We generally believe drugs and devices are prescribed by physicians with strong scientific basis .Unfortunately it is not true in many instances. A drug which is approved for one disease is assumed to be useful in a similar disease (But not tested in clinical trials ) and it becomes an unapproved indication .This is often termed as off label use (A decent terminology for unscientific usage !) .But ,there are pros and cons to this type of physician behavior .
The best example is the role of sildanafil in pulmonary arterial hypertension(PAH) . A drug which was introduced for erectile dysfunction , was found to very useful in regressing pulmonary arteriolar pressure (Mistaking pulmonary arteriole for penile vasculature !?) . A new therapeutic concept was born for a hither to difficult problem of PAH. This successful discovery was attributed to off label usage of a drug .
But this is a rare success story of off label therapy. In real world , we tend to overuse this in many situations and harm is anticipated.
Drug eluting stents was used extensively in off label situation ( Acute MI in a thrombotic milieu, very small vessels , in close proximity to bare metal etc all these are non label or off label use of coronary stents which resulted in many deaths )
Who gave the freedom and liberty for the physicians to use a drug or device off label ?
No body gave it , we assumed , we have it .
When somebody uses a drug for an unapproved indication is it not unscientific and guideline violation ?
It is a violation , but we can afford to do it because every body does so !
Is there any scientific body to sanction and desanction off label usage ?
Unfortunately not !
So what is the solution ?
Self regulation . . . Can it be a fool-proof method ?
or Is it foolish to expect it so in this era of commerce ?
Related video in youtube hosted by me.
Guideline violation in cardiology practice