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Cash-based options with counseling support could theoretically be incorporated into any state or federally funded long-term or chronic-care program serving persons of all ages and many disabilities. Generally, disabled persons would have a choice of a case-managed service benefit or a monthly cash allowance of a monetary value lower than the currently available service benefit e.g., nursing home care ; . To be eligible for the monthly income supplement, an individual with a disability would have to show in some predetermined way that she could effectively use the extra income to meet her long-term support needs. Consumers would be able to spend the money in ways they best see fit. They might choose to purchase services from a home care agency or referral service at current rates, pay a friend or a relative to provide personal assistance services, make needed home modifications or move to an assisted living facility or other new housing arrangement. The counseling component would involve an assessment of need, consumer information and advice about the various service, financing and housing options available. Centers for independent living, area agencies on aging, other public or private organizations, or individuals that do not have a vested financial interest in the decisions made by the consumers would provide.
Violations of US regulations are common. In 1998, television ads for more than half of advertised products were judged by the FDA to violate US regulations.30 From 1997 to 2002 inclusive, 93 brands were advertised on television and radio.31 During this time, the FDA issued 61 untitled or Notice of Violation letters. The main reasons were overstatements of efficacy and minimization of risks. Figure 5 presents an excerpt from a FDA letter on a TV for a drug for adult attention deficit disorder, Strattera amoxteine ; . Repeat violations are also common. Schering-Plough's advertising of loratadine Claritin ; was found to violate FDA regulations 11 times from 1997 to January 2001. The FDA cited Glaxo Wellcome 14 times for illegal advertising of two forms of fluticasone proprionate Flovent and Flknase ; , 32 and Pfizer four times for broadcast and print ads for atorvastatin Lipitor ; . In November 2001, the FDA introduced a new administrative policy requiring its legal department to review letters of violation before they are sent to the company.33 The result was a sharp drop in the frequency of regulatory actions. There was no evidence of an accompanying improvement in DTCA quality. In September 2005, Thomas Abrams, director of DDMAC, the FDA division that regulates drug advertising, noted that "DDMAC has expressed some concerns this year about the quality of DTC [ads] declining over the past several years."34 The FDA published two additional draft guidelines on DTCA in January 2004. One warns companies not to run visually similar reminder and disease-oriented ads, as they will be treated as full product ads requiring risk information.35 It also states that disease-oriented advertising must not suggest or represent a specific brand. Additional suggestions are to be accurate, to convey a responsible public health message, and to avoid encouraging selfdiagnosis and self-treatment. The second guideline allows companies to present risk information in print advertising in consumer-friendly language.36 The withdrawal of Vioxx rofecoxib ; has led to public commentary in the US about the role of DTCA in stimulating sales of drugs that prove to be unacceptably hazardous. Legislators, such as US Senate Majority leader William Frist, have been quoted as saying that additional restrictions on DTCA were needed.37 In the months following Vioxx's withdrawal, Pfizer mounted a major advertising campaign for Celebrex celecoxib ; , 38 a drug in the same class as Vioxx. Questions had been raised about whether the cardiac risks were a class effect. In December 2004, the FDA asked Pfizer to stop all DTCA for Celebrex after evidence of cardiac risks had emerged from a long-term cancer trial. This is the first time that the FDA has asked a company to stop all DTCA for a specific brand. Pfizer complied with this request. The FDA subsequently judged the Celebrex ads to be illegal because of minimization of risks and overstatements of efficacy.39 PhRMA Pharmaceutical Research and Manufacturers of America ; , the US industry trade association, announced voluntary guidelines in July 2005, and 23 companies have agreed to abide by these guidelines.37 These are the most important new provisions: a delay in DTCA campaigns post-launch to first educate health professionals no time period is specified.
