211 people died in six months during clinical trials in India
Union health minister Ghulam Nabi Azad said on Friday that the deaths could be related to diseases such as cancer or administration of drugs and their side-effects. In 2011, 438 cases of SAE were reported, of which 16 were found to be due to clinical trials. The previous year, 668 cases of SAE were reported, of which 22 were caused due to the trials.
The Union health ministry says approval for conducting clinical trials now includes a condition in the consent form that in case of a study-related injury or death, the applicant will provide medical care and pay compensation. All trials are now compulsorily registered with the Indian Council of Medical Research.
The compensation, however, is so far, "according to the will" of pharmaceutical companies. This could change as the Central Drugs Standard Control Organization has for the first time proposed a formula "on the basis of age of the deceased, income, seriousness and severity of the disease the subject was suffering at the time of his/her participation in the trial and percentage of permanent disability."
'Young patients must get higher compensation'
The Central Drugs Standard Control Organization has for the first time proposed a formula to curb serious adverse events (SAE) during clinical trials.
The CDSCO formula stipulates that the younger the patient, the higher will be the compensation.
Families of the 22 people who died during clinical trials in 2010 were paid around Rs 50 lakh in all by 10 pharmaceutical companies, including well-known names such as Wyeth, Quintiles, Lilly, Amgen, Bayer, Bristol Mayer, Sanofi, PPD and Pfizer. The individual compensation ranged from Rs 1.08 lakh to Rs 10 lakh. Most of the families received Rs 1.5 lakh and Rs 2.5 lakh as a one-time settlement. This, after companies initially refused to pay compensation for majority of the deaths.
"When a 70-year-old patient who is terminally ill dies during a clinical trial due to an adverse reaction of the drug, the compensation should be less than that given to a 22-year-old man in the first stage of the same disease who dies of the same drug," said a CDSCO official. "The youth could be the sole bread-winner of the family and would have lived longer but for the adverse drug reaction. So, the guidelines quantify accordingly who should get how much compensation. At present, both could get the same amount and it could be abysmally low if decided by the pharmaceutical company."
CDSCO says a research-related injury is that which occurs to a subject as a result of research participation. Injuries may be relatively minor (such as bruises or infected wounds), major (such as organ damage or temporary disability) or catastrophic (such as permanent disability). An injury may require only acute or emergency care, or it may require continuing care. Injuries can be physical or psychological/emotional. The Drug Technical Advisory Board on October 10, 2011 had given its nod to the CDSCO to put in place a "compensation chart" or extensive guidelines that will specify amount to be paid.