Posts Tagged ‘drugs’

Research is the  guiding force for advancement in medical science.New drug and devices are developed every year that result in major break throughs.There need to be  a strong purpose and meaning for every research concepts in Medicine.The fundamental  principle in medical research  should be . . .

In basic science

It need to  generate a  new concept  that should help solve a existing  problem  or find an  eluding  answer ( Eg mechanism of an organ or cell function,  Genetic research  etc)

In clinical science

  1. An applied scientific concept  that can generate new treatment  modalities.
  2. Development of new diagnostic tools that can add new information to the existing imaging modalities.It should have either a cost or effectiveness advantages .
  3. Development of new drugs  or devices or surgical methods with  less side effects.
  4. Development of new drugs, which has a new additional benefit with less side effects.

A .What is Junk research or duplication of research

Most of the research methods testing  “non inferiority”  hypothesis can be considered junk  research (Note – Exceptions will be there. )

The most exploited concept in drug research  is  the concept of testing   non inferiority as it  allows comparing  new drugs with a proven old  drugs .Why should some one produce a drug which is likely to have a same effect  with  no additional benefit. Huge amount of time  , money  efforts  are wasted in  such  research

What is the need for 20 different ACE inhibitors  and 10 different ARBs when the basic structure  and function is almost similar ? Similarly Statins, analgesics, H2 receptor blockers, various forms of heparin  the list is end less . . .

There need to be a  strict vigil  on which research question the industry is trying to raise  and answer ?

Drug are released periodically  like movies with same old  screen play ( With a new  name  of course !) but with   a huge  cost.If any novel or music or art work or done in similar fashion there is  vibrant media to expose it, or  some times even legal action follows.  Alas . . . In medicine  it is free for all as  any one can legally plagiarise with  loopholes in plenty. Some times these drugs are hurriedly marketed as it has to generate the funds  before risk of it getting banned due to unforeseen side effects. In this sense some drugs exactly mimic a movie with good box office run for the initial few weeks.

A autonomous  world body ( Say WHO ) should supervise which research can be pursued in this world that can help betterment of human health . Currently tighter  regulations come into force only  during human testing .We need act  earlier   to prevent junk research in lab itself ! This can save huge resources .Some  may argue ,scientific work should not be curtailed  however futile they are !  I leave it your judgement .

B.Placebo compared superiority : This is another controversial concept  .This was a prerequisite  for a drug research in the earlier era .Now a drug need to be compared with the best current treatment! not with placebo.

Why superiority studies  are rarely designed by drug companies ?

Realise , how rare it would be to find  a study   where  a patented drug  is  compared  for superiority over another patented drug . Can you  guess the reason . . .  because they can do  superiority studies  easily over the placebos  !

Do we need to restrict drug development with similar structure and function?

The only argument can be in a global economy no body has a right to prevent any company  from  producing whatever they want  to  ! Survival of such  drugs  in this world is left to  market forces .The consequence  such approach could be disastrous ,  as  the  cheap  generic drugs with a  maximal  proven beneficial effect (Eg Hydrocholrthiazide in Hypertension ,  ) may not be manufactured at all in the near future . (Link to msf)

Is  the need for choices ,  an excuse ?

Like any commodity , people need choices so what is wrong  if a same drug is produced by 100 companies.Let the best survive !

Remember drugs can not be compared with other commodities. Even in other sectors , there are restrictions .( You can not allow 100 flights in a same sector or 10 mobile phone companies in a single city ,  however free the economy is ! )Every drug and device company should have a moral and legal obligation not to reduplicate the already proven concepts. Many tend to masquerade as new concept with a very subtle difference.

What is the favorite game  played by the drug companies ?

It is a too competitive market out there in world pharma industry. Drugs and device are developed at huge cost.They have to spend billions of dollors for R &D. They need money. The  manpower , time and cost involved are enormous. A drug or device has to pass on many acid tests and hurdles before releasing into market.Even after releasing there is a very good chances of it being  recalled  in the first few years as real human data start pouring.Apart from these many drugs and devices fail to take off at various levels. There can be a huge financial loss.(Eg Torcirapid HDL reducing agent).

So what is the solution ?

Drug companies involve in futile research that is imitating already proven concepts .And a drug which was approved for one indication by FDA is tested for many other indications as it becomes easier for increasing the market  share.This is can be  called as  the  “Phenomenon of  drugs  looking for a  new indication” .This  against  spirit of clinical research .

The classical example is  the attempt to  widen the  indication  for statins , amiodarone ,  ( Aortic stenosis   etc )Instead our energy  should be focused   into  developing  drug  for incurable  diseases

When can duplication of research  be beneficial ?

Scientists are working hard for a total artificial heart for years.Many teams are pursuing different methodology and concepts. Here the  competition is welcome. Like this there are so many labs  trying to create a solution for a genuine medical issue.


This article has nothing against any pharma industry. It aims to reason out the futility in medical research which is to be addressed for the betterment of human health.

Read related topic in my blog.

Can a Aim of a study be wrong ?

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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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