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Vermont Legislature Passes Law Regulating All Drug/Device Company Marketing, Requiring Disclosure Of Gifts To Doctors
The Vermont Legislature has passed legislation (S 48) that bans nearly all gifts from pharmaceutical and medical device companies to health care providers, administrators and facilities in the state, the New York Times reports. The legislation specifically would prohibit drug and device makers from giving providers no-cost meals. Vermont"s legislation would go further than similar laws in other states like Massachusetts and Minnesota by requiring drug and medical device manufacturers who give gifts to health providers to publicly disclose recipients" names and dollar amounts of payments and gifts. The measure would not require manufacturers to disclose payments for clinical research of products undergoing FDA review, the Times reports. The legislation also would eliminate a loophole that allows manufacturers to conceal certain expenses by claiming them as trade secrets. In a recent report, the Vermont Office of the Attorney General said that medical product makers spent about $2.9 million on promotional efforts to the state"s health care providers in fiscal year 2008 and that nearly half of the state"s 4,573 licensed providers had received some type of incentive from drugmakers in the same year. The report, which was developed prior to passage of the new legislation, offers only aggregate data, as 83% of the manufacturer-declared payments were deemed to be trade secrets, the Times reports.Gov. Jim Douglas (R) is expected to sign the law, which would take effect July 1. Several state medical groups -- including the Vermont Association for Mental Health and the Vermont Medical Society -- have indicated support for the legislation.Marjorie Powell, a senior lawyer for the Pharmaceutical Research and Manufacturers of America, said the requirements under the new law appear redundant with new voluntary guidelines the group has issued on physician gifting practices. She said, "We think this is unnecessary, and it is not going to improve patient care," adding, "It makes it onerous not only for the company but also for the physician in Vermont, because this is going to be on a Web site" (Singer, New York Times, 5/20).

Emerging Health Care Crisis In The Developing World: Gram-Negative Rods Discovered In Two Philippine Neonatal Intensive Care Units
Researchers at Boston University School of Medicine (BUSM) have found a high frequency of multidrug-resistant Gram-negative rods (GNRs) in two of the largest neonatal intensive care units (NICUs) in the city of Manila, Philippines. Improved infection control methods could reduce the vast number of hospital acquired neonatal infections. The BUSM study appears online in the journal Infection Control and Hospital Epidemiology.
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Implanted Defibrillators: New Recommendations For Drivers With ICDs

Patients with an Implantable Cardioverter Defibrillator (ICD) have an ongoing risk of sudden incapacitation that might cause harm to others while driving a car. Driving restrictions are imposed making these recommendations an important guideline for patients. A consensus statement with recommendations for drivers with ICD"s was presented at a press conference at the Europace 2009 meeting, in Berlin, Germany on Sunday 21 June. A team of twelve experts from the European Heart Rhythm Association (EHRA), the Council on Cardiovascular Nursing and Allied Professions in ESC (CCNAP) and the Section Cardiac Rehabilitation of the European Association of Cardiovascular Prevention and Rehabilitation, reviewed the literature, assessed the risk and issued a consensus statement. "Driving restrictions vary across different countries in Europe. We hope the document may serve as an instrument for European and National regulatory authorities to formulate uniform driving regulations", explained Johan Vijgen, chairperson of the task force*. "Driving restrictions are perceived as difficult for patients and their family and have an immediate consequence for their lifestyle. In addition to the psychological and societal impact, the driving ban may also pose a considerable impact on employment and education and thereby economic status", said Vijgen. The document presents recommendations for private driving (group 1) and professional driving (group 2). Definitions of the European Council Directives (80/1263/EEC) and (91/439/EEC) are used. * Group 1: drivers of ordinary motor cycles, cars, and other small vehicles with or without a trailer. * Group 2: drivers of vehicles over 3.5 metric tonnes or passenger carrying vehicles exceeding eight seats excluding the driver. Since the introduction of the ICD in the early 1980s, multiple trials have demonstrated the efficacy of ICDs for the prevention of sudden arrhythmic death. This resulted in a significant increase in the number of implants. In Western Europe alone, 63000 ICDs were implanted in 2006 and 85500 ICDs in 2008. Many patients are currently implanted for primary prevention (treatment of patients at risk for life-threatening arrhythmias who have never had sustained ventricular arrhythmias). The risk for sudden incapacitation is lower in these patients. Therefore, driving restriction should be less strict for these patients, than for patients implanted for secondary prevention (those who have survived a life-threatening arrhythmia). "Patients and their families should receive adequate discharge education and standardized information on driving recommendations. This should result in a better adherence to the recommendations. It should be emphasized that the risk is mainly a consequence of the underlying condition and not of the presence of the ICD", explained Prof Vijgen. The consensus statement will be published in the June issue of Europace, the official journal of the European Heart Rhythm Association. *Members of the task force include Johan Vijgen (chairperson) Belgium, Gianluca Botto (Italy) , John Camm (United Kingdom), Carl-Johan Hoijer (Sweden), Werner Jung (Germany), Jean-Yves Le Heuzey (France), Andrzej Lubinski (Poland), Tone M. Norekvç¥l (Norway), Maurizio Santomauro (Italy), Martin Schalij (The Netherlands), Jean-Paul Schmid (Switzerland), and Panos Vardas (Greece) Notes: EHRA, the European Heart Rhythm Association, aims to serve as the leading organisation in the field of arrhythmias and electrophysiology in Europe, and to attract physicians from all of Europe and beyond to foster the development of this area of expertise. EHRA is a registered branch of the European Society of Cardiology (ESC). EHRA is based in Sophia Antipolis, France. The European Society of Cardiology (ESC) represents more than 50,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe. Information on the scientific programme ESC Press Office European Society of Cardiology


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