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Health activists attack Indian compensation formula for deaths attributed to clinical trials

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f6295 (Published 17 October 2013) Cite this as: BMJ 2013;347:f6295
  1. Ganapati Mudur
  1. 1New Delhi

A formula proposed by the Indian government to calculate the amount of compensation that pharmaceutical companies would need to pay for deaths of subjects who volunteer for clinical trials has drawn criticism from health activists and industry analysts.

A committee of experts set up by the Central Drugs Standard Control Organisation, India’s drug regulatory agency, has proposed a formula that takes into account the age of subjects and a risk value linked to their health status to determine the amount of compensation payable when a death is attributed to a clinical trial.1 A healthy volunteer is assumed to be taking the highest risk and a terminally ill patient the least risk.

The formula leads to compensation amounts ranging from Rs 400 000 (£4064; €4783; $6509) for the death of a 65 year old terminally ill subject with expected survival of less than six months to Rs 7.3m for the death of a 16 year old healthy volunteer. The committee has also fixed Rs 200 000 as compensation for the death of a patient whose expected mortality is 90% within 30 days.

Health activists relying on anecdotal evidence have long expressed concerns that the Indian government has allowed the clinical trials industry to grow in the country without ensuring adequate safeguards to protect the rights of the subjects.

The Central Drugs Standard Control Organisation had approved 1323 clinical trials sponsored by global pharmaceutical companies in India between 2003 and 2010. India’s health ministry, citing data provided by drug companies, has said that 2644 deaths had occurred during clinical trials between January 2005 and June 2012, 80 of which were attributed to clinical trials. But compensation has been paid to only 44 families.

Amulya Nidhi, a health activist in the central Indian town of Indore who is the co-convenor of the Swasthya Adhikar Manch, a non-governmental organisation campaigning for the rights of subjects of clinical trials, told the BMJ, “The payments thus far appear to have been arbitrarily determined without regulatory oversight—and there’s no explanation yet for why the other 36 have not received compensation.”

A petition filed by the Swasthya Adhikar Manch in India’s Supreme Court in February 2012, seeking stronger regulatory controls on clinical trials and compensation for subjects who suffered serious adverse events attributed to clinical trials, is currently being heard.

The health ministry told the court during the hearings earlier this year that 506 serious adverse events had been attributed to clinical trials, but none of the patients had been compensated. However, sponsoring companies have typically covered the costs of medical expenses.

“Even in some cases of deaths, only the expenses for treatment have been paid,” Nidhi said.

The expert committee has acknowledged that compensation needs to ideally be calculated through multiple factors such as a subject’s age, income, number of dependants, health, and the expected survival period if the subject is suffering from an illness. But it said that the proposed formula was also designed to be “simple,” taking into account “all important points” and excluding “less important points.”

Udaya Shankar Mishra, a population health expert at the Centre for Development Studies in Thiruvananthapuram, Kerala, who was not a member of the committee, said that the way in which risk values had been assigned is a “disturbing aspect” of the formula.

“Every subject is unique, but this formula trivialises the complexity of determining risk,” Mishra told the BMJ. “It avoids all the possible variations that may emerge from a risk grading system that takes into account the multiple factors that contribute to risk.”

Mishra also said that the formula does not factor in negligence or irregularities during clinical trials. The health ministry had told the Indian parliament in December 2012 that nine cases of irregularities during clinical trials had emerged over the previous three years.

An association of pharmaceutical industries in India declined to comment on the proposed compensation formula, saying that the issue was being heard in court. But a consultant to the drug industry, who requested anonymity, told the BMJ, “The compensation levels close to the higher end of the range are completely unrealistic—this is likely to drive clinical trials away from India.”

Notes

Cite this as: BMJ 2013;347:f6295

References

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