Wednesday, August 27, 2008

Babies or guinea pigs?

Last week, newspapers reported that 49 babies below the age of 12 months have died at India’s best known medical institute, the All India Institute of Medical Sciences , better known by its acronym AIIMS. The babies have died since January 2006, following the administration of new drugs and therapies.

On Tuesday, August 26, AIIMS said that the drugs used for clinical trials were ’safe’. The institute also strongly refuted allegations that the children chosen for the drug trials were from a poor socio-economic background. Read the PTI report [via The Hindu] here.

News of the infants’ deaths was obtained under the Right to Information Act when Rahul Verma [pl read his comment to AW in the comments section] who is associated with a non-government organisation called the Uday Foundation for Congenital Defects and Rare Blood Groups applied for information on ongoing clinical trials at AIIMS.

What he found out: 4142 babies were registered by AIIMS for clinical trials; of these, 2728 were less than 12 months old. And 49 (or under 2 per cent) had died in the past 30 months. For the same period AIIMS conducted 42 trials in its paediatric department.

As with most things Indian, health minister Anbumani Ramadoss has called for an inquiry to be conducted by the AIIMS director. The findings are expected to be submitted within a week.

AIIMS doctors have been maintaining that the children who died were ’seriously ill’ and were not a part of the intervention programme.

Nevertheless, the deaths seem to have focussed attention on India’s booming outsourced clinical trial business. According to Rahul Verma there is urgent need to regulate India’s booming outsourced clinical trial business, which he pegs at $120 million for the last year and which he estimates is growing at a whopping 25 per cent annually.

“When you are not able to afford a particular treatment in a private health care centre you look forward to getting free medication in something like this,” Verma recently told AFP.

“We wanted to know what are the socioeconomic condition of these people? Are they given consent forms and counselling?”

Good questions. Some years ago, I was in Chennai visiting the facilities of an NGO that provided medical treatment — much of it free — to poor HIV positive patients. The NGO’s director freely admitted that many new drug trials were being conducted at her institute. All the patients, she pointed out, were given counselling and trails were conducted only after their consent had been obtained.

But to a poor man or woman who had been served a death warrant, the promise of a breakthrough by a new drug is too powerful to resist. Especially, when he or she cannot afford expensive anti-retroviral drugs required for the treament of HIV/AIDS

Verma said the hospital did not provide information on the incomes of the families in the infant trials.

Incidentally, a clinical trial conducted in India costs 40 to 60 per cent less than what it would in a developed country. According to consulting firm, Ernst & Young the outsourced clinical research market in India could grow to two billion dollars by 2010.

Ramadoss has promised legislation and regulation of these trials. But given India’s desperately poor population and the numbers that simply cannot afford treatment and medication, there are serious concerns and questions about the practice and ethics of clinical trials in this country.

What do you think?

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