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Mental management of C.diff. "Surfaces should be kept clean, and body substance spills should be managed promptly as outlined in CDC's "Guidelines for Environmental Infection Control in Health-Care Facilities." Hospital approved cleaning products should be used for routine cleaning." : cdc.gov mmwr preview mmwrhtml rr5210a1 "Use an Environmental Protection Agency EPA ; -registered hypochlorite-based disinfectant for environmental surface disinfection after cleaning in accordance with label instructions; generic sources of hypochlorite e.g., household chlorine bleach ; also may be appropriately diluted and used. Note: alcohol-based disinfectants are not effective against C. Difficile and should not be used to disinfect environmental surfaces. ; Hypochlorite-based disinfectants have been used with some success for environmental surface disinfection in those patient-care areas where surveillance and epidemiology indicate ongoing transmission of C. Difficile." Information for Healthcare Providers: Frequently Asked QuesDisease tions : Treatment cdc.gov ncidod dhqp id CdiffFAQ HCP Cleaning and Disinfection The Bottom Line Healthcare disease intervention, infection control practices and communication are key elements to the management of patients with diarrhea who may have C. diff infections. Timely medication intervention, nursing communication of bowel changes and proactive patient placement can prevent the spread of infection in the early stages of infectious diarrhea. The role of housekeeping and collaborative efforts to keep high touch surfaces clean impact the patient's outcome and decadron.
USA The USA reported five per cent turnover growth in the year and this business represents 52 per cent of total pharmaceutical turnover. Advair maintained its strong growth with sales of 1, 235 million driving the overall respiratory growth of 21 per cent. However, this adversely affected sales of its constituent products, Flovent and Serevent, which both showed declines. Fflonase indicated for the treatment of perennial rhinitis grew strongly by 22 per cent. Sales growth of three per cent in the central nervous system products included sales of Wellbutrin up 18 per cent, reflecting the performance of the new once a day formulation Wellbutrin XL. Paxil sales declined nine per cent due to the launch of generic paroxetine in September 2003. By January 2004, GlaxoSmithKline's innovative new product Paxil CR increased its share of total Paxil prescriptions branded and generic ; since the generic launch from 33 per cent to 37 per cent. Paxil CR sales in 2003 were 387 million. Sales in the anti-virals therapeutic area grew four per cent with HIV led by a strong performance of Trizivir up 20 per cent, which partially drew sales from its constituent products. Valtrex, for herpes, grew 26 per cent driven by the FDA approval for the reduced risk of transmission of genital herpes. Sales of Avandia increased by 20 per cent, benefiting from the launch of Avandamet in November 2002. Anti-bacterial sales declined 41 per cent as a result of generic competition that began in the third quarter 2002. Coreg sales increased 28 per cent reflecting the benefit from recent data that showed a highly significant statistical difference in survival between Coreg and metopropol in patients with heart failure. Europe The discussion of individual market performance in the Europe region is on a 'turnover created basis' rather than a 'turnover invoiced basis'. Europe region contributed 28 per cent of pharmaceutical turnover. Although overall turnover growth in the region was only two per cent, good growth was recorded in Italy and Central and Eastern Europe, but government healthcare reforms, including pricing and reimbursement restrictions, adversely affected turnover in France, Spain and Germany. Seretide, GlaxoSmithKline's largest selling product in Europe, reported notable growth in France, Italy and the UK, although this was partly offset by expected declines in Serevent and Flixotide. Trizivir showed strong growth in all of the major markets in the region. The decline in sales of the herpes franchise was mainly as a result of generic competition for Zovirax partially offset by patients switching to the newer Valtrex product.
Flixotide Flovent and Becotide Beclovent are inhaled steroids for the treatment of inflammation associated with asthma and COPD. Serevent is a long-acting bronchodilator used to treat asthma and COPD, and Ventolin is a selective short-acting bronchodilator used to treat bronchospasm. Flixonase Flonas and Beconase are steroid intra-nasal preparations for the treatment of perennial and seasonal rhinitis and rhinocort.
