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Posts Tagged ‘ethics’

                                                 It is now mandatory for all  journals  to declare the  conflict  of interest by the authors  who are involved in medical research .The purpose apparently is to make all transactions or links  between the researchers and their funding agencies transparent .Even major journals  do not go beyond this . Some ensure it , to appear in the first page of  the article.

 What does the the journals tend to  convey to the reader by publishing the conflicts of interest ?

  •  Does it  mean the article in question  may have a bias or indeed have a bias  ?  and readers are warned  hereby !
  •  Do they send across a message  that the  article may not be really a genuine one and the judgement is left to the the consumers of the articles ?

How often a journal article is rejected purely on the basis of  conflicts of interest ?

Most of  journal articles are rejected  for poor methodology, statistical analysis and so forth .We don’t know how often a paper is rejected  due to a conflict issue per se.If this could happen ,bulk  of drug trials would face a torrid time from the editors.

Why , even the leading scientific  journals never indulge in grading the significance of the conflict ?

Here is an example .

accomplish

nejm1

The much hyped drug trial on Hypertension “ACCOMPLISH”  was published in the  world’s most prestigious medical journal recently .It  left  it to the readers to  have their  own assessment  on the conflict issue.

  The consequence of not , grading and investigating  about the conflicts could have  serious  global health  implications both financially and academically .

This study was designed, formulated, completed and published  with a single hidden aim of neutralising the land mark trial  of ALLHAT which recommended diuretics as a first line drug in HT.Apparently diuretics are very  cheap  , effective  generic drugs.

 Is it a scientific rule  that  the  latest evidence  ,  should always prevail over the older evidence ?

No. Science can never have such a rule ! The question is how good and genuine is the evidence.
Just because an evidence is current , it does not  attain a scientific sanctity !

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One of the important principles of medicine  is  “Diagnosis should  always precede treatment”

This quote , though appear reasonable , can not be practiced always especially in emergencies,  where we  have to first stabilise the patient   without a  prior diagnosis  .(Like administering IV fluids in hypotension , acetaminophen for fever , etc)

Modern medicine  considers treating a patient without a diagnosis as unscientific.

But,  it is a well recognised fact ,  millions  of decision in everyday medical practice is not based on scientific diagnosis  but on clinical acumen and empirical therapy . There are many  instances  wherein , we are never near the  diagnosis  even after exhaustive investigations. 

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                       Ironically , in this era of evidence based medicine , when  we are  unable to  conclude ,  we are forced  to do the most  funniest  thing , namely converting patient’s symptom itself as disease entity and  be happy  in labelling them. Like , Motion sickness ,  poly-arthritis, , chronic fatigue syndrome, adult respiratory distress syndrome ,  pre mature ejaculation, fever of unknown origin  , attention deficit disorder , etc (The list is endless . . .)

               This happens because physicians always feel guilty if they are unable to label a patient with a disease entity.

Is the guilt  justified ?  Not necessarily so !  Symptomatic treatment without  diagnosis  is the most dominant theme even today (Fever, pain etc ).So don’t feel unduly negative* when one is not able to fit a patent’s  symptom into a disease entity  but ensure  he  gets relief from his symptom.

 *Except of course , one has to rule out a serious disorder.

 Comments welcome

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                                            The science of medicine has evolved over 2000 years since the stone age days.It has  currently reached  a glorious era with  cutting edge  scientifc  technology .Today  one can map the entire human genetic blue print and intervene in the  disease  even before they manifest .One can   keep dying people alive for years with multi organ transplantation. Modern medicine has taught us  how human sufferings can be prevented and life can be prolonged (with or without purpose !)

The term conservative management  conveys two different

meanings for medical professionals.

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For other group of physicians

 

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                             Ever since the days of  application of leech over the  head for treating migraine and a crude knife abdominotomy for emergency exit of babies from  pregnant mothers in distress  , healer’s   mind has always  perceived “something  has to be done  urgently when some body suffers”  this sort of  reaction is probably  inherited  and is related to  the primitive flight or fight response .

This may be true in  some of the emergencies but it is untrue in many of the non emergencies.

                                          Unfortunately ,  our mind  finds it difficult   to differentiate  between these  situations . With constant exposure to dramatic medical breakthroughs , modern day physician is made to believe   “Some thing  is always  better than nothing  when illness strikes. Human body is a wonderful machine which has it’s own service station ! in the form autoregulation  and the meticulous  homeostatic mechanisms. Only if the disease process overwhelms,  it needs intervention.( Typical example:In the routine viral fever , you don’t adminster Acyclovir or other antiviral  for all of them !

