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News From The American Chemical Society, May 13, 2009
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AARP Thanks Vice President Biden, Administration, For Working To Improve Health Care For Older Americans
This afternoon, AARP CEO A. Barry Rand delivered the following remarks at the White House Middle Class Task Force Town Hall in Alexandria, Va., during a discussion with Vice President Biden, Health and Human Services Secretary Kathleen Sebelius, and White House Office of Health Reform Director Nancy-Ann DeParle, on how health care reform will lower costs, cut waste, and improve quality for seniors from across the country.
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Republicans Playing 'Abortion Card' On Health Reform, American Prospect Opinion Piece States
The "religious right and its Republican enablers" are "playing the abortion card" with health care reform legislation by contending that "federal government dollars will pay directly for abortions," according to an American Prospect opinion piece by Dana Goldstein, an associate editor for the magazine. It is "unlikely" that federal money would be used this way, but the groups "want grassroots conservatives to believe it will, hoping the resulting outcry will scuttle attempts to reform our expensive health care system," Goldstein continues. She writes, "This rhetoric is beyond hyperbolic -- it is downright deceptive."Goldstein quotes Adam Sonfield, a senior policy associate at the Guttmacher Institute, who said discussion of family planning in federal law ""never includes abortion."" She adds, "In actuality, "family planning" language refers exclusively to contraceptive services, in part because of the Hyde Amendment," which bars the use of federal Medicaid dollars for abortion. She also notes that reproductive health issues are "so politicized ... that even to offer birth control to poor women who do not meet Medicaid"s strict eligibility requirements, individual states must apply for a waiver from the federal government." About half of states have done so, she says. In "choosing what services to cover under any potential public insurance plan," the HHS secretary "will likely be bound by all of the existing laws that prevent the federal government from financing abortion," according to Goldstein. She adds, "None of these restrictions would be explicitly overturned by any of the health reform proposals currently being considered in Congress."Antiabortion-rights Senate Republicans have said they will oppose any health reform bill "that subsidizes abortion coverage or even includes, in the proposed health insurance exchanges, private insurers that cover abortion," Goldstein writes. She adds that 87% of existing health plans include some abortion coverage, meaning that most women would lose coverage under the Republicans" demands. "The result would be a near-blanket restriction on women"s access to insurance-subsidized abortion, one far more radical than the Hyde Amendment," Goldstein says. Meanwhile, women"s health advocates have said that overturning the Hyde Amendment is not currently their top priority because "they are simply too busy playing defense on health reform" and do not have the votes, Goldstein writes.According to Goldstein, by "playing the abortion card, the real goal of anti-choicers is not only to maintain existing restrictions on abortion access, but to use health reform as a vehicle to expand them to the majority of American women." She writes, "If such efforts lead to legislative impasse, many conservatives will be delighted." She concludes, "After all, they"ve never really put any political muscle behind fixing our inadequate health care system" (Goldstein, American Prospect, 7/14).
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FDA Accepts Final Section Of NDA Filing For LUCASSIN(R)

Orphan Therapeutics, LLC and Ikaria Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the final section of the New Drug Application (NDA) filing seeking marketing approval for LUCASSIN(R) (terlipressin for injection) for the treatment of hepatorenal syndrome (HRS) Type 1. The filing was completed on May 4, 2009, and LUCASSIN has been granted Priority Review as well as Orphan Drug status and Fast Track designation. HRS Type 1 is the development of kidney failure in patients with late-stage liver cirrhosis in the absence of any other cause. It is characterized by rapid onset of renal failure with a high mortality rate that exceeds 80% within three months. In September 2008, Ikaria acquired the North American rights to LUCASSIN, including responsibility for manufacturing, distribution, marketing, sales, customer service and post-market development. Those rights will be transferred to Ikaria following marketing approval. LUCASSIN is a synthetic vasopressin analogue that acts via the vasopressin V1 receptor as a systemic vasoconstrictor, mainly in the splanchnic (abdominal) circulation, which appears to increase effective arterial volume and improves renal blood flow, thereby improving renal function in patients with HRS. Terlipressin was recently approved in France, Ireland, Spain and South Korea for the treatment of patients with HRS Type 1. Terlipressin is not approved by the FDA for use in the U.S. About Orphan Therapeutics, LLC Orphan Therapeutics, LLC, is a privately held drug development company dedicated to developing treatments for rare and serious diseases. It was founded in 2003 with the initial purpose to develop and seek U.S. FDA approval for its first product, LUCASSIN(R) (terlipressin), for the treatment of hepatorenal syndrome (HRS) Type 1. About Ikaria Holdings, Inc. Ikaria Holdings, Inc. is a biotherapeutics company whose acute care products and therapies address the significant unmet needs of critically ill patients. The company"s lead product, INOmax(R) (nitric oxide) for inhalation, is the only FDA-approved drug for the treatment of hypoxic respiratory failure in term and near-term newborns, and also is marketed in Canada, Europe, Latin America and Australia. INOmax is approved for marketing in Japan and Mexico. Ikaria is engaged in new and ongoing clinical development of INOmax, carbon monoxide for inhalation and hydrogen sulfide. Ikaria also acquired the North American rights to terlipressin, which currently is under review by the FDA for the treatment of hepatorenal syndrome Type 1. Ikaria is headquartered in Clinton, NJ, with research facilities in Seattle, WA and Madison, WI, and a manufacturing facility in Port Allen, LA. Ikaria Holdings Inc


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