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What in your experience as a group would be the reason(s) useless popular off label treatment occurs...
Amy
From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Ash Paul
Sent: 05 May 2011 08:51 AM
To: [log in to unmask]
Subject: Re: What proportion of our current treatments are 'evidence-based'?
What about Runaway prescribing of recombinant factor VIIa in US hospitals ? Ann Intern Med 2011;154:516-22 Ann Intern Med 2011;154:529-40 I'm quoting from the recent BMJ on the topic: http://www.bmj.com/content/342/bmj.d2593.full.pdf Recombinant factor VIIa is a powerful procoagulant, approved only for people with haemophilia. Off label use has exploded in recent years, and researchers estimate that 97% (95% CI 96% to 98%) of all prescriptions in a selection of US hospitals are now for off label indications, including intracerebral haemorrhage, trauma, cardiac surgery, liver transplantation, and prostatectomy. The same researchers combed the literature for evidence of benefit and found next to nothing. In their review of 16 trials and 48 observational studies, factor VIIa did not save lives when used for any off label indication. It was associated with a significantly increased risk of thromboembolism in patients having cardiac surgery and those with intracranial haemorrhage. Factor VIIa costs around $10 000 (£6113; €6900) a dose, but off label use in US hospitals increased by a factor of 140 between 2000 and 2008. An editorial (p 566) asks how we can control the runaway use of such an expensive, useless, and potentially dangerous drug. Firstly, we need to find out why clinical practice has got so far ahead of the evidence so quickly, and in particular whether marketing by the manufacturer had a contributory role. If evidence of unauthorised marketing comes to light “both civil and criminal responses will probably be brought to bear,” write the authors. Novo Nordisk denies any such practices. The editorial also urges hospital managers to take a close and critical look at use of factor VIIa in their institutions. Off label prescribing is not illegal, but continuing to prescribe in the face of good evidence that a drug doesn’t work (and may harm) could result in civil action.
Ash Dr Ash Paul 21 Kimbolton Road Bedford MK40 2AW Tel no: 01234897224 Email: [log in to unmask]
And there are these other studies that show 'lot of ' evidence for say equivalence of Leukotriene receptor antagonists LTRA and Long acting beta 2 agonists LABA and yet the abstract glaringly proclaims the amount of grants received by the authors from the prime manufacturers of LTRA ( which hitherto didn't have as much evidence to thrive on). On Thu, May 5, 2011 at 4:38 PM, Virginia Barbour <[log in to unmask]" target="_blank">[log in to unmask]> wrote: Dear All - you might be interested in an article just published in PLoS Medicine, which shows how little evidence there is for one specific treatment - Aripiprazole for maintenance of bipolar disorder. (Aripiprazole in the Maintenance Treatment of Bipolar Disorder: A Critical Review of the Evidence and Its Dissemination into the Scientific Literature http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000434) As the authors say "A single trial by Keck et al represents the entirety of the literature on the use of aripiprazole for the maintenance treatment of bipolar disorder. Although careful review identifies four critical limitations to the trial's interpretation and overall utility, the trial has been uncritically cited in the subsequent scientific literature" |