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  • Format Audio, Texts
  • Language/s English
  • Target Audience Self-directed learning
  • EBM Stage 0 - Why EBM?
  • Duration <5 mins
  • Difficulty Introductory

Key Concepts addressed


2010 saw another drug – rosiglitazone, better known by the trade name Avandia – hitting the headlines because of unwanted side-effects involving the cardiovascular system.

Ten years earlier Avandia had been licensed by drug regulators in Europe and the USA as a new approach to the treatment of type 2 diabetes. This form of diabetes occurs when the body does not produce enough insulin, or when the body’s cells do not react to insulin. It is far more common than type 1 diabetes, in which the body does not produce insulin at all.

Type 2 diabetes, which is often associated with obesity, can usually be treated satisfactorily by modifying the diet, exercising, and taking drugs by mouth rather than by injecting insulin. The long-term complications of type 2 diabetes include an increased risk of heart attacks and strokes; the main aim of treatments is to reduce the risk of these complications.

Avandia was promoted as acting in a novel way to help the body’s own insulin work more effectively and was said to be better than older drugs in controlling blood sugar levels. The focus was on the blood sugar and not on the serious complications that cause suffering and ultimately kill patients.

When Avandia was licensed, there was limited evidence of its effectiveness and no evidence about its effect on the risk of heart attacks and strokes. The drug regulators asked the manufacturer to do additional studies, but meanwhile Avandia became widely and enthusiastically prescribed worldwide.

Reports of adverse cardiovascular effects began to appear and steadily mounted; by 2004 the World Health Organization was sufficiently concerned to ask the manufacturer to look again at the evidence of these complications. It did, and confirmed an increased risk. [6]

It took a further six years before the drug regulators took a really hard look at the evidence and acted. In September 2010 the US Food and Drug Administration announced that it would severely restrict the use of Avandia to patients who were unable to control their type 2 diabetes with other drugs; the same month the European Medicines Agency recommended that Avandia be withdrawn from use over the subsequent two months.

Both drug regulators gave the increased risk of heart attacks and strokes as the reason for their decision. Meanwhile independently minded investigators uncovered a litany of missed opportunities for action – and, as one group of health professionals put it, a fundamental need for drug regulators and doctors to ‘demand better proof before we embarked on mass medication of a large group of patients who looked to us for advice and treatment’. [7]

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