Drug majors such as Novartis, Pfizer, Bayer Healthcare, Bristol Mayer Squibb, Sun Pharmaceutical and Dr Reddy’s Laboratories were allegedly involved in clinical trials in which 438 persons died in 2011, according to confidential government data reviewed by Business Standard.
While the companies argue they follow the global standards, experts point at the absence of sound regulations as the main culprit. Although the number of deaths in clinical trials has been growing through the years, it fell in 2011 from the previous year mainly because of flat growth in the clinical research market in India.
Data available with the office of the Drugs Controller General of India (DCGI) for 2011 show 57 deaths during clinical trials conducted by Novartis, 32 in trials by Quintiles, 20 each in the case of Pfizer and Bayer, 19 for Bristol Mayer Squibb and 10 for MSD Pharmaceutical.
|DEATHS DURING TRIALS|
|19||Bristol Mayer Squibb India|
|1||Dr Reddy’s Laboratories|
|Source: Drugs Controller General of India|
Among domestic companies, nine persons allegedly died during the clinical trials of drugs developed by Sun Pharma, three in trials by Jubilant Clinsys and one in the case of Dr Reddy’s Labs. Jubilant has, however, said there were no deaths reported in 2011 that could be attributed to participation in clinical trials conducted by it.
Most other pharma companies argue while trials are conducted on patients suffering from serious diseases with limited or no treatment options, it is inappropriate to blame deaths on clinical trials.
“... 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,” says Shoibal Mukherjee, chief medical officer, Quintiles India, and head, Asia Medical Sciences Group. Quintiles is a leading US-based clinical research organisation (CRO), which conducts clinical studies on behalf of pharma companies.
According to Novartis and MSD India, there have been no deaths due to drugs during clinical trials conducted by them in 2011. Dr Reddy’s Labs 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,” it said.
According to submissions by the government in the Parliament, despite 668 deaths during clinical trials in 2010, compensation was paid in only 22 cases, that too mostly as low as Rs 1.5 lakh. Bayer, currently conducting 600 clinical trials worldwide, says it adheres to globally harmonised standards.
Experts indicate flimsy regulations are resulting in 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,” says Anoop Mishra, chairman, Fortis-C-DOC centre for diabetes and metabolic diseases.
According to a medical practitioner in a hospital, to undertake trials, companies often look for doctors who can quickly get more patients for their drug to be tested and complete the study faster. Most pharma companies generally hire a CRO to conduct trials for them, which in turn enrolls doctors. Some drug makers directly approach doctors to conduct trials.
Many companies are learnt to be paying hefty sums to doctors for trials. “The amount varies depending on the company, the drug and the trial duration,” a medical practitioner said.
While companies claim they seek ethics committee approvals for each participating site, experts point towards the lack of credibility attached to these panels. According to Sanofi Aventis, which reported three deaths in trials where the treating physicians felt it ‘could’ have been due to the drug itself, any death, irrespective of its cause, is reported to health agencies and to the concerned ethics committee for review.
Recently, the Supreme Court had expressed concerns over allegedly illegal clinical trials. However, according to a Pfizer spokesperson, standards applicable to trials in India are no different from those in the US, the EU or elsewhere.