Questionable role of ICMR, DoHR

Why should our children die because of tests on the medicines of an American company? Why don’t our Babus bother about ethics and norms in permitting them to conduct such fatal tests, and thus allow US pharma companies to earn millions? It is so strange that none bothers even to compensate the death of children.

Doesn’t it amount to a series of murders by pharma corporate hand in glove with criminally negligent regulatory officers? But no police investigates. Our lives are so cheap. Are we banana republic or corrupt regulators?

Seventy-Second Report of the Parliamentary Standing Committee on the "Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine" by Programme for Appropriate Technology in Health (PATH) pointed out several irregularities and lapses, after thoroughly examining the deaths of children trials of HPV vaccine in Khammam (AP) and Vadodara (Gujarat).

The Department of Health Research/ICMR is expected to work for promotion and coordination of basic, applied, clinical and operational research in medical, health and bio-medical fields. Uniform Ethical Guidelines for bio-medical research on human subjects are incorporated in Good Clinical Practice (GCP) and ICMR documents which are more observed in breach. PATH functionaries claimed that “HPV vaccine, when available (in India), can prevent HPV and cervical cancer.”

On 16th November, 2006, in an MoU between PATH and ICMR, PATH claimed repeatedly that their objectives of the project as “……….Introduction of HPV vaccines into Universal Immunization Program, and purpose as (i) Increasing understanding of HPV vaccine (i.e. Gardasil) introduction. (ii) To help in decision-making related to the use of HPV (i.e. Gardasil) vaccine in the public and private sector.” But the experts opined that the design of project was faulty. The documents have no column for Serious Adverse Events (SAE) and no diary was to be maintained.

While ICMR functionary was worried of bad publicity in case of side effects, PATH did not provide for urgent expert medical attention in case of serious adverse events whether known or unexpected. The committee wondered whether the programme was a clinical trial or promotional activity. PSC observed that, “the Committee was greatly concerned with the aspect of commercial interests of manufacturers influencing the Government policy on this expensive vaccine. …that the study was initiated by PATH on its own …….. without any reference from the National Technical Advisory Group on Immunization (NTAGI), the official body of the GOI on vaccines.....It is not clear whether the State expenses were funded by PATH or came from their own resources. The monetary contributions of ICMR are also not clear.”

PSC questioned how ICMR supported "the use and promotion of the HPV vaccine and inclusion in UIP" in an MoU signed in 2007 even before the vaccine was approved for use in the country, which actually happened in 2008.
First a vaccine should get the approval from the government and then only it can be used in UIP. Secretary, Department of Health Research/DG, ICMR while responding to the queries, informed that the first discussion with the PATH was held in 2006 agreement signed 2007. At that time HPV vaccine had not been approved in India.

PSC took note of the fact if a drug is tested especially on a large population of 25,000-32,000 children between the age of 10 to 14, according to the CDSCO guidelines, no such trial can be conducted on children until a similar, prior trial is conducted on adults to determine efficacy and safety.

Committee suspects suicide?
PSC noted all seven deaths were summarily dismissed as unrelated to vaccinations without in-depth investigations. Astonishingly an inquiry committee suspected that some committed suicide. It was explained that suicidal ideation is caused by many drugs. A death due to suicide in case of Gardasil also reported in addition to 5 deaths in 2009-10.

Consent norms violated in AP
The Secretary of DHR/ DG, ICMR acknowledged that certain irregularities were reported in the implementation of the project. With regard to Informed Consent, he said that though the consent was taken properly in Gujarat, there were gross violations of norms in Andhra Pradesh. He informed the Committee that DCGI, had sought explanation for the incidents of irregularities.

ICMR’s conflict of interest
The Committee questioned how ethical it was on the part of ICMR to become a party to a project in the name of Public-Private Partnership (PPP mode). How ICMR, which is mandated to formulate ethical guidelines for researchers, can become a direct party in such a study. The Secretary, Department of Health Research admitted that presence of ICMR in the Project’s Advisory Committee – responsible and accountable for various acts of omissions and commissions – clearly indicates Conflict of Interest. Therefore, ICMR owes full moral responsibility for numerous irregularities reportedly committed in the study.

The PAC felt that there was serious dereliction of duty by many of the Institutions and individuals involved and that ICMR representatives, instead of ensuring highest levels of ethical standards in research studies, apparently acted at the behest of the PATH in promoting the interests of manufacturers of the HPV Vaccine. It was unwise on the part of ICMR to go in the PPP mode with PATH, as such an involvement gives rise to grave Conflict of Interest. (Paragraphs 3.18, 3.19 of the 72nd Report)

Surprisingly the ICMR did not refer PATH to National Technical Advisory Group on Immunization (NTAGI), which handled the safety, efficacy and introduction of vaccines in India. ICMR has not even taken NTAGI on board. Questioning the role of ICMR in the entire episode, PSC said that ICMR should have been more responsible in the matter and strongly recommended the Ministry to review the activities of ICMR functionaries involved in PATH project. It was noticed that States were not even capable of monitoring the adverse effects.

The government did not come up with any action taken report on this report of Parliamentary Standing Committee. India should value lives of Indians.