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Medicare Tapped For Savings To Cover Reform Costs, Again
In his weekly Internet and radio address Saturday, President Obama announced a plan to cut $313 billion in Medicare and Medicaid spending over the next decade as a way to raise money for overhauling the health care system and covering millions of the uninsured, the Los Angeles Times reports. The largest savings include "increased efficiencies in the system," cuts to subsidies paid to hospitals for treating the uninsured, cuts to prices the government pays for prescription drugs for seniors. The paper adds: "the proposal -- which includes potential cuts to hospitals, pharmaceutical companies and other providers -- also underscores the political delicacy of the administration"s search for money for a massive healthcare overhaul that could cost more than $1.2 trillion over the next decade" (Levey, 6/15).
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House Education-Labor Panel Passes Health Reform Bill, Rejects Amendments To Ban Abortion Coverage
The House Education and Labor Committee on Friday voted 26-22 to approve the House health reform bill (HR 3200) after adopting 20 amendments, many of which sought to expand the scope of coverage and increase the number of U.S. residents eligible for purchasing coverage through a health insurance exchange, CQ Today reports. The panel voted 19-28 to reject two amendments offered by Rep. Mark Souder (R-Ind.) that would have precluded plans participating in the health insurance exchange -- including the proposed public insurance plan -- from covering abortion services. The committee agreed to allow some existing state and federal programs to obtain waivers from the bill"s requirements. Among the approved amendments was a 400-page amendment by committee Chair George Miller (D-Calif.) that would open the exchange to more small businesses, certain retirees, and families whose premiums and out-of-pocket costs total more than 11% of their income. The amendment was adopted by voice vote (Demirjian, CQ Today, 7/17).
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Man Flu Or Meningitis? Don't Leave It Too Late To Find Out
Men are notoriously reluctant to take their health seriously and are much less likely than women to consult their doctor. With National Men"s Health Week fast approaching (June 15 - 21), the Meningitis Trust is encouraging men to learn the signs and symptoms of meningitis and to be aware of its range of free support services available to them.
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Matthew Lehman Of SPRI Clinical Trials Speaks On Designing Trials For Success At The Trout Group Investor Relations Seminar

In designing and conducting clinical trials, it is critical to meet FDA objectives while preventing program "drift," according to Matthew Lehman, chief operating officer of SPRI Clinical Trials-Global, LLC in his remarks at a recent seminar for biotechnology companies. Lehman spoke on "Designing Trials for Success: Balancing FDA Expectations and Operational Reality," at the Trout Group Investor Relations Seminar: Management"s Guide to Wall Street, held recently in Munich, Germany. He addressed CEOs and CFOs from private and small and mid-cap life science companies. The FDA and other regulators are the gatekeepers to realizing shareholder value and future profits, Lehman said. FDA goals of drug safety, efficacy and economic cost/benefit are consistent with those of the other key stakeholders in the drug development process: patients, clinicians and payors. To maximize long term shareholder value, companies must conduct research that is scientifically and statistically valid, clinically meaningful, and that optimizes the use of capital from a time and effectiveness standpoint, he said. To meet FDA objectives for clinical trials, companies must assure patient safety and evaluate efficacy with validated, clinically meaningful endpoints and statistical significance for the study, Lehman said. "The FDA expects good science and good medicine. Meetings are serious, specific and formal and should have a defined purpose," he said. "Reviewers want to speak scientist to scientist. Companies should deliver reasoned proposals and obtain yes/no answers." Although it should be simple to secure agreement with the FDA and then follow through on a development plan, competing interests and operational realities can take programs off track. Management and shareholders need to be aware of this "program drift" and plan accordingly, Lehman said. "Management must keep the program on track by getting to the meaningful proof of the concept quickly, killing losers swiftly and honestly, and investing in the planning of clinical development to ensure data quality," he said. "Investors should understand the goals of each trial vis-a-vis FDA approval, be clear about the operation and costs of clinical trials, and acknowledge and reward management that kills losing drugs." SPRI Clinical Trials


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