Government Culpable for Inaction in Homicidal Clinical Trials
Bhagwati Prakash Sharma
It is precariously deplorable that the draft rules for providing mandatory compensation to the victims of clinical drug trials are awaiting approval, under industry pressure, inspite of the fact that on an average 10 persons undergoing clinical drug trials have been dying every week since last 4 years. In lack of any such rules, only in 22 of the total 2031 deaths, occurred during the clinical drug trials in last 4 years, the compensation was paid and that too, when a committee chaired by Menka Gandhi, member of the Parliament, probed the matter last year. In most cases a paltry sum of Rs. 1.5 to 2.5 lacs was paid to the families of the victims who died. A sum of mere Rs. 52.33 lacs was paid by 10 companies, in a range of Rs. 1.08 to 10.00 lacs to these 22 victims out of total 432 deaths occurred in 2010-11. No compensation was paid for the 288, 637 and 668 deaths occurred in the preceding three years before the aforesaid probe by Menka Gandhi, according the information provided by the Drugs Controller General of India (DCGI) in an RTI hearing.
Even in the premier institutes like the All India Institute of Medical Sciences. (AIMS), as many as 49 beloved children of their parents had died while undergoing clinical trials. It is precariously strange that two of the infants of less than 1 year age died in the trial, were administered the drugs ‘Olmesartan’ and ‘Valasartan’ used for reducing blood pressure, which cannot be recommended for subjects below the age of 16. When there is no proven trend or incidence of high blood pressure in infants or even in children up to the age of 14, then, was it not a criminal misadventure to administer these drugs on infants? It is also strange that how the ethics committee colluded for such a trial? Is it not a severe blow to medi-ethics? Moreover, the two drugs are not new and are already off the patent in India. Where was the need to try these on infants? In all during this period of 30 months, 42 trials were conducted on 4142 children in the AIIMS, from Jan 2006, of which 2728 children were below the age of 1 year. It is further a hoax upon the poverty of these families whose children were subjected to trials, were mostly poor and illiterates.
The number of victims suffering from permanent injury on account of the side effects of the drugs under trial might be much more in the country, as the DCGI is said to have no such composite data of injury suffered from the trials. It is even more strange that the DCGI has no information of any action taken against the ethics committees, trial-sponsoring pharmaceutical companies (mostly foreign multinational companies) or the Contract Research Organizations (CROs) conducting the trials for the sponsoring companies. Indeed, permitting drug trials without provision of punishment for sponsoring company or ethics committee, guilty for any unethical practices, amount to conniving with the culprits for the culpable homicide.
Of late, more and more foreign pharma MNCs are getting attracted to India for clinical trials as the cost of such trials is as low as, 20 to 40 percent of what it comes in the industrialized countries. Therefore, at a time when the foreign pharma multinational companies (MNCs), involved in drug discoveries and finding India a tempting destination for contract manufacturing and clinical drug trials, delay in finalizing the rules for penalty are punishment for deficiencies in the functioning (including unethical practices) of the contract research organizations (CRO), the sponsoring companies, the ethics committees and other stake holders is intolerable.
In view of this, the Government’s failure to provide any liability for irregularities, fair compensation for the victims and adequate insurance cover for death or permanent injuries arising out of such trials and permitting trials without regulatory safeguards is nonetheless than conniving with the culprits. The draft rules for the purpose, viz. "The Drugs and Cosmetics (3rd Amendment) Rules 2011" released for public debate on November 18, 2011 are yet in abeyance and the industry is exerting its influence for diluting the same.
The draft rules are being opposed by the industry, as they provide that in case of death or grievous injury during the clinical trial, it will be held to have happened because of the trial. The sponsor of trial shall have to prove within 30 days to the contrary or else he will have to pay compensation within 60 days. The industry, including the CROs and pharma companies are insisting that the onus to prove that injury or death has resulted from trial should be shifted upon the victims, instead of fixing it upon the sponsoring company to prove that the same is not caused from the trial. If the Government would succumb to the industry pressure and shift the onus of proof upon the victim, he (victim or his family) would rarely or never be able to prove that the death or injury has resulted from the trial, the subject has undergone. Thereby, the foreign pharma companies would never be under any liability to pay any compensation, as in most of the cases the victim would rarely be able to prove that the death or injury has resulted from the trial alone. The aforesaid draft rules, so proposed have also provided for mandatory registration of ethics committees with the Central Drugs Standard Control Organization (CDSCO). The Informed Consent Form (ICF) should be balanced and give right to claim compensation.
The Government should also not get blackmailed from the allegations being leveled in certain sections of media, that consequent to the enquiry by Menka Gandhi and in view of the new norms being proposed, the number of trials have gone down to 270 in 2011 from 500 in 2010 and the country has missed the projected target of $1.5 billion as the local drug trial segment stands at mere $400 million. Forex earnings cannot prevail over human lives. Rather, fresh trials should not be permitted till the draft rules under consideration are notified in the official gazette. There is substance, in the allegations that the time being taken to approve a trial has increased from 4 months in 2005 to between 6-9 months now. It is also true that the same has come down in South Korea from 6 months in 2005 to 30 days now and it is 3 months in Canada and UK. But, the mere bogey of trials business going to China, South Korea and Malaysia cannot be used to promote clinical drug trials without proper regulatory framework and safeguards. Permission be processed faster but no compromise can be made in providing for compensation and penalty for unethical practices
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