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#India – After 7 deaths DEATHS, government rapped for lapses over clinical trials

, TNN | Aug 31, 2013, 04.31 AM IST

Panel raps government over clinical trials, lapses
In a further indication of the rot in the country’s healthcare system, a parliamentary panel has rapped the government for gross irregularities in , under-reporting and lapses in monitoring serious adverse events and lethargy in safeguarding health, in studies on cervical prevention vaccine by a US-based non-governmental agency.
MUMBAI: In a further indication of the rot in the country’s healthcare system, a parliamentary panel has rapped the government for gross irregularities in drug trials, under-reporting and lapses in monitoring serious adverse events and lethargy in safeguarding health, in studies on cervical cancer prevention vaccine by a US-based non-governmental agency. Charging the government for inaction, the parliamentary committee on health says in a report that the issue has been diluted with no accountability fixed on erring officials for serious violations committed in the studies which led to the death of hapless tribal children three years back.

Raising concern on the manner in which the US NGOPATH (Programme for Appropriate Technology in Health) set up office in the country, the panel says it conducted clinical trials for HPV vaccines under the garb of “observational project” by violating all guidelines.

The trials were suspended following deaths of five girls in Andhra Pradesh, and two deaths in Gujarat in 2009-2010 after being administered the vaccines. The vaccines were provided by two pharmaceutical companies – Merck and GlaxoSmithKline – through , during studies carried out in collaboration with government agency, Indian Council of Medical Research and the states. The project was reportedly funded by Bill and Melinda Gates Foundation.

The sole aim of PATH, the 72nd report on Alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine says, was to “promote the commercial interests” of the manufacturers, who would have benefitted if it was successful in getting the HPV vaccine included in the government-run Universal Immunisation Programme.

The report submitted in the Parliament on Friday comes at a time when the pharma industry has been complaining of inordinate government delays in approvals of drug trials involving human subjects.

Terming it “a serious breach of trust by any entity”, and a “violation of human rights of these girl children who were mostly unaware of the implications”, the panel has asked the government to report the violations to international bodies like World Health Organisation and UNICEF. It has also asked the ministry of health to take up the matter through the ministry of external affairs with the US government so as to ensure appropriate action is taken against PATH.

The report has pulled up the drugs controller general as well as . It says DCGI played a “questionable role”, and “remained a silent spectator, even when its own regulations were being violated”, while “approvals of clinical trials, marketing approvals and import licenses appear to be irregular”.Though the issue was reported after the deaths in 2010, this report details the role of PATH, involvement of regulatory agencies like ICMR and DCGI, lapses in drug side-effects, conflict of interest and the various loop-holes in the system.

The panel says that ICMR instead of ensuring ethical standards in research studies, apparently acted at the behest of PATH in promoting the interests of HPV manufacturers, and that it should have taken the National Technical Advisory Group on Immunization (NTAGI), on board. The safety, efficacy and introduction of vaccines is handled by NTAGI.

Significantly, not only were the adverse events under-reported and not monitored during the studies, the committee noted that HPV vaccine as a possible, if not probable cause of suicidal ideation.

According to approvals given to the companies, vaccines were given to children irrespective of age in the case of Merck’s Gardasil vaccine, while permission was given to use GSK‘s Cervarix vaccine in children (10-14 years), while clinical trials had been conducted on subjects in the age-group of 18-35 years. Thus the safety and well-being of subjects were completely jeopardized, the report adds.

The panel has sought further tightening of regulations, action against the wrong-doers, strict monitoring of serious adverse events during drug trials through an independent mechanism, and government agencies ICMR and DCGI to strictly adhere to regulations, guidelines and methodology like informed consent from subjects. The committee found glaring discrepancies in the informed consent taken from subjects who were given the vaccine.

 

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