Direct-To-Consumer Advertising: An Ethical Standpoint by Terri Wise Mr. Jones was diagnosed with GERD 4 years ago. Recently he saw a commercial for Nexium and decided he wanted to be on the medication. He made an appointment to see his doctor to ask about Nexium. At the appointment, his doctor tries to tell Mr. Jones that his GERD is adequately controlled with the less expensive Prilosec OTC. Mr. Jones argues with his doctor for a few minutes but finally concedes and leaves, aggravated. In the scenario, the patient makes an appointment specifically to ask about a medication he saw advertised on TV. Was it an efficient use of the doctor's time, or the patient's or insurance company's money? The doctor declined the patient's request; however he is risking the possibility of losing a patient because Mr. Jones is upset. This is becoming a more common occurrence in doctors' offices. Prescription drug advertising, otherwise known as direct-to-consumer DTC ; advertising, has become common place in the United States to the point that certain drugs are household names. Viagra is the "little blue pill" and Nexium is the "healing purple pill." Everyone wants to be "Claritin clear." Flonaee advertises with a fun detective scene while Nasonex has a French bumblebee as its mascot. "I have genital herpes" is a common statement heard in Valtrex commercials, showing scenes of people kayaking and running on the beach. Manufacturers of Lunesta and Ambien promote both good sleep and drugs that cause dependence, through TV commercials and magazine ads. Birth control pills are also commonly advertised in magazines. Computer pop-ups regularly appear, advertising drugs. Although, these advertisements are routine, they are highly debated in the medical community. Proponents defend their benefit in consumer education and awareness while opponents argue their harm to the medical profession and cost to the health care system. There are not many studies that examine the true impact of DTC advertising on the health care system, economically, or on doctor-patient relationships. In this paper, the pro and con arguments will be presented to prove that the harm outweighs the benefit, thereby demonstrating that DTC advertising violates the ethical principle of nonmaleficence, meaning do no harm. DTC advertising is defined as any effort by the pharmaceutical companies to Advertising of drugs to present their product in lay media to consumers. 1 consumers dates back to 1708 in which the first advertisement for a patent drug was placed in an American newspaper. 1 Currently, only in the US and New Zealand is DTC advertising legal; although New Zealand is discussing a ban. Also, the US is the only country without price restriction on prescription drugs. After years of debate, in 1997, the FDA and drug companies came to an agreement upon regulations that require advertisements to mention important risks or provide a statement on where to receive more information on the drug, such as a website, a phone number, physicians, and pharmacists. Drug companies spent .7 billion in 2001 which was a threefold increase from 1996. 5 Advertisements in medical journals are decreasing while DTC advertising is increasing with up to 90% of promotional spending for some drugs, such as Claritin, In 2000, Merck spent 0 million to being spent on consumer advertising. 6 promote Vioxx, which is now withdrawn from the market; this was million more than Pepsi advertising. 4.
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With roughly one PCP including physician assistants and nurse practitioners supervised by PCPs ; for each 1000 US residents, 300, 000 primary care providers would be the health care services payers. Private health care fee payment services could bid to administer the money for the government, but neither the government nor the contracting private health care fee payment services would be involved in health care decisionmaking. PCPs and not special interests, government, or insurance company bureaucrats would determine the guidelines for ordering and authorizing insurance payment for tests and treatments. Consequently, each PCP and each patient would have financial incentives to avoid funding tests and treatments that don't work. To help provide alternatives to tests and treatments that don't work and to assure adequate reserves for years when unusual amounts of sickness care are required, the health promotion compassionate care account for each PCP would only be allowed to spend 50% of the money allocated by the health care services payment administrator until at least million accrued in savings as a reserve or buffer for high-spending years. With one-third of health care spending going to health promotion compassionate care needs, this would take about two years on average. This money could be placed partly in relatively liquid investments as protection against high sickness care costing years but largely in creating or acquiring health promotion oriented intentional communities or retreat centers. Health Promotion Retreat Centers-Intentional Communities The health retreat centers-intentional communities, located primarily in rural areas, could serve as sites to provide healthy alternatives to tests and treatments that don't work with the following variety of health-related or health-supporting services to people: 1. Workshops on healthy living topics Chapters 3-19 ; 2. Health promotion activities--low cholesterol diet, aerobic exercise, gardening, exploring nature, etc Chapters 6, 8-11 ; 3. Pregnancy support Chapter 3 ; 4. Intensive support for disabled or chronically ill people Chapters 5 and 21 ; 5. Cardiac rehabilitation after an adverse cardiovascular event Chapter 6 ; 6. Recovery from depression, other mental illness, or stress Chapter 12 ; 7. Rehabilitation from orthopedic problems and injuries Chapter 15 ; 8. Substance abuse rehabilitation Chapter 19 and 21 ; 9. Assisted living Chapter 21 ; 10. Employment--construction, food services, gardening-farming, health care, etc 11. Rest, relaxation, and socializing 12. Spiritual practices--prayer, meditation, contemplation, and reflection 13. Safe and enriched environment for children--charter schools, music, athletics, nature study, etc 14. Sustainable living i.e., minimal autos, local food production, lower consumption, lower cost, higher quality lifestyle ; 15. Active retirement.
