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Archive for the ‘bio ethics’ Category

   

      After  years  of   of experience  I  realised  knowledge and  Ignorance  share  an     intimate relationship !  

       venkat.quotes@2012



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Choosing a pacemaker  is not a child’s play . It is a  complex game played by cardiologists , electro-physiologists and their  ill-informed

patients. The  superiority of dual chamber pacing over single chamber pacing  was never convincingly proven.

Still . . . usage of  dual chamber pacing is steadily increasing over the years  for various reasons.

“Every thing hangs around a key word called quality of life . DDD pacemaker is supposed to enrich life due to their AV synchrony “

World  health organization  says  quality of life  of homo-sapiens are  determined by at least few dozen factors .They are  mostly non medical.

How an extra lead at a cost of  2000 dollars more , is  going to  provide that  elusive “quality of life”  to all those poor patients with bradycardia  in  this world  ,   which     . . . they  any-way lacked even  in their best of times  !

Scientifically also there is  a major  flaw in calling DDDR as physiological pacemaker

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If only we realise . . . even a healthy  human life   . . . has a mortality of 100 % at some point of  life  , the mentally immortal  modern human species won’t demand for  a  2 % chance of living   “30 more  miserable days”   with terminal cancer !

Venkatesan  Sangareddi (2012)


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Doctors would simply hate  this book   because  it tries to  expose them !

I would n’t agree with  the tone and conclusion of  this book . But one should soul search  , why such books are written  in the first place ?

The medical professionals  definitely  need to ponder over this  issue .

I stumbled upon this book  in Amazon book store

 

http://www.amazon.com/Medical-Blunders-Amazing-Stories-Dangerous

How  frequently doctors make blunders  ?   What  is your take ?

Would you like to vote in this poll  ?

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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 !

Answer:

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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In one of the corporate hospitals  which I visited in my city(Chennai*)  ,  happened  to see a nurse taking blood sample from a patient  who has been  just admitted  in a Hi-tech coronary care unit for UA-NSTEMI.

It included blood tests for CRPs,homocysteine,Apo-lioprpitein B etc . She was  being supervised   by  a capitation fee fed  , just delivered  , neo- medical graduate from a country side medical college.

I asked  her  what for you’r doing these  tests.

                        She said ,  it is  to detect risk of developing CAD.

     . . .I  reminded her , the patient  had already developed full blown CAD .

She was too innocent  to say  ” I do not know all those  things sir ,  my consultant asked  me to do it !

This is how  some corporate coronary unit* functions and   handle their  prized  possession . And every one enjoys it , as science  prevails over common sense !

* Shall  I  name the hospital  ?   . . . No , it would invite trouble  . . . oh ,  what  a  freedom of expression we enjoy  !

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It was  the year 1812 ,  exactly 100 years before the Titanic sank  over the Atlantic  , a  small bulletin from  Massachusetts General Hospital was  released .  It  later on became  the  single most  important  journal  for the medical community.  The appearance of  an article about  angina pectoris in the inaugural issue ,   reiterates the  importance of cardiology  even in those   days of primitive  medical care .

The volume. 1  : No. 1  issue of NEJM egan with a classical and critical observation of angina pectoris written  by Jhon Warren .

http://www.nejm.org/doi/pdf/10.1056/NEJM181201010010101

The first issue of NEJM . . . Witness to 200 years of medical excellence

Those were the days  when angina  was treated with tincture  opium and Fowler solution (Arsenic  potash ) .They  can be  termed as  height  of  inappropriateness  and  also  condemnable acts  . . .  is it not  ? 

200 years  later   . . .  in 2012  what  do you think has changed ,  in terms   of  appropriateness  of management   of angina pectoris  ?

What a surprise ,  two centuries  later ,  even as we are  treating  angina  in hi-tech cath labs  with bio-degradable stents and metabolic modulators   ,   bulk of our  population is  grappling with inappropriate therapy for angina pectoris .

Today ,patients are subjected to  questionable modalities  in the management of CAD ,  which the following paper   tries to expose !

Keeping the inappropriate flag high . . .200 years later in 2012


What a way to progress in Medicine !  The reason for this  “200 year  old ailment”  is  attributed to  extreme scarcity of common sense !

