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Health Subcommittee Considers Bill To Eliminate Pre-Emption For Medical Devices
The House Energy and Commerce Health Subcommittee on Tuesday heard testimony on the Medical Device Safety Act of 2009 (HR 1346), which would allow consumers to sue medical device manufacturers in state courts, CQ HealthBeat reports. The bill responds to last year"s Supreme Court ruling that says medical devices with FDA pre-marketing approval can be pre-empted from lawsuits under state law, in accordance with the Medical Device Amendments of 1976. Rep. Frank Pallone (D-N.Y.), who introduced the bill, said that the 2008 Supreme Court ruling "ignor[ed] congressional intent" by providing blanket immunity for medical device makers. According to Rep. John Dingell (D-Mich.), a co-sponsor of the bill, the original 1976 law sought to grant regulatory authority to FDA for medical devices, but it did not aim to eliminate state liability. Committee Chair Rep. Henry Waxman (D-Calif.), another co-sponsor, said last year"s ruling already has caused 1,400 injury cases to be thrown out of court, adding that the threat of litigation provides manufacturers with additional safety incentives. David Vladeck -- a law professor at Georgetown University Law Center who testified at the hearing -- added that immunity from lawsuits "removes incentive to manufacturers to fix devices quickly and get defective devices off the market."Rep. Nathan Deal (R-Ga.) said the class of device that must obtain pre-marketing approval -- which includes pacemakers and replacement heart valves -- represents only 2% of all approved medical devices each year. Rep. Michael Burgess (R-Texas) added that the measure could create an inconsistent system that allows both FDA experts and jurors in various states to make decisions on medical device safety standards. In addition, Rep. Joe Pitts (R-Pa.) cautioned that the bill might encourage manufacturers to limit distribution of their devices to certain states (Kim, CQ HealthBeat, 5/13). Related Editorial

GfK Healthcare's Roper Global Diabetes Program Launches New U.S. Diabetes Patient Market Study
GfK Healthcare"s Roper Global Diabetes Program, the definitive global perspective on diabetes, announced today the launch of its enhanced U.S. Diabetes Patient Market Study. Through a modular approach and with tailored reporting, the study offers health care and related companies in the diabetes category access to patient data and market trends from one of the largest surveys of people with diabetes, and the only one projectable to the U.S. population.
News of the day
Cognitive Function Is Superior In Breast Cancer Patients Treated With Letrozole Versus Tamoxifen
New results show that postmenopausal women with breast cancer receiving adjuvant letrozole have better cognitive function than women being treated with tamoxifen. The data, from a recent meeting of the American Society of Clinical Oncology (ASCO), are drawn from a sub-study of the Breast International Group (BIG) 1-98 trial.
Endocrinology

Study Opens Door To Simple Test To Identify People At Higher Risk Of Sudden Cardiac Death

A large and long term study of Frenchmen suggests there may be a simple way to establish if apparently healthy people have an elevated risk of sudden cardiac death by looking at how their heart responds under conditions of mild mental stress and during peak exercise. The study was the work of Dr Xavier Jouven, a cardiologist at the European Georges Pompidou Hospital in Paris, and colleagues, and is published in the 2 July advance access issue of the European Heart Journal. Sudden cardiac death is a major health problem and accounts for betwee 200,000 and 400,000 deaths every year in the US, wrote the authors. They explained that the most common cause in adults is when fast heart rhythm (ventricular tachycardia) or erratic or uncoordinated contraction of muscle in a heart chamber (ventricular fibrillation) coincides with a loss of blood flow in the heart (ischaemic cardiac event). Fewer than 5 per cent of people who experience this combination of heart events are successfully rescucitated, which is why finding out who might be at risk within the general population is a major public health challenge. Jouven and colleagues had a hunch that people who respond to mild mental stress in preparation for an exercise test with the largest heart rate increases might be at highest risk of sudden cardiac arrest. For this study they used data on nearly 8,000 male French civil servants who took part in the Paris Prospective Study I and were medically examined between 1967 and 1972. The men underwent physical exams, gave blood samples, had electrocardiograms, and answered interview questions. They also had their resting heart rate measured, which was taken by measuring radial pulse for 1 minute after lying down for 5 minutes. Data taken on the participants over a follow up period of 23 years allowed the researchers to compare heart rate changes between rest and mild mental stress (while the participants prepared for an exercise test) between those who experienced sudden cardiac death (81 participants), those who died from a non-sudden coronary event (129 participants), and those who died from any cause (1,306 participants). In their analysis, Jouven and colleagues found that: * The average heart rate increase during mild mental stress was 8.9 ÷± 10.8 beats per minute (bpm). *Risk of sudden cardiac death went up progressively with increase in heart rate during mental stress. *The 33 per cent of participants with the highest heart increase were more than twice as likely to suffer sudden cardiac death as the 33 per cent with the lowest heart rate increase (relative risk 2.09). *This relationship did not exist for non-sudden coronary deaths. The authors concluded that: "An important heart rate increase produced by a mild mental stress predicts long-term risk for sudden cardiac death." They suggested that a simple procedure that measures heart rate changes before an exercise test could be a valuable way to assess risk of sudden cardiac death in the general population. "Excessive heart rate increase during mild mental stress in preparation for exercise predicts sudden death in the general population." Xavier Jouven , Peter J. Schwartz , Sylvie Escolano , Cç©line Straczek , Muriel Tafflet , Michel Desnos , Jean Philippe Empana , and Pierre Ducimetiç¨re. European Heart Journal, Advance Access published on July 2, 2009. DOI 10.1093/eurheartj/ehp160 Eur Heart J 30: 1703-1710. Written by: Catharine Paddock, PhD Copyright: Medical News Today Not to be reproduced without permission of Medical News Today


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