49 babies died during clinical trials at AIIMS in last 30 months

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49 babies died during clinical trials at AIIMS in last 30 months
as reported in By Sindh Today | Aug 17th, 2008

New Delhi, Aug 17 (IANS) As many as 49 babies have died during
clinical trials at the premier All India Institute of Medical Sciences
(AIIMS) during the last two-and-a-half years, the reply to a Right to
Information (RTI) query has revealed.

The AIIMS paediatrics department conducted 42 sets of trials on 4,142
babies - 2,728 of them below the age of one - since Jan 1, 2006.

Forty-nine babies died during the trials. AIIMS says the deaths
amounted to a 1.18 percent mortality rate, according to its reply to
the RTI query.

'A total of 49 deaths corresponding to 1.18 percent mortality among
the enrolled patients were recorded in the studies. These include
deaths both in the control and intervention groups, as per the designs
of individual studies,' the reply says.

The reasons for the babies' deaths, their ages or their gender are not
contained in the reply - since these were not specifically asked by
the applicant, Rahul Verma, founder of NGO Uday Foundation for
Congenital Defects and Rare Blood Groups.

Verma, in fact, had filed separate queries with the same set of
questions with the paediatrics department and the paediatrics surgery
department. He says he received an unsatisfactory reply from the
latter and is going to file an appeal in the case.

Clinical trials are research studies that test how well new medical
formulations work on people. Each study attempts to find better ways
to prevent, screen for, diagnose, and treat a disease.
If carefully conducted, clinical trials are the safest and fastest way
of finding treatments that work.

In reply to a query on who the five top funding agencies for the
trials were, AIIMS named the institute itself, the Indian Council of
Medical Research (ICMR), the Department of Biotechnology (DBT), the
World Health Organisation (WHO) and the Johns Hopkins Bloomberg School
of Public Health in the US.

Five foreign-manufactured medicines were tested during the trials. They were:

• Zinc tablets for treating Zinc deficiency and serving as a
  nutritional supplement,
• Olmesartan and Valsartan for treating blood pressure related problems,
• Rituximab for treating chronic focal encephalitis, a condition
  affecting the brain, and
• Gene-activated human glucocerebrosidase - for treating Gaucher
  disease that affects the liver.

In reply to another query, AIIMS said that before conducting the
trials, it had taken clearance from its own Ethics Committee, the
Health Ministry Steering Committee (HMSC) on ethics and the National
Ethics Committees of ICMR and DBT.

Verma, however, maintained that there were legal and ethical lacunae
in the system as permissions had to be sought from different agencies
depending on the nature of the trials.

'There needs to be a nodal agency, like the Care Prevention Control
for Experimental Animals (CPCEA), whose permission has to be sought
before using animals as guinea pigs,' he contended.

According to Verma, 'the unquestionable ease with which clinical
trials can be conducted on human beings in India makes international
agencies first test their products on the Indian population.'
'This prompted me to find out the details and the ethical procedures
involved if any.

'The fact that of the 4,142 babies on whom clinical trials were
conducted, 2,728 were under one year of age is scary,' Verma
maintained.

In reply to a query on whether the babies on whom the trials were
conducted belonged to the lower socio-economic strata of society,
AIIMS said: 'Children eligible for clinical studies conducted in
department represents a mix of those attending the out-patient and
in-patient services.

'No studies selectively target children belonging to low
socio-economic status (sic). The eligibility is based on the aims of
respective studies,' the reply stated.

The institute, however, was silent to a query on the number of babies
from families living below the poverty line who were part of the
trials.

The reply to another query partly answered this question, saying that
the consent form the parents have to sign 'is read out by the treating
physician for parents who are not able to read themselves'.

'The question is: If the parents can't read or write, do you really
expect them to understand the implications of these trials?' Verma
wondered.

49 babies died during clinical trials at AIIMS in last 30 months | Sindh Today

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As reported by PTI on ptinews.com on 18 August 2008:
Centre asks AIIMS to order probe into children's deaths

Centre asks AIIMS to order probe into children's deaths

New Delhi, Aug 18 (PTI) The Centre today asked the AIIMS director to order a high-level inquiry into deaths of 49 children during clinical trials even as the premier institute claimed the kids did not die due to any new drugs tried on them.
Union Health Secretary Naresh Dayal told reporters that the issue came up for discussion in the Governing Body meeting and Health Minister Anbumani Ramadoss asked the AIIMS Director to conduct a high-level inquiry into the matter and submit the report expeditiously.

The AIIMS administration, however, said all the 49 children were mortally sick and died naturally and not due to any drugs used in the trials.

"We are very happy to announce that after an afternoon faculty review meeting of all available data, we found out that none of the deaths can be attributed to drugs," head of the Paediatric Department V K Paul said.

Among the 49 kids, some were given clinical trial drugs and others standard drugs, he said.