( A study , which says regular exercise  can be  as good as PTCA in multivessel CAD ,  would  sound  as a  “nonsense article”  for most  cardiologists  of  current  generation  !)

Finale

When we look  at human history , where billions  lived ( and continue to live ) in this  age old planet , it  would appear  a trivial matter  whether you treat angina pectoris with Tincture opium / Arsenical potash or  Prasugrel  / Rosuvsatin . . .

Whatever be the scientific advancement  the ultimate outcome on human health will depend on how we apply it. So, all young  medical fellows beware of this   !

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Medical  research can be divided into few  broad  categories

  1. Basic science  research  in animal models
  2. Basic science  research   in Human
  3. Clinical : Bedside-  observational
  4. Clinical:  Epidemiological
  5. Community based long term data analysis
  6. Interventional -Drug /Device/Surgical

*Logically the  top 5  should  constitute  the bulk of research  ,  in reality    last one wins the race with considerable ease . Why ?

The important issues that  confront  today’s medical research  starts  right from the  “Aim” of the research ,  methods , materials statistics,  and  goes on  to   ethical issues , conflicts, futility ,  gimmicks  0f  publication  ,  marketing and ultimately left  for human assimilation .

(Read a related article in this blog   can  Aim of a study be wrong ?)

Data(s)  won’t  lie  . . .humans do  !

Science is nothing but collection of  facts ,  rechecking  the facts , and  finally confirming ,  they are indeed  facts. So medical  data collection becomes vital .  Data,  if  properly collected ,  wont lie.   Bias is always an issue in prospective trials. Further ,  and whenever and wherever  scientifically  motivated  human  beings interact with  data  the later   becomes a vulnerable  target and  get manipulated   for various reasons . (Read the famous article on data torturing  in  NEJM : I will link it soon  ) So blinding  becomes  mandatory   and it should  be total as some studies  tend  to  gain vision half way through !

Image courtesey : Jupeter images

Simplicity of observational studies.

We  give undue importance to RCTs . What we fail to understand is RCTs are required only  in selected situations in medical research (New drugs and interventions ) Meanwhile , we can do wonders with retrospective observational  data. These  data  can not be  manipulated  as the events  have occurred already and those people who collect or record the data  wouldn’t know this data is going to be utilized  for a study (This  , in fact  is  equivalent  to 100 % natural blinding and constitute a  real world study )

Observational  study can involve  patient behavior ,    disease behavior  , community impact, drug action, investigation modality , etc  . . .etc  . Your mind is the limit . Cost of doing a observational study is less but the impact on the society can be great .

Observing skills are the  biggest causality in modern medical times , This was  only scientific weapon of  our ancestors had , which they  used in an exemplary fashion .( Recall how Heberden described angina and Harvey taught us about circulation without even ECG and X RAY chest )

Fraud in medical research

Wherever big money is flowing corruption and fraud is unavoidable . . .at the  least . . .  we  should recognize it

( Many journals  just point out this possibility by simply displaying message of conflicts .They do not bother more than that  . . . just a warning message  )

Now in the modern scientific world  ,   even as the   genuine contributions   from our ancestors  left to  stare  the back of us  , we try to indulge in all sort  of unpleasant things.

In an audit against fraud in medical  research ,  it was found most of the fraudulent research happened with drug and device trials and few in basic science involving genetics and molecular medicine . It  was  rare to identify fraud in research involving purely clinical and  epidemiological  analysis .

Drug trials  need to be prospective . Vested interest can play  havoc in prospective data .There is a  thing called steering committee in all major studies   . . . we do not know what does the  word  steering really   mean .

There has been many  occasions  even well conducted studies turn out be  fraudulent . Now we realise many such studies are struggling to prove its worthiness .

In fact  it is argued every study before getting published   should undergo a  global ,  independent  trial   monitoring  board for genuineness  of the study . (Not the customary  peer review !)

Final message ( Sorry its  a  long one !)

We have a huge problem  here . I am afraid  we  haven’t even  understood ,  what  we  mean by medical  research !

For today’s   youngsters  medical  research means doing sophisticated  tests in nano- labs  , human genome  mapping ,  space age imaging modalities  or  involving a multi- billion dolor drug trials . This is absolute  falsehood.