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XXXXXXXXX also stated that it was not aware of any data to support the contention that 'bilayer' preparations were being targeted for diversion, due to the ease by which pseudoephedrine could be extracted, and it would be premature to make any rescheduling decisions based solely on preliminary data. XXXXXXXXX opposed any further restrictions on pseudoephedrine-containing products and considered the June 2002 meeting decision to restrict access to singleactive ingredient products flawed. XXXXXXXXX stated that it had no plans of modifying XXXXXXXXX formulation based on economic grounds, and advised that the product was not considered a 'bilayer' preparation. In addition, it was indicated that the sales data for XXXXXXXXX did not suggest that it was being targeted for diversion. XXXXXXXXX reaffirmed its earlier statement that further scheduling of pseudoephedrine was inappropriate at this time, and stated that the national strategies and initiatives currently being undertaken should be given an opportunity to take effect. XXXXXXXXX supported rescheduling of all remaining pseudoephedrine containing products in S2 to S3, to ensure such products were stored out of the reach of the public. In addition, XXXXXXXXX stated that this approach would provide an opportunity for consumers to be guided by the pharmacist in selecting the appropriate pseudoephedrine product and astelin.
1. The Cardiac Arrhythmia Suppression Trial CAST ; investigators. Preliminary report: Effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Eng J Med 1989; 321: 406412. Echt DS, Liebson PR, Mitchell LB, Peters RW, ObaisManno D, Barker AH, et al. Mortality and morbidity in patients receiving encainide, flecainide or placebo: The Cardiac Arrhythmia Suppression Trial. N Eng J Med 1991; 324: 781788. Anderson JL, Platia EV, Hallstrom A, Henthorn RW, Buckingham TA, Carlson MD, et al. Interaction of baseline characteristics with the hazard of encainide, flecainide, and moricizine therapy in patients with myocardial infarction: A possible explanation for increased mortality in the Cardiac Arrhythmia Suppression Trial CAST ; . Circulation 1994; 90: 28432852. The Cardiac Arrhythmia Pilot Study CAPS ; investigators. Effects of encainide, flecainide, imipramine and moricizine on ventricular arrhythmias during the year after acute myocardial infarction: The CAPS. J Cardiol 1988; 61: 501 Gottlieb SS. The use of antiarrhythmic agents in heart failure: Implications of CAST. Heart J 1989; 118: 10741077. Podrid PJ, Schoeneberger A, Lown B. Congestive heart failure caused by oral disopyramide. N Eng J Med 1980; 302: 614617. Sami MH, Derbekyan VA, Lisbona R. Hemodynamic effects of encainide in patients with ventricular arrhythmia and poor ventricular function. J Cardiol 1983; 52: 507 DePaola AAV, Horowitz LN, Morganroth J, Senior S, Spielman SR, Greenspan AM, et al. Influence of left ventricular dysfunction on flecainide therapy. J Coll Cardiol 1987; 9: 163168. Shue SS, Lederer WJ. Lidocaine's negative inotropic and antiarrhythmic actions: Dependence on shortening of action potential duration and reduction of intracellular sodium.