In a reply to an RTI application, the AIIMS administration had said that as many 49 children have died during clinical trials of new medicines in the premier institute here during the past two-and-a-half years.

A total of 4,142 children, of whom 2,728 were aged below a year, enrolled for the clinical trials of new drugs and therapies by the Department of Pediatrics since January one, 2006.

Mounting pressure on the institute, Left parties and the Congress had demanded an inquiry into the episode.

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As reported by Jacob Koshy in livemint.com on 19 August 2008:
AIIMS disputes data on infant mortality in its drug clinical trials - Economy and Politics - livemint.com

AIIMS disputes data on infant mortality in its drug clinical trials

The NGO which obtained the figures did not mention that some of the dead were from control groups

Experimental, unestablished drugs didn’t kill any of the children registered for clinical trials at the All India Institute of Medical Sciences (AIIMS), according to V.K. Paul, head of the paediatrics department at the hospital.

Paul was responding to a statement by Uday, a non-governmental organization, that said 49 children died during these trials conducted between 1 January 2006 and June 2008. The statement put the infant mortality rate (IMR) of trial participants at 1.18%, twice more than the 0.56% IMR for the country, according to the latest figures by the health ministry.

However, Rahul Varma of Uday, who obtained these figures from AIIMS through a right to information or RTI, query, hadn’t mentioned that the children who died also included those in a so-called control group—those that were not being administered the test drug.

“It’s a gross misrepresentation of facts,” said Paul. “These were different trials testing a range of therapies and each study has different, designated outcomes. Depending on the complexity of the disease and the patient’s condition, each therapy may have different mortality rates. So there are deaths even in standard therapies.” Paul, however, didn’t give a figure on how many of the deceased children fell within the control groups.

The drugs tested included tablets for treating brain inflammation, blood-pressure related complications, cancer and liver problems.

India is increasingly becoming a preferred destination for drug trials. Arun Bhatt, president of ClinInvent Research Pvt. Ltd, a contract research organization, had previously told Mint that this business is expected to grow at 25-30% annually to touch over $600 million (Rs2,590 crore) by 2010.

However, access to a varied gene pool in India, at a fraction of similar testing costs in the US and some European countries, has led to frequent ethical conflicts regarding the manner in which these trials are conducted.

“There were several issues that weren’t addressed in our RTI query,” said Varma, “ We’d asked how many of the children were below the poverty line, which wasn’t addressed. How can such parents, generally illiterate, understand the intricacies of clinical trials and thus, informed consent?”

Paul says that all trials conducted by the institute were cleared by the AIIMS ethics committee, and if the trials involved international agencies, they were cleared by a separate committee constituted by the health ministry. “We need the consent of parents, and we explicitly tell them what an experimental drug is, and that it is still being tested. They always know that they can opt out,” he added.

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As reported by Special Correspondent in hindu.com on 19 August 2008:
The Hindu : National : Stay all clinical trials on humans: Congress

Stay all clinical trials on humans: Congress

NEW DELHI: The Congress on Monday demanded a probe by independent experts into the death of 49 babies during clinical trials for testing new drugs/therapies in the last two and half years at the All-India Institute of Medical Sciences here.

The information was gathered by an NGO through a Right to Information application.

The party sought a stay on all clinical trials on human beings until the cause of death of each and every baby during clinical trials at the AIIMS was investigated.
139 ongoing trials

“There are 139 ongoing trials on human beings in the country. Pending the probe into the AIIMS trials, let all clinical trials be stopped,” Congress spokesman Manish Tewari said.

While in China there were 98 ongoing clinical trials on human beings, in India, the number was much larger, at 139.

“Obviously there have been violations of the guidelines of the Indian Council of Medical Research.”

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‘AIIMS violated norms for tests’
Agencies, Saturday, August 23, 2008 04:15 IST

BANGALORE: Norms were thrown to the winds in the All India Institute of Medical Sciences (AIIMS) clinical trials that led to deaths of 49 children, all aged below one.

People for Ethical Treatment for Animals (Peta) and the Committee for the Purpose of Supervision and Control of Experiments on Animals (CPCSEA) procured details through the Right to Information (RTI), which revealed that AIIMS continued the tests despite adverse reactions noticed among infants on whom the drugs was tested.

The drugs which failed the clinical trials leading to 49 casualties were zinc tablets for treating zinc deficiency and serving as nutritional supplements, olmesartan and valsartan for treating blood pressure-related problems, rituximab for treating chronic focal encephalitis and gene-activated human glucocerebrosidase for treating Gaucher’s disease which affects the liver.

But family members of the children belonged to economically weaker sections of society, they were not able to understand what was happening, according to Peta member MC Jaisimha. AIIMS has defended the trials stating that the five foreign-manufactured drugs tested are safe.

