Indian Court Shows Concern Over Clinical Trial Practices
The Indian Supreme Court has expressed concern over the failure of regulators to curb illegal and dangerous clinical trials said to be causing “havoc” in the country.
Supreme Court Justice R.M Lodha accused the government of slipping into a “deep slumber” over the issue of clinical trials, during a hearing on a Public Interest Litigation (PIL) submitted by doctors and the NGO Swasthya Adhikar Manch.
The PIL alleged that massive clinical drug trials have been conducted nationwide using Indian citizens as guinea pigs, including a case where doctors at the Bhopal Memorial Hospital and Research Centre (BMHRC) recruited survivors of the 1984 gas leak for clinical trials without their knowledge or consent. It is claimed that 14 deaths occurred during these trials, and that between 2007 and 2012 at least 2,347 people in India have died as a result of unsafe clinical trials.
On the same day the court also issued notice to the government about another PIL, which claims that GlaxoSmithKline carried out unauthorised trials testing the HPV vaccine on 24,000 girls from tribal areas in India. The PIL alleges that some of the girls suffered adverse effects as a result of these trials, and that these were not treated by GSK. A Glaxo spokesman told Pharmalot that “these issues relate to a demonstration project led by an organization called PATH which looked at whether and how to incorporate HPV vaccination into a comprehensive cervical cancer prevention program in India where cervical cancer is the most prevalent cancer amongst women.”
He went on to say that “the project was conducted by PATH in collaboration with government agencies in India. GSK’s vaccine, Cervarix, was administered in the region of Gujarat and during the duration of the project, two deaths were reported. One was attributed to a snake bite and the other to malaria and severe anaemia.” The court has directed the Christian Medical College in Vellore to look into the medical records of the girls and submit a report to the court.
The Supreme Court criticised the government for its slowness to act over the issue of illegal clinical trials; the bench hearing the PIL, comprising justices R.M Lodha and A.R Dave, told the government that “you have to protect health (sic) of citizens of the country. It is your obligation. Deaths must be arrested and illegal trials stayed”. The government had previously contended that various committees had been established to investigate clinical trial practices, but the bench dismissed this as “done just to divert people’s attention on the issue”. Instead, an interim order was declared calling for all clinical trials to be monitored by India’s Health Minister, Ghulam Nabi Azad.
A number of factors including lower costs and a populace less exposed to multiple medications (which can confound trials) have made India a desirable place for foreign companies to trial their drugs – a report citing the Central Drug Standard Control Organization says that around 150,000 people in India are currently enrolled in clinical trials, with the total of participants in clinical trials between 2009 and 2012 number at 352,475. However, as is currently happening in India, awareness of people’s vulnerability in developing countries has led to increased pressure on governments to regulate the way clinical trials are conducted.