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News of the day
White House Budget Chief Says Issue Of Abortion Coverage In Health Reform Still Under Debate
In an appearance on "Fox News Sunday," White House Office of Management and Budget Director Peter Orszag said that he is "not prepared to say explicitly" whether health care reform legislation would prohibit the use of federal tax revenue to fund abortion coverage, the New York Times reports. Orszag"s statement came in reply to a question asking whether he was prepared to say that "no taxpayer money will go to pay for abortions." Orszag said, "It"s obviously a controversial issue, and it"s one of the questions that is playing out in the debate" (Pear/Liptak, New York Times, 7/20).Sen. Judd Gregg (R-N.H.), who also appeared on "Fox News Sunday," said, "No matter what your views are on abortion, you shouldn"t ask people to use their tax dollars if they think that abortion is taking a life." Gregg added, "I would hate to see the health care debate go down over that issue. We do really need health care reform, and it has to be substantive. ... So hopefully we won"t get ourselves wrapped around the wheel of abortion in this debate" (FoxNews.com, 7/19). According to the Times, there is an ongoing behind-the-scenes debate over handling abortion coverage in health overhaul legislation. The debate affects both the public insurance plan the legislation would create and private insurers, who would receive tens of billions of dollars in federal subsidies to expand coverage for low- and moderate-income U.S. residents. A provision in the House health reform bill (HR 3200) calls for a federal advisory committee to advise the HHS secretary on an "essential benefits package" that most insurers would be required to provide. Abortion-rights opponents want abortion coverage excluded from the package, while abortion-rights advocates say the decision should be left to medical professionals. House committees working on health reform legislation have rejected Republican amendments that would have restricted abortion coverage. The Hyde Amendment, first enacted in 1976, prohibits the use of federal Medicaid money for abortion services. However, abortion-rights opponents argue that federally subsidized coverage of the uninsured would not be subject to the existing restrictions. The National Right to Life Committee issued an analysis of the House bill, stating, "There is no doubt that coverage of abortion will be mandated, unless Congress explicitly excludes abortion from the scope of federal authority to define "essential benefits."" According to the group, even if the HHS secretary did not require abortion coverage, "federal courts would interpret the broadly worded mandatory categories of coverage to include abortion" (New York Times, 7/20).
Medical Devices

FDA Approves Multaq(R) For Patients With Atrial Fibrillation Or Atrial Flutter

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced that the U.S. Food and Drug Administration (FDA) has approved Multaq(R) (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq(R) is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL. Multaq(R) is an anti-arrhythmic indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted. Associated cardiovascular risk factors include age over 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter greater than or equal to 50 mm or left ventricular ejection fraction [LVEF] About dronedarone (Multaq(R)) Multaq(R), discovered and developed by sanofi-aventis, is one of the major therapeutic innovations in patients with atrial fibrillation in the last twenty years. The efficacy and safety of Multaq(R) 400 mg twice daily was evaluated in five controlled studies, ATHENA, ANDROMEDA, EURIDIS, ADONIS, and DAFNE, involving nearly 6,300 patients including more than 3200 patients who received Multaq(R). The ATHENA trial, which involved 4,628 patients with AF or AFL and more than 2,300 patients receiving Multaq(R) on top of standard therapy, demonstrated a 24% reduction in time to first CV hospitalization or all-cause mortality (PImportant Safety Information Multaq(R) is contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA study), patients given dronedarone had a greater than two-fold increase in mortality. Such patients should not be given dronedarone. Multaq(R) is also contraindicated in second- or third-degree atrioventricular (AV) block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker), bradycardia About Atrial Fibrillation/Atrial Flutter Atrial fibrillation is the leading cause of hospitalization for arrhythmia in the U.S. and represents one-third of hospitalizations for arrhythmia in Europe. Hospitalization associated with AF has increased dramatically (two-to-three fold) in recent years in the U.S. Atrial fibrillation is a complex disease that increases the risk of stroke up to five-fold, worsens the prognosis of patients with cardiovascular risk factors, and doubles the risk of mortality. Atrial flutter, another type of arrhythmia generating in the atrium, occurs less frequently, and may evolve into atrial fibrillation. About Sanofi Aventis Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). Forward Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis" management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis" annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements. Sanofi Aventis


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