The ’supreme’ authority
With the Supreme Court closely tracking policy makers, both on the drug pricing and clinical trials front, will the pharmaceutical industry in India finally find a balance between patients and profits?
India is not the only country where the clinical trial sector is facing a backlash. A ‘new low’ is the recent instance when Toshiba recently put out casting adverts for a new reality show, to be called ‘Human Guinea Pigs’, where participants would be egged on and rewarded to try out experimental drugs.
Worried that such a show might negatively impact recruitment rates, the Association for Clinical Research Organisation (ACRO) has strongly protested this moniker, stating that in fact volunteers for clinical trials are actually “medical heroes, not test monkeys”.
In India too, industry associations like the Indian Society for Clinical Research (ISCR), with CROs like Quintiles, are engaging all stakeholders, not least the media, in order to tell their side of the story.
Suddenly, it’s a lot easier to get through to spokespersons of big pharma and big CROs. The effort is to blame the goof ups on ‘black sheep; and the lack of clear guidelines, faulty implementation and poor enforcement.
Hospitals like the Apollo Group, which are the sites of some trials, are also talking about the need for more ethical oversight. This issue (dated October 16-31, 2012) of Express Pharma features a detailed interview with Dr Ranjit Roy Chaudhury, Chairman Task Force for Research, Apollo Hospitals Educational & Research Foundation (AHERF) who is pushing for accreditation of ethics committees and a host of other measures.
Obviously corporate hospitals want to distance themselves from the likes of Indore-based Maharaja Yashwantrao Hospital where 32 people have died in the past five years, thanks to unauthorised clinical trials.
We have to thank brave hearts like Dr Anand Rai of Maharaja Yashwantrao Hospital who first blew the lid of these trials, as well as NGOs like Swasthya Adhikar Manch in Indore and the Delhi-based Jan Swasthya Abhiyan which is at the forefront of the drug pricing policy campaign, for keeping these issues live.
But, will this last? And is this new-found transparency just a smokescreen? It seems that the clinical trial industry is on trial, and like any drug trial, currently operating under scrutiny, as per approved protocols. What happens when the oversight reduces? Will the lessons lead to long lasting changes? Hopefully the supreme authority will keep up the pressure.
Viveka Roychowdhury
Editor
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