By Mary Gabb ([email protected] ) The publication several years ago of Selling Sickness: How the World’s Biggest Pharmaceutical Companies are Turning Us All into Patients by Ray Moynihan and Alan Cassels has brought the concept of disease-mongering into a global debate, and has introduced (or reintroduced) terms such as “medicalisation” and “lifestyle drugs” into today’s…
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The US Food and Drug Administration (FDA) in August proposed a new guideline asking the sponsors of clinical trials to submit annual development safety update reports (DSURs). The guideline, titled “E2F Development Safety Update Report,” is in draft form and describes the format, content, and timing of a DSUR.
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By Julie Stauffer ([email protected]) How quickly can you lay your hands on tomorrow’s meeting agenda, the latest batch of clinical data, or the draft report you’ve been asked to review? Although de-cluttering your desk may fall low on your low priority list, disorganisation carries a hefty price tag. A Gartner Group study revealed that the…
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By David Woods ([email protected]) “Since 2000, the US Food and Drug Administration (FDA) has received more than 95,000 reports of medication errors. These reports are voluntary, so the number of actual medication errors is believed to be higher,” says Carol Holquist, director of the division of medication error prevention in the FDA’s Center for Drug…
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After selling his travel company – the third largest in the US – to American Express for $6 billion, Hal Rosenbluth could have spent his time fishing, golfing, or globetrotting; instead, he co-founded Take Care Health Systems.
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By Duncan Dibble ([email protected] ) If you Google for ‘website’ and ‘traffic’ you’ll be inundated with miracle cures to increase visitors to your site. It will then take you roughly three days to sort out the ‘useful’ material. But there are several ways to increase the number of visitors to your site, although that’s only…
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By David Woods ( [email protected] ) The Association of American Medical Colleges (AAMC) recently issued a 43-page report of its task force on industry funding of medical education. Sections of the report deal with site access by pharmaceutical company representatives. Specifically, the report states that “to protect patients, patient care areas, and work schedules, access…
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By David Woods ([email protected]) Journal editors reject submitted manuscripts because they are: Inappropriate for their audience Poorly designed studies Poorly written Seen to have been submitted elsewhere Suspected of conflict of interest When your manuscript is rejected, there are ways to handle the issue… principally by not taking rejection personally. There may be factors well…
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By Mary Gabb ( [email protected] ) A negative result is defined as one that shows evidence of absent (or no) effect of an intervention; it is not due to absence of evidence, i.e, inconclusive results due to an underpowered study. Traditionally, negative clinical results were considered ‘uninteresting’ and so were not published, or were not…
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By Ruth Whittington ([email protected]) With the NHS in the UK nearing its 60th birthday, there’s been considerable talk about whether the system should be put into retirement. At the recent European-based World Healthcare Congress in Berlin the Chief Executive Officer David Nicholson explained why he felt that there was plenty of life in the old…
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