The AIIMS Clinical Trial 'Scandal'---Few More Points to Note

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’!!!!

5 comments:

  1. Anonymous says

    My Dear Intelligent Friends , I do not know whether you are being paid to write these s blog regarding clinical trials at AIIMS, or you earn some US $ from your google ads or you too are trying to get five minutes fame .

    In you’re blog you failed to mention following points :-

    Why you dear health minister Ramadoss, MBBS set up an inquiry on silly findings of Mr.Verma?

    It was your loving AIIMS you run after news channel when these news was broke , your views please.

    Why your AIIMS did not made name public of the children died due to clinical trials ?

    Why they are not clear on the number of deaths happened in control group and intervention group?

    Why they fail to provide the details of children who belongs to Below Poverty Line ?

    Why they fail to provide socio-economic details of babies ?

    How much you know about Mr.Verma of Uday Foundation , And how many surgeries his little son Arjunuday had ? Which inspired him to start this NGO , Go and Check at www.uday.org.in

    How many of your family members were part of clinical trials till date , please also inform mortality rare in percentage ?

    On August 18, 2008, Times of India carried a news report as “49 babies die during clinical trials at AIIMS. ( copy enclosed) and based on the same report, Health Minister immediately ordered an inquiry with 5 faculty member of AIIMS as members of the same inquiry committee .

    Only after two days of formation on inquiry committee, on August 20, 2008 Times of India carried a news report as “AIIMS panel to probe infant trial deaths” with a remark that “Speaking to TOI, health minister A Ramadoss gave a big thumbs up for the institution. "AIIMS is a renowned research institution. The children must have died because they were already very ill".

    On 22/08/2008, Delhi based news paper MetroNow printed an interview of Dr. Veena Kalra ( former HOD- Pediatrics , AIIMS ) in which she stated that she does not rule out the possibility that the deaths of 49 Babies in Clinical Trials and Parents came from economically-weaker sections could be true. Further she added that It is not that easy to explain, When people do not even understand that dosage of medicines doctors prescribe. It is a tall order to assume something as complex as this can be understood in one sitting. ( details enclosed). It is very important to note that Dr. Veena Kalra (Former HOD Pediatrics, AIIMS) took voluntary retirement in 2008, that means majority of these clinical trials happened when she was the HOD of the pediatrics department.

    More Shockingly, on the same day i.e 22/08/2008 as per news report of a news agency- IANS a news was published with the title “Babies' death in AIIMS clinical trials open Pandora's box” which shockingly reveal that Two of the trial drugs - olmesartan and valsartan, meant for reducing blood pressure - have never been tried on patients below the age of 18 years, according to the interview by Dr. Chandra M. Gulhati, editor of the Monthly Index of Medical Specialties and a keen observer of the clinical trials in India.
    In the same article Dr. Chandra M. Gulhati further added that “Is hypertension in this age group (1-16 years) a problem in India? If yes, what is the incidence and prevalence? If it is not a major problem, why conduct a trial in India and put children at risk without any benefit?"
    To more of our shock he further added that "It is obvious that these trials are being conducted to extend patent period in Western countries with no consequence or benefit for India using Indian children as guinea pigs."
    AIIMS said some of the deaths were of children in the control group — those not being given the test drug — it did not disclose how many.

    According to AIIMS consent of the guardians concerned was taken, it added that forms were read out to those who couldn't read. But it did not answer to the RTI query on how many participants came from below-poverty-line families.

    Now you have proven your intelligence by writing this serious blog reg. Clinical Trials on Human Babies , Please highlight your views on following questions immediately or you scrape your blog with apology to to poor and sick patients of India .

    1. Please provide complete list of the medicine or drug used during clinical trails on human babies made outside of India by Department of Pediatrics Since 1st January 2006 as per following details:-

    • Complete list of Drugs or Medicine along with brand name & country of origin.
    • How many of these drugs has been tested in country of the origin, please provide us details that how many babies were used in the respective country.
    • How many of the drugs tested in clinical trials are now available in the Indian Market and International Market, Please also provide that name of the product


    2. Is any of the drug used in clinical trials since 1st Jan 2006 is already available in the Indian Market under any brand name which is not part of current clinical trials ? Please name the same and reason to include the same drug if it already available in India ?

