Recent report of RNCOS projects a huge growth for clinical trial outsourcing business in India. Their new report titled 'Booming clinical trials market in India' is very optimistic about India to emerge as the dominant destination in coming years.

According to our analysis, India is one of the most economical destinations for conducting global clinical trials. Companies can save a substantial amount in India on both staff and utilities. For instance, the salary of a clinical research associate is only 13% of that in the US and 17% and 19% as that in the UK and Germany respectively. Similarly, the cost of a biostatistician in India is only 15%, 18% and 17% as that in the US, UK and Germany respectively. Companies also save substantially on utilities and land while setting up their operations in India.

India presently occupies a very small pie of the global opportunity. The total number of clinical trials in India stood at 221 in 2007, which equates to less than 2% of the global clinical trials. With all major pharmaceutical/biotech companies and CROs establishing their presence in India, the number of clinical trials in the country is expected to grow several folds in the next five years. The country is projected to conduct nearly 5% of the global clinical trials by 2012.

In a knee jerk reaction, DCGI halts a Wyeth clinical trial in India. Probably the after effect of much-hyped AIIMS clinical trial fiasco.

Wyeth was testing their new pneumococcal vaccine (which covers more strains than the existing one, i.e. 12 Vs 7) in infants through a CRO based in Hyderabad. An infant in Bangalore site ( a medical college hospital) supposedly in control arm of the study died during the trial. It is now known that the infant had associated cardiac anomaly. Now the question is why the inclusion and exclusion criteria were not followed strictly? How this particular patient was included in the study in spite of a comorbid condition? Did Wyeth/CRO give protocol waiver for this?

Whom to blame in this tricky situation is not yet clear. Sponsor, CRO, or Principal Investigator? There is a clear indication of blame-game. Its gonna be interesting. I will come back with the updates.


Read the details here: Wyeth drug tests fall foul of watchdog

Blogger responses

Pharmalot writes India halts Wyeth vaccine trial over infant death

'Research Ethics Blog' posts 'Indian Vaccine trial halted over infant death'

Indian test cricket captain Anil Kumble decides to retire from international cricket. A spectacular career of 18 years comes to an end. I am not a cricket lover. I hardly watch cricket. But I love this thorough gentleman for his humility, great sportsmanship and perseverance.

Seeji

Akira Endo, a Japanese biochemist won the Lasker award for 2008 with four others. Akira is the scientist who discovered an LDL lowering fungi which led to the discovery of statins. He is currently acting as the director of Biopharm research laboratories.

We had written in one of our earlier post that Akira Endo deserves a Nobel. He got a Lasker today. Statistics shows 75 of Lasker awardees have gone on to win the Nobel. I am hopeful of my predictions coming true sooner.

Seeji

This topic has already been dealt in the previous post....Just a few more points to help lay persons realise the nature of this 'scandal':

1.‘As many as 49 babies, many of whom hadn't even celebrated their first birthday, have died at the All India Institute of Medical Sciences while being subjected to clinical trials for testing new drugs and therapies over the last two and a half years’….and then, subsequently, ‘the AIIMS administration admitted that of the 4,142 babies — 2,728 of whom were below the age of one…’.I fail to understand the implication of these lines. Children per se are considered special groups in clinical research. Guidelines are in place to ensure trials in children are conducted ethically and these are lot more stringent compared to those for adult clinical trials. The report itself quotes AIIMS saying it had taken clearance for the trials from its own ethics committee, the health ministry steering committee (HMSC) on ethics and the national ethics committees of ICMR and DBT, leaving no doubt that ethical issues of involving children (and infants) in the trials had been taken care of adequately. Being infant and ‘not celebrating first Birthday’does not make them more vulnerable. It, however, surely makes the headline more sensational, apparently implying AIIMS doctors killed innocent babies, including many infants for the sake of trials!!!

2.The report highlights the ‘foreign-manufactured’ nature of several of the drugs tested, implying Indian children were made to be guinea pigs for testing foreign brands. Testing foreign-made drugs in Indian population is by no means a crime as long as one abides by the regulatory n ethical guidelines. It is not clear, what exactly made Mr Verma n TOI to ‘feel’ that use of these ‘foreign-manufactured’ medicines violated these guidelines. What factual data do they have anyway???


3. Mr Verma seems to have an issue with the literacy status of the parents, who are ‘unable to read n write’. He categorically mentions ‘the consent form that has to be filled by parents was read out by the treating physician for parents who were not able to read it themselves’…my question to Mr Verma, were u present during the IC procedure??? Are you sure there was no one by the designation of LAR (legally Acceptable Representative) or IW (Impartial Witness---has to be a literate person) while taking the Informed Consent of the parents (btw, do u even know what LAR n IW mean and what purpose they serve in the consent process????!!!!!)

4. AIIMS has clarified that most of the diseases on which trials were conducted were of serious nature, with death being the normal outcome and they were trying to see if a new drug can improve the mortality. With irresponsible media reporting like this you are killing all options of future research which might save our kids from hitherto incurable diseases. If you want to ‘save’ Indian children from becoming guinea-pigs to foreign made drugs, first get us the facts and figures so we know that they were really exploited. And till the time you don’t have evidence to support your ‘noble’ cause please keep mum and let the doctors of AIIMS to their bit towards developing new medicines for potentially incurable diseases.


5. Lastly, the concern Mr Verma has expressed in the report (‘I doubt if they even understand what a clinical trial is and what their children are being subjected to’) is a valid one. Only, this is rather more generalized than being confined to AIIMS. Several unethical trials have been conducted in India, thanks to the high illiteracy rate of our population. However, more important than illiteracy per se is the fact that majority of Indian population is ignorant of the basic issues of clinical research and clinical trial. It is an uncomfortable fact (and often a challenge faced by any responsible clinical research professional) that mostly subjects agree to participate in trials because of the assurance of free medicines and more attention from the treating physician that they get by virtue of being enrolled. I see only two options: let the state of ignorance continue and stop all trials altogether on Indian population (who are usually unable to take an informed decision, and thus will always remain vulnerable), or, take some initiative to make our population ‘clinical trials literate’ so they are not deprived of the opportunity of getting better drugs of tomorrow!!

I strongly recommend Times of India should, hereafter regularly publish details of clinical trials, including potential risks of participation, participants’ rights, ethical and GCP related issues to enlighten our common people and protect them from ‘exploitation’ in the hands of ‘White-Coat Murderers’!!!!