This Week
Sept 25, 2006

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• GIBBONS, IOM PANEL BLAST FDA DRUG SAFETY POLICIES, CALLS FOR REFORMS
• PI INVESTIGATORS TO HOST SYMPOSIUM ON MELATONIN RECEPTORS
• DWIVEDI, G PANDY CO-CHAIR INTERNATIONAL SYMPOSIUM ON SUICIDE
• NIDA AWARDS MARTIN 5-YEAR GRANT TO STUDY HIV, DRUG ADDICTION

  Gibbons, IOM Panel Blast FDA Drug Safety Policies, Calls for Reforms
  A 15-member Institute of Medicine committee, which included Robert Gibbons, Ph.D., last Friday issued a long-awaited report that sharply criticized FDA drug safety policies and called for several major policy changes. The analysis, requested by the FDA itself, found that Congress, agency officials and the pharmaceutical industry share responsibility for the problems -- and bear the burden for implementing solutions. The report represents a watershed moment after two years of controversy over the safety of such widely used drugs as pain relievers and antidepressants. The IOM is part of the National Academies, chartered by Congress to advise the government on scientific and health policy issues. Its recommendations traditionally carry great weight. Dozens of news media have covered news of the report, including the New York Times, Washington Post, The Los Angeles Times , and ABC and NBC national TV news.
  
  The 15 experts were unanimous in endorsing the recommendations, which called for several major policy changes. Several of these have long been urged by drug safety advocates but have been resisted by the industry, Congress and the FDA itself. A number of them would require congressional approval. The panel called for a moratorium on consumer advertising of newly approved classes of drugs until they have been on the market long enough for unrecognized side effects and risks to emerge. Packaging for new types of medications should also carry a special symbol, such as the black triangle required in Britain , to alert patients that the drug's safety profile would not be fully known until it had been more widely studied, the report said.
  
  The FDA should reevaluate safety and effectiveness data of such new drugs within five years after initial approval, and the agency needs new powers to impose fines and requirements on drug makers. The report also called for the agency to have authority to place a wider range of restrictions on drugs it deems risky.
  
  Manufacturers should be required to register all clinical trials they sponsor in a government-run database to allow patients and physicians to see the outcome of all studies, not just those published in medical journals, the report said. Studies that show positive results for a drug are more likely to be published by journals than negative ones.
  
  The committee also took aim at FDA management, citing a history of intra-agency squabbling and conflicts of interest on the expert advisory panels appointed by the agency to review the scientific data on proposed new drugs and devices. A substantial majority of advisory panel members should have no ties to industry, it said.
  
  Much of the institute's report focused on a central gap in drug regulation: While the FDA demands strict data on efficacy and safety from clinical trials before approving a new drug, less attention is paid after the drug reaches the market
  
  
  PI Investigators to Host Sept. 29 Symposium on Melatonin ReceptorsPI investigators will host a symposium on melatonin receptors this Friday, Sept. 29, to be held at UIC. Despite substantial public interest in the functions of the pineal hormone melatonin, relatively little is known about mechanisms of its action. New drugs have recently been introduced that act as melatonin receptor agonists. The symposium will focus on current progress in melatonin receptor research. More information on the symposium is available at: < http://www.melatoninreceptor.net >. Internationally renowned speakers will discuss recent progress in this emerging field: 
  
  •  Dr. Weaver ( USA ) will summarize the field of the known high-affinity, G-protein coupled (GPCR) melatonin receptor subtypes in vertebrates.
  •  Dr. Jockers ( France ) will summarize the evidence accumulated over the last 15 years which demonstrates that GPCRs are organized as homo- and heterodimers (oligomers).
  •  Dr. Boutin ( France ) will explain how the MT3 site was purified, and how it was identified as the quinone reductase 2 (QR2).
  •  Dr. Witt-Enderby ( USA ) will discuss the signaling system involved in the effects of melatonin on human bone stem cells. 
  •  Dr. Zhdanova ( USA ) will illustrate the effects of several melatonin receptor ligands on sleep in a diurnal vertebrate, zebrafish.
  •  Dr. Tolga Uz ( USA ) will discuss the role of melatonin receptors in the behavioral actions of drugs of abuse.
  •  Dr. Zoran ( USA ) will discuss intercellular signaling between astrocytes (i.e., glia cells) which is modulated by the pineal neurohormone melatonin.
  •  Dr. Hari Manev ( USA ) will present data from in-vitro and in-vivo studies of the actions of melatonin on neuronal signaling.
  
  
  Dwivedi, G Pandey Co-Chair International Symposium on Suicide
  Yogesh Dwivedi , Ph.D., organized and chaired a symposium, “Neurobiological Abnormalities in Suicide: Focus on Neurochemical, genetic and gene expression studies,” as part of the 11th Symposium on Suicide and suicidal behavior in Portoroz , Slovenia , Sept. 8-12. Shyam Pandey , Ph.D., co-chaired the symposium. More can be found in http://www.esssb11-slo.org/eng/symposium.htm .
  
  
  NIDA Awards Martin Second 5-Year Grant to Study HIV and Drug Addiction
  Eileen Martin , Ph.D., recently obtained a second 5-year award from the National Institute on Drug Abuse for studies of HIV and drug addiction. In separate news, Dr. Martin has been appointed to the Editorial Board of the Journal of Clinical and Experimental Neuropsychology .
  
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