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Acura And King Receive FDA Complete Response Letter Regarding Acurox(R)
Acura Pharmaceuticals, Inc. (Nasdaq: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (NDA) for Acurox (oxycodone HC1, USP and niacin, USP) Tablets CII, an immediate release product intended for the relief of moderate-to-severe pain.
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Washington Post Column Examines Issues Surrounding Supreme Court Confirmation Hearings
"When a Supreme Court nominee such as Judge Sonia Sotomayor comes before the Senate for confirmation, she is promised a full, fair hearing," yet "every nominee"s path is booby-trapped by the history of previous confirmation battles," Washington Post columnist David Broder writes. Broder examines prior confirmation hearings, noting that the "[o]ne thing that may make it harder to forget the partisan and ideological battles of the past is that President Obama found reasons to oppose" Chief Justice John Roberts and Justice Samuel Alito while he was in the Senate.During Roberts" confirmation hearing, Obama said that although he was "sorely tempted to vote for Judge Roberts," he had issues with Roberts in cases where "precedent and rules of construction" are insufficient and where justice "can only be determined on the basis of one"s deepest values." Obama added that the rights of women and minorities are dependent on cases in which "the critical ingredient is supplied by what is in the judge"s heart." Obama said Roberts" record on women"s rights and other issues was not strong enough to quell doubts about Roberts" "deepest values."Broder continues, "Based on the Obama precedent, the White House can hardly complain if Republicans push beyond the question of Sotomayor"s qualifications and examine her values -- and her biases." He concludes, "Someday, the Senate may again be satisfied to examine only professional credentials, recognizing the uncertain dynamics of a nine-person bench," but while past precedents survive, "that is not likely" (Broder, Washington Post, 6/4).
News of the day
House Labor-HHS Spending Bill To Fund 'Teen Pregnancy Prevention Imitative'
On Friday, the House Appropriations Labor, HHS, Education and Related Agencies Subcommittee approved by voice vote a $730.5 billion spending bill to fund the Departments of Labor, Health and Human Services, and Education, CQ Today reports. The bill shifts funding away from abstinence-only sex education toward more comprehensive pregnancy prevention programs. The bill would allocate $114.5 million for a "teenage pregnancy prevention initiative" that offers "evidence-based and other approaches, such as abstinence." The measure continues several prohibitions on using federal funds to cover abortion and restrictions on funding for embryo research (Wolfe, CQ Today, 7/10).The measure includes $73.7 billion in discretionary spending for HHS, $2 billion more than President Obama requested (Hunt, CongressDaily, 7/10). The full committee is scheduled to mark up the bill on July 17 (CQ Today, 7/10).
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Realistic Perception Of Risk Is Key To Motivate People To Take Protective Action Against New Infectious Diseases

With the current outbreak of swine flu, and in the absence of a vaccine or treatment at present, the only way to contain the virus is to get people around the world to take precautionary measures. In a special editorial1 in the latest issue of Springer"s International Journal of Behavioral Medicine, Johannes Brug, Arja Aro, and Jan Hendrik Richardus show that there are three key parameters that convince people to take precautions. Firstly, they need to be aware of the risk to them. Secondly, they need to believe that effective protective actions are available and have confidence in them. Lastly, communications about risk need to be carefully managed so that they express the actual risk accurately to prevent mass scares. The authors review the importance of risk perception and show that for people to voluntarily take precautionary actions, it is essential that they are aware of and understand the risk. Indeed, risk perception is a key feature of many health behavior theories. On the one hand, unrealistic optimism about health risks is often observed in relation to familiar risks and can result in a false sense of security and lack of precautions. On the other hand, pessimism is more likely for new, unfamiliar risks that are perceived to be uncontrollable and may lead to unnecessary mass scares. As a consequence, implementation of precautionary measures requires effective risk communication that leads to realistic perceptions of risk, as well as knowledge and skills to promote precautionary practices. The authors argue that scientific knowledge in the area of infectious disease control is limited. Looking at how risk is communicated, they show that, in the early stages of a possible pandemic, risk perceptions and people"s confidence in recommended protective actions depend on effective communications. In the authors" view: "Risk communication messages that are not comprehended by the public at risk, or communication of conflicting risk messages will result in lack of precautionary actions, as will communications from a non-trustworthy . However, risk communication messages are sometimes very quickly adopted by the media, possibly leading to an "amplification" of risk information that may lead to unnecessary mass scares and unnecessary or ineffective precautionary action." This editorial is published in the latest issue of the International Journal of Behavioral Medicine, dedicated to lessons learned from both the SARS and avian flu outbreaks. Overall, the studies in this issue show that people across Europe and East Asia do regard recently emerging infectious diseases as serious potential health threats, based on information received from various s, with clear differences between countries and regions. The International Journal of Behavioral Medicine is the official journal of the International Society of Behavioral Medicine. Reference 1. Brug J, Aro AR, Richardus JH.(2009). Risk Perceptions and Behaviour: Towards Pandemic Control of Emerging Infectious Diseases. International Journal of Behavioral Medicine. DOI 10.1007/s12529-008-9000-X Renate Bayaz Springer


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