Clinical Deaths Have Dropped in India. However….

Clinical Deaths Have Dropped in India. However….

July 25th, 2012 // 11:46 am @


The number of deaths attributed to clinical trials in India numbered 438 last year, a steep drop from 668 deaths that were recording during the previous year. But the decline was largely attributed to flat growth in clinical trial work in the country and critics continue to maintain that regulations are insufficient to prevent the number of deaths from accumulating each year, according to The Business Standard, which reviewed confidential government data.

The data emerges several months after the Indian health ministry issued new rules that give ethics committees the latitude to review any injuries or deaths that occur during clinical trials and also establish compensation (see this). Last year, the Indian government found that drugmakers running clinical trials had not compensated the survivors of most volunteers who died during their studies (read here). Of the 668 deaths in 2010, compensation was paid in just 22 instances.

The issue, of course, is highly sensitive, but the rules have riled drugmakers and contract research organizations, given that India remains a destination for running studies. They argue that while trials are conducted on patients suffering from serious diseases with limited or no treatment options, blaming deaths on clinical trials is inappropriate when responsbility may often lie, at least in part, with institutions or individual investigators.

“Patients who participate in clinical trials are by definition those who already have a pre-existing medical condition, which could be mild or serious, acute or chronic. Therefore, the death of a patient in a clinical trial could occur due to a variety of reasons, including those unrelated to the trial,” Shoibal Mukherjee, chief medical officer at Quintiles India, one of the largest CROs, tells the paper.

For those keeping score, data from the Drugs Controller General of India show 57 deaths during clinical trials conducted last year by Novartis, 32 deaths in trials run by Quintiles, 20 each involving meds tested by Pfizer and Bayer, 19 for Bristol-Myers Squibb and 10 for MSD Pharmaceutical, the paper writes. Among Indian drugmakers, nine deaths were recorded in trials for Sun Pharma, three in trials by Jubilant Clinsys and one for Dr Reddy’s Labs.

However, Novartis, MSD India and Jubilant denied there were any deaths due to drugs during trials they conducted in 2011. And Dr Reddy’s says though there was one mortality reported in a trial in 2011, it was not related to the study drug. Sun Pharma said its trial was on advanced breast cancer patients, in whom the disease had progressed to the terminal stage. “In all cases, compensation has been paid and one is under process,” the drugmaker tells the paper.

Experts complain that inadequate regulations and oversight are to blame for deaths during clinical trials. “In India, clinical trials can be conducted anywhere with a medical supervision. There are no minimum criteria for a trial site. Even a doctor in his private clinic is eligible to do a trial,” Anoop Mishra, chairman, Fortis-C-DOC centre for diabetes and metabolic diseases, tells the paper.

One hospital doctor tells the paper that drugmakers often use CROs to run trials, but some directly approach physicians to jumpstart the process and will pay for the privilege. “The amount varies depending on the company, the drug and the trial duration,” the anonymous doctor tells the paper.

While drugmakers claim they seek ethics committee approvals for each participating site, critics argue that some lack credibility. Sanofi, which reported three deaths in trials where the treating physicians felt the drug being tested ‘could’ have been to blame, any death is reported to health agencies and ethics committees for review.

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