                                        The problem with early aggressive approach is,  it fails to give an oppurtunity  for the body’s natural defence forces  to respond. Further , we will  never ever know how the administered treatment is going to fare vis a viz the natural response.( With due respects to RCTs).   While the field of medicine   has  so much  evolved , our thought process,  especially  the  aspect of clinical  reasoning  has always been lagging behind .It is now considered  as inferior or even unscientific  treatment  if  some one follows a conservative approach to a problem even if  it  provides   same outcome of that of an invasive or aggressive approach ( The classical example is PCI for chronic stable angina The COURAGE study).

The other major issue is the hazards of unwarrnted  invesitigations , drugs and procedures

Classical example:No one knows how much morbidity or mortality the routine Swan ganz catheter  caused when it was rampantly used for over two decades to monitor central venous pressure .It is estimated  that in modern medicine  there are at least  few  drugs or devices  in each speciality waiting  for the same fate  as that of  the swan ganz catheter.

No body knows when it will be exposed .Our EBM will take it’s own time . . .Till that time humanity need to suffer.

This thinking is not new  The concept  “First do no harm is over 2000 years old”

hippocrates-primum-non-nocere

Questions in search of answers

 Does law of conservation of energy applicable to human body and medicine  ? 

 Can we defy death with modern medicine ?

Final message

  • Conservative management is still  a great medical concept  in many situations  and one should not allow it to die  by the whims and fancies of the modern scientific forces.
  • Whatever you do on the patent’s body  do it ,  only if it is going to helpful for him /her. If you are unsure  Whether a given  treatment  is going to help or not ask this question to an expert .
  • The widely prevailing  dogma  of aggression is always better than  non aggression  has absolutely no evidence.
  • So approach a clinical issue disease by disease ,  individual by individual.
  • Now , in this era  high tech  medicine  ,  It is lot more tougher to choose a conservative path as the pressure to do more and more  looms  larger ! It is easier to follow the crowd  than a path of your own .
  • Always remember it needs a  stronger  mind to  act according to our conscience !

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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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     The greatest discovery in medicine is  “ common sense” and

    “democracy”.           

                       The greatest medical discovery  is the realization that medicine is an constantly evolving science. It needs lot of knowledge to know our ignorance . Common sense has probably saved more lives and reduced suffering in this world than any other single discovery. Note this glaring irony ! It has required a large multi national long term follow  up study (INTERHERT) to prove exercise and physical activity is good for health. Whatever science is teaching us it is we, with our sixth sense have to act appropriately .It is the only defense against the potential exploitation against man kind by various forces.

Another great development is the freedom of expression and democracy in medicine,  for which journals like BMJ, Internet are striving hard . . .

Dr .S.Venkatesan ,Assistant professor of cardiology . Madras medical college Chennai , India

     

 Click on the title to view the article and all nominations . 

 

 

 

 

                         

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Answer: Do  coronary angiogram  for all patients  who had suffered from an acute myocardial infarction* ( Forget about all those mulitpage ACC/AHA  guidelines !).

For an  interventional cardiologist ,  it is often  considered a crime to  follow a conservative  approach !

*Caution This one line guideline is not based on scientific fact  but reality based . Ideally one should identify  high risk subsets among the patients who had an AMI .Patients who had complications during the MI get immediate CAG. Others need  a focused LV function asessment ,  pre discharge  sub maximal excercise stress test or perfusion studies .But this concept has been  virtually replaced by pre discharge coronary angiogram for all ,  in many  of the centres in the world.

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Peer review of an article even in major journals never scrutinise the “Aim of  a study ” . However big is the journal,  they seem to bother only about the authors, materials, methods, and statistical analysis.  If only they peer review an article , right from the “Aim of the study” like ,

  • Who asks the research questions?
  • Who  defines the aim of the study ?
  • Who decides which drug to be compared with which drug ?
  • Who steers the steering commitee of a trial ?

If only , we could answer these questions without bias , pharma industry and their  regulators  would have ,  far more better image than what they have now !

A typical example for , the aim of the study  to be  wrong  , is  the “ONTARGET’ study on telmisartan.

Here they ( Who ? ) raised an inappropriate  question of     “Non inferiority” of one drug with other  without any  valid reason to compare these two drugs that will benefit the man kind !

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