My Blog

Times of India, leading daily, flashed one front page news today. “49 babies die during clinical trials at AIIMS”. My first response was of complete shock. What the hell ! Any unsuspected person who is unaware of the mortality, demographics and current statistics of India will jump to the conclusion that AIIMS doctors killed 49 babies overnight for the sake of clinical trials. It was evident when I reached workplace in the morning. Many people were talking about this news. TOI made some quick bucks at the expense of a sensational headline and story.



Only when you go through the news article, you will understand that

1. This data is of last 2.5 years.
2. Out of 4142 babies enrolled in trials 49 died. (comes to 1.18% mortality or 11.8 per thousand)
3. Only half of them are infants (and the rest I presume to be under-five age group).
4. There is no data on what is the current institutional mortality rate in infants, under-5 age group children otherwise with the standard of care.
5. There is no data on how many of these deaths were attributed to the study medication of clinical trials.

The intention is clear here. Someone by name Mr Verma needs a 5 minute fame on TV channels and TOI needs to sell some thousands copies more today. This amounts to suppression of essential information and giving a false impression. I feel he should be prosecuted for creating distrust in people towards AIIMS and clinical trials in general.

Let us look at the statistics in India at 2006 (the TOI published data starts at 2006)

Under-5 mortality rate at 2006 – 76 per thousand
Infant mortality rate (2006) – 57 per thousand [32.31 in 2008]
[ref: UNICEF]
11.8 per thousand is comparable to the present data. But we can not comment on this, unless we know the institutional mortality rates in children on standard of care.

We don’t have the data for AIIMS in particular. No analysis has been done to compare between mortality rates in children on clinical trials and on standard of care. No attempt has done by Mr Verma, to know the disease specific mortality in these trials. Article does mention some of the trials where the diseases in question are chronic focal encephalitis, Gauchers etc which deemed to have a high mortality.

I would advise Mr Verma to go through all these analysis first and still if he finds a significant rise in mortality associated to clinical trials, with our entire support let him take AIIMS to gallows.

Mr Verma has a valid point in saying that, seriously ill patients are denied admission to accommodate clinical trial patients. This is a serious offense and should be looked into. Community healthcare is the primary objective of any public funded institution like AIIMS. Research comes later. There are issues about informed consent process, which should be carefully monitored. But the approach to these concerns by giving a headline like “49 babies died….” is unacceptable. It has clearly misled people and has given a wrong signal. He should instead concentrate on more serious issues in clinical research in India and contribute to health care constructively.

On personal note, I am aware of the stature of AIIMS. I know of the stringent ethical guidelines their IRB specifies before accepting a clinical trial.

Please do remember that all the generic medicines what we comfortably use today have been tested in western population before. We pop in a 'lipitor' today without giving a thought about thousands of US nationals, who underwent clinical trials to get that wonder drug in market. But we raise a huge cry when a MNC performs a clinical trial in India. Only then we think of ‘guinea pigs’.

Seeji, Pharm House