Posts Tagged ‘fda’

Off label prescription 

  1. Is a great scientific concept
  2. Is a deceit camouflaged  with a pseudo scientific fabric.
  3. Can be encouraged in very selective patient  population and diseases by experienced  cardiologists , as  it may be really useful when no other options are available.
  4. Is diagonally opposite  to evidence based medicine , should be banned in toto !


4 is the correct answer .occasionally 3 can be true

Some of the examples of off label indication

  • Statins for Aortic stenosis
  • VSD device for RSOV closure
  • Ivabradine for cardiac failure

By the way how does an off label become on label?

It is not the ” God ” who  gives the label to them

There are few “Demi Gods” sitting aside  in the regulatory corridors of  New york and  Geneva who decide the fate of these drugs and devices . Ultimately the integrity of these organizations that will either protect or injure our patients !

Final message

Medical science grows my mistakes  . . . hence  we should be encouraged to do more of that  . . . so that we can grow !

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There are thousands of forums for medical science.

Most are aimed at research.  Few are available  to scrutinize  research.

Cardiac safety research consortium

This one from Duke university ,  is a great beginning in collaboration with FDA .

Let us welcome , this whole heartedly and wish all success in it’s motto !

Namely , exposing all safety issues in the modern cardiac therapeutics .

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                                            The growth of medical science has been phenomenal .It is estimated , the quantum of break throughs  and development  in the  last  50 years  is   nearly equal  to  2000 years of evolution of our  knowledge  put together.  Along with this growth , came the  unavoidable misuse , and abuse of medical science. This  is mainly due to contamination of medicine with commerce . Federal drug authority (FDA) and it’s variants  were formed in all countries to monitor the proper usage of  these technologies for the benefit of mankind. It has an authority to ban a drug or device  , if it is found to bring more injury or side effects  than benefit !

But , unfortunately there is no legal authority to ban an  an  investigation  which is  potentially  or (really  harmful )

or  used  extensively without any valid purpose .

The list of such investigation is increasing in every speciality 

In  cardiology

  • Doing a Troponin assay in patients wuth classical STEMI
  • MDCT in general population
  • Pro BNP in all suspected cardiac  failure
  • Routine C reactive protein for CAD
  • Central venous catheters for all pateints with shock.

Is there a case for banning an investigation (Like banning a drug) for the benefit of  our patients ?

Looking superficially , it  may seem  ironical. But we realise many seemingly  innocuous investigations are responsible for uncontrolled misery for many patients.

This especially true in people who throng the wellness clinic (Also called master health check up)

A incidentally high C – reactive protein   can lead on to forearm blood flow assessment of endothelial dysfunction and carotid intimal plaque  that could  lead onto carotid stents ! and life long anticoagulation , and an  excess INR and sudden cerebral bleed and death !

This is one sample story  in one particular speciality

There is a definite case for banning ( Either total or partial)  some of the questionable investigations  which are done routinely !

Just because these investigation do not have any  physical , visible , adverse reactions like a drug , it should not be allowed to be abused  .The consequence of  false positive results of these investigations could be terrible and worse than the real disese itself !

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                Human civilisation has met so many challenges.Man kind has enjoyed the benefits of modern medicine for over a century.Now comes the new threat.Threat from within.The onslaught of marketing force has contaminated the medical science .

              It is widely  recognised  commerce is masquereading as science , from stem cell research to futile and costly  drugs, and  questionable  devices and procedures . 

How is the medical  community responding to this  issue ? 

Silence  is the response !  Why silent ? Are we the part of the problem ?  Occasional articles in the  Annals of medicine, Lancet, BMJ, or JAMA talk about these issues and nothing happens next .

Click below  to read one such article from the recent issue of Annals !



Let us hope the world financial crisis currently we are witnessing , would be good for human health as all futile market driven  , enforced medical expenditure goes bust !

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