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As the FDA's drug approval process comes under increasing scrutiny in the US, Health Canada moves closer to beginning concurrent drug reviews with the American regulator. "We're looking at the potential to implement pilot activities that would allow for concurrent reviews of materials submitted to both Health Canada and to the United States, " says Dr. Robert Peterson, director-general of Health Canada's therapeutic products directorate. "We would hope that that would take place within the next year." The joint reviews would take place under the terms of a memorandum of understanding that Canada and the United States signed in April 2004 CMAJ 2004; 171: 121 ; . The agreement is intended to reduce bureaucratic hurdles for manufacturers applying to have new drugs approved in both jurisdictions, and to bring new drugs to market faster. In the past few months, the FDA has been criticized for the quality of its drug approvals and postmarketing system after problems involving COX-2 inhibitors. The criticisms intensifed when a senior drug reviewer accused the agency of ignoring his warnings about rofecoxib Vioxx ; and 5 other new drug submissions, prompting one US Senator to call for a congressional inquiry. David Graham, associate director for science and medicine in the FDA's Office for Drug Safety, told the US Senate Finance Committee in November that the FDA suppressed his concerns about rofecoxib, as well as other medications. He listed 5 drugs he said should be withdrawn from the market or examined more closely. All of the medications Accutane, Arava, Bextra, Crestor and Merldia ; are also approved in Canada and advisories have been issued Table 1 ; . "Rofecoxib is a terrible tragedy and a profound regulatory failure, " Graham testified at the hearing. "I would argue that the FDA, as currently configured, is incapable of protecting America against another rofecoxib. We are virtually defenceless." Graham cited what he termed the "inherent conflict of interest" in having the same office within the FDA that approves a new drug -- the Center for Drug Evaluation and Research -- responsible for taking postmarket regulatory action against it. "When a serious safety issue arises postmarketing, their immediate reaction is almost always one of denial, rejection and heat. They approved the drug so there can't possibly be anything wrong with it, " Graham said. Canadian experts say Graham's criticisms raise similar questions about Canadian drug regulation, and caution Canadian regulators about getting closer to the FDA. "I don't believe that the issues that the FDA faces are independent to that of Health Canada. You have these same concerns, " says Dr. Muhammed Mamdani, senior scientist with Toronto's Institute for Clinical Evaluative Sciences. In Washington, Dr. Sandra Kweder, deputy director of the Office of New Drugs Center for Drug Evaluation and Research, denied that the agency pressured Graham to withdraw or change findings in a paper he presented about rofecoxib. She also disputed his concerns about the 5 drugs that he says require further study or withdrawal. Health Canada's Peterson refused to comment about Graham's testimony or its impact on the Canadian agency's review of the 5 drugs in question. The department is conducting an ongoing re-evaluation of the drugs' "benefit-to-risk" profiles, he said. But a US watchdog organization, Public Citizen, says it has longstanding concerns about the FDA's drug approval process and the conflict of interest implied by industry funding of the approval process. "The twin engines of the FDA's demise are that the funding of most of the drug review is and mesterolone.
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The tragic fact is Respiratory Distress Syndrome is the leading cause of death among newborns, killing over 7, 000 babies each year. But American Heart Association research scientist John A. Clements, M.D. is working hard to discover its causes - and cures. He has shown that victims don't produce enough of the crucial chemic4l that promotes full lung expansion. Knowing this, doctors can perform a pre-natal test for the presence of this chemical in the womb. If a problem is foreseen, drug therapy can help save the baby and naprosyn.
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FULL DISCLOSURE POLICY AFFECTING CME ACTIVITIES As a provider accredited by the Accreditation Council for Continuing Medical Education ACCME ; , it is the policy of Johns Hopkins University School of Medicine to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or provider has with the manufacturer s ; of any commercial product s ; discussed in an educational presentation. The authors report no relevant financial relationships. No faculty member has indicated that the presentation will include information on off-label products. DISCLAIMER STATEMENT The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. This enduring material is produced for educational purposes only. Use of Johns Hopkins University School of Medicine name implies review of educational format design and approach. Please review the complete prescribing information of specific drugs or combination of drugs, including indications, contraindications, warnings and adverse effects before administering pharmacologic therapy to patients and soma.
