Appreciate Parliamentary Standing Committee’s report on the “Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine by Program for Appropriate Technology in Health (PATH) in India”, health activists have commended “its candid, transparent contents, which reflect the Committee’s acknowledgement of the unethical nature of the HPV trials” conducted in the country.
In the HPV trials, PATH with the support of Bill and Melinda Gates Foundation (BMGF), with approval from the Western Institutional Review Board (WIRB) (all three private international parties), with donations from Merck Sharp and Dohme (MSD) and Glaxo SmithKline (GSK) and in partnership with Indian Council of Medical Research (ICMR), with the machinery of the State governments of Andhra Pradesh and Gujarat, through the National vaccination programme, delivered and administered HPV vaccines to 10 -14 year old girls in Khammam (AP) and Vadodara (Gujarat) districts.
The Committee’s findings, endorsed by MPs from all political parties, are wide-ranging: the nature of the project, the role of ICMR, the role of Drugs Controller General of India (DCGI), the Informed Consent Process, the role of Ethics Committees (EC), the process of inquiry Committee formation and function and the role of PATH. The Committee report points to a serious dereliction of duty by many of the institutions involved. In particular, it questions the role of the ICMR, DCGI, EC members and PATH.
The Parliamentary Committee clearly stated that the demonstration project was a clinical trial, no matter what PATH called it. The report further states, “the demonstration project is a study of a pharmaceutical product carried out on humans and since the primary objective includes the study of serious adverse events, it is clear that clinical trial rule should apply”. PATH by carrying out the clinical trial on the pretext of observation/demonstration project has violated all laws and regulations laid down for clinical trials by the government, a statement issued jointly by Jan Swasthya Abhiyan, Sama – Resource Group for Women and Health, and LOcost/ All India Drug Action Network said.
Though, the Committee brought up the Insurance to the girls it has not mentioned the compensation in its report from the sponsor or an ex-gratia to the parents of the girls who died following the administration of the trial, the statement said while demanding that the parents of the girls who died and the children must be compensated for the grave violations of their rights, as clearly informed consent was not taken from a large number of parents of the girls and no assent was taken from the girls who were given the HPV vaccine, and no follow up or proper management of adverse events and serious adverse events during the trial was done.
“We welcome the recommendations and sincerely hope that the contents and recommendations of the 72 report by the Parliamentary Standing Committee will be acted upon, that there will be concrete early follow up and outcomes of the Committee’s observations and recommendations,” the statement further added.
Meanwhile, reacting to the report, PATH said it was troubled by the report’s “inaccurate characterization of this important work.”
PATH, an international non-profit organization, is committed to meeting the highest scientific, ethical, and legal standards in our work and to contributing our experience and expertise to address the burden of cervical cancer through transformative innovations such as vaccines, a statement issued by PATH said.
“The demonstration project in India was part of a four-country project to explore suitable vaccine delivery strategies and help provide evidence for national health authorities to make informed decisions about the potential benefits and challenges of introducing vaccines against human papillomavirus (HPV), the primary cause of cervical cancer,” the statement said.
PATH said the ICMR, India’s highest medical research authority, reviewed and approved the protocol for this project, including its design and methodology. At the time of its review, the ICMR determined the project was a post-licensure observational study and not a clinical trial. “The project did not seek to evaluate the efficacy or long-term safety of the vaccines, which had already undergone clinical evaluation in India and had been licensed and approved by the Drugs Controller General of India.”
The ICMR’s view was crucial, as it established the approval processes and protocols for the work that followed. PATH designed the project protocols in compliance with the ICMR’s instructions and fully complied with the ICMR’s requirements regarding the necessary approval processes and the requirements of state governments regarding consent processes, according to the statement.
“We believe that by following the guidance provided by the ICMR, as well as two State governments and three ethical review committees, we designed a project that met or exceeded the country’s existing regulatory standards for demonstration projects while providing the greatest health benefit to Indian women,” PATH said.
