost Medicaid $655 for a 2.5 gram vial in fiscal 2004. In the same year only 365 immunosuppressant prescriptions were filled for foster children. Similarly, medications used to treat endocrine system problems, such as growth and development in children, are among the most expensive medications per prescription. For example, a 10 milligram vial of Nutropin, a hormone used to stimulate growth in children, cost the Medicaid program $110 per day. Only 2, 655 endocrinology prescriptions were filled for foster children in fiscal 2004. A dozen of the most expensive urology drugs used to treat foster children's urinary disorders and kidney disease pushed up the average price per prescription for this category of drugs to $158. In fiscal 2004, foster children received 10, 734 prescriptions for these drugs. In fiscal 2004, combined spending on these expensive drug categories--immunosuppressants, urology, cancer and endocrinology--was only $2.1 million, compared to $30 million spent on psychotropic drug prescriptions. Similarly, these four categories combined accounted for only 13, 806 prescriptions to foster children compared to 260, 784 prescriptions for psychotropic drugs. medications of pharmaceutical manufacturers willing to give the plan a price reduction. With Medicaid drug spending rising by 15 percent or more annually over the last ten years, many states are employing a variety of cost-containment mechanisms similar to those utilized in the private sector to reduce their drug expenditures. Many states including Texas have recently created a preferred drug list PDL ; , a list of generic and cost-effective brand-name drugs, and require physicians to obtain prior authorization PA ; from the state before prescribing a drug not on the PDL. To enhance and support their PDLs, many states also have adopted supplemental rebate programs that require drug manufacturers to provide additional rebates for brands included on the PDL. In a January 2003 report, Limited Government, Unlimited Opportunity, the Texas Comptroller recommended that the state should establish a Medicaid PDL, prior authorization and negotiate state supplemental rebates.2 The 2003 Texas Legislature's House Bill 2292 directed the Health and Human Services Commission HHSC ; to implement a PDL for Medicaid and the Children's Health Insurance Program by March 1, 2004. HHSC began implementing the first phase of the Medicaid PDL on February 23, 2004. The state also has a supplemental state rebate program that applies both to brand-name and generic drug manufacturers. Texas was the first state to require generic manufacturers to provide a state supplemental rebate for their drugs to be placed on the PDL. The implementation of the Texas Medicaid PDL and prior authorization is producing a shift in prescribing patterns. For example, between fiscal 2004 and 2005, the number of prescriptions to foster children for the antipsychotic Zyprexa declined 49 percent, most likely because that medication was listed as a non-preferred drug requiring prior authorization. Similarly, the number of prescriptions given to foster children for the.
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Proposed as an iterative process. Once we identify the RTOG populations at highest risk for poor outcomes associated with depression, we will implement a study to target screening and referral interventions to improve outcomes in this population. Principal Investigator Deborah Watkins Bruner, Ph.D. Fox Chase Cancer Center 510 Township Line Rd Cheltenham, PA 19012 Other Participating Researchers Andre Konski, M.D., Benjamin Movsas, M.D. - employed by Fox Chase Cancer Center James Coyne, Ph.D. - employed by University of Pennsylvania Expected Research Outcomes and Benefits The outcomes of this study will be the identification of special populations at risk for poorer outcomes after state-of-the art head and neck, lung and prostate cancer therapies. The benefits of this study are that the findings will lead to targeted interventions to improve quality of life and survival. Specifically, we expect the results of this study to provide pilot data and rationale for at least two larger interventional trials. First, once we identify the cancer patient populations by site, age etc, ; at highest risk for poor outcomes associated with depression, we plan to test methods of early identification and increased mental health referrals to improve outcomes. Second, if our preliminary data on differential outcomes by age and functional status are substantiated in this study, we intend to pursue a protocol of tailored radiotherapy plus or minus chemotherapy for those populations identified by cancer site. Summary of Research Completed We have previously shown patients of lower socioeconomic status with head and neck cancer have poorer outcomes despite receiving standardized treatment on clinical trials. We proposed to further investigate this further to identify which patients are at high risk for the cancer coming back and to develop strategies to target those patients with interventions that would improve outcomes. We propose to evaluate the health outcomes in three different subsets of patients, head and neck patients, lung cancer patients and patients with prostate cancer. The use of tobacco products is a well known carcinogen for patients with head and neck and lung cancer. We will analyze data prospectively collected on patients treated on Radiation Therapy Oncology Group RTOG ; head and neck, lung, and prostate cancer clinical trials to identify new prognostic factors that may lead to poorer outcomes than would normally be expected for equal stage of disease. Depression has been found to adversely affect.
Symptoms vary considerably, often mimicking those recurrence of pain.5 of other medical conditions. Laparoscopic visualization is considered the primary vehicle for definitive diagno- that patients often undergo repeat surgeries for relief sis, although use of this procedure as a diagnostic and of symptoms and may experience surgical complitreatment tool remains controversial. At least a third of cations--and still not obtain long-lasting pain relief. patients with pelvic pain have completely normal pelvic Symptoms may, in fact, become worse and lead to anatomy at laparoscopic evaluation. For many patients complicated medical regimens to manage pain. the degree of disease identified at laparoscopy does Medical treatments demonstrate efficacy similar not seem to correlate with the amount of pain they ex- to that of laparoscopy, and they are marked by simiperience. To some extent the clinically visualized find- lar rates of pain recurrence. It should be noted that ings may represent a "tip of the iceberg" phenomenon, endometriosis represents a condition that cannot be in that deep, infiltrating endometriosis lesions may ap- cured. Treatment must, therefore, involve multifacpear on the surface as minute fibrotic implants. In these eted short- and long-term interventions to manage cases, the extent of the disease cannot be determined symptoms and patient quality of life. by visual inspection. Additionally we must remember In this roundtable discussion, gynecologic surthat laparoscopy can only tell us about structural abnor- geons join a family physician and a nurse practitioner malities in the pelvis. It cannot identify pelvic floor mus- to discuss the challenges and the strategies for mancular sources or functional organic sources of pain.1-4 aging this patient population.
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A class action suit on behalf of those who have suffered negative consequences from zyprexa, was filed last january in the supreme court of british columbia by the law firm of poyner baxter of north vancouver.
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