By Mary Gabb ([email protected] ) Since 1996, DTCA has existed only in the USA and New Zealand , but recent declarations from the European Commission (EC) suggest that the rules governing pharma communication with patients may be loosened. In October, both the Wall Street Journal (WSJ) and the Financial Times (FT) reported intriguing recommendations from…
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.
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…
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…
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…
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…
By David Woods ([email protected]) Whether it’s because of a shortage of primary care physicians, impatience at the length of time it takes to see one, or simply increasing costs, the so-called big-box companies are getting more involved in health issues. Steven Burd, CEO of Safeway, told attendees at the World Health Care Congress (WHCC) in…
By John F P Bridges While outcomes for any given treatment differ significantly among patients, national healthcare systems continue to take a top down population perspective in reviewing not only epidemiologic data but to evaluating the effectiveness and cost-effectiveness of new medicines. This top down approach, coupled with a growing need for cost containment, has…
By Mary Gabb ([email protected]) In a previous issue of HOC , we outlined some of the commonly expressed pros and cons of direct-to-consumer advertising (DTCA), which is currently allowed only in the United States (US) and New Zealand but under consideration for Europe . On May 5, 2008, three executives, from Pfizer, Schering-Plough/Merck and Company,…
By Ruth Whittington ([email protected]) Many of us in health economics and outcomes research look at Canada as one of the leaders in the field; along with Australia , Canada was one of the first countries to demand evidence of cost-effectiveness as a prerequisite for drug approval. To those of us not intimately acquainted with its…