    3. What are the top 10 side effects noted in the period of clinical on Human Babies by Dpt. Of Pediatrics?

    4. Please provide total number of the babies who had side effects due to clinical trials since 1st Jan 2006 . Please also provide details how many of them had serious side effects and how many had mild side effects ?

    5. Name the top 10 medicine which cause side effects (serious & mild) on the babies , Please also provide the data related to the side effects of the same drugs while usage in the children of the country of origin of the drug.

    6. Is it necessary to take approval from Drugs Controller General , Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Government of India before conducting any clinical trials in India ? If yes, did Department of Pediatrics take the necessary approval from Drugs Controller General, CDSCO?

    7. Please name all the sponsors & collaborators of Clinical Trials conducted by Department of Pediatrics Since 1st Jan 2006 and their country of their origin ?

    8. Please provide following data related to Top five Clinical Trials ( in terms of maximum number to of Human Babies used who were under 1 year of age at the time of entering into clinical trials )

    a) Name of the Drug(s)
    b) Regulatory status of the drug in other countries (Names of countries where the drug is approved along with international package insert or where IND application is filed)
    c) Objective of the Study
    d) Phase of Study
    e) Names of the Participating Countries /Investigator sites
    f) Total no. of patients to be enrolled globally
    g) No. of patients to be included in India
    h) Regulatory/ IRB approvals from participating countries
    i) Status of the study in other countries : this should include no. of patients enrolled, no. patients completed the study and no. of patients discontinued & no. patient died.
    j) Suspected Unexpected Serious Adverse Reaction (SUSAR) from other participating countries if any reported
    k) Is any study has been discontinued in any country and in case of discontinuation the reasons for such a discontinuation .
    l) Animal Pharmacology Data & Toxicology Data
    m) Clinical Data
    1. Phase I
    2. Phase II
    3. Phase III
    4. Phase IV

    9. Please provide study brief of all clinical trials conducted by department of pediatric since 1st January 2008 including following details :-

    a) Disease Profile
    b) Study Brief : Including Condition, Intervention & Phase.
    c) Study Objective: Primary & Secondary.
    d) Inclusion & Exclusion Criteria


    Mr Verma is an idiot who unnecessary trying to get into your business, but believe me but if we do not have idiots and fools like Mr.Verma , Intelligent people like you will eat this country.

    It is little difficult to see your SON in ICU as compare to your father, May be it will take some time for super intelligent like you to under stand the same…

    Hope to see the same post on your blog,


    Anonymous says

    My Dear Intelligent Friends , I do not know whether you are being paid to write these s blog regarding clinical trials at AIIMS, or you earn some US $ from your google ads or you too are trying to get five minutes fame .

    In you’re blog you failed to mention following points :-

    Why you dear health minister Ramadoss, MBBS set up an inquiry on silly findings of Mr.Verma?

    It was your loving AIIMS you run after news channel when these news was broke , your views please.

    Why your AIIMS did not made name public of the children died due to clinical trials ?

    Why they are not clear on the number of deaths happened in control group and intervention group?

    Why they fail to provide the details of children who belongs to Below Poverty Line ?

    Why they fail to provide socio-economic details of babies ?

    How much you know about Mr.Verma of Uday Foundation , And how many surgeries his little son Arjunuday had ? Which inspired him to start this NGO , Go and Check at www.uday.org.in

    How many of your family members were part of clinical trials till date , please also inform mortality rare in percentage ?

    On August 18, 2008, Times of India carried a news report as “49 babies die during clinical trials at AIIMS. ( copy enclosed) and based on the same report, Health Minister immediately ordered an inquiry with 5 faculty member of AIIMS as members of the same inquiry committee .

