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A petition has raised questions about the safety and transparency of Rotavirus vaccine trials in three cities. Though the Delhi HC has struck down this PIL, doubts remain

By Meena Menon


A CONTROVERSY is brewing over the Rotavirus vaccine, an anti-diarrhoeal shot for children. While a PIL was filed by pediatrician Dr Jacob Puliyel demanding complete data on clinical trials of the Rotavirus vaccine 116E, the Delhi High Court has rejected it and accepted the center’s contention that the petition was motivated by private interest. 

Despite applications under the RTI Act, online petitions, emails and letters by Dr Puliyel, head of pediatrics at St Stephen’s Hospital, Delhi, segregated data from three centers where the trial was held has not been made public. It is reported that the vaccine is slated to enter Phase IV or post-marketing trials on 1,00,000 children in India.

The petition, which raised ethical issues of medical research and transparency, said the Department of Biotechnology, Ministry of Science and Technology, conducted Phase III clinical trials in three centres—Delhi, Pune and Vellore—of the Rotavirus vaccine. These were done between 2011 and 2013 and 6,799 infants underwent the trial. Of these, 4,532 received the vaccine and the rest were in the control group.

SCARY SCENARIO
According to the petition, results of this trial were reported in the journal Vaccine in August 2014 by Jacob John and other investigators, and indicated a higher rate of intussusceptions (intestinal obstruction which could need surgery to prevent death) among the vaccinated children. Based on the data in the article, the petition contended that this was five to ten times higher than the risk of intussusceptions with Rotashield vaccine which was withdrawn from the market in the US and 70 times higher than Rotateq.

Dr Puliyel noted that the incidence of intussusceptions was higher in Vellore (581/100,000 child years) than in Delhi (27.7/100,000 child years) and the regional differences could mean that it may be more risky to use the vaccine in some areas. The article did not provide the segregated data on numbers of ultrasound diagnosed intussusceptions among the vaccinated and control groups in Vellore.

The petition demanded that the court direct the Department of Biotechnology and other departments to provide complete segregated data on the clinical trial conducted in the three centers, apart from the number of intussusceptions. It asked the court to restrain the government from conducting further trial of the vaccine in India.

Dr Jacob Puliyel, head of pediatrics at St Stephen’s Hospital, Delhi, noted that the incidence of intussusceptions was higher in Vellore than in Delhi an it may be more risky to use the vaccine in some children.
Dr Jacob Puliyel, head of pediatrics at St Stephen’s Hospital, Delhi, noted that the incidence of intussusceptions was higher in Vellore than in Delhi, and it may be more risky to use the vaccine in some children.

Dr Puliyel is a member of the center’s National Technical Advisory Group on Immunization (NTAGI), whose secretariat approved the vaccine in June. However, the full data has not been provided to NTAGI either, Dr Puliyel said in repeated emails to Sunil Chandy, director of Christian Medical College (CMC), Vellore, which was part of the trial. It is a mystery how the NTAGI which is the highest decision-making body on immunization, approved the vaccine without the complete data. Dr Puliyel wrote to all NTAGI members and its heads asking for complete data but to no avail.

DATA NOT RELEASED
In a letter on June 16, 2015, to the Principal Secretary, Prime Minister’s Office (PMO), Dr Puliyel said the number of potentially fatal side-effects was so high in Vellore that the data is not being released but the vaccine has been licensed for general use. In his letter, he said “that Phase III clinical trials began in 2011. However, 12 years before the trial was even started (in 1998), Bill and Melinda Gates Foundation’s PATH had already selected the manufacturer for the vaccine”. The trial, incidentally, is funded by a grant from this Foundation to PATH, US, and others, including Bharat Biotech, the company making Rotavac.

CRITICAL CARE: A child hospitalised due to dehydration from a diarrhoeal infection.

The PMO asked the Subject Expert Committee (SEC) of the government to examine the issue. On June 30, according to the minutes of the meeting, the committee reviewed the submission of the vaccine-related Serious Adverse Event (SAE) during the Phase III clinical trial and “did not find the concerns of non-disclosure of SAE of intussusception and safety from Vellore site well authenticated”.

The SEC was asked to examine the matter again and it referred to the Vaccine article (and not original data). It said that overall, the percentage of intussusception in the vaccine group was 0.28 percent (13/4532) and placebo group 0.26 percent (6/2267) and the difference is not statistically significant. None of the events of intussusceptions required surgical interventions and none were fatal. It suggested further review of data at Vellore with regard to intussusceptions be undertaken based on the observations of the Delhi High Court.

However, in the October 14 order, Chief Justice of the Delhi High Court Justice Jayant Nath noted that the petitioner was a member of NTAGI and it is not in dispute that NTAGI, on being satisfied about its efficacy and safety, has recommended including the vaccine in question for the National Immunization Program. “The learned counsel appearing for the petitioner could not dispute the fact that the entire segregated data on the trial conducted in all these centres was available with NTAGI before making its recommendation.”

HC VIEWS
The court said: “That being so, we are unable to understand the purpose for which the petitioner is insisting on public disclosure of the segregated data.” It held that no case was made out to show that public disclosure of segregated data is mandatory before allowing a Phase IV trial. The clinical trial report has been cleared by NTAGI and the vaccine was approved by Drugs Controller General of India.

“In the circumstances we do not find any substance in the contention of the petitioner that in the absence of the information about the number of cases of intussusceptions in clinical trial at one of the centres, the government cannot be allowed to proceed to take up Phase four study of the vaccine. It appears to us that the prayer in the petition virtually amounts to questioning the correctness/authenticity of the recommendation made by NTAGI to which the petitioner himself is a member.”

“…we do not find any substance in the contention of the petitioner that in the absence of the information about the number of cases of intussusceptions in clinical trial at one of the centres, the government cannot…take up Phase four study of the vaccine.”
—Delhi High Court judgment




The court said that no case of violation of any statutory provision is made out in the petition and no case is also made out to show that disclosure of the segregated data is essential in public interest. “We therefore find substance in the submission of the learned additional solicitor general that the petition is misconceived and motivated with private interest,” the court added.

HELSINKI RULES
However, the revised Declaration of Helsinki in 2013 stated that researchers have a duty to make publicly available their results. “Nega-tive and inconclusive as well as positive results must be published or otherwise made publicly available,” it said. The WHO has strongly advocated public disclosure of clinical trial results.

Dr Puliyel’s advocate, Neha Rathi, asked why, if NTAGI had the data, wouldn’t it share it with the petitioner who is a member? This shrouding of the data has raised doubts; it is the non-disclosure of segregated data that is the point of concern, she added. Dr Puliyel is now planning to file a Special Leave Petition in the Supreme Court shortly.

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