What we need to do is   “search” , ” search”  ,  search again (That is   why it is called re-search )  for all those elusive  problems  our patients   face .Not only in their body , in their  home , in their community,  etc . Every  patient  teach us  few points,    observing and learning new things  and  publishing is  also an important aspect of  research .One can do  a instant   research in the crowded  OPD of a hospital   , in the wards , (What is the profile  of fever pattern in a winter season in your hospital ? does it reveal a new viral epidemic ?)

An ideal research  should  identify a problem and suggest a practical solution to a given problem .There are millions of such issue waiting for our attention in the bed side.  But what is happening  currently ? Current medical research is largely direction less ,  fueled by vested interest ,  makes  sure it avoids  all genuine problem areas !

Many studies  happen  based on  flimsy scientific   basis  .We are still  wasting our time to increase human HDL levels. ( Not with standing  the famous Torcetrapib fiasco  )   .Hundreds  of thousand of dollars   are pumped into this  research even after realising  only the  endogenous HDLs generated by natural methods like  exercise   are  the really  good HDL !)

While we do million dollar research   with a dubious risk factor called  high sensitive C reactive protein  ,   there is  no takers against number one killer disease of human kind  namely  “The  poverty” (WHO ICD codeZ59.5 )*

Let us prey   God  to instill common sense to all of us  . Patients  suffer with disease and we suffer from irresponsibility  or reduced responsibility ! It  makes us happy at-least few forces  like Lancet  , British medical journal etc are fighting lone war  against this  ailment  medical science is suffering .

*Please note :  http://www.icd10data.com   WHO labeled poverty as disease many years  back without much fanfare ! It is rarely mentioned in  any  graduate student**  medical text  in whom our future lies .  I do not know whether  Wars  and terrorist acts  been included as disease  or not !

**Our students  rattle about  about the  exotic  tick borne  Lyme disease happening once a year in remote hills ,    while  most will stare blank   when asked  how to diagnose and  treat  nutritional  anemia with  which millions suffer  every day !

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When you  encounter  a patient  with shock and  hypotension , the first ( instinct ) response would be to  start  an  IV line and push fluids rapidly . This is more so if  the patient is a child. This is what medicine has taught us for over a century . Now this  NEJM article surprises us with  its conclusion.

The accompanying  editorial in NEJM reiterates  a  fact . . . “In medicine there is nothing called  dictum”   , what you perceive as life saving treatment  will be doing the opposite !

Such is  the fragility of  present day  medical facts.

Please  remember , in medical science  not only  the drugs  have  expiry date even  some of the  break through  concepts suffer from it . 

This study may not have  great implications for cardiologists  but the filed of cardiology is also  infested with  many such false dictum(s ) are waiting to be damned !

In this funny world . when the  scientific methods are  imperfect  ,  we have to realise  two such U turns make  the  original path right .

Similarly ,  some of  those who do  not  make the initial   path correction ultimately  travel  in  the right path !

Message to patients

Many of my patients often wonder how two diagonally opposite  views are expressed  by doctors  for a given medical  condition .  My simple answer to them is do not ever  try to understand your medical condition beyond a point , . .  .  we  our-self  have not yet  mastered it  !

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In this world of  evidence based medicine  the  funny bedside vocabulary of  medical statistics   has withstood the test of  time. The following words are liberally used by physicians of all walks of life.

We never bother to find what these words mean to our patients  !

Here is a crude and  wild   numerical attempt to  decode  these words.

  • Always                                    99 %
  • It s a rule                                  95-99%
  • Almost always                       90-95%
  • Very common                       > 90 %
  • Common                                  > 75%
  • Uncommon                            < 30 %
  • Rare                                          < 10 %
  • Very rare                                < 5 %
  • It is an exception                2 -5 %
  • Remote                                   < 2 %
  • Never                                     < 1%

Apart from the above   there two  hugely popular  medical words used over  million times every day in all walks of medical practice.

They are  ” May” and “May not”

The greatness of these words lies  in the fact   it can convey any of the above  10 meanings in a single phrase without any fuss !

Further ,  the words may and may not are numberless un-quantified statistical  jargons that   can convey a deep meaning or  . . . no meaning  depending upon the circumstances !

Doctor ,  is there a possibility of  my stent getting occluded    as i have skipped  the  clopidgrel ,and aspirin for the past two weeks

You may  be at risk  . . . but you may not develop  an heart attack immediately . I would advice you start the drug immediately .

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