    Only after two days of formation on inquiry committee, on August 20, 2008 Times of India carried a news report as “AIIMS panel to probe infant trial deaths” with a remark that “Speaking to TOI, health minister A Ramadoss gave a big thumbs up for the institution. "AIIMS is a renowned research institution. The children must have died because they were already very ill".

    On 22/08/2008, Delhi based news paper MetroNow printed an interview of Dr. Veena Kalra ( former HOD- Pediatrics , AIIMS ) in which she stated that she does not rule out the possibility that the deaths of 49 Babies in Clinical Trials and Parents came from economically-weaker sections could be true. Further she added that It is not that easy to explain, When people do not even understand that dosage of medicines doctors prescribe. It is a tall order to assume something as complex as this can be understood in one sitting. ( details enclosed). It is very important to note that Dr. Veena Kalra (Former HOD Pediatrics, AIIMS) took voluntary retirement in 2008, that means majority of these clinical trials happened when she was the HOD of the pediatrics department.

    More Shockingly, on the same day i.e 22/08/2008 as per news report of a news agency- IANS a news was published with the title “Babies' death in AIIMS clinical trials open Pandora's box” which shockingly reveal that Two of the trial drugs - olmesartan and valsartan, meant for reducing blood pressure - have never been tried on patients below the age of 18 years, according to the interview by Dr. Chandra M. Gulhati, editor of the Monthly Index of Medical Specialties and a keen observer of the clinical trials in India.
    In the same article Dr. Chandra M. Gulhati further added that “Is hypertension in this age group (1-16 years) a problem in India? If yes, what is the incidence and prevalence? If it is not a major problem, why conduct a trial in India and put children at risk without any benefit?"
    To more of our shock he further added that "It is obvious that these trials are being conducted to extend patent period in Western countries with no consequence or benefit for India using Indian children as guinea pigs."
    AIIMS said some of the deaths were of children in the control group — those not being given the test drug — it did not disclose how many.

    According to AIIMS consent of the guardians concerned was taken, it added that forms were read out to those who couldn't read. But it did not answer to the RTI query on how many participants came from below-poverty-line families.

    Now you have proven your intelligence by writing this serious blog reg. Clinical Trials on Human Babies , Please highlight your views on following questions immediately or you scrape your blog with apology to to poor and sick patients of India .

    1. Please provide complete list of the medicine or drug used during clinical trails on human babies made outside of India by Department of Pediatrics Since 1st January 2006 as per following details:-

    • Complete list of Drugs or Medicine along with brand name & country of origin.
    • How many of these drugs has been tested in country of the origin, please provide us details that how many babies were used in the respective country.
    • How many of the drugs tested in clinical trials are now available in the Indian Market and International Market, Please also provide that name of the product


    2. Is any of the drug used in clinical trials since 1st Jan 2006 is already available in the Indian Market under any brand name which is not part of current clinical trials ? Please name the same and reason to include the same drug if it already available in India ?

    3. What are the top 10 side effects noted in the period of clinical on Human Babies by Dpt. Of Pediatrics?

    4. Please provide total number of the babies who had side effects due to clinical trials since 1st Jan 2006 . Please also provide details how many of them had serious side effects and how many had mild side effects ?

    5. Name the top 10 medicine which cause side effects (serious & mild) on the babies , Please also provide the data related to the side effects of the same drugs while usage in the children of the country of origin of the drug.

    6. Is it necessary to take approval from Drugs Controller General , Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Government of India before conducting any clinical trials in India ? If yes, did Department of Pediatrics take the necessary approval from Drugs Controller General, CDSCO?

    7. Please name all the sponsors & collaborators of Clinical Trials conducted by Department of Pediatrics Since 1st Jan 2006 and their country of their origin ?

