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FDA Recommends Gardasil Recipients Sit, Lie Down After Receiving Vaccination
In a posting aimed at health care professionals, FDA on its Web site on Wednesday said that recipients of Merck"s human papillomavirus vaccine, Gardasil, should be closely observed afterward for 15 minutes while they remain seated or lying down to avoid the possibility of fainting, the Wall Street Journal reports. FDA said that since October 2007, Gardasil"s labeling for both health care providers and patients has included a discussion about fainting. The agency said the strengthened recommendation comes in response to reports of "traumatic injuries" among some recipients who experienced fainting (Corbett Dooren, Wall Street Journal, 6/10). Gardasil protects against the strains of HPV that cause most cases of cervical cancer and genital warts. The Centers for Disease Control and Prevention recommends that girls ages 11 and 12 receive the three-dose vaccine before they are sexually active. Girls and women ages 13 to 26 who have not been vaccinated or completed the vaccine series also should receive the vaccine (CDC fact sheet, June 2008). On Wednesday, FDA also approved changes to Gardasil materials that place warnings about fainting in a more prominent place on drug labels and handouts. The agency said that the new recommendations are intended to "prevent falls and injuries" (Wall Street Journal, 6/10).
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Innovative Medicines Initiative: 246 Million Euros To Support Public-private Research Cooperation For A Fast Development Of Better Medicines
Today, 15 new research projects aimed at bringing innovative medicines more quickly to the market have been selected to receive 246 million euros from the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The projects will foster understanding of health issues such as diabetes, pain, severe asthma and psychiatric disorders while increasing drug safety. They will also help improve the training of researchers and clinicians involved in medicines development. The projects were chosen following the first call for proposals launched within the Innovative Medicines Initiative (IMI), a public-private partnership - so called Joint Technology Initiative- between the European Commission and the pharmaceutical industry. With this selection, IMI has reached a key milestone. This initiative marks the first time that pharmaceutical competitors are pooling their res, together with research organisations, patient groups and other stakeholders in large consortia, in order to develop generic, pre-competitive knowledge. The Commission"s contribution of €110 million is backed up with €136 million provided in-kind from the pharmaceutical industry. The successful projects will now enter into the final negotiation phase.
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MSM HIV Infection Rates In Some African Countries Significantly Higher Than General Population Rates, Study Says
HIV infection rates among gay men and other men who have sex with men (MSM) in "some African countries are 10 times that of the general male population, and stigma, poor access to treatment or testing are to blame," according to a Lancet study published online on Monday, AFP/China Post reports. University of Oxford researchers looked at published studies to examine HIV prevalence rates between 2003 and 2009. "The difference varies a lot across Africa, but in most of the countries studied," MSM HIV prevalence rates "were substantially higher than among heterosexuals," writes AFP/China Post (7/20).
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Republicans To Introduce Health Reform Plan That Would Establish State Health Insurance Exchanges, Provide Tax Credits

Congressional Republicans are releasing two health care reform proposals -- one from conservatives and one from moderates -- as alternatives to plans by Democrats, CQ Today reports (Wayne, CQ Today, 5/19). Conservative Plan Conservative Republicans -- led in the Senate by Sens. Tom Coburn (Okla.) and Richard Burr (N.C.) and in the House by Reps. Devin Nunes (Calif.) and Paul Ryan (Wisc.) -- on Wednesday will introduce the Patients" Choice Act, which would establish State Health Insurance Exchanges, where U.S. residents could shop for private insurance. The legislation also would give $5,710 tax credits to families and $2,290 tax credits to individuals to help pay for health insurance (Haberkorn, Washington Times, 5/20). The credits would be funded by taxing employer-provided health benefits (CQ Today, 5/19). Under the plan, U.S. residents could keep their current coverage if they choose and the plan would not require individuals to have insurance. Coverage also would be portable, allowing people to keep their coverage when switching jobs.States would provide direct oversight of health insurers and providers to ensure equal benefits (Washington Times, 5/20). The bill also would create private insurance options through Medicaid and would require higher-income Medicare beneficiaries to pay higher premiums for the Medicare prescription drug benefit (CQ Today, 5/19). The measure also would establish a system of health coverage auto-enrollment at emergency departments, motor vehicle departments and other locations. According to the AP/Washington Post, the group, unlike some Senate Republicans, does not want to work with congressional Democrats on their plans for health care reform legislation. Of the proposals being developed by Democrats, Burr said, "I think within two hours of seeing it we"ll be able to tell people why it won"t work." Burr and Coburn believe that congressional Democrats only will approve legislation that includes a public option, which is not included in their proposal (Werner, AP/Washington Post, 5/19). Moderate Plan The Medical Rights Act -- under development by moderate House Republicans led by Rep. Mark Kirk (Ill.) -- would guarantee that the government would not be able to interfere with medical decisions made by physicians and patients. The measure is scheduled to be released during a press conference on Wednesday. According to Kirk, the measure would make changes to the private insurance market and medical lawsuits to help reduce the cost of health coverage. The bill also would expand the number of public health clinics, increase the use of electronic health records and strengthen state-run high-risk insurance pools, according to Kirk. The proposal does not include a public option or an individual mandate that U.S. residents obtain health coverage. While the cost of the plan is unknown, it would be "extra low compared to where the president"s going," according to Kirk (CQ Today, 5/19). Opinion Piece A new Republican proposal for health care reform is "remarkably different" from current Democratic approaches in which "Congress could regulate its way to a government-dominated market," Galen Institute President Grace-Marie Turner and American Enterprise Institute scholar Joseph Antos write in a Wall Street Journal opinion piece. According to Turner and Antos, Republican senators on Wednesday will "introduce a bill that moves away from federal centralization." They write that the bill -- called the Patients" Choice Act -- "provides a path to universal coverage by redirecting current subsidies for health insurance to individuals," while also guaranteeing access to insurance for U.S. residents with pre-existing conditions. According to Turner and Antos, the plan functions by redistributing the $300 billion annual tax subsidy for employment-based health insurance to individuals as "refundable, advanceable tax credits." They conclude that the plan will put physicians and patients in control of the health care system (Turner/Antos, Wall Street Journal, 5/20). Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.


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