Ref: UF/08/22/01
Date : 25.08.2008
Justice (Dr.) S. Rajendra Babu
National Human Rights Commission,
Faridkot House, Copernicus Marg,
New Delhi, PIN 110001
Re.: Clinical Trials Conducted on Human Babies at Pediatric Department at AIIMS
Respected Sir
Uday Foundation for Congenital Defects and Rare Blood Groups is registered as Trust ( Registration no.2,802 / Book No.4 Vol No.3,179) in New Delhi. We work on various health issues & welfare of children without discrimination of caste, creed etc.
We filed an RTI to find out various facts and figures related to Clinical Trials on Human Babies at department of Pediatrics and Department of Pediatric Surgery at AIIMS (Our Question and Answers received from AIIMS are enclosed with this letter)
We understand that total 4142 babies were used for Clinical Trials Conducted by Dept. Of Pediatrics Since 1st January 2006 out of which 2728 babies were under 1 year of age.
It is also mentioned in the reply that 49 deaths were recorded among the enrolled patients in clinical trials. They further stated that these includes both in the control and intervention group.
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.
Sir, We are surprised with the statements made by Health Minister just after two days of setting-up an inquiry committee, in which he gave clean chit to the department of pediatrics without even waiting for the recommendation of their own internal inquiry committee. It is a serious matter of influencing the on going work of the committee and we are also not clear whether Dr. Veena Kalra ( former HOD, Dptt. Of Pediatrics) is being questioned by this AIIMS’s internal inquiry committee.
We certainly can not ignore the statements given by two senior most doctors in this case i.e Dr. Veena Kalra ( former HOD – Pediatrics as in her tenure period all these clinical trials happened ) and Dr. Chandra M. Gulhati based on his experience on Clinical Trials and details he provided about drugs usage on babies, which according to him , is not meant for children under 18 years of age and according to the reply of pediatrics, total 4142 babies were used for Clinical Trials Conducted by Dept. Of Pediatrics Since 1st January 2006 out of which 2728 babies were under 1 year of age.
In India Article 21 of Fundamental Rights assures the right to live with human dignity, free from exploitation. The state is under a constitutional obligation to see that there is no violation of the fundamental right of any person, particularly when he belongs to the weaker section of the community.
Sir, Lets assume that even one baby died because of clinical trials of drug on him it is a serious human right violation. We have following submissions to NHRC :-
1) Please consider the same matter as serious human right violation and please investigate the matter as soon as possible.
2) Please public the list of all 49 deaths happened during clinical trials on human babies during clinical trials at department of pediatrics and the 5 deaths happed during the clinical trials in the department of pediatric surgery , AIIMS. Including following details :-
· Condition of the baby when the first time he/ she admitted to the hospital
· Numbers of admission to the hospital and duration of treatment.
· Summery of clinical trial conducted on the babies.
· Reason of Death.
· Socio-Economic condition of the parents.
· Copy of approval taken from the parents for clinical trials and copy of consent form dully signed by the parents
3) The Socio- Economic condition of all the 4142 babies were used for Clinical Trials Conducted by Dept. Of Pediatrics and 71 babies used by pediatric surgery should be made public. Further it should also bring to the light the how many of these babies belong to the below poverty line category.
4) It should also be inquired that what are the serious side effects of all the drugs ( included top five mentioned in the reply of our RTI and all the other drugs ) used on the all 4142 during the period of clinical trials conducted on them
5) Is their any recommended diet , nutrition and prescribed environment for the human babies to conduct the clinical trial upon them and did AIIMS followed the same ?
6) Status of the same clinical trials in other countries : this should include no. of babies enrolled, no. babies completed the study and no. of babies discontinued & no. of babies died ?
7) Suspected or Unexpected Serious Adverse Reaction from other participating countries if any reported before these clinical trials been conducted on Human Babies by the department of Pediatrics ?
8) What is the role of Drugs Controller General , Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Government of India before conducting any clinical trials in India ? Is it mandatory to have approval before conducting any clinical trials in India, Did Department of Pediatrics and Pediatric Surgery, AIIMS took the necessary approval from Drugs Controller General, CDSCO?
9) What is the role of internal ethics committee for clinical trials in AIIMS and how many clinical trials site they visited during last two years.
We request you to please look into the matter immediately .
Thanking you
Yours truly,
For Uday Foundation For Congenital Defects and Rare Blood Groups
Rahul Verma
Managing Trustee
Enclosed :
· Human Rights Committee
· Committee on Economic, Social and Cultural Rights
· Committee on the Rights of the Child
· Committee on the Elimination of Racial Discrimination
· Working Group on Arbitrary Detention
· Special Rapporteur on Health
· Special Rapporteur on Violence Against Women
· Special Rapporteur on Extrajudicial, Summary or Arbitrary Executions