Tuesday, 1 March 2016

How many patients died because doctors ignored drug company recommendations?

Vioxx was always a drug considered unsafe in patients in patients with renal failure, or at high risk of developing it. In 2002 the FDA implemented labelling changes to reflect the findings of the VIGOR study. The labelling changes included information about the increase in risk of cardiovascular events, including heart attack. The nature of these risks was such that they were most likely to manifest in patients already at high risk of CVS events, such as the elderly, or those with a recent neck of femur fracture (NOF).
Yet years later, a tertiary trauma hospital was still recommending routine prescription of Vioxx to a NOF patients either with or at high risk of both renal failure and cardiovascular events.
Patient often fall and break their hip because they have had a small cardiac or cerebral event, and even if their kidneys are normal before they fall, their age, dehydration, surgery and anaesthesia, blood transfusions, muscle necrosis and other factors mean they are at considerable risk of developing it. 
Look at a page from the protocol which was approved by the hospital executive, and to be followed by intern and resident doctors. Vioxx was to be prescribed regardless. 
Yet history records that doctors were extremely successful at diverting the blame for patient deaths onto the drug company, despite the fact that its product guidelines advised against the use in patients like these.

ps. note also the endone dosage recommendations. Not at all appropriate for this patient group.

Is there any other teaching hospital in the world that was stupid enough to make vioxx part of a treatment protocol for anyone, let alone high risk patients in Sept 2004? Only Canberra?