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Workers in Russia reported a 12-month prevalence of 31.5%. u However, a much higher prevalence of 66.3% was reported among pharmaceutical workers in Israel. 12 The 12-month prevalence of back pain in this study is within the range of 4 0 - reported in a review of 80 publications concerning hospital workers. 4 It has been suggested that the prevalence of low back pain in low income countries is lower than in high income countries. 13 ' 14 The findings of this study do not corroborate this suggestion.Volinn's allusion14 is based on reports from six low income countries, including Nigeria. The paper from Nigeria 15 described the general health profile of rural dwellers in north-east Nigeria and did not focus on back pain in particular but listed it among several other symptoms of morbidity in the community. As a valid comparison of prevalence of low back pain in low and high income societies can only be made among studies with similar epidemiological designs and objectives, Volinn's argument may not be tenable. In this study, the prevalence of low back pain was higher among women than men. Some studies have reported this trend 16 and others 12 ' 17 have shown no gender differences. The prevalence of low back pain was higher among current smokers and ex-smokers than in non-smokers, but this difference was not statistically significant. Smoking has been associated with low back pain in several studies 11 ' 18 although the biological mechanism is not understood. 19 Respondents in this study, as in other studies, 3 ' 20 " associated low back pain with heavy physical work, bending, poor posture and prolonged sitting or standing. The need for re-design of jobs to reduce work load has been discussed in the literature but this is not a likely option in a rural hospital with only a basic infrastructure for providing healthcare. It is not surprising that the cost of manual handling equipment is not affordable for this small establishment. These factors reduce the scope of preventive measures among these workers. Some respondents suggested the need to increase staff numbers in order to reduce the workload of each individual. As many sufferers from low back pain complain about being overworked, this may offer some relief. Other simple measures suggested by the respondents to reduce the brunt of low back pain is the provision of good chairs. This was suggested by two out of three laboratory staff. Laboratory stools are a particular problem as many are designed without any support for the back. Treatment of back pain remains unsatisfactory. Twenty-nine percent of the respondents with back pain in this study took some rest to relieve their back pain while 70% take analgesics. Acute back pain may not be relieved by bed rest 23 while some studies have shown the positive effects of exercise 24 ' 25 and continuous activity.26 We conclude that the prevalence of back pain in this group of workers is comparable to that in workers in high income countries. Health education on posture and correct lifting techniques should be introduced in the workplace to reduce the burden of low back pain in low income countries.
Benefit of objective corroboration raises important statutory and constitutional issues. This issue is fully addressed in our previous submissions. DDMAC's interpretations of statements in the visual aids present another important issue: the interpretations appear deliberately calculated to be more expansive than could possibly be supported by the manufacturers' cited substantiations. For example, according to the Schering letter, the visual aid for Nasonex implies that patients prefer Nasonex to Flonase "overall." DDMAC alleges that this implied claim of "overall" patient preference cannot be substantiated by data from the study cited by Schering to support the statements in the visual aid. This is bound to be the case, because the cited study was designed to substantiate a narrower preference claim relating to specific sensory attributes such as scent and aftertaste. According to DDMAC: "Patient preference encompasses multiple aspects of patient experiences such as convenience, ease of use, dosing, dosage form, all aspects of efficacy, and adverse events." DDMAC fails to acknowledge that the visual aid does not contain an unqualified claim of "overall" patient preference. Rather, it states that patients preferred Nasonex "[b]ased on scent and taste attributes"--specifically, scent odor, immediate taste, and aftertaste. Moreover, the visual aid carefully explains that the patient preference claims are based on data from a multicenter, double-blind, crossover, clinical preference study of 100 subjects who assessed the products according to 8 sensory attributes: scent odor, immediate taste, aftertaste, less drip down, less run out, soothing, less irritation, and urge to sneeze. The visual aid states prominently that surveyed subjects preferred Nasonex 2: 1 with respect to three of the sensory attributes, and further made clear that the study only included "scent and taste attributes." Using this technique of attributing meaning to selected statements far beyond what could fairly be inferred from the statements, and without regard for either the specific language used by a manufacturer or the nature of the substantiating data, DDMAC is able effectively to ban any statement in a promotional piece to which it objects. As we have previously explained, the First Amendment requires DDMAC to have data corroborating its interpretations of promotional pieces and prohibits DDMAC from banning promotional claims that are based on sources of information that do not meet the unreasonably high "substantial evidence" standard discussed below ; . The untitled letters to Schering and GSK further illustrate the perilous consequences of DDMAC's current policies and procedures, which acknowledge no constitutional limitation. Inappropriate Treatment of Comparative Claims DDMAC's allegation that the detail aid for Flonase contains unsubstantiated superiority claims highlights the agency's firmly established policy of allowing drug manufacturers to make promotional claims regarding products only if those claims are supported by "substantial evidence." According to DDMAC, the reference cited by GSK "does not provide substantial evidence" because the "study design raises multiplicity issues" and the "study was not replicated." DDMAC's position, that promotional claims may only rely for substantiation on sources that meet FDA's high standard--the same standard used to determine whether a drug is approvable--not only harms the public health by keeping new scientific developments from health care practitioners, but also raises significant questions under the First Amendment. As a legal matter, a prescription drug manufacturer is entitled to make statements in its promotional and aristocort.
