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Senate HELP Panel Begins Mark Up Of Bill Placing Tobacco Under FDA Oversight
The Senate Health, Education, Labor and Pensions Committee on Tuesday began marking up a bill (S 982) that would allow FDA to regulate tobacco products, CongressDaily reports. The bill would allow FDA to place larger, color warning labels about the health risks of smoking on cigarette packs, as well as to regulate the marketing of tobacco products and advertising to children. The agency could not ban tobacco products or eliminate nicotine from cigarettes, but it could regulate their production and ban flavored cigarettes other than menthol. Sen. Chris Dodd (D-Conn.) said, "Over the years, this bill has been reviewed; it has been vetted; it has been debated, over and over and over again. The time has come to act." The House in April passed its version of the bill, 298-112 (Hunt, CongressDaily, 5/20). The committee by voice vote approved an amendment proposed by Sen. Jeff Merkley (D-Ore.) that would give FDA priority to review products that contain nicotine, such as candies. Committee ranking member Mike Enzi (R-Wyo.) proposed two amendments, one that would have given regulatory authority over tobacco to CDC and another that would have ordered FDA to study which flavors to ban, instead of a current provision that bans specific flavors. Both amendments were defeated. Enzi said, "I think the FDA is the wrong regulator. It approves cures, not poisons." The only Democrat who opposed the bill was Sen. Kay Hagan (N.C.), who said the measure would harm the tobacco industry in her home state (Armstrong, CQ HealthBeat, 5/19). The panel"s other member from North Carolina, Sen. Richard Burr (R), said he would filibuster the bill. He said, "I put my fellow senators on notice: This is something that will be a much longer time on the floor than it will be in this hearing" (CongressDaily, 5/20). The committee plans to continue marking up the bill Wednesday and possibly Thursday.The Obama administration has expressed its support for the bill (CQ HealthBeat, 5/19). FDA Commissioner Margaret Hamburg also has said her agency should regulate tobacco (Armstrong, CQ HealthBeat, 5/18).
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New Alternatives For Bone Imaging Could Be On The Horizon
On June 4, the U.S. Centers for Medicare & Medicaid Services (CMS) announced that it is considering a pathway for coverage of Sodium Fluoride (NaF-18) for PET bone imaging as an alternative to Technetium-99m imaging. Currently, Tc-99m bone imaging is one of the more commonly performed procedures using this radioisotope. Technetium-99m is in scant supply because of ongoing production outages, resulting in serious delays in patient imaging studies for many medical problems, including oncologic, cardiac and neurologic conditions.
News of the day
Dems Divided As Congressional Health Overhaul Efforts Stall
Senators working feverishly to pass health reform ahead of Congress" August recess raised doubts Wednesday on whether they will be able to pass reform on schedule, The Boston Globe reports.
Oncology

Judges Can Make Poor Decisions About Asylum Seekers

Judges often make poor decisions about the stories asylum seekers tell them because their decisions are based on false assumptions. Dr Stuart Turner, a psychiatrist who runs the Trauma Clinic in London and is Immediate Past President of the International Society for Traumatic Stress Studies, told the Annual Meeting of the Royal College of Psychiatrists in Liverpool that judges often had little information on which to base their decisions. Few asylum seekers had passports or records of their abuse and so the judges relied on their stories. He told the Annual Meeting there was a "positive bias" against asylum seekers, based on a judicial belief that if a story was true then the details would remain consistent with each telling. "It"s a common lay assumption that if the details of a story remain the same then the story is true," said Dr Turner. "But with trauma memories the focus is on the central event, not the peripheral detail. If consistency is used as the gold standard test of credibility, then the most traumatised will be disadvantaged." He said an average of 24,250 asylum seekers a year arrived in Britain between 2005 and 2007. In 2006, 79 per cent were refused entry; but 22 per cent of these decisions were subsequently overturned. Some 7,795 of those whose cases were not overturned applied for further review and 2,845 applied for judicial review. The fact that a fifth of the initial decisions were overturned indicates that judges were making erroneous decisions, Dr Turner argued. He said judges were "mirroring their own assumptions" about the world and how people would behave. He said: "Judges are applying things from their own experience and that may not be relevant to trafficked women, asylum seekers or torture survivors, or people who have been sexually violated. Judges many not have a clue about how people in those situations may behave." Asylum seekers as a group had an increased risk of emotional disturbance because of the trauma that they have endured, Dr Turner told delegates. In an analysis of a large group of Kosovan and Albanian refugees arriving in the UK after the NATO bombing of Serbia in 1999, 21 per cent reported feelings of anxiety and 17 per cent were worried about their family and friends. Some were suffering from post-traumatic stress disorder (PTSD). However, such emotional trauma and its impact on behaviour was not fully grasped by some judges, Dr Turner said. "For instance, one asylum seeker said that he had been tortured every day for three months by the authorities of his country about the whereabouts of his brother. The judge concluded that the man was a liar on the basis that the authorities would not continue to torture every day." Another judge failed to understand why a woman had not immediately reported to the British authorities that she had been raped. Dr Turner emphasised that he was not criticising decisions the judges made, as they had little evidence on which to base them. It was, he said, "an extraordinarily difficult job", and it was natural that they should base their decisions on their common sense. "However, there may be a gap between their commonsense and empirical information and I am questioning whether the assumptions they make about the behaviour of asylum seekers are well-founded assumptions." Dr Turner and his colleagues set up the Centre for the Study of Emotions and Law, a year ago. Their research shows that consistency in the re-telling of stories is a poor way of assessing credibility - around 30 per cent of asylum seekers change the details in their stories. Moreover, those suffering from PTSD are even more inconsistent in recalling detail. "What we want is to give the judiciary empirical information to help work out what the right assumptions might be," he concluded. "We want science to inform their decisions. There are a lot of areas where there is no empirical information - what happens when you"ve been sexually assaulted? Do you stay in your village? Do you run away? Judge A might make one assumption and Judge B another." Reference: Annual Meeting of the Royal College of Psychiatrists, BT Convention Centre, Liverpool, 2 -5 June 2009 Royal College of Psychiatrists


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