Less than 15 watts and 60 lm W for lamps of 15 watts and above. Reflector-type lamps of less than 20 watts must have a luminous efficacy of at least 33 lm W and those of 20 watts and higher 40 lm W. All lamps must have a CRI of greater than 80, a two-year guarantee, and a lifetime of more than 6, 000 hours. Light levels fall off over time with all lamps, a phenomenon called lumen depreciation. ENERGY STAR-labeled lamps must have a lumen depreciation that retains 80% or more a lamp's initial lumens at 40% of its rated lifetime. Other performance criteria for CFLs are available on the ENERGY STAR web site, : energystar.gov index ?c cfls.pr crit cfls. A list of CFLs that have been qualified under the ENERGY STAR program is available for downloading at : energystar.gov ia products prod lists cfl prod list.xls. There are over 1, 675 products listed in the spreadsheet. In every case, the date on which a given product was listed is given, but there are two other columns that give dates when the product was taken off the list either because of being no longer manufactured 7% ; , usually because older models are replaced by newer models, or becoming disqualified 15% ; . Both consumers and manufacturers of high-quality products are benefited by EPA's diligence in taking lower-quality products off the list of ENERGY STAR-qualified CFLs. The list also includes model numbers by manufacturer, packaging description, wattage, rated life, lumen output, color temperature, and type design. The rated lifetime of all of the CFLs that have qualified for ENERGY STAR labeling averages 7800 hours and the average luminous efficacy is 58 lm This number includes many small wattage bulbs which are inherently difficult to manufacture at high efficiencies, an observation that applies to both incandescent and CFLs. For example, small incandescents designed for use in refrigerators typically have luminous efficacies of 10-12 lm W. CFL Economics In assessing the cost effectiveness of CFLs, it is tempting to calculate simple paybacks that compare the CFL incandescent option based on time of use. However, in all cases except those in which a bulb may be in a rarely-accessed attic, we believe it is more appropriate to ask the economic question based on lifetime considerations, to wit, "how much energy and money will this CFL save over its lifetime?" To illustrate, take an ENERGY STAR-labeled 24 watt quadruple tube CFL suitable for a floor lamp. This bulb has an output of 1520 lumens, almost exactly that of a 100 watt incandescent, but a luminous efficacy of 63 lm W, over four times that of the 100 watt incandescent at 15 lm Over its lifetime, the CFL will consume 288 kWh, as compared to 1, 200 kWh consumed by the incandescent, a savings of 912 kWh. At 8.5 cents per kWh, the energy savings is worth $77.52 ignoring the time value of money ; . Of course, over the lifetime of the CFL, one must replace the incandescent on the order of 12 times. Ignoring labor, runs to the hardware store, and land filling 12 times as many burnt out bulbs, the first costs of the CFL and the incandescents over the lifetime of the CFL are effectively a wash. What is the 912 kWh savings at the coal-powered power plant? At 10, 000 Btu kWh, a factor that accounts for the carnot effect and line losses, it is over nine million Btus, the energy equivalent of nine person years of labor. It's also associated with the mining, transporting, and burning of 650 pounds of coal, the evaporation of over 450 gallons of water and the release of.
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Ability analysis in a large sample of IBS patient which allowed stratification into different symptom subgroups. Methods: Twenty-nine female IBS patients and 21 healthy women participated. We stratified our patient group into 14 patients with only lower bowel symptoms IBS + L ; , and 15 patients with both lower and dyspeptic like symptoms IBS + D ; . The protocol included a 30-minute quiet waking period followed by an overnight study in the sleep laboratory. Standard polysomnography was recorded to detect the various stages of sleep as well as the ECG in order to measure the beat-to-beat intervals of the cardiac cycle. Fifteen-minute segments were selected from waking, stage 2 of non-REM sleep, and REM sleep. Each segment was analyzed by spectral analysis to calculate the power in the low frequency LF ; band .04 - .15 Hz ; , a measure of sympathetic activity, power in the high frequency HF ; band .04 - .5 Hz ; , a measure of vagal tone, and the LF HF ratio as an indicator of sympatho-vagal balance. Figure 1.
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Dear Friends, Orange Regional Medical Center's commitment to Excellent customer service is making a difference for our patients. We constantly receive positive feedback from our patients and their families. They are telling us how we have improved, provided Excellent care to them as patients, and extended that same level of caring to their family members. The Patient Satisfaction Scores in our Emergency Departments continue to improve: In the 3rd quarter of 2004, the Arden Hill campus Emergency Department ranked the highest among NORMET * hospitals using National Research Corporation Picker as the survey vendor ; in almost every category. The 4th quarter 2004 results for the Horton campus Emergency Department were their highest scores for the year. In 2005, service excellence plans and activities are being extended to the rest of the hospital organization. We fully expect 2005 to be an Excellent year for the Medical Center, our patients, their families, and for the community. We'll continue to keep you informed about our goals and updated on our results. The posters at left and right are part of our upcoming service excellence campaign and feature our very own Emergency Department staff, who are models of professional excellence in their care and treatment of our patients and their families. These staff members and others represent the best of Orange Regional Medical Center. Thank you for choosing Orange Regional Medical Center in 2004. We look forward to serving you and your family when the need arises.
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