Obtained in later clinical trials. A number of new drugs and biologics have shown promising results in initial clinical trials, but subsequently failed to establish sufficient safety and effectiveness data to obtain necessary regulatory approvals. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. Clinical trials may not demonstrate statistically sufficient safety and effectiveness to obtain the requisite regulatory approvals for product candidates. In addition, as happened with Tysabri, unexpected serious adverse events can occur in patients taking a product after the product has been commercialised. Our failure to successfully develop and commercialise Tysabri and other products would materially adversely affect us.
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In another trial, the potential systemic effects of FLONASE Nasal Spray on the hypothalamicpituitary-adrenal HPA ; axis were also studied in allergic patients. FLONASE Nasal Spray given as 200 mcg once daily or 400 mcg twice daily was compared with placebo or oral prednisone 7.5 or 15 mg given in the morning. FLONASE Nasal Spray at either dosage for 4 weeks did not affect the adrenal response to 6-hour cosyntropin stimulation, while both dosages of oral prednisone significantly reduced the response to cosyntropin. CLINICAL TRIALS A total of 13 randomized, double-blind, parallel-group, multicenter, vehicle placebo-controlled clinical trials were conducted in the United States in adults and pediatric patients 4 years of age and older ; to investigate regular use of FLONASE Nasal Spray in patients with seasonal or perennial allergic rhinitis. The trials included 2, 633 adults 1, 439 men and 1, 194 women ; with a mean age of 37 range, 18 to 79 years ; . A total of 440 adolescents 405 boys and 35 girls ; , mean age of 14 range, 12 to 17 years ; , and 500 children 325 boys and 175 girls ; , mean age of 9 range, 4 to 11 years ; were also studied. The overall racial distribution was 89% white, 4% black, and 7% other. These trials evaluated the total nasal symptom scores TNSS ; that included rhinorrhea, nasal obstruction, sneezing, and nasal itching in known allergic patients who were treated for 2 to 24 weeks. Subjects treated with FLONASE Nasal Spray exhibited significantly greater decreases in TNSS than vehicle placebo-treated patients. Nasal mucosal basophils and eosinophils were also reduced at the end of treatment in adult studies; however, the clinical significance of this decrease is not known. There were no significant differences between fluticasone propionate regimens whether administered as a single daily dose of 200 mcg two 50-mcg sprays in each nostril ; or as 100 mcg one 50-mcg spray in each nostril ; twice daily in 6 clinical trials. A clear dose response could not be identified in clinical trials. In 1 trial, 200 mcg day was slightly more effective than 50 mcg day during the first few days of treatment; thereafter, no difference was seen. Two randomized, double-blind, parallel-group, multicenter, vehicle placebo-controlled 28-day trials were conducted in the United States in 732 patients 243 given FLONASE ; 12 years of age and older to investigate "as-needed" use of FLONASE Nasal Spray 200 mcg ; in patients with seasonal allergic rhinitis. Patients were instructed to take the study medication only on days when they thought they needed the medication for symptom control, not to exceed 2 sprays per nostril on any day, and not more than once daily. "As-needed" use was prospectively defined as average use of study medication no more than 75% of study days. Average use of study medications was 57% to 70% of days for all treatment arms. The studies demonstrated significantly greater reduction in TNSS sum of nasal congestion, rhinorrhea, sneezing, and nasal itching ; with FLONASE Nasal Spray 200 mcg compared to placebo. The relative difference in efficacy with as-needed use as compared to regularly administered doses was not studied. Three randomized, double-blind, parallel-group, vehicle placebo-controlled trials were conducted in 1, 191 patients to investigate regular use of FLONASE Nasal Spray in patients with perennial nonallergic rhinitis. These trials evaluated the patient-rated TNSS nasal obstruction and beconase.
