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
- An applied scientific concept that can generate new treatment modalities.
- Development of new diagnostic tools that can add new information to the existing imaging modalities.It should have either a cost or effectiveness advantages .
- Development of new drugs or devices or surgical methods with less side effects.
- 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.
Disclaimer
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 ?
Dr.S.Venkatesan MD 