US-based PATH and ICMR are under the lens for alleged unethical vaccine trials against cervical cancer on thousands of Indian girls. The case is now in the Supreme Court
By Meena Menon
In 2009, Kampally Swathi, 13, and Sode Sayamma Kumari, 14, were among 14,000 girls in Andhra Pradesh who were administered Gardasil, the HPV vaccine against cervical cancer. In Gujarat, 16,000 girls weresimilarly targeted. They were part of a so-called “demonstration project” by ICMR and US-based PATH (Program for App-ropriate Technology in Health). These trials were later found riddled with unethical practices and led to the death of these girls and five others.
After investigations by NGOs and activists, writ petitions were filed in the Sup-reme Court in 2012 by Kalpana Mehta and others and in 2013 by Sama Resource Group for Women. The matter, which was last heard on August 8, 2015, has now been moved to November 2015.
While the trials were stopped in 2010 after the deaths and protests, an inquiry committee was appointed by the government to look into the matter. However, the 72nd Parliamentary Standing Committee Report (August 2013) on Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) by PATH in India found serious conflict of interest among members of this government committee.
UNLAWFUL MANNER
The parliamentary committee report said a clinical trial under the title—“Post Licensure observational study of the Human Papilloma Virus (HPV) Vaccination–Demonstration Project—was carried out by PATH in 2009. It was funded by the Bill and Melinda Gates Foundation and ICMR lent its platform to PATH in an improper and unlawful manner.
The report said PATH had resorted to an element of subterfuge, as one of its objectives in the proposal submitted to ICMR was to introduce the HPV vaccine into the Univer-sal Immunization Program (UIP). This looks imminent now, with the government asking the National Technical Group on Immu-nization (NTAGI) to conduct a feasibility study on the vaccine so that it can be introduced in the country.
By calling the clinical trials observational studies or a demonstration project, it would avoid the arduous and strictly regulated rules of clinical trials, the parliamentary commi-ttee said.
The nature of the PATH project made it a post-marketing Phase IV clinical trial under the Drugs and Cosmetics Act, the committee pointed out. It also slammed ICMR for committing to support a vaccine (in 2007) even before it was approved in India in 2008 or to commit to including the drug in the UIP. The Drugs Controller-General of India (DCGI) was charged with irregular approvals for trials and the committee felt his role should be inquired into too.
Calling for action against PATH, the committee was concerned that it could set up an office in India without mandatory approvals. It further said it should be made accountable for the project and it had violated all laws and regulations laid down for clinical trials.
PATH countered all this criticism by saying that ICMR had approved the protocol for the project. It further said it was not a clinical trial, but a post licensure observational study.
CRUCIAL QUESTIONS
After the petitions were filed in the apex court, the bench asked the government what action was taken on the parliamentary committee report, if the drug was accepted to be used as a vaccine in India and if the DCGI and the ICMR had followed due procedure. It said the states of Gujarat, Telangana and Andhra Pradesh should be impleaded as
parties and asked for the file by which the DGCI had approved the vaccine for introduction in India.
The Supreme Court also addressed the crucial question of consent in these trials. Lawyers for the petitioners submitted that “innovative” explanations had been submitted by the state governments for the deaths of the girls, including snake bite and fever, when in actuality, it was due to the vaccination. Strangely, there was no data on the adverse effects the girls suffered from after they were given the vaccine.
The court wanted to know the procedure to be followed for consent and what steps are required to find out the suffering of those vaccinated, the liability of compensation, if any, and whose liability it would be. It also wanted to know the reasons for choosing Andhra Pradesh and Gujarat for the vaccines and what caused the deaths and ailments of those who were given the vaccine, the protocol for such trials, steps taken to monitor the vaccine and whether consent was taken from the guardians/parents of the girls.
DEVELOPING COUNTRIES
It all began in 2005 when the ICMR entered into a memorandum of understanding with MSD Pharma Pvt Ltd, a subsidiary of Merck, on HPV vaccine research in India. It was only in 2006 that the US FDA licensed Gardasil, Merck’s HPV vaccine, aimed at preventing cervical cancer.
Merck entered into partnership with PATH to find ways of bringing the vaccine into developing countries, according to the petition filed by Mehta. In 2007, PATH signed an MoU with ICMR for its “Global HPV Vaccines—Evidence for Impact” project, a five-year study with three phases—formative research, demonstration project and operations.
Two drugs were to be used, Cervarix (not licensed anywhere) and Gardasil (not licensed in India), the petition said. In 2007, Merck began a seven-month trial of Gardasil on 110 girls between 9 and 15 years in violation of both DGCI and ICMR guidelines. It was allowed to do this trial without first carrying out a study on adults, the petition said.
On July 9, 2009, AP, along with ICMR and PATH, launched a “demonstration project” for vaccination against cervical cancer.
Gardasil was given to 14,091 girls (between 10 and 14 years) in the three mandals of Bhadrachalam, Kothagudem and Thirumalayapelam in Khammam district of AP. A similar project was kicked off in August 2009 in Gujarat in three blocks of Vadodara district—Dabhoi, Kawant and Shinor aimed at 16,000 girls aged between 10 to 14 years.
According to Sama’s report, “Trial and Error Ethical Violations of HPV Vaccination Trials in India” in 2010, children who were part of this project were from poor socio-economic backgrounds and a majority of them were tribal girls whose parents were laborers. Wardens of residential schools where the girls studied were asked to sign consent forms and the parents were not informed.
Activists said that there are several layers of violations and the government could not get away by saying there can be no penalty. “Why did you go and select vulnerable parti-cipants and why were there no autopsy reports after the deaths. Why should no action be taken against all the offenders? Also, government machinery was used, including the logo of the National Rural Health Mission. This gave the impression to people that it was an official project and that is a serious issue,” said an activist.
Will justice be meted out to the victims?
—The author has served as deputy editor
of The Hindu