Dr Northrup: You bet. I wanted my own daughters to see that kind of person, so I called Woodson Merrell, MD, who runs the Continuum Center at Beth Israel in New York City. That whole hospital is starting to incorporate integrative medicine in surgery and in internal medicine. I asked, "Do you have a good nurse practitioner?" He said, "Yes, we've got somebody who does all the conventional work, but she also provides traditional Mayan GYN massage and is a master herbalist." This nurse practitioner is working right in the middle of New York City, in the hospital, and they're all over the place. This is good news. People like me have been "hiding out" in conventional medicine settings for years and years; back in the 1980s, I used to have to close the door when I talked to a cancer patient about nutrition--for fear that my colleagues would hear this "heresy." Now it's not heresy anymore. I find that there are good people within the system everywhere--but also good people who don't work within the system at all. The best thing, obviously, is to work with somebody who's involved in the conventional medical system as well as integrative medicine, where you can get the best of both worlds. That's going to occur more and more. There's a Duke University program for Integrative Medicine; the University of Minnesota Medical School has a medicine and spirituality section. So this is happening. I think everyone needs a good acupuncturist who does traditional Chinese medicine. Everyone needs a massage therapist. The last person I personally ever go to is MD. Ever.
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Increased cholinergic activity from parasympathetic stimulation is documented in allergic and nonallergic including infectious ; rhinitis Druce, Wright, Kossoff, et al., 1985; Raphael, Baraniuk, and Kaliner, 1991; White, 1995 ; resulting in increased nasal secretions and congestion. Anticholinergic medications can cause a reduction in the volume of nasal secretions and some degree of vasoconstriction. Ipratroprium bromide, available as a nasal spray, is a quaternary derivative of isopropyl noratropine and is poorly absorbed by the nasal mucosa and does not cross the blood brain barrier. It has been demonstrated to be effective in reducing rhinorrhea in adults and children with both allergic and nonallergic rhinitis Bronsky, Druce, Findlay, et al., 1995; Druce, Spector, Fireman, et al., 1992; Georgitis, Banov, Boggs, et al., 1994; Grossman, Banov, Boggs, et al., 1995; Meltzer, 1995; Meltzer, Orgel, Bronsky, et al., 1992 ; . Intranasal corticosteroids, and to a significantly lesser degree, cromolyn sodium, are antiinflammatory medications that have been proven effective in treating patients with more pronounced or protracted allergic rhinitis Weiner, Abramson, and Puy, 1998 ; . The corticosteroids inhibit many of the steps in the cascade of allergic inflammation in allergic rhinitis and are documented to provide excellent symptom relief for all the symptoms of allergic rhinitis, including nasal congestion and blockage Mygind, Nielsen, Hoffmann, et al., 2001 ; . This has resulted in superior efficacy assessments for intranasal corticosteroids when compared to oral antihistamines in the treatment of allergic rhinitis Weiner, Abramson, and Puy, 1998 ; . Many formulations of intranasal corticosteroids are currently available. Examples include Nasonex mometasone furoate ; , Flonase fluticasone propionate ; , Rhinocort budesonide ; , Beconase and Vancenase beclomethasone diproprionate ; , Nasacort triamcinolone acetonide ; , Nasarel and Nasalide fluniolide ; Allen, 2000; Corren, 1999 ; . The onset of action varies but it is believed that all require three to seven days for optimal effect. There are differences in estimated potency and systemic bioavailablity between the different agents, which might alter the long-term safety profile, but clear differences in clinical efficacy have not been established Allen, 2000; Corren, 1999 ; . Prophylactic use with initiation of use two weeks in advance of seasonal pollen symptoms has been proposed for maximal symptom reduction. The corticosteroids can inhibit inflammatory responses whether the inciting agent is allergic, chemical or infectious, and there is documented clinical efficacy of these agents in both allergic rhinitis and nonallergic rhinitis Dykewicz, Fineman, Skoner, et al., 1998 ; . Cromolyn sodium requires frequent dosing four times a day ; for efficacy, and is also best used prophylactically since its postulated mechanism of action is to prevent mast cell degranulation rather to treat the symptoms of an established allergic reaction in the nose. It may require up to two weeks of continuous usage for maximal clinical effect. Its efficacy in treatment of allergic rhinitis is generally considered to be somewhat less than the antihistamines and significantly less than the intranasal corticosteroids Brogden, Speight, and Avery, 1974; Dykewicz, Fineman, Skoner, et al., 1998; Meltzer, 1995 ; . Oral corticosteroids are used for treatment of very severe or intractable nasal symptoms or to treat significant nasal polyposis Dykewicz, Fineman, Skoner, et al., 1998 ; . They are not recommended for the routine treatment of allergic rhinitis or nonallergic rhinitis Allergen desensitization immunotherapy is utilized for patients with more severe allergic rhinitis requiring significant amounts of medication or for those who exhibit poor tolerance or nonresponsiveness to pharmacological treatment Kay, 2001 ; . Specific immunotherapy consists of administering increasing concentrations of extracts of allergen over a long period. A typical course of therapy consists of three or more years of subcutaneous injections of the highest or maintenance level of extract at intervals of two to six weeks. Initial therapy requires a series of weekly!
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Congratulations on your pregnancy! We hope you will find the following questions answers helpful. If you have other questions or would like to discuss this information further, please make notes from this list and bring to your next appointment. During the second trimester, it is normal to feel pains in the pelvis as the uterus grows, your skin stretches and the baby moves around. During the third trimester, it is common to have a backache and sciatica. Sciatica causes shooting pains down the back of the leg and buttocks. Toward the end of the third trimester, ligaments in the hips and pelvis loosen, causing discomfort. The baby may kick nerves on the inside of the uterus causing shooting pains toward your upper abdomen or vagina. Areas of numbness may also occur on your abdomen. 9. WHEN CAN I EXPECT TO FEEL THE BABY MOVE? You can expect to feel the baby move at 20 - 22 weeks of pregnancy. You may not feel regular movements until 28 weeks of pregnancy. 10. IS IT NORMAL TO HAVE VAGINAL SPOTTING OR BLEEDING AFTER MY VAGINAL EXAM during the later part of the third trimester ; OR AFTER INTERCOURSE? Yes. It is common to have spotting or bleeding in these situations as a result of cervical softening. The cervix must soften before dilation can occur. 11. I HAVE ASTHMA OR ALLERGIES ; . CAN I CONTINUE MY REGULAR MEDICATIONS? Yes. You need to be healthy for the baby to be healthy. Use of inhalers such as Ventolin, Asmacort, Proventil, or Flonase will help to keep the breathing passages open. If you are on an antihistamine such as Claritin, Zyrtec or Allegra, you may continue using it. 12. WHEN A PHYSICIAN SAYS I 20 WEEKS PREGNANT, HOW MANY MONTHS IS IT? Obstetricians have standardized timing a pregnancy to 40 weeks so that it is easier to communicate and determine due dates as well as testing. The first day of your last menstrual period is used to calculate your due date. Twenty weeks is exactly half way through your pregnancy or about 4 1 2 months along. 13. IS IT SAFE FOR MY DENTIST TO TAKE X-RAYS? You should continue to care for your teeth in the normal manner. If x-rays are necessary, your dentist will shield the baby. Filling cavities or taking antibiotics for dental procedures is safe and desirable, as pregnancy can increase dental disease. Local anesthetics like novocaine ; are safe. Your dentist should not use nitrous oxide laughing gas ; while you are pregnant. continued on page 2.
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SIGNATURES Pursuant to the requirements of Section 13 or 15 the Securities Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized. INTERMUNE, INC. By: s NORMAN L. HALLEEN Norman L. Halleen Senior Vice President of Finance Administration and Chief Financial Officer Dated: March 16, 2005 POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Norman L. Halleen and Daniel G. Welch, and each of them, as his true and lawful attorneys-in-fact and agents, with full power of substitution for him, and in his name in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, and any of them or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Exchange Act of 1934, the following persons on behalf of the registrant and in the capacities and on the dates indicated have signed this Report below.
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