DNA - India - ‘AIIMS violated norms for tests’ - Daily News & Analysis

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As reported in timesofindia.indiatimes.com on 25 August 2008:
Infants were given adult drugs at AIIMS: RTI-India-The Times of India

Infants were given adult drugs at AIIMS: RTI

NEW DELHI: Just days after news broke of 49 babies dying during clinical trials at AIIMS, Times Now has managed to get the Right to Information (RTI) report that makes a shocking revelation. Two of the four drugs tried on the babies were meant only for adults and not for children below 18.

AIIMS, one of India's premier hospitals, now is in the eye of a storm after news that 49 babies died during clinical trials. The shocking RTI pointed out that that babies who died were administered medicines that were not meant for children below 18.

Expressing shock at the incident, Dr CM Gulhati, Editor of Civil Society journal, Monthly Index of Medical Specialties said, "What is horrifying in the report that has come out of the RTI is that these tests were done from 1 year to 16 years and otherwise there was no division or sub division. It was not that it was tried from 12 to 16 and then you wait for 2 to 3 years and therefore small children over the age of 1 year but below the age of 16 years are all used as guinea pigs - this is the most serious problem with the tests."

So far, AIIMS has remained silent on this controversy but late Saturday night Veena Kalra, the head of the pediatrics ward did admit that some of the babies may have died during to the trials.

This revelation raises a number of questions about how was the hospital given permission to conduct trials of drugs meant for adults on babies. Were these children made guinea pigs because they were from poor families?

Rahul Verma, who had filed for a RTI report said, "We are approaching National Human Rights Commission because now we feel that if we go by the former head of the department Veena Kalra by her statement that she gave to a certain newspaper that yes some of these were poor families and died because of clinical trials - its strictly violation of article 21 - the fundamental right to life.

This RTI has opened up a Pandora's Box when it comes to how easy it is to get clinical trials conducted in India and with the matter being taken to National Human Rights Commission, AIIMS the premier medical institute has a lot of answering to do.

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NGO files complaint on babies' death case in AIIMS trial
As reported in The Hindu, Monday, August 25, 2008

New Delhi (PTI): The NGO, whose RTI query had resulted in the disclosure of clinical trial deaths at AIIMS, on Monday registered a complaint with the National Human Rights Commission following reports that drugs meant for adults had been tried on babies at the premier medical institute.

Rahul Verma of Uday Foundation, submitted a petition to the NHRC invoking violation of the right to life and citing Article 21 of the Constitution, in connection with the case. "We are seeking intervention of the NHRC because we have no faith in any internal inquiry by the institute," Verma said.

Verma added that Health Minister Ambumani Ramadoss had indirectly given a clean chit to the institute earlier. The Health Minister had supported the institute's stand that the children might have died of natural causes.

The petition is now with the NHRC which will decide what action to take.
"We had sought information about the top five drugs tried on children in clinical trials over the past two-and-half years in AIIMS. Now, experts have said two of the four drugs tried on the babies were meant only for people above 18 years of age," Verma told PTI.

The NGO had earlier demanded an independent judicial probe into the case after reports claimed that most of the children involved in trials belonged to economically weaker sections.

Following the direction of the Health Minister, AIIMS had constituted a five-member panel to probe the case. It had earlier clarified that the children died as a result of natural causes and not because of an adverse drug effect.

It was revealed last week that as many as 49 children died during clinical trials of new medicines in AIIMS over the last two-and-a-half years. A total of 4,142 children, of whom 2,728 were under the age of one, were enrolled for the clinical trials of new drugs and therapies by the Department of Pediatrics since January one, 2006.

The Hindu News Update Service

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As reported by Seemi Pasha on ibnlive.com on 08 September 2008:
Clinical trials RTI: Enquiry panel gives AIIMS clean chit

Clinical trials RTI: Enquiry panel gives AIIMS clean chit

New Delhi: The enquiry panel to probe clinical trials at AIIMS has given a clean chit to the pediatrics department.

The enquiry was set up after a RTI filed by the Uday Foundation revealed that 49 babies had died between January 2006 and June 2008 during clinical trials.

In August, reports came saying that clinical trials for testing new drugs and therapies at All India Institute of Medical Sciences (AIIMS) have claimed as many as 49 babies over the last two and a half years.

But, the enquiry report into clinical trials at AIIMS has given a clean chit to the pediatrics department.

The results of enquiry committee report state that the infants died as they were terminally ill. It also says that more deaths were recorded in groups where standard medication was administered.

“If we come out with ridiculous reports claiming that clinical trials should be stopped we will always be at the mercy of the west for medicine and medical advancements,” says Secretary Department of Biotech Dr M K Bhan.

The World Health Organisation (WHO) too came out in defence of the trials. The medical officer of the WHO coordinating with AIIMS in a letter to CNN-IBN says,” The safety of the children and the conduct of the studies has been rigorous and consistent with the most stringent international norms.”

While AIIMS may have been able to come clean from this controversy, experts feel that there is an urgent need to have more stringent guidelines in place for clinical trial especially for the ones that have been sponsored by pharmaceutical companies to check the efficacy of new drugs.