Even as the number of deaths of patients participating in clinical trials are steadily increasing over the years in consonance with the increase in the number of clinical trials by MNCs in the country, experts say there is gross discrimination in payment of compensation to the victims by multinational pharma companies.
According to data made available by the experts, the number of deaths of patients participating in clinical trials have increased as is the number of clinical trials by MNCs involving new drugs in the country. While 137 deaths were registered in the year 2007, the number rose to 288 in 2008, 637 in 2009 and 668 during 2010.
Meanwhile, experts are of the view that these figures are understated because many deaths are not reported to the Drugs Controller General of India (DCGI) by treating them as 'routine deaths not related to clinical trials'. Ironically, the investigators, who are on the payroll of drug companies that sponsor and fund the trials, are the ones who decide the causes of the deaths.
Regretting that the trial victims are well compensated abroad while they are humiliated at home by the MNCs, well-known health expert and Editor of the medical journal MIMS Dr CM Gulhati said that case histories show that there are double standards employed by drug companies in different countries in paying compensation to trial victims.
He said that till the end of 2009, there was not even one case of compensation to patients who died during clinical trials even though it is mandatory in the country. Lately, a total of 10 companies submitted a list of just 22 patients to whose families compensation was paid. In the case of Bayer, only five out of 138 deaths and in the case of sanofi aventis, only three out of 152 patients who died were offered compensation.
A glance at the amounts shows that an arbitrary sum of Rs.1,50,000 was paid to each of the eight victims by five different companies (Merck, Wyeth, Amgen, Sanofi and Pfizer). Bayer paid Rs.2,50,000 each in five cases while Eli Lilly paid Rs.2,00,000 to two families each and Rs.1,00,800 to one family. The average of all payments comes to a measly Rs.2,38,000 (or US$ 5,000) per dead participant.
In comparison, Dr Gulhati said, on August 11 this year, Pfizer started handing over US$ 1,75,000 (Rs.84 lacs) to each victim of its Trovan (trovafloxacin) trial on children in Kano, Nigeria. In addition it agreed to pay US$ 10 million (Rs.48 crore) to the state government of Kano towards legal expenses incurred in long drawn litigation on behalf of its citizens.
In Germany, the erstwhile Hoechst (now part of sanofi aventis) paid more than 60,000 Euros (Rs.40 lacs) to the family of a woman who died during trial of an antidepressant agent nomifensine (Alival) later withdrawn on safety concerns. The company's top executive in the United States was slapped a fine of US$ 300,000 (Rs.1.44 crore) for concealing the drug's adverse effects.
In the United States, US$ 3.8 million (Rs.18 crore) was paid to poor women with high risk pregnancies who did not suffer any physical harm but asserted that that they were not informed that administered drugs were "experimental" and the consent form was far "above their reading level" and therefore invalid.