    8. Please provide following data related to Top five Clinical Trials ( in terms of maximum number to of Human Babies used who were under 1 year of age at the time of entering into clinical trials )

    a) Name of the Drug(s)
    b) Regulatory status of the drug in other countries (Names of countries where the drug is approved along with international package insert or where IND application is filed)
    c) Objective of the Study
    d) Phase of Study
    e) Names of the Participating Countries /Investigator sites
    f) Total no. of patients to be enrolled globally
    g) No. of patients to be included in India
    h) Regulatory/ IRB approvals from participating countries
    i) Status of the study in other countries : this should include no. of patients enrolled, no. patients completed the study and no. of patients discontinued & no. patient died.
    j) Suspected Unexpected Serious Adverse Reaction (SUSAR) from other participating countries if any reported
    k) Is any study has been discontinued in any country and in case of discontinuation the reasons for such a discontinuation .
    l) Animal Pharmacology Data & Toxicology Data
    m) Clinical Data
    1. Phase I
    2. Phase II
    3. Phase III
    4. Phase IV

    9. Please provide study brief of all clinical trials conducted by department of pediatric since 1st January 2008 including following details :-

    a) Disease Profile
    b) Study Brief : Including Condition, Intervention & Phase.
    c) Study Objective: Primary & Secondary.
    d) Inclusion & Exclusion Criteria


    Mr Verma is an idiot who unnecessary trying to get into your business, but believe me but if we do not have idiots and fools like Mr.Verma , Intelligent people like you will eat this country.

    It is little difficult to see your SON in ICU as compare to your father, May be it will take some time for super intelligent like you to under stand the same…

    Hope to see the same post on your blog,


    jhilaam says

    @anonymous

    Please note that the objective of this blog is to deal with CR n trial related stuff. It is NOT a platform to glorify unethical trials. Kindly refer to http://clinpharm.blogspot.com/2006/11/bbc-shows-world-dark-side-of-clinical.html. and you will probably be assured of our intention here and whether or not we are being paid by AIIMS or any Multinational Pharma Company to push their investigational products and to mislead poor, illiterate, vulnerable Indians to increase recruitment.

    I do not know Mr Verma in person; hence I’ve nothing against or for him. I have no objection with anyone filing an RTI query suspecting unethical practice in clinical trials as I’m aware of such practices in India.

    I do appreciate your scientific thinking and the fact that you have put up some very relevant questions. Interestingly, some of those questions occurred to me as well when I read the TOI report. I desperately searched the article for any factual data that would indicate these trials violated ethical and regulatory guidelines, causing death of otherwise healthy babies. To my surprise, they were conspicuous by their absence. When a daily like TOI flaunts a headline of ‘49 babies die during clinical trials at AIIMS’, one is bound feel that all the deaths were caused by some unethical practice during the trials. Unfortunately the article failed to provide any information to indicate that AIIMS was indeed guilty.

    Please note, I’m not implying unethical practices can not occur just because it is AIIMS. Just that, unless one have sufficient information to prove (and share with public) an institute of AIIMS’ stature to be guilty of such serious allegations, one should be cautious with their vocabulary selection. The headline could have been anything less dramatic and sensational, and more factual.

    If we had a more factual article, which stood by the notion that all 49 deaths had occurred due to unethical trials at AIIMS, you would have seen the same topic in this blog with an altogether different heading. And I assure you, if the probing committee result finds AIIMS guilty, you will see another post here.

    Jhilaam.


    dr potdar says

    Hello Jhilaam

    it was good to read your article it was very informative and I liked your arguments

    clinical trial indeed is a hot topic these days

    regards
    Dr. Potdar
    www.cgmp.co.in


    Anonymous says

    Clinical Research is a business in India being done byb Indians. The institutes undertaking these study make subject by telling them free medicine worth of thousans of money is provided.
    They do not tell what will happen incase of malfunction of drug administor to subject.
    Most of subjects are from village area who are not able to read and write even the educated one do not read the consent form and terms and condition.
    Institute go free from law when one sign out as i agree and accept the terms and condition.
    Clinical research is kill and doctors are murdered.