The International journal of risk & safety in medicine
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The impact of the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement, which was published in 2004 and aimed to improve the quality of the safety information presented in clinical trials, remains uncertain. ⋯ The adverse event information was insufficient for the RCTs published in four high-impact medical journals five years after the publication of the extension of the CONSORT statement.
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Review
A compromise too far: a review of Canadian cases of direct-to-consumer advertising regulation.
Since the mid 1990's, Canada has introduced partial direct-to-consumer advertising (DTCA) of prescription drugs through administrative policy shifts. Little documentation exists on how regulation occurs in practice. ⋯ There is an astonishing degree of discordance between public health priorities and regulation of DTCA in Canada. The current approach to enforcement is notable both for its lack of teeth and lack of accountability and transparency.
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At the time of the outbreak of the pandemic of New Influenza A (H1N1) pandemic influenza vaccines became available via an accelerated registration procedure. In 2005 large stocks of the neuraminidase inhibitor oseltamivir were built up in the Netherlands and other western countries. ⋯ There now have been reports of rare and serious side effects. The first reports on the severity of the pandemic in Australia and New Zealand indicated a mild course.