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Health Care Reform Likely Will Not Provide Coverage To Undocumented Immigrants, Sen. Baucus Says
Sen. Max Baucus (D-Mont.), chair of the Senate Finance Committee, on Thursday said that he supports "a version" of government-run health insurance but that such a program would not cover undocumented immigrants, the Washington Times reports. Baucus was speaking at an event sponsored by the Kaiser Family Foundation, Families USA and the National Federation of Independent Business (Haberkorn, Washington Times, 5/22). Baucus said that health care reform likely would provide coverage to between 94% and 96% of U.S. residents but that it would be "too politically explosive" to provide coverage to undocumented residents (Young, The Hill, 5/21). Undocumented immigrants account for between 15% and 22% of the estimated 47 million U.S. residents who lack health insurance, according to analyses by the Center for Immigration Studies and the U.S. Census Bureau. Baucus said the finance committee has not yet discussed whether federal funding to treat low-income, uninsured patients should be expanded to treat undocumented immigrants. "I don"t have a good answer yet to undocumented workers," Baucus said, adding, "There will still be charity care." According to the Dallas Morning News, some immigration advocates have said health reform efforts will not be complete if undocumented immigrants do not have coverage. Jaime Torres, president of Latinos for National Health Insurance, said, "In light of what"s happening now with the flu pandemic, it"s pretty clear that, for any health care system to work, it has to cover everyone residing in the United States" (Landers, Dallas Morning News, 5/22). Torres added, "It"s unfortunate that Sen. Baucus and the Congress might not have the courage to include the undocumented" (Washington Times, 5/22). A podcast and video of the press conference are available online at kff.org.
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Sanofi-Aventis, GlaxoSmithKline Will Donate Influenza Vaccines To WHO
The drugmaker Sanofi-Aventis will donate millions of doses of a vaccine that offers protection against the H1N1 (swine flu) virus to the WHO once the vaccine is ready, the company"s chief executive officer announced Tuesday, Reuters reports (Elsner, Reuters, 6/17). The AP/Google.com writes, "Exceptional times require exceptional responses. We need to act responsibly and we all have to play our part," Sanofi CEO Christopher Viehbacher said in a statement released during the Pacific Health Summit in Seattle. "This flexible donation aims to help the WHO address the needs of these most vulnerable populations," he said.
News of the day
QLT Announces 12-month Results From Novartis Sponsored MONT BLANC Study Evaluating Standard-fluence Visudyne(R) Combination Therapy
QLT Inc. (NASDAQ: QLTI; TSX: QLT) announced that twelve-month primary analysis results from the Novartis sponsored Phase II MONT BLANC study were presented on June 14, 2009 during the 17th Congress of the European Society of Ophthalmology in Amsterdam, the Netherlands. MONT BLANC is the European study of the Novartis sponsored SUMMIT clinical trial program which investigates the efficacy and safety of combining Visudyne(R) (Novartis Pharma AG) and Lucentis(R) (Novartis Pharma AG, Genentech Inc.). SUMMIT also includes the DENALI study in the US and Canada and the EVEREST study in Asia. MONT BLANC is a 24-month randomized, double-masked, multicenter trial in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. The purpose of the study is to evaluate whether Visudyne combined with Lucentis is not inferior to Lucentis monotherapy with respect to the mean change from baseline in visual acuity (VA) and to evaluate the proportion of patients with a treatment-free interval of at least three months duration after Month 2. At the Month 12 examination, mean VA in the Visudyne combination therapy group improved 2.5 letters from baseline compared with a 4.4 letter improvement in the Lucentis monotherapy group. In the combination therapy group, 96% of patients had a three-month treatment-free interval, compared with 92% in the Lucentis monotherapy group.
Public Health

Agendia Supports Genentech's Citizen's Petition Urging FDA To Hold In-Vitro Diagnostic Tests To One Set Of Scientific And Regulatory Standards

Agendia, a world leader in molecular cancer diagnostics, announced its strong support of Genentech"s Citizen"s Petition. Filed on December 5, 2008, Docket No. FDA-2008-P-0638-0001/CP petitions that all in vitro diagnostic tests be held to one set of scientific and regulatory standards. In response, on May 28, 2009, Agendia formally submitted a letter of support to the U.S. Food and Drug Administration (FDA). The Genentech petition and other documents submitted in support of and in opposition to the petition can be accessed here. Agendia"s leading product, MammaPrint(R), is commercialized globally to aid physicians in making informed treatment decisions for breast cancer patients. In 2007, MammaPrint became the first in vitro diagnostic multivariate index assay (IVDMIA) cleared by the FDA. FDA clearance requires clinical and analytical validation and reporting systems that ensure patient safety issues are addressed. Manufacturers of breast cancer recurrence assays that are not FDA-cleared operate solely under CLIA regulations and are free to make claims of superiority, safety or otherwise, regardless of scientific and clinical evidence. Consequently, physicians do not have the scientific and clinical data to evaluate some of the most promising advances in molecular diagnostics. The FDA deemed the need for regulation of the utmost importance and introduced the IVDMIA guidelines in 2006. Formal regulatory decisions on the matter have since been stagnant, however. Agendia believes this has led to a precarious situation that raises patient safety and treatment decision concerns and creates an uneven playing field for providers of molecular diagnostic services. Genentech"s Citizen"s Petition to the FDA is an important step in the movement towards in vitro diagnostic regulatory standardization. Agendia commends Genentech for making clinical validation, regulation and patient safety a top priority and looks forward to remaining engaged with key decision makers on this important healthcare issue. Agendia B.V.


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