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Study Identifies Biomarker That Safely Monitors Tumor Response To New Brain Cancer Treatment; Paves The Way To Phase 1 Clinical Trial
A specific biomarker, a protein released by dying tumor cells, has been identified as an effective tool in an animal model to gauge the response to a novel gene therapy treatment for glioblastoma mulitforme. The finding, reported in the July 1 issue of Clinical Cancer Research, paves the way for a Phase 1 clinical trial expected to begin in late 2009.
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Vermont Legislature Passes Law Regulating All Drug/Device Company Marketing, Requiring Disclosure Of Gifts To Doctors
The Vermont Legislature has passed legislation (S 48) that bans nearly all gifts from pharmaceutical and medical device companies to health care providers, administrators and facilities in the state, the New York Times reports. The legislation specifically would prohibit drug and device makers from giving providers no-cost meals. Vermont"s legislation would go further than similar laws in other states like Massachusetts and Minnesota by requiring drug and medical device manufacturers who give gifts to health providers to publicly disclose recipients" names and dollar amounts of payments and gifts. The measure would not require manufacturers to disclose payments for clinical research of products undergoing FDA review, the Times reports. The legislation also would eliminate a loophole that allows manufacturers to conceal certain expenses by claiming them as trade secrets. In a recent report, the Vermont Office of the Attorney General said that medical product makers spent about $2.9 million on promotional efforts to the state"s health care providers in fiscal year 2008 and that nearly half of the state"s 4,573 licensed providers had received some type of incentive from drugmakers in the same year. The report, which was developed prior to passage of the new legislation, offers only aggregate data, as 83% of the manufacturer-declared payments were deemed to be trade secrets, the Times reports.Gov. Jim Douglas (R) is expected to sign the law, which would take effect July 1. Several state medical groups -- including the Vermont Association for Mental Health and the Vermont Medical Society -- have indicated support for the legislation.Marjorie Powell, a senior lawyer for the Pharmaceutical Research and Manufacturers of America, said the requirements under the new law appear redundant with new voluntary guidelines the group has issued on physician gifting practices. She said, "We think this is unnecessary, and it is not going to improve patient care," adding, "It makes it onerous not only for the company but also for the physician in Vermont, because this is going to be on a Web site" (Singer, New York Times, 5/20). Drugshop to buy zoloft online and other pills.
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Public Health

How An Enzyme Tells Stem Cells Which Way To Divide

Driving Miranda, a protein in fruit flies crucial to switch a stem cell"s fate, is not as complex as biologists thought, according to University of Oregon biochemists. They"ve found that one enzyme (aPKC) stands alone and acts as a traffic cop that directs which roads daughter cells will take. "Wherever aPKC is at on a cell"s cortex or membrane, Miranda isn"t," says Kenneth E. Prehoda, a professor in the chemistry department and member of the UO"s Institute of Molecular Biology. When a stem cell duplicates into daughter cells, the side, or cortical domain, containing aPKC (atypical protein kinase C) continues as a stem cell, while the other domain with Miranda becomes a differentiated cell such as a neuron that forms the central nervous system. Prehoda and co-author Scott X. Atwood, who studied in Prehoda"s lab and recently earned his doctorate, describe how the mechanism works in the May 12 issue of the journal Current Biology. Instead of a complex cascade of protein deactivation steps that many biologists have theorized, Prehoda said, aPKC strips phosphate off an energy-transfer nucleotide known as ATP and then attaches it to Miranda. This process forces Miranda away from aPKC and helps determine the fates of subsequent daughter cells. "This process is pretty simple," he said, when viewed from a biochemical perspective. "What happens is that Miranda gets phosphorylated by aPKC, turning it into an inactivated substrate and pushing it into another location in the cell." Much of the paper in Current Biology is devoted to why the more complex scenarios are not accurate. "There have been a lot of ideas on how this works, and most seemed to be really complicated and difficult to explain. We have found it"s a much simpler mechanism," Prehoda said, adding that the mechanism likely is similar in many other types of cells, not just stem cells. "It"s a basic-research question. How does this polarity occur? In order to develop stem cell-specific therapeutics based on a rational methodology you have to understand the mechanism," he said. If Miranda is improperly isolated into other regions by aPKC, the stem cell divides symmetrically, with both daughter cells adopting the same fate, In turn, Prehoda said, these cells can become tumorous as they continue to rapidly divide without proper polarization. The National Institutes of Health supported the research through a Developmental Biology Training Grant to Atwood and a research grant to Prehoda. Jim